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[null,null,"This Excel workbook contains the Evidence Map on \nPRO tools assessing Head, Neck and Back Pain"]
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[]
[]
[null,null,"How this Evidence Map was generated"]
[null,null,"We searched heoro.com on the 8th January 2018 using the PRO tool filter"]
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[null,null,"The search identified a total of 421 relevant abstracts published since 1960, which were segmented with the following standard heoro.com fields:"]
[null,null,null,"Locations - the geographical setting of the study, or, where this is unknown, the authors' location."]
[null,null,null,"Disease - the type of disease included in the study if any"]
[null,null,null,"Interventions - the interventions evaluated in the study, if any"]
[null,null,null,"PRO tools - the PRO intruments that were cited in the title or abstract."]
[null,null,null,"Study methodology - the type of study that was conducted, e.g. clinical trial, systematic review, tool validation"]
[null,null,null,"Subpopulation - whether the study assessed patients, caregivers, the general public or healthcare professionals (HCPs)"]
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[null,null,"In addition the following publication date segmentations are used:"]
[null,null,null,"1960 to 1990, 1991 to 1995, 1996 to 1999, 2000 to 2004, 2005 to 2009, 2010 to 2014, 2015 to 2017"]
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[null,null,"All data in this Evidence Map is taken from the heoro.com database"]
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[null,null,"Details of the PubMed search strategy used to populate the heoro.com database can be found here."]
[]
[null,null,"Contact us:"]
[null,null,"Address: Crystallise Ltd. Unit 21, Thames Enterpise Centre, Thames Industrial Park, East Tilbury, Essex, UK RM18 8RH"]
[null,null,"Tel: +44 (0)1375 488020"]
[null,null,"Email: alison.martin@crystallise.com"]

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[{"$f":"COUNT(A2:A988)","v":421},"Full citation","DOI","Authors","Title","Abstract","Citation","Locations","Year","Diseases","Interventions","PROtools","Subpopulations","Study types","Study methodologies","LocationsTags","SubpopulationsTags","DiseaseTags","InterventionsTags","StudytypesTags","StudyMethodologyTags","PROtoolTags","DateBand","C1","C2","C3","C4","C5"]
[1,"Abbott,A. D.,et al. (2011). \"Patients' experience post-lumbar fusion regarding back problems,recovery and expectations in terms of the International Classification of Functioning,Disability and Health.\" Disabil Rehabil 33(15-16): 1399-1408.",null,"Abbott,A. D.,et al.","Patients' experience post-lumbar fusion regarding back problems,recovery and expectations in terms of the International Classification of Functioning,Disability and Health","PURPOSE: To describe within the context of the International Classification of Functioning,Disability and Health (ICF),patient's experiences post-lumber fusion regarding back problems,recovery and expectations of rehabilitation and to contrast with the content of outcome measures and the ICF low back pain (LBP) core sets. METHODS: The study has a cross-sectional and retrospective design and involves 20 lumbar fusion patients. Using the ICF,qualitative content analysis of semi-structured interviews 3-6 months post-surgery was performed. This was compared with the ICF related content of the Oswestry Disability Index (ODI),Medical Outcome Study Short Form 36 (SF-36),European Quality of Life Questionnaire (EQ5D) and the ICF LBP core sets. RESULTS: Patient's experiences were most frequently linked to psychological,sensory,neuromusculoskeletal and movement related body function chapters of the ICF. The most frequently linked categories of activity and participation were mobility,domestic activities,family relationships,work,recreation and leisure. Environmental factors frequently linked were the use of analgesics,walking aids,family support,social security systems,health care systems and labour market employment services. CONCLUSIONS: This study highlights important ICF related aspects of patient's experiences post-lumber fusion. The use of the comprehensive ICF core sets is recommended in conjunction with ODI,SF-36 and the EQ5D for a broader analysis of patient outcomes post-lumbar fusion."," Disabil Rehabil 33(15-16): 1399-1408.","Sweden",2011,"Back Pain","Surgical","ODI,ICF","Unknown","PRO study","Observational"]
[2,"Abenstein,J. P. (2009). \"Is BIS monitoring cost-effective?\" Conf Proc IEEE Eng Med Biol Soc 2009: 7041-7044.",null,"Abenstein,J. P.","Is BIS monitoring cost-effective?","BIS monitoring is a processed electroencephalogram (EEG) technology that is designed to follow the effects that anesthetics and sedatives have on cerebral function. Much is know about the technology,it's utility and limitations. The economic case for widespread utilization of this technology is weak. There appears to be little opportunity to decrease health care cost by either reduction of drug costs or improved practice efficiency. General use of BIS monitoring to reduce the incidence of intraoperative recall (IR) would cost about USD 10,000 to 25,000 per avoided IR. Total cost to the heath care system would approach one billion US dollars per year,just for use during general anesthetics. More appropriate use of already available drugs and technology would most likely decrease the incidence of IR as effectively,although individual patients who are at high risk for IR may benefit from this technology. However,based on current health care economic standards general use of BIS monitoring does not seem warranted and appears not to be cost-effective."," Conf Proc IEEE Eng Med Biol Soc 2009: 7041-7044.","USA",2009,"Unspecified","Surgical","BIS","Unknown","Cost-Effectiveness","Narrative review"]
[3,"Abudou,M.,et al. (2013). \"Surgical versus non-surgical treatment for thoracolumbar burst fractures without neurological deficit.\" Cochrane Database Syst Rev(6): Cd005079.",null,"Abudou,M.,et al.","Surgical versus non-surgical treatment for thoracolumbar burst fractures without neurological deficit","BACKGROUND: Spinal burst fractures result from the failure of both the anterior and the middle columns of the spine under axial compression loads. Conservative management is through bed rest and immobilisation once the acute symptoms have settled. Surgical treatment involves either anterior or posterior stabilisation of the fracture,sometimes with decompression involving the removal of bone fragments that have intruded into the vertebral canal. This is an update of a review first published in 2006. OBJECTIVES: To compare the outcomes of surgical with non-surgical treatment for thoracolumbar burst fractures without neurological deficit. SEARCH METHODS: We searched the Cochrane Bone,Joint and Muscle Trauma Group Specialised Register (October 2012),the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012,Issue 8),MEDLINE (1946 to October 2012),EMBASE (1980 to October 2012) and the Chinese Biomedical Literature Database (1978 to October 2012). We also searched trial registers and reference lists of articles. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials comparing surgical with non-surgical treatment of thoracolumbar burst fractures without neurological deficit. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed risk of bias and extracted data independently. Only limited pooling of data was done. MAIN RESULTS: We included two trials that compared surgical with non-surgical treatment for patients with thoracolumbar burst fractures without neurological deficit. These recruited a total of 87 participants and reported outcomes for 79 participants at follow-up of two years or more. Both trials were judged at unclear risk of selection bias and at high risk of performance and detection biases,resulting from lack of blinding.The two trials reported contrasting results for pain and function-related outcomes at final follow-up,and numbers returning to work. One trial found less pain (mean difference (MD) -15.09 mm,95% CI -27.81 to -2.37; 100 mm visual analogue scale),and better function based on the Roland and Morris disability questionnaire results (MD -5.87,95% CI -10.10 to -1.64; 24 points = maximum disability) in the surgical group. Based on the same outcome measures,the other trial found the surgical group had more pain (MD 13.60 mm,95% CI -0.31 to 27.51) and worse function (MD 4.31,95% CI 0.54 to 8.08). Neither trial reported a statistically significant difference in return to work. There were greater numbers of participants with complications in the surgical group of both trials (21/41 versus 6/38; RR 2.85,95% CI 0.83 to 9.75; 2 trials),and only participants of this group had subsequent surgery,involving implant removal either for complications or as a matter of course. One trial reported that surgery was over four times more costly than non-surgical treatment. AUTHORS' CONCLUSIONS: The contradictory evidence provided by two small and potentially biased randomised controlled trials is insufficient to conclude whether surgical or non-surgical treatment yields superior pain and functional outcomes for people with thoracolumbar burst fractures without neurological deficit. It is likely,however,that surgery is associated with more early complications and the need for subsequent surgery,as well as greater initial healthcare costs."," Cochrane Database Syst Rev(6): Cd005079.","China",2013,"Trauma","Surgical","RMDQ","Unknown","PRO study","Systematic review"]
[4,"Adobor,R. D.,et al. (2010). \"Repeatability,reliability,and concurrent validity of the scoliosis research society-22 questionnaire and EuroQol in patients with adolescent idiopathic scoliosis.\" Spine (Phila Pa 1976) 35(2): 206-209.",null,"Adobor,R. D.,et al.","Repeatability,reliability,and concurrent validity of the scoliosis research society-22 questionnaire and EuroQol in patients with adolescent idiopathic scoliosis","STUDY DESIGN: Cross-sectional study in patients with adolescent idiopathic scoliosis (AIS). OBJECTIVES: To evaluate the repeatability,reliability,internal consistency,and concurrent validity (CD) of an adapted Norwegian version of the Scoliosis Research Society 22 questionnaire (SRS-22) and the generic health-related quality of life instrument EuroQol (EQ-5D and EQ-VAS). SUMMARY OF BACKGROUND DATA: SRS-22 is widely used for evaluation of health-related quality of life in AIS. Its repeatability,which is essential for use in follow-up studies,and CD with EuroQol which can be used for cost-utility analysis,has not yet been assessed. METHODS: The forward-backward translation of the English version of the SRS-22 was performed according to guidelines for cross-cultural adaptation of outcome questionnaires. Fifty-seven patients of various ages with AIS and deformity severity filled out standardized questionnaires: SRS-22,EQ-5D,and EQ-VAS,each twice in a 2-week interval. The study was approved by the Regional Ethics Committee for Medical Research in Norway. RESULTS: There were no floor or ceiling effects on the score distributions. The study demonstrated moderate internal consistency and high reliability of SRS-22 questionnaire with Chronbach alpha and intraclass correlation coefficiency ranging from 0.76 to 0.93 for the 5 domains. Repeatability was excellent for all SRS-22 domains with repeatability coefficients <1. CD with EQ-5D was poor to moderate with Pearson's r ranging from 0.14 to 0.58. However,total scores of the 2 instruments showed satisfactory agreement. CONCLUSION: The SRS-22 outcome instrument has satisfactory repeatability,but CD with EQ-5D suggests that the disease-specific and the generic questionnaire measure different constructs."," Spine (Phila Pa 1976) 35(2): 206-209.","Norway",2010,"Spinal Deformity","Not Specified","SRS-HRQOL","Adolescents","Tool Validation","Observational"]
[5,"Adogwa,O.,et al. (2016). \"Pretreatment of Anxiety Before Cervical Spine Surgery Improves Clinical Outcomes: A Prospective,Single-Institution Experience.\" World Neurosurg 88: 625-630.",null,"Adogwa,O.,et al.","Pretreatment of Anxiety Before Cervical Spine Surgery Improves Clinical Outcomes: A Prospective,Single-Institution Experience","BACKGROUND: Affective disorders such as depression and anxiety have been shown to contribute to inferior outcomes after spine surgery. A high baseline level of anxiety is associated with refractory postoperative pain and patient dissatisfaction with surgery. The aim of this prospective study is to assess whether the pretreatment of anxiety before spine surgery improves patient reported outcomes 1-year after an anterior cervical discectomy and fusion (ACDF) procedure. METHODS: A total of 27 adult patients with a known history of anxiety disorder (pretreated cohort: 11 patients,control cohort: 16 patients) undergoing ACDF at Duke University Medical Center were included in this study. All patients were diagnosed with an anxiety disorder at least 6 months before surgery by a board-certified psychiatrist. Enrollment criteria included available demographic,surgical,and clinical outcomes data. All patients had prospectively collected patient reported outcomes measures and a minimum 1-year follow-up. Patients completed the Neck Disability Index (NDI),Short-Form 12 (SF-12),and visual analog scale (VAS) before surgery then at 6 weeks,and 3,6,and 12 months after surgery. Clinical outcomes and complication rates were compared between both patient cohorts. RESULTS: Baseline characteristics were similar between both cohorts. At baseline,there were no significant differences between cohorts in NDI (P = 0.11),SF-12 PCS (P = 0.63),SF-12 MCS (P = 0.90),and VAS neck pain (P = 0.80). There was no nerve root injury or incidental durotomy in either cohort. At 6 months after surgery,patients in the pretreated cohort reported significantly lower postoperative pain compared to the control cohort (P = 0.01). These results were durable through 1 year (P = 0.02). At 1 year,patients who were pretreated for anxiety before surgery reported significantly lower postoperative neck pain scores compared with the control cohort (P = 0.02). CONCLUSION: Our study demonstrates that pretreatment of anxiety before cervical spine surgery results in a significant reduction in postoperative neck pain scores and may be a viable management strategy for patients with coexisting affective disorders and cervical spine pathology. Patients awaiting spine surgery should routinely be assessed for anxiety before surgery,and interventions to reduce and treat anxiety should be provided."," World Neurosurg 88: 625-630.","USA",2016,"Neck Pain","Surgical","NDI","Unknown","PRO study","Prospective Observation"]
[6,"Alanay,A.,et al. (2005). \"Reliability and validity of adapted Turkish Version of Scoliosis Research Society-22 (SRS-22) questionnaire.\" Spine (Phila Pa 1976) 30(21): 2464-2468.",null,"Alanay,A.,et al.","Reliability and validity of adapted Turkish Version of Scoliosis Research Society-22 (SRS-22) questionnaire","STUDY DESIGN: Outcome study to determine the internal consistency,and validity of adapted Turkish version of Scoliosis Research Society-22 (SRS-22) Instrument. OBJECTIVES: To evaluate the validity and reliability of adapted Turkish Version of SRS-22 questionnaire. SUMMARY OF BACKGROUND DATA: The SRS-22 questionnaire is a widely accepted questionnaire to assess the health-related quality of life for scoliotic patients in the United States. However,its adaptation in languages other than the source language is necessary for its multinational use. METHODS: Translation/retranslation of the English version of the SRS-22 was done,and all steps for cross-cultural adaptation process were performed properly by an expert committee. Later,SRS-22 questionnaires and previously validated Short Form-36 (SF-36) outcome instruments were mailed to 82 patients who had been surgically treated for idiopathic scoliosis. All patients had a minimum of 2 years follow-up. Fifty-four patients (66%) responded to the first set of questionnaires. Forty-seven of the first time respondents returned their second survey. The average age of the 47 patients (12 male,35 female) was 19.8 years (range,14-31 years). The two measures of reliability as internal consistency and reproducibility were determined by Cronbach alpha statistics and intraclass correlation coefficient,respectively. Concurrent validity was measured by comparing with an already validated questionnaire (SF-36). Measurement was made using the Pearson correlation coefficient (r). RESULTS: The study demonstrated satisfactory internal consistency with high Cronbach alpha values for the four of the corresponding domains (pain,0.72; self-image,0.80; mental health,0.72; and satisfaction,0.83). However,the Cronbach alpha value for function/activity domain (0.48) was considerably lower than the original questionnaire. The intraclass correlation coefficient for the same domains was 0.80,0.82,0.78,0.81,and 0.76,respectively,demonstrating a satisfactory test/retest reproducibility. Considering concurrent validity,two domains had excellent correlation (r = 0.75-1),while 9 had good correlation (r = 0.50 to 0.75),and 6 had moderate correlation (r =0.25-0.50). Based on these results,question 18 in the function/activity domain with lower Cronbach alpha value was revised while question 15 was excluded. The revised SRS-22 was given to 30 adolescent idiopathic scoliosis patients not included in the index study. The revision could improve the Cronbach alpha value for function/activity domain from 0.48 to 0.81. CONCLUSION: This study demonstrated that,if measures are to be used across cultures,the items must not only be translated well linguistically but also must be culturally adapted to maintain the content validity of the instrument at a conceptual level across different cultures. This may necessitate several validation studies to ensure and improve consistency in the content and face validity between source and target versions of a questionnaire due to difficulty in detecting subtle differences in the living habits of different cultures."," Spine (Phila Pa 1976) 30(21): 2464-2468.","Turkey",2005,"Spinal Deformity","Surgical","SRS-HRQOL","Adults,Adolescents","Tool Validation","Observational"]
[7,"Albaladejo,C.,et al. (2010). \"The efficacy of a short education program and a short physiotherapy program for treating low back pain in primary care: a cluster randomized trial.\" Spine (Phila Pa 1976) 35(5): 483-496.",null,"Albaladejo,C.,et al.","The efficacy of a short education program and a short physiotherapy program for treating low back pain in primary care: a cluster randomized trial","STUDY DESIGN: Cluster randomized clinical trial. OBJECTIVE: To assess the efficacy of a short education program and short physiotherapy program for treating low back pain (LBP) in primary care. SUMMARY OF BACKGROUND DATA: There is sparse evidence on the effectiveness of education and physiotherapy programs that are short enough to be feasible in primary care. METHODS: Sixty-nine primary care physicians were randomly assigned to 3 groups and recruited 348 patients consulting for LBP; 265 (79.8%) were chronic. All patients received usual care,were given a booklet and received a consistent 15 minutes group talk on health education,which focused on healthy nutrition habits in the control group,and on active management for LBP in the \"education\" and \"education + physiotherapy\" groups. Additionally,in the \"education + physiotherapy\" group,patients were given a second booklet and a 15-minute group talk on postural hygiene,and 4 one-hour physiotherapy sessions of exercise and stretching which they were encouraged to keep practicing at home. The main outcome measure was improvement of LBP-related disability at 6 months. Patients' assessment and data analyses were blinded. RESULTS: During the 6-month follow-up period,improvement in the \"control\" group was negligible. Additional improvement in the \"education\" and \"education + physiotherapy\" groups was found for disability (2.0 and 2.2 Roland Morris Questionnaire points,respectively),LBP (1.8 and 2.10 Visual Analogue Scale points),referred pain (1.3 and 1.6 Visual Analogue Scale points),catastrophizing (1.6 and 1.8 Coping Strategies Questionnaire points),physical quality of life (2.9 and 2.9 SF-12 points),and mental quality of life (3.7 and 5.1 SF-12 points). CONCLUSION: The addition of a short education program on active management to usual care in primary care leads to small but consistent improvements in disability,pain,and quality of life. The addition of a short physiotherapy program composed of education on postural hygiene and exercise intended to be continued at home,increases those improvements,although the magnitude of that increase is clinically irrelevant."," Spine (Phila Pa 1976) 35(5): 483-496.","Spain",2010,"Back Pain","Education,Physical Therapy","RMDQ","Adults,Adolescents","PRO study","Clinical trial"]
[8,"Alcantara,J.,et al. (2015). \"The use of validated outcome measures in the chiropractic care of pregnant patients: A systematic review of the literature.\" Complement Ther Clin Pract 21(2): 131-136.",null,"Alcantara,J.,et al.","The use of validated outcome measures in the chiropractic care of pregnant patients: A systematic review of the literature","BACKGROUND: Healthcare systems recognize the need to incorporate patient-reported outcomes as part of their clinical and research measures. We performed this review on the use of validated outcome measures in the chiropractic care of pregnant patients. METHODS: Pubmed,CINAHL,Medline,Index to Chiropractic Literature and MANTIS were searched for (1999) primary investigation reports (i.e.,case reports,case series,case control,randomized controlled trials and survey or surveillance studies) published in English; (2) involving the care of pregnant patient(s) and (3) utilizing a valid outcome measure. RESULTS: Our review found 8 articles using the Patient's Global Impression of Change,the NRS,the Oswestry,Bournemouth,Fear Avoidance Belief and Quebec Disability questionnaires,PROMIS-29 and the Measure Yourself Medical Outcome Profile. CONCLUSION: Despite their heterogeneity and inconsistency of use in the studies reviewed,our findings demonstrate some measure of effectiveness in the chiropractic care of pregnant patients."," Complement Ther Clin Pract 21(2): 131-136.","USA,Canada,Philippines",2015,"Unspecified","Chiropractic","ODI,NRS,BOURNEMOUTH,QBPD","Unknown","PRO study","Systematic review"]
[9,"Allison,D. J.,et al. (2016). \"Targeting inflammation as a treatment modality for neuropathic pain in spinal cord injury: a randomized clinical trial.\" J Neuroinflammation 13(1999): 152.",null,"Allison,D. J.,et al.","Targeting inflammation as a treatment modality for neuropathic pain in spinal cord injury: a randomized clinical trial","BACKGROUND: The purpose of the present study was to examine the effectiveness of an anti-inflammatory intervention as a treatment for neuropathic pain following spinal cord injury (SCI). METHODS: This randomized,parallel-group,controlled clinical trial (NCT02099890) examined 20 participants with varying levels and severities of SCI,randomized (3:2) to either a 12-week anti-inflammatory diet,or control group. Outcome measures consisted of self-determined indices of pain as assessed using the neuropathic pain questionnaire (NPQ) and markers of inflammation as assessed by various pro- and anti-inflammatory cytokines,as well as the eicosanoids PGE2 and LTB4. RESULTS: A significant group x time interaction was found for sensory pain scores (p < 0.01). A Mann-Whitney test revealed that the change scores (3-month baseline) were significantly different between groups for IFN-y (U = 13.0,p = 0.01),IL-1beta (U = 14.0,p = 0.01),and IL-2 (U = 12.0,p = 0.01). A Friedman test revealed the treatment group had a significant reduction in IFN-y (x (2) = 8.67,p = 0.01),IL-1beta (x (2) = 17.78,p < 0.01),IL-6 (x (2) = 6.17,p < 0.05),while the control group showed no significant change in any inflammatory mediator. A stepwise backward elimination multiple regression analysis showed that the change in sensory neuropathic pain was a function of the change in the proinflammatory cytokines IL-2 and IFN-y,as well as the eicosanoid PGE2 (R = 0.689,R (2) = 0.474). CONCLUSIONS: Overall,the results of the study demonstrate the efficacy of targeting inflammation as a means of treating neuropathic pain in SCI,with a potential mechanism relating to the reduction in proinflammatory cytokines and PGE2. TRIAL REGISTRATION: ClinicalTrials.gov,NCT02099890."," J Neuroinflammation 13(1999): 152.","Canada",2016,"Neuropathic Pain","Not Specified","NPDIQ","Unknown","PRO study","RCT"]
[10,"Al-Smadi,J.,et al. (2003). \"A pilot investigation of the hypoalgesic effects of transcutaneous electrical nerve stimulation upon low back pain in people with multiple sclerosis.\" Clin Rehabil 17(7): 742-749.",null,"Al-Smadi,J.,et al.","A pilot investigation of the hypoalgesic effects of transcutaneous electrical nerve stimulation upon low back pain in people with multiple sclerosis","OBJECTIVE: To investigate the hypoalgesic effects of transcutaneous electrical nerve stimulation (TENS) upon low back pain (LBP) in people with multiple sclerosis (MS). DESIGN: A randomized double-blind placebo controlled clinical pilot study. SUBJECTS AND SETTING: Fifteen people with MS were recruited and randomly allocated to one of the following groups under double blind conditions (n = 5 per group): TENS 1 (4 Hz,200 micros),TENS 2 (110 Hz,200 micros),placebo TENS. INTERVENTIONS: Treatment was applied for 45 minutes three times a week for six weeks with a four-week follow-up. OUTCOME MEASURES: The following outcome measures were taken at weeks 1,6,and 10: visual analogue scale (VAS) (for current LBP,right leg pain,left leg pain); Leeds Multiple Sclerosis Quality of Life Questionnaire; Roland Morris Disability Questionnaire; Short Form-36 (SF-36) Version 1; and the McGill Pain Questionnaire (MPQ). VAS for current LBP,right and left leg pain were also taken before and after treatment,and once a week during the follow-up period. RESULTS: Analysis showed no statistically significant effects for any of the data. However,both active treatment groups showed a trend of improvement in the majority of the outcome measures. CONCLUSION: Active TENS was more effective than placebo TENS in decreasing VAS scores following each treatment although results were not statistically significant. Further work in this area is warranted and should include a larger number of participants in the form of a randomized controlled clinical trial to determine the efficacy of this modality."," Clin Rehabil 17(7): 742-749.","Ireland",2003,"Back Pain","Physical Therapy","RMDQ","Unknown","PRO study","RCT"]
[11,"Ament,J. D.,et al. (2014). \"Cost-effectiveness of cervical total disc replacement vs fusion for the treatment of 2-level symptomatic degenerative disc disease.\" JAMA Surg 149(12): 1231-1239.",null,"Ament,J. D.,et al.","Cost-effectiveness of cervical total disc replacement vs fusion for the treatment of 2-level symptomatic degenerative disc disease","IMPORTANCE: Cervical total disc replacement (CTDR) was developed to treat cervical spondylosis,while preserving motion. While anterior cervical discectomy and fusion (ACDF) has been the standard of care for 2-level disease,a randomized clinical trial (RCT) suggested similar outcomes. Cost-effectiveness of this intervention has never been elucidated. OBJECTIVE: To determine the cost-effectiveness of CTDR compared with ACDF. DESIGN,SETTING,AND PARTICIPANTS: Data were derived from an RCT that followed up 330 patients over 24 months. The original RCT consisted of multi-institutional data including private and academic institutions. Using linear regression for the current study,health states were constructed based on the stratification of the Neck Disability Index and a visual analog scale. Data from the 12-item Short-Form Health Survey questionnaires were transformed into utilities values using the SF-6D mapping algorithm. Costs were calculated by extracting Diagnosis-Related Group codes from institutional billing data and then applying 2012 Medicare reimbursement rates. The costs of complications and return-to-work data were also calculated. A Markov model was built to evaluate quality-adjusted life-years (QALYs) for both treatment groups. The model adopted a third-party payer perspective and applied a 3% annual discount rate. Patients included in the original RCT had to be diagnosed as having radiculopathy or myeloradiculopathy at 2 contiguous levels from C3-C7 that was unresponsive to conservative treatment for at least 6 weeks or demonstrated progressive symptoms. MAIN OUTCOMES AND MEASURES: Incremental cost-effectiveness ratio of CTDR compared with ACDF. RESULTS: A strong correlation (R2 = 0.6864; P < .001) was found by projecting a visual analog scale onto the Neck Disability Index. Cervical total disc replacement had an average of 1.58 QALYs after 24 months compared with 1.50 QALYs for ACDF recipients. Cervical total disc replacement was associated with $2139 greater average cost. The incremental cost-effectiveness ratio of CTDR compared with ACDF was $24,594 per QALY at 2 years. Despite varying input parameters in the sensitivity analysis,the incremental cost-effectiveness ratio value stays below the threshold of $50,000 per QALY in most scenarios (range,-$58,194 to $147,862 per QALY). CONCLUSIONS AND RELEVANCE: The incremental cost-effectiveness ratio of CTDR compared with traditional ACDF is lower than the commonly accepted threshold of $50,000 per QALY. This remains true with varying input parameters in a robust sensitivity analysis,reaffirming the stability of the model and the sustainability of this intervention."," JAMA Surg 149(12): 1231-1239.","USA",2014,"Spondylosis","Surgical","NDI","Adults","Cost-Effectiveness","RCT"]
[12,"Ament,J. D.,et al. (2015). \"A Novel Quality-of-Life Utility Index in Patients With Multilevel Cervical Degenerative Disc Disease: Comparison of Anterior Cervical Discectomy and Fusion With Total Disc Replacement.\" Spine (Phila Pa 1976) 40(14): 1072-1078.",null,"Ament,J. D.,et al.","A Novel Quality-of-Life Utility Index in Patients With Multilevel Cervical Degenerative Disc Disease: Comparison of Anterior Cervical Discectomy and Fusion With Total Disc Replacement","STUDY DESIGN: Decision analysis from prior randomized controlled trial (RCT) data. OBJECTIVE: To describe the importance of developing baseline utility indices while identifying effective treatment options for cervical spine disease. SUMMARY OF BACKGROUND DATA: Cervical total disc replacement (CTDR) was developed to treat cervical spondylosis while preserving motion. Although anterior cervical discectomy and fusion (ACDF) has been the standard of care,a recent RCT suggested similar outcomes for 2-level disease. The quality-of-life benefit afforded by both CTDR and ACDF has never been fully elucidated. The purpose of our investigation was to better define the changes in utility and perceived value for patients undergoing these procedures. METHODS: Data were derived from LDR's RCT comparing CTDR and ACDF for 2-level cervical disc disease. Using linear regression,we constructed health states on the basis of the stratification of clinical outcomes used in the RCT,namely,neck disability index and visual analogue scale. Data from SF-12 questionnaires,completed preoperatively and at each follow-up visit,were transformed into utilities using the SF-6D mapping algorithm. SAS v.9.3 was used for the analyses. RESULTS: A strong correlation (R = 0.6864,P < 0.0001) was found between neck disability index and visual analogue scale. We constructed 5 distinct health states by projecting neck disability index intervals onto visual analogue scale. A poorer health state was associated with a lower mean utility value whereas a higher health state was associated with a higher mean utility value (P < 0.0001). The difference in preoperative utility between 2-level ACDF and CTDR was not significant (P = 0.1982),and yet,the difference in the postoperative utility between the cohorts was significant (P < 0.05) at every time point collected from 6 to 60 months. CONCLUSION: This is the first instance in which distinct utility values have been derived for validated health states related to cervical spine disease. There is substantial potential for these to become baseline future indices for cost-utility analyses in similar populations. LEVEL OF EVIDENCE: 1."," Spine (Phila Pa 1976) 40(14): 1072-1078.","Israel",2015,"Spondylosis","Surgical","NDI","Unknown","Tool Validation","Observational"]
[13,"Amorim,C. S.,et al. (2014). \"Effectiveness of global postural reeducation compared to segmental exercises on function,pain,and quality of life of patients with scapular dyskinesis associated with neck pain: a preliminary clinical trial.\" J Manipulative Physiol Ther 37(6): 441-447.",null,"Amorim,C. S.,et al.","Effectiveness of global postural reeducation compared to segmental exercises on function,pain,and quality of life of patients with scapular dyskinesis associated with neck pain: a preliminary clinical trial","OBJECTIVE: The purpose of this study was to assess the effectiveness of global postural reeducation (GPR) relative to segmental exercises (SE) in the treatment of scapular dyskinesis (SD) associated with neck pain. METHODS: Participants with SD and neck pain (n = 30) aged 18 to 65 years were randomly assigned to one of two groups: GPR and SE (stretching exercises). The upper extremity was assessed using the Disabilities of the Arm,Shoulder,and Hand questionnaire; function of the neck was estimated using the Neck Disability Index; pain severity was measured using a visual analogical scale; and health-related quality of life was assessed using the Short Form-12. Assessments were conducted at baseline and after 10 weekly sessions (60 minutes each). The significance level adopted was alpha < .05. RESULTS: For pre-post treatment comparisons,GPR was significantly associated with improvements in function of neck and upper extremities,pain,and physical and mental domains of quality of life (P < .05). Segmental exercises improved function of upper extremities and of the neck and severity of pain (P < .05). When contrasting groups,GPR was significantly superior to SE in improving pain and physical domains of the quality of life. CONCLUSION: This study showed that GPR and SE had similar effects on function of the neck and upper extremity in patients with SD associated with neck pain. When comparing groups,GPR was superior to SE in improving pain and quality of life."," J Manipulative Physiol Ther 37(6): 441-447.","Brazil",2014,"Neck Pain","Physical Therapy","NDI","Adults","PRO study","Clinical trial"]
[14,"Amr,Y. M. (2011). \"Effect of addition of epidural ketamine to steroid in lumbar radiculitis: one-year follow-up.\" Pain Physician 14(5): 475-481.",null,"Amr,Y. M.","Effect of addition of epidural ketamine to steroid in lumbar radiculitis: one-year follow-up","BACKGROUND: Treating sciatica with epidural steroid injection has been a common practice worldwide. N-methyl-D-aspartate (NMDA) receptors are an important component of pain pathways. OBJECTIVES: The aim of this study was to evaluate the safety and efficacy of epidurally administered NMDA receptor antagonists (ketamine) for the treatment of chronic low back pain secondary to radiculopathy and its effect on patients' quality of life. STUDY DESIGN: Randomized,double blind controlled trial. SETTING: Hospital outpatient setting. METHODS: Two hundred participants aged 25 to 50 years old with a diagnosis of lumbar radiculopathic pain secondary to disc herniation were randomized into 2 equal groups. Group I received 80 mg of triamcinolone (2 mL) and 0.25% bupivacaine (3 mL) plus 30 mg (3 mL) of preservative free ketamine. Group II received 80 mg of triamcinolone (2 mL) and 0.25% bupivacaine (3 mL) plus 3 mL of 0.9% saline. Pain scores were obtained before injection,immediately after injection,one week,one month,3 months,6 months,9 months and one year post injection. The Oswestry Low Back Pain Disability Questionnaire was used at baseline and at one month,3,6,9,and 12 months after injection for assessment of quality of life. Patients were asked to report any side effects,particularly those related to ketamine,including nausea,vomiting,visual or auditory hallucinations,and delirium. RESULTS: Immediately after injection there was no statistically significant difference between Group I and II regarding pain scale scores. After one week of injection,pain relief was significantly better in Group I compared to Group II and then at all evaluation times. The Oswestry Low Back Pain Disability Questionnaire score decreased significantly (P < 0.05) from 72 (range 62- 83) and 70 (range 57- 82) to 8 (range 2 - 12) and 17 (range 9 - 27) at one month; 6 (range 4 - 12) and 18 (range 14 - 22) at 3 months; 12 (range 9 - 16) and 28 (range 22 - 34) at 6 months; 17 (range 9 - 24) and 31 (range 21 - 35) at 9 months; and 17 (range 8 - 22) and 33 (range 20 - 37) at 12 months in the groups,respectively. Six patients in the ketamine group showed short-lasting delusions lasting for 45 +/- 12 minutes after injection. LIMITATIONS: The limitations include a lack of placebo control. CONCLUSION: Epidurally administrated ketamine seems to be a safe and useful adjunct to epidural corticosteroid therapy in chronic lumbar radicular pain."," Pain Physician 14(5): 475-481.","Egypt",2011,"Back Pain,Degenerative Disk Disease","Ketamine","ODI","Adults","PRO study","Clinical trial"]
[15,"Armaghani,S. J.,et al. (2016). \"Diabetes Is Related to Worse Patient-Reported Outcomes at Two Years Following Spine Surgery.\" J Bone Joint Surg Am 98(1999): 15-22.",null,"Armaghani,S. J.,et al.","Diabetes Is Related to Worse Patient-Reported Outcomes at Two Years Following Spine Surgery","BACKGROUND: Diabetes has been associated with poor outcomes following elective spine surgery. The purpose of our study was to determine if diabetes predicts worse patient-reported outcomes at two years postoperatively and to evaluate the effect of perioperative blood glucose levels and control on patient-reported outcomes in patients with diabetes. METHODS: One thousand and five patients undergoing elective spine surgery were included in this prospective cohort study. The presence of diabetes and baseline and one and two-year patient-reported outcomes (Short Form-12 [SF-12],EuroQol-5D [EQ-5D],Oswestry Disability Index [ODI] or Neck Disability Index [NDI],and Numeric Rating Scale [NRS] pain scores) were recorded. The mean blood glucose measurements in patients with diabetes were collected during the postoperative period. Multivariable linear regression analyses were performed to determine predictors of one and two-year outcomes as well as the relationship between perioperative blood glucose and patient-reported outcomes in patients with diabetes. RESULTS: Four hundred and thirty-four patients (43%) had diabetes. When compared with patients without diabetes at two years,patients with diabetes had lower SF-12 Physical Component Summary scores (34.4 points for the diabetic group compared with 38.6 points for the non-diabetic group),lower EQ-5D scores (0.67 for the diabetic group compared with 0.74 for the non-diabetic group),higher ODI or NDI scores (32.1 points for the diabetic group compared with 26.8 points for the non-diabetic group),and higher NRS scores (5.1 points for the diabetic group compared with 4.3 points for the non-diabetic group) (p < 0.05 for all). Although patients with diabetes improved significantly over time,they did not improve to the extent that patients without diabetes did in the ODI or NDI and EQ-5D scores (p < 0.05). Diabetes and preoperative opioid use were independent predictors of decreased SF-12 scores,decreased EQ-5D scores,increased ODI or NDI scores,and increased NRS scores (p < 0.05). Diabetes was associated with increased ODI or NDI (by 6.6 points) and decreased EQ-5D (by 0.1) at two years. Perioperative blood glucose control did not predict outcomes at either one or two years in patients with diabetes. CONCLUSIONS: Diabetes was associated with worse patient-reported outcomes when patients with diabetes were compared with patients without diabetes at two years following elective spine surgery. Although patients with diabetes improved when compared from baseline to the time following elective spine surgery,they did not improve to the same extent as patients without diabetes in the ODI or NDI and EQ-5D scores. Providers may use this information to counsel patients with diabetes on expectations following spine surgery."," J Bone Joint Surg Am 98(1999): 15-22.","USA",2016,"Diabetes","Surgical","ODI,NDI","Unknown","PRO study","Prospective Observation"]
[16,"Arnold,P. M.,et al. (2014). \"Mild diabetes is not a contraindication for surgical decompression in cervical spondylotic myelopathy: results of the AOSpine North America multicenter prospective study (CSM).\" Spine J 14(1999): 65-72.",null,"Arnold,P. M.,et al.","Mild diabetes is not a contraindication for surgical decompression in cervical spondylotic myelopathy: results of the AOSpine North America multicenter prospective study (CSM)","BACKGROUND CONTEXT: Cervical spondylotic myelopathy (CSM) is a chronic spinal cord disease and can lead to progressive or stepwise neurologic decline. Several factors may influence this process,including extent of spinal cord compression,duration of symptoms,and medical comorbidities. Diabetes is a systemic disease that can impact multiple organ systems,including the central and peripheral nervous systems. There has been little information regarding the effect of diabetes on patients with coexistent CSM. PURPOSE: To provide empirical data regarding the effect of diabetes on treatment outcomes in patients who underwent surgical decompression for coexistent CSM. STUDY DESIGN/SETTING: Large prospective multicenter cohort study of patients with and without diabetes who underwent decompressive surgery for CSM. PATIENT SAMPLE: Two hundred thirty-six patients without and 42 patients with diabetes were enrolled. Of these,37 were mild cases and five were moderate cases. Four required insulin. There were no severe cases associated with end-organ damage. OUTCOME MEASURES: Self-report measures include Neck Disability Index and version 2 of 36-Item Short Form Health Survey (SF-36v2),and functional measures include modified Japanese Orthopedic Association (mJOA) score and Nurick grade. METHODS: We compared presurgery symptoms and treatment outcomes between patients with and without diabetes using univariate and multivariate models,adjusting for demographics and comorbidities. RESULTS: Diabetic patients were older,less likely to smoke,and more likely to be on social security disability insurance. Patients with diabetes presented with a worse Nurick grade,but there were no differences in mJOA and SF-36v2 at presentation. Overall,there was a significant improvement in all outcome parameters at 12 and 24 months. There was no difference in the level of improvement between the patients with and without diabetes,except in the SF-36v2 Physical Functioning,in which diabetic patients experienced significantly less improvement. There were no differences in surgical complication rates between diabetic patients and nondiabetic patients. CONCLUSIONS: Except for a worse Nurick grade,diabetes does not seem to affect severity of symptoms at presentation for surgery. More importantly,with the exception of the SF-36v2 Physical Functioning scores,outcomes of surgical treatment are similar in patients with diabetes and without diabetes. Surgical decompression is effective and should be offered to patients with diabetes who have symptomatic CSM and are appropriate surgical candidates."," Spine J 14(1999): 65-72.","USA,Canada",2014,"Spondylosis","Surgical","NDI,JOACMEQ,Nurick","Unknown","PRO study","Prospective Observation"]
[17,"Arts,M. P.,et al. (2006). \"Cost-effectiveness of microendoscopic discectomy versus conventional open discectomy in the treatment of lumbar disc herniation: a prospective randomised controlled trial [ISRCTN51857546].\" BMC Musculoskelet Disord 7: 42.",null,"Arts,M. P.,et al.","Cost-effectiveness of microendoscopic discectomy versus conventional open discectomy in the treatment of lumbar disc herniation: a prospective randomised controlled trial [ISRCTN51857546]","BACKGROUND: Open discectomy is the standard surgical procedure in the treatment of patients with long-lasting sciatica caused by lumbar disc herniation. Minimally invasive approaches such as microendoscopic discectomy have gained attention in recent years. Reduced tissue trauma allows early ambulation,short hospital stay and quick resumption of daily activities. A comparative cost-effectiveness study has not been performed yet. We present the design of a randomised controlled trial on cost-effectiveness of microendoscopic discectomy versus conventional open discectomy in patients with lumbar disc herniation. METHODS/DESIGN: Patients (age 18-70 years) presenting with sciatica due to lumbar disc herniation lasting more than 6-8 weeks are included. Patients with disc herniation larger than 1/3 of the spinal canal diameter,or disc herniation less than 1/3 of the spinal canal diameter with concomitant lateral recess stenosis or sequestration,are eliglible for participation. Randomisation into microendoscopic discectomy or conventional unilateral transflaval discectomy will take place in the operating room after induction of anesthesia. The length of skin incision is equal in both groups. The primary outcome measure is the functional assessment of the patient,measured by the Roland Disability Questionnaire for Sciatica,at 8 weeks and 1 year after surgery. We will also evaluate several other outcome parameters,including perceived recovery,leg and back pain,incidence of re-operations,complications,serum creatine kinase,quality of life,medical consumption,absenteeism and costs. The study is a randomised prospective multi-institutional trial,in which two surgical techniques are compared in a parallel group design. Patients and research nurses are kept blinded of the allocated treatment during the follow-up period of 2 years. DISCUSSION: Currently,open discectomy is the golden standard in the surgical treatment of lumbar disc herniation. Whether microendoscopic discectomy is more cost-effective than unilateral transflaval discectomy has to be determined by this trial."," BMC Musculoskelet Disord 7: 42.","Netherlands",2006,"Degenerative Disk Disease","Surgical","RMDQ","Adolescents,Adults","Cost-Effectiveness","RCT"]
[18,"Arts,M. P.,et al. (2008). \"Cost-effectiveness of decompression according to Gill versus instrumented spondylodesis in the treatment of sciatica due to low grade spondylolytic spondylolisthesis: a prospective randomised controlled trial [NTR1300].\" BMC Musculoskelet Disord 9: 128.",null,"Arts,M. P.,et al.","Cost-effectiveness of decompression according to Gill versus instrumented spondylodesis in the treatment of sciatica due to low grade spondylolytic spondylolisthesis: a prospective randomised controlled trial [NTR1300]","BACKGROUND: Nerve root decompression with instrumented spondylodesis is the most frequently performed surgical procedure in the treatment of patients with symptomatic low-grade spondylolytic spondylolisthesis. Nerve root decompression without instrumented fusion,i.e. Gill's procedure,is an alternative and less invasive approach. A comparative cost-effectiveness study has not been performed yet. We present the design of a randomised controlled trial on cost-effectiveness of decompression according to Gill versus instrumented spondylodesis. METHODS/DESIGN: All patients (age between 18 and 70 years) with sciatica or neurogenic claudication lasting more than 3 months due to spondylolytic spondylolisthesis grade I or II,are eligible for inclusion. Patients will be randomly allocated to nerve root decompression according to Gill,either unilateral or bilateral,or pedicle screw fixation with interbody fusion. The main primary outcome measure is the functional assessment of the patient measured with the Roland Disability Questionnaire for Sciatica at 12 weeks and 2 years. Other primary outcome measures are perceived recovery and intensity of leg pain and low back pain. The secondary outcome measures include,incidence of re-operations,complications,serum creatine phosphokinase,quality of life,medical consumption,costs,absenteeism,work perception,depression and anxiety,and treatment preference. The study is a randomised prospective multicenter trial in which two surgical techniques are compared in a parallel group design. Patients and research nurse will not be blinded during the follow-up period of 2 years. DISCUSSION: Currently,nerve root decompression with instrumented fusion is the golden standard in the surgical treatment of low-grade spondylolytic spondylolisthesis,although scientific proof justifying instrumented spondylodesis over simple decompression is lacking. This trial is designed to elucidate the controversy in best surgical treatment of symptomatic patients with low-grade spondylolytic spondylolisthesis."," BMC Musculoskelet Disord 9: 128.","Netherlands",2008,"Back Pain,Spondylosis","Surgical","RMDQ","Adults","Cost-Effectiveness","Prospective Observation"]
[19,"Arts,M. P.,et al. (2010). \"The NEtherlands Cervical Kinematics (NECK) trial. Cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in the treatment of cervical disc herniation; a double-blind randomised multicenter study.\" BMC Musculoskelet Disord 11: 122.",null,"Arts,M. P.,et al.","The NEtherlands Cervical Kinematics (NECK) trial. Cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in the treatment of cervical disc herniation; a double-blind randomised multicenter study","BACKGROUND: Patients with cervical radicular syndrome due to disc herniation refractory to conservative treatment are offered surgical treatment. Anterior cervical discectomy is the standard procedure,often in combination with interbody fusion. Accelerated adjacent disc degeneration is a known entity on the long term. Recently,cervical disc prostheses are developed to maintain motion and possibly reduce the incidence of adjacent disc degeneration. A comparative cost-effectiveness study focused on adjacent segment degeneration and functional outcome has not been performed yet. We present the design of the NECK trial,a randomised study on cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in patients with cervical disc herniation. METHODS/DESIGN: Patients (age 18-65 years) presenting with radicular signs due to single level cervical disc herniation lasting more than 8 weeks are included. Patients will be randomised into 3 groups: anterior discectomy only,anterior discectomy with interbody fusion,and anterior discectomy with disc prosthesis. The primary outcome measure is symptomatic adjacent disc degeneration at 2 and 5 years after surgery. Other outcome parameters will be the Neck Disability Index,perceived recovery,arm and neck pain,complications,re-operations,quality of life,job satisfaction,anxiety and depression assessment,medical consumption,absenteeism,and costs. The study is a randomised prospective multicenter trial,in which 3 surgical techniques are compared in a parallel group design. Patients and research nurses will be kept blinded of the allocated treatment for 2 years. The follow-up period is 5 years. DISCUSSION: Currently,anterior cervical discectomy with fusion is the golden standard in the surgical treatment of cervical disc herniation. Whether additional interbody fusion or disc prosthesis is necessary and cost-effective will be determined by this trial. TRIAL REGISTRATION: Netherlands Trial Register NTR1289."," BMC Musculoskelet Disord 11: 122.","Netherlands",2010,"Radiculopathy,Neck Pain,Degenerative Disk Disease","Surgical","NDI","General","Cost-Effectiveness","Clinical trial"]
[20,"Asher,M. A.,et al. (2006). \"Refinement of the SRS-22 Health-Related Quality of Life questionnaire Function domain.\" Spine (Phila Pa 1976) 31(5): 593-597.",null,"Asher,M. A.,et al.","Refinement of the SRS-22 Health-Related Quality of Life questionnaire Function domain","STUDY DESIGN: Prospective observational case series. OBJECTIVES: To improve the Scoliosis Research Society-22 (SRS-22) Health-Related Quality of Life (HRQL) questionnaire Function domain internal consistency for patients younger than 18 years. SUMMARY OF BACKGROUND DATA: During English validation as well as Spanish and Turkish transcultural adaptation studies,low internal consistency of the Function domain was discovered for patients younger than 18 years. The problem was traced to questions 15 (relating to financial considerations) and 18 (relating to going out with friends). Otherwise,the SRS-22 HRQL questionnaire has been shown to be valid and has been successfully translated into Spanish and Turkish. METHODS: Based on existing data,question 18's stem and responses were revised without changing its content and added to the SRS-22 questionnaire. Question 15 remained unchanged,and the effect of inclusion or exclusion on domain score was determined. During a 3-month period,the questionnaire was completed by 111 outpatients,including four groups: idiopathic scoliosis age < 18 years (n = 37),idiopathic scoliosis age > or = 18 years (n = 32),other spinal disorders age < 18 years (n = 17),and other spinal disorders age > or = 18 years (n = 25). RESULTS: As a result of the revision of question 18,the Function domain internal consistency,Cronbach's alpha,for patients age <18 years was increased from 0.67 to 0.78 for patients with idiopathic scoliosis and from 0.60 to 0.80 for patients with other spinal disorders. Domain internal consistency remained high,0.77 to 0.96 for all the other domain-patient groupings. Removal of question 15 slightly improved Function domain internal consistency for idiopathic scoliosis patients < 18 years old and slightly decreased it for patients < 18 years old with other spinal conditions. CONCLUSION: With a minor revision of question 18 (related to going out) the internal consistency of the SRS-22 Function domain has been improved in idiopathic scoliosis patients < 18 years of age. Deletion of question 15 (related to financial considerations) has a variable,small effect depending on patient group. Retention of question 15 is recommended unless a cultural variable,such as differences in healthcare payment schemes,substantially lowers domain psychometric properties."," Spine (Phila Pa 1976) 31(5): 593-597.","USA",2006,"Spinal Deformity","Not Specified","SRS-HRQOL","Adolescents,Children","Tool Validation","Observational"]
[21,"Asher,M.,et al. (2002). \"Spine deformity correlates better than trunk deformity with idiopathic scoliosis patients' quality of life questionnaire responses.\" Stud Health Technol Inform 91: 462-464.",null,"Asher,M.,et al.","Spine deformity correlates better than trunk deformity with idiopathic scoliosis patients' quality of life questionnaire responses","AIM: To determine whether either spine or trunk deformity measurements correlate with patients quality of life questionnaire responses. MATERIALS AND METHODS: Forty five pre operative patients (5M,40F),average age 15 years,9 months (range,10-20) met the inclusion criteria of age (< or = 20 years),Posterior Trunk Symmetry Index (POTSI) and Suzuki Hump Sum (SHS) determination from surface topography,and Scoliosis Research Society-22 (SRS-22)patient questionnaire completion. Average measurement and measurement ranges were largest Cobb 62 degrees (range,40-137 degrees),POTSI 49 (range,17-149),SHS 16 (5-32),and SRS-22 subtotal score 3.86 (range,4.7-2.35). The individual SRS-22 domain scores were function 4.13 (4.80-2.20),pain 4.01 (5-1.60),self image 3.34 (4.4-1.80) and mental health 4.01 (5-1.80). (Scale 5 Best-1 Worst). Correlations between deformity and questionnaire measurements were determined,p<0.01 considered significant. RESULTS: Spine deformity (Cobb) correlated with the SRS-22 subtotal scores (cc-04207,p<0.005) and with the function and self image SRS-22 domain scores: cc0.5182,p<0.001) and cc-0.3981,p<0.01 respectively. Neither trunk deformity score correlated with the SRS-22 Score: POTSI versus SRS-22 (cc 0.0449,ns) and SHS versus SRS-22 (cc-0.0311,ns) CONCLUSION: Spine deformity correlates well with quality of life questionnaire responses whereas trunk deformity magnitude does not. This is somewhat surprising as it is the trunk deformity that the patient can they themselves see. These findings illustrate the pitfalls of assuming what is important to the patient based on clinical measurements."," Stud Health Technol Inform 91: 462-464.","USA",2002,"Spinal Deformity","Surgical","SRS-HRQOL","Unknown","PRO study","Observational"]
[22,"Asher,M.,et al. (2003). \"Discrimination validity of the scoliosis research society-22 patient questionnaire: relationship to idiopathic scoliosis curve pattern and curve size.\" Spine (Phila Pa 1976) 28(1999): 74-78.",null,"Asher,M.,et al.","Discrimination validity of the scoliosis research society-22 patient questionnaire: relationship to idiopathic scoliosis curve pattern and curve size","STUDY DESIGN: Prospective observational study. OBJECTIVE: To determine the discriminant validity of the Scoliosis Research Society-22 (SRS-22) health-related quality-of-life (HRQL) questionnaire for idiopathic scoliosis patients based on curve pattern and curve size. SUMMARY OF BACKGROUND DATA: An important psychometric attribute of the HRQL questionnaire is the capacity to discriminate between and among patients with differing condition severity. METHOD: Three study groups,with subjects ranging in age from 10 to 16 years,were set up: a control group (C) of 19 persons with scoliosis suspected but unproven with an average age of 13 years; a nonsurgical group (NS) of 68 patients with an average age of 14 years and an average scoliosis (Cobb) of 30 degrees; and a presurgical group (PS) of 32 patients with an average age of 14 years and an average scoliosis of 61 degrees. The NS group was subdivided into untreated (NSU) (n = 54) and braced (NSB) patients (n = 14). Also created were subgroups of the NS and PS groups having similar curve sizes: nonsurgical similar (NSS) and presurgery similar (PSS). Statistical significance of the SRS-22 domain scores by comparison groups was tested by ANOVA. Relationships between the SRS-22 questionnaire and scoliosis deformity measurements were calculated using the Pearson Correlation Coefficients. RESULTS: There were no significant differences between the control (C) and nonsurgical (NS) groups. The presurgical group (PS) scored significantly lower in the pain and self-image domains than the C or NS groups and lower than group C in the mental health domain. A subgroup of the nonsurgical group (NSS) with curves comparable to the presurgical subgroup (PSS) had significantly better self-image scores. There were no significant correlations between SRS-22 scores and curve pattern. For persons with scoliosis,curve size (Cobb) correlated with pain,self-image,and function; trunk asymmetry correlated with self-image. CONCLUSION: The SRS-22 HRQL questionnaire successfully discriminated among persons with no scoliosis or moderate scoliosis and large scoliosis. It did not discriminate among patients with single,double,or triple curves. Self-image and,to a lesser extent,pain and function domain scores correlated with radiographic and trunk asymmetry severity. The SRS-22 HRQL questionnaire may be useful in choosing nonsurgical versus surgical treatment in borderline cases."," Spine (Phila Pa 1976) 28(1999): 74-78.","USA",2003,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","Tool Validation","Observational"]
[23,"Asher,M.,et al. (2003). \"The reliability and concurrent validity of the scoliosis research society-22 patient questionnaire for idiopathic scoliosis.\" Spine (Phila Pa 1976) 28(1999): 63-69.",null,"Asher,M.,et al.","The reliability and concurrent validity of the scoliosis research society-22 patient questionnaire for idiopathic scoliosis","STUDY DESIGN: Outcome study to determine response distribution,internal consistency,reproducibility,and concurrent validity of the Scoliosis Research Society-22 (SRS-22) health-related quality-of-life (HRQL) questionnaire. OBJECTIVES: Further refinement of an HRQL questionnaire specific for idiopathic scoliosis. SUMMARY OF BACKGROUND DATA: Previous experience with the original and modified SRS HRQL questionnaires suggested a need for further refinement and more complete validation. METHODS: The SRS-22 and Short Form 36 (SF-36) HRQL questionnaires were mailed to 83 previously surveyed postoperative idiopathic scoliosis patients. RESULTS: Fifty-eight (70%) patients returned the first set of questionnaires. Their average age at surgery was 14.6 years,and their average follow-up interval since surgery was 10.8 years. Fifty-one (88%) of the 58 returned the second set of questionnaires an average of 28 days later. The psychometric attributes of the instruments were comparable: score distribution,SRS-22 56.9% ceiling and 1.7% floor,SF-36 79.3% ceiling and 1.7% floor; internal consistency (Cronbach alpha),SRS-22 0.92 to 0.75,SF-36 0.91 to 0.36; and reproducibility (intraclass correlation coefficient),SRS-22 0.96 to 0.85,SF-36 0.92 to 0.61. Concurrent validity,determined by Pearson Correlation Coefficients between SRS-22 and SF-36 domains,was 0.70 or greater ( < 0.0001) for 17 relevant comparisons. CONCLUSION: The SRS-22 HRQL questionnaire is reliable with internal consistency and reproducibility comparable to SF-36. In addition,it demonstrated concurrent validity when compared to SF-36. It is shorter and more focused on the health issues related to idiopathic scoliosis than SF-36."," Spine (Phila Pa 1976) 28(1999): 63-69.","USA",2003,"Spinal Deformity","Surgical","SRS-HRQOL","Unknown","Tool Validation","Observational"]
[24,"Asher,M.,et al. (2004). \"The influence of spine and trunk deformity on preoperative idiopathic scoliosis patients' health-related quality of life questionnaire responses.\" Spine (Phila Pa 1976) 29(8): 861-868.",null,"Asher,M.,et al.","The influence of spine and trunk deformity on preoperative idiopathic scoliosis patients' health-related quality of life questionnaire responses","STUDY DESIGN: Retrospective case series. OBJECTIVES: To determine the influence of spine and trunk deformity on preoperative idiopathic scoliosis patients' health-related quality of life questionnaire responses. SUMMARY OF BACKGROUND DATA: Management recommendations for patients with idiopathic scoliosis during adolescence are based heavily on spine deformity and to some extent trunk deformity magnitude. However,the manner in which these objective measures influence the patients' perception of their condition is unclear. METHODS: Of 67 consecutive preoperative patients,61 (91%) had completed the Scoliosis Research Society-22 health-related quality of life questionnaire and had been studied with posterior exposure surface topography. Their average age was 15 years,6 months (range 10 years,10 months-20 years,10 months),and the average maximum Cobb was 63 degrees (range 40-137 degrees). Correlations between spine and trunk deformity measures and Scoliosis Research Society-22 scores were determined by the Pearson correlation coefficient,with P < 0.01 considered significant. RESULTS: For the study group,spine deformity (Cobb) correlated significantly only with Scoliosis Research Society-22 function (r = -0.39,P = 0.0022) domain. Neither coronal nor transverse plane trunk deformity composite scores correlated with any Scoliosis Research Society-22 scores. The Hump Index component of the transverse plane Suzuki Hump Sum composite score was the only trunk measurement to correlate significantly (function r = -0.45,P = 0.003; self image,r = -0.36,P = 0.0040). The strongest correlations occurred when the single thoracic curves,King classifications III and IV,were combined: Cobb versus function r = -0.53,P = 0.0027; Cobb versus self-image r = -0.46,P = 0.0099; and Hump Index versus function r = -0.60,P = 0.0005. There were no significant correlations between either spine deformity or any trunk deformity measure with Scoliosis Research Society-22 responses for either the double or thoracolumbar curve pattern groups. CONCLUSION: Both spine and upper thoracic transverse plane trunk deformity significantly influenced preoperative idiopathic scoliosis patients' perception of function and self-image,but not pain or mental health. However,in spite of a fairly rigorous standard of proof,P < or = 0.01,the significant r values ranged from -0.33 to -0.68,suggesting that there are factors other than spine and trunk deformity influencing the idiopathic scoliosis patients' health-related quality of life questionnaire responses. Future studies are necessary to define these factors."," Spine (Phila Pa 1976) 29(8): 861-868.","USA",2004,"Spinal Deformity","Surgical","SRS-HRQOL","Unknown","PRO study","Observational"]
[25,"Atalay,N. S.,et al. (2013). \"Comparison of efficacy of neural therapy and physical therapy in chronic low back pain.\" Afr J Tradit Complement Altern Med 10(3): 431-435.",null,"Atalay,N. S.,et al.","Comparison of efficacy of neural therapy and physical therapy in chronic low back pain","The aim of this prospective study was to evaluate the effects of neural therapy,and physical therapy on level of pain,disability,quality of life,and psychological status in patients with chronic low back pain. Patients admitted to the physical therapy and rehabilitation outpatient clinic with the complaint of low back pain of at least 3 months duration. Group 1 (n=27),physical therapy (PT,hotpack,ultrasound,TENS 15 sessions),group 2 (n=33),neural therapy (NT,1:1 mixture of 20 mg/mL Lidocaine HCl (Jetokain simplex(R)) and saline for 5 sessions. For pain,Visual Analogue Scale (VAS),for disability Roland Morris Disability Questionnaire (RMDQ),for quality-of-life Nottingham-Health-Profile (NHP),for depression,and anxiety,Hospital Anxiety-Depression Scale (HADS) were used before and after the treatment. Mean age was 47.3+/-11.32 years,symptom time was 13.78+/-11.98 months. There were no differences for demographic variables between groups. Significant improvements were detected for VAS,RMDQ,NHP-Pain,NHP-Physical activity,HADS for both of two groups after treatment. In addition to these findings,significant improvements were found for NHP-Energy,NHP-Social isolation in NT group. The differences of pre- and post-treatment values of parameters were evaluated for each group. Although there were no differences for VAS,NHP-sleep,NHP-Emotional reaction,HADS between groups,RMDQ,NHP-Pain,NHP-Physical activity,NHP-Social isolation were higher in NT than PT before treatment,the improvements for these parameters were better in NT than PT. In conclusion both of NT and PT are effective on pain,function,quality of life,anxiety,and depression in patients with chronic low back pain."," Afr J Tradit Complement Altern Med 10(3): 431-435.","Turkey",2013,"Back Pain","Physical Therapy","RMDQ","Adults","PRO study","Observational"]
[26,"Atlas,S. J.,et al. (2003). \"The Maine-Seattle back questionnaire: a 12-item disability questionnaire for evaluating patients with lumbar sciatica or stenosis: results of a derivation and validation cohort analysis.\" Spine (Phila Pa 1976) 28(16): 1869-1876.",null,"Atlas,S. J.,et al.","The Maine-Seattle back questionnaire: a 12-item disability questionnaire for evaluating patients with lumbar sciatica or stenosis: results of a derivation and validation cohort analysis","STUDY DESIGN: Analysis of health-related quality of life data obtained from a prospective cohort study of patients with sciatica due to an intervertebral disc herniation or lumbar spinal stenosis. OBJECTIVE: To derive and validate a shortened version of a previously validated 23-item modification of the Roland-Morris Disability Questionnaire. SUMMARY OF BACKGROUND DATA: For patients with low back pain,improving health-related quality of life is often the main goal of therapy. The Roland-Morris Disability Questionnaire is one of the best validated and most frequently used back-specific functional status measures. A shortened version may permit more widespread use in clinical and research settings. METHODS: Data from 507 patients with sciatica enrolled in the Maine Lumbar Spine Study were used to derive a shortened version of a 23-item modification of the original Roland-Morris Disability Questionnaire using qualitative and cluster analysis techniques. The internal consistency,construct validity,reproducibility,and responsiveness in detecting change over a 3-month period for a new 12-item scale was compared to the original 23-item scale. The 12-item scale was then validated in an independent cohort of 148 patients with lumbar spinal stenosis. RESULTS: Internal consistency was very good but modestly lower for the 12-item instrument compared to the 23-item original scale. Reproducibility over a 3-month interval was good and did not differ between the 12-item and original scale. Findings from the validation cohort were similar or better than the derivation cohort. A high degree of construct validity with patient-reported symptoms was demonstrated for the 12-item and original scales. The responsiveness and interpretability of the 12-item scale over 3 months was excellent and comparable to the original scale. Responsiveness assessed in patients with lumbar spinal stenosis in the independent validation cohort showed consistent findings compared to patients with a disc herniation in the derivation cohort. CONCLUSIONS: This short,simple,self-administered 12-item back-specific functional status questionnaire performed extremely well in comparison with the original 23-item scale. If validated in additional study populations,this new questionnaire may be useful in the clinical setting as a way for providers to prospectively compare their outcomes of care to other patient populations,and to study treatment effectiveness."," Spine (Phila Pa 1976) 28(16): 1869-1876.","USA",2003,"Back Pain,Degenerative Disk Disease","Not Specified","Maine","Unknown","Tool Validation","Observational"]
[27,"Auffinger,B.,et al. (2013). \"Usefulness of minimum clinically important difference for assessing patients with subaxial degenerative cervical spine disease: statistical versus substantial clinical benefit.\" Acta Neurochir (Wien) 155(12): 2345-2354; discussion 2355.",null,"Auffinger,B.,et al.","Usefulness of minimum clinically important difference for assessing patients with subaxial degenerative cervical spine disease: statistical versus substantial clinical benefit","BACKGROUND: The measurement of the therapeutic outcome of cervical spine surgeries commonly relies on four main patient reported outcomes (PROs): Neck Disability Index (NDI),Visual Analog Scale (VAS) for pain,and Short Form-36 (SF-36) Physical (PCS) and Mental (MCS) Component Summary. However,the clinical impact of such scores and how they could effectively measure therapeutic efficacy remains unclear. In this context,the concept of minimum clinically important difference (MCID) is developing into the standard by which to evaluate treatments,patient satisfaction and cost-effectiveness. METHODS: Eighty-eight consecutive patients undergoing surgery for subaxial degenerative cervical spine disease were selected from a prospective blinded database. PROs (NDI,PCS,MCS and VAS) were collected preoperatively,and together with blinded Surgeon Ratings (SR) at 3 months and 6 months post-surgery. Four anchor-based approaches were used to calculate different MCIDs. Three anchors (VAS,HTI (Health Transition Item of the SF-36) and SR) were used to evaluate surgery outcome. The best clinically and statistically relevant MCID was chosen. RESULTS: On average,all patients presented with a statistically significant improvement (p < 0.001) postoperatively for NDI (27.42 to 19.42),PCS (33.02 to 42.03),MCS (44 to 50.74) and VAS (2.85 to 1.93). The four MCID anchor-based approaches yielded a range of values for each PRO: 2.23-16.59 for PCS,0.11-16.27 for MCS and 2.72-12.08 for NDI. When compared to the VAS and HTI anchors,the area under the ROC curve was greater for SR. This finding suggests that SR may be a more reliable anchor for MCID calculation. CONCLUSION: The MDC (minimum detectable change) approach together with the SR anchor appears to be the most appropriate MCID method. It offers the greatest area under the ROC curve (threshold above the 95 % CI),and the choice of the anchor did not significantly affect this result. MCID values for this dataset were 5.6 for PCS,5.12 for MCS and 2.41 for NDI."," Acta Neurochir (Wien) 155(12): 2345-2354; discussion 2355.","USA",2013,"Spine Disease","Surgical","NDI","Unknown","Cost-Effectiveness","Observational"]
[28,"Ayvaz,M.,et al. (2014). \"Posterior all-pedicle screw instrumentation combined with multiple chevron and concave rib osteotomies in the treatment of adolescent congenital kyphoscoliosis.\" Spine J 14(1999): 11-19.",null,"Ayvaz,M.,et al.","Posterior all-pedicle screw instrumentation combined with multiple chevron and concave rib osteotomies in the treatment of adolescent congenital kyphoscoliosis","BACKGROUND CONTEXT: Congenital kyphoscoliosis is a disorder that often requires surgical treatment. Although many methods of surgical treatment exist,posterior-only vertebral column resection with instrumentation and fusion seem to have become the gold standard for very severe and very rigid curves. Multiple chevron and concave rib osteotomies have been previously reported to be effective in the treatment of neglected severe idiopathic curves. We hypothesized that this method may also be used successfully in the treatment of congenital kyphoscoliosis. PURPOSE: To evaluate the effectiveness and safety of multiple chevron osteotomies combined with concave rib osteotomy and posterior pedicle screw instrumentation. STUDY DESIGN: Retrospective chart review in the spine service of a large university hospital. PATIENT SAMPLE: Adolescent patients undergoing a specific surgical treatment for the indication of rigid congenital kyphoscoliotic deformity. OUTCOME MEASURES: Radiographic images were used for the measurement of deformity correction. The Turkish version of the Scoliosis Research Society 22 (SRS-22) Patient Questionnaire has been used as a clinical outcome measure in the patient population. METHODS: A retrospective chart review was performed. Patients admitted to Hacettepe Hospital Spine Center during the period of 2005 to 2009 were included. Criteria for inclusion were as follows: adolescent age group (10-16 years); congenital kyphoscoliosis; formation and/or segmentation defect of at least two vertebral motion segments; surgical treatment of deformity by posterior all-pedicle screw instrumentation,multiple chevron osteotomies,and multiple concave rib osteotomies; follow-up of at least 24 months; and a complete set of preoperative,postoperative,and follow-up standing posteroanterior and lateral full spinal radiographs. The patients' hospital records and X-rays were reviewed. Duration of surgery,intraoperative blood loss,postoperative transfusion requirements,postoperative stay in postanesthesia care unit (PACU),time of hospitalization,and complications were recorded. Deformity in both coronal and sagittal planes was analyzed for correction and maintenance of the correction in preoperative,postoperative,and follow-up radiographs. Patients' health-related quality of life was assessed using the SRS-22 questionnaire at the final follow-up. RESULTS: Eighteen patients met the inclusion criteria. Their average age was 13.6 years (range,11-16 years). Chevron osteotomies were performed at apical segments (three to seven levels) and concave rib osteotomies at Cobb-to-Cobb (five to eight levels). No patient had preoperative cord compression because of the sharply angulated deformity or neurologic deficit. The average preoperative scoliosis was 66.0 degrees (range,31 degrees -116 degrees ),52.4 degrees (range,22 degrees -85 degrees ) on flexibility X-rays,and became 24.9 degrees (range,12 degrees -52 degrees ) postoperatively. The average preoperative global kyphosis (T2-T12) of 75.9 degrees (range,50 degrees -106 degrees ) became 49.5 degrees (range,18 degrees -66 degrees ). The average preoperative local kyphosis of 71.9 degrees (range,35 degrees -114 degrees ) became 31.4 degrees (range,-44 degrees to 64 degrees ). The average intraoperative bleeding was 989 cc,surgical time was 292 minutes,and intraoperative transfusion was 2.3 units. The maximum PACU stay was overnight. There were no neurologic complications except one pneumothorax and one pneumonia. The average follow-up was 34.3 months. At follow-up,average scoliosis was 27.5 degrees (range,10 degrees -50 degrees ),global kyphosis was 50.3 degrees (range,28 degrees -73 degrees ),and local kyphosis was 36.9 degrees (range,-36 degrees to 58 degrees ). Performed on the last follow-up,the average scores for the five domains of SRS-22 were 4.3,4.4,4.2,4.1,and 4.8 for function,pain,self-image,mental health,satisfaction,and total,respectively. CONCLUSIONS: Multiple chevron and concave rib osteotomies with posterior instrumentation provide an acceptable rate of deformity correction and maintenance of correction at 2 years with acceptable intraoperative bleeding,surgical time,postoperative morbidity,and rate of complications. It can be considered as an alternative in the treatment of rigid congenital curves involving more than three levels or multiple curves separated by at least two segments that would otherwise require multiple vertebral resections."," Spine J 14(1999): 11-19.","Turkey",2014,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Retrospective review"]
[29,"Azad,T. D.,et al. (2016). \"Building an electronic health record integrated quality of life outcomes registry for spine surgery.\" J Neurosurg Spine 24(1999): 176-185.",null,"Azad,T. D.,et al.","Building an electronic health record integrated quality of life outcomes registry for spine surgery","OBJECTIVE: Demonstrating the value of spine care requires adequate outcomes assessment. Long-term outcomes are best measured as overall improvement in quality of life (QOL) after surgical intervention. Present registries often require parallel data entry,introducing inefficiencies and limiting compliance. The authors detail the methodology of constructing an integrated electronic health record (EHR) system to collect QOL metrics and demonstrate the effect of data collection on routine clinical workflow. A streamlined approach to collecting QOL data can capture patient data without requiring dual data entry and without increasing clinic visit times. METHODS: Through extensive literature review,a combination of QOL assessments was selected,consisting of the Patient Health Questionnaire-2 and -9,Oswestry Disability Index,Neck Disability Index,and visual analog scale for pain. These metrics were used to provide assessment of QOL following spine surgery and were incorporated into standard clinic workflow by a multidisciplinary team of surgeons,advanced practice providers,and health care information technology specialists. A clinical dashboard tracking more than 25 patient variables was developed. Clinic flow was assessed and opportunities for improvement reviewed. Duration of clinic visits before and after initiation of QOL measure capture was recorded,with assessment of mean clinic visit times for the 12 months before and the 12 months after implementation. RESULTS: The integrated QOL capture was instituted for 3 spine surgeons in a tertiary care academic center. In the 12-month period prior to initiating collection of QOL data,806 new patient visits were completed with an average visit time of 127.9 +/- 51.5 minutes. In the 12 months after implementation,1013 new patient visits were recorded,with 791 providing QOL measures with an average visit time of 117.0 +/- 45.7 minutes. Initially the primary means of collecting patient outcome data was via paper form,with gradual transition to collection via entry into the electronic medical records system. To improve electronic data capture,paper forms were eliminated and an online portal used as part of the patient rooming process. This improved electronic capture to nearly 98% without decreasing the number of patients enrolled in the process. CONCLUSIONS: A systematic approach to collecting spine-related QOL data within an EHR system is feasible and offers distinct advantages over registries that require dual data entry. The process of data collection does not impact patients' clinical visit or providers' clinical workflow. This approach is scalable,and may form the foundation for a decentralized outcomes registry network."," J Neurosurg Spine 24(1999): 176-185.","USA",2016,"Back Pain","Surgical","ODI,NDI","Unknown","PRO study","Observational"]
[30,"Bago,J.,et al. (2004). \"The Spanish version of the SRS-22 patient questionnaire for idiopathic scoliosis: transcultural adaptation and reliability analysis.\" Spine (Phila Pa 1976) 29(15): 1676-1680.",null,"Bago,J.,et al.","The Spanish version of the SRS-22 patient questionnaire for idiopathic scoliosis: transcultural adaptation and reliability analysis","STUDY DESIGN: Validation of the transcultural adaptation of a questionnaire for measuring health-related quality of life. OBJECTIVES: To translate and culturally adapt the SRS-22 questionnaire to Spanish. To determine the metric qualities (internal consistency and test-retest reproducibility) of this questionnaire. SUMMARY OF BACKGROUND DATA: The SRS-22 Patient Questionnaire has proven to be a valid instrument for clinical assessment of patients with idiopathic scoliosis. The widespread use of the SRS-22 in non-English-speaking countries requires its transcultural adaptation. METHODS: Transcultural adaptation of the SRS-22 was carried out according to the International Quality of Life Assessment Project guidelines and included two translations and two back-translations of the material. A committee of experts decided on the final version. The questionnaire was administered to 175 individuals (152 women and 23 men) with idiopathic scoliosis. The mean age of the participants at the time they received the questionnaire was 18.9 years,thoracic curve magnitude was 28.8 degrees,and lumbar curve magnitude was 28.1 degrees. At this time,85 patients had been treated surgically,45 had been treated with orthesis,and 45 were under observation. A subgroup of 30 patients completed the questionnaire a second time 1 week later. Internal consistency was determined with Cronbach's alpha coefficient and test-retest reliability with the intraclass correlation coefficient. RESULTS: The overall alpha coefficient of the questionnaire was 0.89. Coefficients for individual domains were as follows: function/activity,0.67; pain,0.81; mental health,0.83; self-image,0.73; and satisfaction,0.78. The questionnaire as a whole had an intraclass correlation coefficient of 0.96. Intraclass correlation coefficients for individual domains were as follows: pain,0.93; function,0.82; self-image,0.94; mental health,0.94; and satisfaction,0.98. CONCLUSIONS: The Spanish version of the SRS-22 Patient Questionnaire demonstrated adequate internal consistency for the majority of domains and excellent reproducibility. These results suggest that the process of adaptation has produced an instrument that is apparently equivalent to the original and suitable for clinical research."," Spine (Phila Pa 1976) 29(15): 1676-1680.","Spain",2004,"Spinal Deformity","Surgical","SRS-HRQOL","Unknown","Tool Validation","Observational"]
[31,"Bailey,C. S.,et al. (2014). \"Orthosis versus no orthosis for the treatment of thoracolumbar burst fractures without neurologic injury: a multicenter prospective randomized equivalence trial.\" Spine J 14(11): 2557-2564.",null,"Bailey,C. S.,et al.","Orthosis versus no orthosis for the treatment of thoracolumbar burst fractures without neurologic injury: a multicenter prospective randomized equivalence trial","BACKGROUND CONTEXT: Thoracolumbar burst fractures have good outcomes when treated with early ambulation and orthosis (TLSO). If equally good outcomes could be achieved with early ambulation and no brace,resource utilization would be decreased,especially in developing countries where prolonged bed rest is the default option because bracing is not available or affordable. PURPOSE: To determine whether TLSO is equivalent to no orthosis (NO) in the treatment of acute AO Type A3 thoracolumbar burst fractures with respect to their functional outcome at 3 months. STUDY DESIGN: A multicentre,randomized,nonblinded equivalence trial involving three Canadian tertiary spine centers. Enrollment began in 2002 and 2-year follow-up was completed in 2011. PATIENT SAMPLE: Inclusion criteria included AO-A3 burst fractures between T11 and L3,skeletally mature and older than 60 years,72 hours from their injury,kyphotic deformity lower than 35 degrees,no neurologic deficit. One hundred ten patients were assessed for eligibility for the study; 14 patients were not recruited because they resided outside the country (3),refused participation (8),or were not consented before independent ambulation (3). OUTCOME MEASURES: Roland Morris Disability Questionnaire score (RMDQ) assessed at 3 months postinjury. The equivalence margin was set at delta=5 points. METHODS: The NO group was encouraged to ambulate immediately with bending restrictions for 8 weeks. The TLSO group ambulated when the brace was available and weaned from the brace after 8 to 10 weeks. The following competitive grants supported this work: VHHSC Interdisciplinary Research Grant,Zimmer/University of British Columbia Research Fund,and Hip Hip Hooray Research Grant. Aspen Medical provided the TLSOs used in this study. The authors have no financial or personal relationships that could inappropriately influence this work. RESULTS: Forty-seven patients were enrolled into the TLSO group and 49 patients into the NO group. Forty-six participants per group were available for the primary outcome. The RMDQ score at 3 months postinjury was 6.8 +/- 5.4 (standard deviation [SD]) for the TLSO group and 7.7 +/- 6.0 (SD) in the NO group. The 95% confidence interval (-1.5 to 3.2) was within the predetermined margin of equivalence. Six patients required surgical stabilization,five of them before initial discharge. CONCLUSIONS: Treating these fractures using early ambulation without a brace avoids the cost and patient deconditioning associated with a brace and complications and costs associated with long-term bed rest if a TLSO or body cast is not available."," Spine J 14(11): 2557-2564.","Canada",2014,"Trauma","Surgical","RMDQ","Adults","PRO study","Clinical trial"]
[32,"Bakhsheshian,J.,et al. (2017). \"Impact of poor mental health in adult spinal deformity patients with poor physical function: a retrospective analysis with a 2-year follow-up.\" J Neurosurg Spine 26(1999): 116-124.",null,"Bakhsheshian,J.,et al.","Impact of poor mental health in adult spinal deformity patients with poor physical function: a retrospective analysis with a 2-year follow-up","OBJECTIVE Mental disease burden can have a significant impact on levels of disability and health-related quality of life (HRQOL) measures. Therefore,the authors investigated the significance of mental health status in adults with spinal deformity and poor physical function. METHODS A retrospective analysis of a prospective multicenter database of 365 adult spinal deformity (ASD) patients who had undergone surgical treatment was performed. Health-related QOL variables were examined preoperatively and at the 2-year postoperative follow-up. Patients were grouped by their 36-Item Short Form Health Survey mental component summary (MCS) and physical component summary (PCS) scores. Both groups had PCS scores </= 25th percentile for matched norms; however,the low mental health (LMH) group consisted of patients with an MCS score </= 25th percentile,and the high mental health (HMH) group included patients with an MCS score >/= 75th percentile. RESULTS Of the 264 patients (72.3%) with a 2-year follow-up,104 (28.5%) met the inclusion criteria for LMH and 40 patients (11.0%) met those for HMH. The LMH group had a significantly higher overall rate of comorbidities,specifically leg weakness,depression,hypertension,and self-reported neurological and psychiatric disease processes,and were more likely to be unemployed as compared with the HMH group (p < 0.05 for all). The 2 groups had similar 2-year postoperative improvements in HRQOL (p > 0.05) except for the greater improvements in the MCS and the Scoliosis Research Society-22r questionnaire (SRS-22r) mental domain (p < 0.05) in the LMH group and greater improvements in PCS and SRS-22r satisfaction and back pain domains (p < 0.05) in the HMH group. The LMH group had a higher rate of reaching a minimal clinically important difference (MCID) on the SRS-22r mental domain (p < 0.01),and the HMH group had a higher rate of reaching an MCID on the PCS and SRS-22r activity domain (p < 0.05). On multivariable logistic regression,having LMH was a significant independent predictor of failure to reach an MCID on the PCS (p < 0.05). At the 2-year postoperative follow-up,14 LMH patients (15.1%) were categorized as HMH. Two LMH patients (2.2%),and 3 HMH patients (7.7%) transitioned to a PCS score >/= 75th percentile for age- and sex-matched US norms (p < 0.01). CONCLUSIONS While patients with poor mental and physical health,according to their MCS and PCS scores,have higher medical comorbidity and unemployment rates,they still demonstrate significant improvements in HRQOL measurements postoperatively. Both LMH and HMH patient groups demonstrated similar improvements in most HRQOL domains,except that the LMH patients had difficulties in obtaining improvements in the PCS domain."," J Neurosurg Spine 26(1999): 116-124.","USA",2017,"Spinal Deformity","Surgical","SRS-HRQOL","Adults","PRO study","Retrospective review"]
[33,"Baldus,C.,et al. (2008). \"Age-gender matched comparison of SRS instrument scores between adult deformity and normal adults: are all SRS domains disease specific?\" Spine (Phila Pa 1976) 33(20): 2214-2218.",null,"Baldus,C.,et al.","Age-gender matched comparison of SRS instrument scores between adult deformity and normal adults: are all SRS domains disease specific?","STUDY DESIGN: Prospective,observational study. OBJECTIVE: To further validate the Scoliosis Research Society (SRS) instrument by comparing scores of adult deformity patients with no prior history of spine surgery to the scores of normal adult volunteers in age-gender matched groups. SUMMARY OF BACKGROUND DATA: Efforts have been made to validate the SRS questionnaire in adolescent and adult deformity patients. An important psychometric attribute of any quality of life tool is its ability to discriminate between subjects with and without the condition of interest. Discriminate validity of the SRS questionnaire has not been established in the primary (no prior surgical treatment) adult deformity population. METHODS: The SRS questionnaire was issued prospectively to 935 primary adult deformity patients with a diagnosis of idiopathic or de novo scoliosis and minimum Cobb angle of 30 degrees (average Cobb angle: 54 degrees; range: 30 degrees-132 degrees). Five hundred forty-three patients were treated nonsurgically while 392 patients underwent surgical intervention. Baseline SRS scores of the deformity population were compared to 1222 volunteers with no history of spine disease randomly sampled from the US population. Analysis between the 2 populations was broken down into 6 age-gender groups: male/female; 20-40,41-60,61-80 years of age. RESULTS: SRS domain scores of the deformity subgroups demonstrated significant statistical differences from their corresponding age-gender matched normative group. The only exceptions were the mental health domain in the older males,61-80 years of age. The average SRS subscore for each age-gender subgroup was less than the tenth percentile in the corresponding normative population,indicating substantial limitations in these patients. CONCLUSION: Our findings confirm the SRS instrument has excellent discriminate validity in the adult population. It appears to be disease-specific in the domains of pain,appearance and activity in adult spinal deformity patients who have not had prior surgery."," Spine (Phila Pa 1976) 33(20): 2214-2218.","USA",2008,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","Tool Validation","Prospective Observation"]
[34,"Baldus,C.,et al. (2011). \"The Scoliosis Research Society Health-Related Quality of Life (SRS-30) age-gender normative data: an analysis of 1346 adult subjects unaffected by scoliosis.\" Spine (Phila Pa 1976) 36(14): 1154-1162.",null,"Baldus,C.,et al.","The Scoliosis Research Society Health-Related Quality of Life (SRS-30) age-gender normative data: an analysis of 1346 adult subjects unaffected by scoliosis","STUDY DESIGN: Prospective,cross-sectional study. OBJECTIVE: To determine Scoliosis Research Society (SRS)-30 health-related quality of life (HRQOL) reference values by age and gender in an adult population unaffected by scoliosis thereby allowing clinicians and investigators to compare individual and/or groups of spinal deformity patients to their generational peers. SUMMARY OF BACKGROUND DATA: Normative data are collected to establish means and standard deviations of health-related quality of life outcomes representative of a population. The SRS HRQOL questionnaire has become the standard for determining and comparing treatment outcomes in spinal deformity practices. With the establishment of adult SRS-30 HRQOL population values,clinicians,and investigators now have a reference for interpretation of individual scores and/or the scores of subgroups of adult patients with spinal deformities. METHODS: The SRS-30 HRQOL was issued prospectively to 1346 adult volunteers recruited from across the United States. Volunteers self-reported no history of scoliosis or prior spine surgery. Domain medians,means,confidence intervals,percentiles,and minimum/maximum values were calculated for six generational age-gender groups: male/female; 20-39,40-59,and 60-80 years of age. RESULTS: Median and mean domain values ranged from 4.1 to 4.6 for all age-gender groups. The older the age-gender group,the lower (worse) the reported domain median and mean scores. The only exception was the mental health domain scores in the female groups which improved slightly. Males reported higher (better) scores than females but only the younger males were significantly higher in all domains than their female counterparts. In addition,all male groups reported higher Mental Health domain scores than their female counterparts (P=0.003). CONCLUSION: This study reports population medians,means,standard deviations,percentiles,and confidence intervals for the domains of the SRS-30 HRQOL instrument. Clinicians must be mindful of age-gender differences when assessing deformity populations. Generational decreases noted in the older adult volunteer scores may provide a basis for future investigators to interpret observed score decreases in patient cohorts at long-term follow-up."," Spine (Phila Pa 1976) 36(14): 1154-1162.","USA",2011,"Spinal Deformity","Surgical","SRS-HRQOL","Adults","PRO study","Observational"]
[35,"Barton, M., et al. (2014). \"Invasive candidiasis in low birth weight preterm infants: risk factors, clinical course and outcome in a prospective multicenter study of cases and their matched controls.\" BMC Infect Dis 14: 327.",null,"Barton, M., et al.","Invasive candidiasis in low birth weight preterm infants: risk factors, clinical course and outcome in a prospective multicenter study of cases and their matched controls","BACKGROUND: This multicenter prospective study of invasive candidiasis (IC) was carried out to determine the risk factors for, incidence of, clinical and laboratory features, treatment and outcome of IC in infants of birth weight <1250 g. METHODS: Neonates <1250 g with IC and their matched controls (2:1) were followed longitudinally and descriptive analysis was performed. Survivors underwent neurodevelopmental assessment at 18 to 24 months corrected age. Neurodevelopmental impairment (NDI) was defined as blindness, deafness, moderate to severe cerebral palsy, or a score <70 on the Bayley Scales of Infant Development 2nd edition. Multivariable analyses were performed to determine risk factors for IC and predictors of mortality and NDI. RESULTS: Cumulative incidence rates of IC were 4.2%, 2.2% and 1.5% for birth-weight categories <750 g, <1000 g, <1500 g, respectively. Forty nine infants with IC and 90 controls were enrolled. Necrotizing enterocolitis (NEC) was the only independent risk factor for IC (p=0.03). CNS candidiasis occurred in 50% of evaluated infants, while congenital candidiasis occurred in 31%. Infants with CNS candidiasis had a higher mortality rate (57%) and incidence of deafness (50%) than the overall cohort of infants with IC. NDI (56% vs. 33%; p=0.017) and death (45% vs. 7%; p=0.0001) were more likely in cases than in controls, respectively. IC survivors were more likely to be deaf (28% vs. 7%; p=0.01). IC independently predicted mortality (p=0.0004) and NDI (p=0.018). CONCLUSION: IC occurred in 1.5% of VLBW infants. Preceding NEC increased the risk of developing IC. CNS candidiasis is under-investigated and difficult to diagnose, but portends a very poor outcome. Mortality, deafness and NDI were independently significantly increased in infants with IC compared to matched controls."," BMC Infect Dis 14: 327.","USA",2014,"Low Birth Weight","Not Specified","NDI","Infants","PRO study","Prospective Observation"]
[36,"Bastrom, T. P., et al. (2013). \"Prevalence of postoperative pain in adolescent idiopathic scoliosis and the association with preoperative pain.\" Spine (Phila Pa 1976) 38(21): 1848-1852.",null,"Bastrom, T. P., et al.","Prevalence of postoperative pain in adolescent idiopathic scoliosis and the association with preoperative pain","STUDY DESIGN: Review of a prospective database registry of surgical patients with adolescent idiopathic scoliosis (AIS). OBJECTIVE: The purpose of this study was to examine the prevalence of postoperative pain and its impact on patient-reported postoperative outcomes using the Scoliosis Research Society (SRS)-22 outcomes questionnaire. SUMMARY OF BACKGROUND DATA: Although reportedly rare, postoperative pain can be a devastating situation for the patient with AIS. Most recent studies examining outcomes in AIS surgical treatment use the SRS Pain domain score to assess pain in this population. METHODS: A prospectively enrolled multicenter database was queried. Patients with minimum 2-year follow-up and 2-year SRS scores were included. Postoperative pain after the acute phase of recovery when reported by the patient to the treating surgeon/clinical team in follow-up is recorded as a complication in the database. Patients included in this series were grouped as either reporting pain or not to the surgeon/clinical team postoperatively. Pre- and postoperative SRS scores were then compared between these 2 groups using analysis of variance (P < 0.05). RESULTS: Five hundred and eighty-four patients meeting the inclusion criteria were identified. Sixty-one (11%) reported pain at sometime between 2 weeks and 2 years postoperatively. Thirteen were within the 6-month postoperative period. Of the remaining 48 reporting pain between 6 and 24 months postoperatively, 41 (7% of the total cohort) had no obvious cause for their pain. More than half of these patients (26/41) were referred for further treatment (physical therapy, referral to pain specialist, further imaging). These 41 patients had significantly decreased 2-year SRS scores in the domains of Pain, Self-image, Mental health, and Total score (P < 0.05). The patients with postoperative pain were found to have significantly lower preoperative Pain domain scores (P < 0.001), indicative of greater pain preoperatively, yet there were no other domains effected preoperatively. For this group the pre- to postoperative SRS pain scores did not show significant change (P > 0.05). CONCLUSION: Unexplained pain after the 6-month postoperative period occurred in 7% of the cohort. The results indicate that patients reporting pain to their surgeons/clinical team postoperatively have lower pain scores on a subjective outcome instrument thus further validating the SRS-22 outcome tool. This reported pain seems to be associated with decreases in other SRS-22 domains. Interestingly, these patients also have lower preoperative pain scores than those without postoperative pain. Study into causes of pain in AIS and whether preoperative education and expectations targeted at this population would positively impact outcomes is warranted, especially because on average patients after AIS surgery have less pain. LEVEL OF EVIDENCE: 3."," Spine (Phila Pa 1976) 38(21): 1848-1852.","USA",2013,"Spinal Deformity","Surgical,Physical Therapy","SRS-HRQOL","Adolescents","PRO study","Observational"]
[37,"Beausejour, M., et al. (2009). \"Reliability and validity of adapted French Canadian version of Scoliosis Research Society Outcomes Questionnaire (SRS-22) in Quebec.\" Spine (Phila Pa 1976) 34(6): 623-628.",null,"Beausejour, M., et al.","Reliability and validity of adapted French Canadian version of Scoliosis Research Society Outcomes Questionnaire (SRS-22) in Quebec","STUDY DESIGN: Prospective validation study of a cross-cultural adaptation of the Scoliosis Research Society (SRS) Outcomes Questionnaire. OBJECTIVE: To provide a French Canadian version of the SRS Outcomes Questionnaire and to empirically test its response in healthy adolescents and adolescent idiopathic scoliosis (AIS) patients in Quebec. SUMMARY OF BACKGROUND DATA: The SRS Outcomes Questionnaire is widely used for the assessment of health-related quality of life in AIS patients. METHODS: French translation and back-translation of the SRS-22 (SRS-22-fv) were done by an expert committee. Its reliability was measured using the coefficient of internal consistency, construct validity with a factorial analysis, concurrent validity by using the short form-12 and discriminant validity using ANOVA and multivariate linear regression, on 145 AIS patients, 44 patients with non clinically significant scoliosis (NCSS), and 64 healthy patients. RESULTS: The SRS-22-fv showed a good global internal consistency (AIS: Cronbach alpha = 0.86, NCSS: 0.81, and controls: 0.79) and in all of its domains for AIS patients. The factorial structure was coherent with the original questionnaire (47.4% of explained variance). High correlation coefficients were obtained between SRS-22-fv and short form-12 corresponding domains. Boys had higher scores than girls, scores worsened with age, and with increasing body mass index. Mean Total, Pain, Self-image, and Satisfaction scores, were correlated with Cobb angle. Adjusted regression models showed statistically significant differences between the AIS, NCSS, and control groups in the Total, Pain, and Function scores. CONCLUSION: The SRS-22-fv showed satisfactory reliability, factorial, concurrent, and discriminant validity. This study provides scores in a significant group of healthy adolescents and demonstrates a clear gradient in response between subjects with AIS, NCSS, and controls."," Spine (Phila Pa 1976) 34(6): 623-628.","Canada",2009,"Spinal Deformity","Not Specified","SRS-HRQOL,QBPD","Unknown","Tool Validation","Prospective Observation"]
[38,"Begerow, B., et al. (1999). \"Time since vertebral fracture: an important variable concerning quality of life in patients with postmenopausal osteoporosis.\" Osteoporos Int 10(1999): 26-33.",null,"Begerow, B., et al.","Time since vertebral fracture: an important variable concerning quality of life in patients with postmenopausal osteoporosis","The aim of the study was to identify factors affecting patients with postmenopausal osteoporosis who had experienced one or more vertebral fractures. The overall hypothesis was that time after fracture would influence patients' perception of pain and well-being. The sample (50 patients) was split into two groups (group A, time after fracture < or > 24 months; group B, time after fracture >24 months). A fracture was defined as a vertebral height reduction of more than 20% or at least 4 mm. The assessment was carried out using the Spine Deformity Index and was confirmed by an experienced radiologist. To assess quality of life (QoL) the following measures were used: 'well-being scale' including social extroversion as a subscale, pain scale, and limitations in everyday life. The Sense of Coherence questionnaire developed by Antonovsky measures the ability of a person to see life meaningful, manageable and explicable. This questionnaire may reflect patients' coping abilities and was introduced to establish whether these influence the perception of pain and well-being after vertebral fracture. Variance and covariance analysis was carried out using SPSS (version 6.1). Differences between groups A and B were found for perception of average pain (p = 0.017), social extroversion (p = 0.003) and well-being (p = 0.024). No differences were found for limitations in everyday life (p = 0.607), Sense of Coherence (p = 0.638), the Spine Deformity Index (p = 0.171) and loss of height (p = 0.619). All analyses were corrected for age. Concurrent medication was not found to influence the results. Findings suggest that time after fracture is an important variable when considering QoL and well-being after vertebral fracture and should, therefore, be considered in future studies."," Osteoporos Int 10(1999): 26-33.","Germany",1999,"Osteoporosis","Not Specified","SDI","Adults","PRO study","Observational"]
[39,"Berenguera, A., et al. (2011). \"Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial.\" BMC Musculoskelet Disord 12: 194.",null,"Berenguera, A., et al.","Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial","BACKGROUND: Low back pain (LBP), with high incidence and prevalence rate, is one of the most common reasons to consult the health system and is responsible for a significant amount of sick leave, leading to high health and social costs. The objective of the study is to assess the cost-effectiveness and cost-utility analysis of a multidisciplinary biopsychosocial educational group intervention (MBEGI) of non-specific sub-acute LBP in comparison with the usual care in the working population recruited in primary healthcare centres. METHODS/DESIGN: The study design is a cost-effectiveness and cost-utility analysis of a MBEGI in comparison with the usual care of non-specific sub-acute LBP.Measures on effectiveness and costs of both interventions will be obtained from a cluster randomised controlled clinical trial carried out in 38 Catalan primary health care centres, enrolling 932 patients between 18 and 65 years old with a diagnosis of non-specific sub-acute LBP. Effectiveness measures are: pharmaceutical treatments, work sick leave (% and duration in days), Roland Morris disability, McGill pain intensity, Fear Avoidance Beliefs (FAB) and Golberg Questionnaires. Utility measures will be calculated from the SF-12. The analysis will be performed from a social perspective. The temporal horizon is at 3 months (change to chronic LBP) and 12 months (evaluate the outcomes at long term).Assessment of outcomes will be blinded and will follow the intention-to-treat principle. DISCUSSION: We hope to demonstrate the cost-effectiveness and cost-utility of MBEGI, see an improvement in the patients' quality of life, achieve a reduction in the duration of episodes and the chronicity of non-specific low back pain, and be able to report a decrease in the social costs. If the intervention is cost-effectiveness and cost-utility, it could be applied to Primary Health Care Centres. TRIAL REGISTRATION: ISRCTN: ISRCTN58719694."," BMC Musculoskelet Disord 12: 194.","Spain",2011,"Back Pain","Psychosocial","RMDQ","Unknown","Cost-Effectiveness","Clinical trial"]
[40,"Bishop, F. L., et al. (2010). \"A within-subjects trial to test the equivalence of online and paper outcome measures: the Roland Morris disability questionnaire.\" BMC Musculoskelet Disord 11: 113.",null,"Bishop, F. L., et al.","A within-subjects trial to test the equivalence of online and paper outcome measures: the Roland Morris disability questionnaire","BACKGROUND: Augmenting validated paper versions of existing outcome measures with an equivalent online version may offer substantial research advantages (cost, rapidity and reliability). However, equivalence of online and paper questionnaires cannot be assumed, nor can acceptability to respondents. The aim was to test whether online and written versions of the Roland Morris Disability Questionnaire (RMDQ), a standard measure of functional disability in back pain, are equivalent at both group and individual levels to establish whether they can be used interchangeably. METHODS: This is a within-participants equivalence study. 167 participants with back pain fully completed both the paper and online versions of the RMDQ in random order. Participants were recruited from a chiropractic clinic and patient support groups in Southern England. Limits of equivalence were pre-defined as 0.5 RMDQ points, the Bland-Altman range was calculated, and participants' comments were examined using content analysis. RESULTS: The mean score difference was 0.03 (SD = 1.43), with the 95% Confidence Interval falling entirely within our limits of equivalence (-0.19 to 0.25). The Bland-Altman range was -2.77 to 2.83 RMDQ points. Participants identified unique advantages and disadvantages associated with each version of the RMDQ. CONCLUSIONS: The group and individual level data suggest that online and paper versions of the RMDQ are equivalent and can be used interchangeably. The Bland-Altman range appears to reflect the known measurement properties of the RMDQ. Furthermore, participants' comments confirmed the potential value to be had from offering them the choice of completing the RMDQ online or on paper."," BMC Musculoskelet Disord 11: 113.","UK",2010,"Back Pain","Not Specified","RMDQ","Unknown","PRO study","Clinical trial"]
[41,"Borgstrom, F., et al. (2013). \"The impact of different health dimensions on overall quality of life related to kyphoplasty and non-surgical management.\" Osteoporos Int 24(7): 1991-1.",null,"Borgstrom, F., et al.","The impact of different health dimensions on overall quality of life related to kyphoplasty and non-surgical management","UNLABELLED: This study uses data from a previously published randomised trial where balloon kyphoplasty was compared to non-surgical management. Of the improved overall quality of life, 60 % was caused by decreased pain. However, ignoring other dimensions of quality of life would underestimate the procedure's effect. INTRODUCTION: Acute back pain has been viewed as the most important factor lowering quality of life (QoL) for patients suffering vertebral fractures. The objective of this study was to quantify the impact of different health dimensions on overall QoL using patient-reported outcome measurements (PROMs) collected in Fracture Reduction Evaluation (FREE) trial. METHODS: The analysis was based on patients included in the 2-year-long randomised controlled FREE trial studying the efficacy and safety of balloon kyphoplasty procedure (BKP) compared to non-surgical management (NSM). The PROMs included were EQ-5D, Short Form (SF)-36, visual analogue scale (VAS) pain and the Roland-Morris Disability Questionnaire (RMDQ). The health dimensional contribution to the overall QoL improvements was analysed by isolating the impact of each dimension on QoL in the SF-36 and EQ-5D, respectively. A correlation analysis of the QoL improvement was performed to investigate the relationships between the four instruments. RESULTS: Changes in pain explained 60 % of the quality-adjusted life years (QALY) gained in BKP vs. NSM followed by self-care (17 %), mobility (16 %) and usual activities (10 %) (EQ-5D). Health dimensions capturing the mental state had little impact on the QALY gained. The SF-36 dimensional analysis showed similar results. The correlation analysis showed that the correlation between VAS pain, RMDQ and QALY improvement was fairly weak. CONCLUSIONS: Changes in the pain dimension of health are the most important drivers for changes of overall QoL in patients treated with BKP or NSM. However, ignoring the impact of other dimensions would lead to an underestimation of the actual improvement in overall QoL."," Osteoporos Int 24(7): 1991-1.","Sweden",2013,"Spinal Fracture","Surgical","RMDQ","Adults","PRO study","Clinical trial"]
[42,"Boucher, M., et al. (2001). \"Health-related quality of life after short segment instrumentation of lumbar burst fractures.\" J Spinal Disord 14(5): 417-426.",null,"Boucher, M., et al.","Health-related quality of life after short segment instrumentation of lumbar burst fractures","Management of lumbar burst fractures remains controversial. Surgical reduction/stabilization is becoming more popular; however, the functional impact of operative intervention is not clear. The purpose of this study was to assess health-related quality of life and functional outcome after posterior fixation of lumbar burst fractures with either posterolateral or intrabody bone grafting. Twenty-four subjects were included. Radiographs and computed tomography scans were evaluated for deformity (kyphosis, vertebral compression, lateral angulation, lateral body height, and canal compromise) postoperatively, at 1 year, and at final follow-up (mean 3.2 years). Patients completed the SF 36 Health Survey and the Oswestry Low Back Pain Disability Questionnaire at final follow-up. Significant improvement was noted in midsagittal diameter compromise, vertebral compression, and kyphosis. The difference observed between the respondents mean scores on the SF 36 was not significantly different from those presented as the U.S. national average (p = 0.053). Data from the Oswestry questionnaire indicated a similarly high level of function. Overall, we found posterior spinal instrumentation to correlate with positive functional outcome based on both general health (SF 36) and joint-specific outcome scales (Oswestry). Posterior instrumentation provides sound canal decompression, kyphotic reduction, and maintains vertebral height with minimal transgression and long-term sequelae. In cases of severe initial deformity and neurologic compromise, intrabody bone grafting is most certainly indicated; the additional support provided by a posterolateral graft may also prove beneficial as an adjunct."," J Spinal Disord 14(5): 417-426.","Canada",2001,"Back Pain","Surgical","ODI","Adults","PRO study","Observational"]
[43,"Braun, M., et al. (2011). \"Effectiveness of traditional Chinese \"gua sha\" therapy in patients with chronic neck pain: a randomized controlled trial.\" Pain Med 12(3): 362-369.",null,"Braun, M., et al.","Effectiveness of traditional Chinese \"gua sha\" therapy in patients with chronic neck pain: a randomized controlled trial","OBJECTIVE: Gua sha is a traditional East Asian healing technique where the body surface is press-stroked with a smooth-edged instrument to intentionally raise therapeutic petechiae. A traditional indication of Gua sha is neck pain; no data from controlled trials exist to support this claim. The researchers aimed to investigate the effectiveness of Gua sha in the symptomatic treatment of chronic neck pain. DESIGN: The study was designed as an open randomized controlled clinical trial. SETTING: The study was set in Kliniken Essen-Mitte, Academic Teaching Hospital of the University Duisburg-Essen, Germany. SUBJECTS: Forty-eight outpatients (58.5+/-8.0 years; 41 female) with chronic mechanical neck pain were the subjects of the study. INTERVENTION: Patients were randomized into Gua sha (N=24) or control groups (N=24) and followed up for 7 days. Gua sha patients were treated once with Gua sha, while control patients were treated with a local thermal heat pad. OUTCOME MEASURES: Primary outcome was change of neck pain severity after 1 week as assessed by visual analog scale. Secondary outcomes included pain at motion, the neck disability index (NDI) and quality-of-life (Short-Form [36] Health Survey). RESULTS: Neck pain severity after 1 week improved significantly better in the Gua sha group compared with the control group (group difference -29.9 mm, 95% confidence interval: -43.3; -16.6 mm; P<0.001). Significant treatment effects were also found for pain at motion, scores on the NDI, and dimensions of quality-of-life. The treatment was safe and well tolerated. CONCLUSION: Gua sha has beneficial short-term effects on pain and functional status in patients with chronic neck pain. The value of Gua sha in the long-term management of neck pain and related mechanisms remains to be clarified."," Pain Med 12(3): 362-369.","Germany",2011,"Neck Pain","Other","NDI","Adults","PRO study","Clinical trial"]
[44,"Bridwell, K. H., et al. (2007). \"Is the SRS-22 instrument responsive to change in adult scoliosis patients having primary spinal deformity surgery?\" Spine (Phila Pa 1976) 32(20): 2220-2225.",null,"Bridwell, K. H., et al.","Is the SRS-22 instrument responsive to change in adult scoliosis patients having primary spinal deformity surgery?","STUDY DESIGN: Multicenter study. OBJECTIVE: The purpose of this study is to prospectively analyze responsiveness of the SRS-22 to change at 1 and 2 years following primary surgery. SUMMARY OF BACKGROUND DATA: A number of efforts have been directed at validation of the SRS-22 instrument in the setting of adolescent and adult spinal deformity. However, few have extensively analyzed the ability of the instrument to detect change (brought on by surgical treatment) in adult scoliosis patients. METHODS: A multicenter prospective series of consecutive adult scoliosis patients (all primary/no revisions) were administered SRS-22, Oswestry Disability Index (ODI)and Short Form-12 (SF-12) questionnaires preoperation and 1 and 2 years postoperation. Fifty-six patients had preoperative, 1-year postoperative, and 2-year postoperative data. RESULTS: The greatest changes from preoperation to 2-year postoperation were the SRS self-image domain followed by SRS total, SRS pain, and ODI scores. SRS pain and function scores significantly (P < 0.05) improved from 1-year to 2-year postoperation. There were not substantial differences in the outcome measures according to age or curve type. All outcome measures except SF-12 mental health showed statistically significant (P < 0.05) improvement from baseline to 2-year follow-up. CONCLUSION: Based on these 3 outcome tools, the greatest responsiveness to change was demonstrated by the SRS self-image domain followed by SRS total, then SRS pain, then ODI. This suggests that the SRS tool is more responsive than ODI, which is more responsive than SF-12 to change brought on by primary surgical treatment of adult scoliosis patients. Surgical treatment in adult scoliosis significantly improved pain, self-image, and function based on the health-related quality of life measures used in this study."," Spine (Phila Pa 1976) 32(20): 2220-2225.","USA",2007,"Spinal Deformity","Surgical","ODI,SRS-HRQOL","Adults","Tool Validation","Prospective Observation"]
[45,"Briggs, A. M., et al. (2013). \"Low back pain-related beliefs and likely practice behaviours among final-year cross-discipline health students.\" Eur J Pain 17(5): 766-775.",null,"Briggs, A. M., et al.","Low back pain-related beliefs and likely practice behaviours among final-year cross-discipline health students","BACKGROUND: Evidence points to clinicians' beliefs and practice behaviours related to low back pain (LBP), which are discordant with contemporary evidence. While interventions to align beliefs and behaviours with evidence among clinicians have demonstrated effectiveness, a more sustainable and cost-effective approach to positively developing workforce capacity in this area may be to target the emerging workforce. The aim of this study was to investigate beliefs and clinical recommendations for LBP, and their alignment to evidence, in Australian university allied health and medical students. METHODS: Final-year students in chiropractic, medicine, occupational therapy, pharmacy and physiotherapy disciplines in three Western Australian universities responded to a survey. Demographic data, LBP-related beliefs data [modified Health Care Providers Pain and Impact Relationship Scale (HC-PAIRS) and the Back Pain Beliefs Questionnaire (BBQ)] and activity, rest and work clinical recommendations for an acute LBP clinical vignette were collected. RESULTS: Six hundred two students completed the survey (response rate 74.6%). Cross-discipline differences in beliefs and clinical recommendations were observed (p > 0.001). Physiotherapy and chiropractic students reported significantly more helpful beliefs compared with the other disciplines, while pharmacy students reported the least helpful beliefs. A greater proportion of chiropractic and physiotherapy students reported guideline-consistent recommendations compared with other disciplines. HC-PAIRS and BBQ scores were strongly associated with clinical recommendations, independent to the discipline of study and prior experience of LBP. CONCLUSIONS: Aligning cross-discipline university curricula with current evidence may provide an opportunity to facilitate translation of this evidence into practice with a focus on a consistent, cross-discipline approach to LBP management."," Eur J Pain 17(5): 766-775.","Australia",2013,"Back Pain","Physical Therapy","BBQ","Unknown","Cost-Effectiveness","Observational"]
[46,"Broekema, A. E., et al. (2017). \"Study protocol for a randomised controlled multicentre study: the Foraminotomy ACDF Cost-Effectiveness Trial (FACET) in patients with cervical radiculopathy.\" BMJ Open 7(1999): e012829.",null,"Broekema, A. E., et al.","Study protocol for a randomised controlled multicentre study: the Foraminotomy ACDF Cost-Effectiveness Trial (FACET) in patients with cervical radiculopathy","INTRODUCTION: Cervical radiculopathy due to discogenic or spondylotic stenosis of the neuroforamen can be surgically treated by an anterior discectomy with fusion (ACDF) or a posterior foraminotomy (FOR). Most surgeons prefer ACDF, although there are indications that FOR is as effective as ACDF, has a lower complication rate and is less expensive. A head-to-head comparison of the 2 surgical techniques in a randomised controlled trial has not yet been performed. The study objectives of the Foraminotomy ACDF Cost-Effectiveness Trial (FACET) study are to compare clinical outcomes, complication rates and cost-effectiveness of FOR to ACDF. METHODS AND ANALYSIS: The FACET study is a prospective randomised controlled trial conducted in 7 medical centres in the Netherlands. The follow-up period is 2 years. The main inclusion criterion is a radiculopathy of the C4, C5, C6 or C7 nerve root, due to a single-level isolated cervical foraminal stenosis caused by a soft disc and/or osteophytic component, requiring operative decompression. A sample size of 308 patients is required to test the hypothesis of clinical non-inferiority of FOR versus ACDF. Primary outcomes are: 'operative success', the measured decrease in radiculopathy assessed by the visual analogue scale and 'patient success', assessed by the modified Odom's criteria. Secondary outcomes are: Work Ability Index (single-item WAI), quality of life (EuroQol 5 Dimensions 5 level Survey, EQ-5D-5L), Neck Disability Index (NDI) and complications. An economic evaluation will assess cost-effectiveness. In addition, a budget impact analysis will be performed. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Institutional Ethics Committee of the University Medical Center Groningen. Results of this study will be disseminated through national and international papers. The participants and relevant patient support groups will be informed about the results of the study. TRIAL REGISTRATION NUMBER: NTR5536, pre-results."," BMJ Open 7(1999): e012829.","Netherlands",2017,"Radiculopathy,Spondylosis","Surgical","NDI,Odom","Unknown","Cost-Effectiveness","RCT"]
[47,"Brouwer, P. A., et al. (2009). \"Effectiveness of percutaneous laser disc decompression versus conventional open discectomy in the treatment of lumbar disc herniation; design of a prospective randomized controlled trial.\" BMC Musculoskelet Disord 10: 49.",null,"Brouwer, P. A., et al.","Effectiveness of percutaneous laser disc decompression versus conventional open discectomy in the treatment of lumbar disc herniation; design of a prospective randomized controlled trial","BACKGROUND: The usual surgical treatment of refractory sciatica caused by lumbar disc herniation, is open discectomy. Minimally invasive procedures, including percutaneous therapies under local anesthesia, are increasingly gaining attention. One of these treatments is Percutaneous Laser Disc Decompression (PLDD). This treatment can be carried out in an outpatient setting and swift recovery and return to daily routine are suggested. Thus far, no randomized trial into cost-effectiveness of PLDD versus standard surgical procedure has been performed. We present the design of a randomized controlled trial, studying the cost-effectiveness of PLDD versus conventional open discectomy in patients with sciatica from lumbar disc herniation. METHODS/DESIGN: The study is a randomized prospective multi-center trial, in which two treatment strategies are compared in a parallel group design. Patients (age 18-70 years) visiting the neurosurgery department of the participating hospitals, are considered for inclusion in the trial when sciatica due to lumbar disc herniation has lasted more than 8 weeks. Patients with disc herniation smaller than 1/3 of the spinal canal diameter, without concomitant lateral recess stenosis or sequestration, are eligible for participation, and are randomized into one of two treatment arms; either Percutaneous Laser Disc Decompression or conventional discectomy. The functional outcome of the patient, as assessed by the Roland Disability Questionnaire for Sciatica at 8 weeks and 1 year after treatment, is the primary outcome measure. The secondary outcome parameters are recovery as perceived by the patient, leg and back pain, incidence of re-intervention, complications, quality of life, medical consumption, absence of work and secondary costs. DISCUSSION: Open discectomy is still considered to be the golden standard in the surgical treatment of lumbar disc herniation. Whether Percutaneous Laser Disc Decompression has at least as much efficacy as the standard surgical procedure, and is more cost-effective, will be determined by this trial."," BMC Musculoskelet Disord 10: 49.","Netherlands",2009,"Degenerative Disk Disease","Surgical","RMDQ","Adults","Cost-Effectiveness","RCT"]
[48,"Buchbinder, R., et al. (2001). \"2001 Volvo Award Winner in Clinical Studies: Effects of a media campaign on back pain beliefs and its potential influence on management of low back pain in general practice.\" Spine (Phila Pa 1976) 26(23): 2535-2542.",null,"Buchbinder, R., et al.","2001 Volvo Award Winner in Clinical Studies: Effects of a media campaign on back pain beliefs and its potential influence on management of low back pain in general practice","STUDY DESIGN: Quasi-experimental, nonrandomized, nonequivalent, parallel group-controlled study involving before and after telephone surveys of the general population and postal surveys of general practitioners was conducted, with an adjacent state used as a control group. OBJECTIVES: To evaluate the effectiveness of a population-based intervention designed to alter beliefs about back pain, influence medical management, and reduce disability and workers' compensation-related costs. SUMMARY OF BACKGROUND DATA: A multimedia campaign begun during 1997 in Victoria, Australia, positively advised patients with back pain to stay active and exercise, not to rest for prolonged periods, and to remain at work. METHODS: The campaign's impact on population beliefs about back pain and fear-avoidance beliefs was measured in telephone surveys, and the effect of the campaign on the potential management of low back pain by general practitioners was assessed by eliciting their likely approach to two hypothetical scenarios in mailed surveys. Demographically identical population groups in Victoria and the control state, New South Wales, were surveyed at three times: before, during, and after intervention in Victoria. RESULTS: The studies were completed by 4730 individuals in the general population and 2556 general practitioners. There were large statistically significant improvements in back pain beliefs over time in Victoria (mean scores on the Back Beliefs Questionnaire, 26.5, 28.4, and 29.7), but not in New South Wales (26.3, 26.2, and 26.3, respectively). Among those who reported back pain during the previous year, fear-avoidance beliefs about physical activity improved significantly in Victoria (mean scores on the Fear-Avoidance Beliefs Questionnaire for physical activity, 14, 12.5, and 11.6), but not in New South Wales (13.3, 13.6, and 12.7, respectively). General practitioners in Victoria reported significant improvements over time in beliefs about back pain management, as compared with their interstate colleagues. There were statistically significant interactions between state and time for 7 of 10 responses on management of acute low back pain, and for 6 of 10 responses on management of subacute low back pain. CONCLUSION: A population-based strategy of providing positive messages about back pain improves the beliefs of the general population and general practitioners about back pain and appears to influence medical management."," Spine (Phila Pa 1976) 26(23): 2535-2542.","Australia",2001,"Back Pain","Exercise","BBQ","Unknown","PRO study","Clinical trial"]
[49,"Buchbinder, R., et al. (2001). \"Population based intervention to change back pain beliefs and disability: three part evaluation.\" Bmj 322(7301): 1516-1520.",null,"Buchbinder, R., et al.","Population based intervention to change back pain beliefs and disability: three part evaluation","OBJECTIVE: To evaluate the effectiveness of a population based, state-wide public health intervention designed to alter beliefs about back pain, influence medical management, and reduce disability and costs of compensation. DESIGN: Quasi-experimental, non-randomised, non-equivalent, before and after telephone surveys of the general population and postal surveys of general practitioners with an adjacent state as control group and descriptive analysis of claims database. SETTING: Two states in Australia. PARTICIPANTS: 4730 members of general population before and two and two and a half years after campaign started, in a ratio of 2:1:1; 2556 general practitioners before and two years after campaign onset. MAIN OUTCOME MEASURES: Back beliefs questionnaire, knowledge and attitude statements about back pain, incidence of workers' financial compensation claims for back problems, rate of days compensated, and medical payments for claims related to back pain and other claims. RESULTS: In the intervention state beliefs about back pain became more positive between successive surveys (mean improvement in questionnaire score 1.9 (95% confidence interval 1.3 to 2.5), P<0.001 and 3.2 (2.6 to 3.9), P<0.001, between baseline and the second and third survey, respectively). Beliefs about back pain also improved among doctors. There was a clear decline in number of claims for back pain, rates of days compensated, and medical payments for claims for back pain over the duration of the campaign. CONCLUSIONS: A population based strategy of provision of positive messages about back pain improves population and general practitioner beliefs about back pain and seems to influence medical management and reduce disability and workers' compensation costs related to back pain."," Bmj 322(7301): 1516-1520.","Australia",2001,"Back Pain","Not Specified","BBQ","Adults","PRO study","Clinical trial"]
[50,"Bunge, E. M., et al. (2007). \"Health-related quality of life in patients with adolescent idiopathic scoliosis after treatment: short-term effects after brace or surgical treatment.\" Eur Spine J 16(1999): 83-89.",null,"Bunge, E. M., et al.","Health-related quality of life in patients with adolescent idiopathic scoliosis after treatment: short-term effects after brace or surgical treatment","For treatment of teenagers with progressive adolescent idiopathic scoliosis in an early stage, two options are generally considered: treatment with a brace or observation followed by surgery if necessary. Many doctors and patients prefer conservative treatment (i.e. brace treatment) to surgical treatment, because surgery of the spine is generally considered a drastic intervention. Because potential differences in health-related quality of life (HRQoL) after treatment between braced and surgically treated patients are not well explored, this study aimed to determine whether short-term differences exist in HRQoL between adolescents treated with a brace or treated surgically. A cross-sectional analysis of HRQoL was made of 109 patients with adolescent idiopathic scoliosis who, after completing treatment, filled out the Dutch SRS-22 Patient Questionnaire. All patients had been treated either with a brace or surgery, or with a brace followed by surgery. Patients treated surgically had significantly higher mean scores in the satisfaction with management domain than those treated with a brace. No other consistent differences in HRQoL were found between patients treated with a brace and patients treated surgically. Gender, curve type and curve size had no relevant effect on HRQoL. We conclude that short-term differences in HRQoL after treatment in adolescent patients with idiopathic scoliosis are negligible and cannot support preference of one treatment above the other."," Eur Spine J 16(1999): 83-89.","Netherlands",2007,"Spinal Deformity","Surgical","SRS-HRQOL","Unknown","PRO study","Narrative review"]
[51,"Burgstaller, J. M., et al. (2016). \"The Impact of Obesity on the Outcome of Decompression Surgery in Degenerative Lumbar Spinal Canal Stenosis: Analysis of the Lumbar Spinal Outcome Study (LSOS): A Swiss Prospective Multicenter Cohort Study.\" Spine (Phila Pa 1976) 41(1999): 82-89.",null,"Burgstaller, J. M., et al.","The Impact of Obesity on the Outcome of Decompression Surgery in Degenerative Lumbar Spinal Canal Stenosis: Analysis of the Lumbar Spinal Outcome Study (LSOS): A Swiss Prospective Multicenter Cohort Study","STUDY DESIGN: Prospective, multicenter cohort study including 8 medical centers of the Cantons Zurich, Lucerne, and Thurgau, Switzerland. OBJECTIVE: The aim of the study was to assess whether obese patients benefit after decompression surgery for degenerative lumbar spinal stenosis (DLSS). SUMMARY AND BACKGROUND DATA: Lumbar decompression surgery has been shown to improve quality of life in patients with DLSS. In the existing literature, the efficacy of lumbar decompression in the obese population remains controversial. METHODS: Baseline patient characteristics and outcomes were analyzed at 6 and 12 months follow-up with the Spinal Stenosis Measure (SSM), the Numeric Rating Scale (NRS), Feeling Thermometer (FT), the EQ-5D-EL, and the Roland and Morris Disability Questionnaire (RMDQ). Body mass index (BMI) was classified into 3 categories according to the WHO. Minimal clinically important differences (MCIDs) in SSM for different BMI categories were considered as main outcome. RESULTS: Of the 656 patients in the Lumbar Spinal Outcome Study database as of end of October 2014, 166 patients met the inclusion criteria. Fifty (30.1%) had a BMI less than 25 (underweight and normal weight group), 72 (43.4%) had a BMI between 25 and less than 30 (preobesity group), and 44 (26.5%) patients had a BMI at least 30 (obese group). We found for the main outcome that in obese patients 36% reached MCID at 6 months, and 48% at 12 months. The estimated odds ratios for MCID in the obese group were 0.78 (0.34-1.82) at 6 months and 0.99 (0.44-2.23) at 12 months in a logistic regression model adjusting for levels of laminectomy. In the additional outcomes, SSM, NRS, FT, and RMDQ showed statistically significant mean improvements in the 6 and 12 months follow-up. CONCLUSION: Obese patients can expect clinical improvement after lumbar decompression for DLSS, but the percentage of patients with a meaningful improvement is lower than in the group of patients with underweight, normal weight, and preobese weight at 6 and 12 months."," Spine (Phila Pa 1976) 41(1999): 82-89.","Switzerland",2016,"Spinal Deformity","Surgical","RMDQ,SSM","Unknown","PRO study","Prospective Observation"]
[52,"Cairns, M. C., et al. (2006). \"Randomized controlled trial of specific spinal stabilization exercises and conventional physiotherapy for recurrent low back pain.\" Spine (Phila Pa 1976) 31(19): E670-681.",null,"Cairns, M. C., et al.","Randomized controlled trial of specific spinal stabilization exercises and conventional physiotherapy for recurrent low back pain","STUDY DESIGN: Pragmatic, multicentered randomized controlled trial, with 12-month follow-up. OBJECTIVE: To evaluate the effect of adding specific spinal stabilization exercises to conventional physiotherapy for patients with recurrent low back pain (LBP) in the United Kingdom. SUMMARY OF BACKGROUND DATA: Spinal stabilization exercises are a popular form of physiotherapy management for LBP, and previous small-scale studies on specific LBP subgroups have identified improvement in outcomes as a result. METHODS: A total of 97 patients (18-60 years old) with recurrent LBP were recruited. Stratified randomization was undertaken into 2 groups: \"conventional,\" physiotherapy consisting of general active exercise and manual therapy; and conventional physiotherapy plus specific spinal stabilization exercises. Stratifying variables used were laterality of symptoms, duration of symptoms, and Roland Morris Disability Questionnaire score at baseline. Both groups received The Back Book, by Roland et al. Back-specific functional disability (Roland Morris Disability Questionnaire) at 12 months was the primary outcome. Pain, quality of life, and psychologic measures were also collected at 6 and 12 months. Analysis was by intention to treat. RESULTS: A total of 68 patients (70%) provided 12-month follow-up data. Both groups showed improved physical functioning, reduced pain intensity, and an improvement in the physical component of quality of life. Mean change in physical functioning, measured by the Roland Morris Disability Questionnaire, was -5.1 (95% confidence interval -6.3 to -3.9) for the specific spinal stabilization exercises group and -5.4 (95% confidence interval -6.5 to -4.2) for the conventional physiotherapy group. No statistically significant differences between the 2 groups were shown for any of the outcomes measured, at any time. CONCLUSIONS: Patients with LBP had improvement with both treatment packages to a similar degree. There was no additional benefit of adding specific spinal stabilization exercises to a conventional physiotherapy package for patients with recurrent LBP."," Spine (Phila Pa 1976) 31(19): E670-681.","UK",2006,"Back Pain","Exercise","RMDQ","Adults","PRO study","RCT"]
[53,"Cameron, I. D., et al. (2011). \"A randomized trial comparing acupuncture and simulated acupuncture for subacute and chronic whiplash.\" Spine (Phila Pa 1976) 36(26): E1659-1665.",null,"Cameron, I. D., et al.","A randomized trial comparing acupuncture and simulated acupuncture for subacute and chronic whiplash","STUDY DESIGN: A randomized controlled trial with 3 and 6 months follow-up. OBJECTIVE: To compare the effectiveness of acupuncture with simulated acupuncture in patients with subacute and chronic whiplash-associated disorders. SUMMARY OF BACKGROUND DATA: Acupuncture is widely used for the treatment of neck and other musculoskeletal pain, and there is some evidence supporting its effectiveness for short-term pain relief. The effectiveness of acupuncture in the treatment of whiplash-associated disorders is not clear. METHODS: A total of 124 patients between 18 and 65 years with chronic (85%) or subacute whiplash-associated disorders (Grade I or II) were randomly allocated to real or simulated electroacupuncture treatment for 12 sessions during a 6-week period. Both treatments involved skin penetration with acupuncture needles and were provided by a single university-trained acupuncturist in a University Clinic in Sydney, Australia. Primary outcome measures were pain intensity (10-cm visual analog scale), disability (Neck Disability Index), and health-related quality of life (SF-36). Secondary outcomes were patient-specific activity scales, and the McGill Pain Rating Index. RESULTS: Mean initial pain intensity for all participants was 5.6 cm. Participants receiving the real electroacupuncture treatment had significantly greater reduction in pain intensity at 3 and 6 months, 0.9 cm (P = 0.05) and 1.3 cm (P = 0.007), respectively, in comparison to the sham electro-acupuncture group. After adjustment for baseline status, there was no significant reduction in disability, or improvement in health-related quality of life. There was an improvement in the activity scales of a similar size to the reduction in pain, but no difference in the McGill Index. CONCLUSION: Real electroacupuncture was associated with a significant reduction in pain intensity over at least 6 months. This reduction was probably not clinically significant. There was no improvement in disability or quality of life."," Spine (Phila Pa 1976) 36(26): E1659-1665.","Australia",2011,"Trauma","Acupuncture","NDI","Adults","PRO study","RCT"]
[54,"Campbell, L., et al. (2015). \"Trauma-focused cognitive behaviour therapy and exercise for chronic whiplash: protocol of a randomised, controlled trial.\" J Physiother 61(4): 218.",null,"Campbell, L., et al.","Trauma-focused cognitive behaviour therapy and exercise for chronic whiplash: protocol of a randomised, controlled trial","INTRODUCTION: As a consequence of a road traffic crash, persistent pain and disability following whiplash injury are common and incur substantial personal and economic costs. Up to 50% of people who experience a whiplash injury will never fully recover and up to 30% will remain moderately to severely disabled by the condition. The reason as to why symptoms persist past the acute to sub-acute stage and become chronic is unclear, but likely results from complex interactions between structural injury, physical impairments, and psychological and psychosocial factors. Psychological responses related to the traumatic event itself are becoming an increasingly recognised factor in the whiplash condition. Despite this recognition, there is limited knowledge regarding the effectiveness of psychological interventions, either delivered alone or in combination with physiotherapy, in reducing the physical and pain-related psychological factors of chronic whiplash. Pilot study results have shown positive results for the use of trauma-focused cognitive behaviour therapy to treat psychological factors, pain and disability in individuals with chronic whiplash. The results have indicated that a combined approach could not only reduce psychological symptoms, but also pain and disability. AIMS: The primary aim of this randomised, controlled trial is to investigate the effectiveness of combined trauma-focused cognitive behavioural therapy, delivered by a psychologist, and physiotherapy exercise to decrease pain and disability of individuals with chronic whiplash and post-traumatic stress disorder (PTSD). The trial also aims to investigate the effectiveness of the combined therapy in decreasing post-traumatic stress symptoms, anxiety and depression. PARTICIPANTS AND SETTING: A total of 108 participants with chronic whiplash-associated disorder (WAD) grade II of > 3 months and < 5 years duration and PTSD (diagnosed with the Clinician Administered PTSD Scale (CAPS) according to the DSM-5) will be recruited for the study. Participants will be assessed via phone screening and in person at a university research laboratory. Interventions will take place in southeast Queensland, Australia and southern Denmark. INTERVENTION: Psychological therapy will be delivered once a week over 10 weeks, with participants randomly assigned to either trauma-focused cognitive behavioural therapy or supportive therapy, both delivered by a clinical psychologist. Participants will then receive ten sessions of evidence-based physiotherapy exercise delivered over a 6-week period. OUTCOME MEASURES: The primary outcome measure is neck disability (Neck Disability Index). Secondary outcomes focus on: pain intensity; presence and severity of PTSD (CAPS V and PTSD Checklist 5); psychological distress (Depression, Anxiety Stress Scale 21); patient perceived functionality (SF-12, Tampa Scale of Kinesiophobia, and Patient-Specific Functional Scale); and pain-specific self-efficacy and catastrophising (Pain Self-Efficacy Questionnaire and Pain Catastrophizing Scale). After psychotherapy (10 weeks after randomisation) and physiotherapy (16 weeks after randomisation), as well as at the 6-month and 12-month follow-ups, a blind assessor will measure the outcomes. ANALYSIS: All analyses will be conducted on an intention-to-treat basis. The primary and secondary outcomes that are measured will be analysed using linear mixed and logistic regression models. Any effect of site (Australia or Denmark) will be evaluated by including a site-by-treatment group-by-time interaction term in the mixed models analyses. Effect modification will only be assessed for the primary outcome of the Neck Disability Index. DISCUSSION: This study will provide a definitive evaluation of the effects of adding trauma-focused cognitive behaviour therapy to physiotherapy exercise for individuals with chronic WAD and PTSD. This study is likely to influence the clinical management of whiplash injury and will have immediate clinical applicability in Australia, Denmark and the wider international community. The study will also have implications for both health and insurance policy makers in their decision-making regarding treatment options and funding."," J Physiother 61(4): 218.","Australia,Denmark",2015,"Trauma","CBT","NDI","Adults","Cost and Resource Use","Narrative review"]
[55,"Carreon, L. Y., et al. (2011). \"Predicting SF-6D utility scores from the neck disability index and numeric rating scales for neck and arm pain.\" Spine (Phila Pa 1976) 36(6): 490-494.",null,"Carreon, L. Y., et al.","Predicting SF-6D utility scores from the neck disability index and numeric rating scales for neck and arm pain","STUDY DESIGN: Cross-sectional cohort. OBJECTIVE: This study aims to provide an algorithm to estimate Short Form-6D (SF-6D) utilities using data from the Neck Disability Index (NDI), neck pain, and arm pain scores. SUMMARY OF BACKGROUND DATA: Although cost-utility analysis is increasingly used to provide information about the relative value of alternative interventions, health state values or utilities are rarely available from clinical trial data. The Neck Disability Index (NDI) and numerical rating scales for neck and arm pain are widely used disease-specific measures in patients with cervical degenerative disorders. The purpose of this study is to provide an algorithm to allow estimation of SF-6D utilities using data from the NDI, and numerical rating scales for neck and arm pain. METHODS: SF-36, NDI, neck and arm pain rating scale scores were prospectively collected before surgery, at 12 and 24 months after surgery in 2080 patients undergoing cervical fusion for degenerative disorders. SF-6D utilities were computed, and Spearman correlation coefficients were calculated for paired observations from multiple time points between NDI, neck and arm pain scores, and SF-6D utility scores. SF-6D scores were estimated from the NDI, neck and arm pain scores were estimated using a linear regression model. Using a separate, independent dataset of 396 patients in which NDI scores were available, SF-6D was estimated for each subject and compared to their actual SF-6D. RESULTS: The mean age for those in the development sample was 50.4 +/- 11.0 years and 33% were male. In the validation sample, the mean age was 53.1 +/- 9.9 years and 35% were male. Correlations between the SF-6D and the NDI, neck and arm pain scores were statistically significant (P < 0.0001) with correlation coefficients of 0.82, 0.62, and 0.50, respectively. The regression equation using NDI aloneto predict SF-6D had an R of 0.66 and a root mean square error of 0.056. In the validation analysis, there was no statistically significant difference (P 5 0.961) between actual mean SF-6D (0.49 6 0.08) and the estimated mean SF-6D score (0.49 6 0.08), using the NDI regression model. CONCLUSION: This regression-based algorithm may be a useful tool to predict SF-6D scores in studies of cervical degenerative disease that have collected NDI but not utility scores."," Spine (Phila Pa 1976) 36(6): 490-494.","USA",2011,"Neck Pain,Spondylosis","Surgical","NDI","Adults","Tool Validation","Prospective Observation"]
[56,"Carreon, L. Y., et al. (2014). \"Estimating EQ-5D values from the Neck Disability Index and numeric rating scales for neck and arm pain.\" J Neurosurg Spine 21(3): 394-399.",null,"Carreon, L. Y., et al.","Estimating EQ-5D values from the Neck Disability Index and numeric rating scales for neck and arm pain","OBJECT: The Neck Disability Index (NDI) and numeric rating scales (0 to 10) for neck pain and arm pain are widely used cervical spine disease-specific measures. Recent studies have shown that there is a strong relationship between the SF-6D and the NDI such that using a simple linear regression allows for the estimation of an SF-6D value from the NDI alone. Due to ease of administration and scoring, the EQ-5D is increasingly being used as a measure of utility in the clinical setting. The purpose of this study is to determine if the EQ-5D values can be estimated from commonly available cervical spine disease-specific health-related quality of life measures, much like the SF-6D. METHODS: The EQ-5D, NDI, neck pain score, and arm pain score were prospectively collected in 3732 patients who presented to the authors' clinic with degenerative cervical spine disorders. Correlation coefficients for paired observations from multiple time points between the NDI, neck pain and arm pain scores, and EQ-5D were determined. Regression models were built to estimate the EQ-5D values from the NDI, neck pain, and arm pain scores. RESULTS: The mean age of the 3732 patients was 53.3 +/- 12.2 years, and 43% were male. Correlations between the EQ-5D and the NDI, neck pain score, and arm pain score were statistically significant (p < 0.0001), with correlation coefficients of -0.77, -0.62, and -0.50, respectively. The regression equation 0.98947 + (-0.00705 x NDI) + (-0.00875 x arm pain score) + (-0.00877 x neck pain score) to predict EQ-5D had an R-square of 0.62 and a root mean square error (RMSE) of 0.146. The model using NDI alone had an R-square of 0.59 and a RMSE of 0.150. The model using the individual NDI items had an R-square of 0.46 and an RMSE of 0.172. The correlation coefficient between the observed and estimated EQ-5D scores was 0.79. There was no statistically significant difference between the actual EQ-5D score (0.603 +/- 0.235) and the estimated EQ-5D score (0.603 +/- 0.185) using the NDI, neck pain score, and arm pain score regression model. However, rounding off the coefficients to fewer than 5 decimal places produced less accurate results. CONCLUSIONS: The regression model estimating the EQ-5D from the NDI, neck pain score, and arm pain score accounted for 60% of the variability of the EQ-5D with a relatively large RMSE. This regression model may not be sufficient to accurately or reliably estimate actual EQ-5D values."," J Neurosurg Spine 21(3): 394-399.","USA",2014,"Spine Disease,Neck Pain","Not Specified","NDI","Adults","PRO study","Prospective Observation"]
[57,"Carrico, G., et al. (2012). \"Cross-cultural adaptation and validity of an adapted Brazilian Portuguese version of Scoliosis Research Society-30 questionnaire.\" Spine (Phila Pa 1976) 37(1999): E60-63.",null,"Carrico, G., et al.","Cross-cultural adaptation and validity of an adapted Brazilian Portuguese version of Scoliosis Research Society-30 questionnaire","STUDY DESIGN: Prospective clinical study developed at a tertiary teaching facility to test an adapted Brazilian Portuguese version of the Scoliosis Research Society-30 (SRS-30) questionnaire. OBJECTIVE: To perform cross-cultural adaptation and evaluate the validity of the adapted Brazilian Portuguese version of SRS-30 questionnaire. SUMMARY OF BACKGROUND DATA: Quality-of-life measurement is a common practice to assess spine diseases. The SRS questionnaires have been proven to be a valid tool in the clinical evaluation of patients diagnosed with idiopathic scoliosis in United States. However, adaptation into languages other than the source language is necessary to allow multinational use respecting cultural and lingual differences. METHODS: A translation/retranslation of the English version of the SRS-30 into Brazilian Portuguese was conducted, and all steps for cross-cultural adaptation process were performed, including a pretest with 20 patients. Sixty-four postoperative patients were submitted to the final version of the Brazilian SRS-30 questionnaire, through oral interviews. The average age of all patients who joined the study was 18.5 years. Internal consistency of the instrument was determined with Cronbach alpha coefficient. RESULTS: The study demonstrated high Cronbach alpha values for 4 of the corresponding domains (pain, 0.68; self-image, 0.75; mental health, 0.78; and function/activity, 0.57). However, the Cronbach alpha value for satisfaction domain (0.28) was considerably lower than the original English questionnaire. The overall Cronbach alpha values achieved 0.85 for all domains. CONCLUSION: The adapted Brazilian version of the SRS-30 questionnaire can be used to assess the outcome of treatment for Brazilian Portuguese-speaking patients with idiopathic scoliosis."," Spine (Phila Pa 1976) 37(1999): E60-63.","Brazil",2012,"Spinal Deformity","Surgical","SRS-HRQOL","Adults","Tool Validation","Prospective Observation"]
[58,"Castro-Sanchez, A. M., et al. (2016). \"Benefits of Craniosacral Therapy in Patients with Chronic Low Back Pain: A Randomized Controlled Trial.\" J Altern Complement Med 22(8): 650-657.",null,"Castro-Sanchez, A. M., et al.","Benefits of Craniosacral Therapy in Patients with Chronic Low Back Pain: A Randomized Controlled Trial","OBJECTIVES: To evaluate the effects of craniosacral therapy on disability, pain intensity, quality of life, and mobility in patients with low back pain. DESIGN: A single-blinded randomized controlled trial. PATIENTS: Sixty-four patients with chronic nonspecific low back pain (mean age +/- SD, 50 +/- 12 years; 66% female) who were referred for physical therapy at a clinical unit of the Health Science School of the University of Almeria (Spain). INTERVENTIONS: Participants were randomly assigned to an experimental group (10 sessions of craniosacral therapy) or a control group (10 sessions of classic massage). OUTCOME MEASURES: Disability (Roland Morris Disability Questionnaire [RMQ, primary outcome] and Oswestry Disability Index), pain intensity (10-point numeric pain rating scale), kinesiophobia (Tampa Scale of Kinesiophobia), isometric endurance of trunk flexor muscles (McQuade test), lumbar mobility in flexion, hemoglobin oxygen saturation, systolic blood pressure, diastolic blood pressure, hemodynamic measures (cardiac index), and biochemical estimation of interstitial fluid. These outcomes were registered at baseline, after treatment, and 1-month follow-up. RESULTS: No statistically significant differences were seen between groups for the main outcome of the study, the RMQ (p = 0.060). However, patients receiving craniosacral therapy experienced greater improvement in pain intensity (p </= 0.008), hemoglobin oxygen saturation (p </= 0.028), and systolic blood pressure (p </= 0.029) at immediate- and medium-term and serum potassium (p = 0.023) level and magnesium (p = 0.012) at short-term than those receiving classic massage. CONCLUSIONS: Ten sessions of craniosacral therapy resulted in a statistically greater improvement in pain intensity, hemoglobin oxygen saturation, systolic blood pressure, serum potassium, and magnesium level than did 10 sessions of classic massage in patients with low back pain."," J Altern Complement Med 22(8): 650-657.","Spain",2016,"Back Pain","Physical Therapy","ODI,RMDQ","Adults","PRO study","RCT"]
[59,"Celenay, S. T., et al. (2016). \"A Comparison of the Effects of Stabilization Exercises Plus Manual Therapy to Those of Stabilization Exercises Alone in Patients With Nonspecific Mechanical Neck Pain: A Randomized Clinical Trial.\" J Orthop Sports Phys Ther 46(2): 44-55.",null,"Celenay, S. T., et al.","A Comparison of the Effects of Stabilization Exercises Plus Manual Therapy to Those of Stabilization Exercises Alone in Patients With Nonspecific Mechanical Neck Pain: A Randomized Clinical Trial","STUDY DESIGN: Randomized clinical trial. BACKGROUND: Little is known about the efficacy of providing manual therapy in addition to cervical and scapulothoracic stabilization exercises in people with mechanical neck pain (MNP). Objectives To compare the effects of stabilization exercises plus manual therapy to those of stabilization exercises alone on disability, pain, range of motion (ROM), and quality of life in patients with MNP. METHODS: One hundred two patients with MNP (18-65 years of age) were recruited and randomly allocated into 2 groups: stabilization exercise without (n = 51) and with (n = 51) manual therapy. The program was carried out 3 days per week for 4 weeks. The Neck Disability Index, visual analog pain scale, digital algometry of pressure pain threshold, goniometric measurements, and Medical Outcomes Study 36-Item Short-Form Health Survey were used to assess participants at baseline and after 4 weeks. RESULTS: Improvements in Neck Disability Index score, night pain, rotation ROM, and the Medical Outcomes Study 36-Item Short-Form Health Survey score were greater in the group that received stabilization exercise with manual therapy compared to the group that only received stabilization exercise. Between-group differences (95% confidence interval) were 2.2 (0.1, 4.3) points for the Neck Disability Index, 1.1 (0.0, 2.3) cm for pain at night measured on the visual analog scale, -4.3 degrees (-8.1 degrees , -0.5 degrees ) and -5.0 degrees (-8.2 degrees , -1.7 degrees ) for right and left rotation ROM, respectively, and -2.9 (-5.4, -0.4) points and -3.1 (-6.2, 0.0) points for the Medical Outcomes Study 36-Item Short-Form Health Survey physical and mental components, respectively. Changes in resting and activity pain, pressure pain threshold, and cervical extension or lateral flexion ROM did not differ significantly between the groups. Pressure pain threshold increased only in those who received stabilization exercise with manual therapy (P<.05). CONCLUSION: The results of this study suggest that stabilization exercises with manual therapy may be superior to stabilization exercises alone for improving disability, pain intensity at night, cervical rotation motion, and quality of life in patients with MNP. LEVEL OF EVIDENCE: Therapy, level 1b."," J Orthop Sports Phys Ther 46(2): 44-55.","Unknown",2016,"Neck Pain","Exercise","NDI","Adults","PRO study","RCT"]
[60,"Challier, B., et al. (2001). \"Is quality of life affected by season and weather conditions in ankylosing spondylitis?\" Clin Exp Rheumatol 19(3): 277-281.",null,"Challier, B., et al.","Is quality of life affected by season and weather conditions in ankylosing spondylitis?","OBJECTIVE: To examine the links between the quality of life (QOL) and season and weather conditions in ankylosing spondylitis (AS) patients. METHODS: A cohort of 146 AS patients (67% males), with a mean age of 47.3 years and a mean disease duration of 12.8 years, answered a self-administered questionnaire, the AS-AIMS2 validated for AS, 4 times over a period of one year in a postal survey. Clinical measures were assessed in a subsample of the cohort. Meterological data including daily temperature, hygrometry, wind speed and atmospheric pressure were collected over the same period. RESULTS: In this cohort, 106 patients completed the follow-up. A higher lumbar spine flexibility (Schober index) was associated with a higher climatic temperature and lower wind speed. Physical QOL improved in the summer, as did Social Interaction in the summer and fall, while Role QOL decreased in winter. A lower perceived QOL was significantly associated with a higher temperature and wind speed over the past 4 weeks, and with a higher hygrometry and atmospheric pressure over the past 2 days prior to completion of the questionnaire. CONCLUSION: This study provides some support to the popular belief and frequent patient complaints of a link between health status and perceived quality of life, as assessed by a specific questionnaire, with season and weather conditions."," Clin Exp Rheumatol 19(3): 277-281.","France",2001,"Spondylosis","Not Specified","Schober","Adults","PRO study","Prospective Observation"]
[61,"Chamorro Comesana, A., et al. (2017). \"Effect of myofascial induction therapy on post-c-section scars, more than one and a half years old. Pilot study.\" J Bodyw Mov Ther 21(1999): 197-204.",null,"Chamorro Comesana, A., et al.","Effect of myofascial induction therapy on post-c-section scars, more than one and a half years old. Pilot study","Myofascial Induction Therapy (MIT) is a manually-applied method used in physiotherapy and focused on restoring altered fascial tissue. In a healthy body, the fascial system maintains elasticity and coordination of movements. However, injuries and their after-effects, such as scars, may reduce this tissue role, causing a dysfunction. The aim of this study is to ascertain the effect of MIT on scars which have completed the repair process in healthy individuals without any associated pathology that might affect the healing process. In all 10 cases studied, changes were observed after applying MIT on the structure of the scar fold, both at deep (shown by ultrasound) and at superficial (shown by scar fold measurement) levels. Eight weekly MIT sessions were applied, establishing this number as a reference for future studies. Functional improvement was determined using Schober's Test and patient quality of life was measured with a specific questionnaire. These outcomes lay the groundwork for future research."," J Bodyw Mov Ther 21(1999): 197-204.","Spain",2017,"Unspecified","Physical Therapy","Schober","Unknown","PRO study","Prospective Observation"]
[62,"Chapman, J. R., et al. (2011). \"Evaluating common outcomes for measuring treatment success for chronic low back pain.\" Spine (Phila Pa 1976) 36(21 Suppl): S54-68.",null,"Chapman, J. R., et al.","Evaluating common outcomes for measuring treatment success for chronic low back pain","STUDY DESIGN: Systematic review. OBJECTIVE: To identify, describe, and evaluate common outcome measures in patients with chronic low back pain (CLBP). SUMMARY OF BACKGROUND DATA: The treatment of CLBP has been associated with multiple clinical challenges. Further complicating this is the myriad of outcome scores used to assess treatment of CLBP. These scores have been used to examine different domains of patient satisfaction and quality of life in the literature. Critical assessment of the frequency, parity, and the quality of these outcomes are essential to improve our understanding of CLBP. METHODS: A systematic review of the English-language literature was undertaken for articles published from January 2001 through December 31, 2010. Electronic databases and reference lists of key articles were searched to identify measures used to evaluate outcomes in six different domains in patients with CLBP. The titles and abstracts of the peer-reviewed literature of LBP were searched to determine which of these measures were most commonly reported in the literature and which have been validated in populations with CLBP. RESULTS: We identified 75 outcome measures cited to evaluate CLBP. Twenty-nine of these outcome measures were excluded because of only a single citation leaving 46 measures for the evaluation. The most commonly used functional outcomes were the Oswestry Disability Index, Roland Morris Disability Index, and range of motion. For pain, the Numeric Pain Rating Scale, Brief Pain Inventory, Pain Disability Index, McGill Pain Questionnaire, and visual analog scale were most commonly cited. For psychosocial function, the Fear Avoidance Beliefs Questionnaire, Tampa Scale for Kinesiophobia, and Beck Depression Inventory were most commonly used. For generic quality of life, short form 36, Nottingham Health Profile, short form 12, and Sickness Impact Profile were the most common measures. For objective measures, the work status/return to work, complications or adverse events, and medications used were the most commonly cited. For preference-based measures, the Euro-Quol 5 dimensions and short form 6 dimensions were most commonly cited. The validity, reliability, responsiveness, universality, and potential proprietary requirements are summarized for each. CONCLUSION: Outcome measures should be routinely assessed in patients with CLBP. The choice of appropriate outcome measure should be influenced by the study objectives and design, as well as properties of the particular measure within the context of CLBP. CLINICAL RECOMMENDATIONS: Recommendation 1: When selecting the appropriate outcome measures for clinical or research purposes, consider domains that best measure what are most important to patients. Measures that are valid, reliable, and responsive to change should be considered first. Other considerations include the number of items required (especially in the context of multiple measures), whether the measure is validated in the relevant language, and the associated costs or fees. Strength: Strong Recommendation 2: Domains of greatest importance include pain, function, and quality of life. If cost utilization is a priority, then preference-based measures should be considered. For pain, we recommend the VAS and NRPS because of their ease of administration and responsiveness. For function, we recommend the ODI and RMDQ. The SF-36 and its shorter versions are most commonly used and should be considered if quality of life is important. If cost utility is important, consider the EQ-5D or SF-6D. Psychosocial tests are best used as screening tools prior to surgery because of their lack of responsiveness. Complications should always be assessed as a standard of clinical practice. Return to work and medication use are complicated outcome measures and not recommended unless the specific study question is focused on these domains. Consider staff and patient burden when prioritizing one's battery of measures."," Spine (Phila Pa 1976) 36(21 Suppl): S54-68.","USA",2011,"Back Pain","Surgical","ODI,RMDQ","Unknown","PRO study","Systematic review"]
[63,"Checchia, G. A., et al. (2017). \"Observational multicentric study on chronic sciatic pain: clinical data from 44 Italian centers.\" Eur Rev Med Pharmacol Sci 21(7): 1653-1664.",null,"Checchia, G. A., et al.","Observational multicentric study on chronic sciatic pain: clinical data from 44 Italian centers","OBJECTIVE: To provide information on the clinical presentation of sciatic neuropathy and its management in a real-world setting, and to analyze the effects of a multimodal approach based on the association of physical and pharmacological therapy. PATIENTS AND METHODS: A multicentric observational prospective study was conducted in 44 Italian tertiary centers specialized in Physical Medicine and Rehabilitation, Orthopedics, Neurology, Neurosurgery, and Rheumatology. To develop a shared management of LPB with sciatica, a dedicated clinical record was proposed to collect data about diagnosis, treatment, and outcomes. Pain, disability, and quality of life were recorded trough validated questionnaires at baseline and after a two-month follow-up. RESULTS: 394 patients (age, mean +/- SD 55.7 +/- 14.1 years, 57.1% females) with chronic LBP and sciatica were enrolled in the study. The characteristics of the selected group showed a certain variability in the clinical presentation. At baseline, patients received several different therapeutic options among physical, pharmacological and neurotrophic treatments. A subgroup of 312 patients was treated with a combination of neurotrophic agents containing alpha-lipoic acid (ALA). After a two-month follow-up, a general improvement in both perceived pain and functional disabilities was observed. A significant improvement (p < 0.001) in the Pain Numeric Rating Scale (NRS), Roland e Morris Disability Questionnaire (RMDQ) and Brief Pain Inventory (BPI) Italian short version was observed. CONCLUSIONS: Sciatic neuropathy is a multifaceted condition managed by means of a wide spectrum of therapeutic options. The results of this study suggest that a multimodal approach based on the association of ALA with physical and pharmacological therapies can be beneficial in the treatment of LBP with sciatica."," Eur Rev Med Pharmacol Sci 21(7): 1653-1664.","Italy",2017,"Degenerative Disk Disease","Surgical","RMDQ","Adults","PRO study","Narrative review"]
[64,"Chen, C. Y., et al. (2015). \"Is rehabilitation intervention during hospitalization enough for functional improvements in patients undergoing lumbar decompression surgery? A prospective randomized controlled study.\" Clin Neurol Neurosurg 129 Suppl 1: S41-46.",null,"Chen, C. Y., et al.","Is rehabilitation intervention during hospitalization enough for functional improvements in patients undergoing lumbar decompression surgery? A prospective randomized controlled study","OBJECTIVE: Rehabilitation has been reported to improve pain and disability for patients after lumbar surgery. However, studies to investigate the rehabilitation intervention for lumbar decompression surgery during hospitalization are scarce. The aim of this study was to examine outcomes of perioperative rehabilitation intervention for patients who underwent lumbar decompression surgery (LDS). METHODS: Patients aged 18-65 years old who received their first LDS were randomized into the perioperative rehabilitation group (PG) or control group (CG). The PG received rehabilitation intervention during hospitalization for lumbar decompression surgery. Pain, functional capacity, Roland-Morris Disability Questionnaire (RMDQ), and Short-Form Health Survey (SF-12) were assessed on admission, at discharge, and at follow-ups one month, three months, and six months after surgery. Two-way repeated measures ANOVAs were used for statistical analysis. RESULTS: A total of 60 patients scheduled for decompression surgery for lumbar stenosis were enrolled into the study. After surgery, the PG showed significant pain relief and improvement of disability as well as quality of life, but there were no significant functional improvements compared with the CG. CONCLUSIONS: The findings of this study indicate that the rehabilitation intervention during hospitalization improves pain intensity as well as disability and quality of life, yet has limited effects on the functional performance over time up to six months post-surgery in patients who received LDS. The study suggest that rehabilitation interventions during hospitalization must include regular support for patient adherence to the intervention program and focus on task-oriented programs for lower extremities such as closed-chain exercises in functional postures."," Clin Neurol Neurosurg 129 Suppl 1: S41-46.","Taiwan",2015,"Spine Disease","Surgical","RMDQ","Adults","PRO study","RCT"]
[65,"Cheng, I., et al. (2005). \"Apical sublaminar wires versus pedicle screws--which provides better results for surgical correction of adolescent idiopathic scoliosis?\" Spine (Phila Pa 1976) 30(18): 2104-2112.",null,"Cheng, I., et al.","Apical sublaminar wires versus pedicle screws--which provides better results for surgical correction of adolescent idiopathic scoliosis?","STUDY DESIGN: The results of correction for adolescent idiopathic scoliosis (AIS) were compared using apical sublaminar wires versus pedicle screws. OBJECTIVE: To compare comprehensively the 2-year minimum postoperative results of posterior correction and spinal fusion using translational correction through either hybrid hook/sublaminar wire/pedicle screw constructs versus in situ rod-contouring correction with pedicle screw constructs in the treatment of AIS at 2 institutions. SUMMARY OF BACKGROUND DATA: Despite the reports of satisfactory correction of scoliotic curves by both apical (sublaminar wire) instrumentation and apical pedicle screw instrumentation, to our knowledge, no reports on the comprehensive comparison of hybrid (hook/sublaminar wire/pedicle screw) instrumentation versus segmental pedicle screw instrumentation exist. METHODS: A total of 50 patients with AIS at 2 institutions who underwent posterior spinal fusion with sublaminar wire (25 patients) or pedicle screw (25) constructs were sorted and matched according to 4 criteria: (1999) similar age at surgery (14.2 years in the sublaminar wire and 14.4 in the pedicle screw group, P = 0.72); (2) similar number of fused vertebrae (11.4 in the sublaminar wire and 11.8 in the pedicle screw group, P = 0.36); (3) similar operative methods; and (4) identical Lenke curve types and similar preoperative major curve measurements (63.5 degrees in the sublaminar wire and 59.5 degrees in the pedicle screw group, P = 0.42). Patients were evaluated preoperatively, immediately postoperatively, and at 2-year follow-up according to radiographic changes in curve correction, operating time, intraoperative blood loss, implant costs, and the Scoliosis Research Society patient questionnaire (SRS-24) scores. RESULTS: After surgery, average major curve correction was 67.4% in the sublaminar wire and 68.1% in the pedicle screw group (P = 0.56). At 2-year follow-up, loss of the major curve correction was 4.6% in the sublaminar wire compared to 5.1% in the pedicle screw group (P = 0.79). Postoperative global coronal and sagittal balance were similar in both groups. No significant difference was found in the average number of levels fused from the distal end vertebra (1.48 in the sublaminar wire and 0.64 in the pedicle screw group, P = 0.21). Operating time averaged 350 minutes in the sublaminar wire and 357 in the pedicle screw group (P = 0.86). Intraoperative blood loss was significantly different in both groups (1791 +/- 816 mL in the sublaminar wire and 824 +/- 440 mL in the pedicle screw group) (P = 0.0003). Average implant cost in the sublaminar wire group (16.0 fixation points; 8,341 US dollars) was significantly lower than that of the pedicle screw group (17.1 fixation points; 13,462 US dollars) (P < 0.0001). Postoperative 2-year SRS-24 scores were similar in both groups (sublaminar wire = 107.3, pedicle screw = 103.5, P = 0.19). There were no neurologic or visceral complications related to sublaminar wire or pedicle screw instrumentation and no reoperations at a minimum 2-year follow-up. CONCLUSIONS: Apical sublaminar wire and pedicle screw instrumentation both offer similar major curve correction with similar fusion lengths without neurologic problems in the operative treatment of AIS. Although more expensive, pedicle screw constructs had significantly less blood loss and slightly shorter fusion lengths than the sublaminar wire constructs."," Spine (Phila Pa 1976) 30(18): 2104-2112.","USA",2005,"Spinal Deformity,Spinal Fusion","Surgical","SRS-HRQOL","Adolescents","Tool Validation","Prospective Observation"]
[66,"Cherkin, D. C., et al. (2014). \"Comparison of complementary and alternative medicine with conventional mind-body therapies for chronic back pain: protocol for the Mind-body Approaches to Pain (MAP) randomized controlled trial.\" Trials 15: 211.",null,"Cherkin, D. C., et al.","Comparison of complementary and alternative medicine with conventional mind-body therapies for chronic back pain: protocol for the Mind-body Approaches to Pain (MAP) randomized controlled trial","BACKGROUND: The self-reported health and functional status of persons with back pain in the United States have declined in recent years, despite greatly increased medical expenditures due to this problem. Although patient psychosocial factors such as pain-related beliefs, thoughts and coping behaviors have been demonstrated to affect how well patients respond to treatments for back pain, few patients receive treatments that address these factors. Cognitive-behavioral therapy (CBT), which addresses psychosocial factors, has been found to be effective for back pain, but access to qualified therapists is limited. Another treatment option with potential for addressing psychosocial issues, mindfulness-based stress reduction (MBSR), is increasingly available. MBSR has been found to be helpful for various mental and physical conditions, but it has not been well-studied for application with chronic back pain patients. In this trial, we will seek to determine whether MBSR is an effective and cost-effective treatment option for persons with chronic back pain, compare its effectiveness and cost-effectiveness compared with CBT and explore the psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes. METHODS/DESIGN: In this trial, we will randomize 397 adults with nonspecific chronic back pain to CBT, MBSR or usual care arms (99 per group). Both interventions will consist of eight weekly 2-hour group sessions supplemented by home practice. The MBSR protocol also includes an optional 6-hour retreat. Interviewers masked to treatment assignments will assess outcomes 5, 10, 26 and 52 weeks postrandomization. The primary outcomes will be pain-related functional limitations (based on the Roland Disability Questionnaire) and symptom bothersomeness (rated on a 0 to 10 numerical rating scale) at 26 weeks. DISCUSSION: If MBSR is found to be an effective and cost-effective treatment option for patients with chronic back pain, it will become a valuable addition to the limited treatment options available to patients with significant psychosocial contributors to their pain. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01467843."," Trials 15: 211.","USA",2014,"Back Pain","CBT","RMDQ,Bothersomeness","Unknown","PRO study","Narrative review"]
[67,"Cheung, K. M., et al. (2007). \"Outcome assessment of bracing in adolescent idiopathic scoliosis by the use of the SRS-22 questionnaire.\" Int Orthop 31(4): 507-511.",null,"Cheung, K. M., et al.","Outcome assessment of bracing in adolescent idiopathic scoliosis by the use of the SRS-22 questionnaire","The SRS-22 questionnaire is specifically designed for the assessment of quality of life in spinal deformity patients. This study is the first to use it to assess the quality of life of adolescent idiopathic scoliosis patients under brace treatment and compares the results with an observational group matched by age and curve magnitude. Forty-six patients were enrolled into each group. Overall, it was found that patients under observation had a significantly better quality of life than braced patients. Specifically, the domains for function/activity and self-image were most affected. This effect was most apparent in those with a curve magnitude of under 20 degrees . The scores did not improve significantly with the duration of brace wear, suggesting little adaptation. This study has implications for treatment, and more attention will need to be given to those with mild but progressive curves to help improve patients' understanding of their treatment and hence their compliance and satisfaction."," Int Orthop 31(4): 507-511.","China",2007,"Spinal Deformity","Brace","SRS-HRQOL","Adolescents","PRO study","Prospective Observation"]
[68,"Cheung, K. M., et al. (2007). \"Reliability and concurrent validity of the adapted Chinese version of Scoliosis Research Society-22 (SRS-22) questionnaire.\" Spine (Phila Pa 1976) 32(10): 1141-1145.",null,"Cheung, K. M., et al.","Reliability and concurrent validity of the adapted Chinese version of Scoliosis Research Society-22 (SRS-22) questionnaire","STUDY DESIGN: Validation study to define validity and reliability of an adapted and translated questionnaire. OBJECTIVE: Assessment of the concurrent validity and reliability of a Chinese version of SRS-22 outcome instrument. SUMMARY OF BACKGROUND DATA: No valid health-related quality of life (HRQL) outcome instrument exists for patients with spinal deformity in Chinese. The modified SRS-22 questionnaire was proven to be an appropriate outcome instrument in English, and has already been translated and validated in several other languages. METHODS: The English version of the SRS-22 questionnaire was adapted to Chinese according to the International Quality of Life Assessment Project guidelines. To assess reliability, 48 subjects with adolescent idiopathic scoliosis (mean age, 16.5 years) filled the questionnaire on 2 separate occasions (Group 1). To assess concurrent validity, 50 subjects (mean age, 21 years) filled in the same questionnaire and a previously validated Chinese version of the Short Form-36 (SF36) questionnaire (Group 2). Internal consistency, reproducibility and concurrent validity were determined with Cronbach's alpha coefficient, interclass correlation coefficient and Pearson correlation coefficient, respectively. RESULTS: Cronbach's alpha coefficient for the 4 major domains (function/activity, pain, self-image/appearance and mental health) were high. Intraclass correlation was also excellent for all domains. For concurrent validity, excellent correlation was found in 1 domain, good in 12 domains, moderate in 3 domains, and poor in 1 domain of the 17 relevant domains. DISCUSSION: Both cultural adaptation and linguistic translation are essential in any attempt to use a HRQL questionnaire across cultures. The Chinese version of the SRS-22 outcome instrument has satisfactory internal consistency and excellent reproducibility. It is ready for use in clinical studies on idiopathic scoliosis in Chinese-speaking societies."," Spine (Phila Pa 1976) 32(10): 1141-1145.","China",2007,"Spinal Deformity","Not Specified","SRS-HRQOL","Adolescents","Tool Validation","Observational"]
[69,"Chien, A., et al. (2014). \"Translation, cross-cultural adaptation, and validation of a Chinese version of the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire.\" Spine (Phila Pa 1976) 39(12): 963-970.",null,"Chien, A., et al.","Translation, cross-cultural adaptation, and validation of a Chinese version of the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire","STUDY DESIGN: Translation and psychometric testing of a questionnaire. OBJECTIVE: To adapt the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ) cross-culturally to Chinese language and to investigate the psychometric properties of the translated Chinese JOACMEQ. SUMMARY OF BACKGROUND DATA: The recently developed JOACMEQ is a self-reported questionnaire used to assess the severity of the cervical spondylotic myelopathy. Despite its acceptance in the literature, the JOACMEQ has not been translated and validated for Chinese-speaking patients. METHODS: Translation and cross-cultural adaptation of the original JOACMEQ was performed according to published guidelines. A total of 105 patients with a predominant complain of neck pain that included but not limited to patients with a clinically confirmed cervical spondylotic myelopathy were included. Psychometric testing of the responses included construct validity (factor analysis), internal consistency (Cronbach alpha), test-retest reproducibility (intraclass correlation coefficient), and concurrent validity (Spearman rho). The discriminatory power of differentiating those with myelopathy from those without was assessed by the area under the receiver operating characteristic curve and with the optimal cutoff points determined. RESULTS: Construct validity testing revealed a comparable factorial structure of the Chinese JOACMEQ with the original JOACMEQ. The Cronbach alpha of the Chinese JOACMEQ was 0.88, indicating good internal consistency. Good to excellent test-retest reliability was demonstrated for all 5 domain scores (intraclass correlation coefficient range = 0.79-0.90). A significant strong association between the Chinese Neck Disability Index and the quality of life domain of the Chinese JOACMEQ (Spearman rho= -0.76, P < 0.01) was identified. The upper and lower extremity function domain scores were found to be significant, with the area under the receiver operating characteristic curve found to be 0.75 (P = 0.04) and 0.82 (P = 0.02), respectively. CONCLUSION: The results indicated that the Chinese JOACMEQ successfully retained the psychometric properties of the original JOACMEQ and support the usefulness of the Chinese JOACMEQ as an appropriate supplementary diagnostic and outcome measure for Chinese patients suspected of cervical spondylotic myelopathy."," Spine (Phila Pa 1976) 39(12): 963-970.","Taiwan",2014,"Spondylosis,Cervical Myelopathy,Neck Pain","Not Specified","JOACMEQ","Unknown","Tool Validation","Observational"]
[70,"Chino, B., et al. (2009). \"Subjective assessments of the quality of life, well-being and self-efficacy in patients with schizophrenia.\" Psychiatry Clin Neurosci 63(4): 521-528.",null,"Chino, B., et al.","Subjective assessments of the quality of life, well-being and self-efficacy in patients with schizophrenia","AIM: The present study examined three kinds of subjective assessment scales in the same patient group with schizophrenia to analyze the correlations among scores obtained in relation to the background data. METHOD: Thirty-six patients with schizophrenia were examined with the 26-item short form of the World Health Organization Quality of Life (WHO-QOL 26), Subjective Well-being under Neuroleptic drug treatment: Short Japanese version (SWNS) and Self-Efficacy for Community Life scale (SECL) for subjective assessment scales, five kinds of neurocognitive tests, Positive and Negative Syndrome Scale (PANSS) for clinical symptom, Social Functioning Scale (SFS), and Global Assessment of Functioning (GAF) scale for social functioning. RESULT: The scores for delusions (components of positive syndrome), anxiety and depression (components of general psychopathology) on the PANSS significantly correlated with QoL and subjective well-being scores. In contrast, the scores for components of negative syndrome were not correlated with the subjective assessment scores. Furthermore, none of the clinical symptom scores were correlated with the score in self-efficacy scale. The SFS and GAF scores were significantly correlated with the subjective assessment scores. There were significant correlations among the scores on the three subjective assessment scales. CONCLUSION: Each scale has different features and should be utilized depending upon the expected effect of treatment or the purpose of assessment. The treatments provided to patients must be directed at improving both psychological and social impairments, in order to enhance the social functioning and QoL of patients."," Psychiatry Clin Neurosci 63(4): 521-528.","Japan",2009,"Schizophrenia","Psychosocial","SWNS","Unknown","PRO study","Observational"]
[71,"Chotai, S., et al. (2015). \"Quality of Life and General Health After Elective Surgery for Cervical Spine Pathologies: Determining a Valid and Responsive Metric of Health State Utility.\" Neurosurgery 77(4): 553-560; discussion 560.",null,"Chotai, S., et al.","Quality of Life and General Health After Elective Surgery for Cervical Spine Pathologies: Determining a Valid and Responsive Metric of Health State Utility","BACKGROUND: As part of the Affordable Care Act, health utility metrics are being investigated to define a cost-effective, value-based health care model. EuroQOL-5D (EQ-5D) and Short Form-6D (SF-6D) are commonly used quality-of-life instruments. Domains in the EQ-5D questionnaire are thought to be less responsive in measuring quality of life after cervical surgery. OBJECTIVE: To evaluate the validity and responsiveness of SF-6D and EQ-5D in determining health and quality of life after elective cervical spine surgery. METHODS: A total of 420 patients undergoing elective cervical spine surgery over a period of 2 years were enrolled in a prospective longitudinal registry. Patient-reported outcomes Neck Disability Index (NDI), EQ-5D, and SF-12 were recorded. Based on previously published equations, SF-6D was calculated using NDI and SF-12 scores. Patients were asked whether \"surgery met their expectations\" (meaningful improvement). The validity and relative responsiveness of SF-6D (NDI), SF-6D (SF-12), and EQ-5D to discriminate between meaningful and nonmeaningful improvement were calculated. RESULTS: Sixty-six percent of patients (277) reported a level of improvement after surgery that met their expectations (meaningful improvement). SF-6D (NDI) (area under the curve [AUC] = 0.69) was a more valid discriminator of meaningful improvement compared with the SF-6D (SF-12) (AUC = 0.65) and EQ-5D (AUC = 0.62). SF-6D (NDI) was also a more responsive measure compared with SF-6D (SF-12) and EQ-5D (standardized response mean difference: 0.66, 0.48, and 0.44, respectively). CONCLUSION: SF-6D is a more valid and responsive measure of general health and quality of life compared with EQ-5D. SF-6D derived from disease-specific disability scores was more valid and responsive than that derived from the generic preference-based SF-12. Cost-effective studies should use SF-6D as a measure of QALY after cervical spine surgery."," Neurosurgery 77(4): 553-560; discussion 560.","USA",2015,"Unspecified","Surgical","NDI","Unknown","Cost-Effectiveness","Observational"]
[72,"Chotai, S., et al. (2016). \"Effect of obesity on cost per quality-adjusted life years gained following anterior cervical discectomy and fusion in elective degenerative pathology.\" Spine J 16(11): 1342-1350.",null,"Chotai, S., et al.","Effect of obesity on cost per quality-adjusted life years gained following anterior cervical discectomy and fusion in elective degenerative pathology","BACKGROUND: Obese patients have greater comorbidities along with higher risk of complications and greater costs after spine surgery, which may result in increased cost and lower quality of life compared with their non-obese counterparts. PURPOSE: The aim of the present study was to determine cost-utility following anterior cervical discectomy and fusion (ACDF) in obese patients. STUDY DESIGN: This study analyzed prospectively collected data. PATIENT SAMPLE: Patients undergoing elective ACDF for degenerative cervical pathology at a single academic institution were included in the study. OUTCOME MEASURES: Cost and quality-adjusted life years (QALYs) were the outcome measures. METHODS: One- and two-year medical resource utilization, missed work, and health state values (QALYs) were assessed. Two-year resource use was multiplied by unit costs based on Medicare national payment amounts (direct cost). Patient and caregiver workday losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). Total cost (direct+indirect) was used to compute cost per QALY gained. Patients were defined as obese for body mass index (BMI) >/=35 based on the WHO definition of class II obesity. A subgroup analysis was conducted in morbidly obese patients (BMI>/=40). RESULTS: There were significant improvements in pain (neck pain or arm pain), disability (Neck Disability Index), and quality of life (EuroQol-5D and Short Form-12) at 2 years after surgery (p<.001). There was no significant difference in post-discharge health-care resource utilization, direct cost, indirect cost, and total cost between obese and non-obese patients at postoperative 1-year and 2-year follow-up. Mean 2-year direct cost for obese patients was $19,225+/-$8,065 and $17,635+/-$6,413 for non-obese patients (p=.14). There was no significant difference in the mean total 2-year cost between obese ($23,144+/-$9,216) and non-obese ($22,183+/-$10,564) patients (p=.48). Obese patients had a lower mean cumulative gain in QALYs versus non-obese patients at 2-years (0.34 vs. 0.42, p=.32). Two-year cost-utility in obese ($68,070/QALY) versus non-obese patients ($52,816/QALY) was not significantly different (p=.11). Morbidly obese patients had lower QALYs gained (0.17) and higher cost per QALYs gained ($138,094/QALY) at 2 years. CONCLUSIONS: Anterior cervical discectomy and fusion provided a significant gain in health state utility in obese patients, with a mean 2-year cost-utility of $68,070 per QALYs gained, which can be considered moderately cost-effective. Morbidly obese patients had lower cost-effectiveness; however, surgery does provide a significant improvement in outcomes. Obesity, and specifically morbid obesity, should to be taken into consideration as physician and hospital reimbursements move toward a bundled model."," Spine J 16(11): 1342-1350.","USA",2016,"Neck Pain","Surgical","NDI","Adults","Cost and Resource Use","Observational"]
[73,"Chow, R. T., et al. (2006). \"The effect of 300 mW, 830 nm laser on chronic neck pain: a double-blind, randomized, placebo-controlled study.\" Pain 124(1-2): 201-210.",null,"Chow, R. T., et al.","The effect of 300 mW, 830 nm laser on chronic neck pain: a double-blind, randomized, placebo-controlled study","A randomized, double-blind, placebo-controlled study of low-level laser therapy (LLLT) in 90 subjects with chronic neck pain was conducted with the aim of determining the efficacy of 300 mW, 830 nm laser in the management of chronic neck pain. Subjects were randomized to receive a course of 14 treatments over 7 weeks with either active or sham laser to tender areas in the neck. The primary outcome measure was change in a 10 cm Visual Analogue Scale (VAS) for pain. Secondary outcome measures included Short-Form 36 Quality-of-Life questionnaire (SF-36), Northwick Park Neck Pain Questionnaire (NPNQ), Neck Pain and Disability Scale (NPAD), the McGill Pain Questionnaire (MPQ) and Self-Assessed Improvement (SAI) in pain measured by VAS. Measurements were taken at baseline, at the end of 7 weeks' treatment and 12 weeks from baseline. The mean VAS pain scores improved by 2.7 in the treated group and worsened by 0.3 in the control group (difference 3.0, 95% CI 3.8-2.1). Significant improvements were seen in the active group compared to placebo for SF-36-Physical Score (SF36 PCS), NPNQ, NPAD, MPQVAS and SAI. The results of the SF-36 - Mental Score (SF36 MCS) and other MPQ component scores (afferent and sensory) did not differ significantly between the two groups. Low-level laser therapy (LLLT), at the parameters used in this study, was efficacious in providing pain relief for patients with chronic neck pain over a period of 3 months."," Pain 124(1-2): 201-210.","Australia",2006,"Neck Pain","Laser Therapy","NPDS,Northwick","Unknown","PRO study","RCT"]
[74,"Cleland, J. A., et al. (2009). \"Does continuing education improve physical therapists' effectiveness in treating neck pain? A randomized clinical trial.\" Phys Ther 89(1999): 38-47.",null,"Cleland, J. A., et al.","Does continuing education improve physical therapists' effectiveness in treating neck pain? A randomized clinical trial","BACKGROUND AND PURPOSE: Physical therapists often attend continuing education (CE) courses to improve their overall clinical performance and patient outcomes. However, evidence suggests that CE courses may not improve the outcomes for patients receiving physical therapy for the management of neck pain. The purpose of this study was to investigate the effectiveness of an ongoing educational intervention for improving the outcomes for patients with neck pain. PARTICIPANTS: The study participants were 19 physical therapists who attended a 2-day CE course focusing on the management of neck pain. All patients treated by the therapists in this study completed the Neck Disability Index (NDI) and a pain rating scale at the initial examination and at their final visit. METHODS: Therapists from 11 clinics were invited to attend a 2-day CE course on the management of neck pain. After the CE course, the therapists were randomly assigned to receive either ongoing education consisting of small group sessions and an educational outreach session or no further education. Clinical outcomes achieved by therapists who received ongoing education and therapists who did not were compared for both pretraining and posttraining periods. The effects of receiving ongoing education were examined by use of linear mixed-model analyses with time period and group as fixed factors; improvements in disability and pain as dependent variables; and age, sex, and the patient's initial NDI and pain rating scores as covariates. RESULTS: Patients treated by therapists who received ongoing education experienced significantly greater reductions in disability during the study period (pretraining to posttraining) than those treated by therapists who did not receive ongoing training (mean difference=4.2 points; 95% confidence interval [CI]=0.69, 7.7). Changes in pain did not differ for patients treated by the 2 groups of therapists during the study period (mean difference=0.47 point; 95% CI=-0.11, 1.0). Therapists in the ongoing education group also used fewer visits during the posttraining period (mean difference=1.5 visits; 95% CI=0.81, 2.3). DISCUSSION AND CONCLUSION: The results of this study demonstrated that ongoing education for the management of neck pain was beneficial in reducing disability for patients with neck pain while reducing the number of physical therapy visits. However, changes in pain did not differ for patients treated by the 2 groups of therapists. Although it appears that a typical CE course does not improve the overall outcomes for patients treated by therapists attending that course, more research is needed to evaluate other educational strategies to determine the most clinically effective and cost-effective interventions."," Phys Ther 89(1999): 38-47.","USA",2009,"Neck Pain","Physical Therapy","NDI","Therapists","PRO study","Clinical trial"]
[75,"Cleland, J., et al. (2011). \"Assessing dimensionality and responsiveness of outcomes measures for patients with low back pain.\" Pain Pract 11(1999): 57-69.",null,"Cleland, J., et al.","Assessing dimensionality and responsiveness of outcomes measures for patients with low back pain","OBJECTIVE: To provide a systematic literature review of the responsiveness of patient-reported health outcomes measures for the evaluation of low back pain (LBP). METHODS AND DESIGN: Searches of MEDLINE and EMBASE were performed for articles published in English through June 29, 2009 using the search terms \"back pain\" or \"low back pain\" and \"questionnaires\" or \"instrument\" or \"survey\" or \"measure\" or \"patient report outcome.\" Information on responsiveness was gathered through additional measure-specific searches that included the measure name, first author of the original paper, and \"respons*\" or \"sensit*.\" Responsiveness was determined based on use of a receiver operating characteristics curve or effect size statistics. RESULTS: Of 43 identified measures, 31 were reported as being responsive to treatment or clinical change, 25 of which were evaluated for responsiveness using methods considered adequate. When considering both the responsiveness evaluation and the underlying factor structure, 13 measures were identified as being adequately validated for use in evaluating responsiveness in the research or clinical practice setting. The majority of the LBP outcome assessment studies were comprised of patients undergoing physical and interventional therapies from clinical practice and clinical trials. The Roland Morris Disability Questionnaire and the Oswestry Disability Index were the most comprehensively validated measures with respect to responsiveness. CONCLUSIONS: We identified 13 measures of LBP that can be used to evaluate responsiveness to change. Choice of a measure warrants careful evaluation of its construct and responsiveness properties in order to maximize the observed impact on pain and functional improvement in subjects with LBP."," Pain Pract 11(1999): 57-69.","USA",2011,"Back Pain","Physical Therapy","ODI,RMDQ","Unknown","PRO study","Systematic review"]
[76,"Climent, J. M. and J. Sanchez (1999). \"Impact of the type of brace on the quality of life of Adolescents with Spine Deformities.\" Spine (Phila Pa 1976) 24(18): 1903-1908.",null,"Climent, J. M. and J. Sanchez","Impact of the type of brace on the quality of life of Adolescents with Spine Deformities","STUDY DESIGN: A group of 102 brace-treated adolescents, aged 10-19 years with spine deformities participated in a cross-sectional study. OBJECTIVES: To determine the effect of various types of orthoses on self-perceived health status. SUMMARY OF BACKGROUND DATA: Spinal orthosis is an effective means of controlling progressive scoliosis, but bracing has shown a considerable impact on several aspects of adolescent functioning. METHODS: Skeletally immature patients with spine deformities (75% with idiopathic scoliosis) who visited consecutively for routine biannual follow-up evaluations of orthotic treatment were studied. Twenty-five patients used the Milwaukee brace, 30 the Boston brace, 13 the thoracolumbosacral orthosis (TLSO), and 34 the Charleston bending orthosis. Patients completed the Quality of Life Profile for Spine Deformities (QLPSD), a specific instrument that measures quality of life in five areas labeled psychosocial functioning, sleep disturbances, back pain, body image, and back flexibility. Higher QLPSD scores mean a high level of impairment of quality of life. RESULTS: Milwaukee brace-treated patients scored significantly higher than Boston brace-treated and TLSO-braced patients and patients with Charleston bending orthosis in the overall QLPSD score (mean +/- SD, 53.60 +/- 13.26 vs. 45.65 +/- 12.81 and 42.79 +/- 12.99, respectively) and in back flexibility and psychosocial functioning. Other quality-of-life-related variables selected in multivariate analysis were the Risser sign, clinical diagnosis, duration of brace treatment, and degrees of correction. CONCLUSION: In cases of different orthoses of proven similar effectiveness in controlling the scoliotic curves, the use of bracing with the lowest impact on the quality of life should be recommended."," Spine (Phila Pa 1976) 24(18): 1903-1908.","Spain",1999,"Spinal Deformity","Psychosocial","QLPSD,BrQ","Adolescents","PRO study","Observational"]
[77,"Climent, J. M., et al. (1995). \"Construction and validation of a specific quality of life instrument for adolescents with spine deformities.\" Spine (Phila Pa 1976) 20(18): 2006-2011.",null,"Climent, J. M., et al.","Construction and validation of a specific quality of life instrument for adolescents with spine deformities","STUDY DESIGN: The development and construction of a specific instrument for measuring quality of life in adolescents with spine deformities was investigated. OBJECTIVES: To assess the validity and reliability of the Quality of Life Profile for Spine Deformities. SUMMARY OF BACKGROUND DATA: An 88-item questionnaire was self-administered to 174 patients ranging in age from 10 to 20 years with spine deformities. Items were rated on a five-point Likert scale. Higher scores means high level of impairment in quality of life. Age, gender, menarche or voice change, salient symptoms in the medical record, ordinary parameters on physical examination, and measurements on standard anteroposterior and lateral radiographs were recorded. The retest was done 10 days after the initial administration in a subsample of 35 patients. METHODS: The test-retest reliability was analyzed calculating the intraclass correlation coefficient. Internal consistency was measured with the Cronbach's alpha method. Factor analysis was used to obtain a reduced number of variables. Construct validity was assessed using the principal components model of factor analysis based on the correlation matrix and using the varimax computer algorithm for orthogonal rotation. Discriminant validity was assessed using the Kruskal-Wallis test. RESULTS: The Quality of Life Profile for Spine Deformities contained 21 items and five factors in conceptual terms labeled psychosocial functioning, sleep disturbances, back pain, body image, and back flexibility. The overall questionnaire score showed an internal consistency of 0.88 and a test-retest correlation of 0.91. Patients with structural curves showed significantly higher scores in all dimensions of the Quality of Life Profile for Spine Deformities except for the subscale of body image than patients with postural curves. When patients were grouped according to the symptom of back pain, those with backache had a significantly higher quality of life overalls score and scores in the dimensions of sleep disturbances and pain. Brace-treated patients showed statistically significant differences in the quality of life overall score and scores in the dimensions of psychosocial functioning and back flexibility. CONCLUSIONS: The instrument developed for measuring quality of life in patients with spine deformities during the period of bone growth has validity, internal consistency, and high test-retest reliability. The conceptualization of quality of life of the Quality of Life Profile for Spine Deformity includes psychosocial dimensions and pain and function."," Spine (Phila Pa 1976) 20(18): 2006-2011.","Spain",1995,"Spinal Deformity","Psychosocial","QLPSD","Adolescents","Tool Validation","Observational"]
[78,"Climent, J. M., et al. (2005). \"Validity of the Spanish version of the Scoliosis Research Society-22 (SRS-22) Patient Questionnaire.\" Spine (Phila Pa 1976) 30(6): 705-709.",null,"Climent, J. M., et al.","Validity of the Spanish version of the Scoliosis Research Society-22 (SRS-22) Patient Questionnaire","STUDY DESIGN: A cross-sectional multicenter study was performed to validate the Spanish version of the Scoliosis Research Society-22 (SRS-22) Patient Questionnaire. OBJECTIVES: To determine the construct validity and convergent validity of the instrument. METHODS: The Spanish version of the SRS-22 was given to 175 patients with scoliosis (mean age, 19 years old and 86% women). A subgroup of 31 patients also received the Quality of Life for Spine Deformities Profile (QLSDP). Construct validity was studied by factor analysis. Discriminant validity was assessed analyzing the relation between SRS-22 scores and the variables of deformity severity. Convergent validity as related to the QLSDP was studied with a multitrait-multimethod matrix analysis. RESULTS: Factor analysis offered a solution of four factors coherent with the dimensions of the original instrument. SRS-22 scores were worse in older patients (r = -0.34); patients using analgesics demonstrated lower scores (P < 0.001). Patients treated with a brace had a poorer self-image and were less satisfied with their treatment (P < 0.001) than the other treatment groups. Angular improvement of the curves was associated with better self-image scores (r = 0.34). The SRS-22 and QLSDP demonstrated high correlation coefficients in the convergent validity tests (r = 0.84). CONCLUSION: The Spanish version of the SRS-22 is valid. It has a factorial structure similar to that of the original questionnaire. Moreover, it relates to known severity characteristics of the disease, distinguishes among scoliosis patient groups, and shows concordant values with another valid instrument for measuring self-perceived health."," Spine (Phila Pa 1976) 30(6): 705-709.","Spain",2005,"Spinal Deformity","Brace","SRS-HRQOL,QLSDP","Adults","Tool Validation","Observational"]
[79,"Cohen, M., et al. (2011). \"Acupuncture as analgesia for low back pain, ankle sprain and migraine in emergency departments: study protocol for a randomized controlled trial.\" Trials 12: 241.",null,"Cohen, M., et al.","Acupuncture as analgesia for low back pain, ankle sprain and migraine in emergency departments: study protocol for a randomized controlled trial","BACKGROUND: Pain is the most common reason that patients present to an emergency department (ED) and is often inadequately managed. Evidence suggests that acupuncture is effective for pain relief, yet it is rarely practiced in the ED. The current study aims to assess the efficacy of acupuncture for providing effective analgesia to patients presenting with acute low back pain, migraine and ankle sprain at the EDs of four hospitals in Melbourne, Australia. METHOD: The study is a multi-site, randomized, assessor-blinded, controlled trial of acupuncture analgesia in patients who present to an ED with low back pain, migraine or ankle sprain. Patients will be block randomized to receive either acupuncture alone, acupuncture as an adjunct to pharmacotherapy or pharmacotherapy alone. Acupuncture will be applied according to Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). Pain after one hour, measured using a visual analogue scale (VAS), is the primary outcome. Secondary outcomes measures include the following instruments; the Oswestry low back pain disability questionnaire, 24-hour Migraine Quality of Life questionnaire and Patient's Global Assessment of Ankle Injury Scale. These measures will be recorded at baseline, 1 hour after intervention, each hour until discharge and 48+/-12 hours of ED discharge. Data will also be collected on the safety and acceptability of acupuncture and health resource utilization. DISCUSSION: The results of this study will determine if acupuncture, alone or as an adjunct to pharmacotherapy provides effective, safe and acceptable pain relief for patients presenting to EDs with acute back pain, migraine or ankle sprain. The results will also identify the impact that acupuncture treatment may have upon health resource utilisation in the ED setting. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000989246."," Trials 12: 241.","Australia",2011,"Back Pain","Acupuncture","ODI","Unknown","PRO study","RCT"]
[80,"Constant, F., et al. (1998). \"Use of spa therapy to improve the quality of life of chronic low back pain patients.\" Med Care 36(9): 1309-1314.",null,"Constant, F., et al.","Use of spa therapy to improve the quality of life of chronic low back pain patients","OBJECTIVES: This study assessed the effectiveness of adding spa therapy to usual drug treatment in chronic low back pain patients. METHODS: A total of 224 patients were assigned randomly to either a treatment (n=128) or a control (n=96) group. Subjects in both groups received usual drug therapy. Those in the treatment group also underwent spa therapy in Vittel, France, for 6 days a week for 3 consecutive weeks. Effectiveness was assessed using a quality-of-life scale (the Duke Health Profile), clinical measures, and the Roland and Morris disability questionnaire. Groups were compared using an analysis of variance with repeated measures. RESULTS: At both 3 weeks and 3 months, patients in the treatment group exhibited significant improvement in measures of: physical and mental dimensions of quality of life, anxiety, depression, pain duration, pain intensity, and functional disability. CONCLUSION: This study suggests that spa therapy is an effective treatment for chronic low back pain patients."," Med Care 36(9): 1309-1314.","France",1998,"Back Pain","Other","RMDQ","Unknown","PRO study","RCT"]
[81,"Corniola, M. V., et al. (2016). \"Correlation of pain, functional impairment, and health-related quality of life with radiological grading scales of lumbar degenerative disc disease.\" Acta Neurochir (Wien) 158(3): 499-505.",null,"Corniola, M. V., et al.","Correlation of pain, functional impairment, and health-related quality of life with radiological grading scales of lumbar degenerative disc disease","BACKGROUND: It is generally believed that radiological signs of lumbar degenerative disc disease (DDD) are associated with increased pain and functional impairment as well as lower health-related quality of life (HRQoL). Our aim was to assess the association of the Modic and Pfirrmann grading scales with established outcome questionnaires and the timed-up-and-go (TUG) test. METHODS: In a prospective two-center study with patients scheduled for lumbar spine surgery, visual analogue scale (VAS) for back and leg pain, Roland-Morris Disability Index, Oswestry Disability Index and HRQoL, as determined by the Short-Form (SF)-12 and the Euro-Qol, were recorded. Functional mobility was measured with the TUG test. Modic type (MOD) and Pfirrmann grade (PFI) of the affected lumbar segment were assessed with preoperative imaging. Uni- and multivariate logistic regression analysis was performed to estimate the effect size of the relationship between clinical and radiological findings. RESULTS: Two hundred eighty-four patients (mean age 58.5, 119 (42 %) females) were enrolled. None of the radiological grading scales were significantly associated with any of the subjective or objective clinical tests. There was a tendency for higher VAS back pain (3.48 vs. 4.14, p = 0.096) and lower SF-12 physical component scale (31.2 vs. 29.4, p = 0.065) in patients with high PFI (4-5) as compared to patients with low PFI (0-3). In the multivariate analysis, patients with MOD changes of the vertebral endplates were 100 % as likely as patients without changes to show an impaired TUG test performance (odds ratio (OR) 1.00, 95 % confidence interval (CI) 0.56-1.80, p = 0.982). Patients with high PFI were 145 % as likely as those with low PFI to show an impaired TUG test performance (OR 1.45, 95 % CI 0.79-2.66, p = 0.230). CONCLUSIONS: There was no association between established outcome questionnaires of symptom severity and two widely used radiological classifications in patients undergoing surgery for lumbar DDD."," Acta Neurochir (Wien) 158(3): 499-505.","Switzerland,Australia",2016,"Spine Disease","Surgical","ODI,RMDQ","Unknown","PRO study","Prospective Observation"]
[82,"Corona, J., et al. (2011). \"Measuring quality of life in children with early onset scoliosis: development and initial validation of the early onset scoliosis questionnaire.\" J Pediatr Orthop 31(2): 180-185.",null,"Corona, J., et al.","Measuring quality of life in children with early onset scoliosis: development and initial validation of the early onset scoliosis questionnaire","BACKGROUND: Treatment of children with early onset scoliosis (EOS) seeks to improve natural history and health related quality of life (QOL). QOL measurement presents a significant challenge given the young age, comorbidities, and heterogeneity of this population. The purpose of this study is to develop a disease specific measure reflecting issues of importance to EOS patients and caretakers that is responsive to clinical and treatment changes. METHODS: Review of the literature and relevant measures informed development of semistructured qualitative interviews. Interviews of caregivers of EOS patients were interpreted through the framework technique. A masterlist of 75 items was created and responses were scaled on a 5-point Likert scale. Psychometric analysis was carried out to group items into domains, to maintain score distribution, to create a responsive instrument, and to identify question redundancy. RESULTS: Content validation showed 8 items with low content validity indices (<0.70). Item distribution analysis showed 19 items with skewed distribution. Item reliability showed redundant items within domains (r>/=0.5). Construct validity showed unique domains measuring intended issues of interest. The resulting Early Onset Scoliosis Questionnaire (EOSQ) includes 33 items in 13 domains: General Health, Pain, Physical Function, Pulmonary Function, Daily Living, Fatigue, Emotion, Surgical Concerns, Satisfaction, Transfer, Financial Burden, Parental Burden, and Treatment Outcomes. CONCLUSIONS: The EOSQ reflects QOL and caregiver burden in the EOS population. The EOSQ will expand options for outcome assessment in this unique population."," J Pediatr Orthop 31(2): 180-185.","USA",2011,"Spinal Deformity","Surgical","EOSQ","Infants","PRO study","Narrative review"]
[83,"Coste, J., et al. (2004). \"Prognosis and quality of life in patients with acute low back pain: insights from a comprehensive inception cohort study.\" Arthritis Rheum 51(2): 168-176.",null,"Coste, J., et al.","Prognosis and quality of life in patients with acute low back pain: insights from a comprehensive inception cohort study","OBJECTIVE: To investigate the respective contribution of various biologic and psychosocial factors, especially initial health-related quality of life (HRQOL), in the natural history of acute low back pain (LBP) and to evaluate the impact of this condition on HRQOL. METHODS: For 3 months, we assessed 113 patients consulting for nonspecific acute LBP of <72 hours duration at inclusion and treated with acetaminophen. Endpoints included pain, disability assessed by the Roland Disability Questionnaire, and HRQOL assessed by the Short Form 36 health survey (SF-36). RESULTS: Seventy-three percent of patients recovered within 2 weeks and 5% of patients developed chronic LBP. Prior low back surgery, higher initial disability questionnaire score, lower SF-36 score, and temporary compensation status were independently associated with delayed recovery. The impact of the acute LBP episode on HRQOL was brief and moderate, except for patients with comorbidity, psychiatric disorders, those of foreign origin, unemployed, or with job dissatisfaction. The impact of compensation status, sick leave, and bed rest was more profound and lasting. CONCLUSIONS: This study highlights the large contribution of work-related factors, but also initial HRQOL, to the prognosis of LBP. It also suggests that LBP impairs HRQOL mainly through compensation and inappropriate medical care, and that, in turn, impaired HRQOL favors the condition becoming chronic. These findings have implications for future research into the management of LBP."," Arthritis Rheum 51(2): 168-176.","France",2004,"Back Pain","Surgical","RMDQ","Unknown","Cost-Effectiveness","Prospective Observation"]
[84,"Coulombe, B. J., et al. (2017). \"Core Stability Exercise Versus General Exercise for Chronic Low Back Pain.\" J Athl Train 52(1999): 71-72.",null,"Coulombe, B. J., et al.","Core Stability Exercise Versus General Exercise for Chronic Low Back Pain","Reference: Wang XQ, Zheng JJ, Yu ZW, et al. A meta-analysis of core stability exercise versus general exercise for chronic low back pain. PLoS One. 2012;7(12):e52082. Clinical Questions: Is core stability exercise more effective than general exercise in the treatment of patients with nonspecific low back pain (LBP)? DATA SOURCES: The authors searched the following databases: China Biological Medicine disc, Cochrane Library, Embase, and PubMed from 1970 through 2011. The key medical subject headings searched were chronic pain, exercise, LBP, lumbosacral region, and sciatica. STUDY SELECTION: Randomized controlled trials comparing core stability exercise with general exercise in the treatment of chronic LBP were investigated. Participants were male and female adults with LBP for at least 3 months that was not caused by a specific known condition. A control group receiving general exercise and an experimental group receiving core stability exercise were required for inclusion in the meta-analysis. Core stability was defined as the ability to ensure a stable neutral spine position, but the type of exercise was not specified. Outcome measures of pain intensity, back-specific functional status, quality of life, and work absenteeism were recorded at 3-, 6-, and 12-month intervals. DATA EXTRACTION: The study design, participant information, description of interventions in the control and experimental groups, outcome measures, and follow-up period were extracted. The mean difference (MD) and 95% confidence interval (CI) were calculated to evaluate statistical significance. Risk of bias was assessed using the Cochrane Collaboration Recommendations, and all articles were rated as high risk for other bias with no further explanation given. MAIN RESULTS: Five studies involving 414 patients were included. Four studies assessed pain intensity using the visual analog scale or numeric rating scale. In the core stability exercise group, the reduction in pain was significant at 3 months (MD = -1.29, 95% CI = -2.47, -0.11; P = .003) but not at 6 months (MD = -0.50, 95% CI = -1.36, 0.35; P = .26). Functional status was improved at 3 months (MD = -7.14, 95% CI = -11.64, -2.65; P = .002) but not at 6 months (MD = -0.50, 95% CI = 0.36, 0.35; P = .26) or 12 months (MD = -0.32, 95% CI = -0.87, 0.23; P = .25). All of the included studies assessed back-specific functional status: 4 used the Oswestry Disability Index and 1 used the Roland-Morris Disability Questionnaire. Patients in the core stability exercise groups experienced improved functional status versus the general exercise group at 3 months (MD = -7.14, 95% CI = -11.64, -2.65; P = .002); no results were recorded at 6 or 12 months. CONCLUSIONS: In the short term, core stability exercise was more effective than general exercise for decreasing pain and increasing back-specific functional status in patients with LBP."," J Athl Train 52(1999): 71-72.","USA",2017,"Back Pain","Exercise","ODI,RMDQ","Unknown","PRO study","Systematic review"]
[85,"Cramer, H., et al. (2011). \"Randomized controlled trial of pulsating cupping (pneumatic pulsation therapy) for chronic neck pain.\" Forsch Komplementmed 18(6): 327-334.",null,"Cramer, H., et al.","Randomized controlled trial of pulsating cupping (pneumatic pulsation therapy) for chronic neck pain","BACKGROUND: Pneumatic pulsation therapy may combine the effects of cupping therapy and massage. This study investigated the effect of pneumatic pulsation therapy on chronic neck pain compared to standard medical care. METHODS: 50 patients (79.15% female; 46.17 +/- 12.21 years) with chronic nonspecific neck pain were randomized to treatment group (TG; n = 25) or control group (CG; n = 25). The TG received 5 pneumatic pulsation treatments over a period of 2 weeks utilizing a mechanical device. Treatment was applied as a combination of moving and stationary pulsating cupping. Main outcome measure was pain intensity in pain diaries (numerical rating scale). Secondary outcome measures included functional disability (NDI), quality of life (SF-36), and pain at motion. Sensory thresholds, including pressure pain threshold, were measured at pain-related sites. RESULTS: After the intervention, significant group differences occurred regarding pain intensity (baseline: 4.12 +/- 1.45 in TG and 4.20 +/- 1.57 in CG; post-intervention: 2.72 +/- 1.62 in TG and 4.44 +/- 1.96 in CG; analysis of covariance: p = 0.001), NDI (baseline: 25.92 +/- 8.23 and 29.83; post-intervention: 20.44 +/- 10.17 and 28.83; p = 0.025), and physical quality of life (baseline: 43.85 +/- 7.65 and 41.66 +/- 7.09; post-intervention: 47.60 +/- 7.93 and 40.49 +/- 8.03; p = 0.002). Further significant group differences were found for pain at motion (p = 0.004) and pressure pain threshold (p = 0.002). No serious adverse events were reported. CONCLUSION: Pneumatic pulsation therapy appears to be a safe and effective method to relieve pain and to improve function and quality of life in patients with chronic neck pain."," Forsch Komplementmed 18(6): 327-334.","Germany",2011,"Neck Pain","Other,Massage","NDI","Adults","PRO study","RCT"]
[86,"Cramer, H., et al. (2013). \"Randomized-controlled trial comparing yoga and home-based exercise for chronic neck pain.\" Clin J Pain 29(3): 216-223.",null,"Cramer, H., et al.","Randomized-controlled trial comparing yoga and home-based exercise for chronic neck pain","OBJECTIVES: Chronic neck pain is a significant public health problem with only very few evidence-based treatment options. There is growing evidence for the effectiveness of yoga for relieving musculoskeletal disorders. The aim of this study was to evaluate the effect of Iyengar yoga compared with exercise on chronic nonspecific neck pain. METHODS: Patients were randomly assigned to either yoga or exercise. The yoga group attended a 9-week yoga course and the exercise group received a self-care manual on home-based exercises for neck pain relief. The main outcome measure was the present neck pain intensity (100 mm visual analog scale). Secondary outcome measures included functional disability (Neck Disability Index), pain at motion (visual analog scale), health-related quality of life (Short Form-36 questionnaire), cervical range of motion, proprioceptive acuity, and pressure pain threshold. RESULTS: Fifty-one patients (mean age 47.8 y ; 82.4% female) were randomized to yoga (n=25) and exercise (n=26) intervention. After the study period, patients in the yoga group reported significantly less neck pain intensity compared with the exercise group [mean difference: -13.9 mm (95% CI, -26.4 to -1.4), P=0.03]. The yoga group reported less disability and better mental quality of life. Range of motion and proprioceptive acuity were improved and the pressure pain threshold was elevated in the yoga group. DISCUSSION: Yoga was more effective in relieving chronic nonspecific neck pain than a home-based exercise program. Yoga reduced neck pain intensity and disability and improved health-related quality of life. Moreover, yoga seems to influence the functional status of neck muscles, as indicated by improvement of physiological measures of neck pain."," Clin J Pain 29(3): 216-223.","Germany",2013,"Neck Pain","Yoga","NDI","Unknown","PRO study","RCT"]
[87,"Cramer, H., et al. (2013). \"Yoga for chronic neck pain: a 12-month follow-up.\" Pain Med 14(4): 541-548.",null,"Cramer, H., et al.","Yoga for chronic neck pain: a 12-month follow-up","OBJECTIVES: To assess the effects of a 9-week yoga intervention on chronic nonspecific neck pain 12 months after completion. DESIGN: Twelve-month follow-up of the pooled data of both arms of a randomized, controlled trial. SETTING: Department of Internal and Integrative Medicine at an academic teaching hospital. SUBJECTS: Fifty-one patients with chronic nonspecific neck pain (mean age 47.8 years; 82.4% female). INTERVENTIONS: A 9-week yoga group intervention. OUTCOME MEASURES: Neck pain intensity (100-mm visual analog scale), functional disability (neck disability index), health-related quality of life (short-form 36 questionnaire, SF-36), generic disability (days with restricted activities), and global improvement. RESULTS: From baseline to 12-month follow-up, pain intensity improved from 48.81 +/- 17.71 to 32.31 +/- 20.68 (P < 0.001), neck-related disability decreased from 25.26 +/- 9.02 to 19.49 +/- 11.52 (P = 0.001), and bodily pain in the SF-36 improved from 49.37 +/- 12.40 to 59.26 +/- 17.57 (P = 0.005). Improvements in pain intensity were predicted by weekly minutes of yoga practice during the past 4 weeks (r(2) = 0.12, P = 0.028); improved neck-related disability (r(2) = 0.24, P = 0.001) and bodily pain (r(2) = 0.26, P = 0.006) were predicted by regular yoga practice during the past 12 months. Generic disability did not decrease significantly. Twenty-four patients (68.6%) rated their health as at least somewhat improved. CONCLUSIONS: A 9-week yoga intervention improved pain and neck-related disability for at least 12 months after completion. Sustained yoga practice seems to be the most important predictor of long-term effectiveness."," Pain Med 14(4): 541-548.","Germany",2013,"Neck Pain","Yoga","NDI","Adults","PRO study","RCT"]
[88,"Cramer, H., et al. (2014). \"Validation of the German version of the Neck Disability Index (NDI).\" BMC Musculoskelet Disord 15: 91.",null,"Cramer, H., et al.","Validation of the German version of the Neck Disability Index (NDI)","BACKGROUND: The Neck Disability Index (NDI) is the most commonly used outcome measure for neck pain. This study aimed to determine the psychometric properties of a German version of the NDI. Cross-cultural translation and psychometric testing of the NDI were performed. METHODS: The 10-item NDI was translated into German and administered to 558 patients with chronic unspecific neck pain (Mean age 49.9 +/- 11.4 years, 76% female). The factor structure and reliability of the NDI were assessed using factor analysis, Cronbach's alpha, split-half reliability (Spearman-Brown coefficient), and intra-class correlation (ICC2,1). To determine convergent validity, pain intensity (visual analog scale; VAS), pain on movement (VAS), and quality of life (Short Form 36 Health Survey Questionnaire; SF-36) were correlated with the NDI. Correlation with range of motion and sensitivity to change were also assessed in a subsample of 49 patients. RESULTS: The mean NDI score was 32.75 +/- 13.09. Factor analysis revealed a single factor that explained 39.8% of the variance. Cronbach's alpha was 0.81; Spearman-Brown coefficient was 0.80; and intra-class correlation was 0.81 (95% confidence interval = 0.78, 0.83). Significant correlations were found for pain intensity (r = 0.22, p < 0.01), pain on movement (r = 0.39, p < 0.01), quality of life (r = -0.30 to -0.45, p < 0.01), and range of motion (r = -0.34, p = 0.02). Patients who reported global improvement of health after an exercise or yoga intervention showed a higher decrease on the NDI than patients who reported no global improvement (p < 0.01). CONCLUSIONS: The German version of the NDI has a comparable factor structure as the original version, acceptable psychometric properties, and is sensitive to change after physical activity. Neck disability is associated with other measures of neck pain."," BMC Musculoskelet Disord 15: 91.","Germany",2014,"Neck Pain","Exercise","NDI","Adults","Tool Validation","Observational"]
[89,"Critchley, D. J., et al. (2007). \"Effectiveness and cost-effectiveness of three types of physiotherapy used to reduce chronic low back pain disability: a pragmatic randomized trial with economic evaluation.\" Spine (Phila Pa 1976) 32(14): 1474-1481.",null,"Critchley, D. J., et al.","Effectiveness and cost-effectiveness of three types of physiotherapy used to reduce chronic low back pain disability: a pragmatic randomized trial with economic evaluation","STUDY DESIGN: Pragmatic, randomized, assessor blinded, clinical trial with economic analysis. OBJECTIVE: To compare the effectiveness and cost-effectiveness of three kinds of physiotherapy commonly used to reduce disability in chronic low back pain. SUMMARY OF BACKGROUND DATA: Physiotherapy reduces disability in chronic back pain, but there are several forms of physiotherapy and it is unclear which is most effective or cost effective. METHODS: A total of 212 patients referred to physiotherapy with chronic low back pain were randomized to receive usual outpatient physiotherapy, spinal stabilization classes, or physiotherapist-led pain management classes. Primary outcome was Roland Disability Questionnaire score 18 months from baseline; secondary measures were pain, health-related quality of life, and time off work. Healthcare costs associated with low back pain and quality-adjusted life years (QALYs) were also measured. RESULTS.: A total of 71 participants were assigned to usual outpatient physiotherapy, 72 to spinal stabilization, and 69 to physiotherapist-led pain management. A total of 160 (75%) provided follow-up data at 18 months, showing similar improvements with all interventions: mean (95% confidence intervals) Roland Disability Questionnaire score improved from 11.1 (9.6-12.6) to 6.9 (5.3-8.4) with usual outpatient physiotherapy, 12.8 (11.4-14.2) to 6.8 (4.9-8.6) with spinal stabilization, and 11.5 (9.8-13.1) to 6.5 (4.5-8.6) following pain management classes. Pain, quality of life, and time off work also improved within all groups with no between-group differences. Mean (SD) healthcare costs and QALY gain were pound474 (840) and 0.99 (0.27) for individual physiotherapy, pound379 (1040) and 0.90 (0.37) for spinal stabilization, and pound165 (202) and 1.00 (0.28) for pain management. CONCLUSIONS: For chronic low back pain, all three physiotherapy regimens improved disability and other relevant health outcomes, regardless of their content. Physiotherapist-led pain management classes offer a cost-effective alternative to usual outpatient physiotherapy and are associated with less healthcare use. A more widespread adoption of physiotherapist-led pain management could result in considerable cost savings for healthcare providers."," Spine (Phila Pa 1976) 32(14): 1474-1481.","UK",2007,"Back Pain","Physical Therapy","RMDQ","Adults","Cost-Effectiveness","RCT"]
[90,"Cuesta-Vargas, A. I. and C. P. Gabel (2014). \"Validation of a Spanish version of the Spine Functional Index.\" Health Qual Life Outcomes 12: 96.",null,"Cuesta-Vargas, A. I. and C. P. Gabel","Validation of a Spanish version of the Spine Functional Index","BACKGROUND: The Spine Functional Index (SFI) is a recently published, robust and clinimetrically valid patient reported outcome measure. OBJECTIVES: The purpose of this study was the adaptation and validation of a Spanish-version (SFI-Sp) with cultural and linguistic equivalence. METHODS: A two stage observational study was conducted. The SFI was cross-culturally adapted to Spanish through double forward and backward translation then validated for its psychometric characteristics. Participants (n = 226) with various spine conditions of >12 weeks duration completed the SFI-Sp and a region specific measure: for the back, the Roland Morris Questionnaire (RMQ) and Backache Index (BADIX); for the neck, the Neck Disability Index (NDI); for general health the EQ-5D and SF-12. The full sample was employed to determine internal consistency, concurrent criterion validity by region and health, construct validity and factor structure. A subgroup (n = 51) was used to determine reliability at seven days. RESULTS: The SFI-Sp demonstrated high internal consistency (alpha = 0.85) and reliability (r = 0.96). The factor structure was one-dimensional and supported construct validity. Criterion specific validity for function was high with the RMQ (r = 0.79), moderate with the BADIX (r = 0.59) and low with the NDI (r = 0.46). For general health it was low with the EQ-5D and inversely correlated (r = -0.42) and fair with the Physical and Mental Components of the SF-12 and inversely correlated (r = -0.56 and r = -0.48), respectively. The study limitations included the lack of longitudinal data regarding other psychometric properties, specifically responsiveness. CONCLUSIONS: The SFI-Sp was demonstrated as a valid and reliable spine-regional outcome measure. The psychometric properties were comparable to and supported those of the English-version, however further longitudinal investigations are required."," Health Qual Life Outcomes 12: 96.","Spain",2014,"Unspecified","Not Specified","NDI,SFI","Unknown","Tool Validation","Prospective Observation"]
[91,"Cuesta-Vargas, A. I. and M. Gonzalez-Sanchez (2014). \"Ability to discriminate between healthy and low back pain sufferers using ultrasound during maximum lumbar extension.\" Arch Phys Med Rehabil 95(6): 1093-1099.",null,"Cuesta-Vargas, A. I. and M. Gonzalez-Sanchez","Ability to discriminate between healthy and low back pain sufferers using ultrasound during maximum lumbar extension","OBJECTIVE: To analyze the ability to discriminate between healthy individuals and individuals with chronic nonspecific low back pain (CNLBP) by measuring the relation between patient-reported outcomes and objective clinical outcome measures of the erector spinae (ES) muscles using an ultrasound during maximal isometric lumbar extension. DESIGN: Cross-sectional study with screening and diagnostic tests with no blinded comparison. SETTING: University laboratory. PARTICIPANTS: Healthy individuals (n=33) and individuals with CNLBP (n=33). INTERVENTIONS: Each subject performed an isometric lumbar extension. With the variables measured, a discriminate analysis was performed using a value >/= 6 in the Roland and Morris disability questionnaire (RMDQ) as the grouping variable. Then, a logistic regression with the functional and architectural variables was performed. A new index was obtained from each subject value input in the discriminate multivariate analysis. MAIN OUTCOME MEASURES: Morphologic muscle variables of the ES muscle were measured through ultrasound images. The reliability of the measures was calculated through intraclass correlation coefficients (ICCs). The relation between patient-reported outcomes and objective clinical outcome measures was analyzed using a discriminate function from standardized values of the variables and an analysis of the reliability of the ultrasound measurement. RESULTS: The reliability tests show an ICC value >.95 for morphologic and functional variables. The independent variables included in the analysis explained 42% (P=.003) of the dependent variable variance. CONCLUSIONS: The relation between objective variables (electromyography, thickness, pennation angle) and a subjective variable (RMDQ >/= 6) and the capacity of this relation to identify CNLBP within a group of healthy subjects is moderate. These results should be considered by clinicians when treating this type of patient in clinical practice."," Arch Phys Med Rehabil 95(6): 1093-1099.","Spain",2014,"Back Pain","Not Specified","RMDQ","Unknown","PRO study","Observational"]
[92,"Cuesta-Vargas, A. I. and M. Gonzalez-Sanchez (2015). \"Changes in disability, physical/mental health states and quality of life during an 8-week multimodal physiotherapy programme in patients with chronic non-specific neck pain: a prospective cohort study.\" PLoS One 10(2): e0118395.",null,"Cuesta-Vargas, A. I. and M. Gonzalez-Sanchez","Changes in disability, physical/mental health states and quality of life during an 8-week multimodal physiotherapy programme in patients with chronic non-specific neck pain: a prospective cohort study","AIM: The aim of this study was to analyse the effect of an 8-week multimodal physiotherapy programme (MPP), integrating physical land-based therapeutic exercise (TE), adapted swimming and health education, as a treatment for patients with chronic non-specific neck pain (CNSNP), on disability, general health/mental states and quality of life. METHODS: 175 CNSNP patients from a community-based centre were recruited to participate in this prospective study. INTERVENTION: 60-minute session (30 minutes of land-based exercise dedicated to improving mobility, motor control, resistance and strengthening of the neck muscles, and 30 minutes of adapted swimming with aerobic exercise keeping a neutral neck position using a snorkel). Health education was provided using a decalogue on CNSNP and constant repetition of brief advice by the physiotherapist during the supervision of the exercises in each session. STUDY OUTCOMES: primary: disability (Neck Disability Index); secondary: physical and mental health states and quality of life of patients (SF-12 and EuroQoL-5D respectively). Differences between baseline data and that at the 8-week follow-up were calculated for all outcome variables. RESULTS: Disability showed a significant improvement of 24.6% from a mean (SD) of 28.2 (13.08) at baseline to 16.88 (11.62) at the end of the 8-week intervention. All secondary outcome variables were observed to show significant, clinically relevant improvements with increase ranges between 13.0% and 16.3% from a mean of 0.70 (0.2) at baseline to 0.83 (0.2), for EuroQoL-5D, and from a mean of 40.6 (12.7) at baseline to 56.9 (9.5), for mental health state, at the end of the 8-week intervention. CONCLUSION: After 8 weeks of a MPP that integrated land-based physical TE, health education and adapted swimming, clinically-relevant and statistically-significant improvements were observed for disability, physical and mental health states and quality of life in patients who suffer CNSNP. The clinical efficacy requires verification using a randomised controlled study design. TRIAL REGISTRATION: ClinicalTrials.gov NCT02046876."," PLoS One 10(2): e0118395.","Spain",2015,"Neck Pain","Exercise","NDI","Unknown","PRO study","Prospective Observation"]
[93,"Cui, X. J., et al. (2017). \"Shi-style cervical manipulations for cervical radiculopathy: A multicenter randomized-controlled clinical trial.\" Medicine (Baltimore) 96(31): e7276.",null,"Cui, X. J., et al.","Shi-style cervical manipulations for cervical radiculopathy: A multicenter randomized-controlled clinical trial","BACKGROUND: There is a lack of high-quality evidence supporting the use of manipulation therapy for patients with cervical radiculopathy (CR). This study aimed to evaluate the effectiveness of Shi-style cervical manipulations (SCMs) versus mechanical cervical traction (MCT) for CR. METHODS: This was a randomized, open-label, controlled trial carried out at 5 hospitals in patients with CR for at least 2 weeks and neck pain. The patients received 6 treatments of SCM (n = 179) or MCT (n = 180) over 2 weeks. The primary outcome was participant-rated disability (neck disability index), measured 2 weeks after randomization. The secondary outcomes were participant-rated pain (visual analog scale) and health-related quality of life (36-Item Short Form Health Survey [SF-36]). Assessments were performed before, during, and after (2, 4, 12, and 24 weeks) intervention. RESULTS: After 2 weeks of treatment, the SCM group showed a greater improvement in participant-rated disability compared with the control group (P = .018). The SCM group reported less disability compared with the control group (P < .001) during the 26-week follow-up. The difference was particularly important at 6 months (mean -28.91 +/- 16.43, P < .001). Significant improvements in SF-36 were noted in both groups after 2 weeks of treatment, but there were no differences between the 2 groups. CONCLUSION: SCM could be a better option than MCT for the treatment of CR-related pain and disability."," Medicine (Baltimore) 96(31): e7276.","China",2017,"Radiculopathy,Neck Pain","Manipulations","NDI","Unknown","PRO study","RCT"]
[94,"Dalton, J. E., et al. (2017). \"Accuracy of Cardiovascular Risk Prediction Varies by Neighborhood Socioeconomic Position: A Retrospective Cohort Study.\" Ann Intern Med 167(7): 456-464.",null,"Dalton, J. E., et al.","Accuracy of Cardiovascular Risk Prediction Varies by Neighborhood Socioeconomic Position: A Retrospective Cohort Study","Background: Inequality in health outcomes in relation to Americans' socioeconomic position is rising. Objective: First, to evaluate the spatial relationship between neighborhood disadvantage and major atherosclerotic cardiovascular disease (ASCVD)-related events; second, to evaluate the relative extent to which neighborhood disadvantage and physiologic risk account for neighborhood-level variation in ASCVD event rates. Design: Observational cohort analysis of geocoded longitudinal electronic health records. Setting: A single academic health center and surrounding neighborhoods in northeastern Ohio. Patients: 109 793 patients from the Cleveland Clinic Health System (CCHS) who had an outpatient lipid panel drawn between 2007 and 2010. The date of the first qualifying lipid panel served as the study baseline. Measurements: Time from baseline to the first occurrence of a major ASCVD event (myocardial infarction, stroke, or cardiovascular death) within 5 years, modeled as a function of a locally derived neighborhood disadvantage index (NDI) and the predicted 5-year ASCVD event rate from the Pooled Cohort Equations Risk Model (PCERM) of the American College of Cardiology and American Heart Association. Outcome data were censored if no CCHS encounters occurred for 2 consecutive years or when state death data were no longer available (that is, from 2014 onward). Results: The PCERM systematically underpredicted ASCVD event risk among patients from disadvantaged communities. Model discrimination was poorer among these patients (concordance index [C], 0.70 [95% CI, 0.67 to 0.74]) than those from the most affluent communities (C, 0.80 [CI, 0.78 to 0.81]). The NDI alone accounted for 32.0% of census tract-level variation in ASCVD event rates, compared with 10.0% accounted for by the PCERM. Limitations: Patients from affluent communities were overrepresented. Outcomes of patients who received treatment for cardiovascular disease at Cleveland Clinic were assumed to be independent of whether the patients came from a disadvantaged or an affluent neighborhood. Conclusion: Neighborhood disadvantage may be a powerful regulator of ASCVD event risk. In addition to supplemental risk models and clinical screening criteria, population-based solutions are needed to ameliorate the deleterious effects of neighborhood disadvantage on health outcomes. Primary Funding Source: The Clinical and Translational Science Collaborative of Cleveland and National Institutes of Health."," Ann Intern Med 167(7): 456-464.","USA",2017,"Cardiovascular Disease","Not Specified","NDI","Adults","Tool Validation","Retrospective review"]
[95,"Damian, M. and C. Zalpour (2011). \"Trigger point treatment with radial shock waves in musicians with nonspecific shoulder-neck pain: data from a special physio outpatient clinic for musicians.\" Med Probl Perform Art 26(4): 211-217.",null,"Damian, M. and C. Zalpour","Trigger point treatment with radial shock waves in musicians with nonspecific shoulder-neck pain: data from a special physio outpatient clinic for musicians","Musicians often suffer from disorders of the musculoskeletal system that are related to their instrument playing. Among the most frequent symptoms are complaints in the shoulder-neck area. Radial shock wave therapy is increasingly used in trigger point treatment, but only few high-level studies have examined of shock wave therapy used together with physical therapy in the treatment of musicians. METHODS: This randomized blinded study in musicians (n = 26) with nonspecific shoulder-neck problems was done to examine the effect of shock wave therapy in addition to current physical therapy on the symptoms and quality of life of the musicians as well as their habits of playing musical instruments (intervention group shock wave vs reference group placebo). The effects were documented by a pain VAS and other instruments. A questionnaire designed specifically for musicians (with initial and final questions) recorded intensity and manifestation of pain and handicaps in daily life, especially when practicing and playing. The Shoulder Pain and Disability Index (SPADI) and the Neck Pain Disability Index Questionnaire (NPDIQ) were also used. RESULTS: Both groups reported subjective improvement in pain, but significance was found only for the intervention group for the SPADI and NPDIQ. CONCLUSIONS: Trigger point treatment with radial shock wave used in combination with physical therapy makes the subjects feel temporarily relieved of neck and shoulder pains. The effects of radial shock wave without physical therapy will need to be examined in further studies."," Med Probl Perform Art 26(4): 211-217.","Germany",2011,"Back Pain,Neck Pain","Physical Therapy","NPDIQ","Unknown","PRO study","RCT"]
[96,"Danielsson, A. J. and K. Romberg (2013). \"Reliability and validity of the Swedish version of the Scoliosis Research Society-22 (SRS-22r) patient questionnaire for idiopathic scoliosis.\" Spine (Phila Pa 1976) 38(21): 1875-1884.",null,"Danielsson, A. J. and K. Romberg","Reliability and validity of the Swedish version of the Scoliosis Research Society-22 (SRS-22r) patient questionnaire for idiopathic scoliosis","STUDY DESIGN: Two quality-of-life questionnaires were completed, once or twice, by patients with idiopathic scoliosis from 3 centers for scoliosis care in Sweden. These patients were under observation, during brace treatment, or after treatment with either a brace or surgery. OBJECTIVE: The aim of the study was to translate and validate the revised version of the Scoliosis Research Society Questionnaire (SRS-22r) for use in Sweden. SUMMARY OF BACKGROUND DATA: In modern outcome research, the patient's own view of outcome is of great importance. The SRS-22 Questionnaire has been specially designed to measure quality of life in patients with scoliosis and has been used in a number of recent studies. This questionnaire had not previously been used in Sweden. METHODS: The SRS-22r was translated into Swedish according to accepted methods for the translation of quality-of-life questionnaires. One hundred and forty one patients answered the questionnaire together with the SF-36. Statistical analyses were performed and revealed a somewhat low internal consistency (Cronbach alpha) of the Function domain/SRS-22, which was found to originate in question number 18. After retranslation, another 52 patients completed the improved questionnaire. Analyses were repeated, and the results improved. When suitable, all 193 patients were therefore analyzed together. RESULTS: Descriptive statistics, distributions, test-retest, and test for concurrent validity showed satisfactory results. After retranslation, the Cronbach alpha for all domain scores was at least 0.72. Discriminant validity was only shown for self-image and management satisfaction/dissatisfaction. CONCLUSION: The SRS-22r Questionnaire was found to be appropriate for use in our language. Further testing for discriminant validity will be performed. LEVEL OF EVIDENCE: N/A."," Spine (Phila Pa 1976) 38(21): 1875-1884.","Sweden",2013,"Spinal Deformity","Surgical","SRS-HRQOL","Unknown","Tool Validation","Observational"]
[97,"Danielsson, A. J., et al. (2012). \"Body appearance and quality of life in adult patients with adolescent idiopathic scoliosis treated with a brace or under observation alone during adolescence.\" Spine (Phila Pa 1976) 37(9): 755-762.",null,"Danielsson, A. J., et al.","Body appearance and quality of life in adult patients with adolescent idiopathic scoliosis treated with a brace or under observation alone during adolescence","STUDY DESIGN: The Scoliosis Research Society (SRS) brace study (published in the JBJS-A, 1995) was comprised of patients with adolescent idiopathic scoliosis with moderate curve sizes (25 degrees -35 degrees ). Forty observed and 37 braced patients (77% of the original group) attended a follow-up, a mean of 16 years after onset of maturity. OBJECTIVE: To analyze whether the subjectively evaluated present body appearance affects outcome as measured by quality of life in adult patients, previously treated by observation alone (nonbraced) or with a brace during adolescence. SUMMARY OF BACKGROUND DATA: Few reports exist where validated outcome measures for body appearance have been used. METHODS: Two quality-of-life questionnaires, the Scoliosis Research Society-22 (SRS-22) questionnaire and the 36-Item Short-Form Survey Instrument (SF-36), were answered. The patient's opinion on body appearance was evaluated pictorially (i.e., sketches) using the spinal appearance questionnaire, in which 7 aspects of asymmetry are graded. These scores were compared with curve sizes, scoliometer measurements for grading trunk asymmetry, and quality-of-life measures. RESULTS: At follow-up, both groups were similar in terms of age (mean = 32 years) and curve size (mean = 35 degrees ). Distortion was inversely related to SRS-22 total score and satisfaction/dissatisfaction with management subscore, but not related to the SRS-22 function subscore. No difference was found between the groups in terms of trunk rotation, where the means were 10.7 degrees and 10.8 degrees for the nonbraced and braced patients, respectively. The nonbraced patients estimated that their body appearance was significantly less distorted than the braced patients (mean = 12.9 and 15.0, respectively; P = 0.0028). CONCLUSION: Patients who experienced less body asymmetry were more satisfied with treatment and had a better quality of life. In spite of similar curve sizes and trunk rotation in both groups, the nonbraced patients felt that their body appearance was less distorted than that of the braced patients."," Spine (Phila Pa 1976) 37(9): 755-762.","Sweden",2012,"Spinal Deformity","Brace","SRS-HRQOL","Adults","PRO study","Retrospective review"]
[98,"DeBerard, M. S., et al. (2001). \"Outcomes of posterolateral lumbar fusion in Utah patients receiving workers' compensation: a retrospective cohort study.\" Spine (Phila Pa 1976) 26(7): 738-746; discussion 747.",null,"DeBerard, M. S., et al.","Outcomes of posterolateral lumbar fusion in Utah patients receiving workers' compensation: a retrospective cohort study","STUDY DESIGN: A retrospective cohort study consisting of a medical record review and a follow-up telephone survey of patients with lumbar fusion, at least 2 years after their surgery, was performed. OBJECTIVE: To identify presurgical correlates and long-term outcomes from posterolateral lumbar fusion in Utah patients receiving workers' compensation. SUMMARY OF BACKGROUND DATA: Lumbar fusion has been criticized for its highly variable outcomes, and compensated workers are at particular risk for poor outcomes. Evidence suggests that presurgical psychosocial factors may be important modifiers of back pain reporting and back surgery outcomes. METHODS: The patients in this study were 185 compensated workers in Utah who underwent posterolateral lumbar fusion. Patient medical records were independently reviewed, and medical and sociodemographic variables were coded. A telephone outcome survey was completed with 130 patients (70%) an average of 4.6 years after their surgery. RESULTS: Reported solid fusion, reoperation, and disability rates for the follow-up sample were 74%, 24%, and 25%, respectively. As reported by the patients, 41% experienced no change or a worsened quality of life. Mean scores from the Roland and Morris Back Pain Disability Questionnaire, the Stauffer-Coventry-Index, and the Short-Form 20 Multidimensional Health Survey indicate that many patients experienced postsurgical dysfunction. Presurgical predictors of outcomes were number of prior low back operations, income at time of injury, age, litigation, and depression. CONCLUSIONS: Outcomes of posterolateral lumbar fusion among compensated workers in Utah are inconsistent. Outcomes can be predicted by presurgical sociodemographic variables. Screening for such presurgical risk factors may be important for prudent surgical decisions and rehabilitation planning."," Spine (Phila Pa 1976) 26(7): 738-746; discussion 747.","USA",2001,"Back Pain","Surgical","RMDQ,SCI","Adults","PRO study","Retrospective review"]
[99,"del Pozo-Cruz, B., et al. (2012). \"An occupational, internet-based intervention to prevent chronicity in subacute lower back pain: a randomised controlled trial.\" J Rehabil Med 44(7): 581-587.",null,"del Pozo-Cruz, B., et al.","An occupational, internet-based intervention to prevent chronicity in subacute lower back pain: a randomised controlled trial","OBJECTIVE: To investigate whether an online occupational postural and exercise intervention reduced patients' overall risk status for chronicity in subacute non-specific low back pain compared with conventional treatment, and to determine whether changes in risk of chronicity correlate with changes in specific outcomes (i.e. Functional Status and QoL) for low back pain. DESIGN: Prospective, single-blinded randomized intervention study. SUBJECTS: University office workers with subacute non-specific low back pain (n=100) were randomized 1:1 to an intervention group, who received an online occupational postural and exercise intervention, and a control group. METHODS: Exercise and education materials used in the intervention were developed as an online resource, and included video demonstrations recorded in a laboratory. All sessions included exercises combining postural stability (for abdominal, lumbar, hip and thigh muscles) strengthening, flexibility, mobility, and stretching. Outcome measures included STarT Back Screening Tool (SBST), Roland Morris score, and European Quality of Life Questionnaire -5 dimensions - 3 levels. At 9 months, SBST was analysed and compared with the baseline and controls. RESULTS: Significant positive effects were found on mean scores recorded in the online occupational exercise intervention group for risk of chronicity (p<0.019). A correlation between functional disability, health-related quality of life and risk of chronicity of low back pain was observed. CONCLUSION: This study supports the potential utility of a real-time occupational internet-based intervention for preventing progression to chronicity of subacute non-specific low back pain among office workers."," J Rehabil Med 44(7): 581-587.","Spain",2012,"Back Pain","Exercise","RMDQ","Unknown","PRO study","Observational"]
[100,"del Pozo-Cruz, B., et al. (2013). \"Musculoskeletal fitness and health-related quality of life characteristics among sedentary office workers affected by sub-acute, non-specific low back pain: a cross-sectional study.\" Physiotherapy 99(3): 194-200.",null,"del Pozo-Cruz, B., et al.","Musculoskeletal fitness and health-related quality of life characteristics among sedentary office workers affected by sub-acute, non-specific low back pain: a cross-sectional study","OBJECTIVES: To establish the level of musculoskeletal fitness and health-related quality of life (HRQoL) in sedentary office workers with sub-acute, non-specific low back pain, and compare the results with reference data for healthy sedentary office workers. DESIGN: Cross-sectional study. SETTING: Occupational secondary prevention setting. PARTICIPANTS: One-hundred and ninety sedentary office workers: 118 suffering from sub-acute, non-specific low back pain (47 men and 71 women) and 72 age-matched healthy controls (30 men and 42 women). MAIN OUTCOME MEASURES: Participants were assessed using a musculoskeletal fitness battery (sit-and-reach test, hand grip strength, lumbar and abdominal trunk muscle endurance, and back scratch test), the EuroQol-5D-3L, Oswestry Disability Questionnaire, and Roland Morris Disability Questionnaire. Data for both genders and conditions were compared. RESULTS: Subjects with low back pain achieved lower scores in most of the fitness tests compared with healthy, age-matched controls. Trunk flexor and extensor endurance demonstrated the greatest difference in both men {flexion: median difference 59 [95% confidence interval (CI) 26 to 90]seconds; extension: median difference 24 [95% CI 20 to 68]} and women [flexion: median difference 59 (95% CI 5 to 85.50)seconds; extension: median difference 41 (95% CI 30 to 55)seconds]. Differences in HRQoL were also demonstrated between groups for both men and women, with the exception of the pain/discomfort dimension in women. CONCLUSIONS: Sedentary office workers with sub-acute, non-specific low back pain had lower musculoskeletal fitness than healthy, age-matched controls, with the main difference found in endurance of the trunk muscles. HRQoL was also lower in workers with low back pain."," Physiotherapy 99(3): 194-200.","Spain",2013,"Back Pain","Not Specified","ODI,RMDQ","Unknown","PRO study","Observational"]
[101,"Drury, T., et al. (2009). \"Degenerative spondylolisthesis in patients with neurogenic claudication effects functional performance and self-reported quality of life.\" Spine (Phila Pa 1976) 34(25): 2812-2817.",null,"Drury, T., et al.","Degenerative spondylolisthesis in patients with neurogenic claudication effects functional performance and self-reported quality of life","STUDY DESIGN: The effect of degenerative spondylolisthesis on functional performance and self reported quality of life in patients with lumbar spinal stenosis was compared to patients with lumbar spinal stenosis and no degenerative spondylolisthesis. OBJECTIVE: To define the relationship degenerative spondylolisthesis shares with functional performance and self reported quality of life in patients with symptomatic lumbar spinal stenosis. SUMMARY OF BACKGROUND DATA: Neurogenic claudication is a clinical syndrome that reflects symptoms caused by anatomic spinal stenosis. This condition limits functional status and impacts overall health satisfaction. Degenerative spondylolisthesis is one cause of spinal stenosis and is present to different degrees in patients with neurogenic claudication. METHODS: Thirty-eight women and 39 men diagnosed with lumbar spinal stenosis and neurogenic claudication were prospectively enrolled in the study. All underwent routine, screening side-lying, lateral flexion and extension radiographs. The evaluation included a shuttle walking test, as well as patient self-assessment using the Swiss Spinal Stenosis Questionnaire, and Short Form 36. RESULTS: The overall walking distance did not differ based on the presence of degenerative spondylolisthesis. No correlation between magnitude of deformity and decreased walking distance was identified. Men walked on average 231.3 m (SD: 159.2) and women walked 251.3 m (SD: 138.4). No statistical difference was noted between men and women and their walking ability (P < 0.56). The Swiss Spinal Stenosis Questionnaire and the Short Form 36 were both strongly correlated with decreased walking ability (P < 0.05). CONCLUSION: The presence and magnitude of degenerative spondylolisthesis does not correlate with decreased functional capacity. The Swiss Spinal Stenosis Questionnaire and Short Form 36 are accurate in defining the functional status of a patient. Comprehensive evaluation of patients with symptomatic lumbar spinal stenosis using functional assessment and self-assessment questionnaires are helpful in determining the severity of a patient's disability. Plain radiographs may be valuable adjuncts for surgical decision-making, but are not useful in quantifying the degree to which a patient is impaired."," Spine (Phila Pa 1976) 34(25): 2812-2817.","USA",2009,"Spondylosis","Surgical","SSSQ","Unknown","PRO study","Prospective Observation"]
[102,"Duffy, S. A., et al. (2002). \"Effect of smoking, alcohol, and depression on the quality of life of head and neck cancer patients.\" Gen Hosp Psychiatry 24(3): 140-147.",null,"Duffy, S. A., et al.","Effect of smoking, alcohol, and depression on the quality of life of head and neck cancer patients","This pilot study examined the relationship between smoking, alcohol intake, depressive symptoms and quality of life (QoL) in head and neck cancer patients. A questionnaire on smoking, alcohol, depressive symptoms and QoL was distributed to head and neck cancer patients (N=81). Over one-third (35%) of the respondents had smoked within the last 6 months, 46% had drunk alcohol within the last 6 months and 44% screened positive for significant depressive symptoms. About one-third (32%) of smokers were interested in smoking cessation services and 37% of patients with depressive symptoms were interested in depression services. However, only 9% of those who drank alcohol expressed interest in alcohol services. Smoking was negatively associated with five scales of the SF-36V including Physical Functioning, General Health, Vitality, Social Functioning, and Role-Emotional Health. Depressive symptoms were negatively associated with all eight scales on the SF-36V and all four scales of the Head and Neck Quality of Life instrument. Surprisingly, alcohol was not found to be associated with any of the QoL scales. While smoking, alcohol intake and depression may be episodically treated, standardized protocols and aggressive intervention strategies for systematically addressing these highly prevalent disorders are needed in this population."," Gen Hosp Psychiatry 24(3): 140-147.","USA",2002,"Cancer","Not Specified","HNQOL","Unknown","PRO study","Observational"]
[103,"Dundar, U., et al. (2009). \"Clinical effectiveness of aquatic exercise to treat chronic low back pain: a randomized controlled trial.\" Spine (Phila Pa 1976) 34(14): 1436-1440.",null,"Dundar, U., et al.","Clinical effectiveness of aquatic exercise to treat chronic low back pain: a randomized controlled trial","STUDY DESIGN: This study was a prospective, randomized, controlled study. OBJECTIVE: To compare the effectiveness of aquatic exercise interventions with land-based exercises in the treatment of chronic low back pain (CLBP). SUMMARY OF BACKGROUND DATA: Land-based exercise and physiotherapy are the main treatment tools used for CLBP. Clinical experience indicates that aquatic exercise may have advantages for patients with musculoskeletal disorders. METHODS: A total of 65 patients with CLBP were included in this study. Patients were randomly assigned to receive aquatic exercise or land-based exercise treatment protocol. Aquatic exercise program consisted of 20 sessions, 5 x per week for 4 weeks in a swimming pool at 33 degrees C. Land-based exercise (home-based exercise) program were demonstrated by a physiotherapist on one occasion and then they were given written advice The patients were assessed for spinal mobility, pain, disability, and quality of life. Evaluations were performed before treatment (week 0) and after treatment (week 4 and week 12). RESULTS: In both groups, statistically significant improvements were detected in all outcome measures (except modified Schober test) compared with baseline. However, improvement in modified Oswestry Low Back Pain Disability questionnaire and physical function and role limitations due to physical functioning subpart of Short-Form 36 Health Survey were better in aquatic exercise group (P < 0.05). CONCLUSION: It is concluded that a water-based exercises produced better improvement in disability and quality of life of the patients with CLBP than land-based exercise."," Spine (Phila Pa 1976) 34(14): 1436-1440.","Turkey",2009,"Back Pain","Exercise","ODI","Unknown","PRO study","Prospective Observation"]
[104,"Dundar, U., et al. (2014). \"Effect of aquatic exercise on ankylosing spondylitis: a randomized controlled trial.\" Rheumatol Int 34(11): 1505-1511.",null,"Dundar, U., et al.","Effect of aquatic exercise on ankylosing spondylitis: a randomized controlled trial","Ankylosing spondylitis (AS) is a chronic systemic inflammatory disease that affects mainly the axial skeleton and causes significant pain and disability. Aquatic (water-based) exercise may have a beneficial effect in various musculoskeletal conditions. The aim of this study was to compare the effectiveness of aquatic exercise interventions with land-based exercises (home-based exercise) in the treatment of AS. Patients with AS were randomly assigned to receive either home-based exercise or aquatic exercise treatment protocol. Home-based exercise program was demonstrated by a physiotherapist on one occasion and then, exercise manual booklet was given to all patients in this group. Aquatic exercise program consisted of 20 sessions, 5x per week for 4 weeks in a swimming pool at 32-33 degrees C. All the patients in both groups were assessed for pain, spinal mobility, disease activity, disability, and quality of life. Evaluations were performed before treatment (week 0) and after treatment (week 4 and week 12). The baseline and mean values of the percentage changes calculated for both groups were compared using independent sample t test. Paired t test was used for comparison of pre- and posttreatment values within groups. A total of 69 patients with AS were included in this study. We observed significant improvements for all parameters [pain score (VAS) visual analog scale, lumbar flexion/extension, modified Schober test, chest expansion, bath AS functional index, bath AS metrology index, bath AS disease activity index, and short form-36 (SF-36)] in both groups after treatment at week 4 and week 12 (p < 0.05). Comparison of the percentage changes of parameters both at week 4 and week 12 relative to pretreatment values showed that improvement in VAS (p < 0.001) and bodily pain (p < 0.001), general health (p < 0.001), vitality (p < 0.001), social functioning (p < 0.001), role limitations due to emotional problems (p < 0.001), and general mental health (p < 0.001) subparts of SF-36 were better in aquatic exercise group. It is concluded that a water-based exercises produced better improvement in pain score and quality of life of the patients with AS compared with home-based exercise."," Rheumatol Int 34(11): 1505-1511.","Turkey",2014,"Spondylosis","Exercise","Schober","Unknown","PRO study","RCT"]
[105,"Dundar, U., et al. (2015). \"Effect of high-intensity laser therapy in the management of myofascial pain syndrome of the trapezius: a double-blind, placebo-controlled study.\" Lasers Med Sci 30(1999): 325-332.",null,"Dundar, U., et al.","Effect of high-intensity laser therapy in the management of myofascial pain syndrome of the trapezius: a double-blind, placebo-controlled study","Myofascial pain syndrome (MPS) of the trapezius muscle is one of the main causes of neck pain. In this randomized, double-blind study, we evaluated the effects of high-intensity laser therapy (HILT) in female patients with chronic MPS of the trapezius muscle. The patients were assigned to two groups. The HILT group was treated with HILT and exercise, and the sham therapy group was treated with placebo HILT and exercise. The patients were assessed for pain, cervical active range of motion, disability, and quality of life. Evaluations were performed before treatment (week 0) and after treatment (weeks 4 and 12). Both groups showed significant improvement in all parameters at weeks 4 and 12. However, in a comparison of the percentage changes in the parameters at weeks 4 and 12 relative to pretreatment values, the HILT group showed greater improvement in pain scores, the neck disability index, and several subparts of the short-form 36 health survey (SF-36) (physical functioning, role limitations due to physical functioning, bodily pain, general health perceptions, social functioning, and role limitations due to emotional problems) than did the sham therapy group. We conclude that HILT is an effective therapeutic method in the treatment of patients with chronic MPS of the trapezius muscle."," Lasers Med Sci 30(1999): 325-332.","Turkey",2015,"Neck Pain","Laser Therapy","NDI","Unknown","PRO study","RCT"]
[106,"Dvorak, M. F., et al. (2007). \"Clinical outcomes of 90 isolated unilateral facet fractures, subluxations, and dislocations treated surgically and nonoperatively.\" Spine (Phila Pa 1976) 32(26): 3007-3013.",null,"Dvorak, M. F., et al.","Clinical outcomes of 90 isolated unilateral facet fractures, subluxations, and dislocations treated surgically and nonoperatively","STUDY DESIGN: A retrospective outcomes study. OBJECTIVE: The purposes of this study were 1) to identify plausible patient and interventional variables that influence the outcome of unilateral facet injuries and 2) to determine if patients return to normal general health status after unilateral facet injuries. SUMMARY OF BACKGROUND DATA: The management of unilateral subaxial cervical facet fractures and dislocations lacks agreement on treatment options and the variables that influence outcome. METHODS: Injury data, radiographs, and outcomes (North American Spine Society Cervical Follow-up Questionnaire and Short Form-36) were collected from 9 centers and 13 surgeons, members of the Spine Trauma Study Group. RESULTS: Causally motor vehicle accidents (49%) and sports (31%) predominated. The C6-C7 level accounted for 60% of injuries and C5-C6 represented 17%. The mean SF-36 PCS score of the operative patients with follow-up >18 months was 6.70 points higher than the mean of the nonoperative patients (P = 0.017). The SF-36 Bodily Pain mean of all patients was 67.2 (SD = 27.6), significantly lower (more pain) than the normative mean of 75.2 (SD = 23.7) (P = 0.014). Nonoperative patients also reported a mean Bodily Pain score of 63.0 (SD = 30.5) that was significantly worse than normative values (P = 0.031). Similarly, the NASS PD mean score for all patients was 84.8 (SD = 17.9), significantly lower than the normative mean of 89.1 (SD = 15.5) (P = 0.014). CONCLUSION: To our knowledge this is the largest reported series of facet injuries to date and the only one using health-related quality of life instruments. Unilateral facet injuries of the subaxial cervical spine led to reported levels of pain and disability that are significantly worse than those of the healthy population. Although further study is required, we suggest that nonoperatively treated patients report worse outcomes than operatively treated patients, particularly at longer follow-up despite having a more benign fracture pattern. The presence of comorbidities, associated injuries, and advanced age adversely impact clinical outcomes."," Spine (Phila Pa 1976) 32(26): 3007-3013.","Canada",2007,"Spinal Fracture","Surgical","NASS-L","Unknown","PRO study","Retrospective review"]
[107,"Ehrlich, G. E. (2003). \"Back pain.\" J Rheumatol Suppl 67: 26-31.",null,"Ehrlich, G. E.","Back pain","Back pain is ubiquitous and probably plagues almost everyone in all cultures and ethnic groups at some time (around 20% annually), and in up to 50% of these at least once a year. The WHO-COPCORD epidemiologic investigations have established its prevalence even in countries that had been unaware of its frequency in their populace, and factors involving type of work and training probably accounted for this misperception. Medical journals are replete with articles addressing diagnosis and treatment, but the majority fail to meet the standards needed for metaanalysis or comparison. A task force of the Agency for Health Care Policy and Research of the United States Department of Health and Human Services screened more than 10,000 abstracts, eliminated the majority of these studies and papers, and still was unable to recommend the best approach even to acute back pain; the problem of subacute and chronic back pain is even more formidable. Yet back pain has been identified as perhaps the major cause of disability and absenteeism from the workplace worldwide. WHO chiefly addressed subacute back pain, as most acute back pain is self-limited and ends spontaneously, almost regardless of the treatment. Subacute pain is the intermediate stage toward chronic pain, which defies most treatments. Specific causes for back pain, such as infections, tumors, osteoporosis, spondyloarthropathies, and trauma, actually represent a minority of such pain syndromes, qualifying for specific therapeutic approaches. A major problem in defining the burden of disease for back pain has been a dearth of agreed-upon outcome measures by which to judge the various interventions, and this was the task that the WHO Low Back Pain Initiative took upon itself. Among measures recommended to be included in all studies, so that valid comparisons could be made, were measurement of pain by visual analog scales, somatic perception, the Oswestry disability and modified Zung questionnaires, and a modified Schober test of spinal mobility. These measures are needed for studies, not for diagnosis or treatment of individual patients. They have been translated into various major languages and validated by back-translations, and applied in comparative studies in various cultures to medical, chiropractic, and other common interventions. The importance of such scientifically sound studies cannot be overemphasized, as the costs of health care are mounting everywhere and it therefore becomes imperative to develop cost-effective approaches. All the more so as conversion of acute back pain to chronic back pain is often iatrogenic, with strong psychosocial factors as well, so that not only what to do but also what not to do become important public health issues. The general lack of attention to back pain by governments and organizations probably results from the fact that it is perceived as a syndromic presentation with myriad causes rather than as a specific disease entity. Even if the \"disease\" names classify like presentations but are not necessarily etiologically discrete, syndromic diagnoses that subsume a variety of causes receive less attention; international rankings of common disabilities and public health problems tend to emphasize the named disorders rather than the grouped disorders. Moreover, back pain is often self-treated with nonprescription medications or alternative therapies, and by nonmedical practitioners or treatments in many parts of the world. Validation of outcomes therefore not only reduces invalidism and direct costs but also reduces the indirect costs of absenteeism and medical care."," J Rheumatol Suppl 67: 26-31.","USA",2003,"Back Pain,Spondylosis","Psychosocial","ODI","Unknown","Tool Validation","Narrative review"]
[108,"Eklund, A., et al. (2014). \"Prevention of low back pain: effect, cost-effectiveness, and cost-utility of maintenance care - study protocol for a randomized clinical trial.\" Trials 15: 102.",null,"Eklund, A., et al.","Prevention of low back pain: effect, cost-effectiveness, and cost-utility of maintenance care - study protocol for a randomized clinical trial","BACKGROUND: Low back pain (LBP) is a prevalent condition and a socioeconomic problem in many countries. Due to its recurrent nature, the prevention of further episodes (secondary prevention), seems logical. Furthermore, when the condition is persistent, the minimization of symptoms and prevention of deterioration (tertiary prevention), is equally important. Research has largely focused on treatment methods for symptomatic episodes, and little is known about preventive treatment strategies. METHODS/DESIGN: This study protocol describes a randomized controlled clinical trial in a multicenter setting investigating the effect and cost-effectiveness of preventive manual care (chiropractic maintenance care) in a population of patients with recurrent or persistent LBP.Four hundred consecutive study subjects with recurrent or persistent LBP will be recruited from chiropractic clinics in Sweden. The primary outcome is the number of days with bothersome pain over 12 months. Secondary measures are self-rated health (EQ-5D), function (the Roland Morris Disability Questionnaire), psychological profile (the Multidimensional Pain Inventory), pain intensity (the Numeric Rating Scale), and work absence.The primary utility measure of the study is quality-adjusted life years and will be calculated using the EQ-5D questionnaire. Direct medical costs as well as indirect costs will be considered.Subjects are randomly allocated into two treatment arms: 1) Symptom-guided treatment (patient controlled), receiving care when patients feel a need. 2) Preventive treatment (clinician controlled), receiving care on a regular basis. Eligibility screening takes place in two phases: first, when assessing the primary inclusion/exclusion criteria, and then to only include fast responders, i.e., subjects who respond well to initial treatment. Data are collected at baseline and at follow-up as well as weekly, using SMS text messages. DISCUSSION: This study investigates a manual strategy (chiropractic maintenance care) for recurrent and persistent LBP and aims to answer questions regarding the effect and cost-effectiveness of this preventive approach. Strict inclusion criteria should ensure a suitable target group and the use of frequent data collection should provide an accurate outcome measurement. The study utilizes normal clinical procedures, which should aid the transferability of the results. TRIAL REGISTRATION: Clinical trials.gov; NCT01539863, February 22, 2012. The first patient was randomized into the study on April 13th 2012."," Trials 15: 102.","Sweden",2014,"Back Pain","Psychosocial","RMDQ","Adults","Cost-Effectiveness","RCT"]
[109,"el Barzouhi, A., et al. (2014). \"Reliability of gadolinium-enhanced magnetic resonance imaging findings and their correlation with clinical outcome in patients with sciatica.\" Spine J 14(11): 2598-2607.",null,"el Barzouhi, A., et al.","Reliability of gadolinium-enhanced magnetic resonance imaging findings and their correlation with clinical outcome in patients with sciatica","BACKGROUND CONTEXT: Gadolinium-enhanced magnetic resonance imaging (Gd-MRI) is often performed in the evaluation of patients with persistent sciatica after lumbar disc surgery. However, correlation between enhancement and clinical findings is debated, and limited data are available regarding the reliability of enhancement findings. PURPOSE: To evaluate the reliability of Gd-MRI findings and their correlation with clinical findings in patients with sciatica. STUDY DESIGN: Prospective observational evaluation of patients who were enrolled in a randomized trial with 1-year follow-up. PATIENTS SAMPLE: Patients with 6- to 12-week sciatica, who participated in a multicentre randomized clinical trial comparing an early surgery strategy with prolonged conservative care with surgery if needed. In total 204 patients underwent Gd-MRI at baseline and after 1 year. OUTCOME MEASURES: Patients were assessed by means of the Roland Disability Questionnaire (RDQ) for sciatica, visual analog scale (VAS) for leg pain, and patient-reported perceived recovery at 1 year. Kappa coefficients were used to assess interobserver reliability. METHODS: In total, 204 patients underwent Gd-MRI at baseline and after 1 year. Magnetic resonance imaging findings were correlated to the outcome measures using the Mann-Whitney U test for continuous data and Fisher exact tests for categorical data. RESULTS: Poor-to-moderate agreement was observed regarding Gd enhancement of the herniated disc and compressed nerve root (kappa<0.41), which was in contrast with excellent interobserver agreement of the disc level of the herniated disc and compressed nerve root (kappa>0.95). Of the 59 patients with an enhancing herniated disc at 1 year, 86% reported recovery compared with 100% of the 12 patients with nonenhancing herniated discs (p=.34). Of the 12 patients with enhancement of the most affected nerve root at 1 year, 83% reported recovery compared with 85% of the 192 patients with no enhancement (p=.69). Patients with and without enhancing herniated discs or nerve roots at 1 year reported comparable outcomes on RDQ and VAS-leg pain. CONCLUSIONS: Reliability of Gd-MRI findings was poor-to-moderate and no correlation was observed between enhancement and clinical findings at 1-year follow-up."," Spine J 14(11): 2598-2607.","Netherlands",2014,"Degenerative Disk Disease","Surgical","RMDQ","Unknown","PRO study","RCT"]
[110,"Fakurnejad, S., et al. (2015). \"The likelihood of reaching minimum clinically important difference and substantial clinical benefit at 2 years following a 3-column osteotomy: analysis of 140 patients.\" J Neurosurg Spine 23(3): 340-348.",null,"Fakurnejad, S., et al.","The likelihood of reaching minimum clinically important difference and substantial clinical benefit at 2 years following a 3-column osteotomy: analysis of 140 patients","OBJECT: Three-column osteotomies (3COs) are technically challenging techniques for correcting severe rigid spinal deformities. The impact of these interventions on outcomes reaching minimum clinically important difference (MCID) or substantial clinical benefit (SCB) is unclear. The objective of this study was to determine the rates of MCID and SCB in standard health-related quality of life (HRQOL) measures after 3COs in patients with adult spinal deformity (ASD). The impacts of location of the uppermost instrumented vertebra (UIV) on clinical outcomes and of maintenance on sagittal correction at 2 years postoperatively were also examined. METHODS: The authors conducted a retrospective multicenter analysis of the records from adult patients who underwent 3CO with complete 2-year radiographic and clinical follow-ups. Cases were categorized according to established radiographic thresholds for pelvic tilt (> 22 degrees ), sagittal vertical axis (> 4.7 cm), and the mismatch between pelvic incidence and lumbar lordosis (> 11 degrees ). The cases were also analyzed on the basis of a UIV in the upper thoracic (T1-6) or thoracolumbar (T9-L1) region. Patient-reported outcome measures evaluated preoperatively and 2 years postoperatively included Oswestry Disability Index (ODI) scores, the Physical Component Summary and Mental Component Summary (MCS) scores of the 36-Item Short Form Health Survey, and Scoliosis Research Society-22 questionnaire (SRS-22) scores. The percentages of patients whose outcomes for these measures met MCID and SCB were compared among the groups. RESULTS: Data from 140 patients (101 women and 39 men) were included in the analysis; the average patient age was 57.3 +/- 12.4 years (range 20-82 years). Of these patients, 94 had undergone only pedicle subtraction osteotomy (PSO) and 42 only vertebral column resection (VCR); 113 patients had a UIV in the upper thoracic (n = 63) orthoracolumbar region (n = 50). On average, 2 years postoperatively the patients had significantly improved in all HRQOL measures except the MCS score. For the entire patient cohort, the improvements ranged from 57.6% for the SRS-22 pain score MCID to 24.4% for the ODI score SCB. For patients undergoing PSO or VCR, the likelihood of their outcomes reaching MCID or SCB ranged from 24.3% to 62.3% and from 16.2% to 47.8%, respectively. The SRS-22 self-image score of patients who had a UIV in the upper thoracic region reached MCID significantly more than that of patients who had a UIV in the thoracolumbar region (70.6% vs 41.9%, p = 0.0281). All other outcomes were similar for UIVs of upper thoracic and thoracolumbar regions. Comparison of patients whose spines were above or below the radiographic thresholds associated with disability indicated similar rates of meeting MCID and SCB for HRQOL at the 2-year follow-up. CONCLUSIONS: Outcomes for patients having UIVs in the upper thoracic region were no more likely to meet MCID or SCB than for those having UIVs in the thoracolumbar region, except for the MCID in the SRS-22 self-image measure. The HRQOL outcomes in patients who had optimal sagittal correction according to radiographic thresholds determined preoperatively were not significantly more likely to reach MCID or SCB at the 2-year follow-up. Future work needs to determine whether the Schwab preoperative radiographic thresholds for severe disability apply in postoperative settings."," J Neurosurg Spine 23(3): 340-348.","USA",2015,"Spinal Deformity","Surgical","ODI,SRS-HRQOL","Adults","PRO study","Retrospective review"]
[111,"Fallah, A., et al. (2012). \"Anterior cervical discectomy with arthroplasty versus arthrodesis for single-level cervical spondylosis: a systematic review and meta-analysis.\" PLoS One 7(8): e43407.",null,"Fallah, A., et al.","Anterior cervical discectomy with arthroplasty versus arthrodesis for single-level cervical spondylosis: a systematic review and meta-analysis","OBJECTIVE: To estimate the effectiveness of anterior cervical discectomy with arthroplasty (ACDA) compared to anterior cervical discectomy with fusion (ACDF) for patient-important outcomes for single-level cervical spondylosis. DATA SOURCES: Electronic databases (MEDLINE, EMBASE, Cochrane Register for Randomized Controlled Trials, BIOSIS and LILACS), archives of spine meetings and bibliographies of relevant articles. STUDY SELECTION: We included RCTs of ACDF versus ACDA in adult patients with single-level cervical spondylosis reporting at least one of the following outcomes: functionality, neurological success, neck pain, arm pain, quality of life, surgery for adjacent level degeneration (ALD), reoperation and dysphonia/dysphagia. We used no language restrictions. We performed title and abstract screening and full text screening independently and in duplicate. DATA SYNTHESIS: We used random-effects model to pool data using mean difference (MD) for continuous outcomes and relative risk (RR) for dichotomous outcomes. We used GRADE to evaluate the quality of evidence for each outcome. RESULTS: Of 2804 citations, 9 articles reporting on 9 trials (1778 participants) were eligible. ACDA is associated with a clinically significant lower incidence of neurologic failure (RR = 0.53, 95% CI = 0.37-0.75, p = 0.0004) and improvement in the Neck pain visual analogue scale (VAS) (MD = 6.56, 95% CI = 3.22-9.90, p = 0.0001; Minimal clinically important difference (MCID) = 2.5. ACDA is associated with a statistically but not clinically significant improvement in Arm pain VAS and SF-36 physical component summary. ACDA is associated with non-statistically significant higher improvement in the Neck Disability Index Score and lower incidence of ALD requiring surgery, reoperation, and dysphagia/dysphonia. CONCLUSIONS: There is no strong evidence to support the routine use of ACDA over ACDF in single-level cervical spondylosis. Current trials lack long-term data required to assess safety as well as surgery for ALD. We suggest that ACDA in patients with single level cervical spondylosis is an option although its benefits and indication over ACDF remain in question."," PLoS One 7(8): e43407.","Canada",2012,"Neck Pain,Spondylosis","Surgical","NDI","Unknown","PRO study","Systematic review"]
[112,"Fan, H., et al. (2016). \"Comparison of Functional Outcome and Quality of Life in Patients With Idiopathic Scoliosis Treated by Spinal Fusion.\" Medicine (Baltimore) 95(19): e3289.",null,"Fan, H., et al.","Comparison of Functional Outcome and Quality of Life in Patients With Idiopathic Scoliosis Treated by Spinal Fusion","Longer spinal fusions have been shown to result in improved deformity correction; however, loss of normal flexibility in the fusion area should not be ignored. Current consensus was to achieve a shorter fusion in primary surgery, with the goal of preserving as much of the distal motion segment as possible. However, the correlation between the length of fusion and functional outcome remains controversial. To the best of our knowledge, a previous study has demonstrated the function outcomes and the differences in HRQoL with specific fusion levels.In this cross-sectional study, 172 patients (mean age, 17.8 y) with idiopathic scoliosis treated by spinal fusion (mean time since surgery, 29.7 mo) were included to measure lumbar spine mobility and quality of life using validated outcome instruments in the study population. Patients were assigned to 5 groups according to the lower instrumented vertebra (LIV) level: group A (fusion above L2) 26 patients; group B (fusion to L2) 21 patients; group C (fusion to L3) 46 patients; group D (fusion to L4) 53 patients; and group E (fusion to L5) 26 patients. At each follow-up, patients were asked to complete the Scoliosis Research Society 22 (SRS-22) Questionnaire. Lumbar mobility was assessed using a dual digital inclinometer.Average spinal range of motion (ROM) was 41.4 degrees (SD, 20.7), forward flexion was 29.2 degrees (SD, 15.0), and backward extension was 12.2 degrees (SD, 9.5). The total spinal range of motion and forward flexion dropped noticeably as the LIV got more distal. Statistically significant between-group differences (1-way ANOVA) were found for ROM (P < 0.001), forward flexion (P < 0.001), or backward extension (P < 0.001). The motion segments preserved significantly correlated with ROM (r = 0.76, P < 0.001), ROMF (r = 0.76, P < 0.001), and ROME (r = 0.39, P < 0.001). However, no significant between-group differences was found for each domain of SRS-22 questionnaire.The motion segments preserved strongly correlated with lumbar mobility. Less fusion levels can preserve better lumbar flexibility by keeping more motion segments."," Medicine (Baltimore) 95(19): e3289.","China",2016,"Spinal Fusion,Spinal Deformity","Surgical","SRS-HRQOL","Unknown","Tool Validation","Observational"]
[113,"Fehlings, M. G., et al. (2013). \"Efficacy and safety of surgical decompression in patients with cervical spondylotic myelopathy: results of the AOSpine North America prospective multi-center study.\" J Bone Joint Surg Am 95(18): 1651-1658.",null,"Fehlings, M. G., et al.","Efficacy and safety of surgical decompression in patients with cervical spondylotic myelopathy: results of the AOSpine North America prospective multi-center study","BACKGROUND: Cervical spondylotic myelopathy is the leading cause of spinal cord dysfunction worldwide. The objective of this study was to evaluate the impact of surgical decompression on functional, quality-of-life, and disability outcomes at one year after surgery in a large cohort of patients with this condition. METHODS: Adult patients with symptomatic cervical spondylotic myelopathy and magnetic resonance imaging evidence of spinal cord compression were enrolled at twelve North American centers from 2005 to 2007. At enrollment, the myelopathy was categorized as mild (modified Japanese Orthopaedic Association [mJOA] score >/= 15), moderate (mJOA = 12 to 14), or severe (mJOA < 12). Patients were followed prospectively for one year, at which point the outcomes of interest included the mJOA score, Nurick grade, Neck Disability Index (NDI), and Short Form-36 version 2 (SF-36v2). All outcomes at one year were compared with the preoperative values with use of univariate paired statistics. Outcomes were also compared among the severity classes with use of one-way analysis of variance. Finally, a multivariate analysis that adjusted for baseline differences among the severity groups was performed. Treatment-related complication data were collected and the overall complication rate was calculated. RESULTS: Eighty-five (30.6%) of the 278 enrolled patients had mild cervical spondylotic myelopathy, 110 (39.6%) had moderate disease, and 83 (29.9%) had severe disease preoperatively. One-year follow-up data were available for 222 (85.4%) of 260 patients. There was a significant improvement from baseline to one year postoperatively (p < 0.05) in the mJOA score, Nurick grade, NDI score, and all SF-36v2 health dimensions (including the mental and physical health composite scores) except general health. With the exception of the change in the mJOA, the degree of improvement did not depend on the severity of the preoperative symptoms. These results remained unchanged after adjusting for relevant confounders in the multivariate analysis. Fifty-two patients experienced complications (prevalence, 18.7%), with no significant differences among the severity groups. CONCLUSIONS: Surgical decompression for the treatment of cervical spondylotic myelopathy was associated with improvement in functional, disability-related, and quality-of-life outcomes at one year of follow-up for all disease severity categories. Furthermore, complication rates observed in the study were commensurate with those in previously reported cervical spondylotic myelopathy series."," J Bone Joint Surg Am 95(18): 1651-1658.","Canada",2013,"Spondylosis","Surgical","NDI,Nurick","Unknown","PRO study","Prospective Observation"]
[114,"Fehlings, M. G., et al. (2013). \"Predictors of treatment outcomes in geriatric patients with odontoid fractures: AOSpine North America multi-centre prospective GOF study.\" Spine (Phila Pa 1976) 38(11): 881-886.",null,"Fehlings, M. G., et al.","Predictors of treatment outcomes in geriatric patients with odontoid fractures: AOSpine North America multi-centre prospective GOF study","STUDY DESIGN: Multicenter prospective cohort study. OBJECTIVE: To identify patient and treatment characteristics associated with treatment success or failure in the management of odontoid fractures. SUMMARY OF BACKGROUND DATA: Odontoid fractures are the most common cervical spine fractures in the elderly and represent a significant management challenge with widely divergent views regarding operative versus nonoperative management. METHODS: A total of 159 patients 65 years and older with radiographically confirmed type II odontoid fractures were enrolled at 10 sites in the United States and 1 site in Canada between January 2006 and May 2009. Subjects were followed at 6 and 12 months post-initial treatment with Neck Disability Index and SF-36v2 scores. Final treatment outcome was classified as failure or success. Treatment failure was defined as death by any cause, decline in Neck Disability Index by more than 9.5 absolute points, or occurrence of a major treatment-related complication. Baseline characteristics between the groups were compared using t test for the continuous variables and chi2 test for the categorical variables. Baseline characteristics associated with treatment outcomes were identified by multiple logistic stepwise regression analysis. RESULTS: A total of 101 (63.5%) patients were treated surgically and 58 (36.5%) conservatively. Forty-four (27.7%) patients had a successful outcome and 86 (54.1%) had a treatment failure; for 29 patients (18.2%), treatment status could not be determined (3 withdrew; 26 were lost to follow-up). Twenty-nine (18.2%) patients expired before the 12-month follow-up. Follow-up information was available for 103 of 127 surviving (81.1%) patients. Twelve-month SF-36v2 scores were worse in the failure group. The characteristics associated with treatment failure were older age (odds ratio [OR] = 1.08 for each year of age); initial nonsurgical treatment (OR = 3.09); male sex (OR = 4.33), and baseline neurological system comorbidity (OR = 4.13). CONCLUSION: Older age, initial nonsurgical treatment, and male sex are associated with failure of treatment in patients with geriatric odontoid fractures."," Spine (Phila Pa 1976) 38(11): 881-886.","Canada",2013,"Spinal Fracture","Surgical","NDI","Elderly","PRO study","Prospective Observation"]
[115,"Fehlings, M. G., et al. (2017). \"Laminectomy and fusion versus laminoplasty for the treatment of degenerative cervical myelopathy: results from the AOSpine North America and International prospective multicenter studies.\" Spine J 17(1999): 102-108.",null,"Fehlings, M. G., et al.","Laminectomy and fusion versus laminoplasty for the treatment of degenerative cervical myelopathy: results from the AOSpine North America and International prospective multicenter studies","BACKGROUND CONTEXT: It remains unclear whether cervical laminoplasty (LP) offers advantages over cervical laminectomy and fusion (LF) in patients undergoing posterior decompression for degenerative cervical myelopathy (DCM). PURPOSE: The objective of this study is to compare outcomes of LP and LF. STUDY DESIGN/SETTING: This is a multicenter international prospective cohort study. PATIENT SAMPLE: A total of 266 surgically treated symptomatic DCM patients undergoing cervical decompression using LP (N=100) or LF (N=166) were included. OUTCOME MEASURES: The outcome measures were the modified Japanese Orthopaedic Association score (mJOA), Nurick grade, Neck Disability Index (NDI), Short-Form 36v2 (SF36v2), length of hospital stay, length of stay in the intensive care unit, treatment complications, and reoperations. METHODS: Differences in outcomes between the LP and LF groups were analyzed by analysis of variance and analysis of covariance. The dependent variable in all analyses was the change score between baseline and 24-month follow-up, and the independent variable was surgical procedure (LP or LF). In the analysis of covariance, outcomes were compared between cohorts while adjusting for gender, age, smoking, number of operative levels, duration of symptoms, geographic region, and baseline scores. RESULTS: There were no differences in age, gender, smoking status, number of operated levels, and baseline Nurick, NDI, and SF36v2 scores between the LP and LF groups. Preoperative mJOA was lower in the LP compared with the LF group (11.52+/-2.77 and 12.30+/-2.85, respectively, p=.0297). Patients in both groups showed significant improvements in mJOA, Nurick grade, NDI, and SF36v2 physical and mental health component scores 24 months after surgery (p<.0001). At 24 months, mJOA scores improved by 3.49 (95% confidence interval [CI]: 2.84, 4.13) in the LP group compared with 2.39 (95% CI: 1.91, 2.86) in the LF group (p=.0069). Nurick grades improved by 1.57 (95% CI: 1.23, 1.90) in the LP group and 1.18 (95% CI: 0.92, 1.44) in the LF group (p=.0770). There were no differences between the groups with respect to NDI and SF36v2 outcomes. After adjustment for preoperative characteristics, surgical factors and geographic region, the differences in mJOA between surgical groups were no longer significant. The rate of treatment-related complications in the LF group was 28.31% compared with 21.00% in the LP group (p=.1079). CONCLUSIONS: Both LP and LF are effective at improving clinical disease severity, functional status, and quality of life in patients with DCM. In an unadjusted analysis, patients treated with LP achieved greater improvements on the mJOA at 24-month follow-up than those who received LF; however, these differences were insignificant following adjustment for relevant confounders."," Spine J 17(1999): 102-108.","Canada",2017,"Cervical Myelopathy","Surgical","NDI,Nurick","Unknown","PRO study","Prospective Observation"]
[116,"Feise, R. J., et al. (2005). \"Construction and validation of the scoliosis quality of life index in adolescent idiopathic scoliosis.\" Spine (Phila Pa 1976) 30(11): 1310-1315.",null,"Feise, R. J., et al.","Construction and validation of the scoliosis quality of life index in adolescent idiopathic scoliosis","STUDY DESIGN: A prospective cross-sectional design was used to evaluate the Scoliosis Quality of Life Index (SQLI). SQLI is a 22-item self-reporting health-related quality-of-life questionnaire for idiopathic scoliosis patients. OBJECTIVE: The goal of this study was to evaluate the psychometric qualities of SQLI. SUMMARY OF BACKGROUND DATA: SQLI, a modification of the Scoliosis Research Society-22 (SRS-22) questionnaire, is intended to be more applicable to patients with adolescent idiopathic scoliosis (AIS) between 10 and 18 years of age. METHODS: Eighty-four subjects with a mean age of 14.9 years participated. We determined reliability, validity, distribution of scores, and clinical utility of SQLI in a hospital setting. Seventy patients were AIS patients (16 postsurgical, 30 braced, 24 unbraced) with a mean Cobb angle of 30.7 degrees, and 14 patients were sibling controls. RESULTS: Reliability: Intraclass correlation coefficient for test-retest reliability of the global index was very good (ICC 2,1 = 0.80); Spearman's rho correlations between items and domains was 0.39 to 0.89 and between domains and global index was 0.55 to 0.78; Cronbach's alpha scores were more than 0.80 (0.82-0.89). VALIDITY: construct validity was established by correlations between SQLI's global index and Quality of Life Profile for Spine Deformities (QLPSD) global index (Spearman's rho, 0.79) and between SQLI domains and QLPSD domains (0.46-0.81); discriminate validity was established by SQLI's global index successfully partitioned controls and AIS subjects (Kruskal-Wallis test, P = 0.0013). Time required by the patient averaged 2.5 minutes per administration. CONCLUSIONS: SQLI is reliable and valid and demonstrates satisfactory distribution of scores. SQLI is a promising instrument in the assessment of AIS patients."," Spine (Phila Pa 1976) 30(11): 1310-1315.","USA",2005,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Observational"]
[117,"Fernandez-Fairen, M., et al. (2012). \"Is anterior cervical fusion with a porous tantalum implant a cost-effective method to treat cervical disc disease with radiculopathy?\" Spine (Phila Pa 1976) 37(20): 1734-1741.",null,"Fernandez-Fairen, M., et al.","Is anterior cervical fusion with a porous tantalum implant a cost-effective method to treat cervical disc disease with radiculopathy?","STUDY DESIGN: Retrospective cost-effectiveness analysis. OBJECTIVE: To determine the relative cost-effectiveness of anterior cervical discectomy with fusion (ACDF) using a porous tantalum implant compared with autograft with plating, for single-level cervical disc disease with radiculopathy. SUMMARY OF BACKGROUND DATA: ACDF with autograft as an interbody spacer is a generally accepted method to treat degenerated cervical discs with radiculopathy. Concerns about donor site morbidity and the structural characteristics of autograft stimulated investigations of alternative materials. Techniques may differ in their operative risks, complications, outcomes, and resource use. METHODS: A retrospective review of clinical outcomes and total cost of illness for 5 years postsurgery was performed for 61 consecutive patients enrolled for this study. Twenty-eight patients were treated with single-level ACDF using either a stand-alone, porous tantalum implant, without graft inside the implant, and 33 patients received autograft and plating. A cost-effectiveness analysis comparing the 2 ACDF treatment methods was conducted. This article reports clinical assessments, quality adjusted life years gained, and an incremental cost-effectiveness ratio analysis. RESULTS: Patients in both cohorts reported improved clinical outcomes, including neck disability index, visual analogue scale, Short-Form 36, Odom's clinical assessment, and patient satisfaction at 5 years postindex surgery. The mean cost of illness for the study period, including preoperative through 5 years postoperative assessments, was 6806 per patient treated with tantalum and 10,143 per patient receiving autograft and plate. Quality-adjusted life years (QALY) gained were 9.41 and 7.14 for the tantalum and control cohorts, respectively. The cost per QALY for the tantalum group was 723 and 1420 for the control group. The incremental cost-effectiveness ratio of ACDF with a porous tantalum implant compared with ACDF with autograft and plate was -1473 per patient per year for the duration of this study. CONCLUSION: This cost-effectiveness analysis reports favorable results for ACDF procedures utilizing a tantalum implant. The data reported suggest that using porous tantalum as a stand-alone device is less costly and more effective than autograft and plate in ACDF procedures."," Spine (Phila Pa 1976) 37(20): 1734-1741.","Spain",2012,"Radiculopathy","Surgical","NDI,Odom","Unknown","Cost-Effectiveness","retrospective review"]
[118,"Filiz, M., et al. (2005). \"The effectiveness of exercise programmes after lumbar disc surgery: a randomized controlled study.\" Clin Rehabil 19(1999): 4-11.",null,"Filiz, M., et al.","The effectiveness of exercise programmes after lumbar disc surgery: a randomized controlled study","OBJECTIVE: To compare two different exercise programmes versus a control group, after lumbar disc surgery. DESIGN: A prospective, single-blind, randomized controlled study. SETTING: Outpatient clinic of Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation. SUBJECTS: Sixty patients diagnosed as having single level lumbar disc herniation with clinical examination and MRI evaluation and who had undergone lumbar discectomy (post-operative first month) at a single level. Patients with serious pathologies involving the cardiac and respiratory systems that could prevent them from doing exercises were excluded. INTERVENTION: The patients were randomly split into three groups. The first group received an intensive exercise programme and back school education while the second group received a home exercise programme and back school education. The third group was defined as the control group and did not receive education or exercise. MAIN MEASURES: The patients were evaluated at the beginning and end of the treatment with clinical parameters, pain levels, endurance tests and weight-lifting tests, modified Oswestry Disability Index, Beck Depression Inventory, Low Back Pain Rating Scale and return to work. RESULTS: The groups doing exercises experienced a decrease in the severity of pain and disability, also functional parameters showed better improvement than the control group. The intensive exercise programme was better than the home exercise programme. CONCLUSIONS: It seems that intensive exercise is more effective in reduction of pain and disability, but whether it is cost-effective is not clear."," Clin Rehabil 19(1999): 4-11.","Turkey",2005,"Back Pain,Degenerative Disk Disease","Surgical","ODI","Unknown","PRO study","RCT"]
[119,"Fisher, C., et al. (2004). \"Outcome evaluation of the operative management of lumbar disc herniation causing sciatica.\" J Neurosurg 100(4 Suppl Spine): 317-324.",null,"Fisher, C., et al.","Outcome evaluation of the operative management of lumbar disc herniation causing sciatica","OBJECT: The authors conducted a study to assess health-related quality of life (HRQOL) and the appropriateness of surgery in patients who have undergone elective lumbar discectomy. METHODS: The study involved a prospective cohort of 82 surgically treated patients with lumbar disc herniation causing lower-extremity radiculopathy. An independent study coordinator recorded demographic data and administered the North American Spine Society (NASS) lumbar spine instrument and the Short Form-36 (SF-36) before treatment, and at 6 months and 1 year after surgery. The HRQOL results were also compared with normative data for the NASS and SF-36. The influence of baseline variables on HRQOL was determined using regression modeling. The InterQual Indicators for Surgery and Procedures (ISP) were used to compare surgeon practice patterns with standardized indications for surgery. The NASS neurogenic symptom (NSS) and pain/disability scores (PDSs) showed very significant improvement at 6 months and little change between 6 months and 1 year. The SF-36 physical function and bodily pain scale scores were associated with the greatest improvement. Interestingly, the 1-year NASS (NSS and PDS) and SF-36 (only PCS) scores remained lower than those of age-matched normative data. Other than preoperative HRQOL scores, the only other variable that inversely influenced HRQOL was the duration of time between symptom onset and surgery. Ninety-five percent of ISP forms were completed, and 97% of the indications recorded by the surgeon matched the criteria. CONCLUSIONS: The reporting of standardized outcomes in association with indications for surgery is feasible and may help elucidate the ideal rate for discectomy."," J Neurosurg 100(4 Suppl Spine): 317-324.","Canada",2004,"Degenerative Disk Disease","Surgical","NASS-L","Unknown","PRO study","Prospective Observation"]
[120,"Foletti, A. and J. Pokorny (2015). \"Biophysical approach to low back pain: a pilot report.\" Electromagn Biol Med 34(2): 156-159.",null,"Foletti, A. and J. Pokorny","Biophysical approach to low back pain: a pilot report","Since biophysical treatment has been reported to be effective in the general management of pain, we decided to assess the specific effect and treatment duration of this therapeutic strategy in low back pain. We were interested in verifying the possibility that a single clinical procedure could reduce pain and improve patients' quality of life within a period of three months. An Electromagnetic Information Transfer Through Aqueous System was employed to record endogenous therapeutic signals from each individual using an electromagnetic recording device (Med Select 729). A highly significant reduction in the Roland Morris low back pain and disability questionnaire score was observed after 3 months following a single biophysical intervention (11.83 +/- 6 at baseline versus 2.3 +/- 3.25 at 3 months, p < 0.0001). This preliminary report provides further evidence of the theoretical implications and clinical applications of Quantum Electro Dynamic concepts in biology and medicine."," Electromagn Biol Med 34(2): 156-159.","Italy",2015,"Back Pain","Not Specified","RMDQ","Unknown","PRO study","Observational"]
[121,"Forestier, R., et al. (2007). \"French version of the Copenhagen neck functional disability scale.\" Joint Bone Spine 74(2): 155-159.",null,"Forestier, R., et al.","French version of the Copenhagen neck functional disability scale","We conducted a study to validate the French version of the Copenhagen Neck Functional Disability Scale (CNFDS). METHODS: We used the CNFDS on data generated by a previous randomized controlled trial comparing pulsed electromagnetic field therapy (PEMFT), spa therapy, and standard therapy in patients with neck pain. Patients were recruited locally and examined by a physician who was unaware of the treatment group and independent from the trial. Treatment efficacy was evaluated based on a visual analog scale (VAS) for pain, the short-form-36 quality-of-life instrument (SF36), payments by public healthcare insurance, and overall assessments by the patients and physicians. Efficacy was evaluated at baseline, at treatment completion, and after 3 and 6 months. In addition, the patients completed the CNFDS at these time points. RESULTS: CNFDS scores were normally distributed. CNFDS scores and their variations correlated well with the other efficacy criteria. CNFDS scores were less sensitive to change than the VAS pain scores and more sensitive to change than the other efficacy criteria. CONCLUSION: The CNFDS holds promise as a tool for evaluating neck pain. Score reproducibility needs to be studied. The CNFDS can be added to the other instruments that have been translated in recent years to serve as tools for clinical research. However, the ease of completion of the CNFDS is consistent with use in clinical practice."," Joint Bone Spine 74(2): 155-159.","France",2007,"Neck Pain","Other","CNFDS","Adults","Tool Validation","RCT"]
[122,"Foster, N. E., et al. (2014). \"Effect of stratified care for low back pain in family practice (IMPaCT Back): a prospective population-based sequential comparison.\" Ann Fam Med 12(2): 102-111.",null,"Foster, N. E., et al.","Effect of stratified care for low back pain in family practice (IMPaCT Back): a prospective population-based sequential comparison","PURPOSE: We aimed to determine the effects of implementing risk-stratified care for low back pain in family practice on physician's clinical behavior, patient outcomes, and costs. METHODS: The IMPaCT Back Study (IMplementation to improve Patient Care through Targeted treatment) prospectively compared separate patient cohorts in a preintervention phase (6 months of usual care) and a postintervention phase (12 months of stratified care) in family practice, involving 64 family physicians and linked physical therapy services. A total of 1,647 adults with low back pain were invited to participate. Stratified care entailed use of a risk stratification tool to classify patients into groups at low, medium, or high risk for persistent disability and provision of risk-matched treatment. The primary outcome was 6-month change in disability as assessed with the Roland-Morris Disability Questionnaire. Process outcomes captured physician behavior change in risk-appropriate referral to physical therapy, diagnostic tests, medication prescriptions, and sickness certifications. A cost-utility analysis estimated incremental quality-adjusted life-years and back-related health care costs. Analysis was by intention to treat. RESULTS: The 922 patients studied (368 in the preintervention phase and 554 in the postintervention phase) had comparable baseline characteristics. At 6 months follow-up, stratified care had a small but significant benefit relative to usual care as seen from a mean difference in Roland-Morris Disability Questionnaire scores of 0.7 (95% CI, 0.1-1.4), with a large, clinically important difference in the high risk group of 2.3 (95% CI, 0.8-3.9). Mean time off work was 50% shorter (4 vs 8 days, P = .03) and the proportion of patients given sickness certifications was 30% lower (9% vs 15%, P = .03) in the postintervention cohort. Health care cost savings were also observed. CONCLUSIONS: Stratified care for back pain implemented in family practice leads to significant improvements in patient disability outcomes and a halving in time off work, without increasing health care costs. Wider implementation is recommended."," Ann Fam Med 12(2): 102-111.","UK",2014,"Back Pain","Physical Therapy","RMDQ","Unknown","PRO study","Prospective Observation"]
[123,"Froud, R., et al. (2015). \"Primary outcome measure use in back pain trials may need radical reassessment.\" BMC Musculoskelet Disord 16: 88.",null,"Froud, R., et al.","Primary outcome measure use in back pain trials may need radical reassessment","BACKGROUND: The answers to patient reported outcome measures and global transition questions for back pain can be discordant. For example, the most commonly used outcome measure in back pain trials, the Roland Morris Disability Questionnaire (RMDQ), can show improvement even though participants say that their back pain is worse. This gives cause for concern as transition questions are used as anchors to estimate minimally important change (MIC) thresholds on patient reported outcome measures such as the RMDQ. We aimed to explore and compare what people with back pain think when they respond to a transition question and when they complete the RMDQ. METHODS: We purposively sampled people enrolled on a back pain randomised controlled trial who completed the RMDQ and two transition questions. One enquired about change in ability to perform tasks, the other about change in back pain. We sampled participants with discordance (in both directions), and participants with concordant scores. We explored participants' thought processes using in-depth interviews. RESULTS: We completed 35 in-depth interviews. People with discordant RMDQ change and transition question responses attend to different factors when responding to transition questions compared to people with concordant scores. In particular, those for whom the RMDQ change indicated greater improvement than transition questions, prioritised their pain ahead of functional disability. When completing the RMDQ, participants' thought processes were comparatively more objective, and specific to each statement. CONCLUSION: Approaches to primary outcome assessment in back pain needs re-assessment. The RMDQ may be unsuitable for use as a primary outcome measure since patients may not attend to thinking about their back pain when completing it: patients' abilities to cope with tasks can be independent of the change in their back pain. Some participants who improve on the RMDQ consider themselves globally worse. As transition questions can be driven by pain and other physical factors, transition questions should not be used to anchor minimally important change thresholds on the RMDQ."," BMC Musculoskelet Disord 16: 88.","UK",2015,"Back Pain","Not Specified","RMDQ","Unknown","PRO study","RCT"]
[124,"Froum, S. J., et al. (2007). \"Narrow-diameter implants: a restorative option for limited interdental space.\" Int J Periodontics Restorative Dent 27(5): 449-455.",null,"Froum, S. J., et al.","Narrow-diameter implants: a restorative option for limited interdental space","The present study reports on the results of the use of a screw-retained narrow-diameter implant (NDI) system as an option for implant placement in areas of limited bone volume. This retrospective report followed 48 NDIs in 27 patients for 1 to 5 years postloading. No implant failures were reported, yielding a 100% survival rate. The screw-retained attribute of this system allows retrievability of the restorations, which may require replacement because of porcelain fracture, chipping, or a desire to change color. The three diameters available--1.8 mm, 2.2 mm, and 2.4 mm--allow flexibility for a variety of narrow edentulous spaces. These NDIs present a cost-effective alternative for restoring limited spaces with implant restorations, without the bone augmentation or orthodontic procedures required for conventional fixed restorations. The NDI system is approved by the U.S. Food and Drug Administration for long-term use."," Int J Periodontics Restorative Dent 27(5): 449-455.","USA",2007,"Spinal Fracture","Not Specified","NDI","Unknown","PRO study","Retrospective review"]
[125,"Fuchs, S., et al. (2005). \"Intraarticular hyaluronic acid versus glucocorticoid injections for nonradicular pain in the lumbar spine.\" J Vasc Interv Radiol 16(11): 1493-1498.",null,"Fuchs, S., et al.","Intraarticular hyaluronic acid versus glucocorticoid injections for nonradicular pain in the lumbar spine","PURPOSE: To investigate the efficacy and safety of intraarticular sodium hyaluronate (SH) compared with intraarticular glucocorticoids (triamcinolone acetonide; TA) in the treatment of chronic nonradicular lumbar pain. MATERIALS AND METHODS: Sixty patients were included in this randomized, controlled, blind-observer clinical study and randomly assigned to two groups to receive 10 mg SH or 10 mg TA per facet joint. The facet joints on both sides at levels S1-L5, L5-L4, and L4-L3 were treated once per week under computed tomographic guidance. The study visits were timed to permit assessment of the immediate effect as well as possible carryover effects at 3 and 6 months after completion of treatment. Changes in pain were assessed with a visual analog scale (VAS) and changes in function and quality of life were assessed by the Roland Morris Questionnaire (RMQ), the Oswestry Disability Questionnaire (ODQ), the Low Back Outcome Score (LBOS), and the Short Form 36 (SF-36) questionnaire. RESULTS: Patients reported lasting pain relief, better function, and improved quality of life with both treatments. Mann-Whitney analyses of the patient questionnaires (RMQ, ODQ, and LBOS) very consistently showed that SH is not inferior to TA. In addition, the efficacy of SH was largely comparable with that of TA on the VAS and SF-36. No adverse effects were reported after administration of the test products. The intraarticular treatment of facet joints (levels S1-L5, L5-L4, and L4-L3) with SH in patients with chronic nonradicular pain in the lumbar spine resulted in a marked reduction in pain with improved function and better quality of life, which was at least equal to the effect of a course of TA injections. SH-treated patients showed greater benefits in the long term. CONCLUSION: Intraarticular SH is a very promising new option for the treatment of patients with chronic nonradicular lumbar symptoms."," J Vasc Interv Radiol 16(11): 1493-1498.","Germany",2005,"Back Pain","Glucocorticoids","ODI,RMDQ,LBOS","Unknown","PRO study","RCT"]
[126,"Fujiwara, H., et al. (2016). \"Correlations and time-dependent changes of upper arm performance tests, the Japanese Orthopaedic Association score, and a newly developed patient-based outcome measure : the Japanese Orthopaedic Cervical Myelopathy Questionnaire.\" Bone Joint J 98-b(7): 990-996.",null,"Fujiwara, H., et al.","Correlations and time-dependent changes of upper arm performance tests, the Japanese Orthopaedic Association score, and a newly developed patient-based outcome measure : the Japanese Orthopaedic Cervical Myelopathy Questionnaire","AIMS: In this prospective observational study, we investigated the time-dependent changes and correlations of upper arm performance tests (ten-second test and Simple Test for Evaluating Hand Function (STEF), the Japanese Orthopaedic Association (JOA) score, and the JOA Cervical Myelopathy Evaluation Questionnaire (JOACMEQ) in 31 patients with cervical myelopathy who had undergone surgery. PATIENTS AND METHODS: We hypothesised that all the indices correlate with each other, but show slightly different recovery patterns, and that the newly described JOACMEQ is a sensitive outcome measure. RESULTS: Peak recoveries were achieved one month post-operatively in the ten-second test and JOACMEQ upper extremity function (UEF) subscale, and at three months in the JOA and STEF scores. The recoveries of all indices were maintained until six months post-operatively. The upper extremity function (UEF) subscale in the JOACMEQ showed the strongest correlation with STEF although all the indices correlated with each other. Patients with >/= 20 and < 20 acquired points in the UEF subscale were classified into the UEF-improved and UEF-unimproved groups. Comparisons between the groups showed that pre-operative evaluation of \"coordinated motion\" of the STEF was significantly low in the UEF-unimproved group. CONCLUSION: These results indicate that the JOACMEQ is a concise, sensitive, patient-based outcome measure for evaluating functional recovery in patients with cervical myelopathy who have undergone surgery. Cite this article: Bone Joint J 2016;98-B:990-6."," Bone Joint J 98-b(7): 990-996.","Japan",2016,"Cervical Myelopathy","Surgical","JOACMEQ","Unknown","PRO study","Prospective Observation"]
[127,"Fukui, M., et al. (2007). \"An outcome measure for patients with cervical myelopathy: Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ): Part 1.\" J Orthop Sci 12(3): 227-240.",null,"Fukui, M., et al.","An outcome measure for patients with cervical myelopathy: Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ): Part 1","BACKGROUND: An outcome measure to evaluate the neurological function of cervical myelopathy was proposed by the Japanese Orthopaedic Association in 1975 (JOA score), and has been widely used in Japan. However, the JOA score does not include patients' satisfaction, disability, handicaps, or general health, which can be affected by cervical myelopathy. The purpose of this study was to develop a new outcome measure for patients with cervical myelopathy. METHODS: This study was conducted in eight university hospitals and their affiliated hospitals from February to May 2002. The questionnaire included 77 items. Forty-one questions, which were originally listed by the authors, were for evaluation of the physical function of the cervical spine and spinal cord. The Medical Outcome Study Short-Form 36-Item Health Survey (SF-36) was used to examine health-related quality of life (QOL). Patients with cervical myelopathy and healthy volunteers were recruited at each institution. After analysis of the answers from patients and volunteers, irrelevant questions using the following criteria were excluded: (1999) a question 80% of answers for which were concentrated on one choice, (2) a question whose answer was highly correlated with that of other questions, (3) a question that could be explained by other questions, and (4) a question for which the distribution of the answers obtained from the patients was not different from that obtained from the normal volunteers. RESULTS: The patients comprised 164 men and 86 women, and the healthy volunteers 96 men and 120 women. Thirteen items from the questions about the physical functions of the cervical spine and the spinal cord and 11 items from SF-36 remained as candidates that should be included in the final outcome measure questionnaire. CONCLUSION: Twenty-four questions remained as candidates for the final questionnaire. This new self-administered questionnaire might be used to evaluate the outcomes in patients with cervical myelopathy more efficiently."," J Orthop Sci 12(3): 227-240.","Japan",2007,"Cervical Myelopathy","Not Specified","JOACMEQ","Unknown","Tool Validation","Observational"]
[128,"Fukui, M., et al. (2007). \"JOA back pain evaluation questionnaire: initial report.\" J Orthop Sci 12(5): 443-450.",null,"Fukui, M., et al.","JOA back pain evaluation questionnaire: initial report","BACKGROUND: There is no widely accepted objective evaluation for lumbar spine disorders. New outcome measures should be patient-oriented and should measure symptoms and self-reported functional status in multiple dimensions. The aim of this study was to identify items to be included in the disease-specific quality of life (QOL) questionnaire for the assessments of patients with lumbar spine disorders. METHODS: The draft of the QOL questionnaire that consisted of a total of 60 items, including 24 items derived from the Japanese version of the Roland Morris Disability Questionnaire (RDQ) and 36 items derived from the Japanese version of Short Form 36 (SF-36), were administered to patients and controls. After obtaining written informed consent, the following data were collected from the patient group (n = 328) and the control group (n = 213): (1999) background characteristics, including age, diagnosis, Japanese Orthopaedic Association (JOA) score, and finger to floor distance; (2) responses to the questionnaire; (3) the identification rate by discrimination analysis to select the candidates for adoption and by adopting explanatory variables. The items to be excluded were determined by examining the explanatory variables, which were selected after the discrimination analysis, by setting the candidate to-be-excluded items as an objective variable. RESULTS: Based on the distribution of the responses, two items, RDQ-15 and RDQ-19, were excluded. From the results of the correlation coefficient calculation for each question in the patient group, 33 items were excluded and 27 candidate items were adopted. Based on the adoption explanatory variable used in the discrimination analysis, 25 of the 27 candidate items for adoption were accepted. CONCLUSIONS: This study identified the 25 specific questionnaire items that should be included in the questionnaire to evaluate QOL of patients with various lumbar spine disorders."," J Orthop Sci 12(5): 443-450.","Unknown",2007,"Spinal Deformity","Not Specified","RMDQ","Unknown","PRO study","Clinical trial"]
[129,"Fukui, M., et al. (2008). \"Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ): part 4. Establishment of equations for severity scores. Subcommittee on low back pain and cervical myelopathy, evaluation of the clinical outcome committee of the Japanese Orthopaedic Association.\" J Orthop Sci 13(1999): 25-31.",null,"Fukui, M., et al.","Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ): part 4. Establishment of equations for severity scores. Subcommittee on low back pain and cervical myelopathy, evaluation of the clinical outcome committee of the Japanese Orthopaedic Association","BACKGROUND: To establish a patient-oriented outcome measure for cervical myelopathy, a subcommittee of the Japanese Orthopaedic Association (JOA) developed a new scoring system to evaluate the overall clinical status of patients, which could be completed by patients themselves. The subcommittee completed three large-scale studies to select and modify questions derived from various preexisting outcome measures including Short Form-36, and then finalized and validated the questionnaire, which comprised 24 questions. METHODS: The finalized questionnaire was administered to 369 patients with cervical myelopathy due to disc herniation, spondylosis, or ossification of posterior longitudinal ligament by randomly selected board-certified spine surgeons. Patients with different severities of myelopathy were included to insure accuracy and responsiveness of this questionnaire against patients' different neurological status. RESULTS: Data of 236 patients were employed and were subjected to rigorous statistical analyses. There was no question that was difficult to answer and distribution of answers for each question was not concentrated to one choice, indicating the appropriateness of all 24 questions. Results of factor analysis suggested that the 24 questions could be divided into five different factors or functional domains. The factors were defined as follows: factor 1, lower extremity function; factor 2, quality of life; factor 3, cervical spine function; factor 4, bladder function; and factor 5, upper extremity function. Finally, equations that would yield scores for the five factors were assembled. The score to be used to represent the degree of patients' disability or status in each domain can be calculated by multiplying prefixed numbers of selected answers to questions by preassigned coefficients. Coefficients were defined to make the minimum score 0 and the maximum score 100. CONCLUSIONS: We have successfully established a questionnaire that is able to demonstrate the status of patients suffering cervical myelopathy from five different aspects represented by five intuitive numerical scores. The final issue to be confirmed is the responsiveness of this questionnaire to changes in patients' status after various surgical and nonsurgical treatments."," J Orthop Sci 13(1999): 25-31.","Japan",2008,"Degenerative Disk Disease,Spondylosis","Surgical","JOACMEQ","Unknown","PRO study","Observational"]
[130,"Fukui, M., et al. (2008). \"Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ): part 4. Establishment of equations for severity scores. Subcommittee on low back pain and cervical myelopathy, evaluation of the clinical outcome committee of the Japanese Orthopaedic Association.\" J Orthop Sci 13(1999): 25-31.",null,"Fukui, M., et al.","Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ): part 4. Establishment of equations for severity scores. Subcommittee on low back pain and cervical myelopathy, evaluation of the clinical outcome committee of the Japanese Orthopaedic Association","BACKGROUND: To establish a patient-oriented outcome measure for cervical myelopathy, a subcommittee of the Japanese Orthopaedic Association (JOA) developed a new scoring system to evaluate the overall clinical status of patients, which could be completed by patients themselves. The subcommittee completed three large-scale studies to select and modify questions derived from various preexisting outcome measures including Short Form-36, and then finalized and validated the questionnaire, which comprised 24 questions. METHODS: The finalized questionnaire was administered to 369 patients with cervical myelopathy due to disc herniation, spondylosis, or ossification of posterior longitudinal ligament by randomly selected board-certified spine surgeons. Patients with different severities of myelopathy were included to insure accuracy and responsiveness of this questionnaire against patients' different neurological status. RESULTS: Data of 236 patients were employed and were subjected to rigorous statistical analyses. There was no question that was difficult to answer and distribution of answers for each question was not concentrated to one choice, indicating the appropriateness of all 24 questions. Results of factor analysis suggested that the 24 questions could be divided into five different factors or functional domains. The factors were defined as follows: factor 1, lower extremity function; factor 2, quality of life; factor 3, cervical spine function; factor 4, bladder function; and factor 5, upper extremity function. Finally, equations that would yield scores for the five factors were assembled. The score to be used to represent the degree of patients' disability or status in each domain can be calculated by multiplying prefixed numbers of selected answers to questions by preassigned coefficients. Coefficients were defined to make the minimum score 0 and the maximum score 100. CONCLUSIONS: We have successfully established a questionnaire that is able to demonstrate the status of patients suffering cervical myelopathy from five different aspects represented by five intuitive numerical scores. The final issue to be confirmed is the responsiveness of this questionnaire to changes in patients' status after various surgical and nonsurgical treatments."," J Orthop Sci 13(1999): 25-31.","Japan",2008,"Degenerative Disk Disease,Spondylosis","Surgical","JOACMEQ","Unknown","PRO study","Observational"]
[131,"Gadjradj, P. S., et al. (2016). \"Clinical outcomes after percutaneous transforaminal endoscopic discectomy for lumbar disc herniation: a prospective case series.\" Neurosurg Focus 40(2): E3.",null,"Gadjradj, P. S., et al.","Clinical outcomes after percutaneous transforaminal endoscopic discectomy for lumbar disc herniation: a prospective case series","OBJECTIVE Throughout the last decades, full-endoscopic techniques to treat lumbar disc herniation (LDH) have gained popularity in clinical practice. To date, however, no Class I evidence on the efficacy of percutaneous transforaminal endoscopic discectomy (PTED) has been published, and studies describing its safety and short- and long-term efficacy are scarce. In this study the authors aimed to evaluate the clinical outcomes and safety in patients undergoing PTED for LDH. METHODS Patients who underwent PTED for LDH between January 2009 and December 2012 were prospectively followed. The primary outcomes were the visual analog scale (VAS) score for leg pain and the score on the Quebec Back Pain Disability Scale (QBPDS). Secondary outcomes were the perceived experience with the local anesthesia used and satisfaction with the results after 1 year using Likert-type scales. The pretreatment means were compared with the means obtained 6 and 52 weeks after surgery using paired t-tests. RESULTS A total of 166 patients underwent surgery for a total of 167 LDHs. The mean duration of surgery (+/- SD) was 51.0 +/- 9.0 minutes. The 1-year follow-up rate was 95.2%. The mean reported scores on the VAS and QBPDS were 82.5 +/- 17.3 mm and 60.0 +/- 18.4 at baseline, respectively. Six weeks after surgery, the scores on the VAS and QBPDS were significantly reduced to 28.8 +/- 24.5 mm and 26.7 +/- 20.6, respectively (p < 0.001). After 52 weeks of follow-up, the scores were further reduced compared with baseline scores (p < 0.001) to 19.6 +/- 23.5 mm on the VAS and 20.2 +/- 18.1 on the QBPDS. A total of 4 complications were observed, namely 1 dural tear, 1 deficit of ankle dorsiflexion, and 2 cases of transient paresis in the foot due to the use of local anesthetics. CONCLUSIONS PTED appears to be a safe and effective intervention for LDH and has similar clinical outcomes compared to conventional open microdiscectomy. High-quality randomized controlled trials are required to study the efficacy and cost-effectiveness of PTED."," Neurosurg Focus 40(2): E3.","USA",2016,"Degenerative Disk Disease","Surgical","QBPD","Unknown","PRO study","RCT"]
[132,"Garner, M. J., et al. (2007). \"Chiropractic care of musculoskeletal disorders in a unique population within Canadian community health centers.\" J Manipulative Physiol Ther 30(3): 165-170.",null,"Garner, M. J., et al.","Chiropractic care of musculoskeletal disorders in a unique population within Canadian community health centers","OBJECTIVE: This study was part of a larger demonstration project integrating chiropractic care into publicly funded Canadian community health centers. This pre/post study investigated the effectiveness of chiropractic care in reducing pain and disability as well as improving general health status in a unique population of urban, low-income, and multiethnic patients with musculoskeletal (MSK) complaints. METHODS: All patients who presented to one of two community health center-based chiropractic clinics with MSK complaints between August 2004 and December 2005 were recruited to participate in this study. Outcomes were assessed by a general health measure (Short Form-12), a pain scale (VAS), and site-specific disability indexes (Roland-Morris Questionnaire and Neck Disability Index), which were administered before and after a 12-week treatment period. RESULTS: Three hundred twenty-four patients with MSK conditions were recruited into the study, and 259 (80.0%) of them were followed to the study's conclusion. Clinically important and statistically significant positive changes were observed for all outcomes (Short Form-12: physical composite score mean change = 4.9, 95% confidence interval [CI] = 3.8-6.0; VAS: current pain mean change = 2.3, 95% CI = 1.9-2.6; Neck Disability Index: mean change = 6.8, 95% CI = 5.4-8.1; Roland-Morris Questionnaire: mean change = 4.3, 95% CI = 3.6-5.1). No adverse events were reported. CONCLUSIONS: Patients of low socioeconomic status face barriers to accessing chiropractic services. This study suggests that chiropractic care reduces pain and disability as well as improves general health status in patients with MSK conditions. Further studies using a more robust methodology are needed to investigate the efficacy and cost-effectiveness of introducing chiropractic care into publicly funded health care facilities."," J Manipulative Physiol Ther 30(3): 165-170.","Canada",2007,"Unspecified","Not Specified","RMDQ,NDI","Unknown","PRO study","Clinical trial"]
[133,"Gautschi, O. P., et al. (2016). \"Influence of age on pain intensity, functional impairment and health-related quality of life before and after surgery for lumbar degenerative disc disease.\" Clin Neurol Neurosurg 150: 33-39.",null,"Gautschi, O. P., et al.","Influence of age on pain intensity, functional impairment and health-related quality of life before and after surgery for lumbar degenerative disc disease","BACKGROUND: Demographic changes will lead to an increase of elderly people in our population and consecutively to a higher prevalence of patients suffering from degenerative disc disease (DDD). The goal of this study was to investigate age-related differences in pain intensity, subjective and objective functional impairment and health-related quality of life (HRQoL) in patients with lumbar DDD. METHODS: In a prospective two-center study, back and leg pain intensity (visual analogue scale (VAS)), functional impairment (Oswestry Disability Index (ODI), Roland-Morris Disability Index (RMDI)) and HRQoL (EuroQol-5D (EQ-5D), Short-Form (SF12)) were collected for consecutive patients undergoing lumbar spine surgery. Objective functional impairment (OFI) was measured using the Timed Up and Go (TUG) test. Adjusted partial correlation was used to correlate age to each scale preoperatively, as well as to the postoperative improvement at six weeks. RESULTS: A total of n=377 patients (161 females, 42.7%) with a mean age of 58.5 years (SD 15.7, range 18.0-93.7) were included. Unadjusted TUG test raw times naturally increased with age, whereas the age-effect on standardized OFI T-scores was close to zero in patients with a lumbar disc herniation (LDH; r=-0.0666, p=0.367) or lumbar spinal stenosis (LSS; r=-0.0134, p=0.879). There was a weak correlation between age and higher ODI (LDH: r=0.1289, p=0.089; LSS: r=0.1975; p=0.027), lower EQ-5D (LSS: r=-0.1824, p=0.042) and higher RMDI by trend (LSS: r=0.1679, p=0.061). The correlation between age and postoperative improvement was negative on the VAS for back pain (LDH: r=-0.3189, p=0.026), VAS for leg pain (LDH: r=-0.3656, p=0.009) and RMDI by trend (LSS: r=-0.2004, p=0.069), as well as positive on the EQ-5D index (r=0.2412, p=0.011), indicating that younger patients showed better improvement. Due to in-group heterogeneity, no age-effect could be calculated for patients scheduled for surgical fusion. CONCLUSIONS: The influence of age on subjective and objective measures of pain, functional impairment and HRQoL is limited for patients with LDH and LSS, but suggests an age-dependent increase of functional disability. Younger patients generally showed greater postoperative improvement at six weeks than older patients."," Clin Neurol Neurosurg 150: 33-39.","Switzerland,Australia",2016,"Degenerative Disk Disease","Surgical","ODI,RMDQ","Elderly","PRO study","Prospective Observation"]
[134,"Gautschi, O. P., et al. (2016). \"Sex differences in lumbar degenerative disc disease.\" Clin Neurol Neurosurg 145: 52-57.",null,"Gautschi, O. P., et al.","Sex differences in lumbar degenerative disc disease","OBJECTIVES: A growing number of studies focus on sex differences in the pre- and postoperative setting in patients with degenerative disc disease (DDD). The exact pathomechanism behind this phenomenon, however, remains unclear. The objective of this study was to investigate pre- and postoperative sex differences in patients with lumbar DDD. PATIENTS AND METHODS: In a prospective two-center study, back and leg pain (Visual Analogue Scale (VAS)), functional disability (Oswestry Disability Index (ODI) and Roland-Morris Disability Index) and health-related quality of life (HRQoL) (EuroQol 5D and Short-Form (SF12)) were collected for patients scheduled for lumbar spine surgery. In addition to the subjective functional impairment (SFI), objective functional impairment (OFI) was estimated using age- and sex-adjusted cut-off values for the timed-up-and-go (TUG) test. The 6-week responder status was defined using minimally clinically important differences of the ODI, SF12 PCS, VAS back and leg pain in all patients. Six months and one year follow-up (FU) was available in n=127 and n=87 patients, respectively. RESULTS: The patient cohort comprised of n=214 patients (41.6% females). Preoperatively, female patients scored significantly worse on VAS back and leg pain, ODI and SF12 PCS (p<0.033), while OFI was similar (p=0.334). At the 6 week FU, sex-related differences had resolved for SFI and OFI was similar as well (p=0.333). There were no sex differences in the mean improvement after 6 weeks for all measures of pain intensity, functional impairment and HRQoL (p>0.182). Male and female patients profited equally on measures of SFI and HRQoL up to six months and one year after surgery (p>0.091). CONCLUSION: Preoperatively, female patients scored worse in terms of SFI, while OFI was similar. Consecutively, OFI appears to be less prone to sex bias and may thus serve as a valuable surrogate-marker of disability. The disadvantageous preoperative SFI-status did not translate into worse postoperative results, as no sex differences were present at the 6-week, 6-months and 1-year follow-up."," Clin Neurol Neurosurg 145: 52-57.","Switzerland,Australia",2016,"Spine Disease","Surgical","ODI,RMDQ","Unknown","Tool Validation","Prospective Observation"]
[135,"Gautschi, O. P., et al. (2016). \"Sex differences in subjective and objective measures of pain, functional impairment, and health-related quality of life in patients with lumbar degenerative disc disease.\" Pain 157(5): 1065-1071.",null,"Gautschi, O. P., et al.","Sex differences in subjective and objective measures of pain, functional impairment, and health-related quality of life in patients with lumbar degenerative disc disease","Sex differences in pain perception are known to exist; however, the exact pathomechanism remains unclear. This work aims to elucidate sex differences in subjective and objective measures of pain, functional impairment, and health-related quality of life (HRQoL) in patients with lumbar degenerative disc disease. In a prospective 2-center study, back and leg pain (visual analogue scale [VAS]), functional disability (Oswestry Disability Index and Roland-Morris Disability Index), and HRQoL (EuroQol-5D and Short Form [SF12]) were collected for consecutive patients undergoing lumbar spine surgery. Objective functional impairment (OFI) was estimated using age-adjusted and sex-adjusted cutoff values for the timed-up-and-go (TUG) test. A healthy cohort of n = 110 subjects served as the control group. Univariate and multivariate analyses were performed to test the association between sex and pain, subjective and OFIs, and HRQoL. The study comprised n = 305 patients (41.6% females). Female patients had more VAS back pain (P = 0.002) and leg pain (P = 0.014). They were more likely to report higher functional impairment in terms of Oswestry Disability Index (P = 0.005). Similarly, HRQoL measured with the EuroQol-5D index (P = 0.012) and SF12 physical composite score (P = 0.005) was lower in female patients. Female patients reported higher VAS back and leg pain, functional impairment, and reduced HRQoL than male patients. However, there were no sex differences with respect to the presence and degree of OFI measured by the TUG test using age-adjusted and sex-adjusted cutoff values. As such, the TUG may be a good test to overcome sex bias for the clinical assessment of patients with degenerative disc disease."," Pain 157(5): 1065-1071.","Switzerland",2016,"Spine Disease","Surgical","ODI,RMDQ","Unknown","PRO study","Prospective Observation"]
[136,"Ghogawala, Z., et al. (2014). \"Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 2: assessment of functional outcome following lumbar fusion.\" J Neurosurg Spine 21(1999): 7-13.",null,"Ghogawala, Z., et al.","Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 2: assessment of functional outcome following lumbar fusion","Assessment of functional patient-reported outcome following lumbar spinal fusion continues to be essential for comparing the effectiveness of different treatments for patients presenting with degenerative disease of the lumbar spine. When assessing functional outcome in patients being treated with lumbar spinal fusion, a reliable, valid, and responsive outcomes instrument such as the Oswestry Disability Index should be used. The SF-36 and the SF-12 have emerged as dominant measures of general health-related quality of life. Research has established the minimum clinically important difference for major functional outcomes measures, and this should be considered when assessing clinical outcome. The results of recent studies suggest that a patient's pretreatment psychological state is a major independent variable that affects the ability to detect change in functional outcome."," J Neurosurg Spine 21(1999): 7-13.","USA",2014,"Spinal Fusion","Psychosocial","ODI","Unknown","PRO study","Narrative review"]
[137,"Gilbert, F. J., et al. (2004). \"Low back pain: influence of early MR imaging or CT on treatment and outcome--multicenter randomized trial.\" Radiology 231(2): 343-351.",null,"Gilbert, F. J., et al.","Low back pain: influence of early MR imaging or CT on treatment and outcome--multicenter randomized trial","PURPOSE: To establish whether early use of magnetic resonance (MR) imaging or computed tomography (CT) influences treatment and outcome of patients with low back pain (LBP) and whether it is cost-effective. MATERIALS AND METHODS: In a multicenter randomized study, two imaging policies for LBP were compared in 782 participants with symptomatic lumbar spine disorders who were referred to orthopedists or neurosurgeons. Participants were randomly allocated to early (393 participants; mean age, 43.9 years; range, 16-82 years) or delayed selective (389 participants; mean age, 42.8 years; range, 14-82 years) imaging groups. Delayed selective imaging referred to imaging restricted to patients in whom a clear clinical need subsequently developed. Main outcome measures were Aberdeen Low Back Pain (ALBP) score, Short Form 36 (SF-36) score (for multidimensional health status), EuroQol (EQ-5D) score (for quality-adjusted life-year [QALY] estimates), and healthcare resource use at 8 and 24 months after randomization. Data were evaluated with analysis of covariance, ordinal logistic regression analysis, and chi(2) and Mann-Whitney tests. RESULTS: Both groups showed improvement in ALBP score, but this was greater in the early group (adjusted mean difference between groups, -3.05 points [95% CI: -5.16, -0.95; P =.005] and -3.62 points [95% CI: -5.92, -1.32; P =.002] at 8 and 24 months, respectively). Scores for SF-36 (bodily pain domain) and EQ-5D were also significantly better at 24 months. Clinical treatment was similar in both groups. Differences in total costs reflected cost of imaging. Imaging provided an adjusted mean additional QALY of 0.041 during 24 months at a mean incremental cost per QALY of $2,124. CONCLUSION: Early use of imaging does not appear to affect treatment overall. Decisions about the use of imaging depend on judgments concerning whether the small observed improvement in outcome justifies additional cost."," Radiology 231(2): 343-351.","UK",2004,"Back Pain","Not Specified","Aberdeen LBP","Adults","Cost-Effectiveness","RCT"]
[138,"Glassman, S. D., et al. (2007). \"The impact of perioperative complications on clinical outcome in adult deformity surgery.\" Spine (Phila Pa 1976) 32(24): 2764-2770.",null,"Glassman, S. D., et al.","The impact of perioperative complications on clinical outcome in adult deformity surgery","STUDY DESIGN: Retrospective case-control series. OBJECTIVE: The purpose of this study is to determine whether perioperative complications alter subsequent clinical outcome measures in adult spinal deformity surgery. SUMMARY OF BACKGROUND DATA: Increasingly, the benefit of surgical intervention is being evaluated based on patient reported outcomes and standardized health related quality of life (HRQOL) measures. As improvement or deterioration in HRQOL scores becomes a standard for clinical evaluation in adult spinal deformity, the correlation between HRQOL outcome scores and historic benchmarks, such as curve correction, sagittal balance, fusion healing, or the occurrence of a complication, must be clarified. METHODS: This study analyzes a prospective multicenter data base for adult spinal deformity. Patients with major, minor, and no complications were matched using a logistic regression technique producing 46 patients in each group. Standardized outcome measures at baseline and at 1 year postop were compared. RESULTS: Forty-seven major complications were reported in 46 patients. Sixty-two minor complications were noted in 46 patients. Comparison between the 3 complication groups revealed that 1-year postoperative outcome measures were not statistically different for the Scoliosis Research Society Outcomes Instrument, Medical Outcomes Short Form-36 (SF-12), Oswestry Disability Index, or Numerical Pain Scales. The only significant interaction was in the rate of change from preop to 1-year postop for the SF-12 general health subscale. For the group with major complications, SF-12 general health deteriorated by 2.1 points from preop to 1-year postop. During the same period, the group with minor complications experienced an improvement of 4.2 points and the group with no complications experienced an improvement of 1.5 points. CONCLUSION: This study suggests that risk for minor complications may be a less substantial obstacle than previously assumed for surgical treatment in adult spinal deformity. In contrast, major complications were reported in approximately 10% of cases and adversely affected outcome as evidenced by the deterioration in SF-12 general health scores at 1 year after surgery."," Spine (Phila Pa 1976) 32(24): 2764-2770.","USA",2007,"Spinal Deformity","Surgical","ODI,SRS-HRQOL","Unknown","PRO study","Prospective Observation"]
[139,"Glassman, S. D., et al. (2009). \"Do 1-year outcomes predict 2-year outcomes for adult deformity surgery?\" Spine J 9(4): 317-322.",null,"Glassman, S. D., et al.","Do 1-year outcomes predict 2-year outcomes for adult deformity surgery?","BACKGROUND CONTEXT: Health-related quality-of-life (HRQOL) measures are being used more frequently in the evaluation of the adult deformity patient. This is due in part to the validation of the deformity-specific Scolios Research Society-22 (SRS-22). Hence, relationships between HRQOL outcomes and traditional measures of success such as deformity correction, fusion healing, and complications are being established. PURPOSE: To examine the pattern of HRQOL outcome responses after adult deformity surgery. STUDY DESIGN: Analysis of prospective multicenter cohort. PATIENT SAMPLE: Two hundred and eighty-three adult deformity patients with preoperative, 1-, and 2-year postoperative outcome measures. OUTCOME MEASURES: SRS-22, Short Form-12 (SF-12), Oswestry Disability Index (ODI), and back and leg pain numeric rating scale scores. METHODS: Preoperative versus postoperative health status measures were evaluated by matched-pairs sample t test statistics and post hoc analysis of variance (ANOVA) findings. RESULTS: SRS-22 improved from a mean 3.03 points at baseline to 3.21 points at 6 months, 3.71 points at 1 year, and 3.70 points at 2 years post-op. Mean ODI score was 37.0 points pre-op and improved to 27.0 points at 6 months, and 22.8 points at 1 and 2 years post-op. Mean SF-12 physical component score was 33.7 points at baseline, improving to 36.9 points at 6 months, 40.6 points at 1 year, and 40.5 points at 2 years post-op. Paired samples analysis comparing 6-month and 1-year post-op scores showed deterioration for numeric rating scale leg pain (p=0.05). There was a trend for improvement in SF-12 physical component score (p=0.06). Significant improvement between 6 months and 1 year post-op was noted for ODI (p=0.02) and SRS total score (p<0.0001). Comparison of 1- versus 2-year postoperative scores revealed no statistically significant differences for any of the HRQOL parameters. CONCLUSIONS: This study supports the application of HRQOL measures, including the deformity-specific SRS-22, as a valuable tool in the assessment of adult deformity patients. Change in outcome score stabilized after the 1-year postoperative interval, for most patients."," Spine J 9(4): 317-322.","USA",2009,"Spinal Deformity","Surgical","ODI,SRS-HRQOL","Unknown","PRO study","Prospective Observation"]
[140,"Glassman, S. D., et al. (2010). \"The costs and benefits of nonoperative management for adult scoliosis.\" Spine (Phila Pa 1976) 35(5): 578-582.",null,"Glassman, S. D., et al.","The costs and benefits of nonoperative management for adult scoliosis","STUDY DESIGN: A prospective cohort of adult scoliosis patients treated nonoperatively had a minimum of 2-year follow-up during which time data were collected on the type and quantity of nonoperative treatment used. OBJECTIVE: To quantify the use, cost, and effectiveness of nonoperative treatment for adult scoliosis. SUMMARY OF BACKGROUND DATA: A 2007 systematic review of nonsurgical treatment in adult scoliosis revealed minimal data, and concluded that evidence for nonoperative care was lacking. METHODS: Duration of use and frequency of visits were collected for 8 specific treatment methods: medication, physical therapy, exercise, injections/blocks, chiropractic care, pain management, bracing, and bed rest. Costs for each intervention were determined using the Medicare Fee schedule. Outcome measures were the SRS-22, SF-12, and ODI. Analysis was performed for the entire group, and for subsets of high (ODI, >40), mid (ODI = 21-40) and low (ODI, <or=20) symptom patients. RESULTS: A total of 123 patients (111 females, 12 males) with a mean age of 53.3 (18-79) years were evaluated. In 55 scoliosis patients who received no treatment, the only significant change in HRQOL measures over the 2-year period was in SRS satisfaction subscore (0.3 points, P = 0.014). Among the 68 adult scoliosis patients who used nonoperative resources, there was no significant change in any of the HRQOL outcome parameters. Mean treatment cost over the 2-year period was $10,815. Mean cost over the 2-year period averaged $9704 in the low symptom patients, $11,116 in the mid symptom, and $14,022 in the high symptom patients. CONCLUSION: This study questions the value of nonoperative treatment commonly used for adult scoliosis patients. Documented costs are substantial and no improvement in health status was observed. An important caveat is that treatment was not randomized and therefore the treatment group might have deteriorated if not for the treatment they received."," Spine (Phila Pa 1976) 35(5): 578-582.","USA",2010,"Spinal Deformity","Surgical,Physical Therapy","SRS-HRQOL","Adults","Cost and Resource Use","Clinical trial"]
[141,"Glattes, R. C., et al. (2007). \"The reliability and concurrent validity of the Scoliosis Research Society-22r patient questionnaire compared with the Child Health Questionnaire-CF87 patient questionnaire for adolescent spinal deformity.\" Spine (Phila Pa 1976) 32(16): 1778-1784.",null,"Glattes, R. C., et al.","The reliability and concurrent validity of the Scoliosis Research Society-22r patient questionnaire compared with the Child Health Questionnaire-CF87 patient questionnaire for adolescent spinal deformity","STUDY DESIGN: This is a clinic-based cross-sectional study involving 2 health-related quality-of-life (HRQL) questionnaires. OBJECTIVES: To compare the score distribution and reliability of the spinal deformity specific Scoliosis Research Society-22r (SRS-22r) questionnaire and the established generic Child Health Questionnaire-CF87 (CHQ-CF87), and to assess the concurrent validity of the SRS-22r using the CHQ-CF87 in an adolescent spine deformity population. SUMMARY OF BACKGROUND DATA: Different questionnaires are commonly thought to be necessary to assess the HRQL of adolescent and adult populations. But since spinal deformities usually begin in the second decade of life, longitudinal follow-up with the same HRQL is desirable. The SRS-22r HRQL has recently been validated for score distribution and internal consistency in a spinal deformity population ranging in age from 7 to 78 years. METHODS: The SRS-22r and CHQ-CF87 HRQLs were completed by 70 orthopedic spinal deformity outpatients 8 to 18 years of age, of whom 54 returned mailed retest questionnaires at an average of 24 days later. RESULTS: The ceiling effect averaged 27% for the SRS-22r and 36% for the CHQ-CF87. Respective values for internal consistency (Cronbach alpha) were 0.81 and 0.82, and for test-retest reproducibility the intraclass correlations (ICC) were 0.73 and 0.61. Concurrent validity was r > or = 0.68 or more for relevant function, pain, and mental health domains. The SRS Self-Image and particularly the Satisfaction/Dissatisfaction with Management domains did not correlate well with any CHQ-CF87 domains (r = 0.50 and 0.30, respectively). CONCLUSION: In a spinal deformity population 8 to 18 years of age, the score distribution and reliability, internal consistency, and reproducibility of the SRS-22r were at least as good as the CHQ-CF87. The SRS-22r function, pain, and mental health domains were concurrently valid in comparison to relevant CHQ-CF87 domains, but the SRS-22r self-image and satisfaction/dissatisfaction domains were not, thereby providing health-related quality-of-life information not provided for by the CHQ-CF87."," Spine (Phila Pa 1976) 32(16): 1778-1784.","USA",2007,"Spinal Deformity","Not Specified","SRS-HRQOL","Adolescents","PRO study","Observational"]
[142,"Gnanenthiran, S. R., et al. (2012). \"Nonoperative versus operative treatment for thoracolumbar burst fractures without neurologic deficit: a meta-analysis.\" Clin Orthop Relat Res 470(2): 567-577.",null,"Gnanenthiran, S. R., et al.","Nonoperative versus operative treatment for thoracolumbar burst fractures without neurologic deficit: a meta-analysis","BACKGROUND: Decision-making regarding nonoperative versus operative treatment of patients with thoracolumbar burst fractures in the absence of neurologic deficits is controversial. Lack of evidence-based practice may result in patients being treated inappropriately and being exposed to unnecessary adverse consequences. PURPOSE: Using meta-analysis, we therefore compared pain (VAS) and function (Roland Morris Disability Questionnaire) in patients with thoracolumbar burst fractures without neurologic deficit treated nonoperatively and operatively. Secondary outcomes included return to work, radiographic progression of kyphosis, radiographic progression of spinal canal stenosis, complications, cost, and length of hospitalization. METHODS: We searched MEDLINE, EMBASE((R)), and the Cochrane Central Register of Controlled Trials for 'thoracic fractures', 'lumbar fractures', 'non-operative', 'operative' and 'controlled clinical trials'. We established five criteria for inclusion. Data extraction and quality assessment were in accordance with Cochrane Collaboration guidelines. The main analyses were performed on individual patient data from randomized controlled trials. Sensitivity analyses were performed on VAS pain, Roland Morris Disability Questionnaire score, kyphosis, and return to work, including data from nonrandomized controlled trials and using fixed effects meta-analysis. We identified four trials, including two randomized controlled trials consisting of 79 patients (41 with operative treatment and 38 with nonoperative treatment). The mean followups ranged from 24 to 118 months. RESULTS: We found no between-group differences in baseline pain, kyphosis, and Roland Morris Disability Questionnaire scores. At last followup, there were no between-group differences in pain, Roland Morris Disability Questionnaire scores, and return to work rates. We found an improvement in kyphosis ranging from means of 12.8 masculine to 11 masculine in the operative group, but surgery was associated with higher complication rates and costs. CONCLUSIONS: Operative management of thoracolumbar burst fractures without neurologic deficit may improve residual kyphosis, but does not appear to improve pain or function at an average of 4 years after injury and is associated with higher complication rates and costs. LEVEL OF EVIDENCE: Level II, therapeutic study. See the Guidelines for Authors for a complete description of level of evidence."," Clin Orthop Relat Res 470(2): 567-577.","Australia",2012,"Trauma","Surgical","RMDQ","Adults","Cost and Resource Use","Systematic review"]
[143,"Godfrey, E., et al. (2016). \"Physiotherapy informed by Acceptance and Commitment Therapy (PACT): protocol for a randomised controlled trial of PACT versus usual physiotherapy care for adults with chronic low back pain.\" BMJ Open 6(6): e011548.",null,"Godfrey, E., et al.","Physiotherapy informed by Acceptance and Commitment Therapy (PACT): protocol for a randomised controlled trial of PACT versus usual physiotherapy care for adults with chronic low back pain","INTRODUCTION: Chronic low back pain (CLBP) is a common condition and source of significant suffering, disability and healthcare costs. Current physiotherapy treatment is moderately effective. Combining theory-based psychological methods with physiotherapy could improve outcomes for people with CLBP. The primary aim of this randomised controlled trial (RCT) is to evaluate the efficacy of Physiotherapy informed by Acceptance and Commitment Therapy (PACT) on functioning in patients with CLBP. METHODS AND ANALYSIS: The PACT trial is a two-armed, parallel-group, multicentre RCT to assess the efficacy of PACT in comparison with usual physiotherapy care (UC). 240 patients referred to physiotherapy with CLBP will be recruited from three National Health Service (NHS) hospitals trusts. Inclusion criteria are: age >/=18 years, CLBP >/=12-week duration, scoring >/=3 points on the Roland-Morris Disability Questionnaire (RMDQ) and adequate understanding of spoken and written English to participate. Patients will be randomised to PACT or UC (120 per arm stratified by centre) by an independent randomisation service and followed up at 3 and 12 months post randomisation. The sample size of 240 will provide adequate power to detect a standardised mean difference of 0.40 in the primary outcome (RMDQ; 5% significance, 80% power) assuming attrition of 20%. Analysis will be by intention to treat conducted by the trial statistician, blind to treatment group, following a prespecified analysis plan. Estimates of treatment effect at the follow-up assessments will use an intention-to-treat framework, implemented using a linear mixed-effects model. ETHICS AND DISSEMINATION: This trial has full ethical approval (14/SC/0277). It will be disseminated via peer-reviewed publications and conference presentations. The results will enable clinicians, patients and health service managers to make informed decisions regarding the efficacy of PACT for patients with CLBP. TRIAL REGISTRATION NUMBER: ISRCTN95392287; Pre-results."," BMJ Open 6(6): e011548.","UK",2016,"Back Pain","Physical Therapy","RMDQ","Adults","PRO study","Clinical trial"]
[144,"Godil, S. S., et al. (2013). \"Accurately measuring outcomes after surgery for adult Chiari I malformation: determining the most valid and responsive instruments.\" Neurosurgery 72(5): 820-827; discussion 827.",null,"Godil, S. S., et al.","Accurately measuring outcomes after surgery for adult Chiari I malformation: determining the most valid and responsive instruments","BACKGROUND: There has been a transition to using patient-reported outcome instruments (PROi) to assess surgical effectiveness. However, none of these instruments have been validated for outcomes of adult Chiari I malformation (CMI). OBJECTIVE: The aim of this study was to determine the relative validity and responsiveness of various PROi in measuring outcomes after surgery for CMI. METHODS: Fifty patients undergoing suboccipital craniotomy for adult CMI were prospectively followed for 1 year. Baseline and 1-year patient-reported outcomes (visual analog scale for head pain and visual analog scale for neck pain, Neck Disability Index [NDI], Headache Disability Index, SF-12, Zung Self-Rating Depression Scale, and EuroQol-5D [EQ-5D]) were assessed. A level of improvement in general health after surgery was defined as meaningful improvement. Receiver-operating characteristic curves were generated to assess the validity of PROi to discriminate between meaningful improvement and not. The difference between standardized response means (SRMs) in patients reporting meaningful improvement vs not as calculated to determine the relative responsiveness of each outcome instrument. RESULTS: For pain and disability, the NDI was the most accurate discriminator of meaningful effectiveness (area under the curve: 0.90) and also most responsive to postoperative improvement (standardized response means difference: 1.87). For general health and quality of life, the SF-12 PCS, EQ-5D, and Zung Self-Rating Depression Scale were all accurate discriminators; however, SF-12 Physical Component Scale (SF-12 PCS) and EQ-5D were most accurate. SF-12 PCS was also most responsive. CONCLUSION: For pain and disability, NDI is the most valid and responsive measure of improvement after surgery for CMI. For health-related quality of life, SF-12 PCS and EQ-5D are the most valid and responsive measures. NDI with SF-12 or EQ-5D is the most valid in patients with CMI and should be considered in cost-effectiveness studies."," Neurosurgery 72(5): 820-827; discussion 827.","USA",2013,"Neck Pain","Surgical","NDI","Unknown","Cost and Resource Use","Prospective Observation"]
[145,"Gordon, A., et al. (2010). \"Buprenorphine transdermal system for opioid therapy in patients with chronic low back pain.\" Pain Res Manag 15(3): 169-178.",null,"Gordon, A., et al.","Buprenorphine transdermal system for opioid therapy in patients with chronic low back pain","OBJECTIVE: The present randomized, double-blinded, crossover study compared the efficacy and safety of a seven-day buprenorphine transdermal system (BTDS) and placebo in patients with low back pain of moderate or greater severity for at least six weeks. METHODS: Prestudy analgesics were discontinued the evening before random assignment to 5 microg/h BTDS or placebo, with acetaminophen 300 mg/codeine 30 mg, one to two tablets every 4 h to 6 h as needed, for rescue analgesia. The dose was titrated to effect weekly, if tolerated, to 10 microg/h and 20 microg/h BTDS. Each treatment phase was four weeks. RESULTS: Fifty-three patients (28 men, 25 women, mean [+/- SD] age 54.5+/-12.7 years) were evaluable for efficacy (completed two weeks or more in each phase). Baseline pain was 62.1+/-15.5 mm (100 mm visual analogue scale) and 2.5+/-0.6 (five-point ordinal scale). BTDS resulted in lower mean daily pain scores than in the placebo group (37.6+/-20.7 mm versus 43.6+/-21.2 mm on a visual analogue scale, P=0.0487; and 1.7+/-0.6 versus 2.0+/-0.7 on the ordinal scale, P=0.0358). Most patients titrated to the highest dose of BTDS (59% 20 microg/h, 31% 10 microg/h and 10% 5 microg/h). There were improvements from baseline in pain and disability (Pain Disability Index), Pain and Sleep (visual analogue scale), Quebec Back Pain Disability Scale and Short-Form 36 Health Survey scores for both BTDS and placebo groups, without significant differences between treatments. While there were more opioid-related side effects with BTDS treatment than with placebo, there were no serious adverse events. A total of 82% of patients chose to continue BTDS in a long-term open-label evaluation, in whom improvements in pain intensity, functionality and quality of life were sustained for up to six months without analgesic tolerance. CONCLUSION: BTDS (5 microg/h to 20 microg/h) represents a new treatment option for initial opioid therapy in patients with chronic low back pain."," Pain Res Manag 15(3): 169-178.","Canada",2010,"Back Pain","Opioid","QBPD","Adults","PRO study","Clinical trial"]
[146,"Gornet, M. F., et al. (2016). \"The Effect of Workers' Compensation Status on Outcomes of Cervical Disc Arthroplasty: A Prospective, Comparative, Observational Study.\" J Bone Joint Surg Am 98(2): 93-99.",null,"Gornet, M. F., et al.","The Effect of Workers' Compensation Status on Outcomes of Cervical Disc Arthroplasty: A Prospective, Comparative, Observational Study","BACKGROUND: Receiving Workers' Compensation benefits has been associated with inferior outcomes after lumbar fusion. The purpose of our study was to compare the outcomes of cervical disc arthroplasty between patients receiving and those not receiving Workers' Compensation. METHODS: Patient-reported outcomes, reoperations, complications, and return-to-work status were analyzed at one year after surgery in an observational cohort of consecutive patients who underwent single-level or multilevel cervical disc arthroplasty for symptomatic cervical disc conditions, including radiculopathy or discogenic pain with or without radiculopathy, exclusive of myelopathy. RESULTS: Of the 189 patients who underwent cervical disc arthroplasty, 144 received Workers' Compensation and forty-five did not. The mean scores on all patient-reported measures improved significantly from preoperative baseline to one year after surgery (p < 0.001), and the improvement in patient-reported outcomes did not differ significantly between the Workers' Compensation and the non-Workers' Compensation group (respectively, 22.7 compared with 25.0 for the Neck Disability Index; 8.3 compared with 9.6 for the Short Form (SF)-36 physical component summary; 7.9 compared with 9.6 for the SF-36 mental component summary; 3.5 compared with 3.7 for neck pain; and 2.6 compared with 2.8 for arm pain). The two groups also did not differ significantly in the rate of reoperations (7.6% for those receiving Workers' Compensation compared with 13.3% for those not receiving Workers' Compensation) and complications (2.8% compared with 4.4%, respectively). At one year after surgery, the proportion of patients who had returned to work was comparable (77.7% in the Workers' Compensation group and 79.4% in the non-Workers' Compensation group); however, the patients receiving Workers' Compensation had significantly more days off before returning to work (a mean of 145.2 compared with 61.9 days; p = 0.001). CONCLUSIONS: After cervical disc arthroplasty, patients receiving Workers' Compensation had outcomes that were similar to those of patients not receiving Workers' Compensation in terms of patient-reported outcomes, surgery-related complications, reoperations, and return-to-work status. Patients receiving Workers' Compensation remained off work for a longer interval than did patients not receiving Workers' Compensation. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence."," J Bone Joint Surg Am 98(2): 93-99.","USA",2016,"Neck Pain","Surgical","NDI","Unknown","PRO study","Prospective Observation"]
[147,"Gorton, G. E., 3rd, et al. (2012). \"Accuracy, reliability, and validity of a 3-dimensional scanner for assessing torso shape in idiopathic scoliosis.\" Spine (Phila Pa 1976) 37(11): 957-965.",null,"Gorton, G. E., 3rd, et al.","Accuracy, reliability, and validity of a 3-dimensional scanner for assessing torso shape in idiopathic scoliosis","STUDY DESIGN: Prospective cohort with concurrent controls. OBJECTIVE: To establish accuracy, reliability, and validity of the Vitronic 3D Body Scanner for the evaluation of torso asymmetry in patients with idiopathic scoliosis. SUMMARY OF BACKGROUND DATA: Improved appearance is an important expectation of treatment for patients with scoliosis and their parents. Despite being the \"gold standard\" for quantifying outcomes, Cobb angles do not explain perception of appearance or quality of life. Surface topography is an attractive noninvasive alternative to radiography but has not been studied in the context of patient-centered outcomes. METHODS: Thirty-six adolescents with idiopathic scoliosis undergoing surgical correction had pre- and postoperative radiographs and evaluation of standing posture, torso surface shape, and responses to the Scoliosis Research Society-22 and Spinal Appearance Questionnaire. Twenty-one adolescents without scoliosis were evaluated for comparison. Scanner accuracy was assessed by scanning an object of known dimensions. Within-session reliability of body shape measures constructed from scan data was assessed. Discriminant validity was assessed by examining pre- to postoperative differences. Concurrent validity was examined through correlations of scan measures with radiographs, optoelectronic measures of posture, and self-report responses to the Scoliosis Research Society-22 and Spinal Appearance Questionnaire. RESULTS: Scan system measurement error was 1.74 +/- 1.56 mm. Within-session reliability was excellent for the control (intraclass correlation coefficient = 0.83) and scoliosis (intraclass correlation coefficient = 0.94) groups. Medial/lateral torso shift, rotation, and right/left asymmetry differed significantly among the preoperative, postoperative, and control groups (analysis of variance, P < 0.05). Torso asymmetry measures correlated with radiographical measures (r = 0.43-0.51), optoelectronical measures of posture and symmetry (r = 0.33-0.75), and appearance and quality-of-life domains of the Scoliosis Research Society-22 (r = 0.35-0.64) and the Spinal Appearance Questionnaire (r = 0.48-0.67). CONCLUSION: The Vitronic 3D Body Scanner has sufficient accuracy, reliability, and validity to monitor torso asymmetry due to scoliosis. Scan-based measures differentiate between normal and pathological and between preoperative and postoperative body shape and show good correlation with measures of appearance and quality of life."," Spine (Phila Pa 1976) 37(11): 957-965.","USA",2012,"Spinal Deformity","Surgical","SRS-HRQOL,SAQ","Adolescents","PRO study","Prospective Observation"]
[148,"Gorzkowicz, B. and M. Kolban (2012). \"The influence of the degree of spine curvature on the quality of life assessment among patients treated surgically with the Cotrel-Dubousset method.\" Stud Health Technol Inform 176: 423-427.",null,"Gorzkowicz, B. and M. Kolban","The influence of the degree of spine curvature on the quality of life assessment among patients treated surgically with the Cotrel-Dubousset method","Physical appearance and psychomotor ability rank high in the hierarchy of values accepted by children and teenagers. Therefore Idiopathic Scoliosis (IS), which is accompanied by the dysfunction of locomotive organ and often requires troublesome treatment, may lead to poor body image and frustration. Other common effects are a low self-esteem, identity problems and depressive symptoms. METHOD: Prospective examination was done in two independent groups of IS patients treated in one of Szczecin's clinic. The first group of 35 patients was examined twice: after being selected for surgery and 12 months after surgery. The second group of 52 patients was examined after a minimum of two years from operation. Research tools consisted of: personal data questionnaire, the assessment form of the clinical state and the Scoliosis Research Society (SRS)-22. The results were statistically analyzed using STATISTICA 5 software. Pearson's linear correlation coefficients and Spearman's rank correlation coefficients were calculated to determine the relationship between the pairs of variables. RESULTS/FINDINGS: Preoperatively, the Cobb angle of thoracic curves was found to significantly correlate only with the Physical Activity (rs = -0.41, p<0.02) and Self-Image (rs = - 0.51, p<0.002). Postoperatively, a positive correlation with statistical significance was observed only with correction values in thoracic section with total scores of the SRS-22 (p<0.03) in the 24-month period. CONCLUSIONS: 1. Clinical assessment appears insufficient to decide how advanced the disease is and what the treatment results are. 2. The degree of spinal curvature, especially in the postoperative period, have little effect on quality of patients' lives. 3. Studies with the use of the SRS-22 HRQL instrument suggest that other non-clinical factors may affect the quality of life assessment."," Stud Health Technol Inform 176: 423-427.","Poland",2012,"Spinal Deformity","Surgical","SRS-HRQOL","Infants","PRO study","Prospective Observation"]
[149,"Green, A., et al. (2016). \"Physiotherapeutic Rehabilitation Following Lumbar Total Disc Replacement: A Retrospective Study.\" Physiother Res Int 21(3): 155-163.",null,"Green, A., et al.","Physiotherapeutic Rehabilitation Following Lumbar Total Disc Replacement: A Retrospective Study","BACKGROUND AND PURPOSE: This study sought to answer the following questions: What are the outcomes of physiotherapy post lumbar total disc replacement (LTDR) compared with patient self-mediated rehabilitation? Is a difference in outcomes related to the number of physiotherapy sessions? METHODS: This is a retrospective observational study of 600 patients post TDR. Patient outcomes for self-mediated rehabilitation (Group 1), 1-3 sessions of clinic-based physiotherapy (Group 2) and >/=4 sessions of clinic-based physiotherapy (Group 3) were analysed. Outcomes measures included the Oswestry Disability Index (ODI), Roland Morris Disability Questionnaire (RMQ), Short Form-36 Physical (SF-36 PCS) and Mental Subscale Components (SF-36 MCS), Visual Analogue Scale (VAS) for back and leg pain intensity. Patient's pre-operative baseline measures and post-operative follow-up measures at 3, 6, 12 and 24 months post-operatively were analysed. RESULTS: Oswestry Disability Index and RMQ had significantly lower scores in Group 3 compared with Group 1 at 3, 6, 12 and 24 months follow-up. Significantly lower scores for Group 2 compared with Group 1 were observed for the ODI at 3 months follow-up and for the RMQ at 3 and 6 months follow-up. Significantly lower scores were observed in Group 3 compared with Group 1 for VAS back pain at 3 months and VAS leg pain at 6 months follow-up. Significantly higher scores in Group 3 compared with Group 1 were also observed in the SF-36 PCS at 6, 12 and 24 months. Significantly higher scores in Group 2 compared with Group 1 were observed at 6 months follow up. These trends were also observed when investigating the percentage of patients with a greater 50% improvement in the outcome measure. CONCLUSIONS: Physiotherapy post-LTDR produces statistically significant and possibly clinically important improvements in functional disability, pain and quality of life outcomes compared with self-mediated rehabilitation. Copyright (c) 2015 John Wiley & Sons, Ltd."," Physiother Res Int 21(3): 155-163.","Australia,Sweden",2016,"Degenerative Disk Disease","Physical Therapy","ODI,RMDQ","Unknown","PRO study","Retrospective review"]
[150,"Groeneweg, R., et al. (2010). \"The effectiveness and cost-evaluation of manual therapy and physical therapy in patients with sub-acute and chronic non specific neck pain. Rationale and design of a Randomized Controlled Trial (RCT).\" BMC Musculoskelet Disord 11: 14.",null,"Groeneweg, R., et al.","The effectiveness and cost-evaluation of manual therapy and physical therapy in patients with sub-acute and chronic non specific neck pain. Rationale and design of a Randomized Controlled Trial (RCT)","BACKGROUND: Manual Therapy applied to patients with non specific neck pain has been investigated several times. In the Netherlands, manual therapy as applied according to the Utrecht School of Manual Therapy (MTU) has not been the subject of a randomized controlled trial. MTU differs in diagnoses and treatment from other forms of manual therapy. METHODS/DESIGN: This is a single blind randomized controlled trial in patients with sub-acute and chronic non specific neck pain. Patients with neck complaints existing for two weeks (minimum) till one year (maximum) will participate in the trial. 180 participants will be recruited in thirteen primary health care centres in the Netherlands.The experimental group will be treated with MTU during a six week period. The control group will be treated with physical therapy (standard care, mainly active exercise therapy), also for a period of six weeks.Primary outcomes are Global Perceived Effect (GPE) and functional status (Neck Disability Index (NDI-DV)). Secondary outcomes are neck pain (Numeric Rating Scale (NRS)), Eurocol, costs and quality of life (SF36). DISCUSSION: This paper presents details on the rationale of MTU, design, methods and operational aspects of the trial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00713843."," BMC Musculoskelet Disord 11: 14.","Netherlands",2010,"Neck Pain","Exercise","NDI","Unknown","Cost and Resource Use","RCT"]
[151,"Groessl, E. J., et al. (2016). \"Yoga for veterans with chronic low back pain: Design and methods of a randomized clinical trial.\" Contemp Clin Trials 48: 110-118.",null,"Groessl, E. J., et al.","Yoga for veterans with chronic low back pain: Design and methods of a randomized clinical trial","Chronic low back pain (CLBP) afflicts millions of people worldwide, with particularly high prevalence in military veterans. Many treatment options exist for CLBP, but most have limited effectiveness and some have significant side effects. In general populations with CLBP, yoga has been shown to improve health outcomes with few side effects. However, yoga has not been adequately studied in military veteran populations. In the current paper we will describe the design and methods of a randomized clinical trial aimed at examining whether yoga can effectively reduce disability and pain in US military veterans with CLBP. A total of 144 US military veterans with CLBP will be randomized to either yoga or a delayed treatment comparison group. The yoga intervention will consist of 2x weekly yoga classes for 12weeks, complemented by regular home practice guided by a manual. The delayed treatment group will receive the same intervention after six months. The primary outcome is the change in back pain-related disability measured with the Roland-Morris Disability Questionnaire at baseline and 12-weeks. Secondary outcomes include pain intensity, pain interference, depression, anxiety, fatigue/energy, quality of life, self-efficacy, sleep quality, and medication usage. Additional process and/or mediational factors will be measured to examine dose response and effect mechanisms. Assessments will be conducted at baseline, 6-weeks, 12-weeks, and 6-months. All randomized participants will be included in intention-to-treat analyses. Study results will provide much needed evidence on the feasibility and effectiveness of yoga as a therapeutic modality for the treatment of CLBP in US military veterans."," Contemp Clin Trials 48: 110-118.","USA",2016,"Back Pain","Yoga","RMDQ","Unknown","PRO study","Clinical trial"]
[152,"Gudavalli, M. R., et al. (2015). \"Development of an attention-touch control for manual cervical distraction: a pilot randomized clinical trial for patients with neck pain.\" Trials 16: 259.",null,"Gudavalli, M. R., et al.","Development of an attention-touch control for manual cervical distraction: a pilot randomized clinical trial for patients with neck pain","BACKGROUND: Manual cervical distraction (MCD) is a traction-based therapy performed with a manual contact over the cervical region producing repeating cycles while patients lie prone. This study evaluated a traction force-based minimal intervention for use as an attention-touch control in clinical trials of MCD for patients with chronic neck pain. METHODS: We conducted a mixed-methods, pilot randomized clinical trial in adults with chronic neck pain. Participants were allocated to three traction force ranges of MCD: low force/minimal intervention (0-20 N), medium force (21-50 N), or high force (51-100 N). Clinicians delivered five treatments over two weeks consisting of three sets of five cycles of MCD at the C5 vertebra and occiput. Traction forces were measured at each treatment. Patient-reported outcomes included a pain visual analogue scale (VAS), Neck Disability Index (NDI), Credibility and Expectancy Questionnaire (CEQ), and adverse effects. A qualitative interview evaluated treatment group allocation perceptions. RESULTS: We randomized 48 participants, allocating an average of five each month. Forty-five participants completed the trial with three participants lost to follow-up. Most participants were women (65%) and white (92%) with a mean (SD) age of 46.8 (12.5) years. Mean traction force values were within the prescribed force ranges for each group at the C5 and occiput levels. Neck pain VAS demonstrated a benefit for high traction force MCD compared to the low force group [adjusted mean difference 15.6; 95% confidence interval (CI) 1.6 to 29.7]. Participants in the medium traction force group demonstrated improvements in NDI compared to the low force group (adjusted mean difference 3.0; 95% CI 0.1 to 5.9), as did participants in the high traction force group (adjusted mean difference 2.7; 95% CI -0.1 to 5.6). CEQ favored the high force group. Most low force participants correctly identified their treatment allocation in the qualitative interview. No serious adverse events were documented. CONCLUSIONS: This pilot study demonstrated the feasibility of a clinical trial protocol and the utility of a traction-based, minimal intervention as an attention-touch control for future efficacy trials of MCD for patients with neck pain. TRIAL REGISTRATION: ClinicalTrials.gov NCT01765751 (Registration Date 30 May 2012)."," Trials 16: 259.","USA",2015,"Neck Pain","Manipulations","NDI","Adults","PRO study","RCT"]
[153,"Gugliotta, M., et al. (2016). \"Surgical versus conservative treatment for lumbar disc herniation: a prospective cohort study.\" BMJ Open 6(12): e012938.",null,"Gugliotta, M., et al.","Surgical versus conservative treatment for lumbar disc herniation: a prospective cohort study","OBJECTIVES: Evidence comparing the effectiveness of surgical and conservative treatment of symptomatic lumbar disc herniation is controversial. We sought to compare short-term and long-term effectiveness of surgical and conservative treatment in sciatica symptom severity and quality of life in patients with lumbar disc herniation in a routine clinical setting. METHODS: A prospective cohort study of a routine clinical practice registry consisting of 370 patients. Outcome measures were the North American Spine Society questionnaire and the 36-Item Short-Form Health Survey to assess patient-reported back pain, physical function, neurogenic symptoms and quality of life. Primary outcomes were back pain at 6 and 12 weeks. Standard open discectomy was assessed versus conservative interventions at 6, 12, 52 and 104 weeks. We filled in missing outcome variable values with multiple imputation, accounted for repeated measures within patients with mixed-effects models and adjusted baseline group differences in relevant prognostic indicators by inverse probability of treatment weighting. RESULTS: Surgical treatment patients reported less back pain at 6 weeks than those receiving conservative therapy (-0.97; 95% CI -1.89 to -0.09), were more likely to report >/=50% decrease in back pain symptoms from baseline to 6 weeks (48% vs 17%, risk difference: 0.34; 95% CI 0.16 to 0.47) and reported less physical function disability at 52 weeks (-3.7; 95% CI -7.4 to -0.1). The other assessments showed minimal between-group differences with CIs, including the null effect. CONCLUSIONS: Compared with conservative therapy, surgical treatment provided faster relief from back pain symptoms in patients with lumbar disc herniation, but did not show a benefit over conservative treatment in midterm and long-term follow-up."," BMJ Open 6(12): e012938.","Switzerland,Canada,UK",2016,"Degenerative Disk Disease","Surgical","NASS-L","Unknown","PRO study","Prospective Observation"]
[154,"Gurden, M., et al. (2012). \"Evaluation of a general practitioner referral service for manual treatment of back and neck pain.\" Prim Health Care Res Dev 13(3): 204-210.",null,"Gurden, M., et al.","Evaluation of a general practitioner referral service for manual treatment of back and neck pain","AIM: To describe and evaluate a community-based musculoskeletal service, commissioned by National Health Services North East Essex Primary Care Trust (PCT), in terms of patient-reported outcomes and satisfaction. BACKGROUND: Persistent musculoskeletal conditions, including back and neck pain, are costly in terms of primary and secondary healthcare resources. Most patients are assessed and managed by general practitioners (GPs), with referral when necessary to secondary care services. METHOD: Patients consulting for at least four weeks for back or neck pain were referred by their GP according to patient preference to either a chiropractor or osteopath or physiotherapist working in the independent sector. Patients completed questionnaires at baseline and at discharge from the service. RESULTS: Questionnaire data were obtained from 696 patients, 97% of whom were seen within two weeks. About half (51%) had had their pain for less than three months, and of the remainder 49% for more than 12 months. Patients received on average six treatments. Using the Bournemouth Questionnaire, the Bothersomeness scale and the Global Improvement Scale, approximately two-thirds (64.6%, 67.8% and 69.9%, respectively) reported improvement at discharge, and approximately 65% a significant reduction in medication. Almost all (99.5%) patients were satisfied with the service. Similarly, almost all (97%) patients were discharged from the service with advice on self-management; the remainder were recommended for secondary care referral. CONCLUSION: This service improved patient access and choice resulting in shorter waiting times and effective outcomes. An impact analysis of the first 12 months of the service by the PCT showed a reduction in primary care consultations and in inappropriate referrals to secondary care."," Prim Health Care Res Dev 13(3): 204-210.","UK",2012,"Back Pain,Neck Pain","Not Specified","Bournemouth,Bothersomeness","Unknown","PRO study","Prospective Observation"]
[155,"Guzman, J. Z., et al. (2016). \"Patient-Reported Outcome Instruments in Spine Surgery.\" Spine (Phila Pa 1976) 41(5): 429-437.",null,"Guzman, J. Z., et al.","Patient-Reported Outcome Instruments in Spine Surgery","STUDY DESIGN: A critical review of the current literature. OBJECTIVE: The purpose of this study was to determine frequency, trends, and methods of utilization of spine-related PROIs over the last 10 years. SUMMARY OF BACKGROUND DATA: Patient-reported outcome instruments (PROIs) have become the gold standard to assess the efficacy of various medical and surgical treatments. Currently, however, there is an expansive range of PROIs without a clear consensus or guideline addressing which PROIs should be used for a particular diagnosis or surgical intervention. METHODS: A PubMed search was conducted from 2004 to 2013 of 5 orthopedic journals (The Journal of Bone and Joint Surgery, The Bone and Joint Journal, The Spine Journal, The European Spine Journal, and Spine) that publish spine articles, chosen on the basis of readership and impact factor. Journal abstracts were inspected for spine surgery and inclusion of at least 1 PROI. All articles containing PROIs and investigating a surgical intervention with a level of evidence (LOE) 1 to 4 were included for analysis. Article title, LOE, journal, and chosen PROI were recorded for selected articles. RESULTS: Out of 19,736 articles published in our selected time frame, 1,079 utilized PROIs. Most studies were LOE 4 (32.7%). Nearly half (48.9%) of all articles addressed degenerative thoracolumbar conditions. In total, there were 206 unique PROIs in the studies chosen for inclusion. The top 6 instruments utilized were the (1999) visual analog scale, (2) Oswestry disability index, (3) Short Form-36, (4) Japanese Orthopaedic Association Outcome Questionnaire, (5) Neck Disability Index, and (6) Scoliosis Research Society-22. CONCLUSION: The breadth of PROIs in spine surgery is extensive. Although there are preferred patient-reported outcome measures, a consensus or guideline addressing which instruments should be used for a particular diagnosis or procedure may be warranted. LEVEL OF EVIDENCE: 4."," Spine (Phila Pa 1976) 41(5): 429-437.","USA",2016,"Spinal Deformity","Surgical","ODI,JOACMEQ,NDI,SRS-HRQOL","Unknown","PRO study","Systematic review"]
[156,"Haher, T. R., et al. (1999). \"Results of the Scoliosis Research Society instrument for evaluation of surgical outcome in adolescent idiopathic scoliosis. A multicenter study of 244 patients.\" Spine (Phila Pa 1976) 24(14): 1435-1440.",null,"Haher, T. R., et al.","Results of the Scoliosis Research Society instrument for evaluation of surgical outcome in adolescent idiopathic scoliosis. A multicenter study of 244 patients","STUDY DESIGN: An outcome questionnaire was constructed to evaluate patient satisfaction and performance and to discriminate among patients with adolescent idiopathic scoliosis. OBJECTIVES: To determine reliability and validity in a new quality-of-life instrument for measuring progress among scoliosis patients. SUMMARY OF BACKGROUND DATA: Meta-analysis of the surgical treatment of adolescent idiopathic scoliosis determined that a uniform assessment of outcome did not exist. In addition, patient measures of well-being as opposed to process measures (e.g., radiographs) were not consistently reported. This established the need for a standardized questionnaire to assess patient measures in conjunction with process measures. METHODS: The instrument consists of 24 questions divided into seven equally weighted domains as determined by factor analysis: pain, general self-image, postoperative self-image, general function, overall level of activity, postoperative function, and satisfaction. The questionnaire takes approximately 5 minutes to complete and is taken at predetermined time intervals. A total of 244 of patients from three different sites responded to the questionnaire. RESULTS: The reliability based on internal consistency was confirmed with a Cronbach's alpha coefficient greater than 0.6 for each domain. In addition, acceptable correlation coefficient values greater than 0.68 were obtained for each domain by the test-retest method on normal controls. Similarly; to establish validity of the questionnaire, responses of normal high school students were compared with that of the patients. Consistent differences were noted in the domains between the two groups with P < 0.003. The largest differences were in pain (control, 29.96 +/- 0.20; patient, 13.23 +/- 5.55) and general level of activity (control, 14.96 +/- 0.20; patient, 12.16 +/- 3.23). Examination of the relationship between the domains and patient satisfaction showed that pain correlates with satisfaction to the greatest degree (Pearson's correlation co-efficient, r = -0.511; P < 0.001), followed by self-image (r = 0.412; P < 0.001). CONCLUSIONS: This questionnaire addresses patient measures for evaluation of outcome in adolescent idiopathic scoliosis surgery by examining several domains. It also allows for dynamic monitoring of scoliosis patients as they become adults. This is a validated instrument with good reliability measures."," Spine (Phila Pa 1976) 24(14): 1435-1440.","USA",1999,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Systematic review"]
[157,"Hahne, A. J., et al. (2011). \"Specific treatment of problems of the spine (STOPS): design of a randomised controlled trial comparing specific physiotherapy versus advice for people with subacute low back disorders.\" BMC Musculoskelet Disord 12: 104.",null,"Hahne, A. J., et al.","Specific treatment of problems of the spine (STOPS): design of a randomised controlled trial comparing specific physiotherapy versus advice for people with subacute low back disorders","BACKGROUND: Low back disorders are a common and costly cause of pain and activity limitation in adults. Few treatment options have demonstrated clinically meaningful benefits apart from advice which is recommended in all international guidelines. Clinical heterogeneity of participants in clinical trials is hypothesised as reducing the likelihood of demonstrating treatment effects, and sampling of more homogenous subgroups is recommended. We propose five subgroups that allow the delivery of specific physiotherapy treatment targeting the pathoanatomical, neurophysiological and psychosocial components of low back disorders. The aim of this article is to describe the methodology of a randomised controlled trial comparing specific physiotherapy treatment to advice for people classified into five subacute low back disorder subgroups. METHODS/DESIGN: A multi-centre parallel group randomised controlled trial is proposed. A minimum of 250 participants with subacute (6 weeks to 6 months) low back pain and/or referred leg pain will be classified into one of five subgroups and then randomly allocated to receive either physiotherapy advice (2 sessions over 10 weeks) or specific physiotherapy treatment (10 sessions over 10 weeks) tailored according to the subgroup of the participant. Outcomes will be assessed at 5 weeks, 10 weeks, 6 months and 12 months following randomisation. Primary outcomes will be activity limitation measured with a modified Oswestry Disability Index as well as leg and back pain intensity measured on separate 0-10 Numerical Rating Scales. Secondary outcomes will include a 7-point global rating of change scale, satisfaction with physiotherapy treatment, satisfaction with treatment results, the Sciatica Frequency and Bothersomeness Scale, quality of life (EuroQol-5D), interference with work, and psychosocial risk factors (Orebro Musculoskeletal Pain Questionnaire). Adverse events and co-interventions will also be measured. Data will be analysed according to intention to treat principles, using linear mixed models for continuous outcomes, Mann Whitney U tests for ordinal outcomes, and Chi-square, risk ratios and risk differences for dichotomous outcomes. DISCUSSION: This trial will determine the difference in outcomes between specific physiotherapy treatment tailored to each of the five subgroups versus advice which is recommended in guidelines as a suitable treatment for most people with a low back disorder. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000834257."," BMC Musculoskelet Disord 12: 104.","Australia",2011,"Back Pain","Physical Therapy","ODI,Bothersomeness","Unknown","PRO study","Clinical trial"]
[158,"Hallett, A., et al. (2007). \"Foraminal stenosis and single-level degenerative disc disease: a randomized controlled trial comparing decompression with decompression and instrumented fusion.\" Spine (Phila Pa 1976) 32(13): 1375-1380.",null,"Hallett, A., et al.","Foraminal stenosis and single-level degenerative disc disease: a randomized controlled trial comparing decompression with decompression and instrumented fusion","STUDY DESIGN: A randomized controlled trial with 5-year outcome data. OBJECTIVE: To compare clinical outcomes following spinal decompression (Group 1) with those following decompression and instrumented posterolateral fusion (Group 2) and decompression and instrumented posterolateral fusion plus transforaminal interbody fusion (TLIF) (Group 3). SUMMARY OF BACKGROUND DATA: Decompression is frequently advocated for the relief of nerve root stenosis in the presence of degenerate disc disease. It is uncertain if spinal fusion is also necessary. MATERIALS AND METHODS: Following completion of a standardized physiotherapy program, 44 patients with single-level disc disease were randomly assigned to 1 of 3 surgical groups. In those patients undergoing instrumentation, segmental pedicle screw fixation was used to stabilize the spine. Titanium interbody cages filled with autologous bone were inserted into patients in Group 3. Spinal disability, quality of life, and pain were assessed before surgery, and then at 1, 2, and 5 years by an independent researcher. RESULTS: At 2 years, 82% of the patients were pain free or moderately improved. Disability (Low Back Outcome Score and Roland Morris index) were both better in Group 1, but only Low Back Outcome Score was better in Group 2 (P < 0.05). By 5 years, although patients in all 3 groups showed some improvements in all the ratings used (Low Back Outcome Score, SF-36 Physical Functioning, and Roland Morris score), only Group 1 patients showed significant changes in all 3 outcomes (P < 0.05). There was no difference in any score between groups (P > 0.05). Two had secondary surgery for adjacent level stenosis (Group 2 and 3). One patient (Group 1) underwent subsequent lateral mass fusion for chronic pain. No patient required revision surgery for instrumentation failure, cage displacement, or pseudarthrosis. Evidence of at least unilateral lateral mass bone graft incorporation was evident in 95% of Groups 2 and 3. CONCLUSIONS: The results are encouraging in that almost all patients had improved by 5 years. However, it is a concern that no significant additional benefit has been noted from the more complex surgery. This suggests that patients are optimally treated by decompression alone, with the proviso that further operations may be required."," Spine (Phila Pa 1976) 32(13): 1375-1380.","UK",2007,"Back Pain,Spinal Fusion","Surgical","RMDQ,LBOS","Adults","PRO study","Clinical trial"]
[159,"Hansen, I. R., et al. (2011). \"Neck exercises, physical and cognitive behavioural-graded activity as a treatment for adult whiplash patients with chronic neck pain: design of a randomised controlled trial.\" BMC Musculoskelet Disord 12: 274.",null,"Hansen, I. R., et al.","Neck exercises, physical and cognitive behavioural-graded activity as a treatment for adult whiplash patients with chronic neck pain: design of a randomised controlled trial","BACKGROUND: Many patients suffer from chronic neck pain following a whiplash injury. A combination of cognitive, behavioural therapy with physiotherapy interventions has been indicated to be effective in the management of patients with chronic whiplash-associated disorders. The objective is to present the design of a randomised controlled trial (RCT) aimed at evaluating the effectiveness of a combined individual physical and cognitive behavioural-graded activity program on self-reported general physical function, in addition to neck function, pain, disability and quality of life in patients with chronic neck pain following whiplash injury compared with a matched control group measured at baseline and 4 and 12 months after baseline. METHODS/DESIGN: The design is a two-centre, RCT-study with a parallel group design. Included are whiplash patients with chronic neck pain for more than 6 months, recruited from physiotherapy clinics and an out-patient hospital department in Denmark. Patients will be randomised to either a pain management (control) group or a combined pain management and training (intervention)group. The control group will receive four educational sessions on pain management, whereas the intervention group will receive the same educational sessions on pain management plus 8 individual training sessions for 4 months, including guidance in specific neck exercises and an aerobic training programme. Patients and physiotherapists are aware of the allocation and the treatment, while outcome assessors and data analysts are blinded. The primary outcome measures will be Medical Outcomes Study Short Form 36 (SF36), Physical Component Summary (PCS). Secondary outcomes will be Global Perceived Effect (-5 to +5), Neck Disability Index (0-50), Patient Specific Functioning Scale (0-10), numeric rating scale for pain bothersomeness (0-10), SF-36 Mental Component Summary (MCS), TAMPA scale of Kinesiophobia (17-68), Impact of Event Scale (0-45), EuroQol (0-1), craniocervical flexion test (22 mmHg - 30 mmHg), joint position error test and cervical range of movement. The SF36 scales are scored using norm-based methods with PCS and MCS having a mean score of 50 with a standard deviation of 10. DISCUSSION: The perspectives of this study are discussed, in addition to the strengths and weaknesses. TRIAL REGISTRATION: The study is registered in http://www.ClinicalTrials.gov identifier NCT01431261."," BMC Musculoskelet Disord 12: 274.","Denmark",2011,"Trauma,Neck Pain","Exercise","NDI,Bothersomeness","Unknown","PRO study","RCT"]
[160,"Harms, M. C., et al. (2010). \"Low back pain: what determines functional outcome at six months? An observational study.\" BMC Musculoskelet Disord 11: 236.",null,"Harms, M. C., et al.","Low back pain: what determines functional outcome at six months? An observational study","BACKGROUND: The rise in disability due to back pain has been exponential with escalating medical and societal costs. The relative contribution of individual prognostic indicators to the pattern of recovery remains unclear. The objective of this study was to determine the prognostic value of demographic, psychosocial, employment and clinical factors on outcome in patients with low back pain METHODS: A prospective cohort study with six-month follow-up was undertaken at a multidisciplinary back pain clinic in central London employing physiotherapists, osteopaths, clinical psychologists and physicians, receiving referrals from 123 general practitioners. Over a twelve-month period, 593 consecutive patients referred from general practice with simple low back pain were recruited. A baseline questionnaire was developed to elicit information on potential prognostic variables. The primary outcome measures were change in 24-item Roland Morris disability questionnaire score at six months as a measure of low back related functional disability and the physical functioning scale of the SF-36, adjusted for baseline scores. RESULTS: Roland Morris scores improved by 3.8 index points (95% confidence interval 3.23 to 4.32) at six months and SF-36 physical functioning score by 10.7 points (95% confidence interval 8.36 to 12.95). Ten factors were linked to outcome yet in a multiple regression model only two remained predictive. Those with episodic rather than continuous pain were more likely to have recovered at six months (odds ratio 2.64 confidence interval 1.25 to 5.60), while those that classified themselves as non-white were less likely to have recovered (0.41 confidence interval 0.18 to 0.96). CONCLUSIONS: Analysis controlling for confounding variables, demonstrated that participants showed greater improvement if their episodes of pain during the previous year were short-lived while those with Middle Eastern, North African and Chinese ethnicity demonstrated minimal improvement. The study did not support previous findings that a wide range of factors could predict outcome."," BMC Musculoskelet Disord 11: 236.","UK",2010,"Back Pain","Psychosocial","RMDQ","Unknown","Cost and Resource Use","Prospective Observation"]
[161,"Hart, R. A., et al. (2013). \"Lumbar Stiffness Disability Index: pilot testing of consistency, reliability, and validity.\" Spine J 13(2): 157-161.",null,"Hart, R. A., et al.","Lumbar Stiffness Disability Index: pilot testing of consistency, reliability, and validity","BACKGROUND CONTEXT: The primary goal of surgical arthrodesis is to eliminate the motion of spinal segments in an effort to alleviate pain, improve deformity, and reduce disability. However, decreased spinal mobility may impair performance of activities of daily living (ADLs) due to the resulting stiffness or the lack of mobility of the fused segment. Current clinical outcome instruments do not seek information regarding the impact of spinal stiffness on functional ability. Therefore, a patient-reported outcome questionnaire measuring the impact of lumbar stiffness on functional abilities was devised and assessed for internal consistency, retest repeatability, and external validity. PURPOSE: To develop and validate an outcome instrument to measure the collateral effect of stiffness after lumbar fusion on functional ability. STUDY DESIGN: Cross-sectional pilot study. PATIENT SAMPLE: Consecutive cohort of lumbar spine fusion patients from a single surgeon's practice. OUTCOME MEASURES: Lumbar Stiffness Disability Index (LSDI) and Cobb angle measurements from digital radiographs. METHODS: We developed and evaluated a 10-item questionnaire, referred to as the LSDI, which seeks information on the impact of spinal stiffness on ADLs after lumbar spinal arthrodesis. The questionnaire yields a score from 0 to 100, with higher scores indicating greater difficulty resulting from lumbar spinal stiffness in performing 10 different ADLs. The study sample comprised 32 lumbar arthrodesis patients at a minimum of 1 year postoperatively. All patients completed the questionnaire twice via telephone interviews conducted 4 weeks apart. Internal consistency was assessed using the Cronbach alpha, and retest reliability was measured using an intraclass correlation coefficient (ICC). External validity of the questionnaire was evaluated by correlating the scores with lumbar range of motion (LROM) as measured from the angular change between the inferior end plate of T12 and the superior end plate of S1 on standardized digital flexion and extension lateral radiographs. RESULTS: The study sample included 22 women (69%) and 10 men (31%) with an average age of 63 years. The questionnaire demonstrated high internal consistency (Cronbach alpha=0.89). Retest reliability was also high (ICC=0.87). External validity was demonstrated by a statistically significant inverse relationship between LROM and LSDI scores (r=-0.71; p<.001). CONCLUSIONS: This pilot study demonstrates that the LSDI questionnaire is a reliable and valid instrument for assessing functional limitations due to lumbar stiffness among spinal arthrodesis patients. The questionnaire is proposed for use in prospective evaluation of lumbar stiffness impacts after arthrodesis."," Spine J 13(2): 157-161.","USA",2013,"Spine Disease","Surgical","LSDI","Adults","Tool Validation","Observational"]
[162,"Hasegawa, T. M., et al. (2014). \"Acupuncture for acute non-specific low back pain: a randomised, controlled, double-blind, placebo trial.\" Acupunct Med 32(2): 109-115.",null,"Hasegawa, T. M., et al.","Acupuncture for acute non-specific low back pain: a randomised, controlled, double-blind, placebo trial","OBJECTIVE: To assess the efficacy of Yamamoto's acupuncture method on pain, drug intake, functional capacity and quality of life for the treatment of acute non-specific low back pain (ANLBP). METHODS: A prospective, randomised, parallel-group, double-blind, placebo-controlled trial was performed in 80 men and women with ANLBP who were randomly assigned to five acupuncture sessions (intervention group (IG), n=40) and to five non-penetrating acupuncture sessions (sham group (SG), n=40). Patients were evaluated at baseline and at 3, 7, 14, 21 and 28 days. The measurements used were: visual analogue scale (VAS) for cumulative pain (before intervention, VAS1) and immediate pain (after intervention, VAS2); function (Roland-Morris Disability Questionnaire (RM)); quality of life (SF-36); improvement rating; and number of anti-inflammatory tablets taken. The primary endpoint was a decrease of at least 2 cm in VAS1. RESULTS: Pain VAS improved significantly in the IG from day 14 onwards compared with the SG, but the difference did not reach the prespecified clinically relevant value of 2 cm. The IG was significantly superior to the SG in the following outcomes: cumulative pain, function, pain (SF-36) and vitality (SF-36) at days 14, 21 and 28 (p<0.05); limitation in physical aspects (SF-36) at all times (p=0.007 and p=0.02); and functional capacity (SF-36) at days 21 and 28 (p<0.05). The IG also took significantly fewer anti-inflammatory tablets than the SG (p=0.004) at all evaluation times and the improvement rating was better than the SG (p<0.001). CONCLUSIONS: Yamamoto's new scalp acupuncture was more effective than sham treatment with regard to decrease in pain and anti-inflammatory intake as well as improving functional status and quality of life for patients with ANLBP. CLINICALTRIALSGOV: NCT 01124955."," Acupunct Med 32(2): 109-115.","Brazil",2014,"Back Pain","Acupuncture","RMDQ","Unknown","PRO study","RCT"]
[163,"Hashash, J. G., et al. (2008). \"Clinical trial: a randomized controlled cross-over study of flupenthixol + melitracen in functional dyspepsia.\" Aliment Pharmacol Ther 27(11): 1148-1155.",null,"Hashash, J. G., et al.","Clinical trial: a randomized controlled cross-over study of flupenthixol + melitracen in functional dyspepsia","BACKGROUND: Functional dyspepsia is a prevalent condition associated with diminished quality of life (QoL) and high economic burden. AIM: To study the efficacy of a combination of flupenthixol and melitracen (F + M) with anxiolytic and antidepressant properties in functional dyspepsia using a randomized controlled cross-over design. METHODS: Patients met the Rome III criteria for functional dyspepsia and a validated questionnaire was used to exclude those with anxiety or depression. Moreover, patients had to have failed a trial of acid-suppressive therapy and Helicobacter pylori eradication when positive. End points included subjective global symptom relief and QoL assessed by the Nepean Dyspepsia Index (NDI). RESULTS: Twenty-five patients (14 females, 11 males; mean age = 34.3 +/- 9.9 years) were enrolled and 24 completed the 8-week study. There was a significant improvement in subjective global symptom relief with F + M vs. placebo (ITT: 73.9% vs. 26.1%, P = 0.001) and a significant drop in the NDI score vs. placebo (ITT: -9.0 +/- 11.9 vs. -2.4 +/- 8.9, P = 0.03). No difference was noted whether the initial treatment was F + M or placebo. No significant side effects were noted. CONCLUSIONS: A combination of F and M is safe and effective in the short-term treatment of functional dyspepsia. F + M is associated with significant improvement in QoL independent of the presence of anxiety or depression."," Aliment Pharmacol Ther 27(11): 1148-1155.","Lebanon",2008,"Functional Dyspepsia","Not Specified","NDI","Adults","PRO study","RCT"]
[164,"Hayakawa, M., et al. (2015). \"Outcome in VLBW infants with surgical intestinal disorder at 18 months of corrected age.\" Pediatr Int 57(4): 633-638.",null,"Hayakawa, M., et al.","Outcome in VLBW infants with surgical intestinal disorder at 18 months of corrected age","BACKGROUND: Surgical intestinal disorders, such as necrotizing enterocolitis (NEC), focal intestinal perforation (FIP), and meconium-related ileus (MRI), are serious morbidities in very low-birthweight infants (VLBWI). The aim of this study was to compare the composite outcomes of death or neurodevelopmental impairment (NDI) in VLBWI with surgical intestinal disorders and assess independent risk factors for death and NDI at 18 months of corrected age. METHODS: A retrospective matched-cohort study was conducted at 11 institutes. We included VLBWI who had undergone laparotomy for NEC, FIP, and MRI. Two control subjects were chosen for every surgical patient and matched for gestational age and birthweight to form the comparison group. Death and neurodevelopmental outcome at 18 months of corrected age were evaluated. RESULTS: The number of infants in the NEC, FIP, MRI, and control groups was 44, 47, 42, and 261, respectively. In-hospital mortality was higher in infants with NEC and MRI relative to those in the control group (P < 0.001). The incidence rate for NDI at 18 months of corrected age was higher in infants with MRI relative to those in the control group (P = 0.021). On logistic regression analysis, low gestational age, male sex, small for gestational age, intraventricular hemorrhage, and MRI were associated with increased risk of death or NDI at 18 months of corrected age. CONCLUSIONS: NEC and MRI were associated with in-hospital mortality, and MRI was associated with NDI or death at 18 months of corrected age."," Pediatr Int 57(4): 633-638.","Japan",2015,"Low Birth Weight","Surgical","NDI","Infants","PRO study","Retrospective review"]
[165,"Helenius, I., et al. (2008). \"Long-term health-related quality of life after surgery for adolescent idiopathic scoliosis and spondylolisthesis.\" J Bone Joint Surg Am 90(6): 1231-1239.",null,"Helenius, I., et al.","Long-term health-related quality of life after surgery for adolescent idiopathic scoliosis and spondylolisthesis","BACKGROUND: The aim of surgical treatment for adolescent idiopathic scoliosis is primarily to prevent progression and secondarily to correct the deformity, whereas the goal of surgical treatment of pediatric spondylolisthesis is mainly to relieve pain and, in patients with a high-grade slip, to prevent progression. The aim of this study was to compare the long-term health-related quality of life after surgery for idiopathic scoliosis and spondylolisthesis in adolescence. METHODS: One hundred and ninety patients, with a mean age of fifteen years, who were treated surgically for adolescent idiopathic scoliosis and 270 patients, with a mean age of sixteen years, who were treated surgically for low-grade or high-grade spondylolisthesis participated in the present study. The mean duration of follow-up was 14.8 years for the scoliosis group and 17.0 years for the spondylolisthesis group. Radiographs were made preoperatively, at the time of the two-year follow-up, and at the time of the final follow-up. Additionally, a physical examination was performed, and the Scoliosis Research Society-24 and Short Form-36 questionnaires were completed at the final follow-up evaluation. RESULTS: The median total score on the Scoliosis Research Society questionnaire was 102 (range, 63 to 118) for the scoliosis group and 95 (range, 42 to 115) for the spondylolisthesis group (p < 0.001). After adjusting for age at the time of surgery, gender, and duration of follow-up, the patients with scoliosis had a significantly higher odds ratio for a good total score (> or = 90 points) on the Scoliosis Research Society questionnaire than did patients with spondylolisthesis (odds ratio, 2.65 [95% confidence interval, 1.58 to 4.44]; p = 0.0002). Patients in the scoliosis group had better values for general self-image, postoperative self-image, and postoperative function than did patients in the spondylolisthesis group (p < 0.001). Sixteen patients in both groups reported that they had back pain often or very often at rest. The standardized physical component scale on the Short Form-36 yielded slightly but significantly better values for the scoliosis group (median, 53.8 points; range, 32 to 61 points) compared with the spondylolisthesis group (median, 53.4 points; range, 27 to 59 points) (p = 0.01). CONCLUSIONS: Patients have good long-term health-related quality of life after surgery for idiopathic scoliosis and spondylolisthesis in adolescence. Patients who have surgery for idiopathic scoliosis are likely to have better long-term outcomes than are patients who have surgery for spondylolisthesis. It is possible that back pain in adolescence may affect quality of life more than spinal deformity does."," J Bone Joint Surg Am 90(6): 1231-1239.","Finland",2008,"Spinal Deformity,Spondylosis","Surgical","SRS-HRQOL","Adolescents","PRO study","Clinical trial"]
[166,"Hidalgo Ovejero, A. M., et al. (2015). \"Cross-cultural adaptation of the Zurich Claudication Questionnaire.Validation study of the Spanish version.\" An Sist Sanit Navar 38(1999): 41-52.",null,"Hidalgo Ovejero, A. M., et al.","Cross-cultural adaptation of the Zurich Claudication Questionnaire.Validation study of the Spanish version","BACKGROUND: In the last few years, instruments that measure outcomes and quality of life as perceived by the patient have become tools of great clinical value. The Zurich Claudication Questionnaire is one of the main instruments for the assessment of patients suffering from lumbar spinal stenosis. Nonetheless, no valid version has been published for use in the Spanish population. METHODS: The Zurich Claudication Questionnaire was translated and cross-culturally adapted to Spanish and the psychometric characteristics of the new version were then studied. Seventy-six patients were selected who were to undergo epidural steroid injection or were seen in the Hospital Complex of Navarre Spinal Unit. RESULTS: The Spanish version of the Zurich Claudication Questionnaire shows high Cronbach alpha internal consistency values, high reproducibility, a good correlation with the most important low back condition questionnaires used worldwide and good sensitivity for detecting clinical change in patients who undergo epidural steroid injection. CONCLUSION: This study resulted in a version of the Zurich Claudication Questionnaire or Swiss Spinal Stenosis Questionnaire translated and cross-culturally adapted to Spanish, with highly reliable, valid and sensitive psychometric characteristics. These proven properties make the Zurich Claudication Questionnaire available for the Spanish population, to evaluate outcomes and health status as perceived by patients with spinal stenosis and claudication syndrome."," An Sist Sanit Navar 38(1999): 41-52.","Spain",2015,"Unspecified","Not Specified","SSSQ","Unknown","Tool Validation","Observational"]
[167,"Highsmith, J. M., et al. (2011). \"Treatment of cervical stenotic myelopathy: a cost and outcome comparison of laminoplasty versus laminectomy and lateral mass fusion.\" J Neurosurg Spine 14(5): 619-625.",null,"Highsmith, J. M., et al.","Treatment of cervical stenotic myelopathy: a cost and outcome comparison of laminoplasty versus laminectomy and lateral mass fusion","OBJECT: Cervical stenotic myelopathy due to spondylosis or ossification of the posterior longitudinal ligament is often treated with laminoplasty or cervical laminectomy (with fusion). The goal of this study was to compare outcomes, radiographic results, complications, and implant costs associated with these 2 treatments. METHODS: The authors analyzed the records of 56 patients (age range 42-81 years) who were surgically treated for cervical stenosis. Of this group, 30 underwent laminoplasty and 26 underwent laminectomy with fusion. Patients who had cervical kyphosis or spondylolisthesis were excluded. An average of 4 levels were instrumented in the laminoplasty group and 5 levels in the fusion group (p < 0.01). Forty-two percent of the fusions crossed the cervicothoracic junction, but no laminoplasty instrumentation crossed the cervicothoracic junction, and it only reached C-7 in one-third of the cases. Preoperative and postoperative Nurick grades and modified Japanese Orthopaedic Association (mJOA) scores were obtained. Outcomes were also assessed with neck pain visual analog scale (VAS) scores and the Odom outcome criteria. Postoperative length of stay, complications, and implant costs were calculated. RESULTS: The mean duration of follow-up, average patient age, and length of hospital stay were similar for both groups. The mean Nurick scores were also similar in the 2 groups and improved an average of 1.4 points in both (p < 0.01 for preoperative-postoperative comparison in each group). The mean mJOA scores improved 2.7 points in laminoplasty patients and 2.8 points in fusion patients (p < 0.01 for each group). The mean VAS scores for neck pain did not change significantly in the laminoplasty cohort (3.2 +/- 2.8 [SD] preoperatively vs 3.4 +/- 2.6 postoperatively, p = 0.50). In the fusion cohort, the mean VAS scores improved from 5.8 +/- 3.2 to 3.0 +/- 2.3 (p < 0.01). Excellent or good Odom outcomes were observed in 76.7% of the patients in the laminoplasty cohort and 80.8% of those in the fusion cohort (p = 0.71). In the fusion group, complications were twice as common and implant costs were nearly 3 times as high as in the laminoplasty group. When cases involving fusions crossing the cervicothoracic junction were excluded, analysis showed similar complication rates in the 2 groups. CONCLUSIONS: Patients treated with laminoplasty and patients treated with laminectomy and fusion had similar improvements in Nurick scores, mJOA scores, and Odom outcomes. Patients who underwent fusion typically had higher preoperative neck pain scores, but their neck pain improved significantly after surgery. There was no significant change in the neck pain scores of patients treated with laminoplasty. Our series suggests cervical fusion significantly reduces neck pain in patients with stenotic myelopathy, but that the cost of the implant and rate of reoperation are greater than in laminoplasty."," J Neurosurg Spine 14(5): 619-625.","USA",2011,"Neck Pain,Spondylosis","Surgical","Odom,Nurick","Adults","Cost and Resource Use","Observational"]
[168,"Hill, J. C., et al. (2011). \"Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial.\" Lancet 378(9802): 1560-1571.",null,"Hill, J. C., et al.","Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial","BACKGROUND: Back pain remains a challenge for primary care internationally. One model that has not been tested is stratification of the management according to the patient's prognosis (low, medium, or high risk). We compared the clinical effectiveness and cost-effectiveness of stratified primary care (intervention) with non-stratified current best practice (control). METHODS: 1573 adults (aged >/=18 years) with back pain (with or without radiculopathy) consultations at ten general practices in England responded to invitations to attend an assessment clinic. Eligible participants were randomly assigned by use of computer-generated stratified blocks with a 2:1 ratio to intervention or control group. Primary outcome was the effect of treatment on the Roland Morris Disability Questionnaire (RMDQ) score at 12 months. In the economic evaluation, we focused on estimating incremental quality-adjusted life years (QALYs) and health-care costs related to back pain. Analysis was by intention to treat. This study is registered, number ISRCTN37113406. FINDINGS: 851 patients were assigned to the intervention (n=568) and control groups (n=283). Overall, adjusted mean changes in RMDQ scores were significantly higher in the intervention group than in the control group at 4 months (4.7 [SD 5.9] vs 3.0 [5.9], between-group difference 1.81 [95% CI 1.06-2.57]) and at 12 months (4.3 [6.4] vs 3.3 [6.2], 1.06 [0.25-1.86]), equating to effect sizes of 0.32 (0.19-0.45) and 0.19 (0.04-0.33), respectively. At 12 months, stratified care was associated with a mean increase in generic health benefit (0.039 additional QALYs) and cost savings ( pound240.01 vs pound274.40) compared with the control group. INTERPRETATION: The results show that a stratified approach, by use of prognostic screening with matched pathways, will have important implications for the future management of back pain in primary care. FUNDING: Arthritis Research UK."," Lancet 378(9802): 1560-1571.","UK",2011,"Radiculopathy","Not Specified","RMDQ","Adults","PRO study","Clinical trial"]
[169,"Ho, L. F., et al. (2017). \"Efficacy of abdominal acupuncture for neck pain: A randomized controlled trial.\" PLoS One 12(7): e0181360.",null,"Ho, L. F., et al.","Efficacy of abdominal acupuncture for neck pain: A randomized controlled trial","OBJECTIVE: This study aims to provide evidence regarding the clinical efficacy of abdominal acupuncture for neck pain. METHODS: This randomized, patient and assessor-blind, sham-controlled trial was conducted at a Chinese medicine center in Hong Kong between November 2014 and March 2016. A total of 154 eligible participants (age range, 18-65 years) with neck pain were randomly assigned to receive abdominal (n = 77) or non-penetrating sham abdominal (sham group; n = 77) acupuncture. Each participant was administered treatment over six sessions by Registered Chinese Medicine Practitioners, in accordance with a standardized protocol. The primary outcome was mean improvement in neck pain disability scores evaluated by the Northwick Park Neck Pain Questionnaire (NPQ). Secondary outcomes included intensity of neck pain and health-related quality-of-life measures. The outcomes were assessed at baseline and at 2 and 6 weeks from baseline. Patients in the abdominal acupuncture group received additional follow-up evaluation at 14 weeks from baseline. Outcomes were evaluated by intention-to-treat analysis. RESULTS: All participants provided informed consent for treatment and follow-up evaluation. Patients who received abdominal acupuncture exhibited greater improvement in NPQ scores than those who received sham treatment at both 2 and 6 weeks from baseline (intergroup mean differences, -5.75; 95% confidence interval [CI], -9.48 to -2.03; P = 0.008 and -8.65; 95% CI, -12.13 to -5.16; P < 0.001, respectively). The improvement in NPQ scores in the abdominal acupuncture group was even more significant at 14 weeks from baseline. Patients in the abdominal acupuncture group also exhibited significantly greater improvements in intensity of neck pain and a few quality-of-life measures than those in the sham abdominal acupuncture group, without any serious adverse events. CONCLUSION: These findings suggest that abdominal acupuncture is an effective alternative treatment for neck pain. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR-TRC-14004932."," PLoS One 12(7): e0181360.","China",2017,"Neck Pain","Acupuncture","Northwick","Adults","PRO study","Clinical trial"]
[170,"Hoekstra, C. J., et al. (2014). \"Criterion validity, reliability and clinical responsiveness of the CareConnections Functional Index.\" Physiother Theory Pract 30(6): 429-437.",null,"Hoekstra, C. J., et al.","Criterion validity, reliability and clinical responsiveness of the CareConnections Functional Index","This study established the criterion validity, test-retest reliability and responsiveness of the CareConnections Functional Index (CCFI). The CCFI is composed of four body-region specific subscales, measuring functional ability. Reference standards included the Neck Disability Index; Modified Oswestry Disability Index; Quick Disabilities of the Arm, Shoulder and Hand and the Lower Extremity Functional Scale. One hundred subjects per body region were enrolled. Subject's rated their perceived improvement based on the 15-point Global Rating of Change questionnaire. Minimal clinically important differences (MCID) were calculated via receiver operator characteristic curve. Test-retest reliability coefficients were good to excellent. Validity correlations with the reference standard measures were acceptable (r > 0.7) for all subscales. MCID for the cervical subscale = 7 points, lumbar = 8 points, upper extremity = 16 points and lower extremity = 11 points. The results of this study support the use of the CCFI in outpatient physical therapy practice as a responsive tool with good reliability and validity. The results also indicate that future work should focus on the impact of baseline patient factors that may affect future outcome."," Physiother Theory Pract 30(6): 429-437.","USA",2014,"Unspecified","Physical Therapy","ODI,NDI","Unknown","PRO study","Clinical trial"]
[171,"Horng, Y. S., et al. (2005). \"Predicting health-related quality of life in patients with low back pain.\" Spine (Phila Pa 1976) 30(5): 551-555.",null,"Horng, Y. S., et al.","Predicting health-related quality of life in patients with low back pain","STUDY DESIGN: Cross-sectional surveys of health-related quality of life (HRQOL) in patients with low back pain at ambulatory clinics plus 8 weeks of follow-up. OBJECTIVE: The objective of this study is to predict the HRQOL in patients with low back pain. SUMMARY OF BACKGROUND DATA: There is disagreement on the relative contribution of pain, physical impairment, functional status, and psychological factors on the disability and HRQOL in patients with low back pain. METHODS: Data were collected from 232 patients with low back pain who were consecutively recruited from several clinics of physical medicine and rehabilitation. Every patient received physical examination and completed a set of questionnaire, including the Taiwan version of the Brief Questionnaire of the World Health Organization on quality of life (WHOQOL-BREF), Modified Roland and Morris Disability Questionnaire, and visual analogue scale for pain intensity and for HRQOL. These patients were observed with a mail questionnaire 8 weeks later. The results of WHOQOL-BREF were also compared to those obtained from another 213 healthy volunteers who were accompanied persons with patients, volunteer workers in hospitals, and hospital employees. RESULTS: Results showed that there were significant correlations of HRQOL with pain intensity, disability scale, and disability days. Among the results of physical examination, lumbosacral radiculopathy was the only factor with moderate correlation with HRQOL. The significant predictors for HRQOL included physical domain, psychological domain, pain intensity, and family income. Among all the 232 study patients, 100 of them responded to the follow-up questionnaire. Changes in environmental domain, disability days, educational level, receiving herb drugs, and physiotherapy were the significant predictors for the changes of HRQOL. CONCLUSIONS: The HRQOL of patients with low back pain depended on functional status and psychological factors more than simple physical impairment. Future intervention may need to put more emphasis on improving functional status and psychological stress for these patients."," Spine (Phila Pa 1976) 30(5): 551-555.","Taiwan",2005,"Back Pain","Physical Therapy","RMDQ","Unknown","PRO study","Observational"]
[172,"Hurley, D. A., et al. (2004). \"A randomized clinical trial of manipulative therapy and interferential therapy for acute low back pain.\" Spine (Phila Pa 1976) 29(20): 2207-2216.",null,"Hurley, D. A., et al.","A randomized clinical trial of manipulative therapy and interferential therapy for acute low back pain","STUDY DESIGN: A multicenter assessor-blinded randomized clinical trial was conducted. OBJECTIVES: To investigate the difference in effectiveness of manipulative therapy and interferential therapy for patients with acute low back pain when used as sole treatments and in combination. SUMMARY OF BACKGROUND DATA: Both manipulative therapy and interferential therapy are commonly used treatments for low back pain. Evidence for the effectiveness of manipulative therapy is available only for the short-term. There is limited evidence for interferential therapy, and no study has investigated the effectiveness of manipulative therapy combined with interferential therapy. METHODS: Consenting subjects (n = 240) recruited following referral by physicians to physiotherapy departments in the (government-funded) National Health Service in Northern Ireland were randomly assigned to receive a copy of the Back Book and either manipulative therapy (MT; n = 80), interferential therapy (IFT; n = 80), or a combination of manipulative therapy and interferential therapy (CT; n = 80). The primary outcome was a change in functional disability on the Roland Morris Disability Questionnaire. Follow-up questionnaires were posted at discharge and at 6 and 12 months. RESULTS: The groups were balanced at baseline for low back pain and demographic characteristics. At discharge all interventions significantly reduced functional disability (Roland Morris scale, MT: -4.53; 95% CI, -5.7 to -3.3 vs. IFT: -3.56; 95% CI, -4.8 to -2.4 vs. CT: -4.65; 95% CI, -5.8 to -3.5; P = 0.38) and pain (McGill questionnaire, MT: -5.12; 95% CI, -7.7 to -2.5 vs. IFT: -5.87; 95% CI, -8.5 to -3.3 vs. CT: -6.64; 95% CI, -9.2 to -4.1; P = 0.72) and increased quality of life (SF-36 Role-Physical, MT: 28.6; 95% CI, 18.3 to 38.9 vs. IFT: 31.4; 95% CI, 21.2 to 41.5 vs. CT: 30; 95% CI, 19.9 to 40; P = 0.93) to the same degree and maintained these improvements at 6 and 12 months. No significant differences were found between groups for reported LBP recurrence, work absenteeism, medication consumption, exercise participation, or healthcare use at 12 months (P > 0.05). CONCLUSIONS: For acute low back pain, there was no difference between the effects of a combined manipulative therapy and interferential therapy package and either manipulative therapy or interferential therapy alone."," Spine (Phila Pa 1976) 29(20): 2207-2216.","Ireland",2004,"Back Pain","Exercise","RMDQ","Unknown","PRO study","RCT"]
[173,"Itoh, K., et al. (2004). \"Trigger point acupuncture treatment of chronic low back pain in elderly patients--a blinded RCT.\" Acupunct Med 22(4): 170-177.",null,"Itoh, K., et al.","Trigger point acupuncture treatment of chronic low back pain in elderly patients--a blinded RCT","OBJECTIVE: There is some evidence for the efficacy of acupuncture in chronic low back pain, but it remains unclear which acupuncture modes are most effective. Our objective was to evaluate the effects of two different modes of trigger point acupuncture on pain and quality of life in chronic low back pain patients compared to standard acupuncture treatment. METHODS: Thirty five consecutive out-patients (25 women, 10 men; age range: 65-81 years) from the Department of Orthopaedic Surgery, Meiji University of Oriental Medicine, with non-radiating low back pain for at least six months and normal neurological examination, were randomised to one of three groups over 12 weeks. Each group received two phases of acupuncture treatment with an interval between them. Nine patients dropped out during the course of the study. The standard acupuncture group (n=9) received treatment at traditional acupuncture points for low back pain, while the other acupuncture groups received superficial (n=9) or deep (n=9) treatments on trigger points. Outcome measures were VAS pain intensity and Roland Morris Questionnaire. RESULTS: After treatment, the group that received deep needling to trigger points reported less pain intensity and improved quality of life compared to the standard acupuncture group or the group that received superficial needling to trigger points, but the differences were not statistically significant. There was a significant reduction in pain intensity between the treatment and interval in the group that received deep needling to trigger points (P<0.01), but not in the standard acupuncture group or the group that received superficial needling to trigger points. CONCLUSION: These results suggest that deep needling to trigger points may be more effective in the treatment of low back pain in elderly patients than either standard acupuncture therapy, or superficial needling to trigger points."," Acupunct Med 22(4): 170-177.","Japan",2004,"Back Pain","Acupuncture,Surgical","RMDQ","Elderly","PRO study","Clinical trial"]
[174,"Itoh, K., et al. (2006). \"Effects of trigger point acupuncture on chronic low back pain in elderly patients--a sham-controlled randomised trial.\" Acupunct Med 24(1999): 5-12.",null,"Itoh, K., et al.","Effects of trigger point acupuncture on chronic low back pain in elderly patients--a sham-controlled randomised trial","INTRODUCTION: There is some evidence for the efficacy of acupuncture, but it remains unclear whether trigger point acupuncture is effective. Our objective was to evaluate the effects of trigger point acupuncture on pain and quality of life in chronic low back pain patients compared with sham acupuncture. METHODS: Twenty-six consecutive out-patients (17 women, 9 men; age range: 65-91 years) from the Department of Orthopaedic Surgery, Meiji University of Oriental Medicine, with non-radiating low back pain for at least six months and normal neurological examination, were randomised to two groups. Each group received one phase of trigger point acupuncture and one of sham acupuncture with a three week washout period between them, over 12 weeks. Group A (n = 13) received trigger point acupuncture in the first phase and sham acupuncture in the second. Group B (n = 13) received the same interventions in the reverse order. Outcome measures were pain intensity (visual analogue scale, VAS) and Roland Morris Questionnaire. RESULTS: Nineteen patients were included in the analysis. At the end of the first treatment phase, group A receiving trigger point acupuncture scored significantly lower VAS (P < 0.001) and Roland Morris Questionnaire scores (P < 0.01) than the sham control group. There were significant within-group reductions in pain in both groups during the trigger point acupuncture phase but not in the sham treatment phase. However, the beneficial effects were not sustained. CONCLUSION: These results suggest that trigger point acupuncture may have greater short term effects on low back pain in elderly patients than sham acupuncture."," Acupunct Med 24(1999): 5-12.","Japan",2006,"Back Pain","Acupuncture,Surgical","RMDQ","Elderly","PRO study","Prospective Observation"]
[175,"Itoh, K., et al. (2007). \"Randomised trial of trigger point acupuncture compared with other acupuncture for treatment of chronic neck pain.\" Complement Ther Med 15(3): 172-179.",null,"Itoh, K., et al.","Randomised trial of trigger point acupuncture compared with other acupuncture for treatment of chronic neck pain","INTRODUCTION: There is some evidence for the efficacy of acupuncture in chronic neck pain (CNP) treatment, but it remains unclear which acupuncture modes are most effective. Objective was to evaluate the effects of trigger point acupuncture on pain and quality of life (QOL) in CNP patients compared to three other acupuncture treatments (acupoints, non-trigger point and sham treatment). METHODS: Forty out-patients (29 women, 11 men; age range: 47-80 years) from the Department of Orthopaedic Surgery, Meiji University of Oriental Medicine, with non-radiating CNP for at least 6 months and normal neurological examination were randomised to one of four groups over 13 weeks. Each group received two phases of acupuncture treatment with an interval between them. The acupoint group (standard acupuncture; SA, n=10) received treatment at traditional acupoints for neck pain, the trigger point (TrP, n=10) and non-trigger point (non-TrP, n=10) groups received treatment at tenderness points for the same muscle, while the other acupuncture group received sham treatments on the trigger point (SH, n=10). Outcome measures were pain intensity (visual analogue scale; VAS 0-100mm) and disease specific questionnaire (neck disability index; NDI, 60-point scale). RESULTS: After treatment, the TrP group reported less pain intensity and improved QOL compared to the SA or non-TrP group. There was significant reduction in pain intensity between the treatment and the interval for the TrP group (p<0.01, Dunnett's multiple test), but not for the SA or non-TrP group. CONCLUSION: These results suggest that trigger point acupuncture therapy may be more effective on chronic neck pain in aged patients than the standard acupuncture therapy."," Complement Ther Med 15(3): 172-179.","Japan",2007,"Neck Pain","Acupuncture,Surgical","NDI","Adults","PRO study","RCT"]
[176,"Janssen, M. E., et al. (2015). \"ProDisc-C Total Disc Replacement Versus Anterior Cervical Discectomy and Fusion for Single-Level Symptomatic Cervical Disc Disease: Seven-Year Follow-up of the Prospective Randomized U.S. Food and Drug Administration Investigational Device Exemption Study.\" J Bone Joint Surg Am 97(21): 1738-1747.",null,"Janssen, M. E., et al.","ProDisc-C Total Disc Replacement Versus Anterior Cervical Discectomy and Fusion for Single-Level Symptomatic Cervical Disc Disease: Seven-Year Follow-up of the Prospective Randomized U.S. Food and Drug Administration Investigational Device Exemption Study","BACKGROUND: In patients with single-level cervical degenerative disc disease, total disc arthroplasty can relieve radicular pain and preserve functional motion between two vertebrae. We compared the efficacy and safety of cervical total disc arthroplasty with that of anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical degenerative disc disease between C3-C4 and C6-C7. METHODS: Two hundred and nine patients at thirteen sites were randomly treated with either total disc arthroplasty with ProDisc-C (n = 103) or with ACDF (n = 106). Patients were assessed preoperatively; at six weeks and three, six, twelve, eighteen, and twenty-four months postoperatively; and then annually until seven years postoperatively. Outcome measures included the Neck Disability Index (NDI), the Short Form-36 (SF-36), postoperative neurologic parameters, secondary surgical procedures, adverse events, neck and arm pain, and satisfaction scores. RESULTS: At seven years, the overall follow-up rate was 92% (152 of 165). There were no significant differences in demographic factors, follow-up rate, or patient-reported outcomes between groups. Both procedures were effective in reducing neck and arm pain and improving and maintaining function and health-related quality of life. Neurologic status was improved or maintained in 88% and 89% of the patients in the ProDisc-C and ACDF groups, respectively. After seven years of follow-up, thirty secondary surgical procedures had been performed in nineteen (18%) of 106 patients in the ACDF group compared with seven secondary surgical procedures in seven (7%) of 103 patients in the ProDisc-C group (p = 0.0099). There were no significant differences in the rates of any device-related adverse events between the groups. CONCLUSIONS: Total disc arthroplasty with ProDisc-C is a safe and effective surgical treatment of single-level symptomatic cervical degenerative disc disease. Clinical outcomes after total disc arthroplasty with ProDisc-C were similar to those after ACDF. Patients treated with ProDisc-C had a lower probability of subsequent surgery, suggesting that total disc arthroplasty provides durable results and has the potential to slow the rate of adjacent-level disease. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence."," J Bone Joint Surg Am 97(21): 1738-1747.","USA",2015,"Radiculopathy","Surgical","NDI","Unknown","PRO study","RCT"]
[177,"Jarvik, J. G., et al. (2014). \"Back pain in seniors: the Back pain Outcomes using Longitudinal Data (BOLD) cohort baseline data.\" BMC Musculoskelet Disord 15: 134.",null,"Jarvik, J. G., et al.","Back pain in seniors: the Back pain Outcomes using Longitudinal Data (BOLD) cohort baseline data","BACKGROUND: Back pain represents a substantial burden globally, ranking first in a recent assessment among causes of years lived with disability. Though back pain is widely studied among working age adults, there are gaps with respect to basic descriptive epidemiology among seniors, especially in the United States. Our goal was to describe how pain, function and health-related quality of life vary by demographic and geographic factors among seniors presenting to primary care providers with new episodes of care for back pain. METHODS: We examined baseline data from the Back pain Outcomes using Longitudinal Data (BOLD) registry, the largest inception cohort to date of seniors presenting to a primary care provider for back pain. The sample included 5,239 patients >/= 65 years old with a new primary care visit for back pain at three integrated health systems (Northern California Kaiser-Permanente, Henry Ford Health System [Detroit], and Harvard Vanguard Medical Associates [Boston]). We examined differences in patient characteristics across healthcare sites and associations of patient sociodemographic and clinical characteristics with baseline patient-reported measures of pain, function, and health-related quality of life. RESULTS: Patients differed across sites in demographic and other characteristics. The Detroit site had more African-American patients (50%) compared with the other sites (7-8%). The Boston site had more college graduates (68%) compared with Detroit (20%). Female sex, lower educational status, African-American race, and older age were associated with worse functional disability as measured by the Roland-Morris Disability Questionnaire. Except for age, these factors were also associated with worse pain. CONCLUSIONS: Baseline pain and functional impairment varied substantially with a number of factors in the BOLD cohort. Healthcare site was an important factor. After controlling for healthcare site, lower education, female sex, African-American race, and older age were associated with worse physical disability and all of these factors except age were associated with worse pain. TRIAL REGISTRATION: Clinical Trials.gov NCT01776242; Registration date: June 13, 2012."," BMC Musculoskelet Disord 15: 134.","USA",2014,"Back Pain","Not Specified","RMDQ","Adults","PRO study","Retrospective review"]
[178,"Jarvik, J. G., et al. (2015). \"Association of early imaging for back pain with clinical outcomes in older adults.\" Jama 313(11): 1143-1153.",null,"Jarvik, J. G., et al.","Association of early imaging for back pain with clinical outcomes in older adults","IMPORTANCE: In contrast to the recommendations for younger adults, many guidelines allow for older adults with back pain to undergo imaging without waiting 4 to 6 weeks. However, early imaging may precipitate interventions that do not improve outcomes. OBJECTIVE: To compare function and pain at the 12-month follow-up visit among older adults who received early imaging with those who did not receive early imaging after a new primary care visit for back pain without radiculopathy. DESIGN, SETTING, AND PARTICIPANTS: Prospective cohort of 5239 patients 65 years or older with a new primary care visit for back pain (2011-2013) in 3 US health care systems. We matched controls 1:1 using propensity score matching of demographic and clinical characteristics, including diagnosis, pain severity, pain duration, functional status, and prior resource use. EXPOSURES: Diagnostic imaging (plain films, computed tomography [CT], magnetic resonance imaging [MRI]) of the lumbar or thoracic spine within 6 weeks of the index visit. MAIN OUTCOME AND MEASURES: PRIMARY OUTCOME: back or leg pain-related disability measured by the modified Roland-Morris Disability Questionnaire (score range, 0-24; higher scores indicate greater disability) 12 months after enrollment. RESULTS: Among the 5239 patients, 1174 had early radiographs and 349 had early MRI/CT. At 12 months, neither the early radiograph group nor the early MRI/CT group differed significantly from controls on the disability questionnaire. The mean score for patients who underwent early radiography was 8.54 vs 8.74 among the control group (difference, -0.10 [95% CI, -0.71 to 0.50]; mixed model, P = .36). The mean score for the early MRI/CT group was 9.81 vs 10.50 for the control group (difference,-0.51 [-1.62 to 0.60]; mixed model, P = .18). CONCLUSIONS AND RELEVANCE: Among older adults with a new primary care visit for back pain, early imaging was not associated with better 1-year outcomes. The value of early diagnostic imaging in older adults for back pain without radiculopathy is uncertain."," Jama 313(11): 1143-1153.","USA",2015,"Back Pain","Not Specified","RMDQ","Unknown","PRO study","Observational"]
[179,"Jensen, C. E., et al. (2014). \"Study protocol of an economic evaluation of an extended implementation strategy for the treatment of low back pain in general practice: a cluster randomised controlled trial.\" Implement Sci 9: 140.",null,"Jensen, C. E., et al.","Study protocol of an economic evaluation of an extended implementation strategy for the treatment of low back pain in general practice: a cluster randomised controlled trial","BACKGROUND: In Denmark, guidelines on low back pain management are currently being implemented; in association with this, a clinical trial is conducted. A health economic evaluation is carried out alongside the clinical trial to assess the cost-effectiveness of an extended implementation strategy to increase the general practitioners' adherence to the guidelines. In addition to usual dissemination, the extended implementation strategy is composed of visits from a guideline facilitator, stratification tools, and feedback on guideline adherence. The aim of this paper is to provide the considerations on the design of the health economic evaluation. METHODS/DESIGN: The economic evaluation is carried out alongside a cluster randomised controlled trial consisting of 60 general practices in the North Denmark Region. An expected 1,200 patients between the age of 18 and 65 years with a low back pain diagnosis will be enrolled. The economic evaluation comprises both a cost-effectiveness analyses and a cost-utility analysis. Effectiveness measures include referral to secondary care, health-related quality of life measured by EQ-5D-5L, and disability measured by the Roland Morris disability questionnaire. Cost measures include all relevant additional costs of the extended implementation strategy compared to usual implementation. The economic evaluation will be performed from both a societal perspective and a health sector perspective with a 12-month time horizon. DISCUSSION: It is expected that the extended implementation strategy will reduce the number of patients referred to secondary care. It is hypothesised that the additional upfront cost of extended implementation will be counterbalanced by improvements in clinical practice and patient-related outcomes, thereby rendering the extended implementation strategy cost-effective. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01699256."," Implement Sci 9: 140.","Denmark",2014,"Back Pain","Not Specified","RMDQ","Adults","Cost-Effectiveness","Clinical trial"]
[180,"Joslin, C. C., et al. (2004). \"Long-term disability after neck injury. a comparative study.\" J Bone Joint Surg Br 86(7): 1032-1034.",null,"Joslin, C. C., et al.","Long-term disability after neck injury. a comparative study","Claims for personal injury after whiplash injury cost the economy of the United Kingdom more than pound 3 billion per year, yet only very few patients have radiologically demonstrable pathology. Those sustaining fractures of the cervical spine have been subjected to greater force and may reasonably be expected to have worse symptoms than those with whiplash injuries. Using the neck disability index as the outcome measure, we compared pain and functional disability in four groups of patients who had suffered injury to the cervical spine. After a mean follow-up of 3.5 years, patients who had sustained fractures of the cervical spine had significantly lower levels of pain and disability than those who had received whiplash injuries and were pursuing compensation (p < 0.01), but had similar levels to those whiplash sufferers who had settled litigation or had never sought compensation. Functional recovery after neck injury was unrelated to the physical insult. The increased morbidity in whiplash patients is likely to be psychological and is associated with litigation."," J Bone Joint Surg Br 86(7): 1032-1034.","UK",2004,"Trauma","Psychosocial","NDI","Unknown","PRO study","Clinical trial"]
[181,"Joswig, H., et al. (2017). \"Effects of Smoking on Subjective and Objective Measures of Pain Intensity, Functional Impairment, and Health-Related Quality of Life in Lumbar Degenerative Disk Disease.\" World Neurosurg 99: 6-13.",null,"Joswig, H., et al.","Effects of Smoking on Subjective and Objective Measures of Pain Intensity, Functional Impairment, and Health-Related Quality of Life in Lumbar Degenerative Disk Disease","BACKGROUND: Numerous studies assessed the effects of smoking on lumbar degenerative disk disease (DDD); they focused on patient-reported outcome measures (PROMs) and yielded conflicting results. METHODS: In this 2-center study on consecutive patients receiving surgical treatment for lumbar DDD, subjective functional impairment (SFI) in terms of PROMs including visual analog scale back and leg pain, Roland-Morris, Oswestry Disability Index, Euro-Qol-5D, and a Short-Form 12 physical component summary was determined at baseline, 3 days, 6 weeks, 6 months, and 1 year postoperatively. Age- and sex-adjusted T-scores of objective functional impairment (OFI) were determined using the Timed Up and Go test up to 6 weeks postoperatively. The responder status was defined by the minimal clinically important difference. RESULTS: We analyzed 375 patients (n = 96 [25.6%] smokers and n = 279 [74.4%] nonsmokers). SFI on any of the PROMs before treatment was similar in smokers and nonsmokers. Smokers were more likely to have OFI in univariate logistic regression analysis (95% confidence interval 1.31-3.37, P = 0.002). In multivariate analysis, however, this relationship became insignificant (95% confidence interval 0.85-2.38, P = 0.184). The smoking status had no predictive capacity on the 6-week SFI or OFI responder status, and there were no differences in any of the PROMs until the 1-year follow-up. CONCLUSIONS: PROMs measuring SFI for pain intensity, functional impairment, and health-related quality of life were similar in smokers and nonsmokers before surgery for lumbar DDD, as well as postoperatively. The smoking status has negligible impact on the Timed Up and Go test, which appears to be a robust assessment tool for OFI."," World Neurosurg 99: 6-13.","Switzerland,Australia",2017,"Degenerative Disk Disease","Surgical","ODI,RMDQ","Unknown","PRO study","Observational"]
[182,"Joswig, H., et al. (2017). \"Patients' Preference of the Timed Up and Go Test or Patient-Reported Outcome Measures Before and After Surgery for Lumbar Degenerative Disk Disease.\" World Neurosurg 99: 26-30.",null,"Joswig, H., et al.","Patients' Preference of the Timed Up and Go Test or Patient-Reported Outcome Measures Before and After Surgery for Lumbar Degenerative Disk Disease","BACKGROUND: The Timed Up and Go (TUG) test, as a measure of objective functional impairment in lumbar degenerative disk disease (DDD), complements patient-reported outcome measures (PROMs) of subjective functional impairment. METHODS: Prospective 2-center study on consecutive patients scheduled for surgical treatment for lumbar DDD who underwent an objective (TUG test) and subjective (PROMs) functional assessment before and 1 and 3 days after surgery. PROMs included the visual analog scale (VAS), Roland-Morris Disability Index (RMDI), Oswestry Disability Index (ODI), Euro-Qol (EQ-5D), and Short Form 12 (SF-12) questionnaires. On completion of each assessment, patients were asked whether they would prefer performing the TUG test or completing the PROMs questionnaires. RESULTS: A total of 109 of 125 patients (87.2%) completed the assessments. Preoperatively, patients were 2.18 times as likely to prefer the TUG test to the PROMs (odds ratio [OR], 2.18; 95% confidence interval [CI], 1.27-3.75). On postoperative days 1 and 3, patients were 5.79 (OR, 5.79; 95% CI, 3.23-10.37) and 6.33 times as likely to prefer the TUG test to the PROMs, respectively (OR, 6.33; 95% CI, 3.51-11.41). There were no statistical differences in baseline characteristics, TUG t scores, VAS, RMDI, ODI, SF-12, and EQ-5D index between patients preferring either the TUG test or the PROMs questionnaires. CONCLUSIONS: The TUG test is preferred over a battery of PROMs by 60%-70% of patients with lumbar DDD not only in the preoperative, but also in the postoperative, setting. High functional disability does not result in avoidance of the TUG test, and repeated assessments lead to higher preference."," World Neurosurg 99: 26-30.","Switzerland,Australia",2017,"Degenerative Disk Disease","Surgical","ODI,RMDQ","Unknown","PRO study","Prospective Observation"]
[183,"Kang, D. G., et al. (2017). \"Neurologic Deficits Have a Negative Impact on Patient-Related Outcomes in Primary Presentation Adult Symptomatic Lumbar Scoliosis Surgical Treatment at One-Year Follow-up.\" Spine (Phila Pa 1976) 42(7): 479-489.",null,"Kang, D. G., et al.","Neurologic Deficits Have a Negative Impact on Patient-Related Outcomes in Primary Presentation Adult Symptomatic Lumbar Scoliosis Surgical Treatment at One-Year Follow-up","STUDY DESIGN: A retrospective analysis of prospective, multicenter National Institute of Health clinical trial. OBJECTIVE: The aim of this study was to assess the rate of neurologic complications and impact of new neurologic deficits on 1-year postoperative patient-reported outcomes (PROs). SUMMARY OF BACKGROUND DATA: There are limited studies evaluating the impact of new neurologic deficits on PROs following surgery for primary presentation adult lumbar scoliosis. METHODS: Patients were divided into two groups: new postoperative neurological deficit (Def) or no deficit (NoDef). Preoperative and 1-year follow-up PROs were analyzed [Scoliosis Research Society (SRS) Questionnaire, Oswestry Disability Index (ODI), Short Form-12 Physical/Mental Health Composite Scores (PCS/MCS), and back/leg pain Numerical Rating Scale (NRS)]. RESULTS: One hundred forty-one patients: 14 Def (9.9%), 127 NoDef (90.1%). No differences were observed in demographic, radiographic, or PRO data between groups preoperatively. Def group had longer surgical procedures (8.3 vs. 6.9 hours, P = 0.030), greater blood loss (2832 vs. 2606 mL, P = 0.022), and longer hospitalizations (10.6 vs. 7.8 days, P = 0.004). NoDef group reported significant improvement in all PROs from preop to 1-year postoperative. Def group only had improvement in SRS Pain (2.7 preop to 3.4 postop, P = 0.037) and self-image domains (2.7 to 3.6, p = 0.004), and NRS back pain (6.6 to 3.2, P = 0.004) scores with significant worsening of NRS leg pain (4.1 to 6.1, P = 0.045). Group comparisons of 1-year postop PROs found that Def group reported more NRS leg pain (6.1 vs. 1.7, P < 0.001) and worse outcomes than NoDef group for ODI (35.7 vs. 23.1, P = 0.016) and PCS (32.6 vs. 41.9, P = 0.007). CONCLUSION: We found a 9.9% rate of new neurologic deficits following surgery for symptomatic primary presentation adult lumbar scoliosis, much higher than previous studies. Most neurologic deficits improved by 1-year follow-up, but appeared to have a dramatic negative impact on PROs, with increased postoperative leg pain and greater patient-perceived pathology reported in patients experiencing neurological deficits compared with those who did not. LEVEL OF EVIDENCE: 3."," Spine (Phila Pa 1976) 42(7): 479-489.","USA",2017,"Spinal Deformity","Surgical","ODI,SRS-HRQOL","Unknown","PRO study","Clinical trial"]
[184,"Karstens, S., et al. (2015). \"Validation of the German version of the STarT-Back Tool (STarT-G): a cohort study with patients from primary care practices.\" BMC Musculoskelet Disord 16: 346.",null,"Karstens, S., et al.","Validation of the German version of the STarT-Back Tool (STarT-G): a cohort study with patients from primary care practices","BACKGROUND: Current research emphasizes the high prevalence and costs of low back pain (LBP). The STarT Back Tool was designed to support primary care decision making for treatment by helping to determine the treatment prognosis of patients with non-specific low back pain. The German version is the STarT-G. The cross-cultural translation of the tool followed a structured and widely accepted process but to date it was only partially validated with a small sample. The aim of the study was to test the psychometric properties construct validity, discriminative ability, internal consistency and test-retest-reliability of the STarT-G and to compare them with values given for the original English version. METHODS: A consecutive cohort study with a two-week retest was conducted among patients with non-specific LBP, aged 18 to 60 years, from primary care practices. Questionnaires were collected before the first consultation, and two weeks later by post, using the following reference standards: the Roland and Morris disability questionnaire, the Tampa Scale of Kinesiophobia, the Pain Catastrophizing Scale and the Hospital Anxiety and Depression Scale. Psychometric properties examined included the tool's discriminative abilities, whether the psychosocial subscale was one factor, internal consistency, item redundancy, test-retest reliability and floor and ceiling effects. RESULTS: There were 228 patients recruited with a mean age of 42.2 (SD 11.0) years, and 53 % were female. The areas under the curve (AUC) for discriminative ability ranged from 0.70 (STarT-G Subscale - Pain Catastrophizing Scale; CI95 0.63, 0.78) to 0.77 (STarT-G Total - Composite reference standard, CI95 0.60, 0.94). Factor loadings ranged from 0.49 to 0.74. Cronbach's alpha testing the internal consistency and redundancy for the total/subscale scores were alpha = 0.52/0.55 respectively. The STarT-G test-retest reliability Kappa values for the total/subscale scores were 0.67/0.68 respectively. No floor or ceiling effects were present. CONCLUSIONS: The STarT-G shows acceptable psychometric properties although not in exact agreement with the original English version. The items previously regarded as a psychosocial subscale may be better seen as an index of different individual psychosocial constructs. The relevance of using the tool at the point of consultation should be further examined."," BMC Musculoskelet Disord 16: 346.","Germany",2015,"Back Pain","Psychosocial","RMDQ","Adults","Tool Validation","Observational"]
[185,"Kato, S., et al. (2015). \"Comparison of the Japanese Orthopaedic Association (JOA) score and modified JOA (mJOA) score for the assessment of cervical myelopathy: a multicenter observational study.\" PLoS One 10(4): e0123022.",null,"Kato, S., et al.","Comparison of the Japanese Orthopaedic Association (JOA) score and modified JOA (mJOA) score for the assessment of cervical myelopathy: a multicenter observational study","OBJECTIVES: The Japanese Orthopaedic Association (JOA) score is widely used to assess the severity of clinical symptoms in patients with cervical compressive myelopathy, particularly in East Asian countries. In contrast, modified versions of the JOA score are currently accepted as the standard tool for assessment in Western countries. The objective of the present study is to compare these scales and clarify their differences and interchangeability and verify their validity by comparing them to other outcome measures. MATERIALS AND METHODS: Five institutions participated in this prospective multicenter observational study. The JOA and modified JOA (mJOA) proposed by Benzel were recorded preoperatively and at three months postoperatively in patients with cervical compressive myelopathy who underwent decompression surgery. Patient reported outcome (PRO) measures, including Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ), the Short Form-12 (SF-12) and the Neck Disability Index (NDI), were also recorded. The preoperative JOA score and mJOA score were compared to each other and the PRO values. A Bland-Altman analysis was performed to investigate their limits of agreement. RESULTS: A total of ninety-two patients were included. The correlation coefficient (Spearman's rho) between the JOA and mJOA was 0.87. In contrast, the correlations between JOA/mJOA and the other PRO values were moderate (|rho| = 0.03 - 0.51). The correlation coefficient of the recovery rate between the JOA and mJOA was 0.75. The Bland-Altman analyses showed that limits of agreement were 3.6 to -1.2 for the total score, and 55.1% to -68.8% for the recovery rates. CONCLUSIONS: In the present study, the JOA score and the mJOA score showed good correlation with each other in terms of their total scores and recovery rates. Previous studies using the JOA can be interpreted based on the mJOA; however it is not ideal to use them interchangeably. The validity of both scores was demonstrated by comparing these values to the PRO values."," PLoS One 10(4): e0123022.","Japan",2015,"Cervical Myelopathy","Surgical","NDI","Unknown","PRO study","Prospective Observation"]
[186,"Katzman, W. B., et al. (2016). \"Study of Hyperkyphosis, Exercise and Function (SHEAF) Protocol of a Randomized Controlled Trial of Multimodal Spine-Strengthening Exercise in Older Adults With Hyperkyphosis.\" Phys Ther 96(3): 371-381.",null,"Katzman, W. B., et al.","Study of Hyperkyphosis, Exercise and Function (SHEAF) Protocol of a Randomized Controlled Trial of Multimodal Spine-Strengthening Exercise in Older Adults With Hyperkyphosis","BACKGROUND: Hyperkyphosis negatively affects health status, physical mobility, and quality of life, but there is no standard protocol for treating people with hyperkyphosis. Treatment options include targeted exercise. OBJECTIVES: This single-site randomized controlled trial (RCT) will determine the efficacy of a targeted multimodal spine-strengthening exercise program, compared with no exercise intervention, among community-dwelling men and women aged >/=60 years. DESIGN: The RCT is a parallel-group design, with 1:1 randomization to exercise and attentional control groups. SETTING: The study will be conducted at one primary site (one academic medical center partnered with one local community medical center). PARTICIPANTS: One hundred men and women, aged >/=60 years, with thoracic kyphosis >/=40 degrees will be randomized. INTERVENTION: The targeted multimodal spine-strengthening exercise intervention includes exercise and postural training delivered by a physical therapist in a group of 10 participants, 3 times a week for 6 months. Controls receive monthly health education meetings in a group of 10 participants and monthly calls from the study coordinator to monitor physical activity and any adverse events. MEASUREMENTS: The primary outcome is change in Cobb angle of kyphosis measured from lateral spine radiographs at baseline and 6 months. Secondary outcomes include change in physical function (assessed with the modified Physical Performance Test, Timed \"Up & Go\" Test, timed loaded standing, 4-m walk, and Six-Minute Walk Test) and health-related quality of life (assessed with the modified Scoliosis Research Society instrument [SRS-30] self-image domain and Patient Reported Outcomes Measurement Information System [PROMIS] global health and physical function indexes). Additional secondary outcomes include pain, physical activity level, spinal flexion and extension muscle strength, paraspinal extensor muscle density, and adverse events. LIMITATIONS: Blinding of the participants and instructors providing the intervention is not possible. CONCLUSIONS: The efficacy of a high-quality, adequately powered exercise intervention in men and women with kyphosis >/=40 degrees will be evaluated to determine whether targeted multimodal spine-strengthening exercise reduces hyperkyphosis in older adults and improves important secondary outcomes of physical function and health-related quality of life."," Phys Ther 96(3): 371-381.","USA",2016,"Spinal Deformity","Exercise","SRS-HRQOL","Adults","PRO study","RCT"]
[187,"Kelly, R. E., Jr., et al. (2008). \"Surgical repair of pectus excavatum markedly improves body image and perceived ability for physical activity: multicenter study.\" Pediatrics 122(6): 1218-1222.",null,"Kelly, R. E., Jr., et al.","Surgical repair of pectus excavatum markedly improves body image and perceived ability for physical activity: multicenter study","OBJECTIVE: This study evaluated changes in both physical and psychosocial quality of life reported by the parent and child after surgical repair of pectus excavatum. METHODS: As part of a multicenter study of pectus excavatum, a previously validated tool called the Pectus Excavatum Evaluation Questionnaire was administered by the research coordinator, via telephone, to parents and patients (8-21 years of age) before and 1 year after surgery. Eleven North American children's hospitals participated. From 2001 to 2006, 264 patients and 291 parents completed the initial questionnaire, and 247 patients and 274 parents completed the postoperative questionnaire. Responses used a Likert-type scale of 1 to 4, reflecting the extent or frequency of a particular experience, with higher values conveying less-desirable experience. RESULTS: Preoperative psychosocial functioning was unrelated to objective pectus excavatum severity (computed tomographic index). Patients and their parents reported significant positive postoperative changes. Improvements occurred in both physical and psychosocial functioning, including less social self-consciousness and a more-favorable body image. For children, the body image component improved from 2.30+/-0.62 (mean+/-SD) to 1.40+/-0.42 after surgery and the physical difficulties component improved from 2.11+/-0.82 to 1.37+/-0.44. For the parent questionnaire, the child's emotional difficulties improved from 1.81+/-0.70 to 1.24+/-0.36, social self-consciousness improved from 2.86+/-1.03 to 1.33+/-0.68, and physical difficulties improved from 2.14+/-0.75 to 1.32+/-0.39. Ninety-seven percent of patients thought that surgery improved how their chest looked. CONCLUSIONS: Surgical repair of pectus excavatum can significantly improve the body image difficulties and limitations on physical activity experienced by patients. These results should prompt physicians to consider the physiologic and psychological implications of pectus excavatum just as they would any other physical deformity known to have such consequences."," Pediatrics 122(6): 1218-1222.","USA",2008,"Unspecified","Surgical","Pectus","Infants","PRO study","Clinical trial"]
[188,"Khan, K. A., et al. (2014). \"Mapping between the Roland Morris Questionnaire and generic preference-based measures.\" Value Health 17(6): 686-695.",null,"Khan, K. A., et al.","Mapping between the Roland Morris Questionnaire and generic preference-based measures","OBJECTIVES: The Roland Morris Questionnaire (RMQ) is a widely used health status measure for low back pain (LBP). It is not preference-based, and there are currently no established algorithms for mapping between the RMQ and preference-based health-related quality-of-life measures. Using data from randomized controlled trials of treatment for LBP, we sought to develop algorithms for mapping between RMQ scores and health utilities derived using either the EuroQol five-dimensional questionnaire (EQ-5D) or the six-dimensional health state short form (derived from Medical Outcomes Study 36-Item Short-Form Health Survey) (SF-6D). METHODS: This study is based on data from the Back Skills Training Trial in which data were collected from 701 patients at baseline and subsequently at 3, 6, and 12 months postrandomization using a range of outcome measures, including the RMQ, the EQ-5D, and the Short Form 12 item Health Survey (SF-12) (from which SF-6D utilities can be derived). We used baseline trial data to estimate models using both direct and response mapping approaches to predict EQ-5D and SF-6D health utilities and dimension responses. A multistage model selection process was used to assess the predictive accuracy of the models. We then explored different techniques and mapping models that made use of repeated follow-up observations in the data. The estimated mapping algorithms were validated using external data from the UK Back Pain Exercise and Manipulation trial. RESULTS: A number of models were developed that accurately predict health utilities in this context. The best performing model for RMQ to EQ-5D mapping was a beta regression with Bayesian quasi-likelihood estimation that included 24 dummy variables for RMQ responses, age, and sex as covariates (mean squared error 0.0380) based on repeated data. The model selected for RMQ to SF-6D mapping was a finite mixture model that included the overall RMQ score, age, sex, RMQ score squared, age squared, and an interaction term for age and RMQ score as covariates (mean squared error 0.0114) based on repeated data. CONCLUSIONS: It is possible to reasonably predict EQ-5D and SF-6D health utilities from RMQ scores and responses using regression methods. Our regression equations provide an empirical basis for estimating health utilities when EQ-5D or SF-6D data are not available. They can be used to inform future economic evaluations of interventions targeting LBP."," Value Health 17(6): 686-695.","UK",2014,"Back Pain","Exercise","RMDQ","Unknown","PRO study","Retrospective review"]
[189,"Kienapfel, H., et al. (2004). \"Integrated outcome assessment after anterior cervical discectomy and fusion: myelocompression but not adjacent instability affect patient-reported quality of life and cervical spine symptoms.\" Spine (Phila Pa 1976) 29(22): 2501-2509.",null,"Kienapfel, H., et al.","Integrated outcome assessment after anterior cervical discectomy and fusion: myelocompression but not adjacent instability affect patient-reported quality of life and cervical spine symptoms","STUDY DESIGN: The authors conducted a cross-sectional study. OBJECTIVE: Integrated assessment of adjacent instability (AI), myelocompression (MC), magnetic resonance imaging (MRI) signs of myelopathy (MRISM), physician-assessed clinical signs and symptoms, including clinical signs of myelopathy (CSM), patients' self-reported symptoms and quality of life after anterior cervical discectomy and fusion (ACDF). MATERIALS AND METHODS: Fifty-four patients who had ACDF between 1986 and 1995 received MRI scans, conventional and flexion/extension radiographs to assess myelocompression, MRISM, fusion, and AI. Clinical outcome was assessed using signs and symptoms based on selected items of Odom's criteria, Oswestry low back pain disability questionnaire, and the neck disability index. Patients reported their quality of life (QL) on a standardized instrument (Profiles of QL of Chronically Ill [PLC]) and by a specific validated Cervical Spine Symptom Scale (CSSS). RESULTS: Myelocompression was found more frequently than expected (24%). MRISM were seen in 2 patients (4%). One of the 2 patients developed CSM. Fusion was achieved in 94% (with kyphosis in 17%). AI was found in 30%. However, only myelocompression but not AI was associated with statistically significant decreases in most QL scores (i.e., everyday capabilities, positive mood) and high cervical spine symptom burden (all P's < 0.05). CONCLUSIONS: The study results underline the need for a better understanding of the biomechanical changes in the adjacent unfused segments. Consensus is needed on postoperative follow-up guidelines, including pain management strategies. Future studies on the outcome of ACDF will profit from an integrated outcome approach, including assessments based on imaging, physicians, and patients."," Spine (Phila Pa 1976) 29(22): 2501-2509.","Germany",2004,"Cervical Myelopathy,Back Pain","Surgical","ODI,Odom,CSSS","Unknown","Tool Validation","Observational"]
[190,"Kinel, E., et al. (2012). \"Polish validation of Brace Questionnaire.\" Eur Spine J 21(8): 1603-1608.",null,"Kinel, E., et al.","Polish validation of Brace Questionnaire","PURPOSE: The aim of the study was to undertake the process of cultural adaptation of the Brace Questionnaire (BrQ) into Polish. METHODS: The BrQ is an instrument for measuring the quality of life of scoliotic adolescents who are being treated conservatively with wearing a corrective brace. The BrQ consists of 34 Likert-scale items related to eight domains. The translation from the original Greek into Polish was performed. The process of cultural adaptation of the questionnaire was in accordance with the guidelines of the International Quality of Life Assessment Project. It involved 35 adolescents, aged between 10.0 and 16.0 years, all with adolescent idiopathic scoliosis with mean Cobb angle of 35.1 +/- 10.6 degrees, and all wearing the same kind of brace (Cheneau orthosis) for more than 3 months. Statistical analysis calculated the reliability (internal consistency), floor and ceiling effects of the BrQ. RESULTS: The internal consistency was satisfactory; Cronbach's alpha coefficient was 0.94. There was no floor or ceiling effects. CONCLUSIONS: Polish version of the BrQ is reliable and can be used in adolescents with idiopathic scoliosis wearing the brace to assess their quality of life."," Eur Spine J 21(8): 1603-1608.","Poland",2012,"Spinal Deformity","Brace","BrQ","Adolescents","Tool Validation","Observational"]
[191,"Klaber Moffett, J. A., et al. (2005). \"Randomised trial of a brief physiotherapy intervention compared with usual physiotherapy for neck pain patients: outcomes and patients' preference.\" Bmj 330(7482): 75.",null,"Klaber Moffett, J. A., et al.","Randomised trial of a brief physiotherapy intervention compared with usual physiotherapy for neck pain patients: outcomes and patients' preference","OBJECTIVES: Firstly, to compare the effectiveness of a brief physiotherapy intervention with \"usual\" physiotherapy for patients with neck pain. Secondly, to evaluate the effect of patients' preferences on outcome. DESIGN: Non-inferiority randomised controlled trial eliciting preferences independently of randomisation. SETTING: Physiotherapy departments in a community setting in Yorkshire and north Lincolnshire. PARTICIPANTS: 268 patients (mean age 48 years) with subacute and chronic neck pain, who were referred by their general practitioner and randomly assigned to a brief physiotherapy intervention (one to three sessions) using cognitive behaviour principles to encourage self management and return to normal function or usual physiotherapy, at the discretion of the physiotherapist concerned. MAIN OUTCOME MEASURES: The Northwick Park neck pain questionnaire (NPQ), a specific measure of functional disability resulting from neck pain. Also, the short form 36 (SF-36) questionnaire, a generic, health related, quality of life measure; and the Tampa scale for kinesophobia, a measure of fear and avoidance of movement. RESULTS: At 12 months, patients allocated to usual physiotherapy had a small but significant improvement in NPQ scores compared with patients in the brief intervention group (mean difference 1.99, 95% confidence interval 0.45 to 3.52; P = 0.01). Although the result shows a significant inferiority of the intervention, the confidence interval shows that the effect could be in the non-inferiority range for the brief intervention (below 1.2 points of NPQ score). Patients who preferred the brief intervention and received this treatment had similar outcomes to patients receiving usual physiotherapy. CONCLUSIONS: Usual physiotherapy may be only marginally better than a brief physiotherapy intervention for neck pain. Patients with a preference for the brief intervention may do at least as well with this approach. Additional training for the physiotherapists in cognitive behaviour techniques might improve this approach further."," Bmj 330(7482): 75.","UK",2005,"Neck Pain","Physical Therapy","Northwick","Adults","PRO study","RCT"]
[192,"Kofotolis, N., et al. (2016). \"Effects of Pilates and trunk strengthening exercises on health-related quality of life in women with chronic low back pain.\" J Back Musculoskelet Rehabil 29(4): 649-659.",null,"Kofotolis, N., et al.","Effects of Pilates and trunk strengthening exercises on health-related quality of life in women with chronic low back pain","BACKGROUND: Pilates programs are widely used as a form of regular exercise in a broad range of populations investigating their effectiveness for chronic low back pain (CLBP) treatment. OBJECTIVE: The aim of this study was to compare the effects of a Pilates program and a trunk strengthening exercise program on functional disability and health-related quality of life (HRQOL) in women with nonspecific CLBP. METHODS: A total of 101 volunteer women with CLBP provided data with a 3-month follow-up. They were randomized to either a Pilates (n= 37), trunk strengthening exercise (n= 36) or a control group (n= 28), exercising for a period of 8 weeks, three times a week. Data were collected on HRQOL using the Short-Form 36 Health Survey (SF-36v2), and functional disability using the Roland Morris Disability Questionnaire prior to program initiation, mid-intervention, immediately after program termination, and three months post-intervention. RESULTS: The Pilates participants reported greater improvements on self-reported functional disability and HRQOL compared with participants in the trunk strengthening exercise and control groups (p < 0.05). The effects were retained for a period of three months after program termination for the Pilates group and to a lesser extent for the trunk strengthening exercise group. CONCLUSIONS: An 8-week Pilates program improved HRQOL and reduced functional disability more than either a trunk strengthening exercise program or controls among women with CLBP."," J Back Musculoskelet Rehabil 29(4): 649-659.","Greece",2016,"Back Pain","Exercise","RMDQ","Unknown","PRO study","Clinical trial"]
[193,"Konstantinovic, L. M., et al. (2010). \"Acute low back pain with radiculopathy: a double-blind, randomized, placebo-controlled study.\" Photomed Laser Surg 28(4): 553-560.",null,"Konstantinovic, L. M., et al.","Acute low back pain with radiculopathy: a double-blind, randomized, placebo-controlled study","OBJECTIVE: The aim of this study was to investigate the clinical effects of low-level laser therapy (LLLT) in patients with acute low back pain (LBP) with radiculopathy. BACKGROUND DATA: Acute LBP with radiculopathy is associated with pain and disability and the important pathogenic role of inflammation. LLLT has shown significant anti-inflammatory effects in many studies. MATERIALS AND METHODS: A randomized, double-blind, placebo-controlled trial was performed on 546 patients. Group A (182 patients) was treated with nimesulide 200 mg/day and additionally with active LLLT; group B (182 patients) was treated only with nimesulide; and group C (182 patients) was treated with nimesulide and placebo LLLT. LLLT was applied behind the involved spine segment using a stationary skin-contact method. Patients were treated 5 times weekly, for a total of 15 treatments, with the following parameters: wavelength 904 nm; frequency 5000 Hz; 100-mW average diode power; power density of 20 mW/cm(2) and dose of 3 J/cm(2); treatment time 150 sec at whole doses of 12 J/cm(2). The outcomes were pain intensity measured with a visual analog scale (VAS); lumbar movement, with a modified Schober test; pain disability, with Oswestry disability score; and quality of life, with a 12-item short-form health survey questionnaire (SF-12). Subjects were evaluated before and after treatment. Statistical analyses were done with SPSS 11.5. RESULTS: Statistically significant differences were found in all outcomes measured (p < 0.001), but were larger in group A than in B (p < 0.0005) and C (p < 0.0005). The results in group C were better than in group B (p < 0.0005). CONCLUSIONS: The results of this study show better improvement in acute LBP treated with LLLT used as additional therapy."," Photomed Laser Surg 28(4): 553-560.","Serbia",2010,"Back Pain,Radiculopathy","Laser Therapy","ODI","Unknown","PRO study","RCT"]
[194,"Kopec, J. A., et al. (2008). \"Computerized adaptive testing in back pain: validation of the CAT-5D-QOL.\" Spine (Phila Pa 1976) 33(12): 1384-1390.",null,"Kopec, J. A., et al.","Computerized adaptive testing in back pain: validation of the CAT-5D-QOL","STUDY DESIGN: We have conducted an outcome instrument validation study. OBJECTIVE: Our objective was to develop a computerized adaptive test (CAT) to measure 5 domains of health-related quality of life (HRQL) and assess its feasibility, reliability, validity, and efficiency. SUMMARY OF BACKGROUND DATA: Kopec and colleagues have recently developed item response theory based item banks for 5 domains of HRQL relevant to back pain and suitable for CAT applications. The domains are Daily Activities (DAILY), Walking (WALK), Handling Objects (HAND), Pain or Discomfort (PAIN), and Feelings (FEEL). METHODS: An adaptive algorithm was implemented in a web-based questionnaire administration system. The questionnaire included CAT-5D-QOL (5 scales), Modified Oswestry Disability Index (MODI), Roland-Morris Disability Questionnaire (RMDQ), SF-36 Health Survey, and standard clinical and demographic information. Participants were outpatients treated for mechanical back pain at a referral center in Vancouver, Canada. RESULTS: A total of 215 patients completed the questionnaire and 84 completed a retest. On average, patients answered 5.2 items per CAT-5D-QOL scale. Reliability ranged from 0.83 (FEEL) to 0.92 (PAIN) and was 0.92 for the MODI, RMDQ, and Physical Component Summary (PCS-36). The ceiling effect was 0.5% for PAIN compared with 2% for MODI and 5% for RMQ. The CAT-5D-QOL scales correlated as anticipated with other measures of HRQL and discriminated well according to the level of satisfaction with current symptoms, duration of the last episode, sciatica, and disability compensation. The average relative discrimination index was 0.87 for PAIN, 0.67 for DAILY and 0.62 for WALK, compared with 0.89 for MODI, 0.80 for RMDQ, and 0.59 for PCS-36. CONCLUSION: The CAT-5D-QOL is feasible, reliable, valid, and efficient in patients with back pain. This methodology can be recommended for use in back pain research and should improve outcome assessment, facilitate comparisons across studies, and reduce patient burden."," Spine (Phila Pa 1976) 33(12): 1384-1390.","Canada",2008,"Back Pain","Not Specified","ODI,RMDQ","Unknown","Tool Validation","Observational"]
[195,"Korovessis, P., et al. (2007). \"Comparative multifactorial analysis of the effects of idiopathic adolescent scoliosis and Scheuermann kyphosis on the self-perceived health status of adolescents treated with brace.\" Eur Spine J 16(4): 537-546.",null,"Korovessis, P., et al.","Comparative multifactorial analysis of the effects of idiopathic adolescent scoliosis and Scheuermann kyphosis on the self-perceived health status of adolescents treated with brace","Bracing is the most effective non-operative treatment for mild progressive spinal deformities in adolescence but it has shown a considerable impact on several aspects of adolescents' functioning. This cross-sectional study investigated the self-perceived health status of adolescents with the two most common deformities, treated with body orthosis. Seventy-nine adolescents with spinal deformities (idiopathic adolescent scoliosis, thoracic Scheuermann kyphosis) and 62 adolescents without spinal deformities were asked to complete the Quality of Life profile for Spine Deformities Instrument. This study showed that adolescents with deformities are significantly less likely to have back pain in training than controls, but more likely to have difficulty in forward bending, and in the most common daily activities while in brace. These individuals claim they wake up because of back pain and feel quite nervous with the external appearance of their body. These patients face often problems with their relations with friends, while they reported difficulties in getting up from bed and sleep at night more often than their counterparts without deformities. As they grow older, patients feel increasing ashamed of their body, as they are more concerned about the future effect of the deformity on their body. As the bracing time increases, patients have much more probability than controls to get low back pain. Girls with deformity have a higher probability than boys to get low back pain while working in the house and while training. Individuals with larger spinal curvatures have more difficulties in bending and increased incidence of back pain than their counterparts with smaller curvatures. Psychological reasons associated mainly with relations at school and back pain are the main causes for low compliance in adolescents with spinal deformities treated with body orthosis. Careful instructions for all individuals who will undergo brace therapy, psychological support for all patients who develop psychological reactions and physical training particularly for older girls should be recommended to increase bracing compliance."," Eur Spine J 16(4): 537-546.","Greece",2007,"Back Pain,Spinal Deformity","Not Specified","QLSDP","Adolescents","PRO study","Observational"]
[196,"Kotil, K. and R. Tari (2011). \"Two level cervical corpectomy with iliac crest fusion and rigid plate fixation: a retrospective study with a three-year follow-up.\" Turk Neurosurg 21(4): 606-612.",null,"Kotil, K. and R. Tari","Two level cervical corpectomy with iliac crest fusion and rigid plate fixation: a retrospective study with a three-year follow-up","AIM: There is no clear knowlegde in the literature about two-level vertebral corpectomy using the iliac bone crest for fusion and rigid plate fixation. We present our experience with two-vertebral level cervical corpectomy and reconstruction. MATERIAL AND METHODS: Each patient was graded according to the Nuricks Grade (1972) and the modified Japanese Orthopaedic Association (mJOA) Scale (1991), and the recovery rates were calculated. All patients had two-level vertabral corpectomy. Anterior iliac crest bone graft with titanium plate fixation was applied to all patients. RESULTS: Postoperatively the mJOA score raised up to 15.5. Mean recovery rate was 69%. Average 25.2 degrees correction of kyphosis was achieved in 21 patients. Among the postoperative complications, three cases (12%) had temporary C5 nerve palsy that was resolved in three weeks, two cases had (8 %) graft malposition and infection, and three cases (%12) had temporary donor site pain. CONCLUSION: Excellent fusion rates can be achieved following two-level corpectomy with iliac bone graft repacement. This techique is easy, cost effective and safe. If the bone graft is harvested from the iliac crest by standart approach and between anatomical landmarks, most patients do not experience persistent pain at the donor site."," Turk Neurosurg 21(4): 606-612.","Turkey",2011,"Spinal Deformity","Surgical","JOACMEQ,Nurick","Unknown","PRO study","Observational"]
[197,"Kovacs, F. M., et al. (2008). \"Psychometric characteristics of the Spanish version of instruments to measure neck pain disability.\" BMC Musculoskelet Disord 9: 42.",null,"Kovacs, F. M., et al.","Psychometric characteristics of the Spanish version of instruments to measure neck pain disability","BACKGROUND: The NDI, COM and NPQ are evaluation instruments for disability due to NP. There was no Spanish version of NDI or COM for which psychometric characteristics were known. The objectives of this study were to translate and culturally adapt the Spanish version of the Neck Disability Index Questionnaire (NDI), and the Core Outcome Measure (COM), to validate its use in Spanish speaking patients with non-specific neck pain (NP), and to compare their psychometric characteristics with those of the Spanish version of the Northwick Pain Questionnaire (NPQ). METHODS: Translation/re-translation of the English versions of the NDI and the COM was done blindly and independently by a multidisciplinary team. The study was done in 9 primary care Centers and 12 specialty services from 9 regions in Spain, with 221 acute, subacute and chronic patients who visited their physician for NP: 54 in the pilot phase and 167 in the validation phase. Neck pain (VAS), referred pain (VAS), disability (NDI, COM and NPQ), catastrophizing (CSQ) and quality of life (SF-12) were measured on their first visit and 14 days later. Patients' self-assessment was used as the external criterion for pain and disability. In the pilot phase, patients' understanding of each item in the NDI and COM was assessed, and on day 1 test-retest reliability was estimated by giving a second NDI and COM in which the name of the questionnaires and the order of the items had been changed. RESULTS: Comprehensibility of NDI and COM were good. Minutes needed to fill out the questionnaires [median, (P25, P75)]: NDI. 4 (2.2, 10.0), COM: 2.1 (1.0, 4.9). Reliability: [ICC, (95%CI)]: NDI: 0.88 (0.80, 0.93). COM: 0.85 (0.75,0.91). Sensitivity to change: Effect size for patients having worsened, not changed and improved between days 1 and 15, according to the external criterion for disability: NDI: -0.24, 0.15, 0.66; NPQ: -0.14, 0.06, 0.67; COM: 0.05, 0.19, 0.92. VALIDITY: Results of NDI, NPQ and COM were consistent with the external criterion for disability, whereas only those from NDI were consistent with the one for pain. Correlations with VAS, CSQ and SF-12 were similar for NDI and NPQ (absolute values between 0.36 and 0.50 on day 1, between 0.38 and 0.70 on day 15), and slightly lower for COM (between 0.36 and 0.48 on day 1, and between 0.33 and 0.61 on day 15). Correlation between NDI and NPQ: r = 0.84 on day 1, r = 0.91 on day 15. Correlation between COM and NPQ: r = 0.63 on day 1, r = 0.71 on day 15. CONCLUSION: Although most psychometric characteristics of NDI, NPQ and COM are similar, those from the latter one are worse and its use may lead to patients' evolution seeming more positive than it actually is. NDI seems to be the best instrument for measuring NP-related disability, since its results are the most consistent with patient's assessment of their own clinical status and evolution. It takes two more minutes to answer the NDI than to answer the COM, but it can be reliably filled out by the patient without assistance. TRIAL REGISTRATION: Clinical Trials Register NCT00349544."," BMC Musculoskelet Disord 9: 42.","Spain",2008,"Neck Pain","Not Specified","NDI,Northwick","Unknown","Tool Validation","Prospective Observation"]
[198,"Kovacs, F., et al. (2007). \"Fear avoidance beliefs do not influence disability and quality of life in Spanish elderly subjects with low back pain.\" Spine (Phila Pa 1976) 32(19): 2133-2138.",null,"Kovacs, F., et al.","Fear avoidance beliefs do not influence disability and quality of life in Spanish elderly subjects with low back pain","STUDY DESIGN: Correlation between previously validated questionnaires. OBJECTIVE: To assess the association of fear avoidance beliefs (FAB) with disability and quality of life in elderly Spanish subjects. SUMMARY OF BACKGROUND DATA: As opposed to Anglo-Saxon and Northern European patients, in Spanish low back pain (LBP) patients of working age, the influence of FAB on disability and quality of life is sparse and much less than that of pain. The influence of FAB on LBP-related disability and quality of life in the elderly is unknown. METHODS: A visual analogue scale (VAS), the Roland Morris Questionnaire (RMQ), the FAB-Phys questionnaire (FABQ), and the SF-12 questionnaire were used to assess LBP, disability, fear avoidance beliefs, and quality of life in 661 institutionalized elderly in Spain, 439 of whom had LBP. RESULTS: In all subjects, FAB correlated with LBP (r = 0.477), disability (r = 0.458), the Physical Component Summary of SF-12 (PCS SF-12) (r = -0.389), and the Mental Component Summary of SF-12 (MCS SF-12) (r = -0.165). In subjects with LBP, FABs only correlated weakly with disability (r = -0.110). The stronger correlations were found between LBP and disability, both in all subjects (r = 0.803) and LBP patients (r = 0.445). Regression models including all the participants showed that the influence of FABs on physical quality of life was sparse and that FABs were not associated with either disability or mental quality of life. In elderly subjects with LBP, FABs were not associated with either disability or quality of life. CONCLUSION: In Spanish institutionalized elderly subjects, FABs only have a minor influence on physical quality of life, and none on disability or mental quality of life. In elderly subjects with LBP, differences in FABs are not associated with differences in disability or quality of life. Further studies should explore the potential value of FABs in the elderly in other settings."," Spine (Phila Pa 1976) 32(19): 2133-2138.","Spain",2007,"Back Pain","Not Specified","RMDQ","Elderly","PRO study","Observational"]
[199,"Krein, S. L., et al. (2013). \"Pedometer-based internet-mediated intervention for adults with chronic low back pain: randomized controlled trial.\" J Med Internet Res 15(8): e181.",null,"Krein, S. L., et al.","Pedometer-based internet-mediated intervention for adults with chronic low back pain: randomized controlled trial","BACKGROUND: Chronic pain, especially back pain, is a prevalent condition that is associated with disability, poor health status, anxiety and depression, decreased quality of life, and increased health services use and costs. Current evidence suggests that exercise is an effective strategy for managing chronic pain. However, there are few clinical programs that use generally available tools and a relatively low-cost approach to help patients with chronic back pain initiate and maintain an exercise program. OBJECTIVE: The objective of the study was to determine whether a pedometer-based, Internet-mediated intervention can reduce chronic back pain-related disability. METHODS: A parallel group randomized controlled trial was conducted with 1:1 allocation to the intervention or usual care group. 229 veterans with nonspecific chronic back pain were recruited from one Department of Veterans Affairs (VA) health care system. Participants randomized to the intervention received an uploading pedometer and had access to a website that provided automated walking goals, feedback, motivational messages, and social support through an e-community (n=111). Usual care participants (n=118) also received the uploading pedometer but did not receive the automated feedback or have access to the website. The primary outcome was measured using the Roland Morris Disability Questionnaire (RDQ) at 6 months (secondary) and 12 months (primary) with a difference in mean scores of at least 2 considered clinically meaningful. Both a complete case and all case analysis, using linear mixed effects models, were conducted to assess differences between study groups at both time points. RESULTS: Baseline mean RDQ scores were greater than 9 in both groups. Primary outcome data were provided by approximately 90% of intervention and usual care participants at both 6 and 12 months. At 6 months, average RDQ scores were 7.2 for intervention participants compared to 9.2 for usual care, an adjusted difference of 1.6 (95% CI 0.3-2.8, P=.02) for the complete case analysis and 1.2 (95% CI -0.09 to 2.5, P=.07) for the all case analysis. A post hoc analysis of patients with baseline RDQ scores >/=4 revealed even larger adjusted differences between groups at 6 months but at 12 months the differences were no longer statistically significant. CONCLUSIONS: Intervention participants, compared with those receiving usual care, reported a greater decrease in back pain-related disability in the 6 months following study enrollment. Between-group differences were especially prominent for patients reporting greater baseline levels of disability but did not persist over 12 months. Primarily, automated interventions may be an efficient way to assist patients with managing chronic back pain; additional support may be needed to ensure continuing improvements. TRIAL REGISTRATION: ClinicalTrials.gov NCT00694018; http://clinicaltrials.gov/ct2/show/NCT00694018 (Archived by WebCite at http://www.webcitation.org/6IsG4Y90E)."," J Med Internet Res 15(8): e181.","USA",2013,"Back Pain","Exercise","RMDQ","Unknown","PRO study","RCT"]
[200,"Krousel-Wood, M. A., et al. (1994). \"Predicting work status for patients in an occupational medicine setting who report back pain.\" Arch Fam Med 3(4): 349-355.",null,"Krousel-Wood, M. A., et al.","Predicting work status for patients in an occupational medicine setting who report back pain","OBJECTIVE: To determine the ability of patient-reported health status information to predict physician-determined fit-for-work status for patients reporting complaints of low back pain. DESIGN: Cross-sectional study using survey methods. SETTING: Occupational medicine section of a large multispecialty private clinic. PATIENTS: Four hundred sixty-two questionnaire packets were distributed to patients who were seen for work-related conditions or disorders over a 13-week period; 235 questionnaires were returned (51% response rate). One hundred seven responders reported low back pain and completed the Low Back Pain TyPE (Technology of Patient Experience) Tool. The mean (+/- SD) age of respondents was 39 (+/- 12) years; 67% of respondents were male, 70% were white, 87% were receiving worker's compensation, 58% were married, and 55% had a high school education or less. INTERVENTIONS: Questionnaire packets for self-administration containing health/functional status questions (short form [SF]-36, COOP Charts) and the Low Back Pain TyPE Tool were distributed to the patients. Other variables were abstracted from the medical records and administrative databases. MAIN OUTCOME MEASURES: The primary study outcome measured was fitness for work; patients were examined and categorized as fit or not fit for work by physicians who were unaware of the questionnaire results. RESULTS: Logistic regression analysis consisted of variables from 107 patients who reported low back pain. The final model contained the physical functioning scale (SF-36), employment status, smoking status, and physical functioning (SF-36) by gender interaction. Seventy-seven percent of the fit-for-work cases and 90% of the not-fit-for-work cases were correctly classified. CONCLUSION: Patient-reported physical function (as modified by gender), smoking status, and employment status predicted physician-determined work status for patients reporting low back pain in this study. Larger studies will be required to confirm this finding."," Arch Fam Med 3(4): 349-355.","USA",1994,"Back Pain","Not Specified","TyPE","Adults","PRO study","Observational"]
[201,"Kumar, K., et al. (2005). \"Vertebroplasty in osteoporotic spine fractures: a quality of life assessment.\" Can J Neurol Sci 32(4): 487-495.",null,"Kumar, K., et al.","Vertebroplasty in osteoporotic spine fractures: a quality of life assessment","OBJECTIVE: Our goal was to perform a quantitative evaluation of the improvement in functional capacity, quality of life, mental function, reduction in drug intake and impact on hospital admissions after vertebroplasty in the treatment of osteoporotic compression fractures. The efficacy of vertebroplasty in relief of pain has been addressed in previous publications but the quantitative evaluation of improvement in quality of life has not been addressed before. METHODS: This is a prospective study of 42 patients with 83 symptomatic vertebral fractures treated by vertebroplasty with a mean follow-up of 9.1 months. The outcome was measured by pre and postoperatively utilizing the Visual Analogue Scale, the Oswestry Disability Index, the Rolland Morris Scale for Back Pain and EuroQol-5D questionnaire (EQ-5D). The postoperative evaluations were performed at one week, one month, three month, and six month intervals thereafter. RESULTS: In 34 out of 39 active patients, marked pain relief was noted (87%). The Visual Analogue Scale score improved from a mean preoperative score of 8.2 to a mean postoperative score of 2.9 (p=0.0000003) at one week follow up and 3.9 at the last follow-up. The Rolland Morris Scale for Back Pain showed a drop from a mean preoperative rating of 13 to a mean postoperative rating of 10, showing a 25% improvement (p= 0.0207). The Oswestry Disability Index preoperatively was 64.4 which improved to 43.8 postoperatively, showing a 32% improvement (p= 0.0207). The EQ-5D showed a mean preoperative index value of 0.097 and mean postoperative index value of 0.592 (p = 0.0000003). All p-values were determined by the Willcoxin sign-ranked test. CONCLUSION: Vertebroplasty is a safe and efficacious procedure with a resulting improvement in pain and quality of life."," Can J Neurol Sci 32(4): 487-495.","Canada",2005,"Spinal Fracture","Surgical","ODI,RMDQ","Unknown","PRO study","Prospective Observation"]
[202,"Kumar, S., et al. (2017). \"Effectiveness of Ayurvedic Massage (Sahacharadi Taila) in Patients with Chronic Low Back Pain: A Randomized Controlled Trial.\" J Altern Complement Med 23(2): 109-115.",null,"Kumar, S., et al.","Effectiveness of Ayurvedic Massage (Sahacharadi Taila) in Patients with Chronic Low Back Pain: A Randomized Controlled Trial","OBJECTIVES: Ayurveda is one of the oldest comprehensive healthcare systems worldwide. Ayurvedic massage and physical therapy are frequently used to treat patients with chronic pain syndromes and disorders of the musculoskeletal system. This study aimed to evaluate the effectiveness of Ayurvedic massage in nonspecific chronic low back pain by means of a randomized clinical trial. DESIGN: Sixty-four patients (mean age, 54.8 years; 49 women and 15 men) with chronic low back pain who scored >40 mm on a 100-mm visual analogue scale (VAS) were randomly assigned to a 2-week massage group with 6 hours of Ayurvedic massage and external treatment (n = 32) or to a 2-week local thermal therapy group (n = 32). The study observation period was 4 weeks, consisting of a 2-week intervention phase followed by a 2-week follow-up phase. OUTCOME MEASURES: Primary outcome measure was the change of mean pain (VAS) from baseline to week 4. Secondary outcomes included pain-related bothersomeness, the Roland Disability Questionnaire, quality of life (Medical Outcomes Study 36-Item Short Form), the Hanover Functional Ability Questionnaire for measuring back pain-related disability, and psychological outcomes. Outcomes were assessed at baseline and after 2 and 4 weeks. RESULTS: Mean back pain (primary outcome) at week 2 was significantly reduced from 53.4 +/- 18.5 to 21.6 +/- 18.2 in the massage group and from 55.3 +/- 12.9 to 41.8 +/- 19.8 in the standard thermal therapy group (mean group difference, -18.7; 95% confidence interval, -28.7 to -8.7; p < 0.001). While beneficial effects on pain-related bothersomeness and psychological well-being were also apparent, the Ayurvedic intervention did not improve function or disability in the short-term observation period. Both programs were safe and well tolerated. CONCLUSIONS: Ayurvedic external treatment is effective for pain-relief in chronic low back pain in the short term. Further studies with longer observation periods are needed to evaluate the long-term effects of the Ayurvedic external treatment approach on function and disability."," J Altern Complement Med 23(2): 109-115.","Germany",2017,"Back Pain","Massage,Physical Therapy","RMDQ,Bothersomeness","Adults","PRO study","RCT"]
[203,"Kyrola, K., et al. (2017). \"Reliability and Validity Study of the Finnish Adaptation of Scoliosis Research Society Questionnaire Version SRS-30.\" Spine (Phila Pa 1976) 42(12): 943-949.",null,"Kyrola, K., et al.","Reliability and Validity Study of the Finnish Adaptation of Scoliosis Research Society Questionnaire Version SRS-30","STUDY DESIGN: A prospective clinical study to test and adapt a Finnish version of the Scoliosis Research Society 30 (SRS-30) questionnaire. OBJECTIVE: The aim of this study was to perform cross-cultural adaptation and evaluate the validity of the adapted Finnish version of the SRS-30 questionnaire. SUMMARY OF BACKGROUND DATA: The SRS-30 questionnaire has proved to be a valid instrument in evaluating health-related quality of life (HRQoL) in adolescent and adult population with spine deformities in the United States. Multinational availability requires cross-cultural and linguistic adaptation and validation of the instrument. METHODS: The SRS-30 was translated into Finnish using accepted methods for translation of quality-of-life questionnaires. A total of 274 adult patients with degenerative radiographic sagittal spinal disorder answered the questionnaire with sociodemographic data, RAND 36-item health survey questionnaire (RAND Corp. Health, Santa Monica, CA, US), Oswestry disability index, DEPS depression scale, and Visual Analog Scale (VAS) back and leg pain scales within 2 weeks' interval. The cohort included patients with and without previous spine surgery. Internal consistency and validity were tested with Cronbach alpha, intraclass correlation (ICC), standard error of measurement, and Spearman correlation coefficient with 95% confidence intervals (CIs). RESULTS: The internal consistency of SRS-30 was good in both surgery and nonsurgery groups, with Cronbach alpha 0.853 (95% CI, 0.670 to 0.960) and 0.885 (95% CI, 0.854 to 0.911), respectively. The test-retest reproducibility ICC of the SRS-30 total and subscore domains of patients with stable symptoms was 0.905 (95% CI, 0.870-0.930) and 0.904 (95% CI, 0.871-0.929), respectively. The questionnaire had discriminative validity in the pain, self-image, and satisfaction with management domains compared with other questionnaires. CONCLUSION: The SRS-30 questionnaire proved to be valid and applicable in evaluating HRQoL in Finnish adult spinal deformity patients. It has two domains related to deformity that are not covered by other generally used questionnaires. LEVEL OF EVIDENCE: 3."," Spine (Phila Pa 1976) 42(12): 943-949.","Finland",2017,"Spinal Deformity","Surgical","SRS-HRQOL,ODI","Adolescents","Tool Validation","Prospective Observation"]
[204,"Lafage, V., et al. (2009). \"Pelvic tilt and truncal inclination: two key radiographic parameters in the setting of adults with spinal deformity.\" Spine (Phila Pa 1976) 34(17): E599-606.",null,"Lafage, V., et al.","Pelvic tilt and truncal inclination: two key radiographic parameters in the setting of adults with spinal deformity","STUDY DESIGN: Prospective radiographic and clinical analysis. OBJECTIVE: Investigate the relationship between spino-pelvic parameters and patient self reported outcomes on adult subjects with spinal deformities. SUMMARY OF BACKGROUND DATA: It is becoming increasingly recognized that the study of spinal alignment should include pelvic position. While pelvic incidence determines lumbar lordosis, pelvic tilt (PT) is a positional parameter reflecting compensation to spinal deformity. Correlation between plumbline offset (sagittal vertical axis [SVA]) and Health Related Quality of Life (HRQOL) measures has been demonstrated, but such a study is lacking for PT. METHODS: This prospective study was carried out on 125 adult patients suffering from spinal deformity (mean age: 57 years). Full-length free-standing radiographs including the spine and pelvis were available for all patients. HRQOL instruments included: Oswestry Disability Index, Short Form-12, Scoliosis Research Society. Correlation analysis between radiographic spinopelvic parameters and HRQOL measures was pursued. RESULTS: Correlation analysis revealed no significance pertaining to coronal plane parameters. Significant sagittal plane correlations were identified. SVA and truncal inclination measured by T1 spinopelvic inclination (T1-SPI) (angle between T1-hip axis and vertical) correlated with: Scoliosis Research Society (appearance, activity, total score), Oswestry Disability Index, and Short Form-12 (physical component score). Correlation coefficients ranged from 0.42 < r < 0.55 (P < 0.0001). T1-SPI revealed greater correlation with HRQOL compared to SVA. PT showed correlation with HRQOL (0.28 < r < 0.42) and with SVA (r = 0.64, P < 0.0001). CONCLUSION: This study confirms that pelvic position measured via PT correlates with HRQOL in the setting of adult deformity. High values of PT express compensatory pelvic retroversion for sagittal spinal malalignment. This study also demonstrates significant T1-SPI correlation with HRQOL measures and outperforms SVA. This parameter carries the advantage of being an angular measurement which avoids the error inherent in measuring offsets in noncalibrated radiographs."," Spine (Phila Pa 1976) 34(17): E599-606.","USA",2009,"Spinal Deformity","Not Specified","ODI,SRS-HRQOL","Adults","PRO study","Prospective Observation"]
[205,"Lai, S. M., et al. (2006). \"Estimating SRS-22 quality of life measures with SF-36: application in idiopathic scoliosis.\" Spine (Phila Pa 1976) 31(4): 473-478.",null,"Lai, S. M., et al.","Estimating SRS-22 quality of life measures with SF-36: application in idiopathic scoliosis","STUDY DESIGN: Comparison of a generic- with a disorder-specific health-related quality of life (HRQL) questionnaire. OBJECTIVES: To determine the association between generic- and disorder-specific questionnaire domains of similar construct. SUMMARY OF BACKGROUND DATA: Short Form-36 (SF-36), a general HRQL questionnaire, has been widely used to evaluate patients with scoliosis and related spine deformity. How it relates to the disorder-specific Scoliosis Research Society-22 (SRS-22) questionnaire is currently unknown. METHODS: Seventy-eight patients, operated at a mean age 14.5 years for idiopathic scoliosis with a mean largest Cobb of 60 degrees , completed both questionnaires at a mean of 9.25 years after surgery. RESULTS: The predictability of the SRS-22 Mental Health domain is excellent using the SF-36 Mental Health domain, from which it was adapted (R2 = 0.81). The SRS-22 Pain domain predictability using the SF-36 Bodily Pain domain is also excellent (R2 = 0.79). The SRS-22 Function domain predictability using the SF-36 Physical Component Summary domain is good (R2 = 0.64). The SRS-22 Self-Image and Management Satisfaction/Dissatisfaction domains are poorly predicted by the SF-36 General Health and Physical Component Summary domains, respectively, R2 = 0.52 and 0.54. CONCLUSION: SRS-22 Mental Health and Pain domain scores can be accurately calculated from correlating SF-36 domain scores. SRS-22 Function scores can be fairly well predicted from correlated SF-36 domain scores. Self-Image and Management Satisfaction/Dissatisfaction domain scores cannot be approximated from SF-36 domain scores."," Spine (Phila Pa 1976) 31(4): 473-478.","USA",2006,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Prospective Observation"]
[206,"Lai, S. M., et al. (2010). \"Identification of Scoliosis Research Society-22r Health-Related Quality of Life questionnaire domains using factor analysis methodology.\" Spine (Phila Pa 1976) 35(12): 1236-1240.",null,"Lai, S. M., et al.","Identification of Scoliosis Research Society-22r Health-Related Quality of Life questionnaire domains using factor analysis methodology","STUDY DESIGN: Cross-sectional mail questionnaire. OBJECTIVE: Examination of the underlying construct validity of the Scoliosis Research Society-22r (SRS-22r) Health-Related Quality of Life (HRQoL) Questionnaire using factor analysis. SUMMARY OF BACKGROUND DATA: The original SRS-24 HRQoL questionnaire has undergone a series of modifications in an effort to further improve its psychometric properties and validate its use in patients from 10 years of age until well into adulthood. The SRS-22r questionnaire is the result of this effort. To date, the underlying construct validity of the original English version has not been analyzed by factor analysis. METHODS: A questionnaire including all questions on the SRS-24, -23, -22, and -22r questionnaires (49 total questions) was mailed to a consecutive series of 235 patients who had received primary posterior or anterior instrumentation and arthrodesis. Domain structure of the SRS-22r questions was analyzed using iterated principal factor analysis with orthogonal rotation. RESULTS: One hundred twenty-one (51%) of the patients, age 23.34 +/- 4.52 years (range, 14.16-34.57 years), returned the questionnaire at 8.63 +/- 4.00 years (range, 2.32-15.94 years) following surgery. Factor analysis using all 22 questions resulted in 3 factors with many shared items because of significant collinearity of the satisfaction/dissatisfaction with management questions with the others. After 18 iterations, factor analysis using the 20 nonmanagement questions revealed 4 factors that explained 98% of the variance. These factors parallel the assigned domains of the SRS-22r questionnaire. Three questions (2 self-image and 1 function) were identified that had high loading in 2 factors. However, internal consistency was best when 2 of the questions (1 self-image and 1 function) were retained in their assigned SRS-22r domains and the third decreased self-image internal consistency by only 0.01%. The internal consistencies (Cronbach alpha) of the assigned SRS-22r nonmanagement domains were excellent or very good: function 0.83, pain 0.87, self-image 0.80, and mental health 0.90. For the management domain it was good: 0.73. CONCLUSION: Factor analysis of the SRS-22r HRQoL confirms placement of the 20 nonmanagement domain questions in the assigned 4 domains, all with excellent or very good internal consistency."," Spine (Phila Pa 1976) 35(12): 1236-1240.","USA",2010,"Spinal Deformity","Surgical","SRS-HRQOL","Adults","Tool Validation","Observational"]
[207,"Lake, W. B., et al. (2013). \"Comparative effectiveness research in spine surgery.\" J Comp Eff Res 2(1999): 45-51.",null,"Lake, W. B., et al.","Comparative effectiveness research in spine surgery","Degenerative spine disorders are a significant cause of patient morbidity and are a prominent factor in healthcare costs in many countries. Pressure for healthcare cost control and the desire for improved outcomes have led to an expanding emphasis on evidence-based medicine methodologies in spine research. Determination of the optimal treatment paradigm for many common degenerative spinal disorders has proven difficult and comparative effectiveness research is increasingly being employed to examine these clinical dilemmas. The Swedish Spine Registry and the Registry of the Scoliosis Research Society are two of the long-standing databases compiling data for spine patients. Spine surgery professional organizations have recently taken a prominent role in assembling procedural- and diagnosis-based registries, specifically addressing therapeutic outcomes for spine patients. As healthcare systems continue to evolve, comparative effectiveness research driven by spine registries may better elucidate the appropriate clinical choices for patients with these challenging illnesses."," J Comp Eff Res 2(1999): 45-51.","USA",2013,"Spinal Deformity","Surgical","SRS-HRQOL","Unknown","PRO study","Narrative review"]
[208,"Lam, M. W., et al. (2008). \"Quality-of-life outcomes after surgical correction of pectus excavatum: a comparison of the Ravitch and Nuss procedures.\" J Pediatr Surg 43(5): 819-825.",null,"Lam, M. W., et al.","Quality-of-life outcomes after surgical correction of pectus excavatum: a comparison of the Ravitch and Nuss procedures","PURPOSE: The purpose of this study was to compare clinical and health-related quality-of-life (HRQL) outcomes within a group of patients treated for pectus excavatum (PE). METHODS: A retrospective 3-year review of patients undergoing Nuss or Ravitch correction of PE was performed. Health-related quality-of-life assessment was performed using the Child Health Questionnaire (CHQ-CF87) and the 17-item Pectus Excavatum Evaluation Questionnaire, and results were compared between groups and with age-matched CHQ-CF87 normative data. RESULTS: Forty-three patients (39 males; 91%) underwent surgery; 19 (44%) by Nuss procedure. Duration of postoperative opioid analgesia and length of hospital stay (LOS) were significantly longer in Nuss patients. The overall survey response rate was 53%. The groups differed significantly in the CHQ on one item (Change in Health). On the Pectus Excavatum Evaluation Questionnaire, Nuss patients reported being \"less bothered\" by the appearance of their chest. Compared to Australian age-matched norms, the aggregate PE sample showed better scores for family activity domain and worse scores in mental health, general health perceptions, change in health, bodily pain, and self-esteem. CONCLUSIONS: Patients undergoing surgery for PE by either Nuss or Ravitch procedure have similar clinical and HRQL outcomes, but as a group have poorer HRQL scores than age-matched population norms."," J Pediatr Surg 43(5): 819-825.","Canada",2008,"Pectus Excavatum","Surgical","Pectus","Unknown","PRO study","Retrospective review"]
[209,"Lamb, S. E., et al. (2007). \"Managing Injuries of the Neck Trial (MINT): design of a randomised controlled trial of treatments for whiplash associated disorders.\" BMC Musculoskelet Disord 8: 7.",null,"Lamb, S. E., et al.","Managing Injuries of the Neck Trial (MINT): design of a randomised controlled trial of treatments for whiplash associated disorders","BACKGROUND: A substantial proportion of patients with whiplash injuries develop chronic symptoms. However, the best treatment of acute injuries to prevent long-term problems is uncertain. A stepped care treatment pathway has been proposed, in which patients are given advice and education at their initial visit to the emergency department (ED), followed by review at three weeks and physiotherapy for those with persisting symptoms. MINT is a two-stage randomised controlled trial to evaluate two components of such a pathway: 1. use of The Whiplash Book versus usual advice when patients first attend the emergency department; 2. referral to physiotherapy versus reinforcement of advice for patients with continuing symptoms at three weeks. METHODS: Evaluation of the Whiplash Book versus usual advice uses a cluster randomised design in emergency departments of eight NHS Trusts. Eligible patients are identified by clinicians in participating emergency departments and are sent a study questionnaire within a week of their ED attendance. Three thousand participants will be included. Patients with persisting symptoms three weeks after their ED attendance are eligible to join an individually randomised study of physiotherapy versus reinforcement of the advice given in ED. Six hundred participants will be randomised. Follow-up is at 4, 8 and 12 months after their ED attendance. Primary outcome is the Neck Disability Index (NDI), and secondary outcomes include quality of life and time to return to work and normal activities. An economic evaluation is being carried out. CONCLUSION: This paper describes the protocol and operational aspects of a complex intervention trial based in NHS emergency and physiotherapy departments, evaluating two components of a stepped-care approach to the treatment of whiplash injuries. The trial uses two randomisations, with the first stage being cluster randomised and the second individually randomised."," BMC Musculoskelet Disord 8: 7.","UK",2007,"Trauma","Physical Therapy","NDI","Unknown","PRO study","Clinical trial"]
[210,"Lamb, S. E., et al. (2010). \"A multicentred randomised controlled trial of a primary care-based cognitive behavioural programme for low back pain. The Back Skills Training (BeST) trial.\" Health Technol Assess 14(41): 1-253, iii-iv.",null,"Lamb, S. E., et al.","A multicentred randomised controlled trial of a primary care-based cognitive behavioural programme for low back pain. The Back Skills Training (BeST) trial","OBJECTIVES: To estimate the clinical effectiveness of active management (AM) in general practice versus AM plus a group-based, professionally led cognitive behavioural approach (CBA) for subacute and chronic low back pain (LBP) and to measure the cost of each strategy over a period of 12 months and estimate cost-effectiveness. DESIGN: Pragmatic multicentred randomised controlled trial with investigator-blinded assessment of outcomes. SETTING: Fifty-six general practices from seven English regions. PARTICIPANTS: People with subacute and chronic LBP who were experiencing symptoms that were at least moderately troublesome. INTERVENTIONS: Participants were randomised (in a ratio of 2:1) to receive either AM+CBA or AM alone. MAIN OUTCOME MEASURES: Primary outcomes were the Roland Morris Disability Questionnaire (RMQ) and the Modified Von Korff Scale (MVK), which measure LBP and disability. Secondary outcomes included mental and physical health-related quality of life (Short Form 12-item health survey), health status, fear avoidance beliefs and pain self-efficacy. Cost-utility of CBA was considered from both the UK NHS perspective and a broader health-care perspective, including both NHS costs and costs of privately purchased goods and services related to LBP. Quality-adjusted life-years (QALYs) were calculated from the five-item EuroQoL. RESULTS: Between April 2005 and April 2007, 701 participants were randomised: 233 to AM and 468 to AM+CBA. Of these, 420 were female. The mean age of participants was 54 years and mean baseline RMQ was 8.7. Outcome data were obtained for 85% of participants at 12 months. Benefits were seen across a range of outcome measures in favour of CBA with no evidence of group or therapist effects. CBA resulted in at least twice as much improvement as AM. Mean additional improvement in the CBA arm was 1.1 [95% confidence interval (CI) 0.4 to 1.7], 1.4 (95% CI 0.7 to 2.1) and 1.3 (95% CI 0.6 to 2.1) change points in the RMQ at 3, 6 and 12 months respectively. Additional improvement in MVK pain was 6.8 (95% CI 3.5 to 10.2), 8.0 (95% CI 4.3 to 11.7) and 7.0 (95% CI 3.2 to 10.7) points, and in MVK disability was 4.3 (95% CI 0.4 to 8.2), 8.1 (95% CI 4.1 to 12.0) and 8.4 (95% CI 4.4 to 12.4) points at 3, 6 and 12 months respectively. At 12 months, 60% of the AM+CBA arm and 31% of the AM arm reported some or complete recovery. Mean cost of attending a CBA course was 187 pounds per participant with an additional benefit in QALYs of 0.099 and an additional cost of 178.06 pounds. Incremental cost-effectiveness ratio was 1786.00 pounds. Probability of CBA being cost-effective reached 90% at about 3000 pounds and remained at that level or above; at a cost-effectiveness threshold of 20,000 pounds the CBA group had an almost 100% probability of being considered cost-effective. User perspectives on the acceptability of group treatments were sought through semi-structured interviews. Most were familiar with key messages of AM; most who had attended any group sessions had retained key messages from the sessions and two-thirds talked about a reduction in fear avoidance and changes in their behaviour. Group sessions appeared to provide reassurance, lessen isolation and enable participants to learn strategies from each other. CONCLUSIONS: Long-term effectiveness and cost-effectiveness of CBA in treating subacute and chronic LBP was shown, making this intervention attractive to patients, clinicians and purchasers. Short-term (3-month) clinical effects were similar to those found in high-quality studies of other therapies and benefits were maintained and increased over the long term (12 months). Cost per QALY was about half that of competing interventions for LBP and because the intervention can be delivered by existing NHS staff following brief training, the back skills training programme could be implemented within the NHS with relative ease. TRIAL REGISTRATION: Current Controlled Trials ISRCTN37807450. FUNDING: The National Institute for Health Research Health Technology Assessment programme."," Health Technol Assess 14(41): 1-253, iii-iv.","UK",2010,"Back Pain","CBT","RMDQ","Adults","Cost-Effectiveness","RCT"]
[211,"Lamb, S. E., et al. (2010). \"Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis.\" Lancet 375(9718): 916-923.",null,"Lamb, S. E., et al.","Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis","BACKGROUND: Low-back pain is a common and costly problem. We estimated the effectiveness of a group cognitive behavioural intervention in addition to best practice advice in people with low-back pain in primary care. METHODS: In this pragmatic, multicentre, randomised controlled trial with parallel cost-effectiveness analysis undertaken in England, 701 adults with troublesome subacute or chronic low-back pain were recruited from 56 general practices and received an active management advisory consultation. Participants were randomly assigned by computer-generated block randomisation to receive an additional assessment and up to six sessions of a group cognitive behavioural intervention (n=468) or no further intervention (control; n=233). Primary outcomes were the change from baseline in Roland Morris disability questionnaire and modified Von Korff scores at 12 months. Assessment of outcomes was blinded and followed the intention-to-treat principle, including all randomised participants who provided follow-up data. This study is registered, number ISRCTN54717854. FINDINGS: 399 (85%) participants in the cognitive behavioural intervention group and 199 (85%) participants in the control group were included in the primary analysis at 12 months. The most frequent reason for participant withdrawal was unwillingness to complete questionnaires. At 12 months, mean change from baseline in the Roland Morris questionnaire score was 1.1 points (95% CI 0.39-1.72) in the control group and 2.4 points (1.89-2.84) in the cognitive behavioural intervention group (difference between groups 1.3 points, 0.56-2.06; p=0.0008). The modified Von Korff disability score changed by 5.4% (1.99-8.90) and 13.8% (11.39-16.28), respectively (difference between groups 8.4%, 4.47-12.32; p<0.0001). The modified Von Korff pain score changed by 6.4% (3.14-9.66) and 13.4% (10.77-15.96), respectively (difference between groups 7.0%, 3.12-10.81; p<0.0001). The additional quality-adjusted life-year (QALY) gained from cognitive behavioural intervention was 0.099; the incremental cost per QALY was 1786 pound sterling, and the probability of cost-effectiveness was greater than 90% at a threshold of 3000 pound sterling per QALY. There were no serious adverse events attributable to either treatment. INTERPRETATION: Over 1 year, the cognitive behavioural intervention had a sustained effect on troublesome subacute and chronic low-back pain at a low cost to the health-care provider. FUNDING: National Institute for Health Research Health Technology Assessment Programme."," Lancet 375(9718): 916-923.","UK",2010,"Back Pain","CBT","RMDQ","Adults","Cost-Effectiveness","RCT"]
[212,"Lamb, S. E., et al. (2012). \"Group cognitive behavioural interventions for low back pain in primary care: extended follow-up of the Back Skills Training Trial (ISRCTN54717854).\" Pain 153(2): 494-501.",null,"Lamb, S. E., et al.","Group cognitive behavioural interventions for low back pain in primary care: extended follow-up of the Back Skills Training Trial (ISRCTN54717854)","Group cognitive behavioural intervention (CBI) is effective in reducing low back pain and disability over a 12-month period, in comparison to best practice advice in primary care. The aim was to study the effects of this CBI beyond 12 months. We undertook an extended follow-up of our original randomised, controlled trial of a group CBI and best practice advice in primary care, in comparison to best practice advice alone. Participants were mailed a questionnaire including measures of disability, pain, health services resource use, and health-related quality of life. The time of extended follow-up ranged between 20 and 50 months (mean 34 months). Fifty-six percent (395 of 701) of the original cohort provided extended follow-up. Those who responded were older and had less disability and pain at baseline than did the original trial cohort. After 12 months, the improvements in pain and disability observed with CBI were sustained. For disability measures, the treatment difference in favour of CBI persisted (mean difference 1.3 Roland and Morris Disability Questionnaire points, 95% confidence interval 0.27 to 2.26; 5.5 Modified von Korff Scale disability points, 95% confidence interval 0.27 to 10.64). There was no between-group difference in Modified von Korff Scale pain outcomes. The results suggest that the effects of a group CBI are maintained up to an average of 34 months. Although pain improves in response to best practice advice, longer-term recovery of disability remains substantially less."," Pain 153(2): 494-501.","UK",2012,"Back Pain","CBT","RMDQ","Unknown","PRO study","RCT"]
[213,"Lamb, S. E., et al. (2012). \"Managing Injuries of the Neck Trial (MINT): a randomised controlled trial of treatments for whiplash injuries.\" Health Technol Assess 16(49): iii-iv, 1-141.",null,"Lamb, S. E., et al.","Managing Injuries of the Neck Trial (MINT): a randomised controlled trial of treatments for whiplash injuries","OBJECTIVES: To examine the clinical effectiveness of a stepped care approach over a 12-month period after an acute whiplash injury; to estimate the costs and cost-effectiveness of each strategy including treatments and subsequent health-care costs; and to gain participants' perspective on experiencing whiplash injury, NHS treatment, and recovery within the context of the Managing Injuries of the Neck Trial (MINT). DESIGN: Two linked, pragmatic, randomised controlled trials. In Step 1, emergency departments (EDs) were cluster randomised to usual care advice (UCA) or The Whiplash Book advice (WBA)/active management advice. In Step 2, participants were individually randomised to either a single session of advice from a physiotherapist or a physiotherapy package of up to six sessions. An economic evaluation and qualitative study were run in parallel with the trial. SETTING: Twelve NHS trusts in England comprising 15 EDs. PARTICIPANTS: People who attended EDs with an acute whiplash injury of whiplash-associated disorder grades I-III were eligible for Step 1. People who had attended EDs with whiplash injuries and had persistent symptoms 3 weeks after ED attendance were eligible for Step 2. INTERVENTIONS: In Step 1, the control intervention was UCA and the experimental intervention was a psycho-educational intervention (WBA/active management advice). In Step 2 the control treatment was reinforcement of the advice provided in Step 1 and the experimental intervention was a package of up to six physiotherapy treatments. MAIN OUTCOME: The primary outcome was the Neck Disability Index (NDI), which measures severity and frequency of pain and symptoms, and a range of activities including self-care, driving, reading, sleeping and recreation. Secondary outcomes included the mental and physical health-related quality-of-life (HRQoL) subscales of the Short Form questionnaire-12 items (SF-12) and the number of work days lost. RESULTS: A total of 3851 patients were recruited to Step 1 of the trial. 1598 patients attending EDs were randomised to UCA, and 2253 were randomised to WBA/active management. Outcome data were obtained at 12 months for 70% and 80% of participants at Step 1 and Step 2, respectively. The majority of people recovered from the injury. Eighteen per cent of the Step 1 cohort had late whiplash syndrome. There was no statistically or clinically significant difference observed in any of the outcomes for participants attending EDs randomised to UCA or active management advice [difference in NDI 0.5, 95% confidence interval (CI) -1.8 to 2.8]. In Step 2 the physiotherapy package resulted in improvements in neck disability at 4 months compared with a single advice session, but these effects were small at the population level (difference in NDI -3.2, 95% CI -5.8 to -0.7). The physiotherapy package was accompanied by a significant reduction in the number of work days lost at 4-month follow-up (difference -40.2, 95% CI -44.3 to -35.8). CONCLUSIONS: MINT suggests that enhanced psycho-educational interventions in EDs are no more effective than UCA in reducing the burden of acute whiplash injuries. A physiotherapy package provided to people who have persisting symptoms within the first 6 weeks of injury produced additional short-term benefits in neck disability compared with a single physiotherapy advice session. However, from a health-care perspective, the physiotherapy package was not cost-effective at current levels of willingness to pay. Both experimental treatments were associated with increased cost with no discernible gain in health-related quality of life. However, an important benefit of the physiotherapy package was a reduction in work days lost; consequently, the intervention may prove cost-effective at the societal level. TRIAL REGISTRATION: Current Controlled Trials ISRCTN33302125. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 49. See the HTA programme website for further project information."," Health Technol Assess 16(49): iii-iv, 1-141.","UK",2012,"Trauma","Physical Therapy","NDI","Unknown","Cost-Effectiveness","RCT"]
[214,"Lamb, S. E., et al. (2013). \"Emergency department treatments and physiotherapy for acute whiplash: a pragmatic, two-step, randomised controlled trial.\" Lancet 381(9866): 546-556.",null,"Lamb, S. E., et al.","Emergency department treatments and physiotherapy for acute whiplash: a pragmatic, two-step, randomised controlled trial","BACKGROUND: Little is known about the effectiveness of treatments for acute whiplash injury. We aimed to estimate whether training of staff in emergency departments to provide active management consultations was more effective than usual consultations (Step 1) and to estimate whether a physiotherapy package was more effective than one additional physiotherapy advice session in patients with persisting symptoms (Step 2). METHODS: Step 1 was a pragmatic, cluster randomised trial of 12 NHS Trust hospitals including 15 emergency departments who treated patients with acute whiplash associated disorder of grades I-III. The hospitals were randomised by clusters to either active management or usual care consultations. In Step 2, we used a nested individually randomised trial. Patients were randomly assigned to receive either a package of up to six physiotherapy sessions or a single advice session. Randomisation in Step 2 was stratified by centre. Investigator-masked outcomes were obtained at 4, 8, and 12 months. Masking of clinicians and patients was not possible in all steps of the trial. The primary outcome was the Neck Disability Index (NDI). Analysis was intention to treat, and included an economic evaluation. The study is registered ISRCTN33302125. FINDINGS: Recruitment ran from Dec 5, 2005 to Nov 30, 2007. Follow-up was completed on Dec 19, 2008. In Step 1, 12 NHS Trusts were randomised, and 3851 of 6952 eligible patients agreed to participate (1598 patients were assigned to usual care and 2253 patients were assigned to active management). 2704 (70%) of 3851 patients provided data at 12 months. NDI score did not differ between active management and usual care consultations (difference at 12 months 0.5, 95% CI -1.5 to 2.5). In Step 2, 599 patients were randomly assigned to receive either advice (299 patients) or a physiotherapy package (300 patients). 479 (80%) patients provided data at 12 months. The physiotherapy package at 4 months showed a modest benefit compared to advice (NDI difference -3.7, -6.1 to -1.3), but not at 8 or 12 months. Active management consultations and the physiotherapy package were more expensive than usual care and single advice session. No treatment-related serious adverse events or deaths were noted. INTERPRETATION: Provision of active management consultation did not show additional benefit. A package of physiotherapy gave a modest acceleration to early recovery of persisting symptoms but was not cost effective from a UK NHS perspective. Usual consultations in emergency departments and a single physiotherapy advice session for persistent symptoms are recommended. FUNDING: NIHR Health Technology Assessment programme."," Lancet 381(9866): 546-556.","UK",2013,"Trauma","Physical Therapy","NDI","Unknown","PRO study","RCT"]
[215,"Lan, L., et al. (2014). \"Acupuncture for functional dyspepsia.\" Cochrane Database Syst Rev(10): Cd008487.",null,"Lan, L., et al.","Acupuncture for functional dyspepsia","BACKGROUND: Functional dyspepsia (FD) has been a worldwide complaint. More effective therapies are needed with fewer adverse effects than are seen with conventional medications. Acupuncture, as a traditional therapeutic method, has been widely used for functional gastrointestinal disorders in the East. Manual acupuncture and electroacupuncture have been recognized treatments for FD, but to date, no robust evidence has been found for the effectiveness and safety of these interventions in the treatment of this condition. OBJECTIVES: This review was conducted to assess the efficacy and safety of manual acupuncture and electroacupuncture in the treatment of FD. SEARCH METHODS: Trials meeting the inclusion criteria were identified through electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Allied and Complementary Medicine Database (AMED), Chinese Biology Medicine Disc (CBMdisc), China National Knowledge Infrastructure (CNKI), the Wanfang Database, the VIP Database, and six trial registries. Handsearching was done to screen the reference sections of potential trials and reviews. SELECTION CRITERIA: Randomized controlled trials (RCTs) were included if investigators reported efficacy and safety of manual acupuncture or electroacupuncture for patients with FD diagnosed by Rome II or Rome III criteria, compared with medications, blank control, or sham acupuncture. DATA COLLECTION AND ANALYSIS: Data were extracted by independent review authors. Study limitations were assessed by using the tool of The Cochrane Collabration for assessing risk of bias. For dichotomous data, risk ratios (RRs) and 95% confidence intervals (95% CIs) would be applied, and for continuous data, mean differences (MDs) and 95% CIs. A fixed-effect model was applied in the meta-analysis, or a descriptive analysis was performed. The quality of evidence for the outcome measure was assessed by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methods. MAIN RESULTS: Seven studies were included in the review, involving 542 participants with FD (212 males and 330 females). These studies generally had an unclear risk of bias based on inadequate descriptions of allocation concealment and a high risk of bias based on lack of blinding. None of the studies reported on outcomes of the Functional Digestive Disorder Quality of Life questionnaire (FDDQL), the Satisfaction With Dyspepsia Related Health scale (SODA), the Digestive Health Status Instrument (DHSI), or effective/inefficient rate and symptom recurrence six months from completion of acupuncture treatment.Four RCTs of acupuncture versus medications (cisapride, domperidone, and itopride) were included in the review. No statistically significant difference was noted in the reduction in FD symptom scores and the frequency of FD attack by manual acupuncture, manual-electroacupuncture, or electroacupuncture compared with medications. In three trials of acupuncture versus sham acupuncture, all descriptive or quantitative analysis results implied that acupuncture could improve FD symptom scores and scores on the Neck Disability Index (NDI), the 36-Item Short Form Health Survey (SF-36), the Self-Rating Anxiety Scale (SAS), and the Self-Rating Depression Scale (SDS) more or as significantly as sham acupuncture. With regard to adverse effects, acupuncture was superior to cisapride treatment (one study; all minor events), but no statistically significant difference was reported between acupuncture and sham acupuncture. No adverse effects data were reported in studies examining manual acupuncture versus domperidone, manual-electroacupuncture versus domperidone, or electroacupuncture versus itopride.Nevertheless, all evidence was of low or very low quality. The body of evidence identified cannot yet permit a robust conclusion regarding the efficacy and safety of acupuncture for FD. AUTHORS' CONCLUSIONS: It remains unknown whether manual acupuncture or electroacupuncture is more effective or safer than other treatments for patients with FD."," Cochrane Database Syst Rev(10): Cd008487.","China",2014,"Functional Dyspepsia","Acupuncture","NDI","Unknown","PRO study","Systematic review"]
[216,"Landen Ludvigsson, M., et al. (2017). \"Cost-effectiveness of neck-specific exercise with or without a behavioral approach versus physical activity prescription in the treatment of chronic whiplash-associated disorders: Analyses of a randomized clinical trial.\" Medicine (Baltimore) 96(25): e7274.",null,"Landen Ludvigsson, M., et al.","Cost-effectiveness of neck-specific exercise with or without a behavioral approach versus physical activity prescription in the treatment of chronic whiplash-associated disorders: Analyses of a randomized clinical trial","BACKGROUND: Fifty percent of people injured by whiplash still report neck pain after 1 year and costs associated with whiplash associated disorders (WAD) are mostly attributed to health service and sick-leave costs in chronic conditions. With increasing health care expenditures the economic impact of interventions needs to be considered. OBJECTIVE: To analyze the cost-effectiveness of physiotherapist-led neck-specific exercise without (NSE) or with a behavioral approach (NSEB), or prescription of physical activity (PPA) in chronic WAD, grade 2 to 3. METHODS: This is a secondary cost-effectiveness analysis of a multicenter randomized clinical trial of 216 participants with chronic WAD grade 2 to 3. The interventions were physiotherapist-led neck-specific exercise without or with a behavioral approach, or prescription of physical activity for 12 weeks. Incremental cost-effectiveness ratios (ICERs) were determined after 1 year and bootstrapped cost-effectiveness planes and sensitivity analyses of physiotherapy visits were performed. Health care and production loss costs were included and quality-adjusted life years (QALYs) were estimated, using the Euroqol-5D questionnaire. Comparisons with the Short Form-6D, and neck disability index (NDI) were also made. RESULTS: The 1-year follow-up was completed by 170 participants (79%). Both physiotherapist-led groups improved in health related quality of life. The intervention cost alone, per quality-adjusted life year (QALY) gain in the NSE group was US$ 12,067. A trend for higher QALY gains were observed in the NSEB group but the costs were also higher. The ICERs varied depending on questionnaire used, but the addition of a behavioral approach to neck-specific exercise alone was not cost-effective from a societal perspective (ICER primary outcome $127,800 [95% confidence interval [CI], 37,816-711,302]). The sensitivity analyses confirmed the results. The prescription of physical activity did not result in any QALY gain and the societal costs were not lower. CONCLUSION: Neck-specific exercise was cost-effective from a societal perspective in the treatment of chronic WAD compared with the other exercise interventions. ICERS varied depending on health-related quality of life questionnaires used, but the addition of a behavioral approach was not cost-effective from a societal perspective. The prescription of physical activity did not result in any QALY gain and was thus not considered a relevant option."," Medicine (Baltimore) 96(25): e7274.","Sweden",2017,"Neck Pain","Exercise","NDI","Unknown","Cost-Effectiveness","RCT"]
[217,"Lara-Palomo, I. C., et al. (2013). \"Short-term effects of interferential current electro-massage in adults with chronic non-specific low back pain: a randomized controlled trial.\" Clin Rehabil 27(5): 439-449.",null,"Lara-Palomo, I. C., et al.","Short-term effects of interferential current electro-massage in adults with chronic non-specific low back pain: a randomized controlled trial","OBJECTIVES: To analyse the effectiveness of a combined procedure of massage and electrotherapy with interferential current in individuals with chronic non-specific low back pain of mechanical aetiology. DESIGN: A single blinded randomized controlled trial. SETTING: Clinical setting. PARTICIPANTS: Sixty-two individuals with chronic non-specific low back pain were randomly assigned to an experimental or control group. For 10 weeks the experimental group underwent treatment comprising 20 sessions (twice a week) of massage with interferential current in the lumbar and dorsal-lumbar area, and the control group received superficial lower back massage (effleurage, superficial pressure and skin rolling). MAIN OUTCOME VARIABLES: Oswestry Disability Index, pain visual analogue scale, Tampa Scale for Kinesiophobia, Roland Morris Disability Questionnaire, McQuade Test, Side Bridge Test, quality of life scores and the range of trunk anteflexion motion, which were all assessed before the treatment and immediately after the last treatment session. RESULTS: The 2 x 2 mixed model ANOVA with repeated measurements showed statistically significant group * time interactions for the visual analogue scale (F = 12.839; P = 0.001), Oswestry Disability Index (F = 5.850; P = 0.019), Roland Morris Disability Questionnaire (F = 8.237; P = 0.006) and quality of life (physical function (F = 16.792; P = 0.001), physical role (F = 14.839; P = 0.001) and body pain (F = 11.247; P = 0.001)). CONCLUSIONS: In individuals with chronic non-specific low back pain, interferential current electro-massage achieved a significantly greater improvement in disability, pain and quality of life in comparison to superficial massage after 20 treatment sessions."," Clin Rehabil 27(5): 439-449.","Spain",2013,"Back Pain","Massage,Electrotherapy","ODI,RMDQ","Unknown","PRO study","RCT"]
[218,"Lark, R. K., et al. (2013). \"Adding thoracic fusion levels in Lenke 5 curves: risks and benefits.\" Spine (Phila Pa 1976) 38(2): 195-200.",null,"Lark, R. K., et al.","Adding thoracic fusion levels in Lenke 5 curves: risks and benefits","STUDY DESIGN: Multicenter; review of prospectively collected data. OBJECTIVE: To determine the risks and potential benefits of nonselective versus selective fusion in a matched set of patients with Lenke 5 curves. SUMMARY OF BACKGROUND DATA: The Lenke classification suggests a limited thoracolumbar/lumbar fusion for type 5 curves, although many experienced adolescent idiopathic scoliosis surgeons, at times, include a fusion of the thoracic curve. METHODS.: Prospectively collected cases from a multicenter database were analyzed. Patients with Lenke type 5 scoliosis curves were divided into 2 groups: 109 selective or short (only thoracolumbar/lumbar curve fused), and 41 nonselective or long (both thoracolumbar/lumbar and thoracic curves fused). Patients were then matched on the basis of the preoperative radiographical and clinical measures. Two-year postoperative radiographical and clinical outcomes were compared, using analysis of variance, with Bonferroni correction (P < 0.008). RESULTS: Twenty-nine matched pairs (58 patients) with Lenke 5 curves were identified. There were no preoperative differences between groups in age, thoracic or lumbar Cobb angle, curve flexibility, thoracic kyphosis, clinical trunk flexibility, or Scoliosis Research Society outcomes questionnaire scores. Postoperatively, patients in the nonselective group exhibited greater coronal correction for thoracic (residual Cobb; 22 degrees vs. 12 degrees ) and lumbar curves (residual Cobb; 19 degrees vs. 13 degrees ). However, the longer fusions had significantly less thoracic kyphosis (27 degrees vs. 18 degrees ), truncal side bending (14 vs. 10 cm), and rotational flexibility (53 degrees vs. 42 degrees ). There was no difference in clinical balance or Scoliosis Research Society questionnaire, version 22, scores. CONCLUSION: Adolescent idiopathic scoliosis surgeons attempt to achieve balanced correction with the fewest motion segments fused. Our data suggest that fusion of the thoracic curve in primary thoracolumbar scoliosis may improve coronal correction, but at the cost of decreased thoracic kyphosis and clinical flexibility 2 years postoperatively."," Spine (Phila Pa 1976) 38(2): 195-200.","USA",2013,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","Cost and Resource Use","Prospective Observation"]
[219,"Larson, A. N., et al. (2014). \"Does higher anchor density result in increased curve correction and improved clinical outcomes in adolescent idiopathic scoliosis?\" Spine (Phila Pa 1976) 39(7): 571-578.",null,"Larson, A. N., et al.","Does higher anchor density result in increased curve correction and improved clinical outcomes in adolescent idiopathic scoliosis?","STUDY DESIGN: Retrospective review of prospectively collected data. OBJECTIVE: To determine whether anchor density is associated with curve correction and patient-reported outcomes. SUMMARY OF BACKGROUND DATA: There is limited information as to whether anchor density affects the results of adolescent idiopathic scoliosis surgery. METHODS: A total of 952 patients with adolescent idiopathic scoliosis met inclusion criteria (Lenke 1, 2, and 5 curves) with predominantly screw constructs (no. of screws/no. of total anchors >75%). Anchor density was defined as the number of screws, hooks, and wires per level fused, with less than 1.54 considered low density. Analysis of covariance was undertaken to determine association of anchor density with percent curve correction, Scoliosis Research Society (SRS), and Spinal Appearance Questionnaire (SAQ) scores, controlling for flexibility, fusion length, demographics, and surgeon. RESULTS: High- compared with low-anchor density was associated with increased percent curve correction in Lenke 1 curves at 1 year (69% vs. 66% correction, P = 0.0022), controlling for percent preoperative curve flexibility, length of fusion, and sex (model, P < 0.0001). Similar associations held at 2-year follow-up and for Lenke 2 curves. Decreased thoracic kyphosis was found with increased anchor density for Lenke 1 and 2 curve patterns. There were no associations found between anchor density and Lenke 5 curves. For Lenke 1 curve patterns at 2 years postoperatively, in the high- versus low-anchor density cohorts, there were statistically higher SRS Activity (4.3 vs. 4.2, P = 0.019), Appearance (4.3 vs. 4.1, P = 0.0005), Satisfaction (4.5 vs. 4.3, P = 0.028), and Total scores (4.3 vs. 4.2; P = 0.024). Similarly, the SAQ Appearance score at 1 year similarly was improved in the high-anchor density group (high: 14.1 vs. low: 15.0, P = 0.03) for Lenke 1 curve patterns only. CONCLUSION: For Lenke 1 and 2 curve patterns, improved percent correction of major coronal curve was noted in the high-screw density cohort. Although statistical significance was reached, it is unclear whether screw density resulted in clinically significant differences in patient-reported outcomes."," Spine (Phila Pa 1976) 39(7): 571-578.","USA",2014,"Spinal Deformity","Surgical","SRS-HRQOL,SAQ","Adolescents","PRO study","Prospective Observation"]
[220,"Lau, D., et al. (2016). \"The Clinical Correlation of the Hart-ISSG Proximal Junctional Kyphosis Severity Scale With Health-Related Quality-of-life Outcomes and Need for Revision Surgery.\" Spine (Phila Pa 1976) 41(3): 213-223.",null,"Lau, D., et al.","The Clinical Correlation of the Hart-ISSG Proximal Junctional Kyphosis Severity Scale With Health-Related Quality-of-life Outcomes and Need for Revision Surgery","STUDY DESIGN: Retrospective analysis of prospective data. OBJECTIVE: Evaluate the utility of the Hart-International Spine Study Group proximal junctional kyphosis severity scale (Hart-ISSG PJKSS). SUMMARY OF BACKGROUND DATA: Proximal junctional kyphosis (PJK) and failure (PJF) are well-described complications after long-segment instrumentation. The Hart-ISSG PJKSS was recently developed and incorporates neurological deficit, pain, instrumentation issues, degree of kyphosis, presence of fracture, and level of upper-most instrumented vertebrae. METHODS: All adult spinal deformity patients with PJK or PJF were identified from two academic centers over a 7-year period. Health-related quality-of-life (HRQOL) outcomes were prospectively collected: Oswestry Disability Index (ODI), visual analogue scale (VAS) pain, SF-36 questionnaire, and SRS-30 questionnaire. Patients were retrospectively assigned Hart-ISSG PJKSS scores. Correlation between the Hart-ISSG PJKSS and outcomes was assessed with linear regression, Pearson correlation coefficients, and chi(2) analysis. RESULTS: A total of 184 cases were included; 21.2% were men and mean age was 65.0 years. Weakness and/or myelopathy were present in 11.4% of patients and 88.6% had pain. Instrumentation issues occurred in 44.0% and 64.1% had PJK-associated fractures. PJK occurred in the upper thoracic spine in 21.7% of cases. Mean PJKSS score was 5.9. The Hart-ISSG PJKSS was significantly and strongly associated with ODI (P < 0.001, r = 0.611), VAS pain (P < 0.001, r = 0.676), SRS-30 function (P < 0.001, r = -0.401), SRS-30 mental health (P < 0.001, r = -0.592), SRS-30 self-image (P < 0.001, r = -0.511), SRS-30 satisfaction (P < 0.001, r = -0.531), and SRS-30 pain (P < 0.001, r = -0.445). Higher scores were associated with higher proportion of patients undergoing revision surgery (P < 0.001); scores of 9 to 11 and 12 to 15 underwent revision 96.0% and 100.0% of the time, respectively. CONCLUSION: The Hart-ISSG PJKSS was strongly correlated with validated functional outcomes and higher scores were associated with higher rates of revision surgery. The Hart-ISSG PJKSS may be a useful clinical tool in the treatment of patient with PJK. LEVEL OF EVIDENCE: 3."," Spine (Phila Pa 1976) 41(3): 213-223.","USA",2016,"Cervical Myelopathy","Surgical","ODI,SRS-HRQOL","Adults","PRO study","Observational"]
[221,"Lau, H. M., et al. (2011). \"The effectiveness of thoracic manipulation on patients with chronic mechanical neck pain - a randomized controlled trial.\" Man Ther 16(2): 141-147.",null,"Lau, H. M., et al.","The effectiveness of thoracic manipulation on patients with chronic mechanical neck pain - a randomized controlled trial","The aim of our study was to assess the effectiveness of thoracic manipulation (TM) on patients with chronic neck pain. 120 patients aged between 18 and 55 were randomly allocated into two groups: an experimental group which received TM and a control group without the manipulative procedure. Both groups received infrared radiation therapy (IRR) and a standard set of educational material. TM and IRR were given twice weekly for 8 sessions. Outcome measures included craniovertebral angle (CV angle), neck pain (Numeric Pain Rating Scale; NPRS), neck disability (Northwick Park Neck Disability Questionnaire; NPQ), health-related quality of life status (SF36 Questionnaire) and neck mobility. These outcome measures were assessed immediately after 8 sessions of treatment, 3-months and at a 6-month follow-up. Patients that received TM showed significantly greater improvement in pain intensity (p = 0.043), CV angle (p = 0.049), NPQ (p = 0.018), neck flexion (p = 0.005), and the Physical Component Score (PCS) of the SF36 Questionnaire (p = 0.002) than the control group immediately post-intervention. All these improvements were maintained at the 6-month follow-ups. This study shows that TM was effective in reducing neck pain, improving dysfunction and neck posture and neck range of motion (ROM) for patients with chronic mechanical neck pain up to a half-year post-treatment."," Man Ther 16(2): 141-147.","China",2011,"Neck Pain","Manipulations","Northwick","Adults","PRO study","RCT"]
[222,"Lauche, R., et al. (2011). \"The influence of a series of five dry cupping treatments on pain and mechanical thresholds in patients with chronic non-specific neck pain--a randomised controlled pilot study.\" BMC Complement Altern Med 11: 63.",null,"Lauche, R., et al.","The influence of a series of five dry cupping treatments on pain and mechanical thresholds in patients with chronic non-specific neck pain--a randomised controlled pilot study","BACKGROUND: In this preliminary trial we investigated the effects of dry cupping, an ancient method for treating pain syndromes, on patients with chronic non-specific neck pain. Sensory mechanical thresholds and the participants' self-reported outcome measures of pain and quality of life were evaluated. METHODS: Fifty patients (50.5 +/- 11.9 years) were randomised to a treatment group (TG) or a waiting-list control group (WL). Patients in the TG received a series of 5 cupping treatments over a period of 2 weeks; the control group did not. Self-reported outcome measures before and after the cupping series included the following: Pain at rest (PR) and maximal pain related to movement (PM) on a 100-mm visual analogue scale (VAS), pain diary (PD) data on a 0-10 numeric rating scale (NRS), Neck Disability Index (NDI), and health-related quality of life (SF-36). In addition, the mechanical-detection thresholds (MDT), vibration-detection thresholds (VDT), and pressure-pain thresholds (PPT) were determined at pain-related and control areas. RESULTS: Patients of the TG had significantly less pain after cupping therapy than patients of the WL group (PR: Delta-22.5 mm, p = 0.00002; PM: Delta-17.8 mm, p = 0.01). Pain diaries (PD) revealed that neck pain decreased gradually in the TG patients and that pain reported by the two groups differed significantly after the fifth cupping session (Delta-1.1, p = 0.001). There were also significant differences in the SF-36 subscales for bodily pain (Delta13.8, p = 0.006) and vitality (Delta10.2, p = 0.006). Group differences in PPT were significant at pain-related and control areas (all p < 0.05), but were not significant for MDT or VDT. CONCLUSIONS: A series of five dry cupping treatments appeared to be effective in relieving chronic non-specific neck pain. Not only subjective measures improved, but also mechanical pain sensitivity differed significantly between the two groups, suggesting that cupping has an influence on functional pain processing. TRIAL REGISTRATION: The trial was registered at clinicaltrials.gov (NCT01289964)."," BMC Complement Altern Med 11: 63.","Germany",2011,"Neck Pain","Not Specified","NDI","Unknown","PRO study","RCT"]
[223,"Lauche, R., et al. (2013). \"Clinically meaningful differences in pain, disability and quality of life for chronic nonspecific neck pain - a reanalysis of 4 randomized controlled trials of cupping therapy.\" Complement Ther Med 21(4): 342-347.",null,"Lauche, R., et al.","Clinically meaningful differences in pain, disability and quality of life for chronic nonspecific neck pain - a reanalysis of 4 randomized controlled trials of cupping therapy","OBJECTIVES: The assessment of clinically meaningful differences in patients' self-reported outcomes has become increasingly important when interpreting the results of clinical studies. Although these assessments have become quite common there are hardly any data for nonspecific neck pain, especially in the context of complementary and alternative medicine. The aim of this analysis is the determination of minimal clinically important differences (MCID) and substantial clinical benefits (SCB) in patients with chronic nonspecific neck pain after cupping treatment. METHODS: The data set comprised a total of 200 patients with chronic nonspecific neck pain participating in clinical trials on cupping therapy. The MCID and SCB for pain intensity (VAS), neck disability index (NDI) and the subscale bodily pain (SF-36-BP) as well as physical component summary (SF-36-PCS) of the SF-36 were determined using receiver operating characteristic (ROC) curve analysis with an adapted assessment of change in health status (SF-36), i.e. a 5-point Likert scale ranging from \"much better\" to \"much worse\", as anchor. MCID derived from the ROC was the score to distinguish \"somewhat better\" from \"about the same\", and the SCB was the score to distinguish \"much better\" from \"somewhat better\". RESULTS: The calculated MCIDs were: -8mm (-21%) for VAS, -3 points (-10.2%) for NDI, +10 points (+20.5%) for SF-36-BP and +2.6 points (+7.7%) for SF-36-PCS. The SCBs were: -26.5mm (-66.8%) for VAS, -8.4 points (-29%) for NDI, +15.5 points (+43.1%) for SF-36-BP and +5.1 points (+12.9%) for SF-36-PCS. Accuracy of the estimations was good for MCID in general and for SCB regarding VAS and NDI. CONCLUSIONS: The results support the assumption that patients' perceptions of treatment benefits measured by VAS in these trials might be comparable to others in conventional therapies. For NDI and SF-36-PCS the estimated differences were smaller than in previous reports indicating that context factors such as patient characteristics and specific treatment conditions might play an important role. Further studies on MCIDS and SCBs for chronic nonspecific neck pain seem warranted."," Complement Ther Med 21(4): 342-347.","Germany",2013,"Neck Pain","Other","NDI","Unknown","PRO study","Clinical trial"]
[224,"Lauche, R., et al. (2014). \"Reliability and validity of the pain on movement questionnaire (POM) in chronic neck pain.\" Pain Med 15(11): 1850-1856.",null,"Lauche, R., et al.","Reliability and validity of the pain on movement questionnaire (POM) in chronic neck pain","OBJECTIVE: This analysis aimed to determine reliability, validity, and responsiveness of the pain on movement (POM) questionnaire, an instrument developed to determine pain intensity induced by head movement. DESIGN: Data from nine randomized controlled trials for the treatment of chronic nonspecific neck pain were reanalyzed to determine reliability and validity of the POM questionnaire. METHODS: POM was assessed as ratings of pain intensity induced by head movement in six different directions. The instrument's structure was assessed using a factor analysis. Reliability (internal consistency) was determined using Cronbach's alpha, and validity (convergent validity) was determined by correlating the POM with pain at rest on a visual analog scale (VAS), the neck disability index (NDI), quality of life (short-form 36 health survey questionnaire [SF-36]) and range of motion. Responsiveness was indicated by sensitivity to changes over time in a subsample of 49 patients. RESULTS: Overall, 482 patients (mean age 50.3 +/- 12.4 years, 72.3% female) were included in the analysis, and 458 of them provided complete data set for the POM. Average POM was 43.9 +/- 20.8 mm on the VAS. The POM showed very good reliability as indicated by high internal consistency and moderate validity as indicated by significant correlations with the pain at rest, the NDI, and the SF-36. No correlations were found for POM with range of motion. The POM further proved to be responsive as it was sensitive to changes over time, and those changes were correlated to changes in pain intensity and NDI. CONCLUSIONS: The POM seems to be a reliable and valid instrument to assess POM in patients with chronic nonspecific neck pain."," Pain Med 15(11): 1850-1856.","Germany",2014,"Neck Pain","Not Specified","NDI","Adults","PRO study","RCT"]
[225,"Lee, S., et al. (2016). \"Efficacy and safety of Myofascial-meridian Release Acupuncture (MMRA) for chronic neck pain: a study protocol for randomized, patient- and assessor-blinded, sham controlled trial.\" BMC Complement Altern Med 16: 45.",null,"Lee, S., et al.","Efficacy and safety of Myofascial-meridian Release Acupuncture (MMRA) for chronic neck pain: a study protocol for randomized, patient- and assessor-blinded, sham controlled trial","BACKGROUND: The purpose of this study is to evaluate the efficacy and safety of myofascial-meridian release acupuncture (MMRA) in the treatment of chronic neck pain compared with sham acupuncture. METHODS/DESIGN: A protocol for a randomized, patient- and assessor-blinded, sham controlled parallel trial is presented. Seventy-four participants with a >/=3 month history of neck pain and a score of >/=4 on the 11-point pain intensity numerical rating scale (PI-NRS) will be randomly assigned to the MMRA group (n = 37) or sham acupuncture group (n = 37). The participants will receive the MMRA treatment or sham acupuncture treatment twice per week for 4 weeks. The primary outcome is the mean change in the PI-NRS (0 = no pain and 10 = worst possible pain, 11-point Likert scale) from baseline to 4 weeks. The secondary outcomes are the mean change from baseline on the clinical relevance of the pain (ratio of changes greater than 1.5 or with percentiles greater than 30 % and 50 % in the PI-NRS), function (Neck Disability Index and Cervical Range of Motion), autonomic and psychometric measurements (Heart Rate Variability and Perceived Stress Scale), quality of life (EuroQol), global assessment (Patient Global Impression of Change), semi-objective outcomes (pressure pain threshold, consumption of rescue medicine and days of restricted activity) and immunologic/stress biomarkers. Adverse events will be evaluated at every visit. DISCUSSION: The results of this trial will provide evidence to confirm the efficacy and safety of acupuncture for chronic neck pain. TRIAL REGISTRATION: The trial is registered with the Clinical Research Information Service (CRiS), Republic of Korea: KCT0001573 ."," BMC Complement Altern Med 16: 45.","Republic of Korea",2016,"Neck Pain","Acupuncture","NDI","Unknown","Protocol","RCT"]
[226,"Leferink, V. J., et al. (2003). \"Functional outcome in patients with thoracolumbar burst fractures treated with dorsal instrumentation and transpedicular cancellous bone grafting.\" Eur Spine J 12(3): 261-267.",null,"Leferink, V. J., et al.","Functional outcome in patients with thoracolumbar burst fractures treated with dorsal instrumentation and transpedicular cancellous bone grafting","The aim of the study was to develop an insight into the impairments in spinal fracture patients, operatively treated with an internal fixator, and also into their ability to participate in daily living, return to work and quality of life as defined by the World Health Organization. Nineteen patients operated for a type A fracture of the thoracolumbar spine (T9-L4) between 1993 and 1998 in the University Hospital Groningen, the Netherlands, aged between 18 and 60 years, without neurological deficit were included in the study. Operative treatment consisted of fracture reduction and internal fixation using the Universal Spine System, combined with transpedicular cancellous bone grafting and dorsal spondylodesis. No ventral fusion operations, laminectomies or discectomies were done. Restrictions in body function and structure were measured on radiographs and in functional capacity tests, such as lifting tests and ergometry. Restrictions in activities were studied with the Visual Analogue Scale (VAS) Spine Score and the Roland Morris Disability Questionnaire (RMDQ). Restrictions in participation/quality of life were analysed with the Short Form 36 (SF36) and described in the return to work status. The radiological results are comparable to the literature. The reduction of the anterior wedge angle was followed by a gradual partial loss of intervertebral angle and regional angle. The maximum oxygen uptake (VO2-max) was reduced in only 8.3% of the patients. Arm and trunk lift was within the normal range in 87% and 80% of the patients respectively, but only 53% of the patients were able to perform a leg lift within the normal range. A mean RMDQ score of 4.0 positive items (SD 6.0) was found, and the mean VAS Spinal Score was 79.4 (SD 25.0), both better than in other series. No significant differences compared to the values of a comparable (healthy) age group could be identified in any variable of the SF36. A high correlation was seen between RMDQ, VAS Spine Score and the SF36 categories. No correlation was found between the anterior wedge angle and the regional angle on the one hand, and functional capacity tests or questionnaire scores on the other. Of the patients in paid employment before the trauma, 87% had returned to work at follow-up. About 50% of the patients had been obliged to change the intensity of their work or the kind of work they performed after the injury and treatment. In this matter, leg (muscle) performance seems a more important factor than overall condition (VO2-max). The results of the study indicate that patients with thoracolumbar spinal fractures without neurological deficit, treated with dorsal instrumentation, perform like healthy people 3-8 years after injury, according to the RMDQ, VAS Spine Score and SF36 results. Physical capacity tests reveal that leg (muscle) performance seems a more important factor in impairment than arm lift or overall condition."," Eur Spine J 12(3): 261-267.","Netherlands",2003,"Spondylosis,Trauma","Bone Grafting","RMDQ","Adults","PRO study","Observational"]
[227,"Leidig, G., et al. (1990). \"A study of complaints and their relation to vertebral destruction in patients with osteoporosis.\" Bone Miner 8(3): 217-229.",null,"Leidig, G., et al.","A study of complaints and their relation to vertebral destruction in patients with osteoporosis","Patients with spinal osteoporosis suffer from vertebral deformation, loss of height and back pain, as well as from functional limitations and alterations of mood. So far little is known about the extent of these clinical symptoms at all and whether they are related in a predictable manner to the fractures or damages of bone structure. In the present study we investigated the relation between vertebral deformation and clinical symptoms in 70 patients with osteoporosis. Clinical data like pain, functional limitations and parameters of mood were examined by a standardized questionnaire. The numbers of vertebral fractures were determined, and the vertebral destruction was quantified using the Spine Deformity Index (SDI). The symptoms and functional limitations were graded and correlated to the SDI and the number of fractures. Our results underline a relation between the extent of vertebral deformation and the reduction in quality of life by pain, functional limitations and alterations of mood. This relationship was absent or less evident, if the number of fractures was taken into account. Besides the difficulties concerning the grading and quantification of clinical symptoms and outcome of disease, our study revealed that there is a causal relation between the extent of vertebral destruction measured by the SDI and the extent of these clinical parameters."," Bone Miner 8(3): 217-229.","Germany",1990,"Osteoporosis","Not Specified","SDI","Unknown","PRO study","Narrative review"]
[228,"Lerner, T. and U. Liljenqvist (2013). \"Silicate-substituted calcium phosphate as a bone graft substitute in surgery for adolescent idiopathic scoliosis.\" Eur Spine J 22 Suppl 2: S185-194.",null,"Lerner, T. and U. Liljenqvist","Silicate-substituted calcium phosphate as a bone graft substitute in surgery for adolescent idiopathic scoliosis","STUDY DESIGN AND OBJECTIVE: The purpose of this prospective clinical study is to evaluate the clinical and radiographic outcomes using a silicate-substituted calcium phosphate (Si-CaP) as a bone graft substitute in surgery for adolescent idiopathic scoliosis (AIS). In posterior corrective surgery for AIS, harvesting autologous bone from the iliac crest still represents the gold standard to augment the local bone graft though it is comparatively invasive and associated with donor site morbidity. Si-CaP enriched with bone marrow aspirate (BMA) might be an appropriate bone graft extender to overcome these difficulties. METHODS: Eighteen female and three male patients with AIS who underwent corrective posterior instrumentation were observed clinically and radiographically for a minimum of 24 months. In all cases, 20-40 ml Si-CaP granules (ACTIFUSE) mixed with BMA from vertebral bodies was used to extend the local bone graft. Fusion was assessed by standardized conventional radiographs regarding loss of correction and implant failure. Clinical outcome was evaluated with use of the Scoliosis Research Society-22 patient Questionnaire (SRS-22) and a Visual Analog Scale (VAS) for back pain. RESULTS: Cobb angle of major curves averaged 63 degrees preoperatively, 22 degrees after surgery, and 24 degrees at final follow-up, with a maximum loss of correction of 7 degrees recorded after 4 months. No adverse effects related to the study material had been observed. In all patients, there was no evidence of implant failure, and formation of an increasingly densifying 'fusion mass' was visible, as assessed by conventional radiography. VAS score for back pain averaged 1.7 before surgery, 2.3 at discharge, and 1.5 at final follow-up. Outcome assessment using the SRS-22 revealed a significantly enhanced overall health-related quality of life (84 vs. 74 % before surgery; P = 0.0005) due to a significant improvement of the domains 'self image' (77 vs. 59 %; P = 0.0002) and 'pain' (88 vs. 80 %; P = 0.02). Patients' management satisfaction averaged 93 %. CONCLUSIONS: Si-CaP augmented with BMA from vertebral bodies seems to prove an effective, safe, and easy to handle bone graft extender in scoliosis surgery and thus a suitable alternative to bone harvesting procedures."," Eur Spine J 22 Suppl 2: S185-194.","Germany",2013,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Prospective Observation"]
[229,"Lewis, M., et al. (2007). \"An economic evaluation of three physiotherapy treatments for non-specific neck disorders alongside a randomized trial.\" Rheumatology (Oxford) 46(11): 1701-1708.",null,"Lewis, M., et al.","An economic evaluation of three physiotherapy treatments for non-specific neck disorders alongside a randomized trial","OBJECTIVES: Cost-effectiveness and cost-utility analyses were conducted to compare advice and exercise plus manual therapy (MT) and advice and exercise plus pulsed shortwave diathermy (PSWD) with advice and exercise alone (A&E) in the treatment of non-specific neck disorders by experienced physiotherapists. METHODS: Between July 2000 and June 2002, 350 participants with neck disorders from 15 physiotherapy departments were randomized to: A&E (n = 115); MT (n = 114) and PSWD (n = 121). Outcome and resource-use data were collected using physiotherapist case report forms and participant self-complete questionnaires. Outcome measures were the Northwick Park Neck Pain Questionnaire (NPQ) and EuroQoL EQ-5D [used to derive quality-adjusted-life-year (QALY) utility scores]. Two economic viewpoints were considered (health care and societal). Cost-effectiveness acceptability curves were used to assess the probabilities of the interventions being cost-effective at different willingness-to-pay threshold values. RESULTS: Mean improvement in NPQ at 6 months was 11.5 in the A&E group, 10.2 in the MT group and 10.3 in the PSWD group; mean QALY scores were 0.362, 0.342 and 0.360, respectively. Mean health care costs were pound sterling105, pound sterling119 and pound sterling123 in the A&E, MT and PSWD groups, respectively. Mean societal costs were pound sterling373, pound sterling303 and pound sterling 338 in each group, respectively. Depending on the viewpoint and the outcome measure, A&E or MT were most likely to be the cost-effective interventions. PSWD was consistently the least cost-effective intervention. CONCLUSIONS: The cost-effective intervention is likely to be A&E or MT, depending on the economic perspective and preferred outcome, but not PSWD."," Rheumatology (Oxford) 46(11): 1701-1708.","UK",2007,"Neck Pain","Exercise","Northwick","Unknown","Cost-Effectiveness","Retrospective review"]
[230,"Lewis, M., et al. (2015). \"Should General Practitioners Issue a Sick Certificate to Employees Who Consult for Low Back Pain in Primary Care?\" J Occup Rehabil 25(3): 577-588.",null,"Lewis, M., et al.","Should General Practitioners Issue a Sick Certificate to Employees Who Consult for Low Back Pain in Primary Care?","PURPOSE: Back pain is a common problem and has significant societal impact. Sickness certification is commonly issued to patients consulting their general practitioner with low back pain. The aim of this study was to investigate the association of certification for low back pain with clinical outcomes and cost consequences. METHODS: A prospective cohort study using linked questionnaire and medical record data from 806 low back pain patients in 8 UK general practices: comparison of 116 (14.4%) who received a sickness certificate versus 690 who did not receive certification. The primary clinical measure was the Roland and Morris Disability Questionnaire (RMDQ). Data on back pain consultation and work absenteeism were used to calculate healthcare and societal costs. RESULTS: Participants issued a sickness certificate had higher back-related disability at baseline consultation and 6-month follow-up [mean difference 3.1 (95% CI 1.8, 4.4) on the RMDQ], indicating worse health status. After fully adjusting for baseline differences, most changes in clinical outcomes at 6 months were not significantly different between study groups. Productivity losses were significantly higher for the certification group, with most absence occurring after the expected end of certification; mean difference in costs due to absenteeism over 6 months was pound1,956 (95% CI pound941, pound3040). CONCLUSIONS: There was no clear evidence of a difference in clinical outcomes between individuals issued a sickness certificate and those not issued a certification for their back pain. With little overall contrast in clinical outcomes, policy makers and care providers may wish to draw on the likely difference in societal costs alongside issues in ethical and moral care in their consideration of patient care for low back pain."," J Occup Rehabil 25(3): 577-588.","UK",2015,"Back Pain","Not Specified","RMDQ","Unknown","PRO study","Prospective Observation"]
[231,"Li, G., et al. (2009). \"Adult scoliosis in patients over sixty-five years of age: outcomes of operative versus nonoperative treatment at a minimum two-year follow-up.\" Spine (Phila Pa 1976) 34(20): 2165-2170.",null,"Li, G., et al.","Adult scoliosis in patients over sixty-five years of age: outcomes of operative versus nonoperative treatment at a minimum two-year follow-up","STUDY DESIGN: Retrospective case-control study. OBJECTIVE: The purpose of this study was to compare the self-reported outcomes between operatively and nonoperatively treated patients over the age of 65 with adult scoliosis, using 4 distinct self-assessment questionnaires (SRS-22, SF-12, EQ5D, and Oswestry disability index [ODI]) and standard radiographic measurement parameters. SUMMARY OF BACKGROUND DATA: The current spine literature contains no studies that directly compare the self-reported and radiographic outcomes of operatively and nonoperatively treated patients over the age of 65 years with adult scoliosis. METHODS: We retrospectively analyzed the self-reported outcomes of 83 adult scoliosis in patients over the age of 65 years. A total of 34 patients were treated operatively, whereas 49 patients were managed nonoperatively. For each of these patients, standard radiographic measurements were recorded both before and after treatment, and each patient received 4 questionnaires (SRS-22, SF-12, EQ5D, and ODI) that were completed with a minimum of 2-year follow-up from the time the treatment was initiated. The outcomes of both groups were then statistically compared. RESULTS: As compared to the nonoperative group, the operative group reported significantly better self-assessment scores for the EQ5D index, EQ5D Visual Analogue Score, and SRS-22 questionnaires. However, no statistically significant difference between the groups was detected for the ODI, SF-12 Mental Health Component Summary, and SF-12 PCS. Furthermore, the operative group also had a significant improvement in radiographic measurements. CONCLUSION: Adult scoliosis patients over the age of 65 years treated operatively had significantly less pain, a better health-related quality of life, self image, mental health, and were more satisfied with their treatment than patients treated conservatively. However, we found no statistically significant differences in their degree of disability as measured by the ODI as well as physical and mental health by the SF-12 instrument. Preoperative radiographic deformity was not determined to be a significant factor for predicting whether an operative or nonoperative treatment course was chosen."," Spine (Phila Pa 1976) 34(20): 2165-2170.","USA",2009,"Spinal Deformity","Surgical","ODI,SRS-HRQOL","Adults","PRO study","Retrospective review"]
[232,"Li, M., et al. (2009). \"Adapted simplified Chinese (mainland) version of Scoliosis Research Society-22 questionnaire.\" Spine (Phila Pa 1976) 34(12): 1321-1324.",null,"Li, M., et al.","Adapted simplified Chinese (mainland) version of Scoliosis Research Society-22 questionnaire","STUDY DESIGN: Validation study to define validity and reliability of an adapted and translated questionnaire. OBJECTIVE: This study attempted to validate the traditional Chinese (Hong Kong) version of the modified Scoliosis Research Society (SRS) Outcomes Instrument, SRS-22, into simplified Chinese for use in mainland China. SUMMARY OF BACKGROUND DATA: Although a traditional Chinese (Hong Kong) adaptation of the SRS-22 has been previously validated, no culturally adapted, validated SRS-22 exists for use in mainland China. METHODS: Adhering to International Quality of Life Assessment Project guidelines, the adapted traditional Chinese SRS-22 was translated into simplified Chinese while referencing the original English questionnaire. To examine the psychometric properties and clinical application of the adapted simplified Chinese SRS-22, a survey was conducted in a group of randomly selected 87 patients previously surgically treated at an outpatient clinic. Reliability assessment of the simplified Chinese version of the SRS-22 was determined by calculating Cronbach's alpha and intraclass coefficient (ICC) values. Concurrent validity was evaluated by comparing SRS-22 domains with relevant domains of the simplified Short-Form-36 questionnaire; correlation was made using Pearson correlation coefficients. RESULTS: Cronbach's alpha, applied to each of the 22 questions of the adapted SRS-22, revealed very satisfactory internal consistency (Cronbach's alpha = 0.80-0.89) for function/activity and pain, and good consistency (Cronbach's alpha = 0.50-0.79) for the remaining domains. The test/retest reproducibility was found to be good (ICC > or =0.40-0.75) in the function/activity domain, and excellent (ICC > or =0.75) in the remaining domains. In terms of concurrent validity, 3 domains had excellent correlation, while 10 had good correlation, and 21 had moderate correlation. DISCUSSION: The authors report the validation of a simplified Chinese SRS-22 for use in mainland China, which is culturally relevant, reliable, repeatable, psychometrically sound, and suitable for immediate clinical use."," Spine (Phila Pa 1976) 34(12): 1321-1324.","China",2009,"Spinal Deformity","Surgical","SRS-HRQOL","Unknown","Tool Validation","RCT"]
[233,"Liang, Z., et al. (2011). \"Assessment of a traditional acupuncture therapy for chronic neck pain: a pilot randomised controlled study.\" Complement Ther Med 19 Suppl 1: S26-32.",null,"Liang, Z., et al.","Assessment of a traditional acupuncture therapy for chronic neck pain: a pilot randomised controlled study","OBJECTIVE: This study is aimed to assess the efficacy of traditional acupuncture for chronic neck pain in patients by comparing the differences in symptoms, dysfunctions and quality of life. METHODS: The study used a two-arm, single-blinded, randomised controlled design. The patients were randomised to the study group and control group, who respectively received traditional acupuncture and placebo treatment. The Northwick Park Neck Pain Questionnaire (NPQ), visual analogue scale (VAS), Short Form (36) Health Survey (SF-36) and doctor's judgement were applied for measuring effectiveness. The patients' effectiveness outcome was assessed, respectively, before the intervention, immediately after the intervention, at the end of the first month of follow-up and at the end of the third month of follow-up. The statistical analysis was done on Statistical Package for Social Sciences (SPSS) v13, which included comparison of demographic and clinical homogeneity, the repeated measures approach based on the general linear model (GLM) for effectiveness assessment and the sum rank test for doctors' subjective efficacy judgement. RESULTS: Totally, 190 patients were recruited and 178 patients (88 in the study group and 90 in the control group) completed the intervention and follow-up assessment. The scores of NPQ, VAS and SF-36 were improved after the intervention and during follow-up (P<0.01 vs. before the intervention). The patients in the study group had better effectiveness outcome in NPQ, VAS and in the VT, SF and MH domains of SF-36 (P<0.05). CONCLUSION: Traditional acupuncture can relieve pain intensity and improve the quality of daily life with a relative long-term clinical efficacy in patients with chronic neck pain."," Complement Ther Med 19 Suppl 1: S26-32.","China",2011,"Neck Pain","Acupuncture","Northwick","Unknown","PRO study","RCT"]
[234,"Licciardone, J. C. and S. Aryal (2013). \"Prevention of progressive back-specific dysfunction during pregnancy: an assessment of osteopathic manual treatment based on Cochrane Back Review Group criteria.\" J Am Osteopath Assoc 113(10): 728-736.",null,"Licciardone, J. C. and S. Aryal","Prevention of progressive back-specific dysfunction during pregnancy: an assessment of osteopathic manual treatment based on Cochrane Back Review Group criteria","CONTEXT: Back pain during pregnancy may be associated with deficits in physical functioning and disability. Research indicates that osteopathic manual treatment (OMT) slows the deterioration of back-specific functioning during pregnancy. OBJECTIVE: To measure the treatment effects of OMT in preventing progressive back-specific dysfunction during the third trimester of pregnancy using criteria established by the Cochrane Back Review Group. DESIGN: A randomized sham-controlled trial including 3 parallel treatment arms: usual obstetric care and OMT (UOBC+OMT), usual obstetric care and sham ultrasound therapy (UOBC+SUT), and usual obstetric care (UOBC). SETTING: The Osteopathic Research Center within the University of North Texas Health Science Center in Fort Worth. PARTICIPANTS: A total of 144 patients were randomly assigned and included in intention-to-treat analyses. MAIN OUTCOME MEASURES: Progressive back-specific dysfunction was defined as a 2-point or greater increase in the Roland-Morris Disability Questionnaire (RMDQ) score during the third trimester of pregnancy. Risk ratios (RRs) and 95% confidence intervals (CIs) were used to compare progressive back-specific dysfunction in patients assigned to UOBC+OMT relative to patients assigned to UOBC+SUT or UOBC. Numbers needed to treat (NNTs) and 95% CIs were also used to assess UOBC+OMT vs each comparator. Subgroup analyses were performed using median splits of baseline scores on a numerical rating scale for back pain and the RMDQ. RESULTS: Overall, 68 patients (47%) experienced progressive back-specific dysfunction during the third trimester of pregnancy. Patients who received UOBC+OMT were significantly less likely to experience progressive back-specific dysfunction (RR, 0.6; 95% CI, 0.3-1.0; P=.046 vs UOBC+SUT; and RR, 0.4; 95% CI, 0.2-0.7; P<.0001 vs UOBC). The effect sizes for UOBC+OMT vs UOBC+SUT and for UOBC+OMT vs UOBC were classified as medium and large, respectively. The corresponding NNTs for UOBC+OMT were 5.1 (95% CI, 2.7-282.2) vs UOBC+SUT; and 2.5 (95% CI, 1.8-4.9) vs UOBC. There was no statistically significant interaction between subgroups in response to OMT. CONCLUSION: Osteopathic manual treatment has medium to large treatment effects in preventing progressive back-specific dysfunction during the third trimester of pregnancy. The findings are potentially important with respect to direct health care expenditures and indirect costs of work disability during pregnancy."," J Am Osteopath Assoc 113(10): 728-736.","USA",2013,"Back Pain","Ultrasound","RMDQ","Unknown","PRO study","Systematic review"]
[235,"Lim, J. B., et al. (2015). \"Comparison of patient quality of life scores and satisfaction after common orthopedic surgical interventions.\" Eur J Orthop Surg Traumatol 25(6): 1007-1012.",null,"Lim, J. B., et al.","Comparison of patient quality of life scores and satisfaction after common orthopedic surgical interventions","Patient quality of life scores are commonly used to assess patient-reported satisfaction following orthopedic interventions. Our main aim was to review the satisfaction scores of four common orthopedic interventions in our tertiary institution, primary hallux valgus (HV) corrective surgery, primary single-level transforaminal lumbar interbody fusion (TLIF), primary unilateral total knee arthroplasty (TKA) and primary total hip arthroplasty (THA). We retrospectively reviewed prospectively collected data on patients who underwent four different types of orthopedic surgeries using the SF-36 score and two questions adopted from North American Spine Society Questionnaire. The database of a tertiary hospital between January 2007 and December 2009 was reviewed. There were 3488, 374, 184 and 73 patients who underwent TKA, THA, TLIF and HV surgery, respectively. Patients who underwent primary TLIF, TKA and THA had significant degree of improvement in all aspects of SF-36 scores at 6 months and 2 years of follow-up (p < 0.001). Postoperatively at 2 years, the most satisfied postoperative patients were those who underwent THA (91.9 %), followed by TKA (90.5 %), TLIF (86.1 %) and HV (77.4 %). This study shows a significant degree of postoperative improvement in terms of SF-36 scores for common orthopedic interventions in particular to primary TKA, THA and TLIF at 6 months and 2 years of follow-up. With a significant degree of improvement in SF-36 scores postoperatively, this also translated into patient satisfaction and meeting their expectations of surgery."," Eur J Orthop Surg Traumatol 25(6): 1007-1012.","Singapore",2015,"Unspecified","Surgical","NASS-L","Unknown","Tool Validation","Prospective Observation"]
[236,"Lochting, I., et al. (2017). \"The impact of psychological factors on condition-specific, generic and individualized patient reported outcomes in low back pain.\" Health Qual Life Outcomes 15(1999): 40.",null,"Lochting, I., et al.","The impact of psychological factors on condition-specific, generic and individualized patient reported outcomes in low back pain","BACKGROUND: An individualized patient reported outcome (PRO) has recently been recommended within LBP research, but no study has evaluated this instrument with commonly applied PROs. Moreover, the impact of psychological factors has mostly been assessed for disease-specific instruments. The objective of this study was to assess the predictive value of illness perceptions, pain catastrophizing and psychological distress on 12 month outcomes assessed by specific, generic and individualized PROs recommended in low back pain (LBP). METHODS: Secondary analysis of patients with sub-acute or chronic LBP recruited for a cluster randomized controlled trial in primary care who completed a self-administered questionnaire at baseline and 12 months. 12 month scores for the Roland Morris Disability Questionnaire (RMDQ), the EuroQol (EQ-5D), and the Patient Generated Index (PGI) were dependent variables in hierarchical regression analysis. Independent variables included baseline scores for the Brief Illness Perceptions Questionnaire (Brief IPQ), Hopkins Symptom Check List (HSCL-25), Pain Catastrophizing Scale (PCS), health/clinical and sociodemographic variables. RESULTS: Of the 216 eligible patients included, 203 patients responded to the baseline questionnaire and 150 (74%) responded at 12 months. The mean age was 38.3 (SD 10.2) years and 57.6% were female. The Brief IPQ showed a statistically significant variation in the 12-months score of all the PROs, explaining 2.5% in RMDQ, 7.9% in EQ-5D, and 3.6% in PGI. Most of the explained variation for EQ-5D scores related to illness perceptions. The PCS explained 3.7% of the RMDQ and 2.5% in the EQ-5D scores. The HSCL-25 did not make a significant contribution. CONCLUSION: Illness perceptions and pain catastrophizing were associated with 12-month outcomes as assessed by condition-specific, generic and individualized PROs. The Brief IPQ and PCS have relevance to applications in primary care that include interventions designed to enhance psychological aspects of health and where the contribution of such variables to outcomes is of interest. Further studies should assess whether the Brief IPQ perform similarly in LBP populations in other health care settings."," Health Qual Life Outcomes 15(1999): 40.","Norway",2017,"Back Pain","Psychosocial","RMDQ","Adults","PRO study","RCT"]
[237,"Luo, M., et al. (2017). \"Comparison of Consecutive, Interval, and Skipped Pedicle Screw Techniques in Moderate Lenke Type 1 Adolescent Idiopathic Scoliosis.\" World Neurosurg 98: 563-570.",null,"Luo, M., et al.","Comparison of Consecutive, Interval, and Skipped Pedicle Screw Techniques in Moderate Lenke Type 1 Adolescent Idiopathic Scoliosis","OBJECTIVE: To compare perioperative, radiographic, and Scoliosis Research Society-22 (SRS-22) outcomes of consecutive, interval, and skipped pedicle screw techniques in patients with moderate Lenke type 1 adolescent idiopathic scoliosis (AIS). METHODS: We retrospectively reviewed 65 consecutive moderate Lenke type 1 AIS patients at a single institution using all-pedicle screw constructs, with a minimum of 2 years of follow-up. In the consecutive group (C group, n = 22), pedicle screws were instrumented at consecutive levels bilaterally. In the interval group (I group, n = 18), pedicle screws were placed at every level on the concave side while skipping levels on the convex side. In the skipped group (S group, n = 25), pedicle screws were instrumented by skipping levels bilaterally. Perioperative, radiographic, and SRS-22 measurements were analyzed with a 1-way analysis of variance. RESULTS: No significant differences were found in length of hospital stay, fused levels, coronal correction, and SRS-22 scores among the 3 groups. Increased surgery time was found in the C group compared with the I and S groups (P = 0.001 and P = 0.005, respectively). Decreased blood loss and blood transfusions were found in the S group compared with the C group (P = 0.04 and P = 0.047, respectively). Decreased implant costs were found in the S group compared with the C and I groups (P < 0.001 and P = 0.03, respectively). CONCLUSIONS: Consecutive, interval, and skipped pedicle screw techniques all provide satisfactory deformity correction and SRS-22 outcomes with few complications. With better perioperative outcomes, interval and skipped pedicle screw techniques are the more cost-effective options for patients with moderate Lenke type 1 AIS."," World Neurosurg 98: 563-570.","China",2017,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Retrospective review"]
[238,"Machado, D., et al. (2016). \"Abobotulinum Toxin A in the Treatment of Chronic Low Back Pain.\" Toxins (Basel) 8(12).",null,"Machado, D., et al.","Abobotulinum Toxin A in the Treatment of Chronic Low Back Pain","Chronic low back pain is a debilitating condition with a complex and multifactorial pathophysiology. Botulinum neurotoxins (BoNTs) have strong analgesic effects, as shown in both animal models of pain and in human beings. A randomized, double-blind, placebo-controlled, parallel format study to investigate the efficacy of abobotulinum toxin A (aboA) in chronic low back pain was conducted. The study cohort consisted of 18 patients who received 100 units of aboA into each of the five lumbar extensor spinae muscles unilaterally or bilaterally (total dose 500 to 1000 units), and 19 who received normal saline of the same volume. The level of pain and quality of life were assessed using the visual analogue scale (VAS) and three questionnaires including the Oswestry Low Back Pain Disability Questionnaire (OLBPDQ). Patients' perception of improvement was recorded via patient global impression of change (PGIC). The primary outcome measure, the proportion of responders with VAS of <4 at 6 weeks, was not met, but the data was significantly in favor of aboA at 4 weeks (p = 0.008). The total Oswestry score representing quality of life improved in the aboA group compared to the placebo group (p = 0.0448). Moreover, significantly more patients reported their low back pain as \"much improved\" in the abobotulinum toxin A group (0.0293)."," Toxins (Basel) 8(12).","USA",2016,"Back Pain","Abobotulinum toxin A","ODI","Unknown","PRO study","RCT"]
[239,"MacPherson, H., et al. (2013). \"Alexander Technique Lessons, Acupuncture Sessions or usual care for patients with chronic neck pain (ATLAS): study protocol for a randomised controlled trial.\" Trials 14: 209.",null,"MacPherson, H., et al.","Alexander Technique Lessons, Acupuncture Sessions or usual care for patients with chronic neck pain (ATLAS): study protocol for a randomised controlled trial","BACKGROUND: Chronic neck pain is a common condition in the adult population. More research is needed to evaluate interventions aiming to facilitate beneficial long-term change. We propose to evaluate the effect of Alexander Technique lessons and acupuncture in a rigorously conducted pragmatic trial with an embedded qualitative study. METHODS/DESIGN: We will recruit 500 patients who have been diagnosed with neck pain in primary care, who have continued to experience neck pain for at least three months with 28% minimum cut-off score on the Northwick Park Neck Pain Questionnaire (NPQ). We will exclude patients with serious underlying pathology, prior cervical spine surgery, history of psychosis, rheumatoid arthritis, ankylosing spondylitis, osteoporosis, haemophilia, cancer, HIV or hepatitis, or with alcohol or drug dependency currently or in the last 12 months, or actively pursuing compensation or with pending litigation.The York Trials Unit will randomly allocate participants using a secure computer-based system. We will use block randomisation with allocation to each intervention arm being unambiguously concealed from anyone who might subvert the randomisation process.Participants will be randomised in equal proportions to Alexander Technique lessons, acupuncture or usual care alone. Twenty 30-minute Alexander Technique lessons will be provided by teachers registered with the Society of Teachers of the Alexander Technique and twelve 50-minute sessions of acupuncture will be provided by acupuncturists registered with the British Acupuncture Council. All participants will continue to receive usual GP care.The primary outcome will be the NPQ at 12 months, with the secondary time point at 6 months, and an area-under-curve analysis will include 3, 6 and 12 month time-points. Adverse events will be documented. Potential intervention effect modifiers and mediators to be explored include: self-efficacy, stress management, and the incorporation of practitioner advice about self-care and lifestyle. Qualitative material will be used to address issues of safety, acceptability and factors that impact on longer term outcomes. DISCUSSION: This study will provide robust evidence on whether there are significant clinical benefits to patients, economic benefits demonstrating value for money, and sufficient levels of acceptability and safety. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15186354."," Trials 14: 209.","UK",2013,"Neck Pain,Cancer,Spondylosis","Acupuncture,Surgical","Northwick","Unknown","Protocol","RCT"]
[240,"MacPherson, H., et al. (2015). \"Alexander Technique Lessons or Acupuncture Sessions for Persons With Chronic Neck Pain: A Randomized Trial.\" Ann Intern Med 163(9): 653-662.",null,"MacPherson, H., et al.","Alexander Technique Lessons or Acupuncture Sessions for Persons With Chronic Neck Pain: A Randomized Trial","BACKGROUND: Management of chronic neck pain may benefit from additional active self-care-oriented approaches. OBJECTIVE: To evaluate clinical effectiveness of Alexander Technique lessons or acupuncture versus usual care for persons with chronic, nonspecific neck pain. DESIGN: Three-group randomized, controlled trial. (Current Controlled Trials: ISRCTN15186354). SETTING: U.K. primary care. PARTICIPANTS: Persons with neck pain lasting at least 3 months, a score of at least 28% on the Northwick Park Questionnaire (NPQ) for neck pain and associated disability, and no serious underlying pathology. INTERVENTION: 12 acupuncture sessions or 20 one-to-one Alexander lessons (both 600 minutes total) plus usual care versus usual care alone. MEASUREMENTS: NPQ score (primary outcome) at 0, 3, 6, and 12 months (primary end point) and Chronic Pain Self-Efficacy Scale score, quality of life, and adverse events (secondary outcomes). RESULTS: 517 patients were recruited, and the median duration of neck pain was 6 years. Mean attendance was 10 acupuncture sessions and 14 Alexander lessons. Between-group reductions in NPQ score at 12 months versus usual care were 3.92 percentage points for acupuncture (95% CI, 0.97 to 6.87 percentage points) (P = 0.009) and 3.79 percentage points for Alexander lessons (CI, 0.91 to 6.66 percentage points) (P = 0.010). The 12-month reductions in NPQ score from baseline were 32% for acupuncture and 31% for Alexander lessons. Participant self-efficacy improved for both interventions versus usual care at 6 months (P < 0.001) and was significantly associated (P < 0.001) with 12-month NPQ score reductions (acupuncture, 3.34 percentage points [CI, 2.31 to 4.38 percentage points]; Alexander lessons, 3.33 percentage points [CI, 2.22 to 4.44 percentage points]). No reported serious adverse events were considered probably or definitely related to either intervention. LIMITATION: Practitioners belonged to the 2 main U.K.-based professional associations, which may limit generalizability of the findings. CONCLUSION: Acupuncture sessions and Alexander Technique lessons both led to significant reductions in neck pain and associated disability compared with usual care at 12 months. Enhanced self-efficacy may partially explain why longer-term benefits were sustained. PRIMARY FUNDING SOURCE: Arthritis Research UK."," Ann Intern Med 163(9): 653-662.","Unknown",2015,"Neck Pain","Acupuncture","Northwick","Adults","PRO study","RCT"]
[241,"Mannion, A. F., et al. (2012). \"Reliability and validity of the cross-culturally adapted Italian version of the Core Outcome Measures Index.\" Eur Spine J 21 Suppl 6: S737-749.",null,"Mannion, A. F., et al.","Reliability and validity of the cross-culturally adapted Italian version of the Core Outcome Measures Index","Patient-orientated outcome questionnaires are essential for the assessment of treatment success in spine care. Standardisation of the instruments used is necessary for comparison across studies and in registries. The Core Outcome Measures Index (COMI) is a short, multidimensional outcome instrument validated for patients with spinal disorders and is the recommended outcome instrument in the Spine Society of Europe Spine Tango Registry; currently, no validated Italian version exists. A cross-cultural adaptation of the COMI into Italian was carried out using established guidelines. 96 outpatients with chronic back problems (>3 months) were recruited from five practices in Switzerland and Italy. They completed the newly translated COMI, the Roland Morris disability (RM), adjectival pain rating, WHO Quality of Life (WHOQoL), EuroQoL-5D, and EuroQoL-VAS scales. Reproducibility was assessed in a subgroup of 63 patients who returned a second questionnaire within 1 month and indicated no change in back status on a 5-point Likert-scale transition question. The COMI scores displayed no floor or ceiling effects. On re-test, the responses for each individual domain of the COMI were within one category in 100% patients for \"function\", 92% for \"symptom-specific well-being\", 100% for \"general quality of life\", 90% for \"social disability\", and 98% for \"work disability\". The intraclass correlation coefficients (ICC(2,1)) for the COMI back and leg pain items were 0.78 and 0.82, respectively, and for the COMI summary index, 0.92 (95% CI 0.86-0.95); this compared well with 0.84 for RM, 0.87 for WHOQoL, 0.79 for EQ-5D, and 0.77 for EQ-VAS. The standard error of measurement (SEM) for COMI was 0.54 points, giving a ''minimum detectable change'' for the COMI of 1.5 points. The scores for most of the individual COMI domains and the COMI summary index correlated to the expected extent (0.4-0.8) with the corresponding full-length reference questionnaires (r = 0.45-0.72). The reproducibility of the Italian version of the COMI was comparable to that published for the German and Spanish versions. The COMI scores correlated in the expected manner with existing but considerably longer questionnaires suggesting adequate convergent validity for the COMI. The Italian COMI represents a practical, reliable, and valid tool for use with Italian-speaking patients and will be of value for international studies and surgical registries."," Eur Spine J 21 Suppl 6: S737-749.","Switzerland",2012,"Spine Disease","Surgical","RMDQ","Unknown","Tool Validation","Prospective Observation"]
[242,"Markman, J. D., et al. (2015). \"Screening for neuropathic characteristics in failed back surgery syndromes: challenges for guiding treatment.\" Pain Med 16(3): 520-530.",null,"Markman, J. D., et al.","Screening for neuropathic characteristics in failed back surgery syndromes: challenges for guiding treatment","OBJECTIVE: Neuropathic pain screening tools have shown promise in identifying common neuropathic pain characteristics that derive from diverse etiologies (e.g., diabetic peripheral neuropathy, postherpetic neuralgia). However, no prior studies have specifically assessed whether these tools are capable of discerning the underlying pain mechanisms in the vast, heterogeneous group of patients diagnosed with failed back surgery syndrome (FBSS). DESIGN: In this clinical observational study, two tests for neuropathic pain characteristics, the Douleur Neuropathique en 4 (DN4) and Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) questionnaires, were performed on 43 subjects with FBSS. Subjects underwent physical or neurosensory exam components of the DN4 and LANSS in the region of most severe pain (e.g., axial low back or lower extremities). DN4 and LANSS scores were correlated with clinical history and neurologic exam, pain-related quality of life questionnaires, and compared to an independent assessment of pain distribution. RESULTS: The presence of neuropathic characteristics, determined by the DN4 (62% sensitivity, 44% specificity), LANSS (38% sensitivity, 75% specificity; cut-offs of 4 and 12, respectively), or their combination (20% sensitivity, 58% specificity) was associated with higher pain intensity as measured by the visual analog scale (DN4 > 4, P = 0.001; LANSS >/= 12, P = 0.042), modified Brief Pain Inventory-Short Form (DN4 > 4, P = 0.001; LANSS >/= 12, P = 0.082), and Neuropathic Pain Symptom Inventory (DN4 > 4, P = 0.001; LANSS >/= 12, P = 0.001), and greater pain-related functional impairment as measured by the Roland-Morris Disability Questionnaire (DN4 > 4, P = 0.006; LANSS >/= 12, P = 0.018). The percentage of subjects characterized as neuropathic by the DN4 and LANSS lacked concordance (67.4 vs. 25.6), and the distribution of most severe symptoms (i.e., axial vs radicular) did not correlate with subjects determined to have neuropathic pain. CONCLUSIONS: Unlike other neuropathic syndromes, the neuropathic component of FBSS is less reliably identified by the LANSS and DN4."," Pain Med 16(3): 520-530.","USA",2015,"Neuropathic Pain,Radiculopathy","Surgical","RMDQ","Unknown","PRO study","Observational"]
[243,"Martel, J., et al. (2011). \"A randomised controlled trial of preventive spinal manipulation with and without a home exercise program for patients with chronic neck pain.\" BMC Musculoskelet Disord 12: 41.",null,"Martel, J., et al.","A randomised controlled trial of preventive spinal manipulation with and without a home exercise program for patients with chronic neck pain","BACKGROUND: Evidence indicates that supervised home exercises, combined or not with manual therapy, can be beneficial for patients with non-specific chronic neck pain (NCNP). The objective of the study is to investigate the efficacy of preventive spinal manipulative therapy (SMT) compared to a no treatment group in NCNP patients. Another objective is to assess the efficacy of SMT with and without a home exercise program. METHODS: Ninety-eight patients underwent a short symptomatic phase of treatment before being randomly allocated to either an attention-group (n = 29), a SMT group (n = 36) or a SMT + exercise group (n = 33). The preventive phase of treatment, which lasted for 10 months, consisted of meeting with a chiropractor every two months to evaluate and discuss symptoms (attention-control group), 1 monthly SMT session (SMT group) or 1 monthly SMT session combined with a home exercise program (SMT + exercise group). The primary and secondary outcome measures were represented by scores on a 10-cm visual analog scale (VAS), active cervical ranges of motion (cROM), the neck disability index (NDI) and the Bournemouth questionnaire (BQ). Exploratory outcome measures were scored on the Fear-avoidance Behaviour Questionnaire (FABQ) and the SF-12 Questionnaire. RESULTS: Our results show that, in the preventive phase of the trial, all 3 groups showed primary and secondary outcomes scores similar to those obtain following the non-randomised, symptomatic phase. No group difference was observed for the primary, secondary and exploratory variables. Significant improvements in FABQ scores were noted in all groups during the preventive phase of the trial. However, no significant change in health related quality of life (HRQL) was associated with the preventive phase. CONCLUSIONS: This study hypothesised that participants in the combined intervention group would have less pain and disability and better function than participants from the 2 other groups during the preventive phase of the trial. This hypothesis was not supported by the study results. Lack of a treatment specific effect is discussed in relation to the placebo and patient provider interactions in manual therapies. Further research is needed to delineate the specific and non-specific effects of treatment modalities to prevent unnecessary disability and to minimise morbidity related to NCNP. Additional investigation is also required to identify the best strategies for secondary and tertiary prevention of NCNP. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00566930."," BMC Musculoskelet Disord 12: 41.","Canada",2011,"Neck Pain","Exercise","NDI","Unknown","PRO study","Clinical trial"]
[244,"Matamalas, A., et al. (2014). \"Body image in idiopathic scoliosis: a comparison study of psychometric properties between four patient-reported outcome instruments.\" Health Qual Life Outcomes 12: 81.",null,"Matamalas, A., et al.","Body image in idiopathic scoliosis: a comparison study of psychometric properties between four patient-reported outcome instruments","BACKGROUND: Four patient-reported outcome (PRO) instruments are commonly used to assess body image in idiopathic scoliosis (IS): the Quality of Life Profile for Spinal Deformities (QLPSD), SRS-22 Self-Image scale, Spinal Appearance Questionnaire (SAQ), and Trunk Appearance Perception Scale (TAPS). The aim of this study is to compare the psychometric properties of these instruments in patients with IS and report the translational/cultural adaptation of the SAQ to Spanish. METHODS: The four instruments in a Spanish version were administered to 80 patients with IS aged 10 to 40 years old. The sample was stratified according to scoliosis magnitude (less and more than 45 masculine). Analysis was also conducted for age groups. The psychometric properties studied included convergent and divergent construct validity, as well as internal consistency. Convergent validity was evaluated by correlation analysis between the self-image instruments and Cobb angle. Divergent validity was assessed with correlation analysis between PRO scores and SRS-22 dimensions scores such as Function, Pain and Mental Health. RESULTS: In the overall sample, each of the PRO instruments demonstrated high internal consistency (QLPSD Body Image, alpha = 0.80; SRS-22 Self Image, alpha = 0.78; SAQ, alpha = 0.89; TAPS, alpha = 0.87), also both for younger and adult patients subgroups. Correlation with curve magnitude was significant for each of the four scales. However, the correlation was higher for the pictorial scales (SAQ Appearance r = 0.61, TAPS r = -0.62) than for the textual scales (QLPSD-bi r = 0.36, SRS-22 Self-Image scale r = -0.41). In the younger group, correlation between Cobb angle and textual scales (QLPSD-bi and SRS-22 Self-Image Scale) was not significant. Body Image scales showed significant correlations with SRS-22 Pain, Function and Mental Health dimensions. CONCLUSIONS: All four instruments tested have good psychometric properties. Pictorial scales (SAQ Appearance and TAPS) correlated better with the radiological magnitude of the curve and this correlation is independent of age. Unexpectedly, all four scales demonstrated significant correlations with non-body image dimensions and the divergent hypothesis was not confirmed. Globally, pictorial scales showed slightly better construct validity to test body image perception than textual scales."," Health Qual Life Outcomes 12: 81.","Spain",2014,"Spinal Deformity","Not Specified","SRS-HRQOL,SAQ","Adults","Tool Validation","Observational"]
[245,"McMorland, G. and E. Suter (2000). \"Chiropractic management of mechanical neck and low-back pain: a retrospective, outcome-based analysis.\" J Manipulative Physiol Ther 23(5): 307-311.",null,"McMorland, G. and E. Suter","Chiropractic management of mechanical neck and low-back pain: a retrospective, outcome-based analysis","BACKGROUND: Evidence suggests that spinal manipulation is an effective treatment for mechanical neck and low-back pain (LBP). Treatment efficacy is important to establish for these symptoms because combined they account for a considerable amount of disability and substantial associated direct and indirect costs to society. OBJECTIVE: The purpose of this study was to examine the outcome of patients undergoing chiropractic treatment for mechanical neck or LBP. DESIGN AND SETTING: A retrospective, outcome-based analysis was done for patients seeking care at a private chiropractic practice over a 1-year period. A total of 512 files were reviewed, with 119 patients selected for inclusion. Patients were included if their chief symptom was uncomplicated mechanical neck or LBP. Diagnoses included cervical, lumbar, or sacroiliac joint sprain/strain (International Code of Diagnostics version 9 [ICD-9] code: 847.1, 847.3, 846.1, respectively), discogenic LBP (ICD-9: 722.1), and headaches (ICD-9: 784.0) because many patients with neck pain presented with concomitant headaches. Disability and pain were measured with the modified Oswestry scale (for the patients with LBP), Neck Disability Index, and an 11-box visual analogue pain scale before and after treatment. Treatment consisted of spinal manipulation, various soft-tissue techniques, home-care instructions, and ergonomic and return-to-activity advice, including rehabilitative exercises. Patients received an average of 12 treatments over a 4-week period. Statistical analysis was performed on pretreatment and posttreatment values for both disability and pain. Stratification was based on duration (acute/subacute, chronic, acute exacerbation of a chronic condition) and severity (mild, moderate, or severe) of symptoms. RESULTS: Statistically significant reductions in disability and pain scores were achieved in all groups. An average 52.5% and 52.9% reduction in pain and disability, respectively, was achieved in the low-back group. The chronic LBP group realized a less statistically significant reduction of pain and disability (19.7% and 19.8%, respectively) than the acute/subacute (66.8% and 62.5%) or the chronic/recurrent group (56. 5% and 63.4%). The differences were statistically significant. Patients with neck pain had an average 53.8% and 48.4% reduction in their pain and disability, respectively. Patients with concomitant neck pain and headaches had statistically significant higher pretreatment and posttreatment disability and pain scores than those with only neck pain. There was no statistically significant difference in outcomes between groups stratified according to pain intensity. CONCLUSIONS: Patients attending a private chiropractic clinic for treatment of mechanical neck pain or LBP had statistically significant reductions in their pain-related disability after treatment. These results indicate that chiropractic manipulation is beneficial for the treatment of mechanical neck pain and LBP. However, care must be taken when drawing conclusions from these outcomes. The study design does not account for the natural history of low back- or neck pain-related disability and therefore does not allow for claims of treatment efficacy. In addition, it has been suggested that patients presenting to medical doctors with these symptoms have significant overlying comorbidity when compared with patients presenting to a chiropractor."," J Manipulative Physiol Ther 23(5): 307-311.","Canada",2000,"Back Pain,Neck Pain","Exercise","ODI,NDI","Unknown","PRO study","Retrospective review"]
[246,"Mekhail, N., et al. (2012). \"Functional and patient-reported outcomes in symptomatic lumbar spinal stenosis following percutaneous decompression.\" Pain Pract 12(6): 417-425.",null,"Mekhail, N., et al.","Functional and patient-reported outcomes in symptomatic lumbar spinal stenosis following percutaneous decompression","BACKGROUND: Neurogenic claudication due to symptomatic lumbar spinal stenosis (LSS) is a painful condition causing significant functional disability. While the cause of LSS is multifactorial, thickened ligamentum flavum (LF) accounts for up to 85% of spinal canal narrowing. mild percutaneous lumbar decompression allows debulking of the hypertrophic LF while avoiding the morbidities frequently associated with more invasive surgical procedures. METHODS: In this prospective case series study, consecutive LSS patients presenting with neurogenic claudication were treated with percutaneous lumbar decompression. Efficacy was evaluated using the Pain Disability Index (PDI) and Roland-Morris Disability Questionnaire. Pre- and postprocedure Standing Time, Walking Distance, and Visual Analog Score (VAS) were also monitored. Significant device- or procedure-related adverse events were reported. RESULTS: The mild procedure was successfully performed on forty patients. At twelve months, both PDI and Roland-Morris showed significant improvement of 22.6 points (ANOVA, P<0.0001) and 7.7 points (ANOVA, P<0.0001), respectively. Walking Distance, Standing Time, and VAS improvements were also statistically significant, increasing from 246 to 3,956 feet (ANOVA, P<0.0001), 8 to 56 minutes (ANOVA, P<0.0001), and 7.1 to 3.6 points (ANOVA, P<0.0001), respectively. Tukey HSD test found improvement in all 5-outcome measures to be significant from baseline at each follow-up interval. No significant device- or procedure-related adverse events were reported. CONCLUSION: This study demonstrated significant functional improvement as well as decreased disability secondary to neurogenic claudication after mild procedure. Safety, cost-effectiveness, and quality-of-life outcomes are best compared with comprehensive medical management in a randomized controlled fashion and, where ethical, to open lumbar decompression surgery."," Pain Pract 12(6): 417-425.","USA",2012,"Spine Disease","Surgical","RMDQ","Unknown","PRO study","RCT"]
[247,"Miekisiak, G., et al. (2014). \"Reliability and validity of the Polish version of the Core Outcome Measures Index for the neck.\" Eur Spine J 23(4): 898-903.",null,"Miekisiak, G., et al.","Reliability and validity of the Polish version of the Core Outcome Measures Index for the neck","PURPOSE: Patient reported outcome measures play an increasingly important role in the outcomes research. The Core Outcome Measures Index (COMI) is a short, multidimensional instrument initially developed for the use by patients with low back pain. This study is an evaluation of a Polish version of COMI adapted for neck pain. METHODS: One hundred twenty-three patients complaining of neck pain were enrolled. All of them completed a questionnaire booklet containing COMI-neck, Neck Disability Index and Likert-type questions regarding the frequency of use of pain medications and pain frequency. Ninety-eight patients returned the retest questionnaire. Data quality was also assessed. Assessment of psychometric properties included examination of data quality, construct validity, test-retest reliability and factor analysis. RESULTS: The quality of data was good with no missing answers and a little floor effect. Exploratory factor analysis revealed a single-factor structure. Reliability expressed as intraclass correlation coefficient was 0.88 (95% CI 0.84-0.92) for the overall COMI score and was generally good for most of individual core items. The minimum detectable change (MDC95%) was 1.97. CONCLUSION: This version of the COMI-neck is a valid and reliable instrument, with good psychometric properties. It can be recommended for Polish-speaking patients."," Eur Spine J 23(4): 898-903.","Poland",2014,"Back Pain,Neck Pain","Not Specified","NDI","Unknown","PRO study","Prospective Observation"]
[248,"Miller, L. E. and J. E. Block (2011). \"Safety and effectiveness of bone allografts in anterior cervical discectomy and fusion surgery.\" Spine (Phila Pa 1976) 36(24): 2045-2050.",null,"Miller, L. E. and J. E. Block","Safety and effectiveness of bone allografts in anterior cervical discectomy and fusion surgery","STUDY DESIGN: Systematic review. OBJECTIVE: The primary aim of this review was to evaluate clinical and radiographic outcomes in studies of anterior cervical discectomy and fusion (ACDF) using allograft versus ACDF with autograft, ACDF with cage devices, and cervical disc arthroplasty for the treatment of symptomatic cervical disc disease. SUMMARY OF BACKGROUND DATA: ACDF remains the standard of care for patients with cervical radiculopathy who are unresponsive to conservative medical care. However, no known study has compared patient outcomes after ACDF with allograft, ACDF with autograft, ACDF with cage, and disc arthroplasty. METHODS: After applying strict inclusion criteria, 21 comparisons from 20 studies formed the basis for this review. Patient outcomes included neck and arm pain, neck disability index (NDI), physical component summary (PCS), and mental component summary (MCS) scores from the SF-36, radiographic fusion rate, and select adverse events (e.g., wound infection, dysphagia, and adjacent segment degeneration). RESULTS: The four treatment groups included ACDF with allograft (allograft, n = 1341), ACDF with autograft (autograft, n = 568), ACDF with cage (cage, n = 87), and cervical disc arthroplasty (arthroplasty, n = 603). Neck pain was reduced similarly by 63% to 69% in all groups. Comparable improvements were realized in arm pain after ACDF with allograft (75%) or arthroplasty (73%) that were greater than other treatment groups (62-68%). There was notable improvement in neck disability (61-65%) with allograft and arthroplasty after treatment. PCS scores improved with allograft (42%) and arthroplasty (44%). MCS scores improved modestly (16-21%) with allograft and arthroplasty. Fusion rates were 91% for allograft and autograft and 97% for cage. Adverse events were uncommon in all groups. CONCLUSION: ACDF with allograft, ACDF with autograft, ACDF with cage, and cervical disc arthroplasty show similar improvements in pain, function, and quality of life with correspondingly low adverse event rates. All ACDF procedures result in high fusion rates."," Spine (Phila Pa 1976) 36(24): 2045-2050.","USA",2011,"Neck Pain,Radiculopathy","Surgical","NDI","Unknown","PRO study","Retrospective review"]
[249,"Moffett, J. K., et al. (1999). \"Randomised controlled trial of exercise for low back pain: clinical outcomes, costs, and preferences.\" Bmj 319(7205): 279-283.",null,"Moffett, J. K., et al.","Randomised controlled trial of exercise for low back pain: clinical outcomes, costs, and preferences","OBJECTIVE: To evaluate effectiveness of an exercise programme in a community setting for patients with low back pain to encourage a return to normal activities. DESIGN: Randomised controlled trial of progressive exercise programme compared with usual primary care management. Patients' preferences for type of management were elicited independently of randomisation. PARTICIPANTS: 187 patients aged 18-60 years with mechanical low back pain of 4 weeks to 6 months' duration. INTERVENTIONS: Exercise classes led by a physiotherapist that included strengthening exercises for all main muscle groups, stretching exercises, relaxation session, and brief education on back care. A cognitive-behavioural approach was used. MAIN OUTCOME MEASURES: Assessments of debilitating effects of back pain before and after intervention and at 6 months and 1 year later. Measures included Roland disability questionnaire, Aberdeen back pain scale, pain diaries, and use of healthcare services. RESULTS: At 6 weeks after randomisation, the intervention group improved marginally more than the control group on the disability questionnaire and reported less distressing pain. At 6 months and 1 year, the intervention group showed significantly greater improvement in the disability questionnaire score (mean difference in changes 1.35, 95% confidence interval 0.13 to 2.57). At 1 year, the intervention group also showed significantly greater improvement in the Aberdeen back pain scale (4.44, 1.01 to 7.87) and reported only 378 days off work compared with 607 in the control group. The intervention group used fewer healthcare resources. Outcome was not influenced by patients' preferences. CONCLUSIONS: The exercise class was more clinically effective than traditional general practitioner management, regardless of patient preference, and was cost effective."," Bmj 319(7205): 279-283.","UK",1999,"Back Pain","Exercise","Aberdeen LBP","Adults","Cost and Resource Use","RCT"]
[250,"Moffett, J. K., et al. (2006). \"Randomized trial of two physiotherapy interventions for primary care neck and back pain patients: 'McKenzie' vs brief physiotherapy pain management.\" Rheumatology (Oxford) 45(12): 1514-1521.",null,"Moffett, J. K., et al.","Randomized trial of two physiotherapy interventions for primary care neck and back pain patients: 'McKenzie' vs brief physiotherapy pain management","OBJECTIVES: Interventions that take psychosocial factors into account are recommended for patients with persistent back or neck pain. We compared the effectiveness of a brief physiotherapy pain management approach using cognitive-behavioural principles (Solution-Finding Approach-SFA) with a commonly used method of physical therapy (McKenzie Approach-McK). METHODS: Eligible patients referred by GPs to physiotherapy departments with neck or back pain lasting at least 2 weeks were randomized to McK (n= 161) or to SFA (n= 154). They were further randomized to receive an educational booklet or not. The primary outcome was the Tampa Scale of Kinesiophobia (TSK) (Activity-Avoidance scale used as a proxy for coping) at 6 weeks, and 6 and 12 months. RESULTS: Of 649 patients assessed for eligibility, 315 were recruited (219 with back pain, 96 with neck pain). There were no statistically significant differences in outcomes between the groups, except that at any time point SFA patients supported by a booklet reported less reliance on health professionals (Multidimensional Health Locus of Control Powerful Others Scale), while at 6 months McK patients showed slightly more improvement on activity-avoidance (TSK). At 6 weeks, patient satisfaction was greater for McK (median 90% compared with 70% for SFA). Both interventions resulted in modest but clinically important improvements over time on the Roland Disability Questionnaire Scores and Northwick Park Neck Pain Scores. CONCLUSIONS: The McK approach resulted in higher patient satisfaction overall but the SFA could be more cost-effective, as fewer (three vs four) sessions were needed."," Rheumatology (Oxford) 45(12): 1514-1521.","UK",2006,"Neck Pain","Physical Therapy","RMDQ,Northwick","Unknown","PRO study","RCT"]
[251,"Monticone, M., et al. (2010). \"Development of the Italian version of the revised Scoliosis Research Society-22 Patient Questionnaire, SRS-22r-I: cross-cultural adaptation, factor analysis, reliability, and validity.\" Spine (Phila Pa 1976) 35(24): E1412-1417.",null,"Monticone, M., et al.","Development of the Italian version of the revised Scoliosis Research Society-22 Patient Questionnaire, SRS-22r-I: cross-cultural adaptation, factor analysis, reliability, and validity","STUDY DESIGN: Evaluation of the psychometric properties of a translated and culturally adapted questionnaire. OBJECTIVE: Translating, culturally adapting, and validating the Italian version of the revised Scoliosis Research Society-22 Patient Questionnaire (SRS-22r-I) in order to allow its use with Italian-speaking patients with adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: Increasing attention is being given to health-related quality of life measures as a means of adding information about the evaluation of AIS. A translated form of the revised SRS-22 has never been validated in Italian patients with AIS. METHODS: The development of the SRS-22 questionnaire involved its translation and back-translation, a final review by an Expert Committee, and testing of the prefinal version to establish its correspondence to the original English version. Psychometric testing included factor analysis, reliability by internal consistency (Cronbach alpha) and test-retest repeatability (Intraclass Coefficient Correlation), and concurrent validity (Pearson correlation) by comparing the SRS-22r-I domains with the Short-Form Health Survey (SF-36) subscales. RESULTS: It took 4 months to develop a shared version of the SRS-22r-I, which proved to be satisfactorily acceptable when administered to 223 subjects with AIS. Factor analysis indicated a 4-factor solution (54% of the explained variance), and the questionnaire had an acceptable level of internal consistency (alpha = 0.77) and a high level of test-retest reliability (intraclass correlation coefficient = 0.957). In terms of concurrent validity, the correlations with the related Short-Form-36 subscales were moderate to good in the case of the Pain and Mental Health domains, and moderate in the case of the Function and Self-Image domains. CONCLUSION: The Italian translation of the SRS-22r has a good factorial structure and psychometric properties, and replicates the results of existing English versions of the questionnaire. Its use for research purposes can therefore be recommended."," Spine (Phila Pa 1976) 35(24): E1412-1417.","Italy",2010,"Spinal Deformity","Psychosocial","SRS-HRQOL","Adolescents","Tool Validation","Observational"]
[252,"Monticone, M., et al. (2014). \"Active self-correction and task-oriented exercises reduce spinal deformity and improve quality of life in subjects with mild adolescent idiopathic scoliosis. Results of a randomised controlled trial.\" Eur Spine J 23(6): 1204-1214.",null,"Monticone, M., et al.","Active self-correction and task-oriented exercises reduce spinal deformity and improve quality of life in subjects with mild adolescent idiopathic scoliosis. Results of a randomised controlled trial","PURPOSE: To evaluate the effect of a programme of active self-correction and task-oriented exercises on spinal deformities and health-related quality of life (HRQL) in patients with mild adolescent idiopathic scoliosis (AIS) (Cobb angle <25 degrees ). METHODS: This was a parallel-group, randomised, superiority-controlled study in which 110 patients were randomly assigned to a rehabilitation programme consisting of active self-correction, task-oriented spinal exercises and education (experimental group, 55 subjects) or traditional spinal exercises (control group, 55 subjects). Before treatment, at the end of treatment (analysis at skeletal maturity), and 12 months later (follow-up), all of the patients underwent radiological deformity (Cobb angle), surface deformity (angle of trunk rotation) and HRQL evaluations (SRS-22 questionnaire). A linear mixed model for repeated measures was used for each outcome measure. RESULTS: There were main effects of time (p < 0.001), group (p < 0.001) and time by group interaction (p < 0.001) on radiological deformity: training in the experimental group led to a significant improvement (decrease in Cobb angle of >5 degrees ), whereas the control group remained stable. Analysis of all of the secondary outcome measures revealed significant effects of time, group and time by group interaction in favour of the experimental group. CONCLUSIONS: The programme of active self-correction and task-oriented exercises was superior to traditional exercises in reducing spinal deformities and enhancing the HRQL in patients with mild AIS. The effects lasted for at least 1 year after the intervention ended."," Eur Spine J 23(6): 1204-1214.","Italy",2014,"Spinal Deformity","Exercise","SRS-HRQOL","Adolescents","PRO study","RCT"]
[253,"Moorthy, R. K., et al. (2005). \"Quantitative changes in gait parameters after central corpectomy for cervical spondylotic myelopathy.\" J Neurosurg Spine 2(4): 418-424.",null,"Moorthy, R. K., et al.","Quantitative changes in gait parameters after central corpectomy for cervical spondylotic myelopathy","OBJECT: In this study, quantitative gait analysis is used to describe the changes in the kinematic and kinetic parameters of gait after central corpectomy in patients with cervical spondylotic myelopathy (CSM). METHODS: Six men with CSM that was categorized preoperatively as Nurick Grade 3 or 4 were assessed using quantitative gait analysis. The values of various kinematic and kinetic parameters, physiological cost index, and range of motion (ROM) in the lower-limb joints were computed preoperatively as well as at follow-up review 12 months or more postoperatively. Patients also received scores based on the Nurick and Japanese Orthopaedic Association (JOA) lower-limb functional scales pre- and postoperatively. The mean Nurick grade improved from 3.3 to 2 (p = 0.02) and the mean JOA lower-limb score improved from 4.2 to 6 (p = 0.02). The forward ground reaction force showed a statistically significant increase from 10.8+/-4.1% body weight to 12.1+/-3.6% body weight (p = 0.04). There was a significant improvement in the ROM at the knees, from 48.6+/-7.7 degrees to 54.2+/-5.2 degrees (p = 0.03). There was an increase in the mean walking speed, stride length, percentage of single-limb support time, vertical and backward ground reaction forces, and ROM at the hips in the postoperative gait analysis. These results indicate an improved stability of gait as well as greater flexibility in the knee after decompression of the spinal cord. These changes correlated with an improvement in the functional status of patients with CSM after central corpectomy. CONCLUSIONS: Gait analysis can be used as a quantitative tool in the pre- and postoperative evaluation of patients with CSM."," J Neurosurg Spine 2(4): 418-424.","India",2005,"Spondylosis","Surgical","Nurick","Unknown","PRO study","Observational"]
[254,"Morone, G., et al. (2011). \"Quality of life improved by multidisciplinary back school program in patients with chronic non-specific low back pain: a single blind randomized controlled trial.\" Eur J Phys Rehabil Med 47(4): 533-541.",null,"Morone, G., et al.","Quality of life improved by multidisciplinary back school program in patients with chronic non-specific low back pain: a single blind randomized controlled trial","STUDY DESIGN: A three and six months follow-up in a randomized controlled trial. BACKGROUND: Back School has become a widespread exercise program for low back pain (LBP), since its introduction in 1969. Back School could improve quality of life (QoL), but there are controversial data regarding its effectiveness. AIM: To evaluate the effects of the Back School program on quality of life (primary outcome), disability and pain perceptions (secondary outcomes) in patients with chronic and non-specific low back pain. SETTING: Rehabilitative specialized centre. POPULATION: Seventy four patients with chronic non-specific LBP. METHODS: Patients were randomly placed in a 3:2 form and were allocated into 2 groups (treated-control). Treatment group participated in a intensive multidisciplinary Back School program including brief education and active back exercises (BSG, N.=41), while the control group received medical assistance (CG, N.=29). Medication was the same in both groups. The Short Form 36 Health Status Survey, Waddel Index, Oswestry Disability Index and Visual Analogue Scale were collected at baseline, at the end of treatment, and at the three and six month follow-up. RESULTS: Quality of life significantly improved along time more in BSG, both in Physical and Mental Composite Score (repeated measure Anova: interaction time per group: P<0.001 and P=0.002, respectively). We also observed a significant improvement in disability scores along time (P<0.001) in BSG with significant differences between groups at three and at six months for Waddell Index (P=0.006 and P=0.009 respectively) and for Oswestry Disability Index (P=0.018 and 0.011 respectively). Moreover, pain perception score VAS showed a reduction in both groups, but it was significantly lower in BSG at end of treatment and both follow-ups (P<0.001). CONCLUSION: Our Back School program can be considered an effective treatment in people with chronic non-specific LBP."," Eur J Phys Rehabil Med 47(4): 533-541.","Italy",2011,"Back Pain","Exercise","ODI,RMDQ,WADDEL","Unknown","PRO study","RCT"]
[255,"Morone, N. E., et al. (2016). \"A Mind-Body Program for Older Adults With Chronic Low Back Pain: A Randomized Clinical Trial.\" JAMA Intern Med 176(3): 329-337.",null,"Morone, N. E., et al.","A Mind-Body Program for Older Adults With Chronic Low Back Pain: A Randomized Clinical Trial","IMPORTANCE: Treatment of chronic low back pain (LBP) in older adults is limited by the adverse effects of analgesics. Effective nonpharmacologic treatment options are needed. OBJECTIVE: To determine the effectiveness of a mind-body program at increasing function and reducing pain in older adults with chronic LBP. DESIGN, SETTING, AND PARTICIPANTS: This single-blind, randomized clinical trial compared a mind-body program (n = 140) with a health education program (n = 142). Community-dwelling older adults residing within the Pittsburgh metropolitan area were recruited from February 14, 2011, to June 30, 2014, with 6-month follow-up completed by April 9, 2015. Eligible participants were 65 years or older with functional limitations owing to their chronic LBP (>/=11 points on the Roland and Morris Disability Questionnaire) and chronic pain (duration >/=3 months) of moderate intensity. Data were analyzed from March 1 to July 1, 2015. INTERVENTIONS: The intervention and control groups received an 8-week group program followed by 6 monthly sessions. The intervention was modeled on the Mindfulness-Based Stress Reduction program; the control program, on the \"10 Keys\" to Healthy Aging. MAIN OUTCOMES AND MEASURES: Follow-up occurred at program completion and 6 months later. The score on the Roland and Morris Disability Questionnaire was the primary outcome and measured functional limitations owing to LBP. Pain (current, mean, and most severe in the past week) was measured with the Numeric Pain Rating Scale. Secondary outcomes included quality of life, pain self-efficacy, and mindfulness. Intent-to-treat analyses were conducted. RESULTS: Of 1160 persons who underwent screening, 282 participants enrolled in the trial (95 men [33.7%] and 187 women [66.3%]; mean [SD] age,74.5 [6.6] years). The baseline mean (SD) Roland and Morris Disability Questionnaire scores for the intervention and control groups were 15.6 (3.0) and 15.4 (3.0), respectively. Compared with the control group, intervention participants improved an additional -1.1 (mean, 12.1 vs 13.1) points at 8 weeks and -0.04 (mean, 12.2 vs 12.6) points at 6 months (effect sizes, -0.23 and -0.08, respectively) on the Roland and Morris Disability Questionnaire. By 6 months, the intervention participants improved on the Numeric Pain Rating Scale current and most severe pain measures an additional -1.8 points (95% CI, -3.1 to -0.05 points; effect size, -0.33) and -1.0 points (95% CI, -2.1 to 0.2 points; effect size, -0.19), respectively. The changes in Numeric Pain Rating Scale mean pain measure after the intervention were not significant (-0.1 [95% CI, -1.1 to 1.0] at 8 weeks and -1.1 [95% CI, -2.2 to -0.01] at 6 months; effect size, -0.01 and -0.22, respectively). CONCLUSIONS AND RELEVANCE: A mind-body program for chronic LBP improved short-term function and long-term current and most severe pain. The functional improvement was not sustained, suggesting that future development of the intervention could focus on durability. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01405716."," JAMA Intern Med 176(3): 329-337.","USA",2016,"Back Pain","Psychosocial","RMDQ","Adults","PRO study","RCT"]
[256,"Morr, S., et al. (2015). \"Skipped versus consecutive pedicle screw constructs for correction of Lenke 1 curves.\" Eur Spine J 24(7): 1473-1480.",null,"Morr, S., et al.","Skipped versus consecutive pedicle screw constructs for correction of Lenke 1 curves","PURPOSE: Thoracic pedicle screws provide superior curve correction to hook and wire constructs in adolescent idiopathic scoliosis, while increasing cost. The number of implants required for best correction and outcome has not yet been determined. METHODS: We retrospectively reviewed pre- and post-operative radiographs and self-reported outcome measures in an age- and curve-matched cohort of 40 patients with Lenke I AIS who underwent selective fusions between T3/4 and L1. Twenty patients were treated with thoracic pedicle screws at every level bilaterally (CON) and 20 patients with screws at every level on the concave side and skipped levels on the convex side of the curve (SKP). All patients had a minimum 2-year follow-up. Radiographs were assessed for coronal and sagittal curvatures, as well as thoracic torsion and vertebral rotation. Health-related quality of life was assessed using the SRS-22 instrument. Instrumentation cost data were collected for each case. RESULTS: Postoperative follow-up averaged 28 months for the CON group and 29 months for the SKP group. No statistically significant differences were found between groups with respect to age and pre- and post-operative radiographic parameters. Both constructs provided acceptable correction of the main thoracic curves (66.9 vs. 66.6 %, CON group and SKP group, respectively; p = 0.92), and spontaneous correction of the proximal thoracic (41.5 vs. 41.1 %; p = 0.92) and thoracolumbar/lumbar curves (54.8 vs. 54.3 %; p = 0.92). No significant difference was found in postoperative SRS-22 scores (96 vs. 94.3; p = 0.34). The CON group cost for instrumentation was significantly higher than the SKP group ($19,500 vs. $13,300; p = 0.002). There was no statistically significant difference in operating room times between groups. CONCLUSION: Both construct types provide excellent coronal correction and sagittal balance, with no significant differences in radiographic findings or clinical outcomes. A significant decrease in cost was found with use of skipped screw constructs."," Eur Spine J 24(7): 1473-1480.","USA",2015,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Retrospective review"]
[257,"Morris, T., et al. (2015). \"Can we convert between outcome measures of disability for chronic low back pain?\" Spine (Phila Pa 1976) 40(10): 734-739.",null,"Morris, T., et al.","Can we convert between outcome measures of disability for chronic low back pain?","STUDY DESIGN: Retrospective database analysis. OBJECTIVE: A range of patient-reported outcomes were used to measure disability due to low back pain. There is not a single back pain disability measurement commonly used in all randomized controlled trials. We report here our assessment as to whether different disability measures are sufficiently comparable to allow data pooling across trials. SUMMARY OF BACKGROUND DATA: We used individual patient data from a repository of data from back pain trials of therapist-delivered interventions. METHODS: We used data from 11 trials (n=6089 patients) that had at least 2 of the following 7 measurements: Roland-Morris Disability Questionnaire, Chronic Pain Grade disability score, Physical Component Summary of the 12- or 36-Item Short Form Health Survey, Patient Specific Functional Scale, Pain Disability Index, Oswestry Disability Index, and Hannover Functional Ability Questionnaire. Within each trial, the change score between baseline and short-term follow-up was computed for each outcome and this was used to calculate the correlation between the change scores and the Cohen's kappa for the 3-level outcome of change score of less than, equal to, and more than zero. It was considered feasible to pool 2 measures if they were at least moderately correlated (correlation>0.5) and have at least moderately similar responsiveness (kappa>0.4). RESULTS: Although all pairs of measures were found to be positively correlated, most correlations were less than 0.5, with only 1 pair of outcomes in 1 trial having a correlation of more than 0.6. All kappa statistics were less than 0.4 so that in no cases were the criteria for acceptability of pooling measures satisfied. CONCLUSION: The lack of agreement between different outcome measures means that pooling of data on these different disability measurements in a meta-analysis is not recommended. LEVEL OF EVIDENCE: 2."," Spine (Phila Pa 1976) 40(10): 734-739.","UK",2015,"Back Pain","Not Specified","ODI,RMDQ","Unknown","PRO study","Retrospective review"]
[258,"Mousavi, S. J., et al. (2010). \"Reliability and validity of the persian version of the scoliosis research society-22r questionnaire.\" Spine (Phila Pa 1976) 35(7): 784-789.",null,"Mousavi, S. J., et al.","Reliability and validity of the persian version of the scoliosis research society-22r questionnaire","STUDY DESIGN: Cross-sectional validation study to investigate psychometric properties of adapted Persian version of the Scoliosis Research Society-22r (SRS-22r) questionnaire. OBJECTIVES.: To translate the SRS-22r into Persian and to evaluate the internal consistency, reliability, and validity of the Persian SRS-22r. SUMMARY OF BACKGROUND DATA: The SRS-22r has not been translated and validated for Persian-speaking patients with idiopathic scoliosis. This was to provide a validated instrument to measure health-related quality of life in patients with idiopathic scoliosis in Iran. METHODS: The translation and cultural adaptation of the original questionnaire were carried out in accordance with the published guidelines. About 84 patients with adolescent idiopathic scoliosis were participated in the study. The Short Form Health Survey (SF-36) was used to test convergent validity of the Persian SRS-22r. RESULTS: Moderate to high correlations were found between the SRS-22r domains and SF-36 subscales. The correlations ranged from 0.54 to 0.67 (function/activity domain), 0.48 to 0.74 (pain domain), 0.45 to 0.55 (self image domain), 0.66 to 0.85 (mental health domain), and 0.35 to 0.55 (satisfaction domain) (P < 0.01). One-way analysis of variance showed that the Persian questionnaire successfully discriminated between patients undergoing observation, brace, and surgical treatments (P < 0.05). Cronbach alpha coefficient for the Persian SRS-22r domains ranged from 0.68 to 0.78. The Persian SRS-22rdomains showed satisfactory test-retest reliability with Intraclass Correlation Coefficient ranged from 0.79 to 0.87 (P < 0.01). CONCLUSION: The Persian version of the SRS-22r has satisfactory reliability, convergent validity, and discriminant validity to measure health-related quality of life in adolescent patients with scoliosis in Iran. It is simple and easy to use and now can be applied in clinical settings and future outcome studies in Iran."," Spine (Phila Pa 1976) 35(7): 784-789.","USA",2010,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","Tool Validation","Observational"]
[259,"Muehlbacher, M., et al. (2006). \"Topiramate in treatment of patients with chronic low back pain: a randomized, double-blind, placebo-controlled study.\" Clin J Pain 22(6): 526-531.",null,"Muehlbacher, M., et al.","Topiramate in treatment of patients with chronic low back pain: a randomized, double-blind, placebo-controlled study","OBJECTIVE: Chronic low back pain (CLBP) is a widespread ailment. The aim of this study was to assess the efficacy of topiramate in the treatment of CLBP and the changes in anger status and processing, body weight, subjective pain-related disability and health-related quality of life during the course of treatment. METHODS: We conducted a 10-week, randomized, double-blind, placebo-controlled study of topiramate in 96 (36 women) patients with CLBP. The subjects were randomly assigned to topiramate (n=48) or placebo (n=48). Primary outcome measures were changes on the McGill Pain Questionnaire, State-Trait Anger Expression Inventory, Oswestry Low Back Pain Disability Questionnaire and SF-36 Health Survey scales, and in body weight. RESULTS: In comparison with the placebo group (according to the intent-to-treat principle), significant changes on the pain rating index of McGill Pain Questionnaire (Ps<0.001), State-Trait Anger Expression Inventory Scales (all Ps<0.001), Oswestry Low Back Pain Disability Questionnaire (P<0.001), and SF-36 Health Survey scales (all P<0.001, except on the role-emotional scale) were observed after 10 weeks in the patients treated with topiramate. Weight loss was also observed and was significantly more pronounced in the group treated with topiramate than in those treated with placebo (P<0.001). Most patients tolerated topiramate relatively well but 2 patients dropped out because of side effects. DISCUSSION: Topiramate seems to be a relatively safe and effective agent in the treatment of CLBP. Significantly positive changes in pain sensitivity, anger status and processing, subjective disability, health-related quality of life, and loss of weight were observed."," Clin J Pain 22(6): 526-531.","Austria",2006,"Back Pain","Topiramate","ODI","Unknown","PRO study","RCT"]
[260,"Muller, C., et al. (2011). \"Prospective evaluation of physical activity in patients with idiopathic scoliosis or kyphosis receiving brace treatment.\" Eur Spine J 20(7): 1127-1136.",null,"Muller, C., et al.","Prospective evaluation of physical activity in patients with idiopathic scoliosis or kyphosis receiving brace treatment","Bracing is an established method of conservative treatment for adolescent idiopathic scoliosis and kyphosis. Compliance among adolescents is frequently inadequate due to the discomfort of wearing a brace, cosmetic issues, and fear on the part of patients and parents that bracing may reduce everyday physical activities. The aim of this prospective, controlled study was to objectify the impact of spinal bracing on daily step activity in patients receiving conservative treatment for adolescent idiopathic scoliosis (AIS) or adolescent kyphosis (AK). Forty-eight consecutive patients (mean age 13.4 +/- 2.3 years), consisting of 38 AIS patients (33 girls, 5 boys) and 10 AK patients (6 girls, 4 boys) were included. Once the decision to carry out bracing had been taken and while the patients were waiting for the individual brace to be built, step activity was assessed without braces by means of step activity monitoring (SAM) for seven consecutive days. After 8 weeks of brace wearing, step activity was assessed during regular brace treatment, again for seven consecutive days. In addition, brace-wearing times were simultaneously recorded using temperature probes implanted in the braces to measure compliance. Before and during brace treatment, patients completed the Scoliosis Research Society (SRS-22) questionnaire. The SAM was worn for an average of 12.7 +/- 1.5 h/day during the first measurement and 12.3 +/- 1.9 h on average during the second measurement. The mean gait cycles (GCs) per day and per hour before treatment were 5,036 +/- 1,465 and 395 +/- 105, respectively. No significant reduction in step activity was found at the follow-up measurement during bracing, at 4,880 +/- 1,529 GCs/day and 403 +/- 144 GCs/h. Taking the 23-h recommended time for brace wearing as a basis (100%), patients wore the brace for 72.7 +/- 27.6% of the prescribed time, indicating an acceptable level of compliance. Girls showed a higher compliance level (75.6 +/- 25.6%) in comparison with boys (56.7 +/- 31.9%), although the difference was not significant (P = 0.093). The SRS-22 total score showed no differences between the two measurements (2.57 +/- 0.23 vs. 2.56 +/- 0.28). Implementing a simultaneous and objective method of assessing step activity and brace-wearing times in everyday life proved to be feasible, and it expands the information available regarding the impact of bracing on patients' quality of life. The results clearly show that brace treatment does not negatively interfere with daily step activity in AIS and AK patients. This is an important finding that should help reduce patients' and parents' worries concerning bracing."," Eur Spine J 20(7): 1127-1136.","Germany",2011,"Spinal Deformity","Brace","SRS-HRQOL","Adolescents","PRO study","Prospective Observation"]
[261,"Murphy, S. E., et al. (2013). \"The effectiveness of a stratified group intervention using the STarTBack screening tool in patients with LBP--a non randomised controlled trial.\" BMC Musculoskelet Disord 14: 342.",null,"Murphy, S. E., et al.","The effectiveness of a stratified group intervention using the STarTBack screening tool in patients with LBP--a non randomised controlled trial","BACKGROUND: Low back pain (LBP) is costly to society and improving patient outcomes is a priority. Stratifying LBP patients into more homogenous groups is advocated to improve patient outcome. The STarT Back tool, a prognostic screening tool has demonstrated efficacy and greater cost effectiveness in physiotherapy settings. The management of LBP patients in groups is common but to date the utility of the STarT Back tool in group settings has not been explored. The aim of this study is to determine if the implementation of 'stratified care' when delivered in a group setting will lead to significantly better physical and psychological outcomes and greater cost effectiveness in LBP patients compared to a bestcare historical control group. METHODS/DESIGN: This study is a non randomised controlled trial. Low back pain patients recruited from the Waterford Primary Care area (population = 47,000) will be stratified into low, medium or high risk of persisting symptoms using the STarT Back Tool. Low risk patients will be offered a single one off education/exercise class offering positive messages on LBP management in line with recommended guidelines. Medium risk patients will be offered a 12 week group exercise/education intervention addressing their dominant physical obstacles to recovery. A 12 week group cognitive behavioural approach will be delivered to the high risk patients, characterised by the presence of high levels of psychosocial prognostic factors. These patients will be compared with a historical control group where therapists were blinded as to the risk stratification of patients and a generic group intervention was delivered to all patients, irrespective of their initial risk stratification. The primary outcome measure will be disability (Roland Morris Disability Questionnaire). Secondary outcomes will include back pain intensity (Visual Analogue Scale), distress (Distress and Risk Assessment Method), back beliefs (Back Beliefs Questionnaire), health status (Euroqol), global benefit (7 point likert scale), satisfaction (7 point likert scale), cost effectiveness and functional status. Outcome will be measured at baseline, 12 weeks and 6 months. DISCUSSION: This paper details the rationale, design, methods, planned analysis and operational aspects of a study examining the utility of the STarT Back Tool as a 'stratification tool for targeted treatment' in a group intervention. TRIAL REGISTRATION: Current controlled trials: ACTRN12613000431729."," BMC Musculoskelet Disord 14: 342.","USA",2013,"Back Pain","Exercise","RMDQ","Unknown","Cost-Effectiveness","RCT"]
[262,"Murphy, S. E., et al. (2016). \"Comparison of a Stratified Group Intervention (STarT Back) With Usual Group Care in Patients With Low Back Pain: A Nonrandomized Controlled Trial.\" Spine (Phila Pa 1976) 41(8): 645-652.",null,"Murphy, S. E., et al.","Comparison of a Stratified Group Intervention (STarT Back) With Usual Group Care in Patients With Low Back Pain: A Nonrandomized Controlled Trial","STUDY DESIGN: A nonrandomized controlled trial. OBJECTIVE: This study aims to explore the effectiveness of group-based stratified care in primary care. SUMMARY OF BACKGROUND DATA: Stratified care based on psychosocial screening (STarT Back) has demonstrated greater clinical and cost-effectiveness in patients with low back pain. However, low back pain interventions are often delivered in groups and evaluating this system of care in a group setting is important. METHODS: Patients were recruited from 60 general practices and linked physiotherapy services. A new group stratified intervention was compared with a historical nonstratified control group. Patients stratified as low, medium and high risk were offered risk-matched group care. Consenting participants completed self-report measures of functional disability (primary outcome measure), pain, psychological distress, and beliefs. The historical control received a generic group intervention. Analysis was by intention to treat. RESULTS: In total, 251 patients in the new stratified intervention and 332 in the historical control were included in the primary analysis at 12 weeks. The mean age of patients was 43 +/- 10.98 years. Overall adjusted mean changes in the RMDQ scores were higher in the stratified intervention than in the control arm at 12-week follow-up (P = 0.028). Exploring the risk groups, individually the high-risk stratified group, demonstrated better outcome over the controls (P = 0.031). The medium-risk stratified intervention demonstrated equally good outcomes (P = 0.125), and low-risk stratified patients, despite less intervention, did as well as the historical controls (P = 0.993). CONCLUSION: Stratified care delivered in a group setting demonstrated superior outcomes in the high-risk patients, and equally good outcomes for the medium and low-risk groups. This model, embedded in primary care, provides an early and effective model of chronic disease management and adds another dimension to the utility of the STarT Back system of care. LEVEL OF EVIDENCE: 2."," Spine (Phila Pa 1976) 41(8): 645-652.","Ireland",2016,"Back Pain","Physical Therapy","RMDQ","Adults","Cost-Effectiveness","RCT"]
[263,"Murphy, S., et al. (2013). \"The role of clinical specialist physiotherapists in the management of low back pain in a spinal triage clinic.\" Ir J Med Sci 182(4): 643-650.",null,"Murphy, S., et al.","The role of clinical specialist physiotherapists in the management of low back pain in a spinal triage clinic","BACKGROUND: Traditional care pathways for patients with low back pain (LBP) where general practitioners (GPs) refer to consultant specialists can lead to excessive waiting times for patients and questionable use of health care resources. The evaluation of more cost effective pathways is a priority. AIMS: The study aims to determine if clinical specialist physiotherapists can allocate patients into the three distinct diagnostic triage categories in line with international guidelines. A secondary aim is to examine the utility of baseline domains to inform clinical decision making. METHODS: A review of LBP patients (n = 1,532) consecutively referred between 2008 and 2010 to a physiotherapy led spinal triage clinic was undertaken. Baseline demographics, pain severity (Visual Analogue Scale), disability (Roland Morris Disability Questionnaire), distress (Distress and Risk Assessment Method), mobility and function were assessed. Relationships between these factors were analysed. RESULTS: Eighty-five percent of the population were deemed suitable for conservative management and were referred for either group exercise intervention (n = 1,125, 73 %) or individual treatment (n = 178, 12 %), in line with clinical guidelines. Fourteen percent were discharged and only 1 % required a specialist opinion. Patients allocated to the three management streams could be clearly discriminated by baseline measures of pain, distress, disability and function (p < 0.01). CONCLUSION: Clinical Specialist physiotherapists are effective in assessing and selecting appropriate care pathways for LBP patients in line with international LBP clinical guidelines. The utility of the physical and psychological measures to differentiate between groups of varying clinical severity has important implications for treatment selection and management."," Ir J Med Sci 182(4): 643-650.","USA",2013,"Back Pain","Exercise","RMDQ","Unknown","Cost and Resource Use","Observational"]
[264,"Nagoshi, N., et al. (2017). \"Risk Factors for and Clinical Outcomes of Dysphagia After Anterior Cervical Surgery for Degenerative Cervical Myelopathy: Results from the AOSpine International and North America Studies.\" J Bone Joint Surg Am 99(13): 1069-1077.",null,"Nagoshi, N., et al.","Risk Factors for and Clinical Outcomes of Dysphagia After Anterior Cervical Surgery for Degenerative Cervical Myelopathy: Results from the AOSpine International and North America Studies","BACKGROUND: Although dysphagia is a common complication after anterior cervical decompression and fusion, important risk factors have not been rigorously evaluated. Furthermore, the impact of dysphagia on neurological and quality-of-life outcomes is not fully understood. The aim of this study was to determine the prevalence of and risk factors for dysphagia, and the impact of this complication on short and long-term clinical outcomes, in patients treated with anterior cervical decompression and fusion. METHODS: Four hundred and seventy patients undergoing a 1-stage anterior or 2-stage anteroposterior cervical decompression and fusion were enrolled in the prospective AOSpine CSM (Cervical Spondylotic Myelopathy) North America or International study at 26 global sites. Logistic regression analyses were conducted to determine important clinical and surgical predictors of perioperative dysphagia. Preoperatively and at each follow-up visit, patients were evaluated using the modified Japanese Orthopaedic Association scale (mJOA), Nurick score, Neck Disability Index (NDI), and Short Form-36 Health Survey (SF-36). A 2-way repeated-measures analysis of covariance was used to evaluate differences in outcomes at 6 and 24 months between patients with and those without dysphagia, while controlling for relevant baseline characteristics and surgical factors. RESULTS: The overall prevalence of dysphagia was 6.2%. Bivariate analysis showed the major risk factors for perioperative dysphagia to be a higher comorbidity score, older age, a cardiovascular or endocrine disorder, a lower SF-36 Physical Component Summary score, 2-stage surgery, and a greater number of decompressed levels. Multivariable analysis showed patients to be at an increased risk of perioperative dysphagia if they had an endocrine disorder, a greater number of decompressed segments, or 2-stage surgery. Both short and long-term improvements in functional, disability, and quality-of-life scores were comparable between patients with and those without dysphagia. CONCLUSIONS: The most important predictors of dysphagia are an endocrine disorder, a greater number of decompressed levels, and 2-stage surgery. At the time of both short and long-term follow-up, patients with perioperative dysphagia exhibited improvements in functional, disability, and quality-of life scores that were similar to those of patients without dysphagia. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence."," J Bone Joint Surg Am 99(13): 1069-1077.","Japan,Canada,USA,Italy",2017,"Spondylosis","Surgical","NDI,Nurick","Unknown","PRO study","Prospective Observation"]
[265,"Nakashima, H., et al. (2016). \"Comparison of Outcomes of Surgical Treatment for Ossification of the Posterior Longitudinal Ligament Versus Other Forms of Degenerative Cervical Myelopathy: Results from the Prospective, Multicenter AOSpine CSM-International Study of 479 Patients.\" J Bone Joint Surg Am 98(5): 370-378.",null,"Nakashima, H., et al.","Comparison of Outcomes of Surgical Treatment for Ossification of the Posterior Longitudinal Ligament Versus Other Forms of Degenerative Cervical Myelopathy: Results from the Prospective, Multicenter AOSpine CSM-International Study of 479 Patients","BACKGROUND: Degenerative cervical myelopathy (DCM) is an all-encompassing term that includes cervical spondylotic myelopathy (CSM), ossification of the posterior longitudinal ligament (OPLL), and other spinal abnormalities that cause cervical cord compression. It is unclear whether surgery is equally effective and safe for patients with OPLL as it is for those with other forms of DCM. The purpose of this study was to compare surgical outcomes of patients with OPLL and those with other forms of DCM. METHODS: Four hundred and seventy-nine patients with symptomatic DCM were prospectively enrolled in the CSM-International study at sixteen sites. Patients' functional status was evaluated using the modified Japanese Orthopaedic Association scale (mJOA) and the Nurick score. Quality of life was assessed using patient-reported outcome measures, including the Neck Disability Index (NDI) and the Short Form (SF)-36. Postoperative functional and quality-of-life outcomes were assessed at two years of follow-up, and scores were compared between patients with and without OPLL. RESULTS: Of 479 patients, 135 (28.2%) had radiographic evidence of OPLL, and 344 (71.8%) had other forms of DCM. The two groups did not differ significantly in demographics, surgical approach, or baseline myelopathy severity. Patients with OPLL achieved similar functional outcomes by two years following surgery compared with patients with other forms of DCM. With respect to quality of life, the NDI and most of the subscales of the SF-36 were not different between the two diagnostic groups. There was a higher risk of perioperative complications in the OPLL group (p = 0.054), although this relationship did not reach statistical significance. Rates of neurological complications did not differ significantly between diagnostic groups. CONCLUSIONS: Surgical decompression for the treatment of OPLL resulted in improvements in functional status and quality of life comparable to those seen in patients with other forms of DCM. Patients with OPLL were at a higher risk of perioperative complications than patients with other forms of DCM."," J Bone Joint Surg Am 98(5): 370-378.","Canada,Japan,China",2016,"Cervical Myelopathy,Spondylosis","Surgical","NDI,Nurick","Unknown","PRO study","Prospective Observation"]
[266,"Negrini, S., et al. (2012). \"Is the SRS-22 able to detect Quality of Life (QoL) changes during conservative treatments ?\" Stud Health Technol Inform 176: 433-436.",null,"Negrini, S., et al.","Is the SRS-22 able to detect Quality of Life (QoL) changes during conservative treatments ?","BACKGROUND: The SRS-22 has been developed to monitor QoL in scoliosis. Only a few studies have evaluated its effects on therapies. Consequently, doubts exist on its utility in conservative treatment. AIM: To evaluate if SRS-22 is able to detect changes in patients treated conservatively. MATERIAL AND METHODS: Study design. Retrospective controlled cohort study nested in a prospective clinical database. Population. One hundred and thirty six consecutive adolescents at their first evaluation, age 12.8 +/- 2.7, divided into 5 groups according to treatment: 30 brace for 18 hours/day, 7 for 21 h/d, 33 for 23 h/d, 48 exercises and 14 observed (controls). Methods. All patients completed SRS-22 before the first and at the 6 months follow-up evaluations. Statistical analysis. ANOVA and Kruskall-Wallis tests. RESULTS: Controls did not show changes with time, while all treated patients had increase of satisfaction with treatment. Aesthetic improvement was perceived by patients treated with exercises, while brace treated patients showed a negative psychological impact: these statistical changes were not clinically significant (0.2-0.3 points out of 5), excluding satisfaction (1.15-1.8). Between the groups, the 23 h/d showed worst start but best results in functioning, aesthetics, pain and satisfaction. CONCLUSION: SRS-22 appears to detect changes in populations, but its clinical everyday use appears less reliable."," Stud Health Technol Inform 176: 433-436.","Italy",2012,"Spinal Deformity","Exercise","SRS-HRQOL","Adolescents","PRO study","Prospective Observation"]
[267,"Nitikman, M., et al. (2017). \"Internet-administered Health-related Quality of Life Questionnaires Compared With Pen and Paper in an Adolescent Scoliosis Population: A Randomized Crossover Study.\" J Pediatr Orthop 37(2): e75-e79.",null,"Nitikman, M., et al.","Internet-administered Health-related Quality of Life Questionnaires Compared With Pen and Paper in an Adolescent Scoliosis Population: A Randomized Crossover Study","BACKGROUND: Modern technology puts into question the effectiveness of using pen and paper as a means of collecting information from web-enabled patients. This study aimed to validate and test the reliability of using the Internet as a method of administering health-related quality of life questionnaires in a pediatric spine population. METHODS: A prospective randomized crossover study was conducted. Patients aged 11 to 18 with idiopathic scoliosis were invited to participate, and informed consent was obtained from a scoliosis outpatient clinic setting. Participants were randomized to one of 4 groups determining the method of questionnaire administration [Scoliosis Research Society 30 (SRS-30) and Pediatric Outcomes Data Collection Instrument (PODCI)]. Both questionnaires were completed at 2 separate timepoints and 2 weeks apart to prevent recall bias. Groups included: Paper/Paper, Paper/Internet, Internet/Paper, and Internet/Internet. Paired-samples t tests were used to determine the test-retest reliability of each group. Analysis was stratified for surveys returned within or outside of the allotted 4-week timeframe following enrollment. RESULTS: Of the 96 participants who completed and returned both sets of questionnaires, 26 were allocated to the Paper/Paper group (27%), 20 to the Paper/Internet group (21%), 26 to the Internet/Paper group (27%), and 24 to the Internet/Internet group (25%). The second iteration of questionnaires was returned on time by 69 of the participants (71.2%). Of the late questionnaires, 18 (67%) were paper forms. Overall, no differences were observed between Internet-administered compared with pen and paper-administered questionnaires (P=0.206). No differences were observed within any group individually for either the SRS-30 or PODCI questionnaire. In addition, no significant differences were observed within groups for surveys returned within or outside of the 4-week timeframe. Eighty-four percent of the participants who completed both paper and Internet versions of the questionnaires reported a preference of the Internet. CONCLUSION: Internet administration of both the SRS-30 and PODCI questionnaires is a valid and reliable method of acquiring health-related quality of life information in this population LEVEL OF EVIDENCE:: Level II-therapeutic study."," J Pediatr Orthop 37(2): e75-e79.","Canada",2017,"Spinal Deformity","Not Specified","SRS-HRQOL","Unknown","PRO study","Prospective Observation"]
[268,"Nordin, M., et al. (2003). \"Measures for low back pain: a proposal for clinical use.\" Rev Lat Am Enfermagem 11(2): 152-155.",null,"Nordin, M., et al.","Measures for low back pain: a proposal for clinical use","Low back pain represents a serious public health problem. Therefore, great efforts have been made in order to improve and assess the efficacy of its treatment. Reports in international literature have presented important studies concerning instruments to assess pain and functional incapacity in patients with low back pain. This study presents a clinical protocol which was developed by a multidisciplinary team. This protocol consists of the evaluation and distribution of pain, The Spitzer Quality of Life, The Oswestry Low Back Pain Disability Questionnaire, and The Center for Epidemiological Studies Depression Scale. Instruments must be urgently developed or adapted in order to be used according to the Brazilian reality."," Rev Lat Am Enfermagem 11(2): 152-155.","USA",2003,"Back Pain","Not Specified","ODI","Unknown","Protocol","Narrative review"]
[269,"Oestergaard, L. G., et al. (2012). \"The effect of early initiation of rehabilitation after lumbar spinal fusion: a randomized clinical study.\" Spine (Phila Pa 1976) 37(21): 1803-1809.",null,"Oestergaard, L. G., et al.","The effect of early initiation of rehabilitation after lumbar spinal fusion: a randomized clinical study","STUDY DESIGN: A multicenter randomized clinical trial including 82 patients. OBJECTIVE: To examine the effect of early initiation of rehabilitation after instrumented lumbar spinal fusion. SUMMARY OF BACKGROUND DATA: Lumbar spinal fusion has been performed for more than 70 years. Yet, few studies have examined patients' subsequent rehabilitation. Group-based rehabilitation is both efficient and cost-effective in rehabilitation of lumbar spinal fusion patients. METHODS: Patients with degenerative disc diseases undergoing instrumented lumbar spinal fusion were randomly assigned to initiate their rehabilitation 6 weeks (6-wk group) or 12 weeks after lumbar spinal fusion (12-wk group). Both groups received the same group-based rehabilitation. Primary outcome was the Oswestry Disability Index. Secondary outcome was the Dallas Pain Questionnaire, the Low Back Pain Rating Scale, and absence from work. Wilcoxon rank-sum test was used to compare the groups in terms of differences from baseline to 6 months and 1-year follow-up. Results are presented in median with 25th and 75th percentiles. RESULTS: According to the Oswestry Disability Index, at 1-year follow-up, the 6-week-group had a median reduction of -6 (-19; 4) compared with -20 (-30;-7) in the 12-week group (P, 0.05). The Dallas Pain Questionnaire showed overall the same tendency, and within daily activities were significantly reduced in favor of the 12-week group (P, 0.05). For back pain, the 6-week group had a median reduction of -2.2 (-3.0; -0.7) similar with -3.3 (-4.7; -1.7) in the 12-week group (P, 0.05). The results at 6 months of follow-up were similar. No difference was found according to return to work 1 year postsurgery. CONCLUSION: Early start of rehabilitation (6 wk vs. 12 wk) after lumbar spinal fusion resulted in inferior outcomes. The improvements in the 12-week group were 4 times better than that in the 6-week group, indicating that the start-up time of rehabilitation is an important contributing factor for the overall outcome."," Spine (Phila Pa 1976) 37(21): 1803-1809.","Denmark",2012,"Back Pain,Spinal Fusion","Surgical","ODI,ICF","Unknown","Cost-Effectiveness","RCT"]
[270,"Oner, F. C., et al. (2016). \"Toward the Development of a Universal Outcome Instrument for Spine Trauma: A Systematic Review and Content Comparison of Outcome Measures Used in Spine Trauma Research Using the ICF as Reference.\" Spine (Phila Pa 1976) 41(4): 358-367.",null,"Oner, F. C., et al.","Toward the Development of a Universal Outcome Instrument for Spine Trauma: A Systematic Review and Content Comparison of Outcome Measures Used in Spine Trauma Research Using the ICF as Reference","STUDY DESIGN: A systematic literature review. OBJECTIVE: The aim of this study was (1999) to identify patient-reported and clinician-based outcome measures most frequently used to evaluate the function and health of spine trauma patients, (2) to identify and quantify the concepts of these measures using the International Classification of Functioning, Disability, and Health (ICF) as reference, and (3) to describe their clinimetric properties. SUMMARY OF BACKGROUND DATA: There is a real need for a disease-specific outcome instrument to measure the effect size of various treatment options in a variety of traumatic spinal column injuries. METHODS: A systematic literature search was conducted in several databases. From the included studies, outcome measures were extracted. The items and underlying concepts of the identified outcome measures were specified and linked to the ICF categories. Finally, as far as available in literature, the clinimetric properties of the obtained measures were analyzed. RESULTS: Out of 5117 screened references, 245 were included, and 17 different frequently used outcome measures were identified. Meaningful concepts of the items and response options of the retrieved outcome measures were linked to a total of 105 different ICF categories, aggregated to 57 first- or second-level categories. The categories were linked to the components activities and participation (n = 31), body functions (n = 17), environmental factors (n = 8), and body structures (n = 1). Overall, there is only limited evidence on the measurement properties, except for some disease-specific questionnaires, such as Oswestry Disability Index, Roland-Morris Disability Questionnaire, Neck Disability Index, and Cervical Spine Outcome Questionnaire. CONCLUSION: The current systematic literature review revealed great diversity in the use and content of outcome measures to evaluate the functioning and health of spine trauma patients, with 17 different outcome measures linked to 57 unique ICF categories. This study creates an evidence base for a consensus meeting during which a core set of ICF categories for outcome measurement in spine trauma will be decided. LEVEL OF EVIDENCE: 2."," Spine (Phila Pa 1976) 41(4): 358-367.","USA",2016,"Unspecified","Not Specified","ODI,RMDQ,NDI,Oswestry,ICF","Unknown","PRO study","Systematic review"]
[271,"Orgera, G., et al. (2014). \"Percutaneous vertebroplasty for pain management in patients with multiple myeloma: is radiofrequency ablation necessary?\" Cardiovasc Intervent Radiol 37(1999): 203-210.",null,"Orgera, G., et al.","Percutaneous vertebroplasty for pain management in patients with multiple myeloma: is radiofrequency ablation necessary?","PURPOSE: This study was designed to investigate the added role of radiofrequency ablation (RFA) to vertebroplasty on the pain management of patients with multiple myeloma (MM). METHODS: Thirty-six patients (51-82 years) with vertebral localization of MM were randomly divided into two groups: 18 patients (group A) who underwent RFA and then vertebroplasty, and 18 patients (group B) who underwent only vertebroplasty. Primary endpoints were technical success and pain relief score rate measured by the visual analogue pain scores (VAS) and Roland-Morris Questionnaire (RMQ); secondary endpoint was the amount of administered analgesia. Survival and complications were compared. RESULTS: Technical success was 100 % in both groups. The VAS score (at 24 h and 6 weeks postprocedure) decreased in equal manner for both groups from a mean of 9.1-3.4 and 2.0 for group A and from a mean of 9.3-3.0 and 2.3 for group B; RMQ mean score was 19.8 for group A and 19.9 for group B and decreased to a mean of 9.6 and 8.2 for group A and 9.5 and 8.7 for group B. The amount of medication was equally decreased in the two groups. No statistically significant difference was noted. No major complication occurred and two patients died from other causes. CONCLUSIONS: The use of percutaneous vertebroplasty alone appears to be effective for the pain management of the patients with vertebral involvement of multiple myeloma. The use of RFA that includes cost and time does not offer any clear added benefit on the midterm pain management of such patients."," Cardiovasc Intervent Radiol 37(1999): 203-210.","Italy",2014,"Cancer","Surgical","RMDQ","Adults","PRO study","Clinical trial"]
[272,"Ortancil, O., et al. (2009). \"The effect(s) of a six-week home-based exercise program on the respiratory muscle and functional status in ankylosing spondylitis.\" J Clin Rheumatol 15(2): 68-70.",null,"Ortancil, O., et al.","The effect(s) of a six-week home-based exercise program on the respiratory muscle and functional status in ankylosing spondylitis","BACKGROUND: Ankylosing spondylitis (AS) is a chronic, inflammatory rheumatic disease. Involvement of costovertebral and costotransverse joints results in rigidity of the chest wall and inability to expand the chest fully on inspiration. Also significant reduction in exercise capacity in the AS patients was reported. OBJECTIVES: To determine the effects of a 6-week home-based exercise program on the respiratory muscle and energy cost in AS. METHODS: Twenty-two AS patients were included. Chest expansion, tragus-wall distance, modified Schober test, maximal inspiratory pressure, maximal expiratory pressure, 6-minute walking distance, physiologic cost index and functional status Bath Ankylosing Spondylitis Functional Index of patients were measured at baseline and repeated at the end of an open 6-week home-based exercise program. Breathing exercises and upper extremity exercises were taught to all the patients. The patients were then asked to practice these exercises at home individually for 6 weeks. RESULTS: Chest expansion, maximal inspiratory pressure, and maximal expiratory pressure values and Bath Ankylosing Spondylitis Functional Index scores of patients significantly increased after 6 weeks (P < 0.001). Six-minute walking distance and physiologic cost index values did not change at the end of the 6 weeks (P > 0.05). CONCLUSIONS: A home-based exercise program can have an effect on some measures respiratory muscle and functional status. Greater emphasis should be placed on maintaining cardiorespiratory fitness as well as spinal mobility to encourage patients with AS."," J Clin Rheumatol 15(2): 68-70.","Turkey",2009,"Spondylosis","Exercise","Schober","Unknown","PRO study","Clinical trial"]
[273,"Ostelo, R. W. and H. C. de Vet (2005). \"Clinically important outcomes in low back pain.\" Best Pract Res Clin Rheumatol 19(4): 593-607.",null,"Ostelo, R. W. and H. C. de Vet","Clinically important outcomes in low back pain","Four important domains directly related to low back pain are: pain intensity, low-back-pain-specific disability, patient satisfaction with treatment outcome, and work disability. Within each of the domains, different questionnaires have been proposed. This chapter focuses on validated and widely used questionnaires. Details of the background and the measurement properties, and of the minimally clinically important change (MCIC) using these questionnaires, are described. The MCIC can be estimated using various methods and there is no consensus in the literature on what the most appropriate technique is. This chapter focuses primarily on two adequate and frequently used methods for estimating the MCIC. We argue that the MCIC should not be considered as a fixed value and that the MCIC values presented in this chapter are used as indications. For patients with subacute or chronic low back pain, the MCIC for pain on a visual analogue scale (VAS) should at least be 20mm and for acute low back pain it seems reasonable to suggest that the MCIC should at least be at the level of approximately 35mm. If a numerical rating scale (NRS) is used it seems reasonable to suggest that the MCIC should at least be 3.5 and 2.5 for patients with acute and chronic low back pain, respectively. For functional disability as measured with the Roland Disability Questionnaire it seems reasonable that the MCIC should at least be 3.5 points, whereas an MCIC of at least 10 points when the Oswestry Disability Index is used. For global perceived effect, we argue that the MCIC is most appropriately defined in terms of at least 'much improved' or 'very satisfied', instead of including 'slightly improved'. Finally, we argue that, from the point of view of cost effectiveness, every day of earlier return to work is important. The exact value for the MCIC can be determined, taking into account the aim of the measurement, the initial scores, the target population and the method used to assess MCIC."," Best Pract Res Clin Rheumatol 19(4): 593-607.","Netherlands",2005,"Back Pain","Not Specified","ODI,RMDQ","Unknown","PRO study","Narrative review"]
[274,"Padua, R., et al. (2001). \"Patient outcomes after Harrington instrumentation for idiopathic scoliosis: a 15- to 28-year evaluation.\" Spine (Phila Pa 1976) 26(11): 1268-1273.",null,"Padua, R., et al.","Patient outcomes after Harrington instrumentation for idiopathic scoliosis: a 15- to 28-year evaluation","STUDY DESIGN: A retrospective study was performed, using the Short Form-36 Health Survey and the Roland and Morris Disability Questionnaire, to investigate patient outcomes after fusion for adolescent idiopathic scoliosis using Harrington rod instrumentation. OBJECTIVE: To evaluate health-related quality of life and low back pain in a long-term follow-up study of surgery for adolescent idiopathic scoliosis. SUMMARY OF BACKGROUND DATA: The commonly accepted surgical treatment for idiopathic evolutive scoliosis is vertebral fusion. It has been suggested that this procedure may cause low back pain and a poor quality of life over the long term. Outcome measures after surgery for adolescent idiopathic scoliosis have focused mainly on objective parameters such as radiographic measures. However, this information has proved to be correlated only weakly with outcomes that are more relevant to patients, such as functional status and symptoms. Until recently, only a few long-term outcome studies have used standardized and validated patient-oriented tools to evaluate surgically treated patients with scoliosis. METHODS: In this study, 70 patients treated with a standard Harrington technique were recontacted and evaluated by means of self-administered questionnaires (Short Form-36 Health Survey and Roland and Morris Disability, clinical examination, and radiographic analysis. Preoperative and follow-up radiographic findings were registered. Relations between radiographic and patient-oriented data were evaluated. RESULTS: A comparison between the current sample and the Italian age-matched normative data for the Short Form-36 Health Survey showed them to have a similar pattern. Findings showed the patient-oriented outcome to be correlated inversely with the extension of vertebral fusion and the preoperative Cobb angle. CONCLUSION: Long-term follow-up evaluation of Harrington rod fusion for adolescent idiopathic scoliosis showed no important impairment of health-related quality of life, as measured by patient-oriented evaluation."," Spine (Phila Pa 1976) 26(11): 1268-1273.","Italy",2001,"Spinal Deformity","Surgical","RMDQ","Adolescents","PRO study","Retrospective review"]
[275,"Paleri, V., et al. (2001). \"Quality of life in laryngectomees: a post-treatment comparison of laryngectomy alone versus combined therapy.\" J Laryngol Otol 115(6): 450-454.",null,"Paleri, V., et al.","Quality of life in laryngectomees: a post-treatment comparison of laryngectomy alone versus combined therapy","Patients with advanced and recurrent laryngeal and hypopharyngeal cancer often need combined therapy, which is associated with greater morbidity than single modality treatment. The aim of this study was to assess the quality of life in laryngectomees and to assess whether differences exist between the irradiated and the non-irradiated patients. The University of Michigan Head and Neck Quality of Life questionnaire, a validated instrument for assessing the head and neck cancer related functional status and well-being, was used for this purpose. Subjects for the study included patients who had undergone total laryngectomy for laryngeal or hypophyarngeal squamous cancer. No significant difference between the groups was evident in the various domain scores, although a trend towards higher scores was seen in the combined therapy group. This study suggests that long-term side effects induced by radiotherapy do not adversely affect the quality of life in laryngectomised patients."," J Laryngol Otol 115(6): 450-454.","UK",2001,"Cancer","Surgical","HNQOL","Unknown","PRO study","Clinical trial"]
[276,"Pallay, R. M., et al. (2004). \"Etoricoxib reduced pain and disability and improved quality of life in patients with chronic low back pain: a 3 month, randomized, controlled trial.\" Scand J Rheumatol 33(4): 257-266.",null,"Pallay, R. M., et al.","Etoricoxib reduced pain and disability and improved quality of life in patients with chronic low back pain: a 3 month, randomized, controlled trial","BACKGROUND: Chronic low back pain (LBP) is a growing health problem. Non-steroidal anti-inflammatory drugs (NSAIDs) are used to treat this condition, but have not demonstrated efficacy beyond 2 weeks, and no studies have shown that NSAIDs produce durable improvements in disability. METHODS: To evaluate the efficacy and durability of effect of etoricoxib for chronic LBP, a randomized, double blind, placebo-controlled trial was conducted at 46 centres. Three hundred and twenty-five patients with chronic LBP requiring treatment with an NSAID or paracetamol were randomized 1:1:1 to etoricoxib 60 mg (n=109), 90 mg (n=106), or placebo (n=110), daily for 3 months. Pre-specified endpoints over 3 months included LBP intensity scale (visual analog scale 0-100 mm) time-weighted average change from baseline, the Roland-Morris Disability Questionnaire (RMDQ), the LBP bothersomeness scale, patient and investigator global assessments, and measures of quality of life. RESULTS: Both etoricoxib groups experienced significant reductions in LBP intensity at 4 weeks versus placebo [-15.15 mm and -13.03 mm for 60 and 90 mg, respectively, probability (p)<0.001 for each], which was maintained over 3 months. Treatment resulted in significant improvement from baseline compared to placebo in RMDQ scores (etoricoxib 60 mg, -2.82 and 90 mg, -2.38, p<0.001 for each) over 12 weeks and most other efficacy endpoints. There were no significant differences between treatments in incidence of adverse events (AEs) or discontinuations due to AEs. CONCLUSION: Etoricoxib provided significant relief of symptoms and disability associated with chronic LBP detected at 1 week, confirmed at 4 weeks, and maintained over 3 months. Reductions in chronic LBP severity corresponded to improvements in physical functioning and quality of life. All treatments were generally well tolerated."," Scand J Rheumatol 33(4): 257-266.","USA",2004,"Back Pain","NSAID","RMDQ,Bothersomeness","Unknown","PRO study","RCT"]
[277,"Paolucci, T., et al. (2012). \"Psychological features and outcomes of the Back School treatment in patients with chronic non-specific low back pain. A randomized controlled study.\" Eur J Phys Rehabil Med 48(2): 245-253.",null,"Paolucci, T., et al.","Psychological features and outcomes of the Back School treatment in patients with chronic non-specific low back pain. A randomized controlled study","BACKGROUND: Low back pain is a worldwide health problem, affecting up to 80% of adult population. Psychological factors are involved in its development and maintenance. Many clinical trials have evaluated the efficacy of different interventions for chronic non-specific low back pain. In this field, Back School program has been demonstrated effective for people with chronic non-specific low back. AIM: To evaluate the relationship between the effects of the Back School treatment and psychological features measured by MMPI-II of patients with chronic non-specific low back pain. DESIGN: A randomised controlled trial with three and six-month follow-up. SETTING: Ambulatory rehabilitative university centre. POPULATION: Fifty patients with chronic non-specific low back pain out of 77 screened patients. METHODS: Patients were randomly placed in a 3:2 form and were allocated into two groups (Treatment versus Control). The Treatment Group participated to an intensive multidisciplinary Back School program (BSG, N.=29), while the Control Group received medical assistance (CG, N.=21). Medication was the same in both groups. Then, patients were subgrouped in those with at least an elevation in one scale of MMPI-II, and those without it. The Short Form 36 Health Status Survey for the assessment of quality of life (primary outcome measure), pain Visual Analogue Scale, Waddel Index and Oswestry Disability Index were collected at baseline, at the end of treatment, and at the three and six-month follow-up. RESULTS: Only the two treated subgroups showed a significant improvements in terms of quality of life, disability and pain. Among treated subjects, only those with at least one scale elevation in MMPI-II showed also a significant improvement in terms of Short Form 36 mental composite score and relevant subscores. CONCLUSION: These results suggest that Back School program has positive effects, even in terms of mental components of quality of life in patients with scale elevations of MMPI-II. Probably these findings are due to its educational and cognitive-behavioural characteristics. CLINICAL REHABILITATION IMPACT: Because of its educational purposes, the Back School treatment can have positive effects also on the mental status of patients with low back pain when it affects their psychological features."," Eur J Phys Rehabil Med 48(2): 245-253.","Italy",2012,"Back Pain","Psychosocial","ODI,Waddel","Unknown","PRO study","RCT"]
[278,"Parent, E. C., et al. (2010). \"The association between Scoliosis Research Society-22 scores and scoliosis severity changes at a clinically relevant threshold.\" Spine (Phila Pa 1976) 35(3): 315-322.",null,"Parent, E. C., et al.","The association between Scoliosis Research Society-22 scores and scoliosis severity changes at a clinically relevant threshold","STUDY DESIGN: Cross-sectional correlation study. OBJECTIVE: To determine the threshold in spinal deformity severity measurements beyond which there is a progressive decline in health-related quality-of-life (HRQOL). SUMMARY OF BACKGROUND DATA: The associations between HRQOL and scoliosis deformity measures are at best moderate when assessed using linear regressions. This may be because HRQOL is not affected until a severity threshold is reached. Identifying the thresholds in deformity beyond which HRQOL deteriorates could assist in treatment recommendations. METHODS: The Scoliosis Research Society-22 (SRS-22) questionnaire was completed by 101 females with adolescent idiopathic scoliosis (age, 15.0 +/- 1.8; largest Cobb angle, 36.9 degrees +/- 14.6 degrees). Radiographs and surface topography were used to quantify the severity of the internal (largest Cobb angle) and external deformity (cosmetic score, decompensation, trunk twist), respectively. Segmented linear regression models were estimated to determine the association between SRS-22 domains and spinal deformity measures. This analysis also identifies deformity thresholds beyond which HRQOL is more affected. The percentage of variance explained (R2) by linear and segmented models were compared (alpha = 0.05) to identify the best models. RESULTS: Cobb angle predicted significantly more variance in all SRS-22 domains except mental health using segmented models (R2: 0.09-0.30) than linear models (R2: 0.02-0.21). Segmented models with a single threshold estimated at a Cobb angle between 43 degrees and 48 degrees predicted between 3% and 11% more variance compared to corresponding linear model using the same variables. Surface topography parameters were not strongly associated with SRS-22 variables with linear and segmented models explaining less than 10% of the variance. CONCLUSION: Deterioration in SRS-22 scores is mildly associated with increases in the severity of the internal deformity. HRQOL is stable until the curve reaches a maximal Cobb angle threshold at approximately 45 degrees where HRQOL declines linearly with increasing internal deformity. The association between HRQOL and scoliosis severity is low, but is better explained by segmented rather than linear models."," Spine (Phila Pa 1976) 35(3): 315-322.","Canada",2010,"Spinal Deformity","Not Specified","SRS-HRQOL","Adolescents","PRO study","Observational"]
[279,"Passias, P. G., et al. (2015). \"Magnitude of preoperative cervical lordotic compensation and C2-T3 angle are correlated to increased risk of postoperative sagittal spinal pelvic malalignment in adult thoracolumbar deformity patients at 2-year follow-up.\" Spine J 15(8): 1756-1763.",null,"Passias, P. G., et al.","Magnitude of preoperative cervical lordotic compensation and C2-T3 angle are correlated to increased risk of postoperative sagittal spinal pelvic malalignment in adult thoracolumbar deformity patients at 2-year follow-up","BACKGROUND CONTEXT: Cervical deformity (CD) is prevalent among patients with adult spinal deformity (ASD). The effect of baseline cervical alignment on achieving optimal thoracolumbar alignment in ASD surgery is unclear. PURPOSE: This study assesses the relationship between preoperative (preop) cervical spinal parameters and global alignment after thoracolumbar ASD surgery at 2-year follow-up. STUDY DESIGN/SETTING: This study is a retrospective review of a multicenter, prospective database. PATIENT SAMPLE: Surgical ASD patients with 2-year follow-up and cervical X-rays were included. OUTCOME MEASURES: The outcome measures were radiographic parameters and self-reported health-related quality-of-life measures (Short-Form 36 [SF-36], Oswestry Disability Index [ODI], and Scoliosis Research Society 22 [SRS-22]). METHODS: Surgical ASD patients of 18 years and older with scoliosis greater than or equal to 20 degrees and one of the following radiographic parameters were included: sagittal vertical axis (SVA) greater than or equal to 5 cm, pelvic tilt (PT) greater than or equal to 25 degrees , or thoracic kyphosis (TK) greater than 60 degrees . The SRS-Schwab sagittal modifiers (PT, global alignment, and pelvic incidence and lumbar lordosis [PI-LL]) were assessed at 2-year postoperatively as either normal (\"0\") or abnormal (\"+\" or \"++\"). Patients were classified in the aligned group (AG) or malaligned group (MG) at 2-year follow-up if all three sagittal modifiers were normal or abnormal, respectively. Patients were assessed for CD based on the following criteria: C2-C7 SVA greater than 4 cm, C2-C7 SVA less than 4 cm, cervical kyphosis (CL greater than 0), cervical lordosis (CL less than 0), any deformity (C2-C7 SVA greater than 4 cm or CL greater than 0), and both CD (C2-C7 SVA greater than 4 cm and CL greater than 0). Univariate testing was performed using t or chi-square test, looking at the following preop parameters: CD, C2-C7 SVA, C2-T3 SVA, CL, T1 slope (T1S), T1S-CL, C2-T3 angle, LL, TK, PT, C7-S1 SVA, and PI-LL. RESULTS: One hundred four patients met the initial inclusion criteria with 70 in the AG and 34 in MG. Preoperative, patients in the MG had a higher CL (11.7 vs. 4.9, p=.03), higher C2-T3 angle (13.59 vs 4.9 p=.01), higher PT (p<.0001), higher SVA (p<.0001), and higher PI-LL (p<.0001) compared with the AG. Interestingly, the prevalence of CD at baseline was similar for both groups. There was no statistically significant difference among groups in the amount of improvement more than 2 years on the ODI or the Physical Component Summary of SF-36. CONCLUSIONS: Patients with sagittal spinal malalignment associated with significant cervical compensatory lordosis are at increased risk of realignment failure at 2-year follow-up. Assessment of the degree of cervical compensation may be helpful in preop evaluation to assist in realignment outcome prediction."," Spine J 15(8): 1756-1763.","USA",2015,"Spinal Deformity","Surgical","SRS-HRQOL","Unknown","PRO study","Prospective Observation"]
[280,"Passias, P. G., et al. (2015). \"Postoperative cervical deformity in 215 thoracolumbar patients with adult spinal deformity: prevalence, risk factors, and impact on patient-reported outcome and satisfaction at 2-year follow-up.\" Spine (Phila Pa 1976) 40(5): 283-291.",null,"Passias, P. G., et al.","Postoperative cervical deformity in 215 thoracolumbar patients with adult spinal deformity: prevalence, risk factors, and impact on patient-reported outcome and satisfaction at 2-year follow-up","STUDY DESIGN: Retrospective review of prospective multicenter database. OBJECTIVE: Quantify the incidence of new onset cervical deformity (CD) after adult spinal deformity surgery of the thoracolumbar spine, identify predictors of development, and determine the impact on outcomes. SUMMARY OF BACKGROUND DATA: High prevalence of residual CD has been identified after surgical treatment of adult spinal deformity. Development of new onset CD is less understood and its clinical impact unclear. METHODS: A total of 215 patients with complete 2-year follow-up and full-length radiographs met inclusion criteria. CD was defined by T1 slope minus Cervical Lordosis (CL) more than 20 degrees , C2-C7 sagittal vertical axis more than 40 mm, or C2-C7 kyphosis more than 10 degrees . Univariate analysis was performed using t tests or tests of proportion. Multivariate logistic regression was used to determine independent predictors of new onset CD. The impact of CD on health-related quality of life and satisfaction was measured using repeated measures mixed models or logistic regression as appropriate, accounting for potential confounders. RESULTS: The overall rate of CD at 2 years after surgery was 63%. Univariate analysis revealed that patients who developed new onset CD postoperatively had higher incidence of diabetes (7.35% vs. 1.28%, P = 0.05), increased preoperative C2-C7 sagittal vertical axis (P = 0.04) and C2 slope (P = 0.038), and smaller diameter rods used at surgery (P = 0.032). Independent predictors of new onset CD at 2 years included: diabetes (odds ratio, 10.49; P = 0.046) and increased preoperative T1 slope minus cervical lordosis (odds ratio, 1.08/ masculine; P = 0.022). Ending instrumentation below T4 was a negative predictor (odds ratio, 0.31; P = 0.019). Patients with and without CD experienced improvements in 2-year 36-Item Short Form Health Survey (P = 0.0001), Oswestry Disability Index (P = 0.0001), and Scoliosis Research Society (P = 0.0001). Rates and overall improvement were similar. CD was not associated with decreased satisfaction (P = 0.28). CONCLUSION: A total of 47.7% of patients without preoperative CD developed new onset postoperative CD after thoracolumbar surgery. Independent predictors of new onset CD at 2 years included diabetes, higher preoperative T1 slope minus cervical lordosis, and ending instrumentation above T4. Significant improvements in health-related quality of life scores occurred despite the development of postoperative CD. LEVEL OF EVIDENCE: 2."," Spine (Phila Pa 1976) 40(5): 283-291.","USA",2015,"Spinal Deformity","Surgical","ODI,SRS-HRQOL","Unknown","PRO study","Retrospective review"]
[281,"Patel, S., et al. (2014). \"Primum non nocere: shared informed decision making in low back pain--a pilot cluster randomised trial.\" BMC Musculoskelet Disord 15: 282.",null,"Patel, S., et al.","Primum non nocere: shared informed decision making in low back pain--a pilot cluster randomised trial","BACKGROUND: Low back pain is a common and disabling condition leading to large health service and societal costs. Although there are several treatment options for back pain little is known about how to improve patient choice in treatment selection. The purpose of this study was to pilot a decision support package to help people choose between low back pain treatments. METHODS: This was a single-centred pilot cluster randomised controlled trial conducted in a community physiotherapy service. We included adults with non-specific low back pain referred for physiotherapy. Intervention participants were sent an information booklet prior to their first consultation. Intervention physiotherapists were trained to enhance their skills in shared informed decision making. Those in the control arm received care as usual. The primary outcome was satisfaction with the treatment received at four months using a five-point Likert Scale dichotomised into \"satisfaction\" (very satisfied or somewhat satisfied) and \"non-satisfaction\" (neither satisfied nor dissatisfied, somewhat dissatisfied or very dissatisfied). RESULTS: We recruited 148 participants. In the control arm 67% of participants were satisfied with their treatment and in the intervention arm 53%. The adjusted relative risk of being satisfied was 1.28 (95% confidence interval 0.79 to 2.09). For most secondary outcomes the trend was towards worse outcomes in the intervention group. For one measure; the Roland Morris Disability Questionnaire, this difference was clinically important (2.27, 95% confidence interval 0.08 to 4.47). Mean healthcare costs were slightly lower ( pound38 saving per patient) within the intervention arm but health outcomes were also less favourable (0.02 fewer QALYs); the estimated probability that the intervention would be cost-effective at an incremental threshold of pound20,000 per QALY was 16%. CONCLUSION: We did not find that this decision support package improved satisfaction with treatment; it may have had a substantial negative effect on clinical outcome, and is very unlikely to prove cost-effective. That a decision support package might have a clinically important detrimental effect is of concern. To our knowledge this has not been observed previously. Decision support packages should be formally tested for clinical and cost-effectiveness, and safety before implementation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN46035546 registered on 11/02/10."," BMC Musculoskelet Disord 15: 282.","UK",2014,"Back Pain","Physical Therapy","RMDQ","Adults","PRO study","RCT"]
[282,"Paulus, M. C., et al. (2014). \"Cost and value of spinal deformity surgery.\" Spine (Phila Pa 1976) 39(5): 388-393.",null,"Paulus, M. C., et al.","Cost and value of spinal deformity surgery","STUDY DESIGN: Literature review. OBJECTIVE: To assess (1999) quality of life in patients with adult scoliosis who underwent nonoperative and/or surgical treatment, and (2) cost-effectiveness of different scoliosis treatment modalities. SUMMARY OF BACKGROUND DATA: Recently, there has been an interest in examining quality of life of patients undergoing treatment for adult scoliosis, comparing the value of nonoperative versus operative management. This article reviews the current literature on treatment of adult scoliosis, in the hopes of drawing conclusions for the best approach to these patients. METHODS: MEDLINE and PubMed databases were searched to identify articles. Health-related quality of life measures included Oswestry Disability Index scores, Scoliosis Research Society (SRS) instrument scores, 12-Item Short Form Health Survey, and numerical rating scale for leg and/or back pain. Studies included were those involving patients with adult scoliosis who underwent primary surgery or nonoperative management. The studies that focused on the change in validated outcome scores from the onset of the study to final follow-up were found to be valuable. Studies on predominantly adolescent scoliosis and those that only measured postoperative outcomes scores were excluded. RESULTS: The SRS-22, Oswestry Disability Index, 12-Item Short Form Health Survey, and numerical rating scale were found to be validated for measuring quality of life in patients with scoliosis. Thirteen studies were included, which evaluated changes in health-related quality of life outcomes from baseline in surgical and nonsurgical treatment of adult scoliosis. There was a trend toward improved quality of life measures in patients undergoing surgical treatment for adult scoliosis. CONCLUSION: Adults with painful and disabling scoliosis may benefit from surgical treatment compared with nonsurgical treatment, given the proper indications. Nonsurgical treatment does not seem to be cost-effective and has not shown to have a positive impact on quality of life, although there is a possibility that patients' health may have deteriorated if they did not receive the nonsurgical treatment. Future prospective studies focusing on the cost-effectiveness of adult scoliosis treatment and improvement of quality of life are needed to confirm the assertion of the current retrospective literature that surgery provides better quality of life than nonoperative treatment. LEVEL OF EVIDENCE: N/A."," Spine (Phila Pa 1976) 39(5): 388-393.","USA",2014,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","Cost-Effectiveness","Observational"]
[283,"Pawar, S. G., et al. (2017). \"Software version of Roland Morris Disability questionnaire for outcome assessment in low back pain.\" Neurol Res 39(4): 292-297.",null,"Pawar, S. G., et al.","Software version of Roland Morris Disability questionnaire for outcome assessment in low back pain","BACKGROUND: Developing and using the software version of existing validated paper version of patient-related outcome can go a long way in saving cost, time and effort. However, the equivalence of paper version and software versions cannot be assumed. The aim of the study is to test the equivalence between paper version and software version of Roland Morris Disability Questionnaire and its acceptability among patients. METHODS: This is a within-subject cross over equivalence study. Fifty-five patients with back pain were asked to complete the paper and software version of RMDQ in random order. Patients were included from the Neuro Spinal surgery outpatient department of Lilavati Hospital and Research Center. RESULTS: Statistical analysis of 52 patients who completed the study showed high agreement between the paper and software version of the questionnaire (intraclass correlation coefficient 0.994, 95% confidence interval (0.989-0.996)). High sensitivity and specificity of 84 and 88% of the software version was noted. About 69.2% patients preferred software version over paper version. CONCLUSION: Our study shows that software version is comparable to the paper version. It may prove to be a useful tool for epidemiological studies and patient follow-up over longer period."," Neurol Res 39(4): 292-297.","India",2017,"Back Pain","Surgical","RMDQ","Unknown","PRO study","Observational"]
[284,"Pellegrino, L. N. and O. Avanzi (2014). \"Prospective evaluation of quality of life in adolescent idiopathic scoliosis before and after surgery.\" J Spinal Disord Tech 27(8): 409-414.",null,"Pellegrino, L. N. and O. Avanzi","Prospective evaluation of quality of life in adolescent idiopathic scoliosis before and after surgery","STUDY DESIGN: Prospective observational study. OBJECTIVE: To assess patient quality of life before and after surgical treatment of adolescent idiopathic scoliosis (AIS) and determine whether an association exists between quality of life and curve magnitude, curve correction, and type of instrumentation. SUMMARY OF BACKGROUND DATA: Assessment of AIS surgery outcomes has always been based on analysis of radiographic measurements and postoperative curve correction. However, there is a current trend toward greater emphasis on patient-centered outcomes. Assessment of treatment success on the basis of these outcomes requires prospective use of quality-of-life surveys before and after AIS treatment. METHODS: Prospective study of 33 patients undergoing surgical treatment of AIS. Mean age was 15.6 years and mean Cobb angle was 70.5 degrees. Patients were randomly allocated into one of 2 instrumentation groups (hybrid and pedicle screws alone), and the Scoliosis Research Society-30 questionnaire (SRS-30) and Short Form-36 Health Survey (SF-36) questionnaires were administered preoperatively and at 3-, 6-, and 12-month follow-up. Statistical testing was performed to determine whether survey scores correlated with Cobb angle, curve correction, or type of instrumentation. RESULTS: SRS-30 and SF-36 scores improved significantly. The greatest changes occurred in the self-image and satisfaction with management domains of the SRS-30 survey. SRS-30 and SF-36 scores showed worsening pain and decreased function at 3-month follow-up, but significant improvement from baseline at 12 months. Total SRS-30 scores were significantly improved at 6- and 12-month follow-up, as were subscores in the general health, vitality, and social functioning domains of SF-36. Curve magnitude, percent curve correction, and type of instrumentation had no significant influence on final SRS-30 and SF-36 scores. CONCLUSIONS: Surgical treatment of AIS improved patient quality of life, as shown by significant improvement on all SRS-30 and SF-36 domains. Questionnaire scores did not correlate with Cobb angle, curve correction, or type of instrumentation."," J Spinal Disord Tech 27(8): 409-414.","Brazil",2014,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Prospective Observation"]
[285,"Peloso, P. M., et al. (2004). \"Analgesic efficacy and safety of tramadol/ acetaminophen combination tablets (Ultracet) in treatment of chronic low back pain: a multicenter, outpatient, randomized, double blind, placebo controlled trial.\" J Rheumatol 31(12): 2454-2463.",null,"Peloso, P. M., et al.","Analgesic efficacy and safety of tramadol/ acetaminophen combination tablets (Ultracet) in treatment of chronic low back pain: a multicenter, outpatient, randomized, double blind, placebo controlled trial","OBJECTIVE: To evaluate the analgesic efficacy and safety of tramadol 37.5 mg/acetaminophen 325 mg (tramadol/APAP) combination tablets for treatment of chronic low back pain (LBP). METHODS: This 91 day, multicenter, outpatient, randomized, double blind, placebo controlled study enrolled 338 patients with chronic LBP requiring daily medication for > or = 3 months. Patients with at least moderate pain [pain visual analog scale (VAS) with scores > or = 40/100 mm] after washout were randomized to tramadol/APAP or placebo. After a 10 day titration, patients received 1 or 2 tablets QID. Primary outcome measure was final pain VAS score. Secondary measures included pain relief, quality of life and physical functioning, efficacy failure, and overall medication assessments. RESULTS: In total, 336 intent-to-treat patients received tramadol/APAP (n = 167) or placebo (n = 169). Mean baseline pain VAS score was 67.8. Intent-to-treat analysis showed significantly better mean final pain VAS scores (47.4 vs 62.9; p < 0.001) and mean final pain relief scores (1.8 vs 0.7; p < 0.001) for tramadol/APAP than for placebo. Roland Disability Questionnaire scores and physical-related subcategories of the McGill Pain Questionnaire and the Medical Outcome Study Short Form-36 Health Survey were significantly better for tramadol/APAP patients. More patients rated tramadol/APAP as \"very good\" or \"good\" than placebo (63.6 vs 25.2%; p < 0.001). Kaplan-Meier estimates of cumulative discontinuation rates due to efficacy failures were 22.9% (tramadol/APAP) vs 54.7% (placebo; p < 0.001). The most common treatment related adverse events with tramadol/APAP were nausea (12.0%), dizziness (10.8%), and constipation (10.2%). Average daily dose of tramadol/APAP was 4.2 tablets (tramadol 158 mg/APAP 1369 mg). CONCLUSION: Tramadol 37.5 mg/APAP 325 mg combination tablets show efficacy in pain reduction, in measures of physical functioning and quality of life, and in overall medication assessments, with a tolerability profile comparable with other opioids used for the treatment of chronic LBP."," J Rheumatol 31(12): 2454-2463.","USA",2004,"Back Pain","Tramadol","RMDQ","Unknown","PRO study","RCT"]
[286,"Peolsson, A., et al. (2013). \"Effects of neck-specific exercise with or without a behavioural approach in addition to prescribed physical activity for individuals with chronic whiplash-associated disorders: a prospective randomised study.\" BMC Musculoskelet Disord 14: 311.",null,"Peolsson, A., et al.","Effects of neck-specific exercise with or without a behavioural approach in addition to prescribed physical activity for individuals with chronic whiplash-associated disorders: a prospective randomised study","BACKGROUND: Up to 50% of chronic whiplash associated disorders (WAD) patients experience considerable pain and disability and remain on sick-leave. No evidence supports the use of physiotherapy treatment of chronic WAD, although exercise is recommended. Previous randomised controlled studies did not evaluate the value of adding a behavioural therapy intervention to neck-specific exercises, nor did they compare these treatments to prescription of general physical activity. Few exercise studies focus on patients with chronic WAD, and few have looked at patients' ability to return to work and the cost-effectiveness of treatments. Thus, there is a great need to develop successful evidence-based rehabilitation models. The study aim is to investigate whether neck-specific exercise with or without a behavioural approach (facilitated by a single caregiver per patient) improves functioning compared to prescription of general physical activity for individuals with chronic WAD. METHODS/DESIGN: The study is a prospective, randomised, controlled, multi-centre study with a 2-year follow-up that includes 216 patients with chronic WAD (> 6 months and < 3 years). The patients (aged 18 to 63) must be classified as WAD grade 2 or 3. Eligibility will be determined with a questionnaire, telephone interview and clinical examination. The participants will be randomised into one of three treatments: (A) neck-specific exercise followed by prescription of physical activity; (B) neck-specific exercise with a behavioural approach followed by prescription of physical activity; or (C) prescription of physical activity alone without neck-specific exercises. Treatments will be performed for 3 months. We will examine physical and psychological function, pain intensity, health care consumption, the ability to resume work and economic health benefits. An independent, blinded investigator will perform the measurements at baseline and 3, 6, 12 and 24 months after inclusion. The main study outcome will be improvement in neck-specific disability as measured with the Neck Disability Index. All treatments will be recorded in treatment diaries and medical records. DISCUSSION: The study findings will help improve the treatment of patients with chronic WAD. TRIALS REGISTRATION: ClinicalTrials.gov identifier: NCT01528579."," BMC Musculoskelet Disord 14: 311.","Sweden",2013,"Trauma","Exercise","NDI","Adults","Cost-Effectiveness","RCT"]
[287,"Peolsson, A., et al. (2016). \"Effects of Neck-Specific Exercises Compared to Waiting List for Individuals With Chronic Whiplash-Associated Disorders: A Prospective, Randomized Controlled Study.\" Arch Phys Med Rehabil 97(2): 189-195.",null,"Peolsson, A., et al.","Effects of Neck-Specific Exercises Compared to Waiting List for Individuals With Chronic Whiplash-Associated Disorders: A Prospective, Randomized Controlled Study","OBJECTIVE: To determine whether 3 months of neck-specific exercises (NSEs) could benefit individuals with chronic whiplash-associated disorder (WAD) who were on a waiting list (WL) for treatment. DESIGN: A prospective, randomized controlled study. SETTING: Primary health care. PARTICIPANTS: Individuals (N=41; 31 women, 10 men; mean age +/- SD, 38+/-11.2y) with chronic (6-36mo) WAD, grades 2 and 3, were analyzed. INTERVENTIONS: Patients were randomly assigned to NSEs or no treatment for 3 months. MAIN OUTCOME MEASURES: Neck-specific disability (Neck Disability Index [NDI]), neck pain (visual analog scale), general pain-related disability (Pain Disability Index [PDI]), self-perceived performance ability (Self-Efficacy Scale [SES]), and health-related quality of life (EuroQol 5 dimensions [EQ-5D]) were measured. RESULTS: NSEs significantly improved the NDI, SES, and EQ-5D compared with WL (P<.01). There was significant improvement (P<.0001) over time in all outcomes for NSEs, and apart from the PDI, significant worsening (P=.002-.0002) over time for the untreated group. CONCLUSIONS: NSEs were more beneficial than no intervention while on a WL for individuals with chronic WAD."," Arch Phys Med Rehabil 97(2): 189-195.","Sweden",2016,"Neck Pain","Exercise","NDI","Unknown","PRO study","RCT"]
[288,"Perez-Grueso, F. S., et al. (2000). \"The low lumbar spine below Cotrel-Dubousset instrumentation: long-term findings.\" Spine (Phila Pa 1976) 25(18): 2333-2341.",null,"Perez-Grueso, F. S., et al.","The low lumbar spine below Cotrel-Dubousset instrumentation: long-term findings","STUDY DESIGN: Retrospective review of long instrumented fusions down to the low lumbar spine for the treatment of adolescent idiopathic scoliosis. OBJECTIVES: To evaluate whether the use of instrumentation systems that preserve the sagittal profile could reduce the incidence of early degenerative changes. SUMMARY OF BACKGROUND DATA: Long fusions and distractive Harrington instrumentation in the surgical treatment of adolescent idiopathic scoliosis (AIS) are known to produce pain and degenerative changes in the free lumbar segments. Reports on the use of Cotrel-Dubousett instrumentation (CDI) confirm that the instrumentation maintains physiologic lumbar lordosis, but the evolution of the spine below the fusion is not addressed. METHOD: Thirty-five patients with AIS and CDI were studied. Their spines were fused to L3 or lower, and they had a minimum follow-up of 10 years. Radiologic measurements were recorded from frontal and lateral radiographs. At the time of last examination, lateral flexion-extension dynamic radiographs and magnetic resonance imaging evaluated the health of the disks below the fusion. Clinical outcome was assessed with the Scoliosis Research Society instrument. A control group consisting of 35 peers without scoliosis served as a reference for the outcome questionnaire. RESULTS: Surgery kept the sagittal profile in a physiologic range. All but two patients were satisfied with the results of surgery. There were no differences between patients and control group insofar as pain, self-image, general function, and daily activity were concerned. Eleven patients showed instability signs in dynamic radiographs and more than half of patients showed incipient degeneration on magnetic resonance images. These findings are similar to those found in the general population, according to the literature, and could evidence normal aging processes. CONCLUSIONS: Cotrel-Dubousset instrumentation maintains the physiologic sagittal contour. Although there are some degenerative changes in magnetic resonance images and dynamic radiographs, the quality of life and daily activities of the patients after surgery are similar to those of a normal population of the same age."," Spine (Phila Pa 1976) 25(18): 2333-2341.","Spain",2000,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Retrospective review"]
[289,"Perillo, M. and R. Bulbulian (2003). \"Responsiveness of the Bournemouth and Oswestry questionnaires: a prospective pilot study.\" J Manipulative Physiol Ther 26(2): 77-86.",null,"Perillo, M. and R. Bulbulian","Responsiveness of the Bournemouth and Oswestry questionnaires: a prospective pilot study","BACKGROUND: The assessment of health-related quality-of-life outcome information has become an essential feature in the delivery of quality health care. Outcome assessment and increased clinical research capacity have been identified as recommended areas of priority for chiropractic research, chiropractic colleges, and the profession. OBJECTIVE: This article reports the results of a multisite pilot project utilizing New York Chiropractic College's 3 off-campus health centers. In the project, we sought to examine generic issues related to research infrastructure and feasibility, perform pilot testing of the responsiveness of the revised Oswestry Disability Index (ODI) and the Bournemouth Questionnaire (BQ), and develop estimates of change and population size for the possible future projects. METHODS: We describe the infrastructure created to conduct the project, including an on-site clinician research manager; on-site student research assistants; identification, recruitment, and patient flow; demographic and clinical characteristics; and abstraction instruments. Responsiveness study subjects completed 3 health-related quality-of-life assessments at baseline, 15 days, and 30 days. At 45 days, or at discharge, subjects completed the same questionnaires and a global rating of change. Responsiveness is reported by analysis of standardized estimates of change, relative efficiency, and receiver operator characteristic (ROC) curve plots. RESULTS: We successfully identified 82% of possible study patients; the real eligibility rate in our population was 30%. In 4 months, 70 patients were accrued, and 26 patients followed through to provide global ratings of change scores. Responsiveness by standardized change scores was numerical rating scale (NRS) = 1.19, ODI = 0.91, BQ = 0.78; by relative efficiency it was BQ/ODI = 0.86, ODI/NRS = 0.76, BQ/NRS = 0.66. Area under the curves ranged from 0.69 for the BQ to 0.86 for the NRS. CONCLUSIONS: Recommendations for modification and use of the infrastructure, research capacity, and future outcome and appropriateness assessment projects are offered."," J Manipulative Physiol Ther 26(2): 77-86.","USA",2003,"Unspecified","Not Specified","Bournemouth,ODI","Unknown","Tool Validation","Observational"]
[290,"Petcharaporn, M., et al. (2007). \"The relationship between thoracic hyperkyphosis and the Scoliosis Research Society outcomes instrument.\" Spine (Phila Pa 1976) 32(20): 2226-2231.",null,"Petcharaporn, M., et al.","The relationship between thoracic hyperkyphosis and the Scoliosis Research Society outcomes instrument","STUDY DESIGN: A retrospective chart review and radiographic analysis. OBJECTIVE: To evaluate the association between thoracic hyperkyphosis and patient quality of life measures as determined by the Scoliosis Research Society (SRS) outcomes instrument. SUMMARY OF BACKGROUND DATA: Although validated outcomes questionnaires (e.g., Pediatric Outcomes Data Collection Instrument and SRS) have been used to evaluate patients with scoliosis, there has been little written about the effects of sagittal plane alignment on these functional outcome measurements. METHODS: Data from the SRS outcomes instrument were collected from patients with thoracic hyperkyphosis as well as those with normal spinal alignment. A total of 50 patients with thoracic kyphosis >or=45 degrees were compared with 50 normal patients with thoracic kyphosis <45 degrees . Correlation analysis was performed to identify significant relationships between the magnitude of the major kyphotic curve and the 4 SRS outcome questionnaire domains (Total Pain, General Self-Image, General Function, and Activity). Lower SRS scores indicate an increase in symptoms. RESULTS: The average age of the subjects was 14 +/- 4 years (range, 8-18 years). The thoracic kyphosis varied between 11 degrees and 95 degrees for all subjects. Significant negative correlations were found between kyphosis magnitude and the total pain, general self-image, general function, overall level of activity, and total SRS scores (P < 0.0001). Of the 4 domains, self-image had the highest correlation with kyphosis magnitude while activity had the lowest. CONCLUSION: These findings indicate that higher kyphosis magnitudes were associated with increased pain, lower self-image, and decreased function and activity. Patients with thoracic hyperkyphosis were significantly more symptomatic than normal subjects in all domains. The r values for this analysis of kyphosis (0.40-0.66), in fact were substantially greater than those previously reported for scoliosis magnitude versus SRS Questionnaire scores (0.16-0.26), suggesting this instrument may be even better suited for the evaluation of hyperkyphosis patients."," Spine (Phila Pa 1976) 32(20): 2226-2231.","USA",2007,"Spinal Deformity","Not Specified","SRS-HRQOL","Adults","PRO study","Retrospective review"]
[291,"Petraglia, A. L., et al. (2010). \"Cervical laminoplasty as a management option for patients with cervical spondylotic myelopathy: a series of 40 patients.\" Neurosurgery 67(2): 272-277.",null,"Petraglia, A. L., et al.","Cervical laminoplasty as a management option for patients with cervical spondylotic myelopathy: a series of 40 patients","BACKGROUND: Cervical spondylotic myelopathy (CSM) is one of the leading causes of spinal cord dysfunction in the adult population. Laminoplasty is an effective decompressive procedure for the treatment of CSM. OBJECTIVE: We present our experience with 40 patients who underwent cervical laminoplasty using titanium miniplates for CSM. METHODS: We performed a retrospective review of the medical records of a consecutive series of patients with CSM treated with laminoplasty at the University of Rochester Medical Center or Rochester General Hospital. We documented patient demographic data, presenting symptoms, and postoperative outcome. Data are also presented regarding the general cost of constructs for a hypothetical 3-level fusion. RESULTS: Forty patients underwent cervical laminoplasty; all were available for follow-up. The mean number of levels was 4. All patients were myelopathic, and 17 (42.5%) had signs of radiculopathy preoperatively. Preoperatively, 62.5% of patients had a Nurick grade of 2 or worse. The average follow-up was 31.3 months. The median length of stay was 48 hours. On clinical evaluation, 36 of 40 patients demonstrated an improvement in their myelopathic symptoms; 4 were unchanged. Postoperative kyphosis did not develop in any patients. CONCLUSION: The management of CSM for each of its etiologies remains controversial. As demonstrated in our series, laminoplasty is a cost-effective, decompressive procedure for the treatment of CSM, providing a less destabilizing alternative to laminectomy while preserving mobility. Cervical laminoplasty should be considered in the management of multilevel spondylosis because of its ease of exposure, ability to decompress, effective preservation of motion, maintenance of spinal stability, and overall cost."," Neurosurgery 67(2): 272-277.","USA",2010,"Spondylosis","Surgical","Nurick","Unknown","PRO study","Retrospective review"]
[292,"Phillips, F. M., et al. (2015). \"Long-term Outcomes of the US FDA IDE Prospective, Randomized Controlled Clinical Trial Comparing PCM Cervical Disc Arthroplasty With Anterior Cervical Discectomy and Fusion.\" Spine (Phila Pa 1976) 40(10): 674-683.",null,"Phillips, F. M., et al.","Long-term Outcomes of the US FDA IDE Prospective, Randomized Controlled Clinical Trial Comparing PCM Cervical Disc Arthroplasty With Anterior Cervical Discectomy and Fusion","STUDY DESIGN: Prospective, multicenter, randomized clinical trial. OBJECTIVE: To evaluate the long-term safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in treatment of patients with symptomatic single-level degenerative spondylosis between C3-C4 and C7-T1 with or without prior cervical fusion. SUMMARY OF BACKGROUND DATA: The 2-year results of the PCM Cervical Disc trial have been reported previously. The current study reports the long-term results of the same trial. METHODS: Patients with single-level cervical spondylosis and radiculopathy with or without myelopathy unresponsive to nonoperative treatment were enrolled. The per protocol patient sample at 5 years included 293 patients (163 PCM, 130 ACDF). Adverse events and secondary surgical procedures are reported on the cohorts through current follow-up, which include 110 patients (68 PCM, 42 ACDF) at 7 years. RESULTS: At 5 years postoperative, all patient-reported outcomes-neck and arm pain visual analogue scale score, neck disability index, and general health (36-Item Short Form Health Survey physical and mental component scores: physical component summary, mental component summary)-were significantly improved from baselines in both groups, and mean scores were significantly better in the PCM group for neck disability index (P=0.001), neck pain (P=0.002), general health (Pphysical component summary=0.014; Pmental component summary=0.004), and patient satisfaction (P=0.005). PCM patients trended toward fewer 2- to 7-year device-related serious adverse events (1/214, 0.5% PCM; 2/190, 1.1% ACDF) and secondary surgical procedures (7/211, 3.3% PCM; 14/290, 7.6% ACDF). Adjacent-level degeneration was radiographically more frequent after ACDF (33.1% PCM, 50.9% ACDF; P=0.006) and was the primary indication for the increase in late-term secondary surgical procedures after ACDF. CONCLUSION: The long-term results show good clinical outcomes after ACDF and PCM arthroplasty. PCM patients showed greater improvement in neck disability index and neck pain scores with a lower rate of radiographical adjacent-level degeneration and a trend toward fewer secondary surgical procedures. These data support PCM arthroplasty to be a viable and sustainable alternative to ACDF. LEVEL OF EVIDENCE: 1."," Spine (Phila Pa 1976) 40(10): 674-683.","USA",2015,"Neck Pain,Spondylosis","Surgical","NDI","Unknown","PRO study","RCT"]
[293,"Pho, C. and J. Godges (2004). \"Management of whiplash-associated disorder addressing thoracic and cervical spine impairments: a case report.\" J Orthop Sports Phys Ther 34(9): 511-519; discussion 520-513.",null,"Pho, C. and J. Godges","Management of whiplash-associated disorder addressing thoracic and cervical spine impairments: a case report","STUDY DESIGN: Clinical case report. OBJECTIVES: To describe a physical therapy program addressing impairments of the upper thoracic and cervical spine region for an individual with a whiplash-associated disorder. BACKGROUND: A 32-year-old female with complaint of diffuse posterior cervical and upper thoracic region pain was evaluated 2 weeks following a motor vehicle accident. The patient reported that she was unable to sit for longer than 10 minutes or perform household duties for longer than 1 hour. In addition, she was unable to perform her tasks as a postal worker or participate in her customary running and aerobic exercise activities because of pain in the cervical and upper thoracic region. METHODS AND MEASURES: An examination for physical impairments was performed, including the measurement of cervical range of motion using the CROM device, and the assessment of soft tissue and segmental mobility of the upper thoracic and cervical spine regions. The Northwick Park Neck Pain Questionnaire was used to assess functional limitations and disability. Manual therapy and therapeutic exercises were applied to address the identified impairments. Manual therapy techniques included soft tissue mobilization, joint mobilization, and joint manipulation. RESULTS: The patient's cervical range of motion was improved and the disability score improved from 25% to 19.5% 3 days after the initial session addressing the thoracic spine. Following a second session also addressing thoracic spine impairments and the use of therapeutic exercises for 7 days, the disability score improved to 11.1%. At the final visit 17 days following the third visit, which focused on addressing the cervical spine impairments, there was complete resolution of signs and symptoms and disability. CONCLUSIONS: Interventions addressing the impairments of the upper thoracic and cervical spine region were associated with reducing pain, increasing cervical range of motion, and facilitating return to work and physical activities in a patient with a whiplash-associated disorder. There is a need for continued research investigating the efficacy of providing interventions to the thoracic spine for patients with whiplash-related injuries."," J Orthop Sports Phys Ther 34(9): 511-519; discussion 520-513.","USA",2004,"Trauma,Neck Pain","Exercise","Northwick","Unknown","PRO study","Observational"]
[294,"Pink, J., et al. (2014). \"Properties of patient-reported outcome measures in individuals following acute whiplash injury.\" Health Qual Life Outcomes 12: 38.",null,"Pink, J., et al.","Properties of patient-reported outcome measures in individuals following acute whiplash injury","BACKGROUND: The aim of this study was to assess the acceptability, reliability, validity and responsiveness of the Short-Form Health Survey (SF-12) and its preference-based derivative (SF-6D), the EQ-5D and the Neck Disability Index (NDI) in patients recovering from acute whiplash injury. METHODS: Data from the Managing Injuries of the Neck Trial of 3,851 patients with acute whiplash injury formed the basis of this empirical investigation. The EQ-5D and SF-12 were collected at baseline, and all three outcome measures were then collected at 4 months, 8 months and 12 months post-randomisation. The measures were assessed for their acceptability (response rates), internal consistency, validity (known groups validity and discriminant validity) and their internal and external responsiveness. RESULTS: Response rates were broadly similar across the measures, with evidence of a floor effect for the NDI and a ceiling effect for the EQ-5D utility measure. All measures had Cronbach's alpha statistics of greater than 0.7, indicating acceptable internal consistency. The NDI and EQ-5D utility score correlated more strongly with the physical component scale of the SF-12 than the mental component scale, whilst this was reversed for the SF-6D utility score. The smaller standard deviations in SF-6D utility scores meant there were larger effect sizes for differences in utility score between patients with different injury severity at baseline than for the EQ-5D utility measure. However, the EQ-5D utility measure and NDI were both more responsive to longitudinal changes in health status than the SF-6D. CONCLUSIONS: There was no evidence of differences between the EQ-5D utility measure and NDI in terms of their construct validity, discriminant validity or responsiveness in patients with acute whiplash injury. However, both demonstrated superior responsiveness to longitudinal health changes than the SF-6D."," Health Qual Life Outcomes 12: 38.","UK",2014,"Trauma","Not Specified","NDI","Unknown","PRO study","Observational"]
[295,"Protopsaltis, T., et al. (2014). \"TheT1 pelvic angle, a novel radiographic measure of global sagittal deformity, accounts for both spinal inclination and pelvic tilt and correlates with health-related quality of life.\" J Bone Joint Surg Am 96(19): 1631-1640.",null,"Protopsaltis, T., et al.","TheT1 pelvic angle, a novel radiographic measure of global sagittal deformity, accounts for both spinal inclination and pelvic tilt and correlates with health-related quality of life","BACKGROUND: Adult spinal deformity is a prevalent cause of pain and disability. Established measures of sagittal spinopelvic alignment such as sagittal vertical axis and pelvic tilt can be modified by postural compensation, including pelvic retroversion, knee flexion, and the use of assistive devices for standing. We introduce the T1 pelvic angle, a novel measure of sagittal alignment that simultaneously accounts for both spinal inclination and pelvic retroversion. The purpose of this study was to investigate the relationship of the T1 pelvic angle and other established sagittal alignment measures and to correlate these parameters with health-related quality-of-life measures. METHODS: This is a multicenter, prospective, cross-sectional analysis of consecutive patients with adult spinal deformity. Inclusion criteria were adult spinal deformity, an age of greater than eighteen years, and any of the following: scoliosis, a Cobb angle of >/= 20 degrees , sagittal vertical axis of >/= 5 cm, thoracic kyphosis of >/= 60 degrees , and pelvic tilt of >/= 25 degrees . Clinical measures of disability included the Oswestry Disability Index (ODI), Scoliosis Research Society (SRS)-22, and Short Form-36 (SF-36) questionnaires. RESULTS: Five hundred and fifty-nine consecutive patients with adult spinal deformity (mean age, 52.5 years) were enrolled. The T1 pelvic angle correlated with the sagittal vertical axis (r = 0.837), pelvic incidence minus lumbar lordosis (r = 0.889), and pelvic tilt (0.933). Categorizing the patients by increasing T1 pelvic angle (<10 degrees , 10 degrees to 20 degrees , 21 degrees to 30 degrees , and > 30 degrees ) revealed a significant and progressive worsening in health-related quality of life (p < 0.001 for all). The T1 pelvic angle and sagittal vertical axis correlated with the ODI (0.435 and 0.455), SF-36 Physical Component Summary (-0.445 and -0.458), and SRS (-0.358 and -0.383) (p < 0.001 for all). Utilizing a linear regression analysis, a T1 pelvic angle of 20 degrees corresponded to a severe disability (an ODI of >40), and the meaningful change in T1 pelvic angle corresponding to one minimal clinically important difference was 4.1 degrees on the ODI. CONCLUSIONS: The T1 pelvic angle correlates with health-related quality of life in patients with adult spinal deformity. The T1 pelvic angle is related to both pelvic tilt and sagittal vertical axis; however, unlike sagittal vertical axis, it does not vary on the basis of the extent of pelvic retroversion or patient support in standing. Since the T1 pelvic angle is an angular and not a linear measure, it does not require calibration of the radiograph. Thus, the T1 pelvic angle measures sagittal deformity independent of many postural compensatory mechanisms, and it can be useful as a preoperative planning tool, with a target T1 pelvic angle of < 14 degrees . LEVEL OF EVIDENCE: Diagnostic Level II. See Instructions for Authors for a complete description of levels of evidence."," J Bone Joint Surg Am 96(19): 1631-1640.","USA",2014,"Spinal Deformity","Surgical","ODI,SRS-HRQOL","Adults","PRO study","Observational"]
[296,"Qiao, J., et al. (2013). \"Validation of the Simplified Chinese version of the Core Outcome Measures Index (COMI).\" Eur Spine J 22(12): 2821-2826.",null,"Qiao, J., et al.","Validation of the Simplified Chinese version of the Core Outcome Measures Index (COMI)","PURPOSE: To translate the Core Outcome Measures Index (COMI) into Simplified Chinese and then validate it for Mainland Chinese patients with low back pain (LBP). METHODS: A total of 120 consecutive patients with LBP >3 months who visited our outpatient clinic from December 2011 to March 2012 were asked to complete a questionnaire booklet including the following: (1999) the Roland Morris disability questionnaire (RMQ) (Fan et al. in Spine 37(10):875-880, 2012), (2) the Short Form Health Survey (SF-36) (Zhang et al. in Int J Med Sci 9(7):521-526, 2012), (3) the Oswestry Disability Index (ODI) (Liu et al. in Spine 34(11):1211-1216, 2009), (4) visual analogue scale (VAS) measure of pain, and (5) COMI. These patients were also asked to complete a second COMI questionnaire and a transition questionnaire (5-point Likert scale: better, a little better, no change, a little worse, worse) and to return the second COMI questionnaire via mail within 1 month. RESULTS: The floor effects for the COMI items ranged from 5.8 to 12.5 %. High values (28.3, 27.5, and 25.8 %, respectively) were found for symptom-specific quality of life, social disability, and work disability. Regarding the ceiling effects, the social and work disabilities were relatively high at 17.5 and 24.2 %, respectively. For other items, the values ranged from 0 to 14.2 %. Neither floor nor ceiling effects were found for the COMI summary score. Excellent correlations were found between the COMI pain scores and VAS scores (Rho = 0.89) and between the COMI pain and the SF-36 bodily pain domain (Rho = 0.84). Other individual items and summary scores showed a very good correlation (Rho = 0.54-0.72) with the corresponding questionnaires except for \"symptom-specific well-being\" (0.31-0.45). One-way repeated measures ANOVA was used to determine the intraclass correlation coefficient (ICC). The ICC for the entire COMI score was 0.91 (95 % CI 0.85-0.94) and 0.81-0.86 for the two pain scores (back and leg). The \"minimum detectable change'' (MDC 95 %) for the COMI summary score was 1.91 points. No significant difference in the mean values was found for the repeated scores of individual items or the summary score. CONCLUSION: The Simplified Chinese version of COMI showed satisfactory reliability and good psychometric properties. This concise questionnaire is suitable for widespread use in Mainland China."," Eur Spine J 22(12): 2821-2826.","China",2013,"Back Pain","Not Specified","ODI,RMDQ","Unknown","Tool Validation","Observational"]
[297,"Qin, Z., et al. (2016). \"Efficacy of acupuncture for degenerative lumbar spinal stenosis: protocol for a randomised sham acupuncture-controlled trial.\" BMJ Open 6(11): e012821.",null,"Qin, Z., et al.","Efficacy of acupuncture for degenerative lumbar spinal stenosis: protocol for a randomised sham acupuncture-controlled trial","INTRODUCTION: Degenerative lumbar spinal stenosis (DLSS) is a major public health problem and the primary reason why older adults seek lumbar spine surgery. Acupuncture may be effective for DLSS, but the evidence supporting this possibility is still limited. METHODS AND ANALYSIS: A total of 80 participants with DLSS will be randomly allocated to either an acupuncture group or a sham acupuncture (SA) group at a ratio of 1:1. 24 treatments will be provided over 8 weeks. The primary outcome is the score change of the Modified Roland-Morris Disability Questionnaire (RMDQ) responses from baseline to week 8. The secondary outcomes include the assessment of lower back pain and leg pain using the Numeric Rating Scale (NRS), the change in the number of steps per month, and the assessment of the specific quality of life using the Swiss Spinal Stenosis Questionnaire (SSSQ). We will follow-up with the participants until week 32. All of the participants who received allocation will be included in the statistical analysis. ETHICS/DISSEMINATION: This protocol has been approved by the Research Ethical Committee of Guang'anmen Hospital (Permission number: 2015EC114) and Fengtai Hospital of Integrated Traditional and Western Medicine (Permission number: 16KE0409). The full data set will be made available when this trial is completed and published. Applications for the release of data should be made to ZL (principal investigator). TRIAL REGISTRATION NUMBER: NCT02644746."," BMJ Open 6(11): e012821.","China",2016,"Back Pain","Acupuncture,Surgical","RMDQ,SSSQ","Unknown","PRO study","RCT"]
[298,"Qiu, G., et al. (2011). \"Re-evaluation of reliability and validity of simplified Chinese version of SRS-22 patient questionnaire: a multicenter study of 333 cases.\" Spine (Phila Pa 1976) 36(8): E545-550.",null,"Qiu, G., et al.","Re-evaluation of reliability and validity of simplified Chinese version of SRS-22 patient questionnaire: a multicenter study of 333 cases","STUDY DESIGN: A multicenter cross-cultural study to re-evaluate the reliability and validity of the simplified Chinese version of Scoliosis Research Society-22 (SRS-22) Patient Questionnaire. OBJECTIVE: To assess the concurrent validity and reliability of this instrument in mainland China. SUMMARY OF BACKGROUND DATA: The SRS-22 Questionnaire was developed to assess the health-related quality of life for patients with scoliosis in the United States. More recently, the reliability and validity analyses of traditional and simplified Chinese versions of this questionnaire were performed, respectively. However, with respect to the diversity of population and large proportion of rural patients in China, a multicenter study might be necessary to re-evaluate its adaptation. METHODS: The original English version of the SRS-22 Questionnaire was translated into simplified Chinese. Considering the different health care systems in mainland China, the question 15 was modified; the respondent might be the parent if the patient was younger than 18 years. This multicenter study was performed by 13 scoliosis surgeons involving seven spine centers. The SRS-22 Questionnaire and a previously validated 36-Item Short-Form Health Survey Questionnaire were given to 391 patients with idiopathic scoliosis or congenital scoliosis without neurologic deficits. Of those, 136 patients were randomly selected for a second identical SRS-22 Questionnaire filled 1 week later and mailed back with a stamped return envelope. RESULTS: A total of 333 patients fully completed both SRS-22 and 36-Item Short-Form Health Survey Questionnaires. Good consistency was observed for all the five domains of the SRS-22. Poorer internal consistency was found in questions 15 and 18. If question 15 was excluded, the alpha coefficient would increase to 0.68. The pain domain of SRS-22 had a high ceiling effect being 67.5%. The test-retest reproducibility was observed \"good\" in the pain domain and \"excellent\" for the remaining domains of SRS-22 Questionnaire. Good (10 domains) and moderate (23 domains) correlations were demonstrated while seven domains had poor correlation. CONCLUSION: The simplified Chinese version of the SRS-22 Questionnaire was re-evaluated by a multicenter study to respect the diversity of population and cultural differences in mainland China, which showed good internal consistency and satisfactory test-retest reproducibility. It might be useful for clinical evaluation of Chinese adolescents and young adults with scoliosis treated with bracing or surgery, although it also encountered previously reported difficulties with some of the items related to different cultures and health care systems."," Spine (Phila Pa 1976) 36(8): E545-550.","China",2011,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","Tool Validation","Observational"]
[299,"Que, Q., et al. (2013). \"Effectiveness of acupuncture intervention for neck pain caused by cervical spondylosis: study protocol for a randomized controlled trial.\" Trials 14: 186.",null,"Que, Q., et al.","Effectiveness of acupuncture intervention for neck pain caused by cervical spondylosis: study protocol for a randomized controlled trial","BACKGROUND: Neck pain caused by cervical spondylosis has become a common health problem worldwide among >40-year-old adults. Acupuncture intervention is one of the most popular treatment measures for this disorder. However, evidence for its efficacy in relieving neck pain and recovering neck physiological function has not been established in randomized, placebo-controlled trials. The primary aim of this trial is to assess the efficacy and safety of active acupuncture compared with sham acupuncture intervention for neck pain caused by cervical spondylosis. METHODS/DESIGN: We will conduct a randomized, double-blind, parallel-group, placebo-controlled trial comparing active acupuncture with placebo (sham acupuncture). A total of 456 patients with neck pain caused by cervical spondylosis who meet the eligibility criteria from outpatient clinics of the Second People's Hospital of Fujian Province and the Affiliated Rehabilitation Hospital, Fujian University of Traditional Chinese Medicine will be recruited and randomized into an active acupuncture or sham acupuncture group. The participants will undergo treatment sessions with either active or sham acupuncture intervention five times a week for 2 weeks. Evaluation by blinded assessors at baseline and at intervention for 1 and 2 weeks will include demographic characteristics, validated questionnaires (Northwick Park Neck Pain Questionnaire (NPQ) scale, Short-Form 36 (SF-36) scale, and McGill pain scale), examination of neck physiological function, and adverse events. All included patients will be followed up and investigated for relapse of neck pain at 4, 8, and 12 weeks after intervention. DISCUSSION: This paper describes the rationale and design of a randomized double-blind, placebo-controlled trial that aims to determine the efficacy and safety of acupuncture intervention for neck pain caused by cervical spondylosis. The primary outcomes are changes in the NPQ score and neck physiological function. Secondary outcome measures include quality of life, adverse events, and relapse of neck pain. If successful, this project will provide evidence of the efficacy and safety of acupuncture for neck pain caused by cervical spondylosis. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR-TRC-12002206. Registration date: 11 May 2012."," Trials 14: 186.","China",2013,"Neck Pain,Spondylosis","Acupuncture","Northwick","Unknown","PRO study","RCT"]
[300,"Raftery, M. N., et al. (2013). \"Effectiveness of a cognitive behavioural therapy-based rehabilitation programme (Progressive Goal Attainment Program) for patients who are work-disabled due to back pain: study protocol for a multicentre randomised controlled trial.\" Trials 14: 290.",null,"Raftery, M. N., et al.","Effectiveness of a cognitive behavioural therapy-based rehabilitation programme (Progressive Goal Attainment Program) for patients who are work-disabled due to back pain: study protocol for a multicentre randomised controlled trial","BACKGROUND: Psychologically informed rehabilitation programmes such as the Progressive Goal Attainment Program (PGAP) have the potential to address pain-related disability by targeting known psychological factors that inhibit rehabilitation progress. However, no randomised controlled trials of this intervention exist and it has not been evaluated in the Irish health service context. Our objective was to evaluate the clinical efficacy and cost-effectiveness of the PGAP in a multicentre randomised controlled trial with patients who are work-disabled due to back pain. METHODS AND DESIGN: Adult patients (ages 18 years and older) with nonmalignant back pain who are work-disabled because of chronic pain and not involved in litigation in relation to their pain were invited to take part. Patients were those who show at least one elevated psychosocial risk factor (above the 50th percentile) on pain disability, fear-based activity avoidance, fatigue, depression or pain catastrophizing. Following screening, patients are randomised equally to the intervention or control condition within each of the seven trial locations. Patients allocated to the control condition receive usual medical care only. Patients allocated to the PGAP intervention condition attend a maximum of 10 weekly individual sessions of structured active rehabilitation in addition to usual care. Sessions are delivered by a clinical psychologist and focus on graded activity, goal-setting, pacing activity and cognitive-behavioural therapy techniques to address possible barriers to rehabilitation.The primary analysis will be based on the amount of change on the Roland Morris Disability Questionnaire posttreatment. We will also measure changes in work status, pain intensity, catastrophizing, depression, fear avoidance and fatigue. Outcome measures are collected at baseline, posttreatment and 12-month follow-up. Health-related resource use is also collected pre- and posttreatment and at 12-month follow-up to evaluate cost-effectiveness. DISCUSSION: This study will be the first randomized controlled trial of the PGAP in chronic pain patients and will provide important information about the clinical and cost effectiveness of the programme as well as its feasibility in the context of the Irish health service. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN61650533."," Trials 14: 290.","Ireland",2013,"Back Pain","Psychosocial","RMDQ","Adults","Cost-Effectiveness","RCT"]
[301,"Ranieri, M., et al. (2009). \"The use of alpha-lipoic acid (ALA), gamma linolenic acid (GLA) and rehabilitation in the treatment of back pain: effect on health-related quality of life.\" Int J Immunopathol Pharmacol 22(3 Suppl): 45-50.",null,"Ranieri, M., et al.","The use of alpha-lipoic acid (ALA), gamma linolenic acid (GLA) and rehabilitation in the treatment of back pain: effect on health-related quality of life","The aim of this trial was to evaluate the effects of alpha-lipoic acid (ALA) and gamma-linolenic acid (GLA) and the beneficial effect of physical exercise on positive sensory symptoms and neuropathic pain in patients with compressive radiculopathy syndrome from disc-nerve root conflict. Often these painful syndromes after the acute event, tend to recurr becoming subacute or chronic syndromes that become for the period of interest disabiling is an event very important in these cases proper prevention, based on a maintenance drug therapy and the strengthening exercises of paravertebral muscles, flexibility exercises on the spine and when needed on the reduction of body weight. In this Observational Cohort, two-arm trial, 203 patients were enrolled and divided into two groups, the first, ALA and GLA group, (n = 101) received oral dose of 600 mg of alpha-lipoic acid (ALA) and 360 mg of gamma-linolenic acid (GLA) and a rehabilitation program for six weeks, the second (n = 102) treated with only rehabilitation program. Patients were recruited at the centre of Physical Medicine and Rehabilitation, they underwent a physiatric examination at the primary outcome (t0) and secondary outcomes were recorded at monitoring visits scheduled at two weeks = t1, four weeks = t2, six weeks = t3, and at the same has been administered the following scale: VAS scale, SF-36, Oswestry Low Back Pain Disability Questionnaire, Aberdeen Back Pain Scale (ABPS), Revised Leeds Disability Questionnaire (LDQ), Roland and Morris Disability Questionnaire. Significant improvements was noted in the ALA and GLA group for paresthesia, stabbing and burning pain, as showed by VAS (Visual Analogue Scale), Oswestry Low Back Pain Disability Questionnaire, Aberdeen Low Back Pain Scale; also, improvements of quality of life has been noted, in the same group, as showed by SF-36, LDQ (Revised Leeds Disability Questionnaire), Roland and Morris disability questionnaire. All these outcome measure showed statistically significant decreases. Oral treatment with alpha-lipoic acid (ALA) and gamma-linolenic acid (GLA) for six weeks in synergy with rehabilitation therapy improved neuropathic symptoms and deficits in patients with radicular neuropathy."," Int J Immunopathol Pharmacol 22(3 Suppl): 45-50.","Italy",2009,"Neuropathic Pain,Radiculopathy","Exercise","Aberdeen LBP","Unknown","PRO study","Prospective Observation"]
[302,"Rantonen, J., et al. (2014). \"Face-to-face information combined with a booklet versus a booklet alone for treatment of mild low-back pain: a randomized controlled trial.\" Scand J Work Environ Health 40(2): 156-166.",null,"Rantonen, J., et al.","Face-to-face information combined with a booklet versus a booklet alone for treatment of mild low-back pain: a randomized controlled trial","OBJECTIVE: The aim of this study was to determine the effectiveness of face-to-face information for the treatment of mild low-back pain (LBP) in an occupational health (OH) setting. METHODS: We conducted a 48-month randomized controlled trial (RCT) with two 1:1 allocated parallel groups of forestry company employees. Eligibility criteria included permanent employment, age <57 years, and mild LBP [visual analogue scale (VAS) 10-34 mm] in a survey. The intervention group received the Back Book, an information booklet on how to manage LBP, with an additional face-to-face review of the booklet by an OH nurse. The control group received the booklet only. Primary outcomes were physical impairment (Roland-Morris 18-item (RM-18) Disability Questionnaire), LBP (VAS 100 mm), health-related quality of life [15-dimensional quality of life (15-D)] during two years and sickness absence (SA) up to four years. Participants were assigned using block randomization with a computer-generated scheme. RESULTS: The RCT comprised 181 participants (72% male, mean age 44 years). There were no differences between the treatment arms in any of the primary outcomes at any time point. At 24 months, the mean group differences (intervention versus control) were: RM-18: 0 [95% confidence interval (95% CI) -1-1], VAS: 3 mm (95% CI -3-8), and 15-D 0.00 (95% CI -0.02-0.02). The difference in cumulative sickness absence days at 48 months were -3 (95% CI -28-21) for total and 1 (95% CI -3-5) for LBP specific sick leaves. Exploratory analysis revealed no differences at subgroup-levels either. CONCLUSIONS: Face-to-face patient information by an OH nurse in addition to a booklet was not more effective than the booklet alone in treating employees with mild LBP in an OH setting."," Scand J Work Environ Health 40(2): 156-166.","Finland",2014,"Back Pain","Education","RMDQ","Adults","PRO study","RCT"]
[303,"Rasotto, C., et al. (2015). \"Tailored exercise program reduces symptoms of upper limb work-related musculoskeletal disorders in a group of metalworkers: A randomized controlled trial.\" Man Ther 20(1999): 56-62.",null,"Rasotto, C., et al.","Tailored exercise program reduces symptoms of upper limb work-related musculoskeletal disorders in a group of metalworkers: A randomized controlled trial","Work-related musculoskeletal disorders (WRMDs) are a leading cause of work-related disability and loss of productivity in the developed countries; these disorders may concur with the indirect costs of an illness or injury included losses of potential output. Literature on workplace physical activity program provided a mixed but positive impact on health and important worksite outcomes. Therefore, programs of physical activity organized and performed in the workplace could reveal as essential tool to reduce musculoskeletal symptoms. This investigation aimed to assess the effectiveness of a tailored physical activity program, performed in a work-environment, to reduce the symptoms in upper extremities and neck with the novelty in personalizing the approach applied to the exercise protocol, basing on pain and disability levels, to reduce the onset and symptoms in upper extremity and neck WRMDs increasing upper-limb strength and flexibility. 68 metalworkers were recruited, 34 were randomly allocated to an intervention group (IG), while the other 34 to a control group. Primary outcomes concerned pain symptoms measured with visual analog scales while disability was measured by DASH (Disability of the Arm, Shoulder and Hand), and NPDS-I (Neck Pain and Disability Scale) questionnaires. Grip strength, upper-limb mobility, neck and shoulder range of motion were also assessed. After the 9-month intervention, IG reduced pain symptoms on neck, shoulders, elbows and on wrists. Grip strength and upper-limb mobility improved as well as scores on questionnaires. This protocol suggests that performing a tailored physical activity program is beneficial to reduce pain and disability on upper-limb WRMDs."," Man Ther 20(1999): 56-62.","Italy",2015,"Neck Pain","Exercise","NPDS","Unknown","Cost-Effectiveness","RCT"]
[304,"Rayegani, S., et al. (2011). \"Comparison of the effects of low energy laser and ultrasound in treatment of shoulder myofascial pain syndrome: a randomized single-blinded clinical trial.\" Eur J Phys Rehabil Med 47(3): 381-389.",null,"Rayegani, S., et al.","Comparison of the effects of low energy laser and ultrasound in treatment of shoulder myofascial pain syndrome: a randomized single-blinded clinical trial","BACKGROUND: Myofascial pain syndrome (MPS) is one of the most prevalent musculoskeletal diseases. MPS impaired quality of life in the patients. There is a lot of controversy about different treatment options which include medical treatments, physical therapy, injections, ultrasound and laser. The effects of laser in MPS are challenging. AIM: To assess the effects of laser and ultrasound in treatment of MPS. DESIGN: Randomized single blinded clinical trial SETTING: Outpatient physical therapy clinic at university hospital POPULATION: Sixty three subjects (females: 46, males: 17), (age range: 17-55 year old) who had a diagnosis of definite MPS were entered in the study. METHODS: We measured the pain intensity at rest, during activity and at night using Visual Analogue Scale (VAS) questionnaire. The patients also filled the Neck Disability Index (NDI) form and the pain threshold provoked by pressure was determined using algometric assessment. Then, the patients were categorized randomly in groups A, B and C (receiving laser therapy, ultrasound and sham laser therapy, respectively). Six weeks after the initial visit, they were visited again and filled the forms again. RESULTS: Ultrasound was effective in VAS improvement during activity (46%), at rest (39%) and at night (35%). It also improved NDI scores (34%) and algometric assessment (37%). Laser was effective in VAS improving during activity (54%), at night (51%) and at rest (51%) and also improved NDI scores (73%). It was also found effective in algometric assessment improvement (105%). Laser resulted in more NDI score and algometric assessment improvements comparing to ultrasound (p<0.05). CONCLUSION: This study introduces laser as one of the preferred treatments of myofascial pain syndrome in shoulder."," Eur J Phys Rehabil Med 47(3): 381-389.","Iran",2011,"Myofascial pain syndrome","Physical Therapy","NDI","Unknown","PRO study","RCT"]
[305,"Rhyne, A. L., et al. (2012). \"Oxiplex reduces leg pain, back pain, and associated symptoms after lumbar discectomy.\" Spine (Phila Pa 1976) 37(8): 631-641.",null,"Rhyne, A. L., et al.","Oxiplex reduces leg pain, back pain, and associated symptoms after lumbar discectomy","STUDY DESIGN: Prospective, randomized, blinded clinical trial. OBJECTIVE: To evaluate effectiveness of Oxiplex gel for reduction of pain and associated symptoms after lumbar discectomy. SUMMARY OF BACKGROUND DATA: Oxiplex gel (carboxymethylcellulose, polyethylene oxide, and calcium) is used during discectomy to coat the surgical site for reduction of pain and symptoms after lumbar discectomy. METHODS: Patients undergoing single-level lumbar discectomy performed by laminectomy or laminotomy and randomized to receive either surgery plus Oxiplex gel (treatment group) or surgery alone (control group) were assessed 6 months after surgery using (1999) a quality of life questionnaire (Lumbar Spine Outcomes Questionnaire [LSOQ]) and (2) clinical evaluations. RESULTS: There were no statistically significant differences in baseline demographics, surgical procedures, LSOQ scores, and clinical evaluations between treatment (N = 177) and control (N = 175) groups. More gel-treated patients were satisfied with outcome of their surgical treatment than control patients (P = 0.05). The gel-treated group showed greater reductions in pain and symptoms from baseline compared with surgery-only controls. Additional benefits of gel were consistently shown in reduction of leg and back pain at 6 months in the patient population having substantial back pain at baseline (greater than or equal to the median LSOQ pain score of 63). In that population, there was a statistically significant reduction of leg pain and back pain (P < 0.01) in the treatment group compared with controls. Fewer patients in the treatment group had abnormal musculoskeletal physical examinations at 6 months compared with controls. There were no cases of cerebrospinal fluid leaks and no differences in laboratory values or vital signs. Patients in the treatment group had less hypoesthesia, paraesthesia, sensory loss, and fewer reoperations during the 6-month follow-up than controls (1 vs. 6). CONCLUSION: These data demonstrate improvements in clinical outcomes resulting from the use of Oxiplex gel in discectomy procedures for treatment of lumbar disc herniation."," Spine (Phila Pa 1976) 37(8): 631-641.","USA",2012,"Degenerative Disk Disease","Surgical,Oxiplex gel","LSOQ","Unknown","PRO study","RCT"]
[306,"Ribeiro, L. H., et al. (2008). \"Effectiveness of a back school program in low back pain.\" Clin Exp Rheumatol 26(1999): 81-88.",null,"Ribeiro, L. H., et al.","Effectiveness of a back school program in low back pain","OBJECTIVES: To evaluate the effectiveness of a back school program in pain, functional status, quality of life, and in anxiety and depression in patients with non-specific low back pain. METHODS: Sixty patients with low back pain were randomized to an intervention and control group. The intervention group underwent a five-weekly back school program. The control group was seen in weekly medical visits, without educative approaches. Both groups took acetaminophen as analgesic medication. All subjects were evaluated by a blind physiotherapist after randomization, 30, 60 and 120 days. Rolland-Morris, SF-36, STAI and Beck questionnaires, pain visual analogical scale and Schober's test were applied. Non-steroidal anti-inflammatory drugs (NSAID) consumption was considered co-intervention. The statistical analyses were performed using Pearson's Chi-Square analysis and Student's t-test to compare the baseline characteristics of the groups and the analysis of variance (ANOVA) with repeated measures to assess changes inter/intra groups. RESULTS: There were no significant differences in the baseline characteristics between the two groups. Fifty-five patients completed the study. The intervention group showed a significant improvement in the general health domain, assessed by SF-36, and also in the reduction of acetaminophen and NSAID intake. There was no significant difference between the groups in pain, functional status, anxiety or depression. CONCLUSION: The back school program was more effective than any educational intervention in general health status and in decreasing acetaminophen and NSAID intake. It was ineffective in the other quality of life domains, in pain, functional status, anxiety and depression."," Clin Exp Rheumatol 26(1999): 81-88.","Brazil",2008,"Back Pain","NSAID","RMDQ,Schober","Unknown","PRO study","Clinical trial"]
[307,"Richardson, S. S. and S. Berven (2012). \"The development of a model for translation of the Neck Disability Index to utility scores for cost-utility analysis in cervical disorders.\" Spine J 12(1999): 55-62.",null,"Richardson, S. S. and S. Berven","The development of a model for translation of the Neck Disability Index to utility scores for cost-utility analysis in cervical disorders","BACKGROUND CONTEXT: The Neck Disability Index (NDI) is a commonly used disease-specific instrument for cervical spine disorders with good responsiveness and psychometric properties compared with general health status measures. However, NDI scores are unitless and do not have an intrinsic value that is comparable to other health status measures, and these scores have limited value in cost-utility analysis. The translation of disease-specific measures to Short Form-6 Dimensions (SF-6D) utility scores may be useful in cost-utility analysis. PURPOSE: The purpose of this study is to present a model for translating the NDI to SF-6D utility scores, permitting the use of NDI scores in the cost-utility analysis of cervical disorders. STUDY DESIGN/SETTING: A secondary analysis of a multicenter prospective clinical trial of the Synthes ProDisc-C (Synthes, West Chester, PA, USA) was performed. PATIENT SAMPLE: Patients included were randomized to receive either a total disc arthroplasty or anterior cervical discectomy and fusion for treatment of symptomatic cervical disc disease involving one vertebral level between C3 and C7. All subjects completed NDI and 36-Item Short Form Health Survey (SF-36) self-assessments at preoperative and postoperative follow-ups of 6 weeks, 3, 6, 12, 18, and 24 months. OUTCOME MEASURES: The NDI is a validated and widely used self-reported questionnaire designed to assess patient-determined disability resulting from neck pain, including pain level and effects on activities of daily living. The SF-6D is a preference-based health state classification system derived from six health dimensions of the SF-36 self-reported questionnaire, including the domains of physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality. METHODS: The collected data points were divided into two cohorts: one for model formation and one for the assessment of model validity. SF-36 scores were converted to SF-6D utilities via three previously published methods. Correlation analyses and linear regression modeling between SF-6D and NDI created the models for translating scores. For validation, Spearman and Pearson correlations were calculated between the observed and predicted SF-6D utilities, and prediction errors were calculated. RESULTS: Four hundred thirty patients with 2,137 time points were used for creation and validation of the model. Pearson and Spearman correlation coefficients between the NDI and the SF-6D derived from each conversion method were found to be between -0.8255 and -0.8504 (p<.01). R(2) values ranged from 0.68 to 0.71 and root mean squared error (RMSE) from 0.092 to 0.084. Correlations between estimated and observed SF-6D scores ranged from 0.8325 to 0.8372 (p<.01). The mean prediction error was less than 0.006, with standard deviation (SD) between 0.082 and 0.093. DISCUSSION: Correlations between NDI and SF-6D utility scores are strong and statistically significant. The model has a large R(2) and small RMSE. The prediction models produce a small mean prediction error, but the SD of the prediction errors is large. High correlations between NDI and SF-6D permit these models to be used to calculate overall utilities, changes in utilities, and quality-adjusted life-years for large data samples. However, the relatively large observed prediction error SDs may limit the accuracy of translation of individual data points or small sample sizes."," Spine J 12(1999): 55-62.","USA",2012,"Neck Pain","Surgical","NDI","Unknown","Tool Validation","Clinical trial"]
[308,"Richter, H., et al. (2016). \"Dynamic Cervical Implant versus Anterior Cervical Diskectomy and Fusion: A Prospective Study of Clinical and Radiologic Outcome.\" J Neurol Surg A Cent Eur Neurosurg 77(4): 300-307.",null,"Richter, H., et al.","Dynamic Cervical Implant versus Anterior Cervical Diskectomy and Fusion: A Prospective Study of Clinical and Radiologic Outcome","Objective To evaluate clinical and radiologic outcome in patients treated with a dynamic cervical implant (DCI) or anterior cervical diskectomy and fusion (ACDF). Study Design A prospective comparative cohort study. Methods The study included 60 patients with one- or two-level cervical degenerative disk disease (DDD) undergoing treatment with either DCI (n = 30) or ACDF (n = 30). Clinical and radiologic outcomes were assessed 3 and 12 months after surgery. Clinical scoring systems included the Visual Analog Scale for Neck (VAS-N) and Arm pain (VAS-A), the Neck Pain and Disability Scale (NPAD), and the European Quality of Life Scale (EQ-5D). Results Both the DCI and ACDF group showed significant clinical improvement 12 months after surgery using the VAS-N (p = 0.034 and p < 0.001, respectively), VAS-A (p < 0.001 and p < 0.001, respectively), NPAD (p < 0.001 and p < 0.001, respectively), and EQ-5D (p < 0.001 and p < 0.001, respectively). There were no significant differences in clinical outcome comparing both groups at the 3- and 12-month follow-up. The fusion rate at 12 months after surgery was 39.4% and 80.0% in the DCI and ACDF groups, respectively. Radiolucency was found in 90.9% in the DCI group at 12-month follow-up. Conclusion The clinical results for DCI treatment are equivalent to those for ACDF in the treatment of one- and two-level cervical DDD at 12 months after surgery. Further studies are necessary to investigate the high rates of radiolucency and fusion associated with DCI treatment."," J Neurol Surg A Cent Eur Neurosurg 77(4): 300-307.","Switzerland",2016,"Neck Pain","Surgical","NPDS","Unknown","PRO study","Prospective Observation"]
[309,"Ris, I., et al. (2016). \"Does a combination of physical training, specific exercises and pain education improve health-related quality of life in patients with chronic neck pain? A randomised control trial with a 4-month follow up.\" Man Ther 26: 132-140.",null,"Ris, I., et al.","Does a combination of physical training, specific exercises and pain education improve health-related quality of life in patients with chronic neck pain? A randomised control trial with a 4-month follow up","AIM: To investigate the effect of combining pain education, specific exercises and graded physical activity training (exercise) compared with pain education alone (control) on physical health-related quality of life (HR-QoL) in chronic neck pain patients. METHODS: A multicentre randomised controlled trial of 200 neck pain patients receiving pain education. The exercise group received additional exercises for neck/shoulder, balance and oculomotor function, plus graded physical activity training. Patient-reported outcome measures (Short Form-36 Physical and Mental component summary scores, EuroQol-5D, Beck Depression Inventory-II, Neck Disability Index, Pain Bothersomeness, Patient-Specific Functioning Scale, Tampa Scale of Kinesiophobia, Global Perceived Effect) and clinical tests (Aastrand Physical Fitness, cervical Range of Motion, Pressure Pain Threshold at infraspinatus, tibialis anterior and cervical spine, Cranio-cervical Flexion, Cervical Extension muscle function, and oculomotion) were recorded at baseline and after 4 months. RESULTS: The exercise group showed statistically significant improvement in physical HR-QoL, mental HR-QoL, depression, cervical pressure pain threshold, cervical extension movement, muscle function, and oculomotion. Per protocol analyses confirmed these results with additional significant improvements in the exercise group compared with controls. CONCLUSIONS: This multimodal intervention may be an effective intervention for chronic neck pain patients. TRIAL REGISTRATION: The trial was registered on www.ClinicalTrials.govNCT01431261 and at the Regional Scientific Ethics Committee of Southern Denmark S-20100069."," Man Ther 26: 132-140.","Denmark",2016,"Neck Pain","Exercise","Bothersomeness,NDI","Unknown","PRO study","RCT"]
[310,"Rivett, L., et al. (2009). \"The relationship between quality of life and compliance to a brace protocol in adolescents with idiopathic scoliosis: a comparative study.\" BMC Musculoskelet Disord 10: 5.",null,"Rivett, L., et al.","The relationship between quality of life and compliance to a brace protocol in adolescents with idiopathic scoliosis: a comparative study","BACKGROUND: Corrective bracing for adolescent idiopathic scoliosis (AIS) has favourable outcomes when patients are compliant. However, bracing may be a stressful and traumatic experience and compliance with a bracing protocol is likely to be dependent upon patients' physical, emotional and social wellbeing. The Brace Questionnaire (BrQ), a recently-developed, condition-specific tool to measure quality of life (QOL) has enabled clinicians to study relationships between QOL and compliance. METHODS: The BrQ was administered to 31 AIS patients after a minimum of 1 year of wearing a brace. Subjects were 13-16 year old South African girls with Cobb angles of 25-40 degrees. Participants were divided into two groups according to their level of compliance with the bracing protocol. Brace Questionnaire sub- and total scores were compared between the two groups using the t-test for comparison of means. RESULTS: Twenty participants were classified as compliant and 11 as non-compliant. Mean total BrQ scores (expressed as a percentage) were 83.7 for the compliant group and 64.4 for the non-compliant group (p < 0.001), and on analysis of the 8 domains that make up the BrQ, the compliant group scored significantly higher in the 6 domains that measured vitality and social, emotional and physical functioning. CONCLUSION: Poor compliance with a brace protocol is associated with poorer QOL, with non-compliant patients lacking vitality and functioning poorly physically, emotionally and socially. Quality of life for adolescents with idiopathic scoliosis may relate more to psychosocial coping mechanisms than to physical deformity and its consequences. It is important to establish whether remedial programmes are capable of addressing personal, group and family issues, improving QOL and promoting compliance."," BMC Musculoskelet Disord 10: 5.","South Africa",2009,"Spinal Deformity","Psychosocial","BrQ","Adolescents","PRO study","Prospective Observation"]
[311,"Rodriguez-Blanco, T., et al. (2010). \"Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial.\" BMC Health Serv Res 10: 12.",null,"Rodriguez-Blanco, T., et al.","Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial","BACKGROUND: Non-specific low back pain is a common cause for consultation with the general practitioner, generating increased health and social costs. This study will analyse the effectiveness of a multidisciplinary intervention to reduce disability, severity of pain, anxiety and depression, to improve quality of life and to reduce the incidence of chronic low back pain in the working population with non-specific low back pain, compared to usual clinical care. METHODS/DESIGN: A Cluster randomised clinical trial will be conducted in 38 Primary Health Care Centres located in Barcelona, Spain and its surrounding areas. The centres are randomly allocated to the multidisciplinary intervention or to usual clinical care. Patients between 18 and 65 years old (n = 932; 466 per arm) and with a diagnostic of a non-specific sub-acute low back pain are included. Patients in the intervention group are receiving the recommendations of clinical practice guidelines, in addition to a biopsychosocial multidisciplinary intervention consisting of group educational sessions lasting a total of 10 hours. The main outcome is change in the score in the Roland Morris disability questionnaire at three months after onset of pain. Other outcomes are severity of pain, quality of life, duration of current non-specific low back pain episode, work sick leave and duration, Fear Avoidance Beliefs and Goldberg Questionnaires. Outcomes will be assessed at baseline, 3, 6 and 12 months. Analysis will be by intention to treat. The intervention effect will be assessed through the standard error of measurement and the effect-size. Responsiveness of each scale will be evaluated by standardised response mean and receiver-operating characteristic method. Recovery according to the patient will be used as an external criterion. A multilevel regression will be performed on repeated measures. The time until the current episode of low back pain takes to subside will be analysed by Cox regression. DISCUSSION: We hope to provide evidence of the effectiveness of the proposed biopsychosocial multidisciplinary intervention in avoiding the chronification of low back pain, and to reduce the duration of non-specific low back pain episodes. If the intervention is effective, it could be applied to Primary Health Care Centres. TRIAL REGISTRATION: ISRCTN21392091."," BMC Health Serv Res 10: 12.","Spain",2010,"Back Pain","Psychosocial","RMDQ","Unknown","Cost-Effectiveness","RCT"]
[312,"Rodriguez-Romero, B., et al. (2015). \"Impact of musculoskeletal pain on health-related quality of life among fishing sector workers.\" Clin Rheumatol 34(6): 1131-1139.",null,"Rodriguez-Romero, B., et al.","Impact of musculoskeletal pain on health-related quality of life among fishing sector workers","This study aims to determine the impact of musculoskeletal pain (in terms of intensity of the pain, location and functional disability due to back pain) and other factors (socio-demographic, lifestyle and co-morbidity) on the health-related quality of life on a group of shellfish gatherers. This observational transversal study included 929 shellfish gatherers (18-69 years, 98.7 % women) who completed a self-administered questionnaire, including socio-demographic and lifestyle questions, co-morbidity, intensity and location of musculoskeletal pain, and Roland-Morris Disability Questionnaire (RMDQ). Health-related quality of life was assessed using the 36-item Short Form Survey (SF-36). Physical component summary (PCS) and mental component summary (MCS) of the SF-36 were considered as outcome variables. The impact of the different factors on the PCS and MCS scores was evaluated using a stepwise linear regression analysis. Physical health was found to be independently associated to intensity of musculoskeletal pain (regression coefficient, B = -0.96), number of locations with musculoskeletal pain (MSP) (B = -0.77), presence of pain in the hip-knee (B = -2.26), self-reported rheumatic disorders (B = -2.79), lower back pain (B = -1.62) and age (B = -0.06). Mental health was associated with the presence of self-reported depressive syndrome (B = -1043.1) and RMDQ score (B = -42.2). The sample had significantly lower values than the reference population in all of the dimensions of the SF-36. Intensity of the pain, pain in the hip-knee, lower back pain, functional disability due to back pain and number of locations with musculoskeletal pain were found to have a detrimental impact on the physical health of the workers. Depressive syndrome and greater functional disability due to back pain, in turn, predict worse mental health."," Clin Rheumatol 34(6): 1131-1139.","Spain",2015,"Back Pain","Not Specified","RMDQ","Adults","PRO study","Observational"]
[313,"Roitberg, B. Z., et al. (2013). \"Comparison between patient and surgeon perception of degenerative spine disease outcomes--a prospective blinded database study.\" Acta Neurochir (Wien) 155(5): 757-764.",null,"Roitberg, B. Z., et al.","Comparison between patient and surgeon perception of degenerative spine disease outcomes--a prospective blinded database study","BACKGROUND: Few have studied the correlation between patients' and spine surgeons' perception on outcomes, or compared these with patient-reported outcome scores. Outcomes studies are increasingly important in evaluating costs and benefits to patients and surgeons, and in developing metrics for payer evaluation and health care policy-making. OBJECTIVE: To compare patients' and surgeons' assessment of spine treatment outcome in a prospective blinded patient-driven spine surgery outcomes registry, and to correlate perceived outcomes ratings to validated outcomes scores. METHODS: Patients filled out surveys at baseline, 3 months and 6 months postoperatively, including Visual Analog Scale (VAS), and Neck Disability Index (NDI) or Oswestry Disability Index (ODI). Outcome was rated independently by patients and surgeons on a 7-point Likert-type scale. RESULTS: Two-hundred and sixty-five consecutive adult patients were surgical candidates. Of these, 154 (58.1 %) opted for surgery, with 69 (44.8 %) cervical and 85 (55.2 %) lumbar patients. One hundred and thirty-five (87.7 %) had both patient and surgeon postoperative ratings. Surgeons' and patients' ratings correlated strongly (Spearman rho = 0.53, p < 0.0001, 45.9 % identical, 88.2 % +/- 1 grade). The surgeon rated outcomes were better than patients in 29.8 % and worse in 21.15 %. Patient rating correlated better with the most recent NDI/ODI and pain scores than with incremental change from baseline. In multivariate analysis, age, location (cervical vs lumbar), pain ratings, and functional scores (NDI, ODI) did not have significant impact on the discrepancy between patient and surgeon ratings. CONCLUSIONS: Patients' and surgeons' global outcome ratings for spinal disease correlate highly. Patients' ratings correlate better with most recent functional scores, rather than incremental change from baseline."," Acta Neurochir (Wien) 155(5): 757-764.","USA",2013,"Spine Disease","Surgical","NDI","Unknown","Cost and Resource Use","Prospective Observation"]
[314,"Roy, C., et al. (2012). \"Efficacy of combined treatment with medial branch radiofrequency neurotomy and steroid block in lumbar facet joint arthropathy.\" J Vasc Interv Radiol 23(12): 1659-1664.",null,"Roy, C., et al.","Efficacy of combined treatment with medial branch radiofrequency neurotomy and steroid block in lumbar facet joint arthropathy","PURPOSE: To evaluate the long-term efficacy of combined radiofrequency (RF) neurotomy and steroid nerve block in patients with lumbar facet joint arthropathy. MATERIALS AND METHODS: Combined RF neurotomy and steroid nerve block was performed in 34 patients with chronic paravertebral low back pain. The diagnosis was confirmed by comparative double diagnostic block of the medial branch with bupivacaine and lidocaine. Under fluoroscopy, RF thermal ablation of the medial branch was performed (at RF needle tip temperature 85 degrees C for 90 seconds), three times for each target nerve. At the end of the procedure, 20 mg of methylprednisolone acetate (sustained-release preparation) was infiltrated on each ablated nerve. Outcome variable was the degree of improvement in pain using visual analog scale (VAS) and numerical rating scale (NRS). Improvement in the quality of life was assessed using the Roland-Morris (RM) questionnaire. The procedure was repeated in cases of unbearable pain (>5 VAS score). RESULTS: Patients had a mean VAS score of 8.6 before the procedure. Thereafter, VAS score was 0.91 immediately after the procedure and 3.0, 2.8, 3.7, and 3.6 at 1 month, 2 months, 6 months, and 1 year. NRS showed pain relief after the procedure of 85%, 65%, 78%, 62%, and 59.5% at the same time points. RM score was 18 before the procedure, 7.6 at 6 months after the procedure, and 8.5 at 1 year after the procedure. No major complication was noted except local pain in all patients and numbness of the back in six patients after the procedure. CONCLUSIONS: Combined RF neurotomy and steroid nerve block produced substantial improvement in terms of long-term pain relief and quality of life."," J Vasc Interv Radiol 23(12): 1659-1664.","India",2012,"Back Pain","Surgical","RMDQ","Unknown","PRO study","Prospective Observation"]
[315,"Rundell, S. D., et al. (2014). \"Mapping a patient-reported functional outcome measure to a utility measure for comparative effectiveness and economic evaluations in older adults with low back pain.\" Med Decis Making 34(7): 873-883.",null,"Rundell, S. D., et al.","Mapping a patient-reported functional outcome measure to a utility measure for comparative effectiveness and economic evaluations in older adults with low back pain","BACKGROUND: Linking patient-reported back pain outcomes with health utility measures is valuable for informing economic evaluations. METHODS: We used the Back pain Outcomes using Longitudinal Data (BOLD) registry to assess back pain and quality-of-life measures. The BOLD registry includes participants >/=65 years from 3 health systems. We used multiple baseline outcome measures: Roland-Morris Disability Questionnaire (RMDQ), Euroqol-5D (EQ-5D), and back and leg pain numerical rating scales (NRS). To develop and validate a model, we used a standard split-sample method and a novel multisite validation approach. We applied linear regression to map RMDQ to EQ-5D, adjusting for age, sex, pain numerical rating scores, and nonlinear transformations of outcome measures. We computed R (2), root mean squared error, and mean absolute error (MAE) for purposes of model selection. The final model included EQ-5D as the dependent variable with independent variables of age, RMDQ, and back NRS. We used this model to predict EQ-5D scores in validation samples. RESULTS: In total, 5224 participants had both baseline RMDQ and EQ-5D. Mean age was 74 years (65% female). Negative correlations (-0.72) were observed at baseline for RMDQ and EQ-5D. The selected model from all developmental samples had R (2) >0.41 and MAE < 0.119. Validation analyses indicated no differences in estimated v. observed mean EQ-5D scores in the split sample. Validation using the multisite validation approach identified prediction error variability, MAE of 0.081 to 0.119, when predicting EQ-5D. LIMITATIONS: The statistical relationship may not generalize well to all study populations as we demonstrated in our multisite analysis. CONCLUSIONS: An empirical algorithm predicting EQ-5D weights from RMDQ scores provides a currently unavailable link for conducting economic evaluations in low back pain studies."," Med Decis Making 34(7): 873-883.","USA",2014,"Back Pain","Not Specified","RMDQ","Adults","PRO study","Retrospective review"]
[316,"Rundell, S. D., et al. (2015). \"Patient-reported outcomes associated with use of physical therapist services by older adults with a new visit for back pain.\" Phys Ther 95(2): 190-201.",null,"Rundell, S. D., et al.","Patient-reported outcomes associated with use of physical therapist services by older adults with a new visit for back pain","BACKGROUND: Among older adults, it is not clear how different types or amounts of physical therapy may be associated with improvements in back pain and function. OBJECTIVE: The study objective was to investigate the association between types or amounts of physical therapist services and 1-year outcomes among older adults with back pain. DESIGN: This was a prospective cohort study. METHODS: A total of 3,771 older adults who were enrolled in a cohort study and who had a new primary care visit for back pain participated. Physical therapy use was ascertained from electronic health records. The following patient-reported outcomes were collected over 12 months: back-related disability (Roland-Morris Disability Questionnaire) and back and leg pain intensity (11-point numerical rating scale). Marginal structural models were used to estimate average effects of different amounts of physical therapy use on disability and pain for all types of physical therapy and for active, passive, and manual physical therapy. RESULTS: A total of 1,285 participants (34.1%) received some physical therapy. There was no statistically significant gradient in relationships between physical therapy use and back-related disability score. The use of passive or manual therapy was not consistently associated with pain outcomes. Higher amounts of active physical therapy were associated with decreased back and leg pain and increased odds of clinically meaningful improvements in back and leg pain relative to results obtained with no active physical therapy. LIMITATIONS: The fact that few participants had high amounts of physical therapy use limited precision and the ability to test for nonlinear relationships for the amount of use. CONCLUSIONS: Higher amounts of active physical therapy were most consistently related to the greatest improvements in pain intensity; however, as with all observational studies, the results must be interpreted with caution."," Phys Ther 95(2): 190-201.","USA",2015,"Back Pain","Physical Therapy","RMDQ","Adults","PRO study","Prospective Observation"]
[317,"Rushton, A., et al. (2015). \"Physiotherapy Post Lumbar Discectomy: Prospective Feasibility and Pilot Randomised Controlled Trial.\" PLoS One 10(11): e0142013.",null,"Rushton, A., et al.","Physiotherapy Post Lumbar Discectomy: Prospective Feasibility and Pilot Randomised Controlled Trial","OBJECTIVES: To evaluate: acceptability and feasibility of trial procedures; distribution of scores on the Roland Morris Disability Questionnaire (RMDQ, planned primary outcome); and efficient working of trial components. DESIGN AND SETTING: A feasibility and external pilot randomised controlled trial (ISRCTN33808269, assigned 10/12/2012) was conducted across 2 UK secondary care outpatient physiotherapy departments associated with regional spinal surgery centres. PARTICIPANTS: Consecutive consenting patients aged >18 years; post primary, single level, lumbar discectomy. INTERVENTIONS: Participants were randomised to either 1:1 physiotherapy outpatient management including patient leaflet, or patient leaflet alone. MAIN OUTCOME MEASURES: Blinded assessments were made at 4 weeks post surgery (baseline) and 12 weeks post baseline (proposed primary end point). Secondary outcomes included: Global Perceived Effect, back/leg pain, straight leg raise, return to work/function, quality of life, fear avoidance, range of movement, medication, re-operation. RESULTS: At discharge, 110 (44%) eligible patients gave consent to be contacted. 59 (54%) patients were recruited. Loss to follow up was 39% at 12 weeks, with one site contributing 83% losses. Mean (SD) RMDQ was 10.07 (5.58) leaflet and 10.52 (5.94) physiotherapy/leaflet at baseline; and 5.37 (4.91) leaflet and 5.53 (4.49) physiotherapy/leaflet at 12 weeks. 5.1% zero scores at 12 weeks illustrated no floor effect. Sensitivity to change was assessed at 12 weeks with mean (SD) change -4.53 (6.41), 95%CI -7.61 to -1.44 for leaflet; and -6.18 (5.59), 95%CI -9.01 to -3.30 for physiotherapy/leaflet. RMDQ mean difference (95%CI) between change from baseline to twelve weeks was 1.65(-2.46 to 5.75). Mean difference (95%CI) between groups at 12 weeks was -0.16 (-3.36 to 3.04). Participant adherence with treatment was good. No adverse events were reported. CONCLUSIONS: Both interventions were acceptable, and it is promising that they both demonstrated a trend in reducing disability in this population. A randomised controlled trial, using a different trial design, is needed to ascertain the effectiveness of combining the interventions into a stepped care intervention and comparing to a no intervention arm. Findings will guide design changes for an adequately powered randomised controlled trial, using RMDQ as the primary outcome. TRIAL REGISTRATION: ISRCTN registry 33808269."," PLoS One 10(11): e0142013.","UK",2015,"Spine Disease","Surgical,Education","RMDQ","Adults","PRO study","RCT"]
[318,"Sakai, Y., et al. (2015). \"Pharmacological management of chronic low back pain in older patients: a randomized controlled trial of the effect of pregabalin and opioid administration.\" Eur Spine J 24(6): 1309-1317.",null,"Sakai, Y., et al.","Pharmacological management of chronic low back pain in older patients: a randomized controlled trial of the effect of pregabalin and opioid administration","PURPOSE: Pregabalin and opioids are used to treat chronic low back pain (LBP). No previous investigations have compared the efficacy of pregabalin and that of opioids for chronic LBP. METHODS: We performed a randomized controlled trial of pregabalin and opioids in 65 consecutive patients aged 65 years or older who had chronic LBP. Each agent was administered randomly in different phases. Pain and activities of daily living (ADL) were evaluated after 4 weeks of treatment using the visual analog scale, Japanese Orthopaedic Association score, Roland Morris Disability Questionnaire, short-form McGill Pain Questionnaire, EuroQol quality-of-life scale, and geriatric depression scale. Neuropathic pain was evaluated using a neuropathic pain screening questionnaire. RESULTS: The effectiveness rate was 73.3% for pregabalin and 83.3% for opioid, showing no significant difference. The mean durations until the onset of effect were 10.2 and 6.1 days, respectively, albeit without significant difference. Pregabalin was effective for LBP with neuropathic pain, whereas opioids were effective for non-neuropathic pain. The improvement of ADL was greater with opioids than with pregabalin. Pregabalin was effective for LBP in patients with lower limb symptoms, whereas opioids were effective for those without lower limb symptoms. CONCLUSIONS: Aside from screening tests, consideration of neuropathic pain and lower extremity symptoms may be an integral component in the selection of the appropriate medication for chronic LBP. Moreover, the therapeutic objectives, including pain relief and/or improvement of ADL, should be specified."," Eur Spine J 24(6): 1309-1317.","Japan",2015,"Neuropathic Pain","Pregabalin","JOACMEQ,RMDQ","Adults","PRO study","RCT"]
[319,"Salaffi, F., et al. (2007). \"Validity and reliability of the Italian version of the ECOS-16 questionnaire in postmenopausal women with prevalent vertebral fractures due to osteoporosis.\" Clin Exp Rheumatol 25(3): 390-403.",null,"Salaffi, F., et al.","Validity and reliability of the Italian version of the ECOS-16 questionnaire in postmenopausal women with prevalent vertebral fractures due to osteoporosis","OBJECTIVE: To investigate the reliability and validity of the Italian version of ECOS-16 (Assessment of health related quality of life in osteoporosis) in comparison to other questionnaires in postmenopausal women with osteoporosis. METHODS: A cross-sectional multicentre study was carried out among postmenopausal women with osteoporosis who were attending primary care centres and hospital outpatient clinics. The patient group included 234 females (mean age 69 years, range 48-89) who presented vertebral fractures due to osteoporosis. The control group consisted of 244 asymptomatic osteoporotic subjects matched for age with the patient group. The psychometric properties of the questionnaires were evaluated in terms of feasibility, validity (construct validity and discriminant validity) and internal consistency. Test-retest reliability was analysed for 196 outpatients who reported that their general health status due to osteoporosis had not changed after one week. In all patients the ECOS-16, the SF-36 (Medical Outcomes Study Short Form-36), EUROQoL (EQ-5D), mini-OQLQ (mini-Osteoporosis Quality of Life Questionnaire), and RMDQ (Roland-Morris Disability Questionnaire) were administered, and all clinical variables and sociodemographic variables were taken into account. Construct and discriminant validity were assessed by Spearman's correlations, the Wilcoxon rank sum test, the Kruskal Wallis test and by receiver operating characteristic (ROC) curves. Internal consistency was evaluated using Cronbach's alpha and the test-retest reliability was evaluated by intra-class correlation coefficients (ICCs). RESULTS: 96.9% of the patients answered all items of the ECOS-16 questionnaires. The mean administration time was 10 minutes. Factor analysis yielded two factors that accounted for 88.4% of the explained variance in the ECOS-16 questionnaire. The first factor was the ECOS-16 Physical Component Score (PCS) (45.9% of the explained variance) and the second factor was the ECOS-16 Mental Component Score (MCS) (42.4% of the explained variance). The inter-item correlation between the two factors was 0.48. Significant correlations were found between the scores of similar domains or subscales of the ECOS-16 and SF-36, EQ-5D and mini-OQLQ, supporting the concept of convergent construct validity. The total ECOS-16 score progressively increased with the number of prevelant vertebral fractures (p<0.001) and the effect of the first fracture was already statistically significant (p<0.01). On ROC curve analysis the total ECOS-16 score showed the highest performance among the different questionnaires in discriminating between patients with vertebral fractures and controls with no fractures. In the reliability study, internal consistency within the domain of ECOS-16 was generally good, with Chronbach's alpha values ranging from 0.81 to 0.89. Test-retest reliability was 0.87 for the total ECOS-16 score. CONCLUSION: The Italian version of the ECOS-16 questionnaire was demonstrated to have good psychometric properties and could offer a useful tool in research and routine clinical practice to evaluate HRQoL in post-menopausal women with osteoporosis. A full validation of the psychometric properties will require data on its sensitivity to change."," Clin Exp Rheumatol 25(3): 390-403.","Italy",2007,"Spinal Fracture","Not Specified","RMDQ","Adults","PRO study","Observational"]
[320,"Salfinger, H., et al. (2015). \"Nuclear magnetic resonance therapy in lumbar disc herniation with lumbar radicular syndrome: effects of the intervention on pain intensity, health-related quality of life, disease-related disability, consumption of pain medication, duration of sick leave and MRI analysis.\" Eur Spine J 24(6): 1296-1308.",null,"Salfinger, H., et al.","Nuclear magnetic resonance therapy in lumbar disc herniation with lumbar radicular syndrome: effects of the intervention on pain intensity, health-related quality of life, disease-related disability, consumption of pain medication, duration of sick leave and MRI analysis","PURPOSE: The objective was to assess the effects of therapeutic nuclear magnetic resonance (tNMR) as a conservative treatment for lumbar radicular syndrome (LRS) in patients with lumbar disc herniation. METHODS: The prospective, randomised, double-blind, placebo-controlled trial included 94 patients, aged 20-60 years (44.79 +/- 8.83), with LRS caused by lumbar disc herniation confirmed by MRI scans and with clinical signs of a radicular lesion without indication for surgical intervention. Treatment group (TG) and control group (CG) received standard non-surgical therapy. Additionally, the TG had seven sessions with the tNMR device with a magnetic flux density of 2.3 mT and a frequency of 85 kHz; the CG received 7 sham treatments. Outcome parameters were the treatment effect on pain intensity (Visual Analogue Scale-VAS), health-related quality of life (36-item Short Form Health Survey-SF-36), disease-related disability (Roland Morris Disability Questionnaire-RMDQ), pain medication intake, duration of sick leave and morphological changes assessed by MRI scan analysis. RESULTS: VAS scores improved significantly in both groups (p < 0.000). Only in week 4, improvement in the TG significantly surpassed that of the CG (morning pain p = 0.011, evening pain = 0.001). In both groups, SF-36 scores reflected a significant amendment in the physical component score (p < 0.000) and a significant deterioration in the mental component score (p < 0.000). SF-36 scores did not differ significantly between groups. RMDQ showed a significant amelioration in both groups (TG and CG p < 0.000), with a tendency to a superior benefit in the TG (p = 0.083). Patients in the TG recorded significantly fewer days of sick leave in month 3 after treatment (p = 0.026). MRI scan summary scores improved significantly in both groups (L4/5 p < 0.000, L5/S1 p < 0.001) and did not differ significantly between the groups. CONCLUSIONS: This trial was the first to investigate the effects of tNMR as an additional treatment of lumbar disc herniation with LRS. The application of tNMR did not meet MCID criteria. It rendered few statistically significant differences between patient groups. The overall results of this trial make a clinical implementation of tNMR in the treatment of lumbar disc herniation with LRS appear premature. Further research is needed to better understand the mode of action of tNMR on compressed neural tissue and to elucidate the issue of the cost/benefit ratio."," Eur Spine J 24(6): 1296-1308.","Austria",2015,"Degenerative Disk Disease","Surgical","RMDQ","Adults","Cost and Resource Use","Prospective Observation"]
[321,"Saper, R. B., et al. (2014). \"Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial.\" Trials 15: 67.",null,"Saper, R. B., et al.","Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial","BACKGROUND: Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown. METHODS/DESIGN: This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18-64 years old with non-specific low back pain lasting >/= 12 weeks and a self-reported average pain intensity of >/= 4 on a 0-10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using claims databases, electronic medical records, self-report cost data, and study records. Qualitative data from interviews will add subjective detail to complement quantitative data. TRIAL REGISTRATION: This trial is registered in ClinicalTrials.gov, with the ID number: NCT01343927."," Trials 15: 67.","USA",2014,"Back Pain","Exercise","RMDQ","Adults","PRO study","RCT"]
[322,"Saper, R. B., et al. (2017). \"Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial.\" Ann Intern Med 167(2): 85-94.",null,"Saper, R. B., et al.","Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial","Background: Yoga is effective for mild to moderate chronic low back pain (cLBP), but its comparative effectiveness with physical therapy (PT) is unknown. Moreover, little is known about yoga's effectiveness in underserved patients with more severe functional disability and pain. Objective: To determine whether yoga is noninferior to PT for cLBP. Design: 12-week, single-blind, 3-group randomized noninferiority trial and subsequent 40-week maintenance phase. (ClinicalTrials.gov: NCT01343927). Setting: Academic safety-net hospital and 7 affiliated community health centers. Participants: 320 predominantly low-income, racially diverse adults with nonspecific cLBP. Intervention: Participants received 12 weekly yoga classes, 15 PT visits, or an educational book and newsletters. The maintenance phase compared yoga drop-in classes versus home practice and PT booster sessions versus home practice. Measurements: Primary outcomes were back-related function, measured by the Roland Morris Disability Questionnaire (RMDQ), and pain, measured by an 11-point scale, at 12 weeks. Prespecified noninferiority margins were 1.5 (RMDQ) and 1.0 (pain). Secondary outcomes included pain medication use, global improvement, satisfaction with intervention, and health-related quality of life. Results: One-sided 95% lower confidence limits were 0.83 (RMDQ) and 0.97 (pain), demonstrating noninferiority of yoga to PT. However, yoga was not superior to education for either outcome. Yoga and PT were similar for most secondary outcomes. Yoga and PT participants were 21 and 22 percentage points less likely, respectively, than education participants to use pain medication at 12 weeks. Improvements in yoga and PT groups were maintained at 1 year with no differences between maintenance strategies. Frequency of adverse events, mostly mild self-limited joint and back pain, did not differ between the yoga and PT groups. Limitations: Participants were not blinded to treatment assignment. The PT group had disproportionate loss to follow-up. Conclusion: A manualized yoga program for nonspecific cLBP was noninferior to PT for function and pain. Primary Funding Source: National Center for Complementary and Integrative Health of the National Institutes of Health."," Ann Intern Med 167(2): 85-94.","USA",2017,"Back Pain","Physical Therapy","RMDQ","Adults","PRO study","RCT"]
[323,"Sathira-Angkura, V., et al. (2012). \"Validity and reliability of an adapted Thai version of Scoliosis Research Society-22 questionnaire for adolescent idiopathic scoliosis.\" Spine (Phila Pa 1976) 37(9): 783-787.",null,"Sathira-Angkura, V., et al.","Validity and reliability of an adapted Thai version of Scoliosis Research Society-22 questionnaire for adolescent idiopathic scoliosis","STUDY DESIGN: Cross-sectional observational study to investigate psychometric properties of an adapted Thai version of the refined Scoliosis Research Society-22 (SRS-22) questionnaire. OBJECTIVE: To evaluate the reliability and validity of the adapted Thai version of the refined SRS-22 questionnaire. SUMMARY OF BACKGROUND DATA: The SRS-22 questionnaire is a valid instrument for assessing the health-related quality of life for patients with adolescent idiopathic scoliosis. Recently, the questionnaire has been translated and validated in many languages for non-English-speaking countries. METHODS: Translation/retranslation of the English version of the SRS-22 was conducted, and the cross-cultural adaptation process was performed. The Thai version SRS-22 and previously validated Thai version Short-Form survey version 2.0 (SF-36V2) questionnaires were administered to 77 patients with adolescent idiopathic scoliosis who had surgical treatment. Fifty-eight patients (52 adolescent girls) had filled out the first set of questionnaires. Thirty patients of the first-time responders completed the second set of questionnaires. The mean age at the time of operation was 14.6 years and the mean age at the time of the final follow-up was 18.7 years. The mean preoperative scoliosis curve magnitude was 55.4 degrees (range, 30 degrees -95 degrees ) and postoperative curve magnitude was 20.1 degrees (range, 0 degrees -60 degrees ). Internal consistency was determined with Cronbach alpha coefficient. Intraclass correlation coefficient was used for test-retest reliability. Concurrent validity was evaluated by comparing SRS-22 domains with relevant domains in the SF-36V2 questionnaire, using the Pearson correlation coefficient. RESULTS: The mean overall Cronbach alpha coefficient of the adapted Thai version SRS-22 was 0.76. The 2 of corresponding domains (mental health = 0.80 and self-image = 0.83) had satisfactory internal consistency and the remaining domains (pain = 0.78; function/activity = 0.74; and satisfaction = 0.76) were good. The intraclass correlation coefficient for 5 domains was ranged from 0.79 to 0.90, which demonstrated the satisfactory test/retest reproducibility. The concurrent validity, determined by the Pearson correlation coefficient between SRS-22 and SF-36V2 domains, had a good correlation for 15 relevant comparisons (r = 0.50-0.75). CONCLUSION: The adapted Thai version of the SRS-22 questionnaire had validity and reliability, which can be used to assess the outcome of treatment among Thai-speaking patients with adolescent idiopathic scoliosis."," Spine (Phila Pa 1976) 37(9): 783-787.","Thailand",2012,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","Tool Validation","Observational"]
[324,"Sattelmayer, M., et al. (2012). \"Predictive value of the Acute Low Back Pain Screening Questionnaire and the Orebro Musculoskeletal Pain Screening Questionnaire for persisting problems.\" Eur Spine J 21 Suppl 6: S773-784.",null,"Sattelmayer, M., et al.","Predictive value of the Acute Low Back Pain Screening Questionnaire and the Orebro Musculoskeletal Pain Screening Questionnaire for persisting problems","INTRODUCTION: A small proportion of individuals with non-specific low back pain (NSLBP) develop persistent problems. Up to 80% of the total costs for NSLBP are owing to chronic NSLBP. Psychosocial factors have been described to be important in the transition from acute to chronic NSLBP. Guidelines recommend the use of the Acute Low Back Pain Screening Questionnaire (ALBPSQ) and the Orebro Musculoskeletal Pain Screening Questionnaire (OMPSQ) to identify individuals at risk of developing persistent problems, such as long-term absence of work, persistent restriction in function or persistent pain. These instruments can be used with a cutoff value, where patients with values above the threshold are further assessed with a more comprehensive examination. METHODS: We systematically reviewed studies evaluating the accuracy of the ALBPSQ and OMPSQ to predict persistent problems. RESULTS: The 13 included studies used different cutoff values for the screening questionnaires ranging from 68 to 147. The pooled sensitivity was 0.59 (0.43-0.74), while the pooled specificity was 0.77 (0.66-0.86). Heterogeneity (I (2)) was 90.02% for sensitivity and 95.41% for specificity. CONCLUSION: Thus, we do not recommend the use of one cutoff value, but the use of a prediction model with all the individual items."," Eur Spine J 21 Suppl 6: S773-784.","Switzerland",2012,"Back Pain","Psychosocial","ALBPSQ","Unknown","Tool Validation","Observational"]
[325,"Scheer, J. K., et al. (2015). \"Comprehensive study of back and leg pain improvements after adult spinal deformity surgery: analysis of 421 patients with 2-year follow-up and of the impact of the surgery on treatment satisfaction.\" J Neurosurg Spine 22(5): 540-553.",null,"Scheer, J. K., et al.","Comprehensive study of back and leg pain improvements after adult spinal deformity surgery: analysis of 421 patients with 2-year follow-up and of the impact of the surgery on treatment satisfaction","OBJECT Back and leg pain are the primary outcomes of adult spinal deformity (ASD) and predict patients' seeking of surgical management. The authors sought to characterize changes in back and leg pain after operative or nonoperative management of ASD. Outcomes were assessed according to pain severity, type of surgical procedure, Scoliosis Research Society (SRS)-Schwab spine deformity class, and patient satisfaction. METHODS This study retrospectively reviewed data in a prospective multicenter database of ASD patients. Inclusion criteria were the following: age > 18 years and presence of spinal deformity as defined by a scoliosis Cobb angle >/= 20 degrees , sagittal vertical axis length >/= 5 cm, pelvic tilt angle >/= 25 degrees , or thoracic kyphosis angle >/= 60 degrees . Patients were grouped into nonoperated and operated subcohorts and by the type of surgical procedure, spine SRS-Schwab deformity class, preoperative pain severity, and patient satisfaction. Numerical rating scale (NRS) scores of back and leg pain, Oswestry Disability Index (ODI) scores, physical component summary (PCS) scores of the 36-Item Short Form Health Survey, minimum clinically important differences (MCIDs), and substantial clinical benefits (SCBs) were assessed. RESULTS Patients in whom ASD had been operatively managed were 6 times more likely to have an improvement in back pain and 3 times more likely to have an improvement in leg pain than patients in whom ASD had been nonoperatively managed. Patients whose ASD had been managed nonoperatively were more likely to have their back or leg pain remain the same or worsen. The incidence of postoperative leg pain was 37.0% at 6 weeks postoperatively and 33.3% at the 2-year follow-up (FU). At the 2-year FU, among patients with any preoperative back or leg pain, 24.3% and 37.8% were free of back and leg pain, respectively, and among patients with severe (NRS scores of 7-10) preoperative back or leg pain, 21.0% and 32.8% were free of back and leg pain, respectively. Decompression resulted in more patients having an improvement in leg pain and their pain scores reaching MCID. Although osteotomies improved back pain, they were associated with a higher incidence of leg pain. Patients whose spine had an SRS-Schwab coronal curve Type N deformity (sagittal malalignment only) were least likely to report improvements in back pain. Patients with a Type L deformity were most likely to report improved back or leg pain and to have reductions in pain severity scores reaching MCID and SCB. Patients with a Type D deformity were least likely to report improved leg pain and were more likely to experience a worsening of leg pain. Preoperative pain severity affected pain improvement over 2 years because patients who had higher preoperative pain severity experienced larger improvements, and their changes in pain severity were more likely to reach MCID/SCB than for those reporting lower preoperative pain. Reductions in back pain contributed to improvements in ODI and PCS scores and to patient satisfaction more than reductions in leg pain did. CONCLUSIONS The authors' results provide a valuable reference for counseling patients preoperatively about what improvements or worsening in back or leg pain they may experience after surgical intervention for ASD."," J Neurosurg Spine 22(5): 540-553.","USA",2015,"Spinal Deformity","Surgical","ODI","Adults","PRO study","Retrospective review"]
[326,"Scheer, J. K., et al. (2015). \"Postoperative Recovery After Adult Spinal Deformity Surgery: Comparative Analysis of Age in 149 Patients During 2-year Follow-up.\" Spine (Phila Pa 1976) 40(19): 1505-1515.",null,"Scheer, J. K., et al.","Postoperative Recovery After Adult Spinal Deformity Surgery: Comparative Analysis of Age in 149 Patients During 2-year Follow-up","STUDY DESIGN: Retrospective review of a multicenter, prospective adult spinal deformity (ASD) database. OBJECTIVE: We hypothesized that increased age and increased preoperative disability would negatively impact both the length of time needed to achieve maximal recovery and the amount of functional improvement achieved. In order to gauge the recovery process, a normalization process was used to calculate an integrated health state (IHS) during the 2-year postoperative period. SUMMARY OF BACKGROUND DATA: Elderly patients with ASD generally have worse baseline health-related quality of life (HRQOL) measures than younger patients. Current methods of reporting outcomes are limited, perhaps diminishing the health impact of the entire postoperative recovery experience. METHODS: Inclusion criteria included 18 or more years and ASD. Patient groups: young (</=45 yr), middle (46-64), elderly (>/=65) as well as by baseline Oswestry Disability Index (ODI) scores: MILD (0-30), MEDIUM (31-49), and HIGH (>/=50). Collected HRQOL measures included ODI, Short Form-36(PCS/MCS), and Scoliosis Research Society-22 (SRS22) at baseline, 6 weeks, 1, and 2-year postoperative. All HRQOL measures were normalized to each patient's baseline scores. A 2-year IHS was calculated for each individual patient and the means were compared between groups. RESULTS: 149 patients were included (</=45:32, 46-64:67, >/=65:50). All groups significantly improved in all HRQOL at 2-year compared with baseline (P < 0.05) except for MCS, ODI, and SRS activity for the 45 or less group (P > 0.05). Normalized IHS HRQOL for young patients was worse than elderly for ODI, PCS, MCS, SRS activity, pain and total during the 2-year recovery period from index surgery. The MILD ODI group had significantly worse 2-year IHS values than the HIGH group for all HRQOL measured (P < 0.05) except SRS appearance and satisfaction (P > 0.05). CONCLUSION: Contrary to our hypothesis, an IHS analysis suggested that the recovery process was significantly better for elderly patients than young patients and better for patients with high baseline disability. LEVEL OF EVIDENCE: 3."," Spine (Phila Pa 1976) 40(19): 1505-1515.","USA",2015,"Spinal Deformity","Surgical","SRS-HRQOL,ODI","Elderly","PRO study","Prospective Observation"]
[327,"Scheer, J. K., et al. (2017). \"Development of a preoperative predictive model for major complications following adult spinal deformity surgery.\" J Neurosurg Spine 26(6): 736-743.",null,"Scheer, J. K., et al.","Development of a preoperative predictive model for major complications following adult spinal deformity surgery","OBJECTIVE The operative management of patients with adult spinal deformity (ASD) has a high complication rate and it remains unknown whether baseline patient characteristics and surgical variables can predict early complications (intraoperative and perioperative [within 6 weeks]). The development of an accurate preoperative predictive model can aid in patient counseling, shared decision making, and improved surgical planning. The purpose of this study was to develop a model based on baseline demographic, radiographic, and surgical factors that can predict if patients will sustain an intraoperative or perioperative major complication. METHODS This study was a retrospective analysis of a prospective, multicenter ASD database. The inclusion criteria were age >/= 18 years and the presence of ASD. In total, 45 variables were used in the initial training of the model including demographic data, comorbidities, modifiable surgical variables, baseline health-related quality of life, and coronal and sagittal radiographic parameters. Patients were grouped as either having at least 1 major intraoperative or perioperative complication (COMP group) or not (NOCOMP group). An ensemble of decision trees was constructed utilizing the C5.0 algorithm with 5 different bootstrapped models. Internal validation was accomplished via a 70/30 data split for training and testing each model, respectively. Overall accuracy, the area under the receiver operating characteristic (AUROC) curve, and predictor importance were calculated. RESULTS Five hundred fifty-seven patients were included: 409 (73.4%) in the NOCOMP group, and 148 (26.6%) in the COMP group. The overall model accuracy was 87.6% correct with an AUROC curve of 0.89 indicating a very good model fit. Twenty variables were determined to be the top predictors (importance >/= 0.90 as determined by the model) and included (in decreasing importance): age, leg pain, Oswestry Disability Index, number of decompression levels, number of interbody fusion levels, Physical Component Summary of the SF-36, Scoliosis Research Society (SRS)-Schwab coronal curve type, Charlson Comorbidity Index, SRS activity, T-1 pelvic angle, American Society of Anesthesiologists grade, presence of osteoporosis, pelvic tilt, sagittal vertical axis, primary versus revision surgery, SRS pain, SRS total, use of bone morphogenetic protein, use of iliac crest graft, and pelvic incidence-lumbar lordosis mismatch. CONCLUSIONS A successful model (87% accuracy, 0.89 AUROC curve) was built predicting major intraoperative or perioperative complications following ASD surgery. This model can provide the foundation toward improved education and point-of-care decision making for patients undergoing ASD surgery."," J Neurosurg Spine 26(6): 736-743.","USA",2017,"Spinal Deformity","Surgical","ODI,SRS-HRQOL","Adults","Tool Validation","Prospective Observation"]
[328,"Schillberg, B. and B. Nystrom (2000). \"Quality of life before and after microsurgical decompression in lumbar spinal stenosis.\" J Spinal Disord 13(3): 237-241.",null,"Schillberg, B. and B. Nystrom","Quality of life before and after microsurgical decompression in lumbar spinal stenosis","Twenty consecutive patients (10 men and 10 women; median age, 68 years) with lumbar spinal stenosis were studied before and after microsurgical decompression without laminectomy. Fourteen of the patients had pure stenosis symptoms, whereas six had intercurrent diseases that could exacerbate the symptoms of stenosis. The mean duration of symptoms was 4.5 years (range, 1 to 15 years). All patients were interviewed before operation, and an assessment form based on and modified from the Oswestry Low Back Pain Disability Questionnaire was completed. The ability to perform physical activities including house work, gardening, going to the post office, and so forth was markedly reduced before operation for nearly all patients, and social life such as traveling, meeting friends, and participating in hobbies was similarly restricted. Sleeping was also greatly affected before operation, as were psychological parameters including irritability, depression, infirmity, energy, patience, and concentration. At follow-up 2.8 years after surgery, 13 of the 14 patients with pure stenosis evaluated their quality of life as much improved and principally normal. Among the patients with intercurrent diseases, only two of six judged the quality of their lives as much improved."," J Spinal Disord 13(3): 237-241.","Sweden",2000,"Back Pain","Surgical","ODI","Adults","PRO study","Prospective Observation"]
[329,"Schouten, R., et al. (2015). \"Expectations of recovery and functional outcomes following thoracolumbar trauma: an evidence-based medicine process to determine what surgeons should be telling their patients.\" J Neurosurg Spine 22(1999): 101-111.",null,"Schouten, R., et al.","Expectations of recovery and functional outcomes following thoracolumbar trauma: an evidence-based medicine process to determine what surgeons should be telling their patients","OBJECT: The aim of this study was to define the expected functional and health-related quality of life outcomes following common thoracolumbar injuries on the basis of consensus expert opinion and the best available literature. Patient expectations are primarily determined by the information provided by health care professionals, and these expectations have been shown to influence outcome in various medical and surgical conditions. This paper presents Part 2 of a multiphase study designed to investigate the impact of patient expectations on outcomes following spinal injury. Part 1 demonstrated substantial variability in the information surgeons are communicating to patients. Defining the expected outcomes following thoracolumbar injury would allow further analysis of this relationship and enable surgeons to more accurately and consistently inform patients. METHODS: Expert opinion was assembled by distributing questionnaires comprising 4 cases representative of common thoracolumbar injuries to members of the Spine Trauma Study Group (STSG). The 4 cases included a thoracolumbar junction burst fracture treated nonoperatively or with posterior transpedicular instrumentation, a low lumbar (L-4) burst fracture treated nonoperatively, and a thoracolumbar junction flexion-distraction injury managed with posterior fusion. For each case, 5 questions about expected outcomes were posed. The questions related to the proportion of patients who are pain free, the proportion who have regained full range of motion, and the patients' recreational activity restrictions and personal care and social life limitations, all at 1 year following injury, as well as the timing of return to work and length of hospital stay. Responses were analyzed and combined with the results of a systematic literature review on the same injuries to define the expected outcomes. RESULTS: The literature review identified 38 appropriate studies that met the preset inclusion criteria. Published data were available for all injuries, but not all outcomes were available for each type of injury. The survey was completed by 31 (57%) of 53 surgeons representing 24 trauma centers across North America (15), Europe (5), India (1999), Mexico (1999), Japan (1999) and Israel (1999). Consensus expert opinion supplemented the available literature and was used exclusively when published data were lacking. For example, 1 year following cast or brace treatment of a thoracolumbar burst fracture, the expected outcomes include a 40% chance of being pain free, a 70% chance of regaining pre-injury range of motion, and an expected ability to participate in high-impact exercise and contact sport with no or minimal limitation. Consensus expert opinion predicts reemployment within 4-6 months. The length of inpatient stay averages 4-5 days. CONCLUSIONS: This synthesis of the best available literature and consensus opinion of surgeons with extensive clinical experience in spine trauma reflects the optimal methodology for determining functional prognosis after thoracolumbar trauma. By providing consistent, accurate information surgeons will help patients develop realistic expectations and potentially optimize outcomes."," J Neurosurg Spine 22(1999): 101-111.","New Zealand",2015,"Trauma","Surgical,Exercise","STSG","Unknown","PRO study","Narrative review"]
[330,"Schwerla, F., et al. (2008). \"Osteopathic treatment of patients with chronic non-specific neck pain: a randomised controlled trial of efficacy.\" Forsch Komplementmed 15(3): 138-145.",null,"Schwerla, F., et al.","Osteopathic treatment of patients with chronic non-specific neck pain: a randomised controlled trial of efficacy","OBJECTIVE: Chronic non-specific neck pain (CNP) is a common, often disabling condition which still lacks a reliable therapeutic standard. Empiric evidence suggests that osteopathic interventions might be effective in alleviating CNP symptoms. A randomized controlled clinical trial of efficacy was performed to test this hypothesis. MATERIALS AND METHODS: 135 CNP sufferers were identified through advertisements, and 41 patients who met all relevant predefined criteria were recruited. All participants received a 12-min session of sham ultrasound once a week for an average of 10 weeks. In addition, a test-dependent osteopathic intervention of 45 min was given to 24 participants every other week. 40 participants could be followed up for 12 weeks after the end of therapy. The main outcome parameter was pain intensity measured on a numeric rating scale (NRS, range: 0-10). RESULTS: There were 2 dropouts in the intervention group and 2 in the control group. Average pain intensity decreased from 4.7 to 2.2 in the osteopathic group (p < 0.0005), and from 4.8 to 4.0 in the control group (p = 0.09). The intergroup difference of longitudinal changes was clearly significant, too (p = 0.02). Further slight but comparable reductions were observed at follow-up (0.3 and 0.4 NRS points, respectively). These changes seem to have a positive impact on quality of life, as assessed by generic and specific instruments such as the MOS SF-36 and the Northwick Park Pain Questionnaire. CONCLUSIONS: A series of test-dependent osteopathic interventions may be a promising therapeutic regimen for CNP sufferers. Further studies will have to demonstrate a) whether these findings are reproducible, and b) whether positive long-term outcomes can be achieved."," Forsch Komplementmed 15(3): 138-145.","Germany",2008,"Neck Pain","Osteopathy","Northwick","Unknown","PRO study","RCT"]
[331,"Schwieger, T., et al. (2016). \"Body Image and Quality-of-Life in Untreated Versus Brace-Treated Females With Adolescent Idiopathic Scoliosis.\" Spine (Phila Pa 1976) 41(4): 311-319.",null,"Schwieger, T., et al.","Body Image and Quality-of-Life in Untreated Versus Brace-Treated Females With Adolescent Idiopathic Scoliosis","STUDY DESIGN: The Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) included skeletally immature high-risk patients with adolescent idiopathic scoliosis (AIS) with moderate curve sizes (20 degrees - 40 degrees ). BrAIST was a multicenter, controlled trial using both randomized and preference treatment arms into either an observation group or a brace treatment group. OBJECTIVE: The aim of this study was to analyze and compare body image and quality-of-life (QOL) in female AIS patients who were observed or treated with a brace. SUMMARY OF BACKGROUND DATA: Brace treatment is an effective means for controlling progressive scoliosis and preventing the need for surgery, but there is no consensus regarding the effect of brace treatment on body image or on QOL in adolescents with AIS. METHODS: Data from female BrAIST patients in the randomized (n = 132) or preference (n = 187) arms and were observed (n = 120) or brace treated (n = 199) were analyzed. Patients completed the Spinal Appearance Questionnaire (SAQ) and the Pediatric Quality of Life Inventory (PedsQOL) 4.0 Generic Scales at baseline and 6 month follow-up visits up to 2 years. Items on the SAQ measured three body image constructs (self, ideal, and overall). The PedsQOL measured health, activities, feelings, social factors, and school. RESULTS: . In general, there were no significant differences within or between study arms or treatments regarding body image or QOL through 2 years of follow-up. Poorer body image was significantly correlated with poorer QOL during the first 2 years of follow-up regardless of study arm or treatment. Patients who crossed-over to a different treatment and patients with largest Cobb angles >/= 40 degrees had significantly poorer body image, in particular self-body image, compared with those that did not. CONCLUSION: This study does not support findings from previous research indicating that wearing a brace has a negative impact on or is negatively impacted by body image or QOL. LEVEL OF EVIDENCE: 2."," Spine (Phila Pa 1976) 41(4): 311-319.","USA",2016,"Spinal Deformity","Surgical","SAQ","Adolescents","PRO study","Retrospective review"]
[332,"Seferiadis, A., et al. (2016). \"Basic body awareness therapy or exercise therapy for the treatment of chronic whiplash associated disorders: a randomized comparative clinical trial.\" Disabil Rehabil 38(5): 442-451.",null,"Seferiadis, A., et al.","Basic body awareness therapy or exercise therapy for the treatment of chronic whiplash associated disorders: a randomized comparative clinical trial","PURPOSE: Chronic whiplash-associated disorders (WAD) incur both costs and suffering. Treatments that can relieve chronic WAD are therefore needed. Exercise therapy (ET) has been shown to provide pain relief. Another often used treatment for chronic pain in Scandinavia is basic body awareness therapy (BAT). We compared the effectiveness of 10 weeks of twice-weekly, 90-min sessions of either ET or BAT in a randomized comparative trial. METHOD: We recruited 113 patients suffering from chronic WAD grades I-III and several years' duration of symptoms in a primary health care setting. 57 were allocated to ET and 56 to BAT. Primary outcome measures were Neck Disability Index and SF-36 v.2. RESULTS: From baseline to post-treatment, the BAT group increased their physical functioning (median 5, IQR = 15) more than the ET group (median = 0, IQR = 15), p = 0.032, effect size -0.54. Three months after the end of treatment, the BAT group had less bodily pain (m = 17.5, 95% CI 6.9-17.6) than the ET group (m = 4.9, 95% CI -0.1 to 9.8), p = 0.044, effect size -0.4. The BAT group had also increased their social functioning (m = 13.3, 95% CI 6.6-19.9) more than the ET group (m = 3.5, 95% CI -3 to 9.9), p = 0.037, effect size -0.41. No statistically significant differences between groups were found for the change of other outcomes. No serious adverse effects were found in either groups. CONCLUSIONS: The present trial indicates that BAT led to greater improvements than ET for the patients with chronic WAD. IMPLICATIONS FOR REHABILATION: Chronic whiplash-associated disorders are disabling and incur great costs to society often through inability to work. Exercise therapy (ET) may alleviate symptoms of chronic WAD. Basic body awareness therapy (BAT) is often a component of multimodal pain rehabilitation programs. In this randomized comparative trial, BAT increased physical functioning and led to greater pain reduction and social functioning 3 months after the end of treatment."," Disabil Rehabil 38(5): 442-451.","Sweden",2016,"Trauma,Back Pain","Exercise","NDI","Unknown","PRO study","RCT"]
[333,"Seng, C., et al. (2013). \"Surgically treated cervical myelopathy: a functional outcome comparison study between multilevel anterior cervical decompression fusion with instrumentation and posterior laminoplasty.\" Spine J 13(7): 723-731.",null,"Seng, C., et al.","Surgically treated cervical myelopathy: a functional outcome comparison study between multilevel anterior cervical decompression fusion with instrumentation and posterior laminoplasty","BACKGROUND CONTEXT: Multilevel cervical myelopathy can be treated with anterior cervical discectomy and fusion (ACDF) or corpectomy via the anterior approach and laminoplasty via the posterior approach. Till date, there is no proven superior approach. PURPOSE: To elucidate any potential advantage of one approach over the other with regard to clinical midterm outcomes in this study. STUDY DESIGN: A prospective, 2-year follow-up of patients with cervical myelopathy treated with multilevel anterior cervical decompression fusion and plating and posterior laminoplasty. PATIENT SAMPLE: In total, 116 patients were studied. Sixty-four patients underwent ACDF two levels and above or anterior cervical corpectomy and fusion one level and above. Fifty-two patients underwent posterior cervical surgery (laminoplasty C3-C6 and C3-C7). OUTCOME MEASURES: Self-report measures: Japan Orthopedic Association (JOA) score, JOA recovery rate, visual analog scale for neck pain (VASNP), neck disability index (NDI), and American Academy of Orthopaedic Surgeons (AAOS) neurogenic symptom score (AAOS-NSS). Physiologic measures: range of motion (ROM) flexion and extension of neck. Functional measures: short-form 36 (SF-36) score comprising physical functioning, physical role function, bodily pain, general health, vitality, social role function, emotional role function, and mental health scales. METHODS: Comparison of the JOA scores, JOA recovery rates, NDI scores, SF-36 scores, VASNP, and ROM preoperatively to 2 years. Chi-square and two-sided Student t tests were used to analyze the variables. RESULTS: Posterior surgery took an hour shorter (p<.05) and had better improvement in JOA scores at early follow-up of 6 months (p=.025). Anterior surgery group had better improvement of NDI scores at early follow-up of 6 months (p=.024) and was associated with less blood loss intraoperatively compared with posterior surgery. There was no statistical difference between the two groups for JOA scores, JOA recovery rates, SF-36 quality-of-life scores, NDI, AAOS-NSS, VAS neck pain, and ROM at 2 years. Complications were higher for anterior surgery group: two hematoma postoperation, one vocal cord paresis, and one new onset C6/C7 dermatome numbness versus one dura leak in posterior surgery group. CONCLUSIONS: Our study showed that patients with multilevel disease treated with laminoplasty do well and compare favorably with patients treated with an anterior approach. Notably, posterior surgery was associated with shorter operating time, better improvement in JOA scores at 6 months, and a tendency toward lesser complications. Posterior surgery was not associated with increased neck disability and neck pain at 2 years. Anterior surgery had better NDI improvement at early follow-up. There is a need for a larger study that is prospectively randomized with long-term follow-up before we can confidently advocate one approach over the other in the management of cervical myelopathy."," Spine J 13(7): 723-731.","Singapore",2013,"Cervical Myelopathy,Neck Pain","Surgical","NDI,AAOS-NSS","Adults","PRO study","Prospective Observation"]
[334,"Sepucha, K. R., et al. (2012). \"Psychometric evaluation of a decision quality instrument for treatment of lumbar herniated disc.\" Spine (Phila Pa 1976) 37(18): 1609-1616.",null,"Sepucha, K. R., et al.","Psychometric evaluation of a decision quality instrument for treatment of lumbar herniated disc","STUDY DESIGN: Retrospective and prospective patient surveys and a physician survey using a sample from American Medical Association master file. OBJECTIVE: To evaluate the performance of a new instrument designed to measure the quality of decisions about treatment of herniated disc. SUMMARY OF BACKGROUND DATA: There is growing consensus on the importance of engaging and informing patients to improve the quality of significant medical decisions, yet there are no instruments currently available to measure decision quality. METHODS: The herniated disc-decision quality instrument (HD-DQI) was developed with input from clinical experts, survey research experts, and patients. The HD-DQI produces 2 scores each scaled to 0% to 100%, with higher scores indicating better quality: (1999) a total knowledge score and (2) a concordance score (indicating the percentage of patients who received treatments that matched their goals). We examined hypotheses relating to the acceptability, feasibility, validity, and reliability of the instrument, using data from 3 samples. RESULTS: The HD-DQI survey was feasible to implement and acceptable to patients, with good response rates and low missing data. The knowledge score discriminated between patients who had seen a decision aid or no decision aid (55% vs. 38%, P < 0.001) and between providers and patients (73% vs. 46%, P < 0.001). The knowledge score also had good retest reliability (intraclass correlation coefficient = 0.85). Most patients (78%) received treatments that matched their goals. Patients who received treatments that matched their goals were less likely to regret the decision than those who did not (13% vs. 39%, P = 0.004). CONCLUSION: The HD-DQI met several criteria for high-quality patient-reported survey instruments. It can be used to determine the quality of decisions for treatment of herniated disc. More work is needed to examine acceptability for use as part of routine patient care."," Spine (Phila Pa 1976) 37(18): 1609-1616.","USA",2012,"Degenerative Disk Disease","Not Specified","HD-DQI","Unknown","PRO study","Prospective Observation"]
[335,"Shahgholi, L., et al. (2012). \"Correlation of the National Institutes of Health patient reported outcomes measurement information system scales and standard pain and functional outcomes in spine augmentation.\" AJNR Am J Neuroradiol 33(11): 2186-2190.",null,"Shahgholi, L., et al.","Correlation of the National Institutes of Health patient reported outcomes measurement information system scales and standard pain and functional outcomes in spine augmentation","BACKGROUND AND PURPOSE: The recently developed National Institutes of Health PROMIS initiative provides reliable and valid measures across many health domains. We correlated changes in pain-related PROMIS measures and changes in both an NRS and the RMDI in patients undergoing spine augmentation. MATERIALS AND METHODS: Fifty patients, composed of 26 women (40-91 years of age; mean, 72.6 years) and 24 men (42-78 years of age, mean, 67.5 years) were enrolled in the study. They were asked at initial presentation and at 30 days to rate the intensity of their pain in the past 24 hours by using a 0-10 pain NRS as well at the 23-item RMDI. Study subjects also completed 3 different PROMIS short forms, including physical function, pain behavior, and pain interference. The Spearman correlation was used to assess the correlation between the scales. The RCI x 1.96 was calculated for each measurement tool as an indicator of change. RESULTS: All instruments were responsive to detection of change during 1 month (all, P < .0001). Correlations between changes in physical function, pain interference, and pain behavior PROMIS scores and changes in RMDI scores were 0.37, 0.44, and 0.42, respectively. Direction of changes (declines versus improvements) in RMDI and other scales were the same in approximately 60% of patients. CONCLUSIONS: All measures evaluated had adequate and comparable psychometric properties. The choice of which measure to use depends on the clinical intent of the intervention."," AJNR Am J Neuroradiol 33(11): 2186-2190.","USA",2012,"Spinal Deformity","Not Specified","RMDQ","Adults","PRO study","Prospective Observation"]
[336,"Shahgholi, L., et al. (2015). \"Correlation of the Patient Reported Outcomes Measurement Information System with legacy outcomes measures in assessment of response to lumbar transforaminal epidural steroid injections.\" AJNR Am J Neuroradiol 36(3): 594-599.",null,"Shahgholi, L., et al.","Correlation of the Patient Reported Outcomes Measurement Information System with legacy outcomes measures in assessment of response to lumbar transforaminal epidural steroid injections","BACKGROUND AND PURPOSE: The Patient Reported Outcomes Measurement Information System is a newly developed outcomes measure promulgated by the National Institutes of Health. This study compares changes in pain and physical function-related measures of this system with changes on the Numeric Rating Pain Scale, Roland Morris Disability Index, and the European Quality of Life scale 5D questionnaire in patients undergoing transformational epidural steroid injections for radicular pain. MATERIALS AND METHODS: One hundred ninety-nine patients undergoing transforaminal epidural steroid injections for radicular pain were enrolled in the study. Before the procedure, they rated the intensity of their pain by using the 0-10 Numeric Rating Pain Scale, Roland Morris Disability Index, and European Quality of Life scale 5D questionnaire. Patients completed the Patient Reported Outcomes Measurement Information System Physical Function, Pain Behavior, and Pain Interference short forms before transforaminal epidural steroid injections and at 3 and 6 months. Seventy and 43 subjects replied at 3- and 6-month follow-up. Spearman rank correlations were used to assess the correlation between the instruments. The minimally important differences were calculated for each measurement tool as an indicator of meaningful change. RESULTS: All instruments were responsive in detecting changes at 3- and 6-month follow-up (P < .0001). There was significant correlation between changes in Patient Reported Outcomes Measurement Information System scores and legacy questionnaires from baseline to 3 months (P < .05). There were, however, no significant correlations in changes from 3 to 6 months with any of the instruments. CONCLUSIONS: The studied Patient Reported Outcomes Measurement Information System domains offered responsive and correlative psychometric properties compared with legacy instruments in a population of patients undergoing transforaminal epidural steroid injections for radicular pain."," AJNR Am J Neuroradiol 36(3): 594-599.","USA",2015,"Radiculopathy","Not Specified","RMDQ","Unknown","PRO study","Prospective Observation"]
[337,"Shamji, M. F., et al. (2013). \"Comparison of anterior surgical options for the treatment of multilevel cervical spondylotic myelopathy: a systematic review.\" Spine (Phila Pa 1976) 38(22 Suppl 1): S195-209.",null,"Shamji, M. F., et al.","Comparison of anterior surgical options for the treatment of multilevel cervical spondylotic myelopathy: a systematic review","STUDY DESIGN: Systematic review. OBJECTIVE: The primary objectives of this review were to compare the effectiveness and safety of various anterior cervical decompressive and reconstructive procedures for diffuse or multifocal cervical spondylotic myelopathy (CSM). An additional objective was to describe the most common ancillary stabilization techniques used with the different anterior decompressive procedures. SUMMARY OF BACKGROUND DATA: Surgical management of CSM provides for neurological recovery and disease stabilization in a cost-effective way. Although both retrospective and prospective data support management of CSM by anterior cervical decompression and fusion, the choice decision between various anterior surgical options remains unclear. METHODS: We conducted a systematic search in MEDLINE and the Cochrane Collaboration Library for human studies in the English-language literature published through September 2012. We included studies comparing multiple discectomies with single or multiple corpectomy, multiple discectomies with discectomy-corpectomy hybrid, and multiple corpectomies with discectomy-corpectomy hybrid, comparing effectiveness and safety outcomes of each procedure, and defining the ancillary stabilization techniques used. Exclusion criteria included patients with degenerative disc disease or degenerative joint disease without CSM, single-level CSM, ossified posterior longitudinal ligament (OPLL), spinal tumor, concomitant infection, and ankylozing spondylitis. Case series, case reports, data not reported separately for each comparison group, or studies that consisted of an N less than 10 for either comparison group were excluded. The evidence strength was rated using the GRADE (Grades of Recommendation Assessment, Development, and Evaluation) criteria. RESULTS: Of the 49 citations identified from our search, 10 studies were initially found suitable for inclusion. Patients undergoing any of the 3 procedures generally experienced improvements in clinical outcomes (neck disability index, Japanese Orthopaedic Association score, and Visual Analogue Scale score for pain) as well as overall sagittal alignment, with minimal perioperative morbidity. There is moderate evidence supporting selection of multiple discectomies compared with corpectomy or discectomy-corpectomy hybrid procedures with regard to superior clinical outcomes and postoperative sagittal alignment. Furthermore, if more extensive operation is needed, there is evidence to support the selection of discectomy-corpectomy hybrid procedures compared with multiple corpectomies if it is technically feasible to accomplish the requisite decompression. The multiple discectomies approach also may have a lower incidence of C5 palsy than corpectomy or discectomy-corpectomy hybrid approaches. CONCLUSION: All 3 operative approaches are effective strategies for the anterior surgical management of CSM. When the patient pathoanatomy permits, selection of multiple discectomies is favored compared with corpectomy or discectomy-corpectomy hybrid approaches. EVIDENCE-BASED CLINICAL RECOMMENDATIONS: RECOMMENDATION 1: When pathoanatomically appropriate with minimal retrovertebral disease, we recommend the selection of multiple discectomy over corpectomy or discectomy-corpectomy hybrid procedures. OVERALL STRENGTH OF EVIDENCE: Low. STRENGTH OF RECOMMENDATION: Strong. RECOMMENDATION 2: When retrovertebral disease is significant, we recommend, when possible, that discectomy-corpectomy hybrid procedures be performed instead of multiple corpectomies. OVERALL STRENGTH OF EVIDENCE: Moderate. STRENGTH OF RECOMMENDATION: Strong. SUMMARY STATEMENTS: There is no evidence to guide choice of ancillary external immobilization techniques following multilevel anterior decompression and fusion procedures for CSM."," Spine (Phila Pa 1976) 38(22 Suppl 1): S195-209.","Canada",2013,"Cervical Myelopathy,Spondylosis","Surgical","JOACMEQ,NDI","Unknown","Cost-Effectiveness","Systematic review"]
[338,"Shaughnessy, M. and B. Caulfield (2004). \"A pilot study to investigate the effect of lumbar stabilisation exercise training on functional ability and quality of life in patients with chronic low back pain.\" Int J Rehabil Res 27(4): 297-301.",null,"Shaughnessy, M. and B. Caulfield","A pilot study to investigate the effect of lumbar stabilisation exercise training on functional ability and quality of life in patients with chronic low back pain","In recent times lumbar stabilisation programmes, targeting the local stabilisers in the lumbar region, have increased in popularity in the treatment of chronic low back pain (CLBP) yet their effectiveness in enhancing quality of life remains unclear. The objective of this pilot study was to examine the effectiveness of a programme of lumbar stabilisation exercises in improving quality of life and functional outcomes in patients with CLBP. Forty-one patients with CLBP who volunteered to take part in the study were randomly assigned to a treatment group (n=20) or a control group (n=21). The treatment group underwent a 10-week lumbar stabilisation programme whilst the control group received no intervention. The Roland Disability Questionnaire, Oswestry Disability Questionnaire and the SF-36 survey were administered to subjects in both groups at baseline and follow-up. Significant improvements were seen in all measures in the treatment group whereas control subjects demonstrated either no change or a significant worsening (P<0.05). These results suggest that a programme of lumbar stabilisation is effective in improving quality of life and functional outcome in patients with CLBP."," Int J Rehabil Res 27(4): 297-301.","Ireland",2004,"Back Pain","Exercise","ODI,RMDQ","Unknown","PRO study","Clinical trial"]
[339,"Shirado, O., et al. (2010). \"Multicenter randomized controlled trial to evaluate the effect of home-based exercise on patients with chronic low back pain: the Japan low back pain exercise therapy study.\" Spine (Phila Pa 1976) 35(17): E811-819.",null,"Shirado, O., et al.","Multicenter randomized controlled trial to evaluate the effect of home-based exercise on patients with chronic low back pain: the Japan low back pain exercise therapy study","STUDY DESIGN: Prospective, randomized, controlled trial. OBJECTIVE: To investigate the effectiveness of home-based exercise on pain, dysfunction, and quality of life (QOL) in Japanese individuals with chronic low back pain (CLBP). SUMMARY OF BACKGROUND DATA: Exercise therapy is a widely used treatment for CLBP in many countries. The studies on its effectiveness have been performed only in Western industrialized countries. The existence of cross-cultural differences and heterogeneity of patients in each country may influence the outcome of interventions for CLBP. Data that would enable researchers to compare the effectiveness of interventions between widely different societies is lacking. METHODS: A total of 201 patients with nonspecific CLBP were randomly assigned to either the control or exercise therapy group: 89 men and 112 women with a mean age of 42.2 years. The control group was treated with nonsteroidal anti-inflammatory drugs (NSAIDs), and the exercise group performed trunk muscle strengthening and stretching exercises. The primary outcome measures were pain intensity (visual analogue scale) and dysfunction level (Japan Low back pain Evaluation Questionnaire [JLEQ] and Roland-Morris Disability Questionnaire [RDQ]) over 12 months. The secondary outcome measure was FFD (Finger-floor distance). Statistical analysis was performed using Wilcoxon signed-ranks and Mann-Whitney U tests, and estimation of the median with 95% CI was calculated. RESULTS: In both groups, significant improvement was found at all points of follow-up assessment. However, JLEQ and RDQ were significantly more improved in the exercise group compared to the control group (P = 0.021 in JLEQ, P = 0.023 in RDQ). The 95% CI for the difference of medians of the change ratio between exercise and NSAID groups, [Exercise] - [NSAID], was -0.25 to -0.02 in JLEQ, -0.33 to 0.00 in RDQ, and -0.20 to 0.06 in visual analogue scale. CONCLUSION: The home-based exercise prescribed and monitored by board-certified orthopedic surgeons was more effective than NSAIDs for Japanese patients with CLBP."," Spine (Phila Pa 1976) 35(17): E811-819.","Japan",2010,"Back Pain","Exercise","RMDQ,JOACMEQ","Adults","PRO study","RCT"]
[340,"Silte Karamanlioglu, D., et al. (2016). \"Effectiveness of ultrasound treatment applied with exercise therapy on patients with ankylosing spondylitis: a double-blind, randomized, placebo-controlled trial.\" Rheumatol Int 36(5): 653-661.",null,"Silte Karamanlioglu, D., et al.","Effectiveness of ultrasound treatment applied with exercise therapy on patients with ankylosing spondylitis: a double-blind, randomized, placebo-controlled trial","The aim of our study was to evaluate effectiveness of ultrasound treatment applied with exercise therapy in patients with ankylosing spondylitis. Fifty-two patients, who were diagnosed according to modified New York criteria, were aged 25-60, and have spine pain, were randomly assigned to two groups. Ultrasound (US) and exercise therapy were applied to treatment group (27); placebo US treatment and exercise therapy were applied to control group (25). Patients were evaluated before treatment, at the end of treatment, and 4 weeks after the treatment. Daily and night pain, morning stiffness, patient global assessment (PGA), doctor global assessment (DGA), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire, Ankylosing Spondylitis Disease Activity Score (ASDAS) erythrocyte sedimentation rate (ESR), and ASDAS C-reactive protein (CRP) were used as clinical parameters. In US group, all parameters showed significant improvements at 2 and 6 weeks, in comparison with the baseline. In placebo US group, significant improvement was obtained for all parameters (except tragus-to-wall distance and modified Schober test at 2 weeks and lumbar side flexion and modified Schober test at 6 weeks). Comparison of the groups showed significantly superior results of US group for parameters of BASMI (p < 0.05), tragus-wall distance (p < 0.05), PGA (p < 0.01), and DGA (p < 0.05) at 2 weeks as well as for the parameters of daily pain (p < 0.01), PGA (p < 0.05), DGA (p < 0.01), BASDAI (p < 0.05), ASDAS-CRP (p < 0.05), ASDAS-ESR (p < 0.01), lumbar side flexion (p < 0.01), the modified Schober test (p < 0.01), and ASQoL (p < 0.05) at 6 weeks. Our study showed that ultrasound treatment increases the effect of exercise in patients with ankylosing spondylitis."," Rheumatol Int 36(5): 653-661.","Turkey",2016,"Back Pain,Spondylosis","Exercise","Schober","Unknown","PRO study","RCT"]
[341,"Skare, T. L., et al. (2012). \"Ethnic influence in clinical and functional measures of Brazilian patients with spondyloarthritis.\" J Rheumatol 39(1999): 141-147.",null,"Skare, T. L., et al.","Ethnic influence in clinical and functional measures of Brazilian patients with spondyloarthritis","OBJECTIVE: Spondyloarthritides (SpA) can present different disease spectra according to ethnic background. The Brazilian Registry of Spondyloarthritis (RBE) is a nationwide registry that comprises a large databank on clinical, functional, and treatment data on Brazilian patients with SpA. The aim of our study was to analyze the influence of ethnic background in SpA disease patterns in a large series of Brazilian patients. METHODS: A common protocol of investigation was prospectively applied to 1318 SpA patients in 29 centers distributed through the main geographical regions in Brazil. The group comprised whites (65%), African Brazilians (31.3%), and people of mixed origins (3.7%). Clinical and demographic variables and various disease index scores were compiled. Ankylosing spondylitis (AS) was the most frequent disease in the group (65.1%); others were psoriatic arthritis (18.3%), undifferentiated SpA (6.8%), enteropathic arthritis (3.7%), and reactive arthritis (3.4%). RESULTS: White patients were significantly associated with psoriasis (p = 0.002), positive HLA-B27 (p = 0.014), and use of corticosteroids (p < 0.0001). Hip involvement (p = 0.02), axial inflammatory pain (p = 0.04), and radiographic sacroiliitis (p = 0.025) were associated with African Brazilian descent. Sex distribution, family history, and presence of peripheral arthritis, uveitis, dactylitis, urethritis, and inflammatory bowel disease were similar in the 3 groups, as well as age at disease onset, time from first symptom until diagnosis, and use of anti-tumor necrosis factor-alpha agents (p > 0.05). Schober test and thoracic expansion were similar in the 3 groups, whereas African Brazilians had higher Maastricht Ankylosing Spondylitis Enthesitis Scores (p = 0.005) and decreased lateral lumbar flexion (p = 0.003), while whites had a higher occiput-to-wall distance (p = 0.02). African Brazilians reported a worse patient global assessment of disease (p = 0.011). Other index scores and prevalence of work incapacity were similar in the 3 groups, although African Brazilians had worse performance in the Ankylosing Spondylitis Quality of Life questionnaire (p < 0.001). CONCLUSION: Ethnic background is associated with distinct clinical aspects of SpA in Brazilian patients. African Brazilian patients with SpA have a poorer quality of life and report worse disease compared to whites."," J Rheumatol 39(1999): 141-147.","Brazil",2012,"Spondylosis","Not Specified","Schober","Unknown","PRO study","Prospective Observation"]
[342,"Skljarevski, V., et al. (2010). \"Duloxetine versus placebo in patients with chronic low back pain: a 12-week, fixed-dose, randomized, double-blind trial.\" J Pain 11(12): 1282-1290.",null,"Skljarevski, V., et al.","Duloxetine versus placebo in patients with chronic low back pain: a 12-week, fixed-dose, randomized, double-blind trial","This randomized, double-blind, placebo-controlled study assessed efficacy and safety of duloxetine in patients with chronic low back pain (CLBP). Adults (n = 401) with a nonneuropathic CLBP and average pain intensity of >/= 4 on an 11-point numerical scale (Brief Pain Inventory [BPI]) were treated with either duloxetine 60 mg once daily or placebo for 12 weeks. The primary measure was BPI average pain. Secondary endpoints included Patient's Global Impressions of Improvement (PGI-I), Roland Morris Disability Questionnaire (RMDQ-24), BPI-Severity (BPI-S), BPI-Interference (BPI-I), and response rates (either >/= 30% or >/= 50% BPI average pain reduction at endpoint). Health outcomes included Short Form-36, European Quality of Life-5 Dimensions, and the Work Productivity and Activity Impairment questionnaire. Safety and tolerability were assessed. Compared with placebo-treated patients, duloxetine-treated patients reported a significantly greater reduction in BPI average pain (P </= .001). Similarly, duloxetine-treated patients reported significantly greater improvements in PGI-I, BPI-S, BPI-I, 50% response rates, and some health outcomes. The RMDQ and 30% response rate showed numerical improvements with duloxetine treatment. Significantly more patients in the duloxetine group (15.2%) than patients in the placebo group (5.4%) discontinued because of adverse events (P = .002). Nausea and dry mouth were the most common treatment-emergent adverse events with rates significantly higher in duloxetine-treated patients. PERSPECTIVE: This study provides clinical evidence of the efficacy and safety of duloxetine at a fixed dose of 60 mg once daily in the treatment of chronic low back pain (CLBP). As of December 2009, duloxetine has not received regulatory approval for the treatment of CLBP."," J Pain 11(12): 1282-1290.","USA",2010,"Back Pain","Duloxetine","RMDQ","Adults","PRO study","RCT"]
[343,"Skljarevski, V., et al. (2010). \"Efficacy and safety of duloxetine in patients with chronic low back pain.\" Spine (Phila Pa 1976) 35(13): E578-585.",null,"Skljarevski, V., et al.","Efficacy and safety of duloxetine in patients with chronic low back pain","STUDY DESIGN: This was a randomized, double-blind, placebo-controlled clinical trial. OBJECTIVE: To assess the efficacy and safety of duloxetine in the treatment of chronic low back pain (CLBP). SUMMARY OF BACKGROUND DATA: Imbalance of serotonin and norepinephrine within modulatory pain pathways has been implicated in the development and maintenance of chronic pain. Duloxetine, a selective reuptake inhibitor of serotonin and norepinephrine, has demonstrated clinical efficacy in 3 distinct chronic pain conditions: diabetic peripheral neuropathic pain, fibromyalgia, and chronic pain because of osteoarthritis. METHODS: In this randomized double-blind trial, adult nondepressed patients with a non-neuropathic CLBP and a weekly mean of the 24-hour average pain score>or=4 at baseline (0-10 scale) were treated with either duloxetine or placebo for 13 weeks. The dose of duloxetine during first 7 weeks was 60 mg once daily. At week 7, patients reporting<30% pain reduction had their dose increased to 120 mg. The primary outcome measure was the Brief Pain Inventory (BPI) 24-hour average pain rating. Secondary measures included Roland-Morris Disability Questionnaire-24; Patient's Global Impressions of Improvement; Clinical Global Impressions-Severity (CGI-S); BPI-Severity and -Interference (BPI-I); and weekly means of the 24-hour average pain, night pain, and worst pain scores from patient diaries. Quality-of-life, safety, and tolerability outcomes were also assessed. RESULTS: Compared with placebo-treated patients (least-squares mean change of -1.50), patients on duloxetine (least-squares mean change of -2.32) had a significantly greater reduction in the BPI 24-hour average pain from baseline to endpoint (P=0.004 at week 13). Additionally, the duloxetine group significantly improved on Patient's Global Impressions of Improvement; Roland-Morris Disability Questionnaire-24; BPI-Severity and average BPI-Interference; weekly mean of the 24-hour average pain, night pain, and worst pain. Significantly more patients in the duloxetine group (13.9%) compared with placebo (5.8%) discontinued because of adverse events (P=0.047). The most common treatment-emergent adverse events in the duloxetine group included nausea, dry mouth, fatigue, diarrhea, hyperhidrosis, dizziness, and constipation. CONCLUSION: Duloxetine significantly reduced pain and improved functioning in patients with CLBP. The safety and tolerability were similar to those reported in earlier studies."," Spine (Phila Pa 1976) 35(13): E578-585.","USA",2010,"Neuropathic Pain","Duloxetine","RMDQ","Unknown","PRO study","RCT"]
[344,"Skolasky, R. L., et al. (2011). \"Minimum clinically important differences in the Cervical Spine Outcomes Questionnaire: results from a national multicenter study of patients treated with anterior cervical decompression and arthrodesis.\" J Bone Joint Surg Am 93(14): 1294-1300.",null,"Skolasky, R. L., et al.","Minimum clinically important differences in the Cervical Spine Outcomes Questionnaire: results from a national multicenter study of patients treated with anterior cervical decompression and arthrodesis","BACKGROUND: The minimum clinically important difference is a clinically relevant threshold of improvement. A substantial clinical benefit is a threshold of change that correlates with clinically important improvement. The Cervical Spine Outcomes Questionnaire is a disease-specific, patient-reported outcomes instrument that was developed to be sensitive to changes associated with surgical treatment for degenerative cervical disc disease. To determine thresholds for change in these domain scores that are important from the patient's perspective, we estimated the minimum clinically important difference and substantial clinical benefit values for this questionnaire's domain scores. METHODS: We evaluated 252 patients from the Cervical Spine Research Society Outcomes Study at their six-month follow-up visits after anterior cervical spine decompression and arthrodesis. Using a receiver operating characteristics curve, with the health transition item of the Short Form-36 as an anchor, we determined that the minimum clinically important difference (the value that maximized sensitivity and specificity to differentiate the \"somewhat better\" and \"much better\" responses from others) and the substantial clinical benefit (the value that maximized sensitivity and specificity to differentiate the \"much better\" response from others) for our questionnaire's domain scores. Responses were scaled between 0 and 1 point; higher scores denoted more severe impairment. Patient and clinical characteristics were tested to determine their influence on score changes. RESULTS: The minimum clinically important difference ranged from 0.13 point (for functional disability) to 0.24 point (for arm/shoulder pain). The substantial clinical benefit score ranged from 0.20 point (for functional disability or physical symptoms other than pain) to 0.30 point (for neck or arm/shoulder pain). Age, sex, and duration of current symptoms were not associated with change in our questionnaire's domain scores. CONCLUSIONS: A 0.13-point change in the functional disability domain score indicated a clinically important difference in a self-reported outcome after anterior cervical spine surgery. A 0.30-point change in neck pain after surgery indicated a clinically important clinical benefit. This information, coupled with previous reports of the psychometric stability of the Cervical Spine Outcomes Questionnaire, should increase the clinical utility of this patient-reported outcomes instrument."," J Bone Joint Surg Am 93(14): 1294-1300.","USA",2011,"Neck Pain","Surgical","CSOQ","Unknown","PRO study","Observational"]
[345,"Skolasky, R. L., et al. (2011). \"Predicting health-utility scores from the Cervical Spine Outcomes Questionnaire in a multicenter nationwide study of anterior cervical spine surgery.\" Spine (Phila Pa 1976) 36(25): 2211-2216.",null,"Skolasky, R. L., et al.","Predicting health-utility scores from the Cervical Spine Outcomes Questionnaire in a multicenter nationwide study of anterior cervical spine surgery","STUDY DESIGN: Cross-sectional analysis of the Cervical Spine Research Society Outcomes Study, a longitudinal multicenter cohort study. OBJECTIVE: To provide a statistical model for estimating health utility from the Cervical Spine Outcomes Questionnaire (CSOQ) domain scores. SUMMARY OF BACKGROUND DATA: There is consensus among health-policy researchers that the results of economic evaluations of health can be reported in quality-adjusted life-years (QALY). The CSOQ is a condition-specific instrument that assesses individuals across several domains, including neck and arm/shoulder pain and psychological distress. METHODS: The CSOQ and 36-Item Short Form Health Survey (SF-36) were prospectively administered before surgery (within 4 weeks) and after surgery (at 3, 6, and 24 months) to individuals undergoing anterior cervical decompression and fusion for degenerative disc disease of the cervical spine. Using methods reported by Brazier et al, health utility (SF-6D) was estimated using the SF-36. Regression analyses were used on a training dataset (n = 164) to compute the SF-6D from the domain scores of the CSOQ. A validation dataset (n = 328) was used to estimate the SF-6D for comparison to the calculated health utility from the SF-36. RESULTS.: Domain scores were moderately correlated with health utility (SF-6D) (P < 0.001) with correlation coefficients ranging from 0.48 to 0.70. The regression equation to predict SF-6D on the basis of CSOQ domain scores and patient age using the training dataset accounted for 65% of the variation in health utility. In the validation dataset, predicted SF-6D was positively correlated with observed SF-6D (r = 0.680, P < 0.001). CONCLUSION: Our findings show that the CSOQ's domain scores can be used to estimate health-utility scores among those undergoing elective anterior cervical decompression and fusion for cervical degenerative disc disease. The ability to assess health utility, coupled with the psychometric properties of the CSOQ, should increase the clinical utility of this patient-reported outcomes instrument."," Spine (Phila Pa 1976) 36(25): 2211-2216.","USA",2011,"Spinal Deformity","Surgical","CSOQ","Adults","Tool Validation","Observational"]
[346,"Slater, H., et al. (2013). \"Translating evidence for low back pain management into a consumer-focussed resource for use in community pharmacies: a cluster-randomised controlled trial.\" PLoS One 8(8): e71918.",null,"Slater, H., et al.","Translating evidence for low back pain management into a consumer-focussed resource for use in community pharmacies: a cluster-randomised controlled trial","BACKGROUND: This cluster-randomised controlled trial determined the effectiveness of an evidence-based, pamphlet intervention in improving low back pain (LBP)-related beliefs among pharmacy consumers. METHODS: THIRTY FIVE COMMUNITY PHARMACIES WERE RANDOMISED TO THREE GROUPS: pamphlet+education intervention [n = 11]; pamphlet only intervention [n = 11]; control: usual care [n = 13]. Eligibility requirements for clusters included: community-based pharmacies and proprietor participation consent. Pharmacy consumers (N = 317) aged 18-65 years currently experiencing LBP participated. Intervention group allocation depended on the pharmacy attended. Individual-level outcomes were measured at pre-intervention (T0), at two (T1) and eight (T2) weeks post-intervention and included beliefs about LBP [Back Pain Beliefs Questionnaire (BBQ); Fear Avoidance Beliefs Questionnaire (FABQ)]. Secondary outcomes included pain severity, activity impairment and pamphlet perceived usefulness. Blinding to group allocation included primary investigators, outcome assessors and the statistician. Pharmacy staff and consumers were un-blinded. RESULTS: Of 35 pharmacies recruited (317 consumers), no clusters were lost to follow-up. Follow-up was available for n = 24 at 2 weeks only; n = 38 at 8 weeks only; n = 148 at both time points, with n = 148+24+38 = 210 analysed (107 excluded: no follow up). Adjusting for baseline scores demonstrated no significant differences in beliefs (2 or at 8 weeks) between pamphlet (with or without education) versus control, or between 'pamphlet with' versus 'without' education. Work-related fear (FABQ) was significantly lower in consumers receiving pamphlet (with or without education) versus control (difference -2.3, 95%CI: -4.4 to -0.2). There was no significant difference between \"pamphlet with\" versus \"pamphlet without\" groups. Consumers receiving the \"pamphlet with\" reported greater perceived usefulness than consumers receiving the \"pamphlet without\" (difference 0.9 (95%CI: 0.0 to 1.8)). CONCLUSION: Community pharmacies provided a feasible primary care portal for implementing evidence-based information. The associated improvement in work-related LBP-beliefs for consumers receiving the pamphlet suggests this simple intervention may be a useful component of care. TRIAL REGISTRATION: ACTR.org.au ACTRN12611000053921."," PLoS One 8(8): e71918.","Australia",2013,"Back Pain","Education","BBQ","Adults","PRO study","RCT"]
[347,"Smeets, R. J., et al. (2009). \"More is not always better: cost-effectiveness analysis of combined, single behavioral and single physical rehabilitation programs for chronic low back pain.\" Eur J Pain 13(1999): 71-81.",null,"Smeets, R. J., et al.","More is not always better: cost-effectiveness analysis of combined, single behavioral and single physical rehabilitation programs for chronic low back pain","Several treatment principles for the reduction of chronic low back pain associated disability have been postulated. To examine whether a combination of a physical training and operant-behavioral graded activity with problem solving training is cost-effective compared to either alone one year post-treatment, a full economic analysis alongside a randomized controlled trial was conducted. In total 172 patients with chronic disabling non-specific low back pain referred for rehabilitation treatment, were randomized to 10 weeks of aerobic training and muscle strengthening of back extensors (active physical treatment; APT), 10 weeks of gradual assumption of patient relevant activities based on operant-behavioral principles and problem solving training (graded activity plus problem solving training; GAP), or APT combined with GAP (combination treatment; CT). Total costs, existing of direct health and non-health costs and indirect costs due to absence of paid work were calculated by using cost diaries and treatment attendance lists. The Roland Disability Questionnaire was used to calculate the cost-effectiveness to reduce disability and the gain in quality adjusted life year (QALY) by using the EuroQol-5D. APT, followed by CT showed, although not significant, higher total costs than GAP. Reduction of disability and gain in QALY did not differ significantly between CT and the single treatment modalities. Based on the incremental cost effectiveness ratios (ICERs) and cost-effectiveness acceptability curves CT is not cost-effective at all. However, GAP is cost-effective regarding the reduction of disability and gain in QALY, and to a lesser degree APT is more cost-effective than CT in reducing disability."," Eur J Pain 13(1999): 71-81.","Netherlands",2009,"Back Pain","Physical Therapy","RMDQ","Unknown","Cost-Effectiveness","Clinical trial"]
[348,"Smith, J. S., et al. (2013). \"Change in classification grade by the SRS-Schwab Adult Spinal Deformity Classification predicts impact on health-related quality of life measures: prospective analysis of operative and nonoperative treatment.\" Spine (Phila Pa 1976) 38(19): 1663-1671.",null,"Smith, J. S., et al.","Change in classification grade by the SRS-Schwab Adult Spinal Deformity Classification predicts impact on health-related quality of life measures: prospective analysis of operative and nonoperative treatment","STUDY DESIGN: Multicenter, prospective, consecutive series. OBJECTIVE: To evaluate responsiveness of the Scoliosis Research Society (SRS)-Schwab adult spinal deformity (ASD) classification to changes in health-related quality of life (HRQOL) after treatment for ASD. SUMMARY OF BACKGROUND DATA: Ideally, a classification system should describe and be responsive to changes in a disease state. We hypothesized that the SRS-Schwab classification is responsive to changes in HRQOL measures after treatment for ASD. METHODS: A multicenter, prospective, consecutive series from the International Spine Study Group. INCLUSION CRITERIA: ASD, age more than 18, operative or nonoperative treatment, baseline and 1-year radiographs, and HRQOL measures (Oswestry Disability Index [ODI], SRS-22, Short Form [SF]-36). The SRS-Schwab classification includes a curve descriptor and 3 sagittal spinopelvic modifiers (sagittal vertical axis [SVA], pelvic tilt, pelvic incidence/lumbar lordosis [PI-LL] mismatch). Changes in modifiers at 1 year were assessed for impact on HRQOL from pretreatment values based on minimal clinically important differences. RESULTS: Three hundred forty-one patients met criteria (mean age = 54; 85% females; 177 operative and 164 nonoperative). Change in pelvic tilt modifier at 1-year follow-up was associated with changes in ODI and SRS-22 (total and appearance scores) (P </= 0.034). Change in SVA modifier at 1 year was associated with changes in ODI, SF-36 physical component score, and SRS-22 (total, activity, and appearance scores) (P </= 0.037). Change in PI-LL modifier at 1 year was associated with changes in SF-36 physical component score and SRS-22 (total, activity, and appearance scores) (P </= 0.03). Patients with improvement of pelvic tilt, SVA, or PI-LL modifiers were significantly more likely to achieve minimal clinically important difference for ODI, SF-36 physical component score (SVA and PI-LL only), SRS activity, and SRS pain (PI-LL only). CONCLUSION: The SRS-Schwab classification provides a validated system to evaluate ASD, and the classification components correlate with HRQOL measures. This study demonstrates that the classification modifiers are responsive to changes in disease state and reflect significant changes in patient-reported outcomes. LEVEL OF EVIDENCE: 3."," Spine (Phila Pa 1976) 38(19): 1663-1671.","USA",2013,"Spinal Deformity","Surgical","SRS-HRQOL,ODI","Unknown","PRO study","Prospective Observation"]
[349,"Smith, J. S., et al. (2014). \"Surgical treatment of pathological loss of lumbar lordosis (flatback) in patients with normal sagittal vertical axis achieves similar clinical improvement as surgical treatment of elevated sagittal vertical axis: clinical article.\" J Neurosurg Spine 21(2): 160-170.",null,"Smith, J. S., et al.","Surgical treatment of pathological loss of lumbar lordosis (flatback) in patients with normal sagittal vertical axis achieves similar clinical improvement as surgical treatment of elevated sagittal vertical axis: clinical article","OBJECT: Increased sagittal vertical axis (SVA) correlates strongly with pain and disability for adults with spinal deformity. A subset of patients with sagittal spinopelvic malalignment (SSM) have flatback deformity (pelvic incidence-lumbar lordosis [PI-LL] mismatch > 10 degrees ) but remain sagittally compensated with normal SVA. Few data exist for SSM patients with flatback deformity and normal SVA. The authors' objective was to compare baseline disability and treatment outcomes for patients with compensated (SVA < 5 cm and PI-LL mismatch > 10 degrees ) and decompensated (SVA > 5 cm) SSM. METHODS: The study was a multicenter, prospective analysis of adults with spinal deformity who consecutively underwent surgical treatment for SSM. Inclusion criteria included age older than 18 years, presence of adult spinal deformity with SSM, plan for surgical treatment, and minimum 1-year follow-up data. Patients with SSM were divided into 2 groups: those with compensated SSM (SVA < 5 cm and PI-LL mismatch > 10 degrees ) and those with decompensated SSM (SVA >/= 5 cm). Baseline and 1-year follow-up radiographic and health-related quality of life (HRQOL) outcomes included Oswestry Disability Index, Short Form-36 scores, and Scoliosis Research Society-22 scores. Percentages of patients achieving minimal clinically important difference (MCID) were also assessed. RESULTS: A total of 125 patients (27 compensated and 98 decompensated) met inclusion criteria. Compared with patients in the compensated group, patients in the decompensated group were older (62.9 vs. 55.1 years; p = 0.004) and had less scoliosis (43 degrees vs 54 degrees ; p = 0.002), greater SVA (12.0 cm vs. 1.7 cm; p < 0.001), greater PI-LL mismatch (26 degrees vs. 20 degrees ; p = 0.013), and poorer HRQOL scores (Oswestry Disability Index, Short Form-36 physical component score, Scoliosis Research Society-22 total; p </= 0.016). Although these baseline HRQOL differences between the groups reached statistical significance, only the mean difference in Short Form-36 physical component score reached threshold for MCID. Compared with baseline assessment, at 1 year after surgery improvement was noted for patients in both groups for mean SVA (compensated -1.1 cm, decompensated +4.8 cm; p </= 0.009), mean PI-LL mismatch (compensated 6 degrees , decompensated 5 degrees ; p < 0.001), and all HRQOL measures assessed (p </= 0.005). No significant differences were found between the compensated and decompensated groups in the magnitude of HRQOL score improvement or in the percentages of patients achieving MCID for each of the outcome measures assessed. CONCLUSIONS: Decompensated SSM patients with elevated SVA experience significant disability; however, the amount of disability in compensated SSM patients with flatback deformity caused by PI-LL mismatch but normal SVA is underappreciated. Surgical correction of SSM demonstrated similar radiographic and HRQOL score improvements for patients in both groups. Evaluation of SSM should extend beyond measuring SVA. Among patients with concordant pain and disability, PI-LL mismatch must be evaluated for SSM patients and can be considered a primary indication for surgery."," J Neurosurg Spine 21(2): 160-170.","USA",2014,"Spinal Deformity","Surgical","ODI,SRS-HRQOL","Adults","PRO study","Prospective Observation"]
[350,"Smith, J. S., et al. (2015). \"Comparison of best versus worst clinical outcomes for adult spinal deformity surgery: a retrospective review of a prospectively collected, multicenter database with 2-year follow-up.\" J Neurosurg Spine 23(3): 349-359.",null,"Smith, J. S., et al.","Comparison of best versus worst clinical outcomes for adult spinal deformity surgery: a retrospective review of a prospectively collected, multicenter database with 2-year follow-up","OBJECT: Although recent studies suggest that average clinical outcomes are improved following surgery for selected adult spinal deformity (ASD) patients, these outcomes span a broad range. Few studies have specifically addressed factors that may predict favorable clinical outcomes. The objective of this study was to compare patients with ASD with best versus worst clinical outcomes following surgical treatment to identify distinguishing factors that may prove useful for patient counseling and optimization of clinical outcomes. METHODS: This is a retrospective review of a prospectively collected, multicenter, database of consecutively enrolled patients with ASD who were treated operatively. Inclusion criteria were age > 18 years and ASD. For patients with a minimum of 2-year follow-up, those with best versus worst outcomes were compared separately based on Scoliosis Research Society-22 (SRS-22) and Oswestry Disability Index (ODI) scores. Only patients with a baseline SRS-22 </= 3.5 or ODI >/= 30 were included to minimize ceiling/floor effects. Best and worst outcomes were defined for SRS-22 (>/= 4.5 and </= 2.5, respectively) and ODI (</= 15 and >/= 50, respectively). RESULTS: Of 257 patients who met the inclusion criteria, 227 (88%) had complete baseline and 2-year follow-up SRS-22 and ODI outcomes scores and radiographic imaging and were analyzed in the present study. Of these 227 patients, 187 had baseline SRS-22 scores </= 3.5, and 162 had baseline ODI scores >/= 30. Forthe SRS-22, best and worst outcomes criteria were met at follow-up for 25 and 27 patients, respectively. For the ODI, best and worst outcomes criteria were met at follow-up for 43 and 51 patients, respectively. With respect to the SRS-22, compared with best outcome patients, those with worst outcomes had higher baseline SRS-22 scores (p < 0.0001), higher prevalence of baseline depression (p < 0.001), more comorbidities (p = 0.012), greater prevalence of prior surgery (p = 0.007), a higher complication rate (p = 0.012), and worse baseline deformity (sagittal vertical axis [SVA], p = 0.045; pelvic incidence [PI] and lumbar lordosis [LL] mismatch, p = 0.034). The best-fit multivariate model for SRS-22 included baseline SRS-22 (p = 0.033), baseline depression (p = 0.012), and complications (p = 0.030). With respect to the ODI, compared with best outcome patients, those with worst outcomes had greater baseline ODI scores (p < 0.001), greater baseline body mass index (BMI; p = 0.002), higher prevalence of baseline depression (p < 0.028), greater baseline SVA (p = 0.016), a higher complication rate (p = 0.02), and greater 2-year SVA (p < 0.001) and PI-LL mismatch (p = 0.042). The best-fit multivariate model for ODI included baseline ODI score (p < 0.001), 2-year SVA (p = 0.014) and baseline BMI (p = 0.037). Age did not distinguish best versus worst outcomes for SRS-22 or ODI (p > 0.1). CONCLUSIONS: Few studies have specifically addressed factors that distinguish between the best versus worst clinical outcomes for ASD surgery. In this study, baseline and perioperative factors distinguishing between the best and worst outcomes for ASD surgery included several patient factors (baseline depression, BMI, comorbidities, and disability), as well as residual deformity (SVA), and occurrence of complications. These findings suggest factors that may warrant greater awareness among clinicians to achieve optimal surgical outcomes for patients with ASD."," J Neurosurg Spine 23(3): 349-359.","USA",2015,"Spinal Deformity","Surgical","SRS-HRQOL","Adults","PRO study","Retrospective review"]
[351,"Smucny, M., et al. (2011). \"Patient self-assessment of appearance is improved more by all pedicle screw than by hybrid constructs in surgical treatment of adolescent idiopathic scoliosis.\" Spine (Phila Pa 1976) 36(3): 248-254.",null,"Smucny, M., et al.","Patient self-assessment of appearance is improved more by all pedicle screw than by hybrid constructs in surgical treatment of adolescent idiopathic scoliosis","STUDY DESIGN: A multicenter prospective cohort study. OBJECTIVE: To compare the effect of all pedicle screw versus hybrid constructs on patient self-assessment of appearance after posterior spinal fusion with instrumentation for adolescent idiopathic scoliosis (AIS). This will contribute to future cost-effective analyses on surgical management of AIS. SUMMARY OF BACKGROUND DATA: For surgical management of AIS, the Spinal Appearance Questionnaire (SAQ) and the Scoliosis Research Society outcomes instrument (SRS-30) are reliable surveys of patient satisfaction, but neither tool has been used to assess outcome by implant type. METHODS: Patients received either all pedicle screws or hybrid instrumentation. Self-assessment of appearance pre- and after surgery was measured by SAQ and SRS-30. Statistical significance was evaluated through P values (P < 0.01 in the SAQ, P < 0.05 in the SRS-30) and effect sizes. RESULTS: There were 93 patients in the all pedicle screw cohort and 61 in the hybrid cohort. There were no significant preoperative differences between the cohorts in the SAQ or SRS-30. All pedicle screw patients tended to see more improvement in shoulder level than hybrid patients in 2 separate SAQ questions (P = 0.025, Cohen's D = 0.20; P = 0.013, D = 0.24). The screw patients also tended to have better scores than hybrid patients in the category, \"looking better in clothes\" (P = 0.017, V = 0.24) at 2 years postoperative. All pedicle screw patients self-reported significant greater improvement than hybrid patients in the SRS-30 Appearance and Mental domains (P = 0.016, ES = 0.038; P = 0.005, ES = 0.051). There were no significant differences between cohorts in age, gender, baseline curve, or major curve magnitude. CONCLUSION: All pedicle screw constructs lead to better self-assessment of appearance in operative treatment of AIS, as determined by SAQ and SRS-30."," Spine (Phila Pa 1976) 36(3): 248-254.","USA",2011,"Spinal Deformity,Spinal Fusion","Surgical","SRS-HRQOL,SAQ","Adolescents","Cost and Resource Use","Prospective Observation"]
[352,"Soegaard, R., et al. (2007). \"Costs and effects in lumbar spinal fusion. A follow-up study in 136 consecutive patients with chronic low back pain.\" Eur Spine J 16(5): 657-668.",null,"Soegaard, R., et al.","Costs and effects in lumbar spinal fusion. A follow-up study in 136 consecutive patients with chronic low back pain","Although cost-effectiveness is becoming the foremost evaluative criterion within health service management of spine surgery, scientific knowledge about cost-patterns and cost-effectiveness is limited. The aims of this study were (1999) to establish an activity-based method for costing at the patient-level, (2) to investigate the correlation between costs and effects, (3) to investigate the influence of selected patient characteristics on cost-effectiveness and, (4) to investigate the incremental cost-effectiveness ratio of (a) posterior instrumentation and (b) intervertebral anterior support in lumbar spinal fusion. We hypothesized a positive correlation between costs and effects, that determinants of effects would also determine cost-effectiveness, and that posterolateral instrumentation and anterior intervertebral support are cost-effective adjuncts in posterolateral lumbar fusion. A cohort of 136 consecutive patients with chronic low back pain, who were surgically treated from January 2001 through January 2003, was followed until 2 years postoperatively. Operations took place at University Hospital of Aarhus and all patients had either (1999) non-instrumented posterolateral lumbar spinal fusion, (2) instrumented posterolateral lumbar spinal fusion, or (3) instrumented posterolateral lumbar spinal fusion + anterior intervertebral support. Analysis of costs was performed at the patient-level, from an administrator's perspective, by means of Activity-Based-Costing. Clinical effects were measured by means of the Dallas Pain Questionnaire and the Low Back Pain Rating Scale at baseline and 2 years postoperatively. Regression models were used to reveal determinants for costs and effects. Costs and effects were analyzed as a net-benefit measure to reveal determinants for cost-effectiveness, and finally, adjusted analysis (for non-random allocation of patients) was performed in order to reveal the incremental cost-effectiveness ratios of (a) posterior instrumentation and (b) anterior support. The costs of non-instrumented posterolateral spinal fusion were estimated at DKK 88,285(95% CI 81,369;95,546), instrumented posterolateral spinal fusion at DKK 94,396(95% CI 89,865;99,574) and instrumented posterolateral lumbar spinal fusion + anterior intervertebral support at DKK 120,759(95% CI 111,981;133,738). The net-benefit of the regimens was significantly affected by smoking and functional disability in psychosocial life areas. Multi-level fusion and surgical technique significantly affected the net-benefit as well. Surprisingly, no correlation was found between treatment costs and treatment effects. Incremental analysis suggested that the probability of posterior instrumentation being cost-effective was limited, whereas the probability of anterior intervertebral support being cost-effective escalates as willingness-to-pay per effect unit increases. This study reveals useful and hitherto unknown information both about cost-patterns at the patient-level and determinants of cost-effectiveness. The overall conclusion of the present investigation is a recommendation to focus further on determinants of cost-effectiveness. For example, patient characteristics that are modifiable at a relatively low expense may have greater influence on cost-effectiveness than the surgical technique itself--at least from an administrator's perspective."," Eur Spine J 16(5): 657-668.","Denmark",2007,"Back Pain,Spinal Fusion","Surgical","ICF","Adults","Cost-Effectiveness","Prospective Observation"]
[353,"Steinmetz, M. P., et al. (2008). \"Cervical disc arthroplasty compared with fusion in a workers' compensation population.\" Neurosurgery 63(4): 741-747; discussion 747.",null,"Steinmetz, M. P., et al.","Cervical disc arthroplasty compared with fusion in a workers' compensation population","OBJECTIVE: Patients with cervical radiculopathy and/or myelopathy are often treated with anterior cervical discectomy and fusion. Cervical arthroplasty has recently been advocated as an alternative treatment. Theoretically, arthroplasty should permit early return to activity and protect against adjacent segment disease. Early mobilization and return to activity may, theoretically, reduce cost to the workers' compensation program. METHODS: A subgroup analysis of workers' compensation patients from the randomized controlled trials comparing Prestige ST and Bryan (Medtronic Sofamor Danek, Memphis, TN) cervical arthroplasty to fusion was performed. Primary outcome measures were work status, time to return to work, and neck disability. Secondary outcome measures were neck and arm pain and Medical Outcomes Study Short-Form 36-Item Health Survey score. RESULTS: One thousand four patients were enrolled in the studies, 93 of whom were workers' compensation patients. At 6 weeks and 3 months, significantly more patients in the arthroplasty group were working compared with the fusion group. At 6 months and later, there was no significant difference in return-to-work rates. Overall, patients returned to work at a median of 101 days after arthroplasty, compared with 222 days after anterior cervical discectomy and fusion. This difference was not significant when controlling for sex, study, and preoperative work status. At all time points, the Neck Disability Index was consistently lower in the arthroplasty group compared with the fusion group; however, the difference was not significant at 24 months. There was no statistically significant difference in secondary outcomes, neurological events, or pain-related events. CONCLUSION: In this workers' compensation cohort, it was observed that a greater number of patients in the arthroplasty group returned to work at 6 weeks and 3 months after surgery. A trend toward an earlier return to work was also seen, although this was not statistically significant when controlling for differences in the studies."," Neurosurgery 63(4): 741-747; discussion 747.","USA",2008,"Cervical Myelopathy","Surgical","NDI","Unknown","Cost and Resource Use","RCT"]
[354,"Sterling, M., et al. (2009). \"Dry needling and exercise for chronic whiplash - a randomised controlled trial.\" BMC Musculoskelet Disord 10: 160.",null,"Sterling, M., et al.","Dry needling and exercise for chronic whiplash - a randomised controlled trial","BACKGROUND: Chronic whiplash is a common and costly problem. Sensory hypersensitivity is a feature of chronic whiplash that is associated with poor responsiveness to physical treatments such as exercise. Modalities such as dry-needling have shown some capacity to modulate sensory hypersensitivity, suggesting that when combined with advice and exercise, such an approach may be more effective in the management of chronic whiplash. The primary aim of this project is to investigate the effectiveness of dry-needling, advice and exercise for chronic whiplash. METHOD/DESIGN: A double-blind randomised controlled trial will be conducted. 120 participants with chronic whiplash, grade II will be randomised to receive either 1) dry-needling, advice and exercise or 2) sham dry-needling, advice and exercise. All participants will receive an educational booklet on whiplash. Participants who are randomised to Group 1 will receive 6 treatments of combined dry-needling and exercise delivered in the first 3 weeks of the 6 week program, and 4 treatments of exercise only in the last 3 weeks of the program. Participants randomised to Group 2 will receive an identical protocol, except that a sham dry-needling technique will be used instead of dry-needling. The primary outcome measures are the Neck Disability Index (NDI) and participants' perceived recovery. Outcomes will be measured at 6, 12, 24 and 52 weeks after randomization by an assessor who is blind to the group allocation of the participants. In parallel, an economic analysis will be conducted. DISCUSSION: This trial will utilise high quality trial methodologies in accordance with CONSORT guidelines. The successful completion of this trial will provide evidence of the effectiveness and cost-effectiveness of a combined treatment approach for the management of chronic whiplash. TRIAL REGISTRATION: ACTRN12609000470291."," BMC Musculoskelet Disord 10: 160.","Australia",2009,"Trauma","Exercise","NDI","Unknown","PRO study","RCT"]
[355,"Sterling, M., et al. (2012). \"Assessment and validation of prognostic models for poor functional recovery 12 months after whiplash injury: a multicentre inception cohort study.\" Pain 153(8): 1727-1734.",null,"Sterling, M., et al.","Assessment and validation of prognostic models for poor functional recovery 12 months after whiplash injury: a multicentre inception cohort study","Uncertainty surrounds prognostic factors after whiplash injury. Previously we identified a prognostic model for 6-month pain-related disability in a cohort of 80 participants with acute whiplash. Predictors included initial disability, older age, decreased cold pain thresholds, decreased neck rotation movement, posttraumatic stress symptoms and decreased sympathetic vasoconstriction. The objective of this study was to externally validate this model. In a multicentre inception cohort study, 286 participants with acute whiplash (I, II or III) were assessed at <3 weeks and 12 months after injury. The Neck Disability Index (NDI) was the outcome. Observed and predicted NDI scores were generated using the published equation of the original model. Model discrimination between participants with no or mild disability from those with moderate to severe disability was examined by receiver operating characteristic curves. Initial NDI and cold pain threshold predicted current observed 12-month NDI scores (r(2) = 0.50, 95% confidence interval 0.42 to 0.58). There was a significant site effect, and the estimated marginal mean +/- SE of 12-month NDI for Iceland (27.6 +/- 1.79%) was higher than the other 3 sites (Melbourne 11.2 +/- 5.03%, Canada 16.4 +/- 2.36%, Brisbane 16.8 +/- 1.17%). After adjusting for site, age and Impact of Events Scale scores regained significance (r(2) = 0.56, 95% confidence interval 0.48 to 0.64). The tested model was not precise in predicting NDI as a continuous variable. However, it found good accuracy to discriminate participants with moderate to severe disability at 12 months (area under the receiver operating characteristic curve 0.89 [95% confidence interval 0.84-0.94], P<.001) which is clinically useful."," Pain 153(8): 1727-1734.","Australia",2012,"Trauma","Not Specified","NDI","Unknown","PRO study","Observational"]
[356,"Sterling, M., et al. (2015). \"Dry-needling and exercise for chronic whiplash-associated disorders: a randomized single-blind placebo-controlled trial.\" Pain 156(4): 635-643.",null,"Sterling, M., et al.","Dry-needling and exercise for chronic whiplash-associated disorders: a randomized single-blind placebo-controlled trial","This randomized controlled trial investigated the effectiveness and cost-effectiveness of dry-needling and exercise compared with sham dry-needling and exercise for chronic whiplash-associated disorders (WAD). The setting was a single university centre and 4 physiotherapy practices in Queensland, Australia. Eighty patients with chronic WAD (>3 months) were enrolled between June 2009 and August 2012 with 1-year follow-up completed in August 2013. The interventions were 6 weeks of dry-needling to posterior neck muscles (n = 40) and exercise or sham dry-needling and exercise (n = 40). The primary outcomes of the Neck Disability Index (NDI) and self-rated recovery were measured at baseline, 6 and 12 weeks, 6 and 12 months by a blinded assessor. Analysis was intention to treat. An economic evaluation was planned but missing data deemed further analysis unwarranted. Seventy-nine patients (99%) were followed up at 6 weeks, 78 (98%) at 12 weeks, 74 (93%) at 6 months, and 73 (91%) at 12 months. The dry-needling and exercise intervention was more effective than sham dry-needling and exercise in reducing disability at 6 and 12 months but not at 6 and 12 weeks. The treatment effects were small and not clinically worthwhile. At 6 weeks, the treatment effect on the 0-100 NDI was -0.3 (95% confidence interval -5.4 to 4.7), 12 weeks -0.3 (-5.2 to 4.9), 6 months -4.4 (-9.6 to -0.74), and 12 months -3.8 (-9.1 to -0.5). There was no effect for self-rated recovery. In patients with chronic WAD, dry-needling and exercise has no clinically worthwhile effects over sham dry-needling and exercise."," Pain 156(4): 635-643.","Australia",2015,"Trauma","Other,Exercise","NDI","Unknown","Cost-Effectiveness","RCT"]
[357,"Stienen, M. N., et al. (2015). \"Surgical Resident Education in Noninstrumented Lumbar Spine Surgery: A Prospective Observational Study with a 4.5-Year Follow-Up.\" World Neurosurg 84(6): 1589-1597.",null,"Stienen, M. N., et al.","Surgical Resident Education in Noninstrumented Lumbar Spine Surgery: A Prospective Observational Study with a 4.5-Year Follow-Up","OBJECTIVE: To review the outcomes of noninstrumented lumbar spine surgery performed by trainees as primary operators versus the outcomes of surgery performed by board-certified faculty neurosurgeons. METHODS: This prospective observational study involved patients undergoing noninstrumented surgery for lumbar disc herniation or lumbar spinal stenosis with a 4.5-year follow-up. Teaching cases (patients were operated on by neurosurgical residents in training) and nonteaching cases (patients were operated on by board-certified faculty neurosurgeons) were reviewed. Back and leg pain on a visual analog scale, functional disability using the Roland Morris Disability Questionnaire and Oswestry Disability Index, and health-related quality of life (HRQOL) using the 12-Item Short Form Survey and EuroQol 5D were assessed, and reoperations since the index surgery were recorded. RESULTS: Questionnaires were returned by 30 patients operated on by residents and 74 patients operated on by board-certified faculty neurosurgeons. On the 12-Item Short Form Survey physical component scale metric, teaching cases were 70% as likely as nonteaching cases (odds ratio = 0.70, 95% confidence interval = 0.25-1.98, P = 0.585) to achieve a favorable HRQOL response to surgery. Visual analog scale measures of back and leg pain were similar for teaching and nonteaching cases. The same was true for functional disability as measured by the Roland Morris Disability Questionnaire and Oswestry Disability Index and for HRQOL measured by the EuroQol 5D. The reoperation rate 4.5 years after the index surgery was also similar for both groups ( approximately 10% for both groups). CONCLUSIONS: The global outcome, as measured by HRQOL response after a mean follow-up of 4.5 years, was similar for teaching and nonteaching cases. Patients from both groups scored virtually equal results on various pain, functional, and HRQOL metrics, and the reoperation rate was similar."," World Neurosurg 84(6): 1589-1597.","Switzerland",2015,"Degenerative Disk Disease","Surgical","RMDQ,ODI","Unknown","PRO study","Prospective Observation"]
[358,"Stienen, M. N., et al. (2016). \"Influence of Body Mass Index on Subjective and Objective Measures of Pain, Functional Impairment, and Health-Related Quality of Life in Lumbar Degenerative Disc Disease.\" World Neurosurg 96: 570-577.e571.",null,"Stienen, M. N., et al.","Influence of Body Mass Index on Subjective and Objective Measures of Pain, Functional Impairment, and Health-Related Quality of Life in Lumbar Degenerative Disc Disease","OBJECTIVE: To analyze the influence of body mass index (BMI) on subjective and objective measures of pain, functional impairment, and health-related quality of life in patients with lumbar degenerative disc disease undergoing surgery. METHODS: Prospective institutional review board-approved 2-center study, measuring visual analog scale (VAS) back and leg pain, Roland-Morris Disability Index (RMDI), Oswestry Disability Index (ODI), EuroQol 5D questionnaire, and Short Form-12 at baseline, 6 weeks, 6 months, and 1 year postoperatively. T-scores of objective functional impairment (OFI) were determined using the Timed Up and Go (TUG) test. RESULTS: A total of 375 patients with a median BMI of 26.6 kg/m(2) (94 obese patients [BMI >/=30 kg/m(2)]) were included. Obese patients presented more VAS back pain (mean, 4.7 vs. 3.6; P = 0.001) and greater disability on the RMDI (mean, 12.6 vs. 11.3; P = 0.045). The prevalence and severity of OFI were similar in obese and nonobese patients. There was a weak positive correlation between BMI and VAS back pain (r = 0.1552; P = 0.0026), on both RMDI (r = 0.1138; P = 0.0276) and ODI (r = 0.1075; P = 0.0374). There was no correlation between BMI and TUG T-scores (r = 0.0475; P = 0.3585). Obese patients were as likely as nonobese patients to show a positive 6-week treatment response, and the outcome up to 1 year was similar. CONCLUSIONS: BMI positively correlates with VAS back pain, RMDI, and ODI. Standardized TUG T scores reflect the patient's degree of OFI well, irrespective of BMI. The TUG test appears to be a good means to estimate functional impairment in populations with a high prevalence of obesity."," World Neurosurg 96: 570-577.e571.","Switzerland,Australia",2016,"Back Pain","Surgical","RMDQ,ODI","Unknown","PRO study","Prospective Observation"]
[359,"Stienen, M. N., et al. (2017). \"Validation of the baseline severity stratification of objective functional impairment in lumbar degenerative disc disease.\" J Neurosurg Spine 26(5): 598-604.",null,"Stienen, M. N., et al.","Validation of the baseline severity stratification of objective functional impairment in lumbar degenerative disc disease","OBJECTIVE The Timed Up and Go (TUG) test is a simple, objective, and standardized method to measure objective functional impairment (OFI) in patients with lumbar degenerative disc disease (DDD). The objective of the current work was to validate the OFI baseline severity stratification (BSS; with levels of \"none,\" \"mild,\" \"moderate,\" and \"severe\"). METHODS Data were collected in a prospective IRB-approved 2-center study. Patients were assessed with a comprehensive panel of scales for measuring pain (visual analog scale [VAS] for back and leg pain), functional impairment (Roland-Morris Disability Index [RMDI] and Oswestry Disability Index [ODI]), and health-related quality of life (HRQOL; EQ-5D and SF-12). OFI BSS was determined using age- and sex-adjusted cutoff values. RESULTS A total of 375 consecutive patients scheduled for lumbar spine surgery were included. Each 1-step increase on the OFI BSS corresponded to an increase of 0.53 in the back pain VAS score, 0.69 in the leg pain VAS score, 1.81 points in the RMDI, and 5.93 points in the ODI, as well as to a decrease in HRQOL of -0.073 in the EQ-5D, -1.99 in the SF-12 physical component summary (PCS), and -1.62 in the SF-12 mental component summary (MCS; all p < 0.001). Patients with mild, moderate, and severe OFI had increased leg pain by 0.90 (p = 0.044), 1.54 (p < 0.001), and 1.94 (p < 0.001); increased ODI by 7.99 (p = 0.004), 12.64 (p < 0.001), and 17.13 (p < 0.001); and decreased SF-12 PCS by -2.57 (p = 0.049), -3.63 (p = 0.003), and -6.23 (p < 0.001), respectively. CONCLUSIONS The OFI BSS is a valid measure of functional impairment for use in daily clinical practice. The presence of OFI indicates the presence of significant functional impairment on subjective outcome measures."," J Neurosurg Spine 26(5): 598-604.","Switzerland,Australia",2017,"Spine Disease","Surgical","RMDQ,ODI","Unknown","Tool Validation","Prospective Observation"]
[360,"Stone, J. G., et al. (2015). \"Evaluation of Occipitocervical Arthrodesis Rates with Screw-based Fixation and Osteoinductive Fusion Adjuncts.\" J Neurol Surg A Cent Eur Neurosurg 76(5): 361-368.",null,"Stone, J. G., et al.","Evaluation of Occipitocervical Arthrodesis Rates with Screw-based Fixation and Osteoinductive Fusion Adjuncts","Occipitocervical (OC) instability may be associated with neurologic impairment and even death. There is a paucity of research on the rate of arthrodesis utilizing modern screw-based constructs coupled with adjuvant osteoinductive agents. We reviewed our experience with OC constructs and compared the fusion rate, functional outcome, and rate of adverse events between recombinant human bone morphogenetic protein (BMP)-2, autologous iliac crest bone graft (ICBG), a combination of BMP and ICBG, and local bone autograft alone. We performed a retrospective cohort analysis of all adult admissions for operative treatment of OC instability utilizing segmental screw-based constructs for OC arthrodesis between January 2003 and September 2012. Data concerning demographic characteristics, diagnostic and procedural details, radiographic pathology, and clinical course were abstracted from medical records. The primary end point was evidence of stable fixation and osseous union on either dynamic lateral radiographs or computed tomography (CT) imaging at most recent follow-up. Secondary end points included functional outcome as determined by Nurick scale and Neck disability index (NDI) at >/= 1year postoperation, as well as perioperative morbidity and mortality at 30 days and 3 months. During the study period, 94 patients (mean age: 62 +/- 18 years) underwent OC fixation with segmental screw-based constructs. The four fusion adjunct cohorts analyzed included local autograft alone (32%), ICBG (41%), BMP (14%), or a combination of ICBG and BMP (14%). Notably, demineralized bone matrix was also used in 61% of cases overall, but its use did not differ significantly among the four cohorts (p = 0.28). Median radiographic follow-up was 6 months postoperatively (range: 1.5-54 months). Clinical outcomes were assessed at a median postoperative follow-up of 45 months (range: 12-87 months). Overall, radiographic evidence of arthrodesis was present in 83% of patients assessed and was not significantly different between adjunct cohorts (local autograft 92%, ICBG 77%, BMP 88%, and combination of ICBG and BMP 83%; p = 0.79). This finding persisted despite adjustment for age, pathology, number of levels instrumented, and attendant procedures. Importantly, neither the presence of arthrodesis nor fusion adjunct was significantly associated with functional outcome in both univariate and adjusted regression models. Additionally, perioperative adverse events occurred in 23% of cases and did not vary significantly in incidence or severity between fusion adjunct cohorts. We present a large series of patients treated for OC instability with rigid fixation utilizing modern segmental screw-based constructs. The use of adjuvant osteoinductive agents (BMP, ICBG, or a combination) produced equivalent rates of arthrodesis, functional outcome, and adverse events compared with use of local autograft alone."," J Neurol Surg A Cent Eur Neurosurg 76(5): 361-368.","USA",2015,"Unspecified","Surgical","NDI,Nurick","Adults","PRO study","Retrospective review"]
[361,"Stupar, M., et al. (2015). \"Structural and construct validity of the Whiplash Disability Questionnaire in adults with acute whiplash-associated disorders.\" Spine J 15(11): 2369-2377.",null,"Stupar, M., et al.","Structural and construct validity of the Whiplash Disability Questionnaire in adults with acute whiplash-associated disorders","BACKGROUND CONTEXT: Few instruments are available to measure disability associated with whiplash-associated disorders (WAD). The Whiplash Disability Questionnaire (WDQ) was developed to measure disability resulting from WAD, but its validity is unknown for acute WAD. PURPOSE: The aim was to determine the structural and construct validity of the WDQ in individuals with acute WAD. STUDY DESIGN/SETTING: This was a cohort study. PATIENT SAMPLE: Ontario adults with WAD were enrolled within 3 weeks of their motor vehicle collision. OUTCOME MEASURES: The outcome measure was the WDQ. METHODS: We included insurance claimants who were aged 18 years or older and diagnosed with acute WAD Grades I to III. All participants completed the WDQ, a 13-item questionnaire scored from 0 (no disability) to 130 (complete disability). We assessed the factor structure of the WDQ and tested its construct validity against self-perceived recovery, neck pain (Numerical Rating Scale [NRS]), neck disability (Neck Disability Index [NDI] and Neck Bournemouth Questionnaire), health-related quality of life (36-Item Short Form Health Survey [SF-36]), and depressive symptoms (Center for Epidemiologic Studies Depression Scale [CES-D]). RESULTS: The mean age of the 130 participants was 42.1 years (standard deviation [SD]=13.2), and 70% were women. Twenty-six percent had WAD I, 73.1% had WAD II, and 0.8% had WAD III. Mean time since injury was 6.5 days (SD=4.9). The mean WDQ score was 49.8 (SD=29.1). Our analysis suggested that the WDQ includes two factors: daily activities and emotional status. This factor structure remained stable in sensitivity analyses (eg, zeros imputed for missing values, and the item with the most missing values or resulting in complex loading excluded). Strong correlations were found between the total WDQ score and the NDI, the Bournemouth questionnaire, the SF-36 physical function, and the NRS (for the neck, shoulder, mid and low back pain) satisfying a priori hypotheses. We found a priori hypothesized moderate correlations between the WDQ, and the CES-D and SF-36 mental function. CONCLUSIONS: The WDQ includes two factors and has strong construct validity in individuals with acute WAD. Our results demonstrate that the WDQ is valid for use as an overall summative scale or as the daily activities and emotional subscales in clinical and research settings to determine disability status."," Spine J 15(11): 2369-2377.","Canada",2015,"Trauma,Back Pain,Neck Pain","Not Specified","NDI,Bournemouth","Adults","Tool Validation","Observational"]
[362,"Sufka, A., et al. (1998). \"Centralization of low back pain and perceived functional outcome.\" J Orthop Sports Phys Ther 27(3): 205-212.",null,"Sufka, A., et al.","Centralization of low back pain and perceived functional outcome","McKenzie's methods for evaluating and treating low back pain are used often but studied little. When using the McKenzie system, it is important to observe signs of symptom movement to a central location (centralization). This study investigated the relationships between centralization of low back pain and/or radiculopathy and the subjects' rating of functional outcome. Thirty-six subjects with low back pain volunteered to participate and were evaluated and treated by six researchers. Subjects were tested initially and again 14 days after initiation of treatment using the Oswestry Low Back Pain Disability Questionnaire and the Performance Assessment and Capacity Testing Spinal Function Sort (SFS). Symptoms were monitored for the occurrence of \"complete centralization.\" Of the 36 subjects, 25 showed complete centralization within 14 days. The SFS score changes were significantly higher for subjects who completely centralized (p = 0.015). The results supported the hypothesis that subjects who centralize will have improved functional outcome and, thus, quality of life. However, shorter time to occurrence of complete centralization does not necessarily correlate with improved outcome."," J Orthop Sports Phys Ther 27(3): 205-212.","USA",1998,"Back Pain","Not Specified","ODI,SFS","Unknown","Tool Validation","Observational"]
[363,"Sundseth, J., et al. (2017). \"The Norwegian Cervical Arthroplasty Trial (NORCAT): 2-year clinical outcome after single-level cervical arthroplasty versus fusion-a prospective, single-blinded, randomized, controlled multicenter study.\" Eur Spine J 26(4): 1225-1235.",null,"Sundseth, J., et al.","The Norwegian Cervical Arthroplasty Trial (NORCAT): 2-year clinical outcome after single-level cervical arthroplasty versus fusion-a prospective, single-blinded, randomized, controlled multicenter study","PURPOSE: Standard surgical treatment for symptomatic cervical disc disease has been discectomy and fusion, but the use of arthroplasty, designed to preserve motion, has increased, and most studies report clinical outcome in its favor. Few of these trials, however, blinded the patients. We, therefore, conducted the Norwegian Cervical Arthroplasty Trial, and present 2-year clinical outcome after arthroplasty or fusion. METHODS: This multicenter trial included 136 patients with single-level cervical disc disease. The patients were randomized to arthroplasty or fusion, and blinded to the treatment modality. The surgical team was blinded to randomization until nerve root decompression was completed. Primary outcome was the self-rated Neck Disability Index. Secondary outcomes were the numeric rating scale for pain and quality of life questionnaires Short Form-36 and EuroQol-5Dimension-3 Level. RESULTS: There was a significant improvement in the primary and all secondary outcomes from baseline to 2-year follow-up for both arthroplasty and fusion (P < 0.001), and no observed significant between-group differences at any follow-up times. However, linear mixed model analyses, correcting for baseline values, dropouts and missing data, revealed a difference in Neck Disability Index (P = 0.049), and arm pain (P = 0.027) in favor of fusion at 2 years. The duration of surgery was longer (P < 0.001), and the frequency of reoperations higher (P = 0.029) with arthroplasty. CONCLUSION: The present study showed excellent clinical results and no significant difference between treatments at any scheduled follow-up. However, the rate of index level reoperations was higher and the duration of surgery longer with arthroplasty. TRIAL REGISTRATION: http://www.clinicaltrials.gov NCT 00735176.19."," Eur Spine J 26(4): 1225-1235.","Norway",2017,"Degenerative Disk Disease","Surgical","NDI","Unknown","PRO study","RCT"]
[364,"Svensson, E., et al. (2009). \"The Balanced Inventory for Spinal Disorders: the validity of a disease specific questionnaire for evaluation of outcomes in patients with various spinal disorders.\" Spine (Phila Pa 1976) 34(18): 1976-1983.",null,"Svensson, E., et al.","The Balanced Inventory for Spinal Disorders: the validity of a disease specific questionnaire for evaluation of outcomes in patients with various spinal disorders","STUDY DESIGN: A prospective validation study. OBJECTIVE: To validate the Balanced Inventory for Spinal Disorders (BIS), a questionnaire concerning the extent to which pain affects perceived physical health, social life, mental health, and quality of life. The operational definitions of the items and the verbal descriptive scales were compared with corresponding items in the Short-Form 36 (SF-36), European Quality of Life Scale (EQ), and Oswestry Disability Index (ODI). SUMMARY OF BACKGROUND DATA: In validation studies, scales that intend to measure the same variable are compared. METHODS: The SF-36, EQ, ODI, and the BIS were filled in by 101 patients before surgical treatment. The comparisons were analyzed by statistical methods that take account of the nonmetric properties of ordered categorical data to obtain reliable results. The level of order-consistency between BIS and comparing items, when present, was calculated. The Spearman rank-order correlation coefficient was also calculated. RESULTS: In the paired comparisons between the BIS pain scales and the other pain scales about 80% units more pairs were ordered than disordered, and the disorder was explained by the discriminating ability of the BIS back and leg pain items. The BIS and ODI items of limitation in walking were comparable, and the assessments of social limitations on the questionnaires were consistent; the disordered pairs being explained by different coverage of activities in the items. The assessments of physical and mental health on BIS were disordered, with the responses in SF-36 in favor of the BIS type of scale categories. The few items and response categories in the EQ did not discriminate the assessments. CONCLUSION: The BIS assessments can be regarded as being a valid disease-specific questionnaire that provides interpretable information regarding the impact of back end leg pain on well-defined physical, social and mental aspects, and on the quality of life."," Spine (Phila Pa 1976) 34(18): 1976-1983.","Sweden",2009,"Spinal Deformity","Surgical","BIS,ODI","Unknown","PRO study","Prospective Observation"]
[365,"Takeshita, K., et al. (2013). \"Validity, reliability and responsiveness of the Japanese version of the Neck Disability Index.\" J Orthop Sci 18(1999): 14-21.",null,"Takeshita, K., et al.","Validity, reliability and responsiveness of the Japanese version of the Neck Disability Index","BACKGROUND: The Neck Disability Index (NDI) is one of the most widely used questionnaires for neck pain. The purpose of this study was to validate the Japanese NDI. METHODS: We performed two surveys with an 8-week interval in 130 patients with neck pain, radiculopathy and myelopathy. We asked patients to answer two versions of the Japanese NDI: the original NDI, which had been completed by a forward-backward translation procedure, and the modified NDI, which has the phrase \"because of neck pain\" to the phase \"because of neck pain or numbness in the arm.\" The other parameters examined were the strength of pain and numbness, the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire, the Hospital Anxiety and Depression Scale, and Short Form 36. Attending surgeons judged the symptom severity. Patients were asked to report the patient global impression of change (PGIC) at the second survey. The internal consistency, criterion-related and discriminative validity, and reliability were evaluated. RESULTS: The original NDI and the modified NDI were 26.9 +/- 17.1 and 29.9 +/- 15.5, respectively. The Cronbach alpha values of the original NDI and the modified NDI were 0.92 and 0.89, respectively. Both versions of the NDI had good to excellent correlative coefficients with the related domains. The modified NDI had a higher validity for numbness and mental health-related QOL. The symptom severity was significantly correlated with the modified NDI. The intraclass correlation coefficients of the two surveys of the modified and original NDI were comparable. The effect sizes of the modified and the original NDI were 0.64 and 0.55, respectively. Spearman's rho between the change of the NDI and the PGIC was 0.47 in the original NDI and 0.59 in the modified NDI. CONCLUSIONS: We demonstrated the validity, reliability and responsiveness of the Japanese NDI. The modified NDI was more strongly correlated with numbness and mental health-related QOL."," J Orthop Sci 18(1999): 14-21.","Japan",2013,"Cervical Myelopathy,Neck Pain","Not Specified","JOACMEQ,NDI","Unknown","Tool Validation","Observational"]
[366,"Tan, H. Y., et al. (2015). \"A prospective study of percutaneous vertebroplasty for chronic painful osteoporotic vertebral compression fracture.\" Pain Res Manag 20(1999): e8-e11.",null,"Tan, H. Y., et al.","A prospective study of percutaneous vertebroplasty for chronic painful osteoporotic vertebral compression fracture","BACKGROUND: Percutaneous vertebroplasty (PVP) for patients with chronic painful osteoporotic compression fractures has not been extensively studied. OBJECTIVE: To prospectively evaluate the efficacy of PVP for patients with chronic painful osteoporotic vertebral compression fractures (VCFs). METHODS: Sixty-two consecutive patients with chronic painful osteoporotic VCFs for >/=3 months underwent PVP. All procedures were performed under local anesthesia. The outcomes were pain relief at one week, one month, three months, six months and one year, as measured by visual analogue scale, Oswestry Disability Index, Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) and Roland Morris Disability Questionnaire scores. RESULTS: The PVP procedures were technically successful and well tolerated in all patients. Sixty-two patients underwent PVP on 92 vertebrae in 73 procedures three to five days after referral, and no 30-day mortality was observed. Compared with baseline scores, improvement in visual analogue scale, Oswestry Disability Index, QUALEFFO and Roland Morris Disability Questionnaire scores was significantly greater after PVP at one week (P<0.001), one month (P<0.001), three months (P<0.001), six months (P<0.001) and one year (P<0.001), and the number of patients using drugs for pain treatment was significantly reduced. Five new fractures were reported in five of 62 patients treated with PVP during follow-up. CONCLUSION: PVP is effective in patients with chronic painful osteoporotic VCFs. Pain relief after PVP was immediate, was sustained for one year and may be an important factor for reducing persistent pain."," Pain Res Manag 20(1999): e8-e11.","Unknown",2015,"Back Pain","Surgical","RMDQ,ODI","Unknown","PRO study","Prospective Observation"]
[367,"Tanaka, N., et al. (2014). \"An outcome measure for patients with cervical myelopathy: the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ): an average score of healthy volunteers.\" J Orthop Sci 19(1999): 33-48.",null,"Tanaka, N., et al.","An outcome measure for patients with cervical myelopathy: the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ): an average score of healthy volunteers","BACKGROUND: An outcome measure to evaluate the neurological function of patients with cervical myelopathy was proposed by the Japanese Orthopaedic Association (JOA score) and has been widely used in Japan. However, the JOA score does not include patients' satisfaction, disability, handicaps, or general health, which can be affected by cervical myelopathy. In 2007, a new outcome measure, the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ), which is a self-administered questionnaire, was developed. However, the influence of age and gender on the scores has not been fully examined. The purpose of this study was to establish the standard value of the JOACMEQ by age using healthy volunteers. METHODS: This study was conducted in 23 university hospitals and their affiliated hospitals from September to December 2011. The questionnaire included 24 questions for evaluation of physical function of the cervical spine and spinal cord. A total of 1,629 healthy volunteers were recruited for the study. The ages ranged from 20 to 89 years old. RESULTS: The volunteers comprised 798 men and 831 women. In the elderly healthy volunteers, the JOACMEQ scores decreased with age. In general, the scores for cervical spine function and upper/lower extremity function were retained up to the 60s, then decreased in the 70s and 80s. The scores for quality of life were retained up to the 70s; however, the score for bladder function was retained up to the 40s, then declined with age from the 50s to 80s. CONCLUSION: The standard values of the JOACMEQ by age were established. Differences in the scores were found among different generations. Patients with cervical myelopathy should be evaluated with this new self-administered questionnaire taking into account the standard values according to different ages."," J Orthop Sci 19(1999): 33-48.","Japan",2014,"Cervical Myelopathy","Not Specified","JOACMEQ","Elderly","PRO study","Observational"]
[368,"Tavafian, S. S., et al. (2011). \"Treatment of chronic low back pain: a randomized clinical trial comparing multidisciplinary group-based rehabilitation program and oral drug treatment with oral drug treatment alone.\" Clin J Pain 27(9): 811-818.",null,"Tavafian, S. S., et al.","Treatment of chronic low back pain: a randomized clinical trial comparing multidisciplinary group-based rehabilitation program and oral drug treatment with oral drug treatment alone","OBJECTIVE: This randomized clinical trial examined the efficacies of a group-based multidisciplinary rehabilitation program and oral drug treatment versus oral drug treatment alone in Iran. METHODS: A total of 197 patients with chronic low back pain were randomized to either intervention group (n=97) receiving a group-based, 5-session multidisciplinary rehabilitation program plus oral medication or to control group (n=100) receiving just oral medication. At baseline and at 3 and 6-month follow-ups, patients filled out questionnaires on health-related quality of life (36-item Short-form General Health Survey) and disability Questionnaires (Quebec Disability Scale and Ronald-Morris Disability). Repeated measure analysis of variance was used to compare 2 groups during time. RESULTS: The 2 groups were comparable regarding all baseline characteristics (P>0.05). There were significant differences within each group by time in terms of all subscales of 36-item Short-form (P<0.01) except for mental health (P=0.7). Furthermore, there were significant differences between groups in terms of all domains of SF-36 scale except for general health (P=0.06), social function (P=0.08) and role emotional (P=0.7). Furthermore, according to the scores of Ronald-Morris Disability Questionnaire and Quebec Disability Scale, the disability of patients in the intervention group was improved over time significantly (P=0.01 and P<0.0001, respectively). DISCUSSION: The findings revealed that the group-based multidisciplinary program could improve most domains of quality of life in chronic low back pain patients in the 6-month period. However, there were no significant differences between two groups in sub scales such as general health, social function and role emotional."," Clin J Pain 27(9): 811-818.","Iran",2011,"Back Pain","Rehabilitation","RMDQ,QBPD","Unknown","PRO study","RCT"]
[369,"Tavafian, S. S., et al. (2014). \"Treatment of low back pain: randomized clinical trial comparing a multidisciplinary group-based rehabilitation program with oral drug treatment up to 12 months.\" Int J Rheum Dis 17(2): 159-164.",null,"Tavafian, S. S., et al.","Treatment of low back pain: randomized clinical trial comparing a multidisciplinary group-based rehabilitation program with oral drug treatment up to 12 months","BACKGROUND: This study aimed to examine the effects of a multidisciplinary treatment program on health-related quality of life of Iranian patients living with chronic low back, at 12 months follow-up. METHODS: This study is an extended follow-up of an original randomized, controlled trial with registration number NCT00600197. In the present study 87 patients in an intervention group and 91 patients in a control group were assessed at 12 months follow-up. The intervention was a group-based multidisciplinary rehabilitation program which continued by monthly motivational consultation by telephone from 6 to 12 months after intervention. Data from three standard measures, Short Form 36 (SF-36), QDS and RDQ were collected at 3, 6 and 12 months follow-up and analyzed through repeated measures analysis of variance. RESULTS: Despite the similarity between the two groups who completed the 6 month follow-up in terms of all baseline variables, there were significant differences between the two groups in all domains of the SF-36 scale, as well as QDS and RDQ scales (P < 0.05). Also, there were differences within each group over time in the SF-36 domains and disability measurements (P < 0.05). The physical function mean score differed significantly when the interaction between groups and time points was examined (P = 0.02). CONCLUSION: This study indicates that the multidisciplinary program could improve the domains of health related quality of life and disability in chronic low back pain patients up to 12 months."," Int J Rheum Dis 17(2): 159-164.","Iran",2014,"Back Pain","Rehabilitation","QBPD,RMDQ","Unknown","PRO study","RCT"]
[370,"Terran, J., et al. (2013). \"The SRS-Schwab adult spinal deformity classification: assessment and clinical correlations based on a prospective operative and nonoperative cohort.\" Neurosurgery 73(4): 559-568.",null,"Terran, J., et al.","The SRS-Schwab adult spinal deformity classification: assessment and clinical correlations based on a prospective operative and nonoperative cohort","BACKGROUND: The SRS-Schwab classification of adult spinal deformity (ASD) is a validated system that provides a common language for the complex pathology of ASD. Classification reliability has been reported; however, correlation with treatment has not been assessed. OBJECTIVE: To assess the clinical relevance of the SRS-Schwab classification based on correlations with health-related quality of life (HRQOL) measures and the decision to pursue operative vs nonoperative treatment. METHODS: Prospective analysis of consecutive ASD patients (18 years of age and older) collected through a multicenter group. The SRS-Schwab classification includes a curve type descriptor and 3 sagittal spinopelvic modifiers (sagittal vertical axis, pelvic tilt, pelvic incidence/lumbar lordosis mismatch). Differences in demographics, HRQOL (Oswestry Disability Index, SRS-22, Short Form-36), and classification between operative and nonoperative patients were evaluated. RESULTS: A total of 527 patients (mean age, 52.9 years; range, 18.4-85.1 years) met inclusion criteria. Significant differences in HRQOL were identified based on SRS-Schwab curve type, with thoracolumbar and primary sagittal deformities associated with greater disability and poorer health status than thoracic or double curve deformities. Operative patients had significantly poorer grades for each of the sagittal spinopelvic modifiers, and progressively higher grades were associated with significantly poorer HRQOL (P < .05). Patients with worse sagittal spinopelvic modifier grades were significantly more likely to require major osteotomies, iliac fixation, and decompression (P </= .009). CONCLUSION: The SRS-Schwab classification provides a validated language to describe and categorize ASD. This study demonstrates that the SRS-Schwab classification reflects severity of disease state based on multiple measures of HRQOL and significantly correlates with the important decision of whether to pursue operative or nonoperative treatment."," Neurosurgery 73(4): 559-568.","USA",2013,"Spinal Deformity","Surgical","SRS-HRQOL","Adults","PRO study","Prospective Observation"]
[371,"Terrell, J. E., et al. (1997). \"Head and neck cancer-specific quality of life: instrument validation.\" Arch Otolaryngol Head Neck Surg 123(10): 1125-1132.",null,"Terrell, J. E., et al.","Head and neck cancer-specific quality of life: instrument validation","BACKGROUND: The disfigurement and dysfunction associated with head and neck cancer affect emotional well-being and some of the most basic functions of life. Most cancer-specific quality-of-life assessments give a single composite score for head and neck cancer-related quality of life. OBJECTIVE: To develop and evaluate an improved multidimensional instrument to assess head and neck cancer-related functional status and well-being. METHODS: The item selection process included literature review, interviews with health care workers, and patient surveys. A survey with 37 disease-specific questions and the SF-12 survey were administered to 253 patients in 3 large medical centers. Factor analysis was performed to identify disease-specific domains. Domain scores were calculated as the standardized score of the component items. These domains were assessed for construct validity based on clinical hypotheses and test-retest reliability. RESULTS: Four relevant domains were identified: Eating (6 items), Communication (4 items), Pain (4 items), and Emotion (6 items). Each had an internal consistency (Cronbach alpha value) of greater than 0.80. Construct validity was demonstrated by moderate correlations with the SF-12 Physical and Mental component scores (r=0.43-0.60). Test-retest reliability for each domain demonstrated strong reliability between the 2 time points. Correlations were strong for each individual question, ranging from 0.53 to 0.93. Construct validity testing demonstrated that the direction of differences for each domain were as hypothesized. CONCLUSION: The Head and Neck Quality of Life questionnaire is a promising multidimensional tool with which to assess head and neck cancer-specific quality of life."," Arch Otolaryngol Head Neck Surg 123(10): 1125-1132.","USA",1997,"Cancer","Not Specified","HNQOL","Unknown","Tool Validation","Observational"]
[372,"Terrell, J. E., et al. (1998). \"Long-term quality of life after treatment of laryngeal cancer. The Veterans Affairs Laryngeal Cancer Study Group.\" Arch Otolaryngol Head Neck Surg 124(9): 964-971.",null,"Terrell, J. E., et al.","Long-term quality of life after treatment of laryngeal cancer. The Veterans Affairs Laryngeal Cancer Study Group","OBJECTIVE: To assess long-term quality of life in surviving patients with advanced laryngeal cancer. DESIGN: A follow-up long-term quality-of-life survey of patients randomized to the Veterans Affairs Laryngeal Cancer Study No. 268 on induction chemotherapy and radiation (CT + RT) vs surgery and RT. SETTING AND PATIENTS: Forty-six (71%) of the 65 surviving patients with prior stage III or IV laryngeal cancer who could be contacted completed the survey: 25 from the surgery and RT group and 21 from the CT + RT group. Baseline demographic and clinical characteristics among survey respondents were similar, except that those in the CT + RT group were significantly older (mean, 61.2 years) than those in the surgery and RT group (mean, 55.7 years; P<.05). INTERVENTIONS AND MAIN OUTCOME MEASURES: Patients completed the University of Michigan Head and Neck Quality of Life (HNQOL) instrument, the Medical Outcomes Studies Short-Form 36 (SF-36) general health survey, the Beck Depression Inventory as well as smoking and alcohol consumption surveys. RESULTS: Patients randomized to the CT + RT group had significantly better (P<.05) quality-of-life scores on the SF-36 mental health domain (76.0) than the surgery and RT group (63.0), and also had better HNQOL pain scores (81.3 vs 64.3). Compared with patients who underwent laryngectomy, patients with intact larynges (CT + RT with larynx) had significantly less bodily pain (88.5 vs 56.5), better scores on the SF-36 mental health (79.8 vs 64.7), and better HNQOL emotion (89.7 vs 79.4) scores. More patients in the surgery and RT group (28%) were depressed than in the CT + RT group (15%). CONCLUSION: Better quality-of-life scores in the CT + RT groups appear to be related to more freedom from pain, better emotional well-being, and lower levels of depression than to preservation of speech function."," Arch Otolaryngol Head Neck Surg 124(9): 964-971.","USA",1998,"Cancer","Surgical","HNQOL","Adults","PRO study","Observational"]
[373,"Terrell, J. E., et al. (1999). \"Health impact of head and neck cancer.\" Otolaryngol Head Neck Surg 120(6): 852-859.",null,"Terrell, J. E., et al.","Health impact of head and neck cancer","A multidimensional Head and Neck Quality of Life (HNQOL) instrument and a general health status measure were administered to 397 patients with head and neck cancer. Scores for the 4 domains of the HNQOL (communication, eating, pain, and emotional well-being) were calculated. Patient demographics, comorbidities, clinical characteristics, treatment data, disability status, and a global \"overall bother\" score were assessed. When compared with the US population aged 55 to 64 years, the group had significantly worse scores in the 8 health domains of the SF-36. Patients' overall bother scores from the head and neck cancer treatment correlated best with the HNQOL emotion domain (r = 0.71) and the HNQOL pain domain (r = 0.63), and least with the patients' perception of their response to treatment (r = 0.39). Pain, eating, emotion, physical component summary score, age, and an interaction term between eating and emotion were significant predictors for overall bother. Of the 217 patients who were working before the diagnosis of cancer, 74 (34. 1%) reported that they had become disabled. Patients who had more than 1 type of treatment were 5.9 times more likely to report themselves as disabled (odds ratio [OR] = 5.94, P < 0.01), even after adjusting for age, emotion score, and physical component summary score, which were other factors that predicted disability."," Otolaryngol Head Neck Surg 120(6): 852-859.","USA",1999,"Cancer","Not Specified","HNQOL","Adults","PRO study","Retrospective review"]
[374,"Terrell, J. E., et al. (2000). \"Pain, quality of life, and spinal accessory nerve status after neck dissection.\" Laryngoscope 110(4): 620-626.",null,"Terrell, J. E., et al.","Pain, quality of life, and spinal accessory nerve status after neck dissection","OBJECTIVE: To assess quality of life (QOL) in patients with head and neck cancer who underwent neck dissection and to compare QOL scores for patients in whom the spinal accessory nerve (CN XI) was resected or preserved. SETTING AND DESIGN AND OUTCOMES MEASURES: Three hundred ninety-seven patients who had undergone treatment for head and neck cancer completed the University of Michigan Head and Neck Quality of Life (HNQOL) instrument, the Medical Outcomes Study SF-12 General Health Survey, and questions on \"pain despite pain medications\" and headaches. RESULTS: Of the 397 patients, 222 had no neck dissection, 46 had neck dissections resecting CN XI, and 129 had dissection sparing CN XI. Of the latter group, 68 patients had dissections sparing level V and 61 dissections included level V. Age, sex, primary site distribution, and T stage were not different between the groups. Patients who had neck dissections sparing CN XI had better scores on the HNQOL pain domain (P = .002), had less shoulder or neck pain (P = .003), and took pain medications less frequently (P = .0004) compared with patients who had neck dissections sacrificing CN XI. When CN XI was preserved, patients who had no level V dissection had better pain domain scores (P = .03) and eating domain scores (P = .007) on the HNQOL, had less shoulder or neck pain (P = .006), and had less physical problems (P = .03) than patients who had level V dissected. On multivariate analysis, pain-related QOL scores after neck dissection were significantly better (P < .01) if patients had dissections with preservation of CN XI and if level V was not dissected. CONCLUSION: Neck dissections sparing CN XI are associated with better pain scores on the HNQOL, less shoulder and neck pain, and less need for medications. When CN XI is spared, not dissecting level V of the neck is associated with better HNQOL pain scores, less shoulder or neck pain, and fewer physical problems."," Laryngoscope 110(4): 620-626.","USA",2000,"Neck Pain,Cancer","Surgical","HNQOL","Unknown","PRO study","Retrospective review"]
[375,"Terrell, J. E., et al. (2004). \"Clinical predictors of quality of life in patients with head and neck cancer.\" Arch Otolaryngol Head Neck Surg 130(4): 401-408.",null,"Terrell, J. E., et al.","Clinical predictors of quality of life in patients with head and neck cancer","OBJECTIVE: To identify clinical predictors of quality of life (QoL) in a head and neck cancer patient population. DESIGN, PATIENTS, AND SETTING: A convenience sample of 570 patients with upper aerodigestive tract cancers were surveyed at a tertiary care oncology clinic and Veterans Affairs otolaryngology clinic. INTERVENTIONS: A self-administered health survey was constructed to collect demographic, health, smoking, alcohol, depression symptom, and QoL information. Tumor site and tumor stage, clinical, and treatment data were abstracted from the patient medical records. MAIN OUTCOME MEASURES: Quality of life was assessed using the Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36) and the Head and Neck QoL (HNQoL) instrument. RESULTS: Of the 570 eligible respondents, the presence of a feeding tube had the most negative impact on QoL, with significant decrements in 6 of the 8 SF-36 scales and all 4 HNQoL scales (P<.01). In descending order of severity, medical comorbid conditions, presence of a tracheotomy tube, chemotherapy, and neck dissection were also associated with significant (P<.05) decrements in QoL domains. Patients who took the survey more than 1 year after diagnosis had improved QoL in 7 of 12 domains. Hospital site, age, education level, sex, race, and marital status were also significant predictors of QoL. CONCLUSION: There are at least 13 demographic and clinical characteristics that are significant predictors of QoL in patients with head and neck cancer, which should be considered when treating patients and conducting QoL studies in the future."," Arch Otolaryngol Head Neck Surg 130(4): 401-408.","USA",2004,"Cancer","Not Specified","HNQOL","Unknown","PRO study","Observational"]
[376,"Theologis, A. A., et al. (2016). \"Impact of preoperative depression on 2-year clinical outcomes following adult spinal deformity surgery: the importance of risk stratification based on type of psychological distress.\" J Neurosurg Spine 25(4): 477-485.",null,"Theologis, A. A., et al.","Impact of preoperative depression on 2-year clinical outcomes following adult spinal deformity surgery: the importance of risk stratification based on type of psychological distress","OBJECTIVE The objective of this study was to isolate whether the effect of a baseline clinical history of depression on outcome is independent of associated physical disability and to evaluate which mental health screening tool has the most utility in determining 2-year clinical outcomes after adult spinal deformity (ASD) surgery. METHODS Consecutively enrolled patients with ASD in a prospective, multicenter ASD database who underwent surgical intervention with a minimum 2-year follow-up were retrospectively reviewed. A subset of patients who completed the Distress and Risk Assessment Method (DRAM) was also analyzed. The effects of categorical baseline depression and DRAM classification on the Oswestry Disability Index (ODI), SF-36, and Scoliosis Research Society questionnaire (SRS-22r) were assessed using univariate and multivariate linear regression analyses. The probability of achieving >/= 1 minimal clinically important difference (MCID) on the ODI based on the DRAM's Modified Somatic Perceptions Questionnaire (MSPQ) score was estimated. RESULTS Of 267 patients, 66 (24.7%) had self-reported preoperative depression. Patients with baseline depression had significantly more preoperative back pain, greater BMI and Charlson Comorbidity Indices, higher ODIs, and lower SRS-22r and SF-36 Physical/Mental Component Summary (PCS/MCS) scores compared with those without self-reported baseline depression. They also had more severe regional and global sagittal malalignment. After adjusting for these differences, preoperative depression did not impact 2-year ODI, PCS/MCS, or SRS-22r totals (p > 0.05). Compared with those in the \"normal\" DRAM category, \"distressed somatics\" (n = 11) had higher ODI (+23.5 points), lower PCS (-10.9), SRS-22r activity (-0.9), and SRS-22r total (-0.8) scores (p </= 0.01), while \"distressed depressives\" (n = 25) had lower PCS (-8.4) and SRS-22r total (-0.5) scores (p < 0.05). After adjusting for important covariates, each additional point on the baseline MSPQ was associated with a 0.8-point increase in 2-year ODI (p = 0.03). The probability of improving by at least 1 MCID in 2-year ODI ranged from 77% to 21% for MSPQ scores 0-20, respectively. CONCLUSIONS A baseline clinical history of depression does not correlate with worse 2-year outcomes after ASD surgery after adjusting for baseline differences in comorbidities, health-related quality of life, and spinal deformity severity. Conversely, DRAM improved risk stratification of patient subgroups predisposed to achieving suboptimal surgical outcomes. The DRAM's MSPQ was more predictive than MCS and SRS mental domain for 2-year outcomes and may be a valuable tool for surgical screening."," J Neurosurg Spine 25(4): 477-485.","USA",2016,"Spinal Deformity","Surgical","SRS-HRQOL","Unknown","PRO study","Prospective Observation"]
[377,"Thomas, K. C., et al. (2007). \"Outcome evaluation of surgical and nonsurgical management of lumbar disc protrusion causing radiculopathy.\" Spine (Phila Pa 1976) 32(13): 1414-1422.",null,"Thomas, K. C., et al.","Outcome evaluation of surgical and nonsurgical management of lumbar disc protrusion causing radiculopathy","STUDY DESIGN: Prospective cohort study. OBJECTIVE: To assess health-related quality of life (HRQOL) following either lumbar discectomy or nonoperative care for lumbar disc protrusion causing radiculopathy (LDPR). SUMMARY OF BACKGROUND DATA: Although LDPR is a prevalent disorder, little progress has been made in defining the optimal treatment strategy. METHODS: A total of 497 patients (333 in the lumbar discectomy group and 164 in the nonoperative group) were analyzed. Patients completed baseline as well as 6- and 12-month generic (SF-36) and disease-specific (NASS Lumbar Spine Instrument) HRQOL measures. Demographic comparisons between groups, using standard descriptive statistics, were made. Multivariate analysis was used to obtain a regression coefficient for the primary outcome: the neurogenic symptoms score (NSS) from the NASS instrument. Outcome measures were compared between groups and to published normative data. RESULTS: The mean baseline score was lower in the surgical group (30.9 nonoperative, 25.3 surgical), indicative of greater baseline disability. The scores at follow-up were approximately equivalent (44.6 nonoperative, 43.8 surgical). However, neither group returned to an age-matched normative NSS (51.6) within the timeframe of the study. Using regression analysis, the outcome \"change in NSS\" was not associated with variable \"treatment group.\" CONCLUSIONS: HRQOL after LDPR, as measured in this study by NASS NSS, demonstrated similar improvement in both groups and was not meaningfully associated with the treatment received, within the timeframe of this study. At follow-up, all outcome measures remained lower than population normative scores, suggesting that, irrespective of treatment, an element of disability remained."," Spine (Phila Pa 1976) 32(13): 1414-1422.","Canada",2007,"Radiculopathy","Surgical","NASS-L","Unknown","PRO study","Prospective Observation"]
[378,"Tome-Bermejo, F., et al. (2011). \"Identifying patients with chronic low back pain likely to benefit from lumbar facet radiofrequency denervation: a prospective study.\" J Spinal Disord Tech 24(2): 69-75.",null,"Tome-Bermejo, F., et al.","Identifying patients with chronic low back pain likely to benefit from lumbar facet radiofrequency denervation: a prospective study","STUDY DESIGN: Case series. Prospective study. OBJECTIVE: This is a prospective study of a group of patients with chronic low back facet joint pain, meticulously selected using a combination of clinical history, examination, imaging tests, and lumbar facet joint block with a local anesthetic, aimed at assessing the efficacy of treatment with percutaneous rhizolysis in reducing pain and improving related disability. SUMMARY OF BACKGROUND DATA: Percutaneous radiofrequency facet joint denervation (rhizolysis) provides significant alleviation of pain and functional disability in patients with chronic low back pain of facet joint origin. However, accurate patient selection represents a clinical challenge. Patient selection based only on the result of diagnostic blocks may lead to disappointing results as the false-positive rate of the anesthetic diagnostic blocks is reported to be more than 30%. METHODS: A total of 86 patients (mean age, 49.87; mean duration of pain, 7.12 y) finally selected for treatment with rhizolysis were those who presented with chronic lumbar pain and a clinical history and examination with characteristics specific to facet joint pain; whose imaging tests ruled out a possible origin of pain other than the facet joints; and who finally responded favorably to facet joint block with a local lumbar anesthetic. All patients were clinically evaluated according to the indications of the Spanish Society for the Study of Diseases of the Spine (GEER). A follow-up of a minimum of 1 year was conducted. RESULTS: After rhizolysis, lumbar pain, measured by the visual analog scale and the Oswestry Low Back Pain Disability Questionnaire, improved significantly (P<0.05), with the reduction in disability due to lumbar pain being reflected in a notable improvement in the patients' quality of life. A total of 89% of patients experienced significant relief from pain after rhizolysis, with this relief lasting 6 months or more in 66%, and a minimum of 1 year in 50% of cases. At 1 year, 75.67% of patients stated that they would willingly undergo the same treatment again. CONCLUSIONS: Rhizolysis is a valuable tool for the symptomatic treatment of chronic lumbar facet joint pain. A meticulous selection of patients using a combination of clinical history, examination, imaging tests, and lumbar facet joint block with a local anesthetic, achieves long-lasting results by helping reduce the impact on these patients' daily activities."," J Spinal Disord Tech 24(2): 69-75.","Spain",2011,"Back Pain","Not Specified","ODI","Unknown","PRO study","Prospective Observation"]
[379,"Tomkins-Lane, C. C., et al. (2012). \"Changes in objectively measured physical activity (performance) after epidural steroid injection for lumbar spinal stenosis.\" Arch Phys Med Rehabil 93(11): 2008-2014.",null,"Tomkins-Lane, C. C., et al.","Changes in objectively measured physical activity (performance) after epidural steroid injection for lumbar spinal stenosis","OBJECTIVE: To examine changes in objectively measured physical activity (performance) at 1 week following epidural steroid injection for lumbar spinal stenosis. DESIGN: Prospective cohort. SETTING: University spine program. PARTICIPANTS: Individuals (N=17) who were undergoing fluoroscopically guided epidural steroid injection for symptomatic lumbar spinal stenosis (mean age +/- SD, 70.1+/-6.7; 47% women). INTERVENTION: Fluoroscopically guided epidural injection. MAIN OUTCOME MEASURE(S): The 2 primary outcomes, measured with accelerometers, were total activity (performance) measured over 7 days and maximum continuous activity (capacity). Walking capacity was also assessed with the Self-Paced Walking Test, and subjects completed the Oswestry Disability Index, Swiss Spinal Stenosis Questionnaire, Medical Outcomes Study 36-Item Short-Form Health Survey, visual analog pain scales, and body diagrams. RESULTS: At 1 week postinjection, 58.8% of the subjects demonstrated increased total activity and 53% had increased maximum continuous activity, although neither change was statistically significant. Significant improvements were observed in a number of the self-report instruments, including the Physical Function Scale of the Swiss Spinal Stenosis Questionnaire, general health (Medical Outcomes Study 36-Item Short-Form Health Survey), role-limitation emotional (Medical Outcomes Study 36-Item Short-Form Health Survey), leg pain intensity (visual analog pain scales), and presence of leg weakness. CONCLUSIONS: While patients perceived improvements in pain and function following injection, these improvements were not reflected in significant changes in performance or capacity. Future studies will continue to find value in subjective measures of pain and quality of life. However, with modern technology, performance is no longer a subjective variable. Use of activity monitors to objectively measure performance can result in more rigorous validation of treatment effects, while simultaneously highlighting the potential need for additional postinjection rehabilitation aimed at improving performance."," Arch Phys Med Rehabil 93(11): 2008-2014.","Canada",2012,"Spinal Deformity","Rehabilitation","SSSQ,ODI","Unknown","PRO study","Prospective Observation"]
[380,"Tonga, E., et al. (2015). \"Cross-cultural adaptation, reliability and validity of the Turkish version of the spine functional index.\" Health Qual Life Outcomes 13: 30.",null,"Tonga, E., et al.","Cross-cultural adaptation, reliability and validity of the Turkish version of the spine functional index","BACKGROUND: The Spine Functional Index (SFI) is a patient reported outcome measure with sound clinimetric properties and clinical viability for the determination of whole-spine impairment. To date, no validated Turkish version is available. The purpose of this study is to cross-culturally adapted the SFI for Turkish-speaking patients (SFI-Tk) and determine the psychometric properties of reliability, validity and factor structure in a Turkish population with spine musculoskeletal disorders. METHODS: The SFI English version was culturally adapted and translated into Turkish using a double forward and backward method according to established guidelines. Patients (n = 285, cervical = l29, lumbar = 151, cervical and lumbar region = 5, 73% female, age 45 +/- 1) with spine musculoskeletal disorders completed the SFI-Tk at baseline and after a seven day period for test-retest reliability. For criterion validity the Turkish version of the Functional Rating Index (FRI) was used plus the Neck Disability Index (NDI) for cervical patients and the Oswestry Disability Index (ODI) for back patients. Additional psychometric properties were determined for internal consistency (Chronbach's alpha), criterion validity and factor structure. RESULTS: There was a high degree of internal consistency (alpha = 0.85, item range 0.80-0.88) and test-retest reliability (r = 0.93, item range = 0.75-0.95). The factor analysis demonstrated a one-factor solution explaining 24.2% of total variance. Criterion validity with the ODI was high (r = 0.71, p < 0.001) while the FRI and NDI were fair (r = 0.52 and r = 0.58, respectively). The SFI-Tk showed no missing responses with the 'half-mark' option used in 11.75% of total responses by 77.9% of participants. Measurement error from SEM and MDC90 were respectively 2.96% and 7.12%. CONCLUSIONS: The SFI-Tk demonstrated a one-factor solution and is a reliable and valid instrument. The SFI-Tk consists of simple and easily understood wording and may be used to assess spine region musculoskeletal disorders in Turkish speaking patients."," Health Qual Life Outcomes 13: 30.","Turkey,Australia,Spain",2015,"Spinal Deformity","Not Specified","NDI,ODI,SFI","Unknown","Tool Validation","Observational"]
[381,"Torenbeek, M., et al. (2001). \"Current use of outcome measures for stroke and low back pain rehabilitation in five European countries: first results of the ACROSS project.\" Int J Rehabil Res 24(2): 95-101.",null,"Torenbeek, M., et al.","Current use of outcome measures for stroke and low back pain rehabilitation in five European countries: first results of the ACROSS project","Objectives were to obtain a view on the current use of outcome measures for stroke and low back pain rehabilitation in five European countries. A postal questionnaire, comparable for different cultural situations, was distributed in August 1998 to 581 rehabilitation facilities in Ireland, Germany, Italy, Austria and the Netherlands. Of these, 102 settings responded. In stroke rehabilitation the Barthel Index is the dominant outcome measure, followed by the Functional Independence Measure and the Frenchay Activities Index. Besides the Visual Analogue Scale, the most used outcome measures in low back pain rehabilitation were the Oswestry Pain Disability Questionnaire and the Roland Disability Questionnaire. Outcome measures are more frequently used in stroke than in low back pain rehabilitation. The purpose of use is mainly for the measurement of effectiveness, while a relation with quality management is seldom made. There appears to be little agreement on which outcome measures to use. Little attention was found to have been given to the assessment of handicap, quality of life and patient satisfaction."," Int J Rehabil Res 24(2): 95-101.","Netherlands",2001,"Back Pain,Stroke","Rehabilitation","ODI,RMDQ","Unknown","PRO study","Observational"]
[382,"Tschiesner, U., et al. (2008). \"Content comparison of quality of life questionnaires used in head and neck cancer based on the international classification of functioning, disability and health: a systematic review.\" Eur Arch Otorhinolaryngol 265(6): 627-637.",null,"Tschiesner, U., et al.","Content comparison of quality of life questionnaires used in head and neck cancer based on the international classification of functioning, disability and health: a systematic review","The objective of this study is to provide a content comparison of frequently used questionnaires that assess health-related quality of life (hrQOL) in head and neck cancer (HNC) survivors. This systematic content comparison describes which specific areas of hr-QOL research are covered by each questionnaire. Thereby, it shall assist the clinician in the decision process of instrument selection depending on the content of the study question. As a reference, we chose the international classification of functioning, disability and health (ICF), which was adopted by the WHO in 2001. A systematic literature review identified current hrQOL questionnaires relevant for HNC. The concepts of functioning contained in each questionnaire were translated (linked\") to the ICF according to standardized guidelines. Nine questionnaires were selected for further analyses: EORTC-QLQ (C30 + HN35), FACT (G + HN), UW_QOL, QOL-RTI, HN-QOL, PSS-HN, VHI, LORQ, XQ. Within the selected questionnaires, there are 474 concepts, matching 74 second-level ICF categories. The results are presented in tables, showing for each of the validated questionnaires, which of these 74 categories of functioning are addressed. In terms of diversification of content among the questionnaires, there are just eight categories that are used rather frequently and apply to at least five (out of nine) of the questionnaires: e110 Products for personal consumption (i.e., food, drugs), b510 ingestion function, b152 emotional function, b280 sensation of pain, b310 voice, d550 eating, b130 energy and drive function and d850 employment. This ICF-based content comparison provides detailed information on the content that is covered in each questionnaire and thereby assists questionnaire selection. The results question the assumption that HNC-specific questionnaires generally cover the same content. Depending on the study question, the population to be studied and the intervention, there is no unique ideal questionnaire. Compared with other types of qualitative review, the most important advantage of content comparison based on the ICF is the use of an external and independent reference."," Eur Arch Otorhinolaryngol 265(6): 627-637.","Germany",2008,"Cancer","Not Specified","ICF","Unknown","Tool Validation","Systematic review"]
[383,"Tschiesner, U., et al. (2009). \"Assessment of functioning in patients with head and neck cancer according to the International Classification of Functioning, Disability, and Health (ICF): a multicenter study.\" Laryngoscope 119(5): 915-923.",null,"Tschiesner, U., et al.","Assessment of functioning in patients with head and neck cancer according to the International Classification of Functioning, Disability, and Health (ICF): a multicenter study","OBJECTIVES: To assess the level of functioning in patients with head and neck cancer (HNC) using the the International Classification of Functioning, Disability, and Health (ICF). METHODS: Multicenter study at nine different study centers in four European countries. Data collection included structured interviews according to the extended ICF checklist with 145 HNC patients and completion of the European Organization for Research and Treatment of Cancer-Quality of Life Questionnaires (EORTC-QLQ). The generic ICF checklist was extended by additional HNC-specific categories identified in six HNC-specific questionnaires: EORTC, University of Washington Quality of Life (UW-QOL), Functional Assessment of Cancer Therapy scale (FACT), Performance Status Scale for Head and Neck cancer patients (PSS-HN), Head and Neck Quality of Life instrument (HN-QOL), and Voice Handicap Index (VHI). The ICF qualifier system was applied on a scale from 0 (not impaired) to 4 (completely impaired), as well as \"ns, na\" (not specified, not applicable) and \"c\" (impaired due to comorbidity). ICF categories impaired due to HNC (1-4) in > or = 10% of patients were reported. RESULTS: One hundred fifteen (80%) of 144 categories of the extended ICF checklist were identified to be at least mildly impaired or restricted in > or = 10% of patients. The four areas that were relevant to most of the patients were \"immediate family\" (91%), \"friends\" (86%), \"health services and policies\" (85%) and \"health professionals\" (85%), all belonging to the ICF component of environmental factors. The most often identified categories were \"ingestion\" (75%) for body functions and \"speaking\" (76%) for activities and participation. The summary score of all answers correlated well with the overall level of health and quality of life as assessed in the EORTC questionnaires (0.59, 0.61, respectively). CONCLUSIONS: The ICF identifies problems in functioning in patients with HNC comprehensively. The results emphasize the importance of contextual environmental factors. In particular, environmental factors referring to interpersonal support should be more strongly included in rehabilitation plans for HNC."," Laryngoscope 119(5): 915-923.","Germany",2009,"Cancer","Not Specified","ICF","Unknown","PRO study","Clinical trial"]
[384,"Tunwattanapong, P., et al. (2016). \"The effectiveness of a neck and shoulder stretching exercise program among office workers with neck pain: a randomized controlled trial.\" Clin Rehabil 30(1999): 64-72.",null,"Tunwattanapong, P., et al.","The effectiveness of a neck and shoulder stretching exercise program among office workers with neck pain: a randomized controlled trial","OBJECTIVE: To determine the effectiveness of neck and shoulder stretching exercises for relief neck pain among office workers. DESIGN: Randomized controlled trial. SETTING: An outpatient setting. PARTICIPANTS: A total of 96 subjects with moderate-to-severe neck pain (visual analogue score 5/10) for 3 months. INTERVENTIONS: All participants received an informative brochure indicating the proper position and ergonomics to be applied during daily work. The treatment group received the additional instruction to perform neck and around shoulder stretching exercises two times/day, five days/week during four weeks. MAIN OUTCOMES: Pain, neck functions, and quality of life were evaluated at baseline and week 4 using pain visual analogue scale, Northwick Park Neck Pain Questionnaire, and Short Form-36, respectively. RESULTS: Both groups had comparable baseline data. All outcomes were improved significantly from baseline. When compared between groups, the magnitude of improvement was significantly greater in the treatment group than in the control group (-1.4; 95% CI: -2.2, -0.7 for visual analogue scale; -4.8; 95% CI: -9.3, -0.4 for Northwick Park Neck Pain Questionnaire; and 14.0; 95% CI: 7.1, 20.9 for physical dimension of the Short Form-36). Compared with the patients who performed exercises <3 times/week, those who exercised 3 times/week yielded significantly greater improvement in neck function and physical dimension of quality of life scores (p = 0.005 and p = 0.018, respectively). CONCLUSION: A regular stretching exercise program performed for four weeks can decrease neck and shoulder pain and improve neck function and quality of life for office workers who have chronic moderate-to-severe neck or shoulder pain."," Clin Rehabil 30(1999): 64-72.","Thailand",2016,"Neck Pain","Exercise,Education","Northwick","Unknown","PRO study","RCT"]
[385,"Ulrich, N. H., et al. (2015). \"Clinical outcome in lumbar decompression surgery for spinal canal stenosis in the aged population: a prospective Swiss multicenter cohort study.\" Spine (Phila Pa 1976) 40(6): 415-422.",null,"Ulrich, N. H., et al.","Clinical outcome in lumbar decompression surgery for spinal canal stenosis in the aged population: a prospective Swiss multicenter cohort study","STUDY DESIGN: This is a prospective, multicenter cohort study including 8 medical centers in the metropolitan area of the Canton Zurich, Switzerland. OBJECTIVES: To examine whether outcome and quality of life might improve after decompression surgery for degenerative lumbar spinal stenosis (DLSS) even in patients older than 80 years and to compare data with a younger patient population from our own patient collective. SUMMARY AND BACKGROUND DATA: Lumbar decompression surgery without fusion has been shown to improve quality of life in lumbar spinal canal stenosis. In the population older than 80 years, treatment recommendations for DLSS show conflicting results. METHODS: Eight centers in the metropolitan area of Zurich, Switzerland agreed on the classification of DLSS, surgical principles, and follow-up protocols. Patients were followed from baseline, at 6 months, and 12 months. Baseline characteristics were analyzed with 5 different questionnaires \"Spinal Stenosis Measure, Feeling Thermometer, Numeric Rating Scale, 5D-3L, and Roland and Morris Disability Questionnaire.\" In addition, our study population was compared with a younger control group. Furthermore, we calculated the minimal clinically important differences. RESULTS: Thirty-seven patients with an average age of 82.5 +/- 2.5 years reached the 12-month follow-up. Spinal Stenosis Measure scores, the Feeling Thermometer, the Numeric Rating Scale, and the Roland and Morris Disability Questionnaire showed significant improvements at the 6-month and 12-month follow-ups (P < 0.001). One EQ-5D-3Lsubgroup \"anxiety/depression\" showed no significant improvement (P = 0.109) at 12-month follow-up. The minimal clinically important difference for the \"Symptom Severity scale\" in the Spinal Stenosis Measure was achieved with improvement of 70% in the older patient population. CONCLUSION: Patients 80 years or older can expect a clinically meaningful improvement after lumbar decompression for symptomatic DLSS. Our patient population showed significant positive development in quality of life in the short- and long-term follow-ups. LEVEL OF EVIDENCE: 3."," Spine (Phila Pa 1976) 40(6): 415-422.","Switzerland",2015,"Spinal Deformity","Surgical","RMDQ","Adults","PRO study","Prospective Observation"]
[386,"Ulrich, N. H., et al. (2016). \"The impact of incidental durotomy on the outcome of decompression surgery in degenerative lumbar spinal canal stenosis: analysis of the Lumbar Spinal Outcome Study (LSOS) data--a Swiss prospective multi-center cohort study.\" BMC Musculoskelet Disord 17: 170.",null,"Ulrich, N. H., et al.","The impact of incidental durotomy on the outcome of decompression surgery in degenerative lumbar spinal canal stenosis: analysis of the Lumbar Spinal Outcome Study (LSOS) data--a Swiss prospective multi-center cohort study","BACKGROUND: Incidental durotomy is a well-known complication during surgery for degenerative lumbar spinal stenosis (DLSS). In this prospective multicenter cohort study including eight medical centers our aim was to assess whether incidental durotomy during first-time lumbar spinal stenosis decompression surgery without fusion has an impact on long-term outcome. METHODS: Patients of the multi-center Lumbar Stenosis Outcome Study (LSOS) with confirmed DLSS undergoing first-time decompression without fusion were enrolled in this study. Baseline patient characteristics and outcomes were analyzed at 6, 12, and 24 months follow-up respectively with the Spinal Stenosis Measure (SSM), the Numeric Rating Scale (NRS), Feeling Thermometer (FT), the EQ-5D-EL, and the Roland and Morris Disability Questionnaire (RMDQ). RESULTS: A total of 167 patients met the inclusion criteria. Fifteen (9%) of those patients had an incidental durotomy. Baseline characteristics were similar between the durotomy and no-durotomy group. All patients improved over time. In the group of durotomy patients, the median improvement in SSM symptoms scale was 1.1 points at 6 months, 1.1 points at 12 months, and 1.6 points at 24 months after baseline. For the no-durotomy group, these improvements were 0.8, 0.9, and 0.9. For SSM function the improvements were 1.0, 0.8, and 0.9 in the durotomy group, and 0.6, 0.8, and 0.8 in the no-durotomy group. None of the between-group differences were statistically significant. CONCLUSIONS: Incidental durotomy in patients with DLSS undergoing first-time decompression surgery without fusion did not have negative effect on long-term outcome and quality of life. However, only 15 patients were included in the durotomy group but these findings remained even after adjusting for observed differences in baseline characteristics."," BMC Musculoskelet Disord 17: 170.","Switzerland",2016,"Spinal Deformity","Surgical","RMDQ","Unknown","PRO study","Prospective Observation"]
[387,"Upasani, V. V., et al. (2008). \"Does obesity affect surgical outcomes in adolescent idiopathic scoliosis?\" Spine (Phila Pa 1976) 33(3): 295-300.",null,"Upasani, V. V., et al.","Does obesity affect surgical outcomes in adolescent idiopathic scoliosis?","STUDY DESIGN: A retrospective review of surgical outcomes in adolescents with idiopathic scoliosis. OBJECTIVE: To determine if an association exists between body mass and surgical outcomes in adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: Obesity has reached epidemic proportions globally. In adults, obesity increases the likelihood of developing multiple medical comorbidities and has been associated with an increased incidence of perioperative complications. The effect of obesity on surgical outcomes in the treatment of AIS patients has not been studied previously. METHODS: Radiographic measures, perioperative data, and Scoliosis Research Society Outcomes scores were collected on surgically treated AIS patients. The body mass index (BMI) was calculated for each patient and normalized to sex and age (BMI %). Analysis of variance was used to identify differences between healthy weight (BMI % <85) and overweight patients (BMI % >or=85). The data were checked for normality and equal variances, and the level of significance was set at 0.01. RESULTS: Two hundred forty-one patients (204 women, 37 men; 14.3 +/- 2.0 years) with a minimum of 2-year follow-up met the inclusion criteria for this study. The average BMI (kg/m2) was 20.7 +/- 3.7 (BMI % average: 54.5, range: 1-99). No significant differences were found between the overweight (n = 48) and healthy weight (n = 193) patients with regards to surgical time, estimated blood loss, major Cobb percent correction, maintenance of correction, rate of implant failure, pseudarthrosis, and surgical revision. However, the preoperative thoracic kyphosis was significantly greater in the overweight group (27.0 degrees +/- 12.6 degrees) compared with the healthy weight patients (21.8 degrees +/- 12.5 degrees) (P = 0.004). CONCLUSION: Overweight adolescents (BMI % >or=85) had a greater thoracic kyphosis before surgery compared with their healthy weight peers. Body mass, however, did not affect the ability to achieve coronal or sagittal scoliotic deformity correction, and did not increase perioperative morbidity or mortality. These findings were either influenced by the small sample size of this cohort, or because the comorbidities responsible for increased perioperative complications in adults, had not yet developed in this adolescent population."," Spine (Phila Pa 1976) 33(3): 295-300.","USA",2008,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Retrospective review"]
[388,"Vaccaro, A. R., et al. (2013). \"Functional and quality-of-life outcomes in geriatric patients with type-II dens fracture.\" J Bone Joint Surg Am 95(8): 729-735.",null,"Vaccaro, A. R., et al.","Functional and quality-of-life outcomes in geriatric patients with type-II dens fracture","BACKGROUND: Dens fractures are relatively common in the elderly. The treatment of Type-II dens fractures remains controversial. The aim of this multicenter prospective cohort study was to compare outcomes (assessed with use of validated clinical measures) and complications of nonsurgical and surgical treatment of Type-II dens fractures in patients sixty-five years of age or older. METHODS: One hundred and fifty-nine patients with a Type-II dens fracture were enrolled in a multicenter prospective study. Subjects were treated either surgically (n = 101) or nonsurgically (n = 58) as determined by the treatment preferences of the treating physicians and the patients. The subjects were followed at six and twelve months with validated outcome measures, including the Neck Disability Index (NDI) and Short Form-36v2 (SF-36v2). Treatment complications were prospectively recorded. Statistical analysis was performed to compare outcome measures before and after adjustment for confounding variables. RESULTS: The two groups were similar with regard to baseline characteristics. The most common surgical treatment was posterior C1-C2 arthrodesis (eighty of 101, or 79%) while the most common nonsurgical treatment was immobilization with use of a hard collar (forty-seven of fifty-eight, or 81%). The overall mortality rate was 18% over the twelve-month follow-up period. At twelve months, the NDI had increased (worsened) by 14.7 points in the nonsurgical cohort (p < 0.0001) compared with a nonsignificant increase (worsening) of 5.7 points in the surgical group (p = 0.0555). The surgical group had significantly better outcomes as measured by the NDI and SF-36v2 Bodily Pain dimension compared with the nonsurgical group, and these differences persisted after adjustment. There was no difference in the overall rate of complications, but the surgical group had a significantly lower rate of nonunion (5% versus 21% in the nonsurgical group; p = 0.0033). Mortality was higher in the nonsurgical group compared with the surgical group (annual mortality rates of 26% and 14%, respectively; p = 0.059). CONCLUSIONS: We demonstrated a significant benefit with surgical treatment of dens fractures as measured by the NDI, a disease-specific functional outcome measure. As a result of the nonrandomized nature of the study, the results are vulnerable to the effects of possible residual confounding. We recommend that elderly patients with a Type-II dens fracture who are healthy enough for general anesthesia be considered for surgical stabilization to improve functional outcome as well as the union and fusion rates."," J Bone Joint Surg Am 95(8): 729-735.","USA",2013,"Spinal Fracture","Surgical","NDI","Elderly","PRO study","Prospective Observation"]
[389,"Vaidya, R., et al. (2007). \"Complications of anterior cervical discectomy and fusion using recombinant human bone morphogenetic protein-2.\" Eur Spine J 16(8): 1257-1265.",null,"Vaidya, R., et al.","Complications of anterior cervical discectomy and fusion using recombinant human bone morphogenetic protein-2","The use of bone morphogenetic protein-2 (rhBMP-2) in spinal fusion has increased dramatically since an FDA approval for its use in anterior lumbar fusion with the LT cage. There are several reports of its use in transforaminal lumbar interbody fusion, posterolateral fusion, and anterior cervical fusion. Reports on adverse effects of rhBMP-2 when used in spinal fusion are scarce in literature. An Institutional Review Board approved retrospective study was conducted in patients undergoing anterior spinal fusion and instrumentation following diskectomy at a single center. Forty-six consecutive patients were included. Twenty-two patients treated with rhBMP-2 and PEEK cages were compared to 24 in whom allograft spacers and demineralized bone matrix was used. Patients filled out Cervical Oswestry Scores, VAS for arm pain, neck pain, and had radiographs preoperatively as well at every follow up visit. Radiographic examination following surgery revealed end plate resorption in all patients in whom rhBMP-2 was used. This was followed by a period of new bone formation commencing at 6 weeks. In contrast, allograft patients showed a progressive blurring of end plate-allograft junction. Dysphagia was a common complication and it was significantly more frequent and more severe in patients in whom rhBMP-2 was used. Post operative swelling anterior to the vertebral body on lateral cervical spine X-ray was significantly larger in the rhBMP-2 group when measured from 1 to 6 weeks after which it was similar. These effects are possibly due to an early inflammatory response to rhBMP-2 and were observed to be dose related. With the parameters we used, there was no significant difference in the clinical outcome of patients in the two groups at 2 years. The cost of implants in patients treated with rhBMP-2 and PEEK spacers was more than three times the cost of allograft spacers and demineralized bone matrix in 1, 2, and 3-level cases. Despite providing consistently good fusion rates, we have abandoned using rhBMP-2 and PEEK cages for anterior cervical fusion, due to the side effects, high cost, and the availability of a suitable alternative."," Eur Spine J 16(8): 1257-1265.","USA",2007,"Neck Pain,Spinal Fusion","Surgical","Oswestry","Adults","PRO study","Retrospective review"]
[390,"Vakharia, K. T., et al. (2007). \"Quality-of-life impact of participation in a head and neck cancer support group.\" Otolaryngol Head Neck Surg 136(3): 405-410.",null,"Vakharia, K. T., et al.","Quality-of-life impact of participation in a head and neck cancer support group","OBJECTIVE: To assess if participation by patients in a head and neck cancer support group improves perceived quality of life (QOL). STUDY DESIGN AND SETTING: Subjects for this study included 47 patients at a tertiary Veterans Affairs Medical Center who were previously treated for head and neck cancer. This was a quasi-experimental, post-test study comparing the QOL of 24 patients who participated in a head and neck cancer support group with 23 patients who did not participate. The validated University of Michigan Head and Neck Quality of Life (HNQOL) instrument was used to evaluate head and neck cancer-related QOL. RESULTS: Patients who participated in the head and neck cancer support group exhibited significantly better scores in the domains of eating, emotion, and pain as well as in the global bother and response to treatment questions of the HNQOL instrument compared with those patients who did not participate. Additional subgroup analysis comparing age, type of treatment, and length of time since cancer diagnosis suggests that these variables were less important predictors of QOL than was support group participation. CONCLUSIONS: Our findings suggest that patient participation in a head and neck cancer support group is associated with improved QOL. SIGNIFICANCE: Support groups may be beneficial in improving QOL after head and neck cancer treatment."," Otolaryngol Head Neck Surg 136(3): 405-410.","USA",2007,"Cancer","Not Specified","HNQOL","Unknown","PRO study","Prospective Observation"]
[391,"Valasek, T., et al. (2013). \"Reliability and validity study on the Hungarian versions of the oswestry disability index and the Quebec back pain disability scale.\" Eur Spine J 22(5): 1010-1018.",null,"Valasek, T., et al.","Reliability and validity study on the Hungarian versions of the oswestry disability index and the Quebec back pain disability scale","PURPOSE: Patient-reported outcome measurements (PROMs) are widely used in spine care. The development of reliable and valid National versions of spine-related disability questionnaires is strongly recommended from both the clinical and scientific points-of-view. The aims of this study were to adapt and validate the Oswestry Disability Index (ODI) and the Quebec back pain disability scale (QDS) for use with the Hungarian language. METHODS: After translating and culturally adapting the ODI and QDS, 133 patients with lumbar degenerative spinal disorder filled in the questionnaire booklet twice within 2 weeks. Subjects completed the Hungarian versions of the two PROMs as well as the WHOQoL-BREF validated as a general life quality questionnaire and Visual Analogue Scale of pain. Internal consistency, reliability and construct validity of the questionnaires were determined, as were the standard error of measurement (SEM) and minimal detectable change (MDC) scores. RESULTS: The Hungarian ODI consisted of one factor that showed good internal consistency (Cronbach-alpha 0.890). The QDS showed a four-factor structure with Cronbach-alpha values between 0.788 and 0.917. No significant floor or ceiling effects were observed. The test-retest analysis showed excellent reliability of the Hungarian ODI and QDS. The intraclass correlation coefficients (ICC) were 0.927 and 0.923, respectively. SEM values of 4.8 and 5.2 resulted in a MDC of 13 and 14 points in the Hungarian ODI and QDS, respectively. The correlation coefficient (r) between pain and ODI was 0.680 (p < 0.001) and the correlation between the ODI and the physical subscale of WHOQoL was also very good (r = -0.705, p < 0.001). The QDS total score and its four subscales correlated significantly with pain and with the physical subscale of WHOQoL (r > 0.4, p < 0.001). The level of disability measured by the Hungarian ODI and QDS was significantly higher in the surgical subgroup than in non-surgically treated patients (p < 0.001). CONCLUSIONS: Translation and cultural adaptation of the ODI and QDS were successful. Hungarian versions of the ODI and QDS proved to be reliable, valid PROMs confirming that they can be used in future clinical and scientific work with Hungarian-speaking spine patients."," Eur Spine J 22(5): 1010-1018.","Hungary",2013,"Back Pain","Surgical","ODI,QBPD","Unknown","Tool Validation","Observational"]
[392,"van der Roer, N., et al. (2008). \"Economic evaluation of an intensive group training protocol compared with usual care physiotherapy in patients with chronic low back pain.\" Spine (Phila Pa 1976) 33(4): 445-451.",null,"van der Roer, N., et al.","Economic evaluation of an intensive group training protocol compared with usual care physiotherapy in patients with chronic low back pain","STUDY DESIGN: Economic evaluation from a societal perspective conducted alongside a randomized controlled trial with a follow-up of 52 weeks. OBJECTIVE: To evaluate the cost effectiveness and cost utility of an intensive group training protocol compared with usual care physiotherapy in patients with nonspecific chronic low back pain. The intensive group training protocol combines exercise therapy, back school, and behavioral principles. SUMMARY OF BACKGROUND DATA: Two studies found a significant reduction in absenteeism for a graded activity program in occupational health care. This program has not yet been evaluated in a primary care physiotherapy setting. METHODS: Participating physical therapists in primary care recruited 114 patients with chronic nonspecific low back pain. Eligible patients were randomized to either the protocol group or the guideline group. Outcome measures included functional status (Roland Morris Disability Questionnaire), pain intensity (11-point numerical rating scale), general perceived effect and quality of life (EuroQol-5D). Cost data were measured with cost diaries and included direct and indirect costs related to low back pain. RESULTS: After 52 weeks, the direct health care costs were significantly higher for patients in the protocol group, largely due to the costs of the intervention. The mean difference in total costs amounted to [Euro sign] 233 (95% confidence interval: [Euro sign] -2.185; [Euro sign] 2.764). The cost-effectiveness planes indicated no significant differences in cost effectiveness between the 2 groups. CONCLUSION: The results of this economic evaluation showed no difference in total costs between the protocol group and the guideline group. The differences in effects were small and not statistically significant. At present, national implementation of the protocol is not recommended."," Spine (Phila Pa 1976) 33(4): 445-451.","Netherlands",2008,"Back Pain","Exercise","RMDQ","Unknown","Cost-Effectiveness","Clinical trial"]
[393,"van Dulmen, S. A., et al. (2017). \"Patient reported outcome measures (PROMs) for goalsetting and outcome measurement in primary care physiotherapy, an explorative field study.\" Physiotherapy 103(1999): 66-72.",null,"van Dulmen, S. A., et al.","Patient reported outcome measures (PROMs) for goalsetting and outcome measurement in primary care physiotherapy, an explorative field study","OBJECTIVES: Routine use of patient reported outcome measures (PROMs) may provide an effective way of monitoring patient valued outcomes. In this study we explored (1999) the current use of PROMs; (2) to what extent the goals correspond with the selected PROMs; (3) the health outcomes based on PROMs. DESIGN: Observational clinical cohort study. SETTING: Dutch primary care physiotherapy practices (n=43). PARTICIPANTS: Patients (n=299) with neck pain or low back pain. MAIN OUTCOME MEASURES: The number of PROMs used per patient were calculated. The International Classification of Functioning, Disability and Health was used to map the patients' goals and the percentages of PROMS selected that match the domains of the goals were calculated. Health outcomes were assessed using two approaches for estimating the minimal clinically important difference (MCID). RESULTS: Repeated measurements with the Visual Analogue Scale, the Patient Specific Complaints questionnaire, the Quebec Back Pain Disability Scale, or the Neck Disability Index were completed by more than 60% of the patients. The PROMs used matched in 46% of the cases with goals for pain improvement, and in 43% with goals set at activity/participation level. The mean differences between baseline and follow up scores for all PROMs were statistically significant. Improvements of patients based on MCID varied from 57% to 90%. CONCLUSIONS: PROMs were used in the majority of the patients, showed improved health outcomes and fitted moderately with goals. The results of this study can be used for future research assessing the routine use of outcome measurements with PROMs."," Physiotherapy 103(1999): 66-72.","Netherlands",2017,"Back Pain,Neck Pain","Physical Therapy","NDI,QBPD","Unknown","PRO study","Prospective Observation"]
[394,"van Erp, R. M., et al. (2015). \"A biopsychosocial primary care intervention (Back on Track) versus primary care as usual in a subgroup of people with chronic low back pain: protocol for a randomised, controlled trial.\" J Physiother 61(3): 155.",null,"van Erp, R. M., et al.","A biopsychosocial primary care intervention (Back on Track) versus primary care as usual in a subgroup of people with chronic low back pain: protocol for a randomised, controlled trial","INTRODUCTION: Multidisciplinary biopsychosocial interventions are effective at improving functional disability in people with chronic low back pain. However, these interventions are often expensive and have long waiting times before treatment starts. Therefore, implementing biopsychosocial interventions in primary care settings may be of interest. Because people with chronic low back pain show different biopsychosocial profiles, they might respond differently to specific interventions. RESEARCH QUESTIONS: This study will investigate the difference in (cost) effectiveness between a biopsychosocial primary care intervention, Back on Track, and primary care physiotherapy as usual in a subgroup of adults with chronic low back pain. DESIGN: Double-blind, multicentre (n = 8), randomised, controlled trial. PARTICIPANTS: Eighty-six adults with chronic low back pain, aged 18 to 65 years, experiencing low to moderate levels of disability and in whom the contributing role of psychosocial factors to this disability is restricted. INTERVENTION: The Back on Track intervention: four individual and eight group sessions, based on biopsychosocial approaches from multidisciplinary pain rehabilitation programs and provided by trained physiotherapists. CONTROL: Primary care physiotherapy as usual. MEASUREMENTS: The primary outcome is functional disability (Quebec Back Pain Disability Scale) at post treatment, and 3-month and 12-month follow-up. Secondary measures are: credibility and expectancy, anxiety and depression, catastrophising, pain intensity, kinesiophobia, self-efficacy, participant's global perceived effect, cost-effectiveness, and cost-utility estimated with cost diaries and quality-adjusted life years. ANALYSIS: Linear mixed models using an intention-to-treat principle. Incremental cost-effectiveness and cost-utility ratios will be calculated and plotted on a cost-effectiveness plane. DISCUSSION: This study will provide useful information on a biopsychosocial intervention for chronic low back pain in primary care settings."," J Physiother 61(3): 155.","Netherlands",2015,"Back Pain","Psychosocial","QBPD","Adults","Cost-Effectiveness","RCT"]
[395,"van Hoeven, L., et al. (2016). \"Study protocol for a cluster randomized controlled trial to evaluate a referral strategy for axial spondyloarthritis in young primary care patients with chronic low back pain; an impact study.\" BMC Musculoskelet Disord 17: 278.",null,"van Hoeven, L., et al.","Study protocol for a cluster randomized controlled trial to evaluate a referral strategy for axial spondyloarthritis in young primary care patients with chronic low back pain; an impact study","BACKGROUND: Axial spondyloarthritis (axSpA) is a disabling inflammatory joint disease with chronic low back pain (CLBP) as leading symptom. Recognizing axSpA in the large amount of CLBP patients is difficult for general practioners (GP). This evaluation aims to assess the effect of a referral strategy for axSpA in young primary care patients with CLBP by comparing the use of the strategy with usual care. The effect is measured at three different levels; by patient reported outcomes (the clinical effect), process and costs evaluation. METHODS/DESIGN: This study design is a cluster randomized controlled trial with GP as clusters. GPs throughout the Netherlands are invited to participate and randomized to either the intervention or the control group. Patients from participating GPs are invited to participate if they have ever been registered with low back pain, without radiation (ICPC L03) and aged 18-45 years. To be included in the study, patients need to have current low back pain and chronic low back pain (>12 weeks). In the intervention arm a referral strategy for axSpA will be applied in CLBP patients, in the control arm care as usual will be provided for CLBP patients. The referral strategy consists of four easy to use variables. All are questions about the back pain complaints of the patients. Data is prospectively collected in an online database at baseline (T0), 4 months (T1), 12 months (T2) and 24 months (T3). After time point T1 (4 months) patients from the control group will also receive the intervention i.e. the application of a referral strategy for axSpA. The effect of the referral strategy is measured at three different levels, by patient outcomes (e.g. pain scores, quality of life), process measures (e.g. number of axSpA diagnoses by rheumatologists) and by costs (work productivity and health care resources use). Our primary outcome is the Roland Morris Disability Questionnaire after 4 months, secondary outcomes are pain and quality of life. Costs will be assessed before and after the use of the referral strategy, to estimate if the use of the strategy will lead to a reduction in health care costs and improvement in work participation. DISCUSSION: It is anticipated that using the axSpA referral strategy for primary care CLBP patients will increase the quality of life of CLBP patients, will result in more (correct) diagnoses of axSpA by the rheumatologists, and will be cost-effective. Ultimately, the results of this study may contribute to the startup of a national implementation of the axSpA referral strategy to identify timely CLBP patients with axSpA. TRIAL REGISTRATION: NCT01944163 , date of registration; September 6, 2013 (Clinicaltrials.gov)."," BMC Musculoskelet Disord 17: 278.","Netherlands",2016,"Back Pain,Spondylosis","Radiotherapy","RMDQ","Adults","Cost and Resource Use","RCT"]
[396,"van Hooff, M. L., et al. (2010). \"Daily functioning and self-management in patients with chronic low back pain after an intensive cognitive behavioral programme for pain management.\" Eur Spine J 19(9): 1517-1526.",null,"van Hooff, M. L., et al.","Daily functioning and self-management in patients with chronic low back pain after an intensive cognitive behavioral programme for pain management","Chronic low back pain (CLBP) is associated with persistent or recurrent disability which results in high costs for society. Cognitive behavioral treatments produce clinically relevant benefits for patients with CLBP. Nevertheless, no clear evidence for the most appropriate intervention is yet available. The purpose of this study is to evaluate the mid-term effects of treatment in a cohort of patients with CLBP participating in an intensive pain management programme. The programme provided by RealHealth-Netherlands is based on cognitive behavioral principles and executed in collaboration with orthopedic surgeons. Main outcome parameters were daily functioning (Roland and Morris Disability Questionnaire and Oswestry Disability Questionnaire), self-efficacy (Pain Self-Efficacy Questionnaire) and quality of life (Short Form 36 Physical Component Score). All parameters were measured at baseline, last day of residential programme and at 1 and 12 months follow-up. Repeated measures analysis was applied to examine changes over time. Clinical relevance was examined using minimal clinical important differences (MCID) estimates for main outcomes. To compare results with literature effect sizes (Cohen's d) and Standardized Morbidity Ratios (SMR) were determined. 107 patients with CLBP participated in this programme. Mean scores on outcome measures showed a similar pattern: improvement after residential programme and maintenance of results over time. Effect sizes were 0.9 for functioning, 0.8 for self-efficacy and 1.3 for physical functioning related quality of life. Clinical relevancy: 79% reached MCID on functioning, 53% on self-efficacy and 80% on quality of life. Study results on functioning were found to be 36% better and 2% worse when related to previous research on, respectively, rehabilitation programmes and spinal surgery for similar conditions (SMR 136 and 98%, respectively). The participants of this evidence-based programme learned to manage CLBP, improved in daily functioning and quality of life. The study results are meaningful and comparable with results of spinal surgery and even better than results from less intensive rehabilitation programmes."," Eur Spine J 19(9): 1517-1526.","Netherlands",2010,"Back Pain","CBT,Surgical","ODI,RMDQ","Unknown","PRO study","Clinical trial"]
[397,"Vas, J., et al. (2006). \"Efficacy and safety of acupuncture for the treatment of non-specific acute low back pain: a randomised controlled multicentre trial protocol [ISRCTN65814467].\" BMC Complement Altern Med 6: 14.",null,"Vas, J., et al.","Efficacy and safety of acupuncture for the treatment of non-specific acute low back pain: a randomised controlled multicentre trial protocol [ISRCTN65814467]","BACKGROUND: Low back pain and its associated incapacitating effects constitute an important healthcare and socioeconomic problem, as well as being one of the main causes of disability among adults of working age. The prevalence of non-specific low back pain is very high among the general population, and 60-70% of adults are believed to have suffered this problem at some time. Nevertheless, few randomised clinical trials have been made of the efficacy and efficiency of acupuncture with respect to acute low back pain. The present study is intended to assess the efficacy of acupuncture for acute low back pain in terms of the improvement reported on the Roland Morris Questionnaire (RMQ) on low back pain incapacity, to estimate the specific and non-specific effects produced by the technique, and to carry out a cost-effectiveness analysis. METHODS/DESIGN: Randomised four-branch controlled multicentre prospective study made to compare semi-standardised real acupuncture, sham acupuncture (acupuncture at non-specific points), placebo acupuncture and conventional treatment. The patients are blinded to the real, sham and placebo acupuncture treatments. Patients in the sample present symptoms of non specific acute low back pain, with a case history of 2 weeks or less, and will be selected from working-age patients, whether in paid employment or not, referred by General Practitioners from Primary Healthcare Clinics to the four clinics participating in this study. In order to assess the primary and secondary result measures, the patients will be requested to fill in a questionnaire before the randomisation and again at 3, 12 and 48 weeks after starting the treatment. The primary result measure will be the clinical relevant improvement (CRI) at 3 weeks after randomisation. We define CRI as a reduction of 35% or more in the RMQ results. DISCUSSION: This study is intended to obtain further evidence on the effectiveness of acupuncture on acute low back pain and to isolate the specific and non-specific effects of the treatment."," BMC Complement Altern Med 6: 14.","Spain",2006,"Back Pain","Acupuncture","RMDQ","Adults","PRO study","Prospective Observation"]
[398,"Verma, K., et al. (2014). \"International utilization of the SRS-22 instrument to assess outcomes in adolescent idiopathic scoliosis: what can we learn from a medical outreach group in Ghana?\" J Pediatr Orthop 34(5): 503-508.",null,"Verma, K., et al.","International utilization of the SRS-22 instrument to assess outcomes in adolescent idiopathic scoliosis: what can we learn from a medical outreach group in Ghana?","BACKGROUND: Cross-cultural studies on adolescent idiopathic scoliosis (AIS) populations are limited. This study evaluated the discriminate validity of the Scoliosis Research Society Questionnaire (SRS-22) in Ghana between adolescents with and without AIS. SRS-22 outcomes from AIS and normal adolescents in Ghana were also compared with scores from AIS and normal adolescents in America. METHODS: A retrospective review of preoperative SRS-22 questionnaires from Ghana and New York City was completed. In Ghana, 84 adolescents without scoliosis (healthy-G) (32 female adolescents; mean age, 13.3 y) and 61 patients with AIS (AIS-G) (76 female adolescents; mean age, 15.4 y) were administered with the SRS-22 questionnaire. From the New York City, 450 healthy adolescents (healthy-US) (279 female adolescents; mean age, 16 y) and 302 patients with AIS (AIS-US) (227 female adolescents; mean age, 14.9 y) also completed the SRS-22 questionnaire. Patients with curve magnitudes <40 (nonoperative) were then excluded. All 4 groups were matched based on age and sex, resulting in 4 groups of 40 subjects (25 female adolescents; mean age, 14.5 y for all groups). Differences in SRS-22 scores across the groups were analyzed using analysis of variance and analysis of covariance, with the Bonferroni post hoc tests, to control for differences in curve magnitude. RESULTS: Mean curve magnitude for the matched groups was larger for the AIS-G group [67.2 degrees (range, 42 to 130 degrees)] as compared with the AIS-US group [52 degrees (range, 40 to 76 degrees)] (P<0.01). When controlling for the curve magnitude, a significant difference between all 4 study groups was found within all domains and total score (P<0.01). AIS-G displayed significantly lower scores in the activity, image, pain, and mental health domains (P<0.01); this reached the minimal clinically importance difference for these domains. Healthy-US and healthy-G had better overall and domain-specific scores than AIS-US and AIS-G, respectively (P<0.05). CONCLUSIONS: These findings illustrate the affect of AIS within a culture as well as across cultures. Healthy adolescents had significantly better scores than scoliotic adolescents. Ghanaian adolescents had significantly worse Health-Related Quality-of-Life scores than American adolescents, especially those suffering from AIS. These differences should be kept in mind by those treating this already emotionally vulnerable adolescent population. LEVEL OF EVIDENCE: Level II Prognostic."," J Pediatr Orthop 34(5): 503-508.","USA",2014,"Spinal Deformity","Not Specified","SRS-HRQOL","Adolescents","PRO study","Retrospective review"]
[399,"Vitale, M. G., et al. (2010). \"Development and initial validation of a disease specific outcome measure for early onset scoliosis.\" Stud Health Technol Inform 158: 172-176.",null,"Vitale, M. G., et al.","Development and initial validation of a disease specific outcome measure for early onset scoliosis","INTRODUCTION: Treatment of children with early onset scoliosis (EOS) seeks to improve natural history and health related quality of life (QOL). QOL measurement presents a significant challenge given the young age, comorbidities, and heterogeneity of this population. OBJECTIVE: To develop a disease specific measure reflecting issues of importance to EOS patients and caretakers. MATERIALS AND METHODS: Review of the literature and relevant measures informed development of semi-structured qualitative interviews. Interviews of caregivers of EOS patients were interpreted through the framework technique. A master-list of 75-items was created and responses were scaled on a 5-point Likert-scale. Psychometric analysis was performed to group items into domains, to maintain score distribution, to create a responsive instrument, and to identify question redundancy. RESULTS: Content validation revealed 8-items with low content validity indices. Item distribution analysis demonstrated 19-items with skewed distribution. Item reliability demonstrated redundant items within domains (r> or =0.5). Construct validity demonstrated unique domains measuring intended issues of interest. The resulting Early Onset Scoliosis Questionnaire (EOSQ) includes 33-items in 13-domains: General Health, Pain, Physical Function, Pulmonary Function, Daily Living, Fatigue, Emotion, Surgical Concerns, Satisfaction, Transfer, Financial Burden, Parental Burden, and Treatment Outcomes. CONCLUSION: The EOSQ reflects QOL and caregiver burden in the EOS population. The EOSQ will expand options for outcome assessment in this unique population."," Stud Health Technol Inform 158: 172-176.","USA",2010,"Spinal Deformity","Surgical","EOSQ","Infants","Tool Validation","Observational"]
[400,"Vollenbroek-Hutten, M. M., et al. (2004). \"Differences in outcome of a multidisciplinary treatment between subgroups of chronic low back pain patients defined using two multiaxial assessment instruments: the multidimensional pain inventory and lumbar dynamometry.\" Clin Rehabil 18(5): 566-579.",null,"Vollenbroek-Hutten, M. M., et al.","Differences in outcome of a multidisciplinary treatment between subgroups of chronic low back pain patients defined using two multiaxial assessment instruments: the multidimensional pain inventory and lumbar dynamometry","OBJECTIVE: To investigate the effects of a multidisciplinary back school programme (Roessingh Back Rehabilitation Programme, RRP) compared with usual care, as well as differences in treatment outcome between subgroups defined using two multiaxial assessment instruments: the Multidimensional Pain Inventory (MPI-DLV) and lumbar dynamometry. DESIGN: Randomized controlled trial. SETTING: Rehabilitation. SUBJECTS: One hundred and sixty-three patients with chronic, aspecific low back pain. INTERVENTION: All subjects were randomly assigned either to a multidisciplinary, physically oriented group treatment or to their usual care. MAIN OUTCOME MEASURES: The Roland Disability Questionnaire and health-related quality of life (EuroQol, EQ5-D) were measured as primary outcomes before randomization and after eight weeks and six months follow-up. RESULT: Only 30-50% of the patients in the RRP group showed improvement and this number is not significantly different from the control group. Subgroup analyses give some first indications that multiaxial measurement instruments can be used to identify subgroups with differences in treatment effects. CONCLUSION: The overall effect of a multidisciplinary treatment is disappointing, however multiaxial assessment before admission might be valuable in clinical practice, resulting in more effective treatments for patients with chronic low back pain."," Clin Rehabil 18(5): 566-579.","Netherlands",2004,"Back Pain","Physical Therapy","RMDQ","Unknown","PRO study","Clinical trial"]
[401,"Wand, B. M., et al. (2004). \"Early intervention for the management of acute low back pain: a single-blind randomized controlled trial of biopsychosocial education, manual therapy, and exercise.\" Spine (Phila Pa 1976) 29(21): 2350-2356.",null,"Wand, B. M., et al.","Early intervention for the management of acute low back pain: a single-blind randomized controlled trial of biopsychosocial education, manual therapy, and exercise","STUDY DESIGN: A single blind randomized controlled trial comparing two models of care for patients with acute simple low back pain. OBJECTIVES: To compare two research-based models of care for acute low back pain and investigate the effect of the timing of physical intervention. SUMMARY OF BACKGROUND DATA: National guidelines offer conflicting information on the delivery of physical treatment in the management of acute low back pain. The guidelines suggest two different models of care. Direct comparisons between these models are lacking in the literature. The present study aims to compare these approaches to the management of acute low back pain. METHODS: Among 804 referred patients, 102 subjects met the specific admission criteria and were randomly assigned to an \"assess/advise/treat\" group or an \"assess/advise/wait\" group. The intervention consisted of biopsychosocial education, manual therapy, and exercise. Assessment of short-term outcome enables comparison to be made between intervention and advice to stay active. Assessment of long-term outcome enables comparison to be made between early and late intervention. Study outcomes of reported pain (Visual Analogue Scale), functional disability (the Roland and Morris Disability Questionnaire), mood (Modified Zung Self Rated Depression Score, Modified Somatic Perception Questionnaire, State-Trait Anxiety Inventory), general health (Euroqol), and quality of life (Short Form 36) were assessed at baseline, 6 weeks, 3 months, and 6 months. RESULTS: At 6 weeks, the assess/advise/treat group demonstrated greater improvements in disability, mood, general health, and quality of life than patients in the assess/advise/wait group (P < 0.05). Disability and pain were not significantly different between the groups at long-term follow up (P > 0.05). However, mood, general health, and quality of life remained significantly better in the assess/advise/treat group (P < 0.05). CONCLUSIONS: At short-term, intervention is more effective than advice on staying active, leading to more rapid improvement in function, mood, quality of life, and general health. The timing of intervention affects the development of psychosocial features. If treatment is provided later, the same psychosocial benefits are not achieved. Therefore, an assess/advise/treat model of care seems to offer better outcomes than an assess/advise/wait model of care."," Spine (Phila Pa 1976) 29(21): 2350-2356.","Australia",2004,"Back Pain","Exercise","RMDQ","Unknown","PRO study","RCT"]
[402,"Wang, C., et al. (2009). \"Effect of preoperative brace treatment on quality of life in adolescents with idiopathic scoliosis following corrective surgery.\" Orthopedics 32(8).",null,"Wang, C., et al.","Effect of preoperative brace treatment on quality of life in adolescents with idiopathic scoliosis following corrective surgery","Bracing is frequently used for the treatment of adolescent idiopathic scoliosis. Such treatment is not always effective, and corrective surgery may be warranted. Brace treatment has been suggested to negatively affect quality of life. This study assessed postoperative quality of life and surgical outcome in Chinese patients with adolescent idiopathic scoliosis and failed brace treatment. Ninety-four patients with adolescent idiopathic scoliosis who underwent simple posterior corrective surgery and pedicle screw fixation were studied. The patients were divided into 2 groups: brace and surgery treatment (BS group) and surgery with no brace treatment (S group). Radiological parameters were assessed preoperatively, immediately postoperatively, and >2 years postoperatively. Postoperative quality of life was determined using the Scoliosis Research Society-22 (SRS-22) questionnaire. The preoperative minor curve Cobb angle was significantly greater in the BS group (34.9 degrees vs 29.4 degrees ; P=.037). Postoperative radiological parameters in the coronal and sagittal planes were similar. There were a significantly higher number of fused vertebrae in BS compared to S group patients (10.3 vs 9.6; P=.044). There were no significant postoperative differences between groups in function/activity, pain, mental health, or satisfaction of management as determined by the SRS-22. Self-image/appearance scores were significantly higher in BS compared to S group patients (4.0 vs 3.8; P=.010). Preoperative brace treatment may be a risk factor for minor curve progression but does not appear to significantly influence surgical outcome. Postoperative self-perceived quality of life is not negatively affected by preoperative brace treatment."," Orthopedics 32(8).","China",2009,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Prospective Observation"]
[403,"Warke, K., et al. (2006). \"Efficacy of transcutaneous electrical nerve stimulation (tens) for chronic low-back pain in a multiple sclerosis population: a randomized, placebo-controlled clinical trial.\" Clin J Pain 22(9): 812-819.",null,"Warke, K., et al.","Efficacy of transcutaneous electrical nerve stimulation (tens) for chronic low-back pain in a multiple sclerosis population: a randomized, placebo-controlled clinical trial","OBJECTIVE: This study was designed to investigate the hypoalgesic effects of self-applied transcutaneous electrical nerve stimulation (TENS) on chronic low-back pain (LBP) in a multiple sclerosis (MS) population. METHODS: Ninety participants with probable or definite MS (aged 21 to 78 y) presenting with chronic LBP were recruited and randomized into 3 groups (n=30 per group): (1999) low-frequency TENS group (4 Hz, 200 micros); (2) high-frequency TENS group (110 Hz, 200 micros); and (3) placebo TENS. Participants self-applied TENS for 45 minutes, a minimum of twice daily, for 6 weeks. Outcome measures were recorded at weeks 1, 6, 10, and 32. Primary outcome measures included: Visual Analog Scale for average LBP and the McGill Pain Questionnaire. Secondary outcome measures included: Visual Analog Scale for worst and weekly LBP, back and leg spasm; Roland Morris Disability Questionnaire; Barthel Index; Rivermead Mobility Index; Multiple Sclerosis Quality of Life-54 Instrument, and a daily logbook. Data were analyzed blind using parametric and nonparametric tests, as appropriate. RESULTS: Results indicated a statistically significant interactive effect between groups for average LBP (P=0.008); 1-way analysis of covariance did not show any significant effects at any time point once a Bonferonni correction was applied (P>0.05). However, clinically important differences were observed in some of the outcome measures in both active treatment groups during the treatment and follow-up periods. DISCUSSION: Although not statistically significant, the observed effects may have implications for the clinical prescription and the use of TENS within this population."," Clin J Pain 22(9): 812-819.","UK",2006,"Back Pain","Physical Therapy","RMDQ","Unknown","PRO study","RCT"]
[404,"Werner, E. L., et al. (2016). \"Cognitive Patient Education for Low Back Pain in Primary Care: A Cluster Randomized Controlled Trial and Cost-Effectiveness Analysis.\" Spine (Phila Pa 1976) 41(6): 455-462.",null,"Werner, E. L., et al.","Cognitive Patient Education for Low Back Pain in Primary Care: A Cluster Randomized Controlled Trial and Cost-Effectiveness Analysis","STUDY DESIGN: A pragmatic cluster randomized controlled trial in primary care. OBJECTIVE: The aim of this study was to estimate the clinical effectiveness and cost-effectiveness of a cognitive-based education program on patients with subacute or chronic low back pain (LBP) in primary care, compared to usual treatment, provided by general practitioners (GP) and physiotherapists (PT). SUMMARY OF BACKGROUND DATA: Patient education has been reported to have a favorable effect on patients with chronic musculoskeletal disorders. In this study, an \"Explain Pain\" model was adapted to fit into an ordinary clinical setting in Norwegian primary care. METHODS: Sixteen GPs and 20 PTs participated in the study and a total of 216 patients were recruited. The GPs and PTs were randomly assigned to provide either a cognitive patient education or usual treatment. All patients in both groups were provided with four consultations of 30 min with their provider during the study. In the intervention group the patients were educated according to a specific manual written for the purpose of this study. RESULTS: Eighty-one percent responded at 4-week, and 68% at the 12-month follow-up. There was a substantial improvement in function, pain, and sick leave in both groups. After 4 weeks the intervention group scored 0.51 RMDQ points lower than the control group (Beta -0.506 [95% CI -1.76-0.75]). After 12 months the intervention group scored 0.66 RMDQ points higher than the control group (Beta 0.66 [95% CI -0.56-1.88]). There was no significant difference in QALYs in the two treatment groups; the estimated difference was 0.005 (-0.016-0.027) in favor of the intervention. CONCLUSION: This study showed no clinical or health economic benefits as a result of adding a cognitive education program to usual treatment for patients with subacute and chronic LBP. Potential weaknesses such as a long recruiting period and potentially low compliance with the cognitive intervention warrant a careful interpretation of the results."," Spine (Phila Pa 1976) 41(6): 455-462.","Norway",2016,"Back Pain","CBT","RMDQ","Unknown","Cost-Effectiveness","RCT"]
[405,"Whitehurst, D. G., et al. (2007). \"A brief pain management program compared with physical therapy for low back pain: results from an economic analysis alongside a randomized clinical trial.\" Arthritis Rheum 57(3): 466-473.",null,"Whitehurst, D. G., et al.","A brief pain management program compared with physical therapy for low back pain: results from an economic analysis alongside a randomized clinical trial","OBJECTIVE: Guidelines for the management of acute low back pain in primary care recommend early intervention to address psychosocial risk factors associated with long-term disability. We assessed the cost utility and cost effectiveness of a brief pain management program (BPM) targeting psychosocial factors compared with physical therapy (PT) for primary care patients with low back pain of <12 weeks' duration. METHODS: A total of 402 patients were randomly assigned to BPM or PT. We adopted a health care perspective, examining the direct health care costs of low back pain. Outcome measures were quality-adjusted life years (QALYs) and 12-month change scores on the Roland and Morris disability questionnaire. Resource use data related to back pain were collected at 12-month followup. Cost effectiveness was expressed as incremental ratios, with uncertainty assessed using cost-effectiveness planes and acceptability curves. RESULTS: There were no statistically significant differences in mean health care costs or outcomes between treatments. PT had marginally greater effectiveness at 12 months, albeit with greater health care costs (BPM 142 pounds, PT 195 pounds). The incremental cost-per-QALY ratio was 2,362 pounds. If the UK National Health Service were willing to pay 10,000 pound per additional QALY, there is only a 17% chance that BPM provides the best value for money. CONCLUSION: PT is a cost-effective primary care management strategy for low back pain. However, the absence of a clinically superior treatment program raises the possibility that BPM could provide an additional primary care approach, administered in fewer sessions, allowing patient and doctor preferences to be considered."," Arthritis Rheum 57(3): 466-473.","UK",2007,"Back Pain","Physical Therapy","RMDQ","Adults","Cost-Effectiveness","RCT"]
[406,"Whitfill, T., et al. (2010). \"Early intervention options for acute low back pain patients: a randomized clinical trial with one-year follow-up outcomes.\" J Occup Rehabil 20(2): 256-263.",null,"Whitfill, T., et al.","Early intervention options for acute low back pain patients: a randomized clinical trial with one-year follow-up outcomes","INTRODUCTION: In an earlier study, Gatchel et al. (J Occup Rehabil 13:1-9, 2003) demonstrated that participants at high risk for developing chronic low back pain disability (CLBPD), who received a biopsychosocial early intervention treatment program, displayed significantly more symptom improvement, as well as cost savings, relative to participants receiving standard care. The purpose of the present study was to expand on these results by examining whether the addition of a work-transition component would further strengthen the effectiveness of this early intervention treatment. METHODS: Using an existing algorithm, participants were identified as being high-risk (HR) or low-risk (LR) for developing CLBPD. HR participants were then randomly assigned to one of three groups: early intervention (EI); early intervention with work transition (EI/WT); or standard care (SC). Participants provided information regarding pain, disability, work status, and psychosocial functioning at baseline, periodically during treatment, and again 1 year following completion of treatment. RESULTS: At 1-year follow-up, no significant differences were found between the EI and EI/WT groups in terms of occupational status, self-reports of pain and disability, coping ability or psychosocial functioning. However, significant differences in all these outcomes were found comparing these groups to standard care. CONCLUSION: The addition of a work transition component to an early intervention program for the treatment of ALBP did not significantly contribute to improved work outcomes. However, results further support the effectiveness of early intervention for high-risk ALBP patients."," J Occup Rehabil 20(2): 256-263.","USA",2010,"Back Pain","Psychosocial","Aberdeen LBP","Unknown","PRO study","RCT"]
[407,"Wieland, L. S., et al. (2017). \"Yoga treatment for chronic non-specific low back pain.\" Cochrane Database Syst Rev 1: Cd010671.",null,"Wieland, L. S., et al.","Yoga treatment for chronic non-specific low back pain","BACKGROUND: Non-specific low back pain is a common, potentially disabling condition usually treated with self-care and non-prescription medication. For chronic low back pain, current guidelines state that exercise therapy may be beneficial. Yoga is a mind-body exercise sometimes used for non-specific low back pain. OBJECTIVES: To assess the effects of yoga for treating chronic non-specific low back pain, compared to no specific treatment, a minimal intervention (e.g. education), or another active treatment, with a focus on pain, function, and adverse events. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, five other databases and four trials registers to 11 March 2016 without restriction of language or publication status. We screened reference lists and contacted experts in the field to identify additional studies. SELECTION CRITERIA: We included randomized controlled trials of yoga treatment in people with chronic non-specific low back pain. We included studies comparing yoga to any other intervention or to no intervention. We also included studies comparing yoga as an adjunct to other therapies, versus those other therapies alone. DATA COLLECTION AND ANALYSIS: Two authors independently screened and selected studies, extracted outcome data, and assessed risk of bias. We contacted study authors to obtain missing or unclear information. We evaluated the overall certainty of evidence using the GRADE approach. MAIN RESULTS: We included 12 trials (1080 participants) carried out in the USA (seven trials), India (three trials), and the UK (two trials). Studies were unfunded (one trial), funded by a yoga institution (one trial), funded by non-profit or government sources (seven trials), or did not report on funding (three trials). Most trials used Iyengar, Hatha, or Viniyoga forms of yoga. The trials compared yoga to no intervention or a non-exercise intervention such as education (seven trials), an exercise intervention (three trials), or both exercise and non-exercise interventions (two trials). All trials were at high risk of performance and detection bias because participants and providers were not blinded to treatment assignment, and outcomes were self-assessed. Therefore, we downgraded all outcomes to 'moderate' certainty evidence because of risk of bias, and when there was additional serious risk of bias, unexplained heterogeneity between studies, or the analyses were imprecise, we downgraded the certainty of the evidence further.For yoga compared to non-exercise controls (9 trials; 810 participants), there was low-certainty evidence that yoga produced small to moderate improvements in back-related function at three to four months (standardized mean difference (SMD) -0.40, 95% confidence interval (CI) -0.66 to -0.14; corresponding to a change in the Roland-Morris Disability Questionnaire of mean difference (MD) -2.18, 95% -3.60 to -0.76), moderate-certainty evidence for small to moderate improvements at six months (SMD -0.44, 95% CI -0.66 to -0.22; corresponding to a change in the Roland-Morris Disability Questionnaire of MD -2.15, 95% -3.23 to -1.08), and low-certainty evidence for small improvements at 12 months (SMD -0.26, 95% CI -0.46 to -0.05; corresponding to a change in the Roland-Morris Disability Questionnaire of MD -1.36, 95% -2.41 to -0.26). On a 0-100 scale there was very low- to moderate-certainty evidence that yoga was slightly better for pain at three to four months (MD -4.55, 95% CI -7.04 to -2.06), six months (MD -7.81, 95% CI -13.37 to -2.25), and 12 months (MD -5.40, 95% CI -14.50 to -3.70), however we pre-defined clinically significant changes in pain as 15 points or greater and this threshold was not met. Based on information from six trials, there was moderate-certainty evidence that the risk of adverse events, primarily increased back pain, was higher in yoga than in non-exercise controls (risk difference (RD) 5%, 95% CI 2% to 8%).For yoga compared to non-yoga exercise controls (4 trials; 394 participants), there was very-low-certainty evidence for little or no difference in back-related function at three months (SMD -0.22, 95% CI -0.65 to 0.20; corresponding to a change in the Roland-Morris Disability Questionnaire of MD -0.99, 95% -2.87 to 0.90) and six months (SMD -0.20, 95% CI -0.59 to 0.19; corresponding to a change in the Roland-Morris Disability Questionnaire of MD -0.90, 95% -2.61 to 0.81), and no information on back-related function after six months. There was very low-certainty evidence for lower pain on a 0-100 scale at seven months (MD -20.40, 95% CI -25.48 to -15.32), and no information on pain at three months or after seven months. Based on information from three trials, there was low-certainty evidence for no difference in the risk of adverse events between yoga and non-yoga exercise controls (RD 1%, 95% CI -4% to 6%).For yoga added to exercise compared to exercise alone (1 trial; 24 participants), there was very-low-certainty evidence for little or no difference at 10 weeks in back-related function (SMD -0.60, 95% CI -1.42 to 0.22; corresponding to a change in the Oswestry Disability Index of MD -17.05, 95% -22.96 to 11.14) or pain on a 0-100 scale (MD -3.20, 95% CI -13.76 to 7.36). There was no information on outcomes at other time points. There was no information on adverse events.Studies provided limited evidence on risk of clinical improvement, measures of quality of life, and depression. There was no evidence on work-related disability. AUTHORS' CONCLUSIONS: There is low- to moderate-certainty evidence that yoga compared to non-exercise controls results in small to moderate improvements in back-related function at three and six months. Yoga may also be slightly more effective for pain at three and six months, however the effect size did not meet predefined levels of minimum clinical importance. It is uncertain whether there is any difference between yoga and other exercise for back-related function or pain, or whether yoga added to exercise is more effective than exercise alone. Yoga is associated with more adverse events than non-exercise controls, but may have the same risk of adverse events as other back-focused exercise. Yoga is not associated with serious adverse events. There is a need for additional high-quality research to improve confidence in estimates of effect, to evaluate long-term outcomes, and to provide additional information on comparisons between yoga and other exercise for chronic non-specific low back pain."," Cochrane Database Syst Rev 1: Cd010671.","USA,Germany,UK",2017,"Back Pain","Yoga","RMDQ,ODI","Unknown","PRO study","Systematic review"]
[408,"Wilkens, P., et al. (2010). \"Effect of glucosamine on pain-related disability in patients with chronic low back pain and degenerative lumbar osteoarthritis: a randomized controlled trial.\" Jama 304(1999): 45-52.",null,"Wilkens, P., et al.","Effect of glucosamine on pain-related disability in patients with chronic low back pain and degenerative lumbar osteoarthritis: a randomized controlled trial","CONTEXT: Chronic low back pain (LBP) with degenerative lumbar osteoarthritis (OA) is widespread in the adult population. Although glucosamine is increasingly used by patients with chronic LBP, little is known about its effect in this setting. OBJECTIVE: To investigate the effect of glucosamine in patients with chronic LBP and degenerative lumbar OA. DESIGN, SETTING, AND PARTICIPANTS: A double-blind, randomized, placebo-controlled trial conducted at Oslo University Hospital Outpatient Clinic, Oslo, Norway, with 250 patients older than 25 years of age with chronic LBP (>6 months) and degenerative lumbar OA. INTERVENTIONS: Daily intake of 1500 mg of oral glucosamine (n = 125) or placebo (n = 125) for 6 months, with assessment of effect after the 6-month intervention period and at 1 year (6 months postintervention). MAIN OUTCOME MEASURES: The primary outcome was pain-related disability measured with the Roland Morris Disability Questionnaire (RMDQ). Secondary outcomes were numerical scores from pain-rating scales of patients at rest and during activity, and the quality-of-life EuroQol-5 Dimensions (EQ-5D) instrument. Data collection occurred during the intervention period at baseline, 6 weeks, 3 and 6 months, and again 6 months following the intervention at 1 year. Group differences were analyzed using linear mixed models analysis. RESULTS: At baseline, mean RMDQ scores were 9.2 (95% confidence interval [CI], 8.4-10.0) for glucosamine and 9.7 (95% CI, 8.9-10.5) for the placebo group (P = .37). At 6 months, the mean RMDQ score was the same for the glucosamine and placebo groups (5.0; 95% CI, 4.2-5.8). At 1 year, the mean RMDQ scores were 4.8 (95% CI, 3.9-5.6) for glucosamine and 5.5 (95% CI, 4.7-6.4) for the placebo group. No statistically significant difference in change between groups was found when assessed after the 6-month intervention period and at 1 year: RMDQ (P = .72), LBP at rest (P = .91), LBP during activity (P = .97), and quality-of-life EQ-5D (P = .20). Mild adverse events were reported in 40 patients in the glucosamine group and 46 in the placebo group (P = .48). CONCLUSIONS: Among patients with chronic LBP and degenerative lumbar OA, 6-month treatment with oral glucosamine compared with placebo did not result in reduced pain-related disability after the 6-month intervention and after 1-year follow-up. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00404079."," Jama 304(1999): 45-52.","Norway",2010,"Back Pain","Glucosamine","RMDQ","Adults","PRO study","RCT"]
[409,"Wilkens, P., et al. (2013). \"Prognostic factors of prolonged disability in patients with chronic low back pain and lumbar degeneration in primary care: a cohort study.\" Spine (Phila Pa 1976) 38(1999): 65-74.",null,"Wilkens, P., et al.","Prognostic factors of prolonged disability in patients with chronic low back pain and lumbar degeneration in primary care: a cohort study","STUDY DESIGN: A cohort study with 1-year follow-up. OBJECTIVE: To identify prognostic factors in patients with chronic nonspecific low back pain (LBP). SUMMARY OF BACKGROUND DATA: The factors (e.g., sociodemographical, low back-related, radiological, and biological) associated with persistent pain and disability for patients with chronic nonspecific LBP are uncertain. Furthermore, sparse information exists about the relationship between biological factors like impaired fasting glucose tolerance and chronic nonspecific LBP. METHODS: The participants consisted of 250 patients with nonspecific LBP of more than 6 months duration and degenerative lumbar osteoarthritis. The patients were originally recruited for a randomized controlled trial from the clinics of general practitioners, physiotherapists, and chiropractors. Potential predictors were evaluated at baseline. The outcome was absolute level of pain-related disability (Roland-Morris Disability Questionnaire [RMDQ]) at 1 year. The association between potential prognostic factors and the outcome was analyzed with multivariate linear backward regression. RESULTS: At baseline and 1 year, the RMDQ scores were 9.5 and 5.1 points, respectively. Mean (SD) baseline values for body mass index (BMI), EuroQol (EQ)-index, EQ-visual analogue scale were 25.4 (4.3), 0.60 (0.3), and 61.2 (20.8), respectively. Higher pain-related disability levels (1-year RMDQ score) were associated with 6.1 mmol/L or more fasting glucose level at baseline (beta, 3.7; 95% confidence interval [CI], 1.2-6.1; P = 0.00), baseline pain-related disability (beta 0.2; 95% CI, 0.1-0.4; P = 0.00), BMI (beta, 0.2; 95% CI, 0.1-0.3; P < 0.03), EQ-index (beta, -4.5; 95% CI, 6.9 to 2.1; P = 0.00), and EQ-visual analogue scale (beta, 0.3; 95% CI, -0.6 to -0.0; P = 0.03). However, a limited number of patients had 6.1 mmol/L or more of fasting glucose level at baseline (13/250 patients). The imaging findings, modic changes, and high intensity zones had no predictive ability. CONCLUSION: Increased pain-related disability at 1 year was seen in patients with impaired fasting glucose tolerance, greater pain-related disability, higher BMI, and lower quality of life at baseline."," Spine (Phila Pa 1976) 38(1999): 65-74.","Norway",2013,"Back Pain","Not Specified","RMDQ","Unknown","PRO study","Observational"]
[410,"Williams, N. H., et al. (2003). \"Randomized osteopathic manipulation study (ROMANS): pragmatic trial for spinal pain in primary care.\" Fam Pract 20(6): 662-669.",null,"Williams, N. H., et al.","Randomized osteopathic manipulation study (ROMANS): pragmatic trial for spinal pain in primary care","BACKGROUND: Spinal pain is common and frequently disabling. Management guidelines have encouraged referral from primary care for spinal manipulation. However, the evidence base for these recommendations is weak. More pragmatic trials and economic evaluations have been recommended. OBJECTIVES: Our aim was to assess the effectiveness and health care costs of a practice-based osteopathy clinic for subacute spinal pain. METHODS: A pragmatic randomized controlled trial was carried out in a primary care osteopathy clinic accepting referrals from 14 neighbouring practices in North West Wales. A total of 201 patients with neck or back pain of 2-12 weeks duration were allocated at random between usual GP care and an additional three sessions of osteopathic spinal manipulation. The primary outcome measure was the Extended Aberdeen Spine Pain Scale (EASPS). Secondary measures included SF-12, EuroQol and Short-form McGill Pain Questionnaire. Health care costs were estimated from the records of referring GPs. RESULTS: Outcomes improved more in the osteopathy group than the usual care group. At 2 months, this improvement was significantly greater in EASPS [95% confidence interval (CI) 0.7-9.8] and SF-12 mental score (95% CI 2.7-10.7). At 6 months, this difference was no longer significant for EASPS (95% CI -1.5 to 10.4), but remained significant for SF-12 mental score (95% CI 1.0-9.9). Mean health care costs attributed to spinal pain were significantly greater by 65 UK pounds in the osteopathy group (95% CI 32-155 UK pounds). Though osteopathy also cost 22 UK pounds more in mean total health care cost, this was not significant (95% CI - 159 to 142 UK pounds). CONCLUSION: A primary care osteopathy clinic improved short-term physical and longer term psychological outcomes, at little extra cost. Rigorous multicentre studies are now needed to assess the generalizability of this approach."," Fam Pract 20(6): 662-669.","UK",2003,"Back Pain","Psychosocial","Aberdeen LBP","Unknown","Cost-Effectiveness","RCT"]
[411,"Wilson, P. L., et al. (2002). \"A multicenter study analyzing the relationship of a standardized radiographic scoring system of adolescent idiopathic scoliosis and the Scoliosis Research Society outcomes instrument.\" Spine (Phila Pa 1976) 27(18): 2036-2040.",null,"Wilson, P. L., et al.","A multicenter study analyzing the relationship of a standardized radiographic scoring system of adolescent idiopathic scoliosis and the Scoliosis Research Society outcomes instrument","STUDY DESIGN: A multicenter study examining the association between radiographic and outcomes measures in adolescent idiopathic scoliosis. OBJECTIVES: To evaluate the association between an objective radiographic scoring system and patient quality of life measures as determined by the Scoliosis Research Society outcomes instrument. SUMMARY OF BACKGROUND DATA: Although surgical correction of scoliosis has been reported to be positively correlated with patient outcomes, studies to date have been unable to demonstrate an association between radiographic measures of deformity and outcomes measures in patients with adolescent idiopathic scoliosis. METHODS: A standardized radiographic deformity scoring system and the Scoliosis Research Society outcome tool were used prospectively in seven scoliosis centers to collect data on patients with adolescent idiopathic scoliosis. A total of 354 data points for 265 patients consisting of those with nonoperative or preoperative curves >or=10 degrees, as well as those with surgically treated curves, were analyzed. Correlation analysis was performed to identify significant relationships between any of the radiographic measures, the Harms Study Group radiographic deformity scores (total, sagittal, coronal), and the seven Scoliosis Research Society outcome domains (Total Pain, General Self-Image, General Function, Activity, Postoperative Self-Image, Postoperative Function, and Satisfaction) as well as Scoliosis Research Society outcomes instrument total scores. Radiographic measures that were identified as significantly correlated with Scoliosis Research Society outcome scores were then entered into a stepwise regression analysis. RESULTS: The coronal measures of thoracic curve and lumbar curve magnitude were found to be significantly correlated with the Total Pain, General Self-Image, and total Scoliosis Research Society scores (P < 0.0001). The thoracic and upper thoracic curve magnitudes were also correlated with General Function (P < 0.002). The \"coronal\" subscore as well as the \"total\" score of the Harms Study Group radiographic scoring system were also significantly correlated with these Scoliosis Research Society domain and total scores. No radiographic measures taken after surgery were significantly correlated with the postoperative domains of the Scoliosis Research Society outcomes instrument. Stepwise regression analysis of these radiographic measures as predictors of Scoliosis Research Society scores resulted in adjusted R2 values of 0.03-0.07 (P < 0.0001). Although these results show that a significant association exists between the radiographic Cobb angle measure of the scoliosis and the Scoliosis Research Society outcomes scores, the low R2 values indicate that variables other than the radiographic appearance of the deformity (e.g., psychosocial, functional) must also be affecting these scores. CONCLUSION: The Cobb angle measure of the major deformity has a small, but statistically significant, correlation with the reported Total Pain, General Self-Image, and General Function as measured by the Scoliosis Research Society outcomes instrument. None of the radiographic measures in this population correlated with postoperative domain scores of the Scoliosis Research Society outcomes tool."," Spine (Phila Pa 1976) 27(18): 2036-2040.","USA",2002,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Prospective Observation"]
[412,"Wong, C. K. H., et al. (2017). \"Mapping the SRS-22r questionnaire onto the EQ-5D-5L utility score in patients with adolescent idiopathic scoliosis.\" PLoS One 12(4): e0175847.",null,"Wong, C. K. H., et al.","Mapping the SRS-22r questionnaire onto the EQ-5D-5L utility score in patients with adolescent idiopathic scoliosis","This is a prospective study to establish prediction models that map the refined Scoliosis Research Society 22-item (SRS-22r) onto EuroQoL-5 dimension 5-level (EQ-5D-5L) utility scores in adolescent idiopathic scoliosis (AIS) patients. Comparison of treatment outcomes in AIS can be determined by cost-utility analysis. However, the mainstay spine-specific health-related quality of life outcome measure, the SRS-22r questionnaire does not provide utility assessment. In this study, AIS patients were prospectively recruited to complete both the EQ-5D-5L and SRS-22r questionnaires by trained interviewers. Ordinary least squares regression was undertaken to develop mapping models, which the validity and robustness were assessed by using the 10-fold cross-validation procedure. EQ-5D-5L utility scores were regressed on demographics, Cobb angle, curve types, treatment modalities, and five domains of the SRS-22r questionnaire. Three models were developed using stepwise selection method. EQ-5D-5L scores were regressed on 1) main effects of SRS-22r subscale scores, 2) as per 1 plus squared and interaction terms, and 3) as per 2 plus demographic and clinical characteristics. Model goodness-of-fit was assessed using R-square, adjusted R-square, and information criteria; whereas the predictive performance was evaluated using root mean square error (RMSE), mean absolute error (MAE), and the proportion of absolute error within the threshold of 0.05 and 0.10. A total of 227 AIS patients with mean age of 15.6 years were recruited. The EQ-5D-5L scores were predicted by four domains of SRS-22r (main effects of 'Function', 'Pain', 'Appearance' and 'Mental Health', and squared term of 'Function' and 'Pain'), and Cobb angle in Model 3 with the best goodness-of-fit (R-square/adjusted R-square: 62.1%/60.9%). Three models demonstrated an acceptance predictive performance in error analysis applying 10-fold cross-validation to three models where RMSE and MAE were between 0.063-0.065 and between 0.039-0.044, respectively. Model 3 was therefore recommended out of three mapping models established in this paper. To our knowledge, this is the first study to map a spine-specific health-related quality of life measure onto EQ-5D-5L for AIS patients. With the consideration and incorporation of demographic and clinical characteristics, over 60% variance explained by mapping model 3 enabled the satisfactory prediction of EQ-5D-5L utility scores from existing SRS-22r data for health economic appraisal of different treatment options."," PLoS One 12(4): e0175847.","China",2017,"Spinal Deformity","Not Specified","SRS-HRQOL","Adolescents","PRO study","Prospective Observation"]
[413,"Xia, T., et al. (2014). \"Study protocol for patient response to spinal manipulation - a prospective observational clinical trial on physiological and patient-centered outcomes in patients with chronic low back pain.\" BMC Complement Altern Med 14: 292.",null,"Xia, T., et al.","Study protocol for patient response to spinal manipulation - a prospective observational clinical trial on physiological and patient-centered outcomes in patients with chronic low back pain","BACKGROUND: Low back pain (LBP) is a major health issue due to its high prevalence rate and socioeconomic cost. While spinal manipulation (SM) is recommended for LBP treatment by recently published clinical guidelines, the underlying therapeutic mechanisms remain unclear. Spinal stiffness is routinely examined and used in clinical decisions for SM delivery. It has also been explored as a predictor for clinical improvement. Flexion-relaxation phenomenon has been demonstrated to distinguish between LBP and healthy populations. The primary objective of the current study is to collect preliminary estimates of variability and effect size for the associations of these two physiological measures with patient-centered outcomes in chronic LBP patients. Additionally biomechanical characteristics of SM delivery are collected with the intention to explore the potential dose-response relationship between SM and LBP improvement. METHODS/DESIGN: This is a prospective, observational study applying side-lying, high velocity, low amplitude SM as treatment for patients with LBP over a course of 6 weeks. Approximately 80 participants will be enrolled if they present with chronic LBP of 1, 2 or 3 in Quebec Task Force Classification for spinal disorders, a Roland-Morris Disability Questionnaire (RMDQ) score >/= 6, and persistent LBP >/= 2 with a maximum >/= 4 using numerical rating scale. Patient-centered outcomes include LBP using visual analog scale, RMDQ, and PROMIS-29. Lumbar spine stiffness is assessed using palpation, a hand-held instrumented device, and an automated device. Flexion-relaxation is assessed using surface electromyography at the third level of the lumbar spine. Biomechanical characteristics of SM are assessed using a self-reported, itemized description system, as well as advanced kinetic measures that will be applied to estimate forces and moments at the lumbar segment level targeted by SM. DISCUSSION: Beside alterations in material properties of the passive components of the spine, increased neuromuscular activity may also contribute to a stiffened spine. Examining changes in both spinal stiffness and flexion-relaxation along the course of the treatment provides an opportunity to understand if the therapeutic effect of SM is associated with its action on active and/or passive components of the spine. TRIAL REGISTRATION: NCT01670292 on clinicaltrials.gov."," BMC Complement Altern Med 14: 292.","USA",2014,"Back Pain","Not Specified","RMDQ,QBPD","Unknown","PRO study","Prospective Observation"]
[414,"Xia, T., et al. (2017). \"Association of lumbar spine stiffness and flexion-relaxation phenomenon with patient-reported outcomes in adults with chronic low back pain - a single-arm clinical trial investigating the effects of thrust spinal manipulation.\" BMC Complement Altern Med 17(1999): 303.",null,"Xia, T., et al.","Association of lumbar spine stiffness and flexion-relaxation phenomenon with patient-reported outcomes in adults with chronic low back pain - a single-arm clinical trial investigating the effects of thrust spinal manipulation","BACKGROUND: Spinal manipulation (SM) is used commonly for treating low back pain (LBP). Spinal stiffness is routinely assessed by clinicians performing SM. Flexion-relaxation ratio (FRR) was shown to distinguish between LBP and healthy populations. The primary objective of this study was to examine the association of these two physiological variables with patient-reported pain intensity and disability in adults with chronic LBP (>12 weeks) receiving SM. METHODS: A single-arm trial provided 12 sessions of side-lying thrust SM in the lumbosacral region over 6 weeks. Inclusion criteria included 21-65 years old, Roland-Morris Disability Questionnaire (RMDQ) score >/= 6 and numerical pain rating score >/= 2. Spinal stiffness and FRR were assessed pre-treatment at baseline, after 2 weeks and after 6 weeks of treatment. Lumbar spine global stiffness (GS) were calculated from the force-displacement curves obtained using i) hand palpation, ii) a hand-held device, and iii) an automated indenter device. Lumbar FRR was assessed during trunk flexion-extension using surface electromyography. The primary outcomes were RMDQ and pain intensity measured by visual analog scale (VAS). Mixed-effects regression models were used to analyze the data. RESULTS: The mean age of the 82 participants was 45 years; 48% were female; and 84% reported LBP >1 year. The mean (standard deviation) baseline pain intensity and RMDQ were 46.1 (18.1) and 9.5 (4.3), respectively. The mean reduction (95% confidence interval) after 6 weeks in pain intensity and RMDQ were 20.1 mm (14.1 to 26.1) and 4.8 (3.7 to 5.8). There was a small change over time in the palpatory GS but not in the hand-held or automated GS, nor in FRR. The addition of each physiologic variable did not affect the model-estimated changes in VAS or RMDQ over time. There was no association seen between physiological variables and LBP intensity. Higher levels of hand-held GS at L3 and automated GS were significantly associated with higher levels of RMDQ (p = 0.02 and 0.03, respectively) and lower levels of flexion and extension FRR were significantly associated with higher levels of RMDQ (p = 0.02 and 0.008, respectively) across the 3 assessment time points. CONCLUSIONS: Improvement in pain and disability observed in study participants with chronic LBP was not associated with the measured GS or FRR. TRIAL REGISTRATION: NCT01670292 on clinicaltrials.gov, August 2, 2012."," BMC Complement Altern Med 17(1999): 303.","USA,Canada",2017,"Back Pain","Not Specified","RMDQ","Adults","PRO study","Clinical trial"]
[415,"Xiao, C., et al. (2017). \"Quality of Life and Performance Status From a Substudy Conducted Within a Prospective Phase 3 Randomized Trial of Concurrent Standard Radiation Versus Accelerated Radiation Plus Cisplatin for Locally Advanced Head and Neck Carcinoma: NRG Oncology RTOG 0129.\" Int J Radiat Oncol Biol Phys 97(4): 667-677.",null,"Xiao, C., et al.","Quality of Life and Performance Status From a Substudy Conducted Within a Prospective Phase 3 Randomized Trial of Concurrent Standard Radiation Versus Accelerated Radiation Plus Cisplatin for Locally Advanced Head and Neck Carcinoma: NRG Oncology RTOG 0129","PURPOSE/OBJECTIVE(S): To analyze quality of life (QOL) and performance status (PS) for head and neck cancer (HNC) patients treated on NRG Oncology RTOG 0129 by treatment (secondary outcome) and p16 status, and to examine the association between QOL/PS and survival. METHODS AND MATERIALS: Eligible patients were randomized into either an accelerated-fractionation arm or a standard-fractionation arm, and completed the Performance Status Scale for the Head and Neck (PSS-HN), the Head and Neck Radiotherapy Questionnaire (HNRQ), and the Spitzer Quality of Life Index (SQLI) at 8 time points from before treatment to 5 years after treatment. RESULTS: The results from the analysis of area under the curve showed that QOL/PS was not significantly different between the 2 arms from baseline to year after treatment (P ranged from .39 to .98). The results from general linear mixed models further supported the nonsignificant treatment effects until 5 years after treatment (P=.95, .90, and .84 for PSS-HN Diet, Eating, and Speech, respectively). Before treatment and after 1 year after treatment, p16-positive oropharyngeal cancer (OPC) patients had better QOL than did p16-negative patients (P ranged from .0283 to <.0001 for all questionnaires). However, QOL/PS decreased more significantly from pretreatment to the last 2 weeks of treatment in the p16-positive group than in the p16-negative group (P ranged from .0002 to <.0001). Pretreatment QOL/PS was a significant independent predictor of overall survival, progression-free survival, and local-regional failure but not of distant metastasis (P ranged from .0063 to <.0001). CONCLUSIONS: The results indicated that patients in both arms may have experienced similar QOL/PS. p16-positive patients had better QOL/PS at baseline and after 1 year of follow-up. Patients presenting with better baseline QOL/PS scores had better survival."," Int J Radiat Oncol Biol Phys 97(4): 667-677.","USA,Canada",2017,"Cancer","Radiotherapy","PSSHN","Unknown","PRO study","RCT"]
[416,"Xue, X., et al. (2016). \"Surgical Versus Nonsurgical Treatment for High-Grade Spondylolisthesis in Children and Adolescents: A Systematic Review and Meta-Analysis.\" Medicine (Baltimore) 95(11): e3070.",null,"Xue, X., et al.","Surgical Versus Nonsurgical Treatment for High-Grade Spondylolisthesis in Children and Adolescents: A Systematic Review and Meta-Analysis","The optimal management of high-grade spondylolisthesis in children and adolescent is controversial. There is a paucity of literature regarding operatively or nonoperative management in this setting. To assessment of the current state of evidence regarding high-grade spondylolisthesis treatment with the goal of obtaining outcome comparisons in these patients managed either operatively or nonoperatively. We performed a systematic literature search up to November 2014, using Medline, Embase, and The Cochrane Library. The analysis and eligibility criteria were documented according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA-guidelines) and Cochrane Back Review Group editorial board. We used the Newcastle-Ottawa quality assessment scale (NOS-scale) to assess the quality. Five observational studies were considered eligible for analysis based on the evaluation of 1596 identified papers. The mean overall difference in the Scoliosis Research Society questionnaire 22 between the surgical and nonsurgical groups was not statistically significant (95% CI: -0.17 to 0.21, P = 0.84). The pooled mean difference in progression of slip between the surgical and nonsurgical groups was no significant difference (OR: 0.47, 95% CI: 0.12-1.81, P = 0.27, I = 0%). Because of the preponderance of uncontrolled case series, low-quality evidence indicates that the quality of life and progression of slips was no significant difference between surgery and nonoperation group. Nonoperative patients had no radiologic progression of their slip during the follow-up period."," Medicine (Baltimore) 95(11): e3070.","China",2016,"Spinal Deformity,Spondylosis","Surgical","SRS-HRQOL","Adolescents","PRO study","Systematic review"]
[417,"Yi, H., et al. (2014). \"Reliability and validity of simplified Chinese version of Swiss Spinal Stenosis Questionnaire for patients with degenerative lumbar spinal stenosis.\" Spine (Phila Pa 1976) 39(10): 820-825.",null,"Yi, H., et al.","Reliability and validity of simplified Chinese version of Swiss Spinal Stenosis Questionnaire for patients with degenerative lumbar spinal stenosis","STUDY DESIGN: This was a prospective clinical validation study. OBJECTIVE: To evaluate the reliability and validity of the adapted simplified Chinese version of Swiss Spinal Stenosis (SC-SSS) Questionnaire. SUMMARY OF BACKGROUND DATA: The SSS Questionnaire is a reliable and valid instrument to assess the perception of function and pain for patients with degenerative lumbar spinal stenosis. However, there is no culturally adapted SSS Questionnaire for use in mainland China. METHODS: This was a prospective clinical validation study. The adaption was conducted according to International Quality of Life Assessment Project guidelines. To examine the psychometric properties of the adapted SC-SSS Questionnaire, a sample of 105 patients with lumbar spinal stenosis were included. Thirty-two patients were randomly selected to evaluate the test-retest reliability. Reliability assessment of the SC-SSS Questionnaire was determined by calculating Cronbach alpha and intraclass coefficient values. Concurrent validity was assessed by correlating SC-SSS Questionnaire scores with relevant domains of the 36-Item Short Form Health Survey. RESULTS: Cronbach alpha of the symptom severity scale, physical function scale, patients, and satisfaction scale of SC-SSS Questionnaire are 0.89, 0.86, 0.91, respectively, which revealed very good internal consistency. The test-retest reproducibility was found to be excellent with the intraclass correlation coefficient of 0.93, 0.91, and 0.95. In terms of concurrent validity, SC-SSS Questionnaire had good correlation with physical functioning and bodily pain of 36-Item Short Form Health Survey (r = 0.663, 0.653) and low correlation with mental health (r = 0.289). The physical function scale had good correlation with physical functioning of 36-Item Short Form Health Survey (r = 0.637), whereas the rest had moderate correlation. The satisfaction scale score was highly correlated with the change in the symptom severity (r = 0.71) and physical function (r = 0.68) scale score. CONCLUSION: The SC-SSS Questionnaire showed satisfactory reliability and validity in the evaluation of functionality in patients with lumbar spinal stenosis who are experiencing neurogenic claudication. It is simple and easy to use and can be recommended in clinical and research practice in mainland China. LEVEL OF EVIDENCE: 3."," Spine (Phila Pa 1976) 39(10): 820-825.","China",2014,"Spine Disease","Not Specified","SSSQ","Unknown","PRO study","Prospective Observation"]
[418,"Yildirim, K., et al. (2009). \"Gabapentin monotherapy in patients with chronic radiculopathy: the efficacy and impact on life quality.\" J Back Musculoskelet Rehabil 22(1999): 17-20.",null,"Yildirim, K., et al.","Gabapentin monotherapy in patients with chronic radiculopathy: the efficacy and impact on life quality","OBJECTIVE: The purpose of this, open-label, non-comparative study, was to evaluate the efficacy on quality of life and the efficacy of gabapentin monotherapy in patients with chronic radiculopathy. METHODS: Thirty-five patients with radicular pain and diagnosed as L4, L5 or S1 radiculopathy were treated with oral gabapentin from a total of 300 mg per day once up to a total of 1800 mg per day divided in 3 doses for eight-week trial period. Quality of life, functional disability and psychological mood of the patients were assessed using the Nottingham Healthy Profile (NHP), Oswestry Low Back Pain Disability Questionnaire (ODQ) and Beck Depression Inventory (BDI). RESULTS: Of the patients (n = 35), 25 were females and 10 were males (mean age: 41.8 +/- 10.4, range: 24-60 years); mean radiculopathy duration was 16.4 +/- 14.2 months (range: 3-48 months). The pain intensity at rest, quality of life, functional disability and depression scores were determined significantly improved after treatment and 4 months compared to baseline scores (p < 0.001). 1.5 points compared to baseline for at pain rest and 15 points improvement on the ODQ were obtained. CONCLUSION: Gabapentin may provide benefits in terms of alleviation of pain and overall quality of life in patients with chronic radiculopathy."," J Back Musculoskelet Rehabil 22(1999): 17-20.","Turkey",2009,"Back Pain,Radiculopathy","Gabapentin","Oswestry","Adults","PRO study","Observational"]
[419,"Yoon, S. H., et al. (2009). \"Comparison of 3 needle sizes for trigger point injection in myofascial pain syndrome of upper- and middle-trapezius muscle: a randomized controlled trial.\" Arch Phys Med Rehabil 90(8): 1332-1339.",null,"Yoon, S. H., et al.","Comparison of 3 needle sizes for trigger point injection in myofascial pain syndrome of upper- and middle-trapezius muscle: a randomized controlled trial","OBJECTIVES: To investigate (1999) the relation between needle diameter and treatment efficacy of myofascial pain syndrome and (2) the relation between needle diameter and pain intensity during injection. DESIGN: Randomized controlled trial. SETTING: University-affiliated tertiary-care hospital. PARTICIPANTS: Volunteers (N=77) with myofascial pain syndrome affecting upper- and middle-trapezius muscles with at least 3 months' duration of pain. INTERVENTION: Participants were randomly assigned to receive trigger point injections on 1 side of the trapezius with a 21-, 23-, or 25-gauge needle. After a 1-time injection, participants were followed up for 14 days. Participants and the assessor were blinded for group assignment. MAIN OUTCOME MEASURES: Treatment efficacy was measured with the visual analog scale (VAS; at pretreatment, and posttreatment on days 1, 4, 7, 14) for neck and upper-back pain, the Neck Disability Index (NDI; at pretreatment, and posttreatment on days 7, 14), and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36, at pretreatment and posttreatment on days 7, 14) for health-related quality of life. Pain intensity during injection was evaluated immediately after injection with VAS. RESULTS: VAS scores for posttreatment on days 4, 7, and 14 decreased significantly compared with pretreatment scores in all groups; NDI scores on days 7 and 14 decreased significantly compared with pretreatment scores in all groups; SF-36 scores on days 7 and 14 decreased significantly compared with pretreatment scores in the 21- and 23-gauge needle groups; and SF-36 score on day 14 showed significant difference between the 21- and 25-gauge needle groups. For pain intensity during injection, VAS scores indicated no significant difference between the 3 groups. CONCLUSIONS: No difference between the needle types was observed in terms of VAS or NDI, or in terms of pain intensity felt by patients during injection. In terms of SF-36 scores, injections with 21- or 23-gauge needles were found to be more effective. However, a well-controlled investigation is needed to explore the effect of needle thickness on health-related quality of life."," Arch Phys Med Rehabil 90(8): 1332-1339.","Republic of Korea",2009,"Back Pain","Not Specified","NDI","Unknown","PRO study","RCT"]
[420,"Yuan, J., et al. (2009). \"Different frequencies of acupuncture treatment for chronic low back pain: an assessor-blinded pilot randomised controlled trial.\" Complement Ther Med 17(3): 131-140.",null,"Yuan, J., et al.","Different frequencies of acupuncture treatment for chronic low back pain: an assessor-blinded pilot randomised controlled trial","OBJECTIVES: To examine the feasibility of a main RCT to compare the effectiveness of two frequencies (2 versus 5 times/week) of acupuncture treatment for chronic low back pain (LBP). METHODS: Participants (n=30) with chronic LBP were randomised into two groups to receive 10 acupuncture treatments: Low Frequency Group, 2 times/week for five weeks (n=15); High Frequency Group, 5 times/week for two weeks (n=15). The following outcomes were measured blindly at baseline, 2 weeks, 5 weeks, 3 months and 1 year: pain on a VAS, functional disability using the RMDQ, quality of life using the Measure Yourself Medical Outcome Profile (MYMOP-2), psychological impact with the Coping Strategies Questionnaire (CSQ) and Pain Locus of Control (PLC) questionnaire. Two objective outcomes, the Shuttle Walk Test (SWT) and Lateral Trunk Flexibility (LTF), were also measured. RESULTS: The compliance rate was 100% for each group. Some of the measurements were shown to be sensitive (VAS, RMDQ, MYMOP-2 Wellbeing). 66-330 participants would be required for a fully powered non-inferiority trial. The groups were balanced at baseline for LBP and demographic characteristics. There were no significant differences between the groups in terms of any of the outcomes, at each follow-up time point. It was notable however that the clinically important improvement in terms of pain, functional disability, quality of life, and SWT in both groups was achieved within the first two weeks, which was maintained at one year follow-up. CONCLUSIONS: It is feasible to conduct a main RCT, to compare different frequencies of acupuncture for LBP, using sensitive measurements. Also the trend for early clinically important improvement within a minimum of four measurements is worthy of further study."," Complement Ther Med 17(3): 131-140.","UK",2009,"Back Pain","Acupuncture","RMDQ","Unknown","PRO study","RCT"]
[421,"Zheng, Y., et al. (2015). \"Tolerability of Biphasic-Release Hydrocodone Bitartrate/Acetaminophen Tablets (MNK-155): A Phase III, Multicenter, Open-Label Study in Patients With Osteoarthritis or Chronic Low Back Pain.\" Clin Ther 37(6): 1235-1247.",null,"Zheng, Y., et al.","Tolerability of Biphasic-Release Hydrocodone Bitartrate/Acetaminophen Tablets (MNK-155): A Phase III, Multicenter, Open-Label Study in Patients With Osteoarthritis or Chronic Low Back Pain","PURPOSE: This study aimed to assess the tolerability of the extended use (</=35 days) of MNK-155, a biphasic (immediate-release/extended-release) hydrocodone bitartrate/N-acetyl-p-aminophenol (acetaminophen) (IR/ER HB/APAP) 7.5/325-mg fixed-dose combination analgesic agent, in patients with chronic noncancer pain (CNCP) caused by osteoarthritis or chronic low back pain. IR/ER HB/APAP tablets deliver 25% of the HB dose and 50% of the APAP dose by IR and the remainder by ER over a 12-hour dosing interval. Although IR/ER HB/APAP is being developed for the management of moderate to severe acute pain, this model of CNCP was used for assessing tolerability over a term longer than would be possible in a model of acute pain. METHODS: This Phase III, multicenter, open-label study enrolled patients with moderate to severe OA (knee or hip) pain despite the use of nonopioid or opioid analgesic agents, or with moderate to severe CLBP present for several hours per day for >/=3 months. Patients received a 3-tablet initial dose of IR/ER HB/APAP (total dose, 22.5/975 mg) on day 1, followed by 2 tablets of IR/ER HB/APAP (total dose, 15/650 mg) q12h for up to 35 days. Tolerability, the primary end point, was assessed using time to treatment discontinuation, the prevalence of treatment-emergent adverse events (TEAEs), vital sign measurements, pulse oximetry, clinical laboratory tests, and compliance. Secondary outcomes included the modified Brief Pain Inventory-Short Form, the Western Ontario and McMaster Universities Arthritis Index, and The Roland-Morris Low Back Pain and Disability Questionnaire. FINDINGS: Of the 153 patients enrolled (95 women [62.1%]; mean age, 53.9 [14.5] years; OA, n = 73; CLBP, n = 80), 37 (24.2%) discontinued the study early (mean time to discontinuation, 21.3 days). Thirteen patients (8.5%) discontinued because of TEAEs. A total of 88 patients (57.5%) reported >/=1 TEAE, 65 (42.5%) of whom experienced AEs considered by the investigator as treatment related. The most frequent TEAEs were nausea (16.3%), somnolence (14.4%), and constipation (11.1%). Eight severe TEAEs were experienced by 6 (3.9%) patients and included single occurrences of nausea, fatigue, nasopharyngitis, elevated liver enzymes, headache, nightmare, and ejaculation delay. No serious treatment-related AEs were reported. Clinically significant changes in laboratory values were reported in 13 patients, 6 of whom had abnormal liver function test results that did not meet Hy's law criteria for acute liver failure. Most laboratory abnormalities were mild and transient. Measures of pain intensity, function, and quality of life improved from baseline but in an open-label study these changes cannot be attributed to treatment. IMPLICATIONS: The safety profile of IR/ER HB/APAP during extended use was consistent with those of other low-dose opioid/APAP combination products. IR/ER HB/APAP is intended for acute pain; its efficacy for relief of CNCP would require further evaluation in an active- or placebo-controlled study. ClinicalTrials.gov Identifier: NCT01722864."," Clin Ther 37(6): 1235-1247.","USA",2015,"Back Pain,Cancer","MNK-155","RMDQ","Adults","PRO study","Clinical trial"]

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[]
["Acronym","Full Name"]
["AAOS-NSS","American Academy of Orthopaedic Surgeons Neurogenic Symptom Score"]
["Aberdeen LBP","Aberdeen Low Back Pain Scale"]
["ALBPSQ","Acute Low Back Pain Screening Questionnaire"]
["BBQ","Back Pain Beliefs Questionnaire"]
["BIS","Balanced Inventory for Spinal Disorders"]
["Bothersomeness","Low Back Pain Bothersomeness Scale"]
["Bournemouth","Bournemouth Questionnaire"]
["BrQ","Brace Questionnaire"]
["CNFDS","Copenhagen Neck Functional Disability Scale"]
["CSOQ","Cervical Spine Outcomes Questionnaire"]
["CSSS","Cervical Spine Symptom Scale"]
["EOSQ","early onset scoliosis questionnaire"]
["HD-DQI","herniated disc-decision quality instrument"]
["HNQOL","Head and Neck Quality of Life"]
["ICF","ICF Low Back Pain Core Set"]
["JOACMEQ","Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire"]
["LBOS","Low Back Outcome Score"]
["LSDI","Lumbar Stiffness Disability Index"]
["LSOQ","Lumbar Spine Outcomes Questionnaire"]
["Maine","Maine-Seattle Back Questionnaire"]
["NASS-L","North American Spine Society Lumbar Spine Instrument"]
["NDI","Neck Disability Index"]
["Northwick","Northwick Park Neck Pain Questionnaire"]
["NPDIQ","Neck Pain Disability Index Questionnaire"]
["NPDS","Neck Pain and Disability Scale"]
["NRS","Numeric Rating Scale"]
["Nurick","Nurick grade"]
["ODI","Oswestry Disability Index"]
["Odom","Odom's Clinical Assessment"]
["Oswestry","Cervical Oswestry Score"]
["Pectus","Pectus Excavatum Evaluation Questionnaire"]
["PSSHN","Performance Status Scale for the Head and Neck"]
["QBPD","Quebec Back Pain Disability Scale"]
["QLPSD","Quality of Life Profile for Spine Deformities"]
["RMDQ","Roland Morris Disability Questionnaire"]
["SAQ","Spinal Appearance Questionnaire"]
["Schober","Schober's test"]
["SCI","Stauffer-Coventry-Index"]
["SDI","Spine Deformity Index"]
["SFI","Spine Functional Index"]
["SFS","Performance Assessment and Capacity Testing Spinal Function Sort"]
["SRS-HRQOL","Scoliosis Research Society health-related quality of life questionnaire, SRS-30, SRS-22"]
["SSM","Spinal Stenosis Measure"]
["SSSQ","Swiss Spinal Stenosis Questionnaire"]
["STSG","Spine Trauma Study Group"]
["SWNS","Subjective Well-being under Neuroleptic Treatment scale"]
["TyPE","Low Back Pain TyPE"]
["WADDEL","Waddel Index"]

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[null,"1. Select the first category to be included in the",null,null,null,null,null,null,null,null,"Unallocated","Clinical trial","Narrative review","Observational","Prospective Observation","RCT","Retrospective review","Systematic review"]
[null,"Evidence Map. This will show as a series of rows",null,null,null,null,null,null,null,"Unallocated",0,0,0,0,0,0,0,0]
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[null,"First dimension",null,null,null,null,null,null,null,"ALBPSQ",0,0,0,1,0,0,0,0]
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[null,null,null,null,null,null,null,null,null,"BIS",0,0,1,0,1,0,0,0]
[null,"2. Then select the second category to be shown ",null,null,null,null,null,null,null,"BOURNEMOUTH",0,0,0,2,1,0,0,1]
[null,"as the columns of the Map, or leave blank",null,null,null,null,null,null,null,"Bothersomeness",0,1,1,0,1,4,0,0]
[null,"Second dimension",null,null,null,null,null,null,null,"BrQ",0,0,0,2,1,0,0,0]
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[null,null,null,null,null,null,null,null,null,"CSOQ",0,0,0,2,0,0,0,0]
[null,"3. Click on a cell in the Map, then click the Show",null,null,null,null,null,null,null,"CSSS",0,0,0,1,0,0,0,0]
[null,"Citation button below to see the relevant",null,null,null,null,null,null,null,"EOSQ",0,0,1,1,0,0,0,0]
[null,"citations for that cell ",null,null,null,null,null,null,null,"HD-DQI",0,0,0,0,1,0,0,0]
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[null,null,null,null,null,null,null,null,null,"ICF",0,1,0,1,1,1,0,2]
[null,"Row",{"$f":"IF(AND(selectedRow>3,selectedRow<(4+E7)),OFFSET(tableLoc,(selectedRow-3),0),\"\")","v":""},null,null,null,null," ",null,"JOACMEQ",0,0,0,7,2,2,0,2]
[null,"Column",{"$f":"IF(AND(selectedColumn>10,selectedColumn<(11+columnCount)),OFFSET(tableLoc,0,(selectedColumn-10)),\"\")","v":""},null,null,null,null," ",null,"LBOS",0,1,0,0,0,1,0,0]
[null,null,null,null,null,null,null,null,null,"LSDI",0,0,0,1,0,0,0,0]
[null,"See abbreviations",null,null,null,null,null,null,null,"LSOQ",0,0,0,0,0,1,0,0]
[null,null,null,null,null,null,null,null,null,"Maine",0,0,0,1,0,0,0,0]
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[null,null,null,null,null,null,null,null,null,"Northwick",0,1,0,1,1,10,1,0]
[null,null,null,null,null,null,null,null,null,"Nurick",0,0,0,3,5,0,2,0]
[null,null,null,null,null,null,null,null,null,"ODI",0,6,4,15,25,11,7,7]
[null,null,null,null,null,null,null,null,null,"Odom",0,0,0,2,0,1,1,0]
[null,null,null,null,null,null,null,null,null,"Oswestry",0,0,0,1,0,0,1,1]
[null,null,null,null,null,null,null,null,null,"PSSHN",0,0,0,0,0,1,0,0]
[null,null,null,null,null,null,null,null,null,"Pectus",0,1,0,0,0,0,1,0]
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[null,null,null,null,null,null,null,null,null,"QLPSD",0,0,0,2,0,0,0,0]
[null,null,null,null,null,null,null,null,null,"QLSDP",0,0,0,2,0,0,0,0]
[null,null,null,null,null,null,null,null,null,"RMDQ",0,23,3,20,27,50,7,8]
[null,null,null,null,null,null,null,null,null,"SAQ",0,0,0,1,3,0,1,0]
[null,null,null,null,null,null,null,null,null,"SCI",0,0,0,0,0,0,1,0]
[null,null,null,null,null,null,null,null,null,"SDI",0,0,1,2,0,0,0,0]
[null,null,null,null,null,null,null,null,null,"SFI",0,0,0,1,1,0,0,0]
[null,null,null,null,null,null,null,null,null,"SFS",0,0,0,1,0,0,0,0]
[null,null,null,null,null,null,null,null,null,"SRS-HRQOL",0,3,2,26,31,3,13,3]
[null,null,null,null,null,null,null,null,null,"SSM",0,0,0,0,1,0,0,0]
[null,null,null,null,null,null,null,null,null,"SSSQ",0,0,0,1,3,1,0,0]
[null,null,null,null,null,null,null,null,null,"STSG",0,0,1,0,0,0,0,0]
[null,null,null,null,null,null,null,null,null,"SWNS",0,0,0,1,0,0,0,0]
[null,null,null,null,null,null,null,null,null,"Schober",0,2,0,0,3,2,0,0]
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[null,null,null,null,null,null,null,null,null,"WADDEL",0,0,0,0,0,2,0,0]
[null,null,"Dates"]
[null,null,"None"]
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[1,"Abbott,A. D.,et al. (2011). \"Patients' experience post-lumbar fusion regarding back problems,recovery and expectations in terms of the International Classification of Functioning,Disability and Health.\" Disabil Rehabil 33(15-16): 1399-1408.",null,"Abbott,A. D.,et al.","Patients' experience post-lumbar fusion regarding back problems,recovery and expectations in terms of the International Classification of Functioning,Disability and Health","PURPOSE: To describe within the context of the International Classification of Functioning,Disability and Health (ICF),patient's experiences post-lumber fusion regarding back problems,recovery and expectations of rehabilitation and to contrast with the content of outcome measures and the ICF low back pain (LBP) core sets. METHODS: The study has a cross-sectional and retrospective design and involves 20 lumbar fusion patients. Using the ICF,qualitative content analysis of semi-structured interviews 3-6 months post-surgery was performed. This was compared with the ICF related content of the Oswestry Disability Index (ODI),Medical Outcome Study Short Form 36 (SF-36),European Quality of Life Questionnaire (EQ5D) and the ICF LBP core sets. RESULTS: Patient's experiences were most frequently linked to psychological,sensory,neuromusculoskeletal and movement related body function chapters of the ICF. The most frequently linked categories of activity and participation were mobility,domestic activities,family relationships,work,recreation and leisure. Environmental factors frequently linked were the use of analgesics,walking aids,family support,social security systems,health care systems and labour market employment services. CONCLUSIONS: This study highlights important ICF related aspects of patient's experiences post-lumber fusion. The use of the comprehensive ICF core sets is recommended in conjunction with ODI,SF-36 and the EQ5D for a broader analysis of patient outcomes post-lumbar fusion."," Disabil Rehabil 33(15-16): 1399-1408.","Sweden",2011,"Back Pain","Surgical","ODI,ICF","Unknown","PRO study","Observational","Sweden","Unknown","Back Pain","Surgical","PRO study","Observational","ODI,ICF","2010:2014"]
[2,"Abenstein,J. P. (2009). \"Is BIS monitoring cost-effective?\" Conf Proc IEEE Eng Med Biol Soc 2009: 7041-7044.",null,"Abenstein,J. P.","Is BIS monitoring cost-effective?","BIS monitoring is a processed electroencephalogram (EEG) technology that is designed to follow the effects that anesthetics and sedatives have on cerebral function. Much is know about the technology,it's utility and limitations. The economic case for widespread utilization of this technology is weak. There appears to be little opportunity to decrease health care cost by either reduction of drug costs or improved practice efficiency. General use of BIS monitoring to reduce the incidence of intraoperative recall (IR) would cost about USD 10,000 to 25,000 per avoided IR. Total cost to the heath care system would approach one billion US dollars per year,just for use during general anesthetics. More appropriate use of already available drugs and technology would most likely decrease the incidence of IR as effectively,although individual patients who are at high risk for IR may benefit from this technology. However,based on current health care economic standards general use of BIS monitoring does not seem warranted and appears not to be cost-effective."," Conf Proc IEEE Eng Med Biol Soc 2009: 7041-7044.","USA",2009,"Unspecified","Surgical","BIS","Unknown","Cost-Effectiveness","Narrative review","USA","Unknown","Unspecified","Surgical","Cost-Effectiveness","Narrative review","BIS","2005:2009"]
[3,"Abudou,M.,et al. (2013). \"Surgical versus non-surgical treatment for thoracolumbar burst fractures without neurological deficit.\" Cochrane Database Syst Rev(6): Cd005079.",null,"Abudou,M.,et al.","Surgical versus non-surgical treatment for thoracolumbar burst fractures without neurological deficit","BACKGROUND: Spinal burst fractures result from the failure of both the anterior and the middle columns of the spine under axial compression loads. Conservative management is through bed rest and immobilisation once the acute symptoms have settled. Surgical treatment involves either anterior or posterior stabilisation of the fracture,sometimes with decompression involving the removal of bone fragments that have intruded into the vertebral canal. This is an update of a review first published in 2006. OBJECTIVES: To compare the outcomes of surgical with non-surgical treatment for thoracolumbar burst fractures without neurological deficit. SEARCH METHODS: We searched the Cochrane Bone,Joint and Muscle Trauma Group Specialised Register (October 2012),the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012,Issue 8),MEDLINE (1946 to October 2012),EMBASE (1980 to October 2012) and the Chinese Biomedical Literature Database (1978 to October 2012). We also searched trial registers and reference lists of articles. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials comparing surgical with non-surgical treatment of thoracolumbar burst fractures without neurological deficit. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed risk of bias and extracted data independently. Only limited pooling of data was done. MAIN RESULTS: We included two trials that compared surgical with non-surgical treatment for patients with thoracolumbar burst fractures without neurological deficit. These recruited a total of 87 participants and reported outcomes for 79 participants at follow-up of two years or more. Both trials were judged at unclear risk of selection bias and at high risk of performance and detection biases,resulting from lack of blinding.The two trials reported contrasting results for pain and function-related outcomes at final follow-up,and numbers returning to work. One trial found less pain (mean difference (MD) -15.09 mm,95% CI -27.81 to -2.37; 100 mm visual analogue scale),and better function based on the Roland and Morris disability questionnaire results (MD -5.87,95% CI -10.10 to -1.64; 24 points = maximum disability) in the surgical group. Based on the same outcome measures,the other trial found the surgical group had more pain (MD 13.60 mm,95% CI -0.31 to 27.51) and worse function (MD 4.31,95% CI 0.54 to 8.08). Neither trial reported a statistically significant difference in return to work. There were greater numbers of participants with complications in the surgical group of both trials (21/41 versus 6/38; RR 2.85,95% CI 0.83 to 9.75; 2 trials),and only participants of this group had subsequent surgery,involving implant removal either for complications or as a matter of course. One trial reported that surgery was over four times more costly than non-surgical treatment. AUTHORS' CONCLUSIONS: The contradictory evidence provided by two small and potentially biased randomised controlled trials is insufficient to conclude whether surgical or non-surgical treatment yields superior pain and functional outcomes for people with thoracolumbar burst fractures without neurological deficit. It is likely,however,that surgery is associated with more early complications and the need for subsequent surgery,as well as greater initial healthcare costs."," Cochrane Database Syst Rev(6): Cd005079.","China",2013,"Trauma","Surgical","RMDQ","Unknown","PRO study","Systematic review","China","Unknown","Trauma","Surgical","PRO study","Systematic review","RMDQ","2010:2014"]
[4,"Adobor,R. D.,et al. (2010). \"Repeatability,reliability,and concurrent validity of the scoliosis research society-22 questionnaire and EuroQol in patients with adolescent idiopathic scoliosis.\" Spine (Phila Pa 1976) 35(2): 206-209.",null,"Adobor,R. D.,et al.","Repeatability,reliability,and concurrent validity of the scoliosis research society-22 questionnaire and EuroQol in patients with adolescent idiopathic scoliosis","STUDY DESIGN: Cross-sectional study in patients with adolescent idiopathic scoliosis (AIS). OBJECTIVES: To evaluate the repeatability,reliability,internal consistency,and concurrent validity (CD) of an adapted Norwegian version of the Scoliosis Research Society 22 questionnaire (SRS-22) and the generic health-related quality of life instrument EuroQol (EQ-5D and EQ-VAS). SUMMARY OF BACKGROUND DATA: SRS-22 is widely used for evaluation of health-related quality of life in AIS. Its repeatability,which is essential for use in follow-up studies,and CD with EuroQol which can be used for cost-utility analysis,has not yet been assessed. METHODS: The forward-backward translation of the English version of the SRS-22 was performed according to guidelines for cross-cultural adaptation of outcome questionnaires. Fifty-seven patients of various ages with AIS and deformity severity filled out standardized questionnaires: SRS-22,EQ-5D,and EQ-VAS,each twice in a 2-week interval. The study was approved by the Regional Ethics Committee for Medical Research in Norway. RESULTS: There were no floor or ceiling effects on the score distributions. The study demonstrated moderate internal consistency and high reliability of SRS-22 questionnaire with Chronbach alpha and intraclass correlation coefficiency ranging from 0.76 to 0.93 for the 5 domains. Repeatability was excellent for all SRS-22 domains with repeatability coefficients <1. CD with EQ-5D was poor to moderate with Pearson's r ranging from 0.14 to 0.58. However,total scores of the 2 instruments showed satisfactory agreement. CONCLUSION: The SRS-22 outcome instrument has satisfactory repeatability,but CD with EQ-5D suggests that the disease-specific and the generic questionnaire measure different constructs."," Spine (Phila Pa 1976) 35(2): 206-209.","Norway",2010,"Spinal Deformity","Not Specified","SRS-HRQOL","Adolescents","Tool Validation","Observational","Norway","Adolescents","Spinal Deformity","Not Specified","Tool Validation","Observational","SRS-HRQOL","2010:2014"]
[5,"Adogwa,O.,et al. (2016). \"Pretreatment of Anxiety Before Cervical Spine Surgery Improves Clinical Outcomes: A Prospective,Single-Institution Experience.\" World Neurosurg 88: 625-630.",null,"Adogwa,O.,et al.","Pretreatment of Anxiety Before Cervical Spine Surgery Improves Clinical Outcomes: A Prospective,Single-Institution Experience","BACKGROUND: Affective disorders such as depression and anxiety have been shown to contribute to inferior outcomes after spine surgery. A high baseline level of anxiety is associated with refractory postoperative pain and patient dissatisfaction with surgery. The aim of this prospective study is to assess whether the pretreatment of anxiety before spine surgery improves patient reported outcomes 1-year after an anterior cervical discectomy and fusion (ACDF) procedure. METHODS: A total of 27 adult patients with a known history of anxiety disorder (pretreated cohort: 11 patients,control cohort: 16 patients) undergoing ACDF at Duke University Medical Center were included in this study. All patients were diagnosed with an anxiety disorder at least 6 months before surgery by a board-certified psychiatrist. Enrollment criteria included available demographic,surgical,and clinical outcomes data. All patients had prospectively collected patient reported outcomes measures and a minimum 1-year follow-up. Patients completed the Neck Disability Index (NDI),Short-Form 12 (SF-12),and visual analog scale (VAS) before surgery then at 6 weeks,and 3,6,and 12 months after surgery. Clinical outcomes and complication rates were compared between both patient cohorts. RESULTS: Baseline characteristics were similar between both cohorts. At baseline,there were no significant differences between cohorts in NDI (P = 0.11),SF-12 PCS (P = 0.63),SF-12 MCS (P = 0.90),and VAS neck pain (P = 0.80). There was no nerve root injury or incidental durotomy in either cohort. At 6 months after surgery,patients in the pretreated cohort reported significantly lower postoperative pain compared to the control cohort (P = 0.01). These results were durable through 1 year (P = 0.02). At 1 year,patients who were pretreated for anxiety before surgery reported significantly lower postoperative neck pain scores compared with the control cohort (P = 0.02). CONCLUSION: Our study demonstrates that pretreatment of anxiety before cervical spine surgery results in a significant reduction in postoperative neck pain scores and may be a viable management strategy for patients with coexisting affective disorders and cervical spine pathology. Patients awaiting spine surgery should routinely be assessed for anxiety before surgery,and interventions to reduce and treat anxiety should be provided."," World Neurosurg 88: 625-630.","USA",2016,"Neck Pain","Surgical","NDI","Unknown","PRO study","Prospective Observation","USA","Unknown","Neck Pain","Surgical","PRO study","Prospective Observation","NDI","2015:2018"]
[6,"Alanay,A.,et al. (2005). \"Reliability and validity of adapted Turkish Version of Scoliosis Research Society-22 (SRS-22) questionnaire.\" Spine (Phila Pa 1976) 30(21): 2464-2468.",null,"Alanay,A.,et al.","Reliability and validity of adapted Turkish Version of Scoliosis Research Society-22 (SRS-22) questionnaire","STUDY DESIGN: Outcome study to determine the internal consistency,and validity of adapted Turkish version of Scoliosis Research Society-22 (SRS-22) Instrument. OBJECTIVES: To evaluate the validity and reliability of adapted Turkish Version of SRS-22 questionnaire. SUMMARY OF BACKGROUND DATA: The SRS-22 questionnaire is a widely accepted questionnaire to assess the health-related quality of life for scoliotic patients in the United States. However,its adaptation in languages other than the source language is necessary for its multinational use. METHODS: Translation/retranslation of the English version of the SRS-22 was done,and all steps for cross-cultural adaptation process were performed properly by an expert committee. Later,SRS-22 questionnaires and previously validated Short Form-36 (SF-36) outcome instruments were mailed to 82 patients who had been surgically treated for idiopathic scoliosis. All patients had a minimum of 2 years follow-up. Fifty-four patients (66%) responded to the first set of questionnaires. Forty-seven of the first time respondents returned their second survey. The average age of the 47 patients (12 male,35 female) was 19.8 years (range,14-31 years). The two measures of reliability as internal consistency and reproducibility were determined by Cronbach alpha statistics and intraclass correlation coefficient,respectively. Concurrent validity was measured by comparing with an already validated questionnaire (SF-36). Measurement was made using the Pearson correlation coefficient (r). RESULTS: The study demonstrated satisfactory internal consistency with high Cronbach alpha values for the four of the corresponding domains (pain,0.72; self-image,0.80; mental health,0.72; and satisfaction,0.83). However,the Cronbach alpha value for function/activity domain (0.48) was considerably lower than the original questionnaire. The intraclass correlation coefficient for the same domains was 0.80,0.82,0.78,0.81,and 0.76,respectively,demonstrating a satisfactory test/retest reproducibility. Considering concurrent validity,two domains had excellent correlation (r = 0.75-1),while 9 had good correlation (r = 0.50 to 0.75),and 6 had moderate correlation (r =0.25-0.50). Based on these results,question 18 in the function/activity domain with lower Cronbach alpha value was revised while question 15 was excluded. The revised SRS-22 was given to 30 adolescent idiopathic scoliosis patients not included in the index study. The revision could improve the Cronbach alpha value for function/activity domain from 0.48 to 0.81. CONCLUSION: This study demonstrated that,if measures are to be used across cultures,the items must not only be translated well linguistically but also must be culturally adapted to maintain the content validity of the instrument at a conceptual level across different cultures. This may necessitate several validation studies to ensure and improve consistency in the content and face validity between source and target versions of a questionnaire due to difficulty in detecting subtle differences in the living habits of different cultures."," Spine (Phila Pa 1976) 30(21): 2464-2468.","Turkey",2005,"Spinal Deformity","Surgical","SRS-HRQOL","Adults,Adolescents","Tool Validation","Observational","Turkey","Adults,Adolescents","Spinal Deformity","Surgical","Tool Validation","Observational","SRS-HRQOL","2005:2009"]
[7,"Albaladejo,C.,et al. (2010). \"The efficacy of a short education program and a short physiotherapy program for treating low back pain in primary care: a cluster randomized trial.\" Spine (Phila Pa 1976) 35(5): 483-496.",null,"Albaladejo,C.,et al.","The efficacy of a short education program and a short physiotherapy program for treating low back pain in primary care: a cluster randomized trial","STUDY DESIGN: Cluster randomized clinical trial. OBJECTIVE: To assess the efficacy of a short education program and short physiotherapy program for treating low back pain (LBP) in primary care. SUMMARY OF BACKGROUND DATA: There is sparse evidence on the effectiveness of education and physiotherapy programs that are short enough to be feasible in primary care. METHODS: Sixty-nine primary care physicians were randomly assigned to 3 groups and recruited 348 patients consulting for LBP; 265 (79.8%) were chronic. All patients received usual care,were given a booklet and received a consistent 15 minutes group talk on health education,which focused on healthy nutrition habits in the control group,and on active management for LBP in the \"education\" and \"education + physiotherapy\" groups. Additionally,in the \"education + physiotherapy\" group,patients were given a second booklet and a 15-minute group talk on postural hygiene,and 4 one-hour physiotherapy sessions of exercise and stretching which they were encouraged to keep practicing at home. The main outcome measure was improvement of LBP-related disability at 6 months. Patients' assessment and data analyses were blinded. RESULTS: During the 6-month follow-up period,improvement in the \"control\" group was negligible. Additional improvement in the \"education\" and \"education + physiotherapy\" groups was found for disability (2.0 and 2.2 Roland Morris Questionnaire points,respectively),LBP (1.8 and 2.10 Visual Analogue Scale points),referred pain (1.3 and 1.6 Visual Analogue Scale points),catastrophizing (1.6 and 1.8 Coping Strategies Questionnaire points),physical quality of life (2.9 and 2.9 SF-12 points),and mental quality of life (3.7 and 5.1 SF-12 points). CONCLUSION: The addition of a short education program on active management to usual care in primary care leads to small but consistent improvements in disability,pain,and quality of life. The addition of a short physiotherapy program composed of education on postural hygiene and exercise intended to be continued at home,increases those improvements,although the magnitude of that increase is clinically irrelevant."," Spine (Phila Pa 1976) 35(5): 483-496.","Spain",2010,"Back Pain","Education,Physical Therapy","RMDQ","Adults,Adolescents","PRO study","Clinical trial","Spain","Adults,Adolescents","Back Pain","Education,Physical Therapy","PRO study","Clinical trial","RMDQ","2010:2014"]
[8,"Alcantara,J.,et al. (2015). \"The use of validated outcome measures in the chiropractic care of pregnant patients: A systematic review of the literature.\" Complement Ther Clin Pract 21(2): 131-136.",null,"Alcantara,J.,et al.","The use of validated outcome measures in the chiropractic care of pregnant patients: A systematic review of the literature","BACKGROUND: Healthcare systems recognize the need to incorporate patient-reported outcomes as part of their clinical and research measures. We performed this review on the use of validated outcome measures in the chiropractic care of pregnant patients. METHODS: Pubmed,CINAHL,Medline,Index to Chiropractic Literature and MANTIS were searched for (1999) primary investigation reports (i.e.,case reports,case series,case control,randomized controlled trials and survey or surveillance studies) published in English; (2) involving the care of pregnant patient(s) and (3) utilizing a valid outcome measure. RESULTS: Our review found 8 articles using the Patient's Global Impression of Change,the NRS,the Oswestry,Bournemouth,Fear Avoidance Belief and Quebec Disability questionnaires,PROMIS-29 and the Measure Yourself Medical Outcome Profile. CONCLUSION: Despite their heterogeneity and inconsistency of use in the studies reviewed,our findings demonstrate some measure of effectiveness in the chiropractic care of pregnant patients."," Complement Ther Clin Pract 21(2): 131-136.","USA,Canada,Philippines",2015,"Unspecified","Chiropractic","ODI,NRS,BOURNEMOUTH,QBPD","Unknown","PRO study","Systematic review","USA,Canada,Philippines","Unknown","Unspecified","Chiropractic","PRO study","Systematic review","ODI,NRS,BOURNEMOUTH,QBPD","2015:2018"]
[9,"Allison,D. J.,et al. (2016). \"Targeting inflammation as a treatment modality for neuropathic pain in spinal cord injury: a randomized clinical trial.\" J Neuroinflammation 13(1999): 152.",null,"Allison,D. J.,et al.","Targeting inflammation as a treatment modality for neuropathic pain in spinal cord injury: a randomized clinical trial","BACKGROUND: The purpose of the present study was to examine the effectiveness of an anti-inflammatory intervention as a treatment for neuropathic pain following spinal cord injury (SCI). METHODS: This randomized,parallel-group,controlled clinical trial (NCT02099890) examined 20 participants with varying levels and severities of SCI,randomized (3:2) to either a 12-week anti-inflammatory diet,or control group. Outcome measures consisted of self-determined indices of pain as assessed using the neuropathic pain questionnaire (NPQ) and markers of inflammation as assessed by various pro- and anti-inflammatory cytokines,as well as the eicosanoids PGE2 and LTB4. RESULTS: A significant group x time interaction was found for sensory pain scores (p < 0.01). A Mann-Whitney test revealed that the change scores (3-month baseline) were significantly different between groups for IFN-y (U = 13.0,p = 0.01),IL-1beta (U = 14.0,p = 0.01),and IL-2 (U = 12.0,p = 0.01). A Friedman test revealed the treatment group had a significant reduction in IFN-y (x (2) = 8.67,p = 0.01),IL-1beta (x (2) = 17.78,p < 0.01),IL-6 (x (2) = 6.17,p < 0.05),while the control group showed no significant change in any inflammatory mediator. A stepwise backward elimination multiple regression analysis showed that the change in sensory neuropathic pain was a function of the change in the proinflammatory cytokines IL-2 and IFN-y,as well as the eicosanoid PGE2 (R = 0.689,R (2) = 0.474). CONCLUSIONS: Overall,the results of the study demonstrate the efficacy of targeting inflammation as a means of treating neuropathic pain in SCI,with a potential mechanism relating to the reduction in proinflammatory cytokines and PGE2. TRIAL REGISTRATION: ClinicalTrials.gov,NCT02099890."," J Neuroinflammation 13(1999): 152.","Canada",2016,"Neuropathic Pain","Not Specified","NPDIQ","Unknown","PRO study","RCT","Canada","Unknown","Neuropathic Pain","Not Specified","PRO study","RCT","NPDIQ","2015:2018"]
[10,"Al-Smadi,J.,et al. (2003). \"A pilot investigation of the hypoalgesic effects of transcutaneous electrical nerve stimulation upon low back pain in people with multiple sclerosis.\" Clin Rehabil 17(7): 742-749.",null,"Al-Smadi,J.,et al.","A pilot investigation of the hypoalgesic effects of transcutaneous electrical nerve stimulation upon low back pain in people with multiple sclerosis","OBJECTIVE: To investigate the hypoalgesic effects of transcutaneous electrical nerve stimulation (TENS) upon low back pain (LBP) in people with multiple sclerosis (MS). DESIGN: A randomized double-blind placebo controlled clinical pilot study. SUBJECTS AND SETTING: Fifteen people with MS were recruited and randomly allocated to one of the following groups under double blind conditions (n = 5 per group): TENS 1 (4 Hz,200 micros),TENS 2 (110 Hz,200 micros),placebo TENS. INTERVENTIONS: Treatment was applied for 45 minutes three times a week for six weeks with a four-week follow-up. OUTCOME MEASURES: The following outcome measures were taken at weeks 1,6,and 10: visual analogue scale (VAS) (for current LBP,right leg pain,left leg pain); Leeds Multiple Sclerosis Quality of Life Questionnaire; Roland Morris Disability Questionnaire; Short Form-36 (SF-36) Version 1; and the McGill Pain Questionnaire (MPQ). VAS for current LBP,right and left leg pain were also taken before and after treatment,and once a week during the follow-up period. RESULTS: Analysis showed no statistically significant effects for any of the data. However,both active treatment groups showed a trend of improvement in the majority of the outcome measures. CONCLUSION: Active TENS was more effective than placebo TENS in decreasing VAS scores following each treatment although results were not statistically significant. Further work in this area is warranted and should include a larger number of participants in the form of a randomized controlled clinical trial to determine the efficacy of this modality."," Clin Rehabil 17(7): 742-749.","Ireland",2003,"Back Pain","Physical Therapy","RMDQ","Unknown","PRO study","RCT","Ireland","Unknown","Back Pain","Physical Therapy","PRO study","RCT","RMDQ","2000:2004"]
[11,"Ament,J. D.,et al. (2014). \"Cost-effectiveness of cervical total disc replacement vs fusion for the treatment of 2-level symptomatic degenerative disc disease.\" JAMA Surg 149(12): 1231-1239.",null,"Ament,J. D.,et al.","Cost-effectiveness of cervical total disc replacement vs fusion for the treatment of 2-level symptomatic degenerative disc disease","IMPORTANCE: Cervical total disc replacement (CTDR) was developed to treat cervical spondylosis,while preserving motion. While anterior cervical discectomy and fusion (ACDF) has been the standard of care for 2-level disease,a randomized clinical trial (RCT) suggested similar outcomes. Cost-effectiveness of this intervention has never been elucidated. OBJECTIVE: To determine the cost-effectiveness of CTDR compared with ACDF. DESIGN,SETTING,AND PARTICIPANTS: Data were derived from an RCT that followed up 330 patients over 24 months. The original RCT consisted of multi-institutional data including private and academic institutions. Using linear regression for the current study,health states were constructed based on the stratification of the Neck Disability Index and a visual analog scale. Data from the 12-item Short-Form Health Survey questionnaires were transformed into utilities values using the SF-6D mapping algorithm. Costs were calculated by extracting Diagnosis-Related Group codes from institutional billing data and then applying 2012 Medicare reimbursement rates. The costs of complications and return-to-work data were also calculated. A Markov model was built to evaluate quality-adjusted life-years (QALYs) for both treatment groups. The model adopted a third-party payer perspective and applied a 3% annual discount rate. Patients included in the original RCT had to be diagnosed as having radiculopathy or myeloradiculopathy at 2 contiguous levels from C3-C7 that was unresponsive to conservative treatment for at least 6 weeks or demonstrated progressive symptoms. MAIN OUTCOMES AND MEASURES: Incremental cost-effectiveness ratio of CTDR compared with ACDF. RESULTS: A strong correlation (R2 = 0.6864; P < .001) was found by projecting a visual analog scale onto the Neck Disability Index. Cervical total disc replacement had an average of 1.58 QALYs after 24 months compared with 1.50 QALYs for ACDF recipients. Cervical total disc replacement was associated with $2139 greater average cost. The incremental cost-effectiveness ratio of CTDR compared with ACDF was $24,594 per QALY at 2 years. Despite varying input parameters in the sensitivity analysis,the incremental cost-effectiveness ratio value stays below the threshold of $50,000 per QALY in most scenarios (range,-$58,194 to $147,862 per QALY). CONCLUSIONS AND RELEVANCE: The incremental cost-effectiveness ratio of CTDR compared with traditional ACDF is lower than the commonly accepted threshold of $50,000 per QALY. This remains true with varying input parameters in a robust sensitivity analysis,reaffirming the stability of the model and the sustainability of this intervention."," JAMA Surg 149(12): 1231-1239.","USA",2014,"Spondylosis","Surgical","NDI","Adults","Cost-Effectiveness","RCT","USA","Adults","Spondylosis","Surgical","Cost-Effectiveness","RCT","NDI","2010:2014"]
[12,"Ament,J. D.,et al. (2015). \"A Novel Quality-of-Life Utility Index in Patients With Multilevel Cervical Degenerative Disc Disease: Comparison of Anterior Cervical Discectomy and Fusion With Total Disc Replacement.\" Spine (Phila Pa 1976) 40(14): 1072-1078.",null,"Ament,J. D.,et al.","A Novel Quality-of-Life Utility Index in Patients With Multilevel Cervical Degenerative Disc Disease: Comparison of Anterior Cervical Discectomy and Fusion With Total Disc Replacement","STUDY DESIGN: Decision analysis from prior randomized controlled trial (RCT) data. OBJECTIVE: To describe the importance of developing baseline utility indices while identifying effective treatment options for cervical spine disease. SUMMARY OF BACKGROUND DATA: Cervical total disc replacement (CTDR) was developed to treat cervical spondylosis while preserving motion. Although anterior cervical discectomy and fusion (ACDF) has been the standard of care,a recent RCT suggested similar outcomes for 2-level disease. The quality-of-life benefit afforded by both CTDR and ACDF has never been fully elucidated. The purpose of our investigation was to better define the changes in utility and perceived value for patients undergoing these procedures. METHODS: Data were derived from LDR's RCT comparing CTDR and ACDF for 2-level cervical disc disease. Using linear regression,we constructed health states on the basis of the stratification of clinical outcomes used in the RCT,namely,neck disability index and visual analogue scale. Data from SF-12 questionnaires,completed preoperatively and at each follow-up visit,were transformed into utilities using the SF-6D mapping algorithm. SAS v.9.3 was used for the analyses. RESULTS: A strong correlation (R = 0.6864,P < 0.0001) was found between neck disability index and visual analogue scale. We constructed 5 distinct health states by projecting neck disability index intervals onto visual analogue scale. A poorer health state was associated with a lower mean utility value whereas a higher health state was associated with a higher mean utility value (P < 0.0001). The difference in preoperative utility between 2-level ACDF and CTDR was not significant (P = 0.1982),and yet,the difference in the postoperative utility between the cohorts was significant (P < 0.05) at every time point collected from 6 to 60 months. CONCLUSION: This is the first instance in which distinct utility values have been derived for validated health states related to cervical spine disease. There is substantial potential for these to become baseline future indices for cost-utility analyses in similar populations. LEVEL OF EVIDENCE: 1."," Spine (Phila Pa 1976) 40(14): 1072-1078.","Israel",2015,"Spondylosis","Surgical","NDI","Unknown","Tool Validation","Observational","Israel","Unknown","Spondylosis","Surgical","Tool Validation","Observational","NDI","2015:2018"]
[13,"Amorim,C. S.,et al. (2014). \"Effectiveness of global postural reeducation compared to segmental exercises on function,pain,and quality of life of patients with scapular dyskinesis associated with neck pain: a preliminary clinical trial.\" J Manipulative Physiol Ther 37(6): 441-447.",null,"Amorim,C. S.,et al.","Effectiveness of global postural reeducation compared to segmental exercises on function,pain,and quality of life of patients with scapular dyskinesis associated with neck pain: a preliminary clinical trial","OBJECTIVE: The purpose of this study was to assess the effectiveness of global postural reeducation (GPR) relative to segmental exercises (SE) in the treatment of scapular dyskinesis (SD) associated with neck pain. METHODS: Participants with SD and neck pain (n = 30) aged 18 to 65 years were randomly assigned to one of two groups: GPR and SE (stretching exercises). The upper extremity was assessed using the Disabilities of the Arm,Shoulder,and Hand questionnaire; function of the neck was estimated using the Neck Disability Index; pain severity was measured using a visual analogical scale; and health-related quality of life was assessed using the Short Form-12. Assessments were conducted at baseline and after 10 weekly sessions (60 minutes each). The significance level adopted was alpha < .05. RESULTS: For pre-post treatment comparisons,GPR was significantly associated with improvements in function of neck and upper extremities,pain,and physical and mental domains of quality of life (P < .05). Segmental exercises improved function of upper extremities and of the neck and severity of pain (P < .05). When contrasting groups,GPR was significantly superior to SE in improving pain and physical domains of the quality of life. CONCLUSION: This study showed that GPR and SE had similar effects on function of the neck and upper extremity in patients with SD associated with neck pain. When comparing groups,GPR was superior to SE in improving pain and quality of life."," J Manipulative Physiol Ther 37(6): 441-447.","Brazil",2014,"Neck Pain","Physical Therapy","NDI","Adults","PRO study","Clinical trial","Brazil","Adults","Neck Pain","Physical Therapy","PRO study","Clinical trial","NDI","2010:2014"]
[14,"Amr,Y. M. (2011). \"Effect of addition of epidural ketamine to steroid in lumbar radiculitis: one-year follow-up.\" Pain Physician 14(5): 475-481.",null,"Amr,Y. M.","Effect of addition of epidural ketamine to steroid in lumbar radiculitis: one-year follow-up","BACKGROUND: Treating sciatica with epidural steroid injection has been a common practice worldwide. N-methyl-D-aspartate (NMDA) receptors are an important component of pain pathways. OBJECTIVES: The aim of this study was to evaluate the safety and efficacy of epidurally administered NMDA receptor antagonists (ketamine) for the treatment of chronic low back pain secondary to radiculopathy and its effect on patients' quality of life. STUDY DESIGN: Randomized,double blind controlled trial. SETTING: Hospital outpatient setting. METHODS: Two hundred participants aged 25 to 50 years old with a diagnosis of lumbar radiculopathic pain secondary to disc herniation were randomized into 2 equal groups. Group I received 80 mg of triamcinolone (2 mL) and 0.25% bupivacaine (3 mL) plus 30 mg (3 mL) of preservative free ketamine. Group II received 80 mg of triamcinolone (2 mL) and 0.25% bupivacaine (3 mL) plus 3 mL of 0.9% saline. Pain scores were obtained before injection,immediately after injection,one week,one month,3 months,6 months,9 months and one year post injection. The Oswestry Low Back Pain Disability Questionnaire was used at baseline and at one month,3,6,9,and 12 months after injection for assessment of quality of life. Patients were asked to report any side effects,particularly those related to ketamine,including nausea,vomiting,visual or auditory hallucinations,and delirium. RESULTS: Immediately after injection there was no statistically significant difference between Group I and II regarding pain scale scores. After one week of injection,pain relief was significantly better in Group I compared to Group II and then at all evaluation times. The Oswestry Low Back Pain Disability Questionnaire score decreased significantly (P < 0.05) from 72 (range 62- 83) and 70 (range 57- 82) to 8 (range 2 - 12) and 17 (range 9 - 27) at one month; 6 (range 4 - 12) and 18 (range 14 - 22) at 3 months; 12 (range 9 - 16) and 28 (range 22 - 34) at 6 months; 17 (range 9 - 24) and 31 (range 21 - 35) at 9 months; and 17 (range 8 - 22) and 33 (range 20 - 37) at 12 months in the groups,respectively. Six patients in the ketamine group showed short-lasting delusions lasting for 45 +/- 12 minutes after injection. LIMITATIONS: The limitations include a lack of placebo control. CONCLUSION: Epidurally administrated ketamine seems to be a safe and useful adjunct to epidural corticosteroid therapy in chronic lumbar radicular pain."," Pain Physician 14(5): 475-481.","Egypt",2011,"Back Pain,Degenerative Disk Disease","Ketamine","ODI","Adults","PRO study","Clinical trial","Egypt","Adults","Back Pain,Degenerative Disk Disease","Ketamine","PRO study","Clinical trial","ODI","2010:2014"]
[15,"Armaghani,S. J.,et al. (2016). \"Diabetes Is Related to Worse Patient-Reported Outcomes at Two Years Following Spine Surgery.\" J Bone Joint Surg Am 98(1999): 15-22.",null,"Armaghani,S. J.,et al.","Diabetes Is Related to Worse Patient-Reported Outcomes at Two Years Following Spine Surgery","BACKGROUND: Diabetes has been associated with poor outcomes following elective spine surgery. The purpose of our study was to determine if diabetes predicts worse patient-reported outcomes at two years postoperatively and to evaluate the effect of perioperative blood glucose levels and control on patient-reported outcomes in patients with diabetes. METHODS: One thousand and five patients undergoing elective spine surgery were included in this prospective cohort study. The presence of diabetes and baseline and one and two-year patient-reported outcomes (Short Form-12 [SF-12],EuroQol-5D [EQ-5D],Oswestry Disability Index [ODI] or Neck Disability Index [NDI],and Numeric Rating Scale [NRS] pain scores) were recorded. The mean blood glucose measurements in patients with diabetes were collected during the postoperative period. Multivariable linear regression analyses were performed to determine predictors of one and two-year outcomes as well as the relationship between perioperative blood glucose and patient-reported outcomes in patients with diabetes. RESULTS: Four hundred and thirty-four patients (43%) had diabetes. When compared with patients without diabetes at two years,patients with diabetes had lower SF-12 Physical Component Summary scores (34.4 points for the diabetic group compared with 38.6 points for the non-diabetic group),lower EQ-5D scores (0.67 for the diabetic group compared with 0.74 for the non-diabetic group),higher ODI or NDI scores (32.1 points for the diabetic group compared with 26.8 points for the non-diabetic group),and higher NRS scores (5.1 points for the diabetic group compared with 4.3 points for the non-diabetic group) (p < 0.05 for all). Although patients with diabetes improved significantly over time,they did not improve to the extent that patients without diabetes did in the ODI or NDI and EQ-5D scores (p < 0.05). Diabetes and preoperative opioid use were independent predictors of decreased SF-12 scores,decreased EQ-5D scores,increased ODI or NDI scores,and increased NRS scores (p < 0.05). Diabetes was associated with increased ODI or NDI (by 6.6 points) and decreased EQ-5D (by 0.1) at two years. Perioperative blood glucose control did not predict outcomes at either one or two years in patients with diabetes. CONCLUSIONS: Diabetes was associated with worse patient-reported outcomes when patients with diabetes were compared with patients without diabetes at two years following elective spine surgery. Although patients with diabetes improved when compared from baseline to the time following elective spine surgery,they did not improve to the same extent as patients without diabetes in the ODI or NDI and EQ-5D scores. Providers may use this information to counsel patients with diabetes on expectations following spine surgery."," J Bone Joint Surg Am 98(1999): 15-22.","USA",2016,"Diabetes","Surgical","ODI,NDI","Unknown","PRO study","Prospective Observation","USA","Unknown","Diabetes","Surgical","PRO study","Prospective Observation","ODI,NDI","2015:2018"]
[16,"Arnold,P. M.,et al. (2014). \"Mild diabetes is not a contraindication for surgical decompression in cervical spondylotic myelopathy: results of the AOSpine North America multicenter prospective study (CSM).\" Spine J 14(1999): 65-72.",null,"Arnold,P. M.,et al.","Mild diabetes is not a contraindication for surgical decompression in cervical spondylotic myelopathy: results of the AOSpine North America multicenter prospective study (CSM)","BACKGROUND CONTEXT: Cervical spondylotic myelopathy (CSM) is a chronic spinal cord disease and can lead to progressive or stepwise neurologic decline. Several factors may influence this process,including extent of spinal cord compression,duration of symptoms,and medical comorbidities. Diabetes is a systemic disease that can impact multiple organ systems,including the central and peripheral nervous systems. There has been little information regarding the effect of diabetes on patients with coexistent CSM. PURPOSE: To provide empirical data regarding the effect of diabetes on treatment outcomes in patients who underwent surgical decompression for coexistent CSM. STUDY DESIGN/SETTING: Large prospective multicenter cohort study of patients with and without diabetes who underwent decompressive surgery for CSM. PATIENT SAMPLE: Two hundred thirty-six patients without and 42 patients with diabetes were enrolled. Of these,37 were mild cases and five were moderate cases. Four required insulin. There were no severe cases associated with end-organ damage. OUTCOME MEASURES: Self-report measures include Neck Disability Index and version 2 of 36-Item Short Form Health Survey (SF-36v2),and functional measures include modified Japanese Orthopedic Association (mJOA) score and Nurick grade. METHODS: We compared presurgery symptoms and treatment outcomes between patients with and without diabetes using univariate and multivariate models,adjusting for demographics and comorbidities. RESULTS: Diabetic patients were older,less likely to smoke,and more likely to be on social security disability insurance. Patients with diabetes presented with a worse Nurick grade,but there were no differences in mJOA and SF-36v2 at presentation. Overall,there was a significant improvement in all outcome parameters at 12 and 24 months. There was no difference in the level of improvement between the patients with and without diabetes,except in the SF-36v2 Physical Functioning,in which diabetic patients experienced significantly less improvement. There were no differences in surgical complication rates between diabetic patients and nondiabetic patients. CONCLUSIONS: Except for a worse Nurick grade,diabetes does not seem to affect severity of symptoms at presentation for surgery. More importantly,with the exception of the SF-36v2 Physical Functioning scores,outcomes of surgical treatment are similar in patients with diabetes and without diabetes. Surgical decompression is effective and should be offered to patients with diabetes who have symptomatic CSM and are appropriate surgical candidates."," Spine J 14(1999): 65-72.","USA,Canada",2014,"Spondylosis","Surgical","NDI,JOACMEQ,Nurick","Unknown","PRO study","Prospective Observation","USA,Canada","Unknown","Spondylosis","Surgical","PRO study","Prospective Observation","NDI,JOACMEQ,Nurick","2010:2014"]
[17,"Arts,M. P.,et al. (2006). \"Cost-effectiveness of microendoscopic discectomy versus conventional open discectomy in the treatment of lumbar disc herniation: a prospective randomised controlled trial [ISRCTN51857546].\" BMC Musculoskelet Disord 7: 42.",null,"Arts,M. P.,et al.","Cost-effectiveness of microendoscopic discectomy versus conventional open discectomy in the treatment of lumbar disc herniation: a prospective randomised controlled trial [ISRCTN51857546]","BACKGROUND: Open discectomy is the standard surgical procedure in the treatment of patients with long-lasting sciatica caused by lumbar disc herniation. Minimally invasive approaches such as microendoscopic discectomy have gained attention in recent years. Reduced tissue trauma allows early ambulation,short hospital stay and quick resumption of daily activities. A comparative cost-effectiveness study has not been performed yet. We present the design of a randomised controlled trial on cost-effectiveness of microendoscopic discectomy versus conventional open discectomy in patients with lumbar disc herniation. METHODS/DESIGN: Patients (age 18-70 years) presenting with sciatica due to lumbar disc herniation lasting more than 6-8 weeks are included. Patients with disc herniation larger than 1/3 of the spinal canal diameter,or disc herniation less than 1/3 of the spinal canal diameter with concomitant lateral recess stenosis or sequestration,are eliglible for participation. Randomisation into microendoscopic discectomy or conventional unilateral transflaval discectomy will take place in the operating room after induction of anesthesia. The length of skin incision is equal in both groups. The primary outcome measure is the functional assessment of the patient,measured by the Roland Disability Questionnaire for Sciatica,at 8 weeks and 1 year after surgery. We will also evaluate several other outcome parameters,including perceived recovery,leg and back pain,incidence of re-operations,complications,serum creatine kinase,quality of life,medical consumption,absenteeism and costs. The study is a randomised prospective multi-institutional trial,in which two surgical techniques are compared in a parallel group design. Patients and research nurses are kept blinded of the allocated treatment during the follow-up period of 2 years. DISCUSSION: Currently,open discectomy is the golden standard in the surgical treatment of lumbar disc herniation. Whether microendoscopic discectomy is more cost-effective than unilateral transflaval discectomy has to be determined by this trial."," BMC Musculoskelet Disord 7: 42.","Netherlands",2006,"Degenerative Disk Disease","Surgical","RMDQ","Adolescents,Adults","Cost-Effectiveness","RCT","Netherlands","Adolescents,Adults","Degenerative Disk Disease","Surgical","Cost-Effectiveness","RCT","RMDQ","2005:2009"]
[18,"Arts,M. P.,et al. (2008). \"Cost-effectiveness of decompression according to Gill versus instrumented spondylodesis in the treatment of sciatica due to low grade spondylolytic spondylolisthesis: a prospective randomised controlled trial [NTR1300].\" BMC Musculoskelet Disord 9: 128.",null,"Arts,M. P.,et al.","Cost-effectiveness of decompression according to Gill versus instrumented spondylodesis in the treatment of sciatica due to low grade spondylolytic spondylolisthesis: a prospective randomised controlled trial [NTR1300]","BACKGROUND: Nerve root decompression with instrumented spondylodesis is the most frequently performed surgical procedure in the treatment of patients with symptomatic low-grade spondylolytic spondylolisthesis. Nerve root decompression without instrumented fusion,i.e. Gill's procedure,is an alternative and less invasive approach. A comparative cost-effectiveness study has not been performed yet. We present the design of a randomised controlled trial on cost-effectiveness of decompression according to Gill versus instrumented spondylodesis. METHODS/DESIGN: All patients (age between 18 and 70 years) with sciatica or neurogenic claudication lasting more than 3 months due to spondylolytic spondylolisthesis grade I or II,are eligible for inclusion. Patients will be randomly allocated to nerve root decompression according to Gill,either unilateral or bilateral,or pedicle screw fixation with interbody fusion. The main primary outcome measure is the functional assessment of the patient measured with the Roland Disability Questionnaire for Sciatica at 12 weeks and 2 years. Other primary outcome measures are perceived recovery and intensity of leg pain and low back pain. The secondary outcome measures include,incidence of re-operations,complications,serum creatine phosphokinase,quality of life,medical consumption,costs,absenteeism,work perception,depression and anxiety,and treatment preference. The study is a randomised prospective multicenter trial in which two surgical techniques are compared in a parallel group design. Patients and research nurse will not be blinded during the follow-up period of 2 years. DISCUSSION: Currently,nerve root decompression with instrumented fusion is the golden standard in the surgical treatment of low-grade spondylolytic spondylolisthesis,although scientific proof justifying instrumented spondylodesis over simple decompression is lacking. This trial is designed to elucidate the controversy in best surgical treatment of symptomatic patients with low-grade spondylolytic spondylolisthesis."," BMC Musculoskelet Disord 9: 128.","Netherlands",2008,"Back Pain,Spondylosis","Surgical","RMDQ","Adults","Cost-Effectiveness","Prospective Observation","Netherlands","Adults","Back Pain,Spondylosis","Surgical","Cost-Effectiveness","Prospective Observation","RMDQ","2005:2009"]
[19,"Arts,M. P.,et al. (2010). \"The NEtherlands Cervical Kinematics (NECK) trial. Cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in the treatment of cervical disc herniation; a double-blind randomised multicenter study.\" BMC Musculoskelet Disord 11: 122.",null,"Arts,M. P.,et al.","The NEtherlands Cervical Kinematics (NECK) trial. Cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in the treatment of cervical disc herniation; a double-blind randomised multicenter study","BACKGROUND: Patients with cervical radicular syndrome due to disc herniation refractory to conservative treatment are offered surgical treatment. Anterior cervical discectomy is the standard procedure,often in combination with interbody fusion. Accelerated adjacent disc degeneration is a known entity on the long term. Recently,cervical disc prostheses are developed to maintain motion and possibly reduce the incidence of adjacent disc degeneration. A comparative cost-effectiveness study focused on adjacent segment degeneration and functional outcome has not been performed yet. We present the design of the NECK trial,a randomised study on cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in patients with cervical disc herniation. METHODS/DESIGN: Patients (age 18-65 years) presenting with radicular signs due to single level cervical disc herniation lasting more than 8 weeks are included. Patients will be randomised into 3 groups: anterior discectomy only,anterior discectomy with interbody fusion,and anterior discectomy with disc prosthesis. The primary outcome measure is symptomatic adjacent disc degeneration at 2 and 5 years after surgery. Other outcome parameters will be the Neck Disability Index,perceived recovery,arm and neck pain,complications,re-operations,quality of life,job satisfaction,anxiety and depression assessment,medical consumption,absenteeism,and costs. The study is a randomised prospective multicenter trial,in which 3 surgical techniques are compared in a parallel group design. Patients and research nurses will be kept blinded of the allocated treatment for 2 years. The follow-up period is 5 years. DISCUSSION: Currently,anterior cervical discectomy with fusion is the golden standard in the surgical treatment of cervical disc herniation. Whether additional interbody fusion or disc prosthesis is necessary and cost-effective will be determined by this trial. TRIAL REGISTRATION: Netherlands Trial Register NTR1289."," BMC Musculoskelet Disord 11: 122.","Netherlands",2010,"Radiculopathy,Neck Pain,Degenerative Disk Disease","Surgical","NDI","General","Cost-Effectiveness","Clinical trial","Netherlands","General","Radiculopathy,Neck Pain,Degenerative Disk Disease","Surgical","Cost-Effectiveness","Clinical trial","NDI","2010:2014"]
[20,"Asher,M. A.,et al. (2006). \"Refinement of the SRS-22 Health-Related Quality of Life questionnaire Function domain.\" Spine (Phila Pa 1976) 31(5): 593-597.",null,"Asher,M. A.,et al.","Refinement of the SRS-22 Health-Related Quality of Life questionnaire Function domain","STUDY DESIGN: Prospective observational case series. OBJECTIVES: To improve the Scoliosis Research Society-22 (SRS-22) Health-Related Quality of Life (HRQL) questionnaire Function domain internal consistency for patients younger than 18 years. SUMMARY OF BACKGROUND DATA: During English validation as well as Spanish and Turkish transcultural adaptation studies,low internal consistency of the Function domain was discovered for patients younger than 18 years. The problem was traced to questions 15 (relating to financial considerations) and 18 (relating to going out with friends). Otherwise,the SRS-22 HRQL questionnaire has been shown to be valid and has been successfully translated into Spanish and Turkish. METHODS: Based on existing data,question 18's stem and responses were revised without changing its content and added to the SRS-22 questionnaire. Question 15 remained unchanged,and the effect of inclusion or exclusion on domain score was determined. During a 3-month period,the questionnaire was completed by 111 outpatients,including four groups: idiopathic scoliosis age < 18 years (n = 37),idiopathic scoliosis age > or = 18 years (n = 32),other spinal disorders age < 18 years (n = 17),and other spinal disorders age > or = 18 years (n = 25). RESULTS: As a result of the revision of question 18,the Function domain internal consistency,Cronbach's alpha,for patients age <18 years was increased from 0.67 to 0.78 for patients with idiopathic scoliosis and from 0.60 to 0.80 for patients with other spinal disorders. Domain internal consistency remained high,0.77 to 0.96 for all the other domain-patient groupings. Removal of question 15 slightly improved Function domain internal consistency for idiopathic scoliosis patients < 18 years old and slightly decreased it for patients < 18 years old with other spinal conditions. CONCLUSION: With a minor revision of question 18 (related to going out) the internal consistency of the SRS-22 Function domain has been improved in idiopathic scoliosis patients < 18 years of age. Deletion of question 15 (related to financial considerations) has a variable,small effect depending on patient group. Retention of question 15 is recommended unless a cultural variable,such as differences in healthcare payment schemes,substantially lowers domain psychometric properties."," Spine (Phila Pa 1976) 31(5): 593-597.","USA",2006,"Spinal Deformity","Not Specified","SRS-HRQOL","Adolescents,Children","Tool Validation","Observational","USA","Adolescents,Children","Spinal Deformity","Not Specified","Tool Validation","Observational","SRS-HRQOL","2005:2009"]
[21,"Asher,M.,et al. (2002). \"Spine deformity correlates better than trunk deformity with idiopathic scoliosis patients' quality of life questionnaire responses.\" Stud Health Technol Inform 91: 462-464.",null,"Asher,M.,et al.","Spine deformity correlates better than trunk deformity with idiopathic scoliosis patients' quality of life questionnaire responses","AIM: To determine whether either spine or trunk deformity measurements correlate with patients quality of life questionnaire responses. MATERIALS AND METHODS: Forty five pre operative patients (5M,40F),average age 15 years,9 months (range,10-20) met the inclusion criteria of age (< or = 20 years),Posterior Trunk Symmetry Index (POTSI) and Suzuki Hump Sum (SHS) determination from surface topography,and Scoliosis Research Society-22 (SRS-22)patient questionnaire completion. Average measurement and measurement ranges were largest Cobb 62 degrees (range,40-137 degrees),POTSI 49 (range,17-149),SHS 16 (5-32),and SRS-22 subtotal score 3.86 (range,4.7-2.35). The individual SRS-22 domain scores were function 4.13 (4.80-2.20),pain 4.01 (5-1.60),self image 3.34 (4.4-1.80) and mental health 4.01 (5-1.80). (Scale 5 Best-1 Worst). Correlations between deformity and questionnaire measurements were determined,p<0.01 considered significant. RESULTS: Spine deformity (Cobb) correlated with the SRS-22 subtotal scores (cc-04207,p<0.005) and with the function and self image SRS-22 domain scores: cc0.5182,p<0.001) and cc-0.3981,p<0.01 respectively. Neither trunk deformity score correlated with the SRS-22 Score: POTSI versus SRS-22 (cc 0.0449,ns) and SHS versus SRS-22 (cc-0.0311,ns) CONCLUSION: Spine deformity correlates well with quality of life questionnaire responses whereas trunk deformity magnitude does not. This is somewhat surprising as it is the trunk deformity that the patient can they themselves see. These findings illustrate the pitfalls of assuming what is important to the patient based on clinical measurements."," Stud Health Technol Inform 91: 462-464.","USA",2002,"Spinal Deformity","Surgical","SRS-HRQOL","Unknown","PRO study","Observational","USA","Unknown","Spinal Deformity","Surgical","PRO study","Observational","SRS-HRQOL","2000:2004"]
[22,"Asher,M.,et al. (2003). \"Discrimination validity of the scoliosis research society-22 patient questionnaire: relationship to idiopathic scoliosis curve pattern and curve size.\" Spine (Phila Pa 1976) 28(1999): 74-78.",null,"Asher,M.,et al.","Discrimination validity of the scoliosis research society-22 patient questionnaire: relationship to idiopathic scoliosis curve pattern and curve size","STUDY DESIGN: Prospective observational study. OBJECTIVE: To determine the discriminant validity of the Scoliosis Research Society-22 (SRS-22) health-related quality-of-life (HRQL) questionnaire for idiopathic scoliosis patients based on curve pattern and curve size. SUMMARY OF BACKGROUND DATA: An important psychometric attribute of the HRQL questionnaire is the capacity to discriminate between and among patients with differing condition severity. METHOD: Three study groups,with subjects ranging in age from 10 to 16 years,were set up: a control group (C) of 19 persons with scoliosis suspected but unproven with an average age of 13 years; a nonsurgical group (NS) of 68 patients with an average age of 14 years and an average scoliosis (Cobb) of 30 degrees; and a presurgical group (PS) of 32 patients with an average age of 14 years and an average scoliosis of 61 degrees. The NS group was subdivided into untreated (NSU) (n = 54) and braced (NSB) patients (n = 14). Also created were subgroups of the NS and PS groups having similar curve sizes: nonsurgical similar (NSS) and presurgery similar (PSS). Statistical significance of the SRS-22 domain scores by comparison groups was tested by ANOVA. Relationships between the SRS-22 questionnaire and scoliosis deformity measurements were calculated using the Pearson Correlation Coefficients. RESULTS: There were no significant differences between the control (C) and nonsurgical (NS) groups. The presurgical group (PS) scored significantly lower in the pain and self-image domains than the C or NS groups and lower than group C in the mental health domain. A subgroup of the nonsurgical group (NSS) with curves comparable to the presurgical subgroup (PSS) had significantly better self-image scores. There were no significant correlations between SRS-22 scores and curve pattern. For persons with scoliosis,curve size (Cobb) correlated with pain,self-image,and function; trunk asymmetry correlated with self-image. CONCLUSION: The SRS-22 HRQL questionnaire successfully discriminated among persons with no scoliosis or moderate scoliosis and large scoliosis. It did not discriminate among patients with single,double,or triple curves. Self-image and,to a lesser extent,pain and function domain scores correlated with radiographic and trunk asymmetry severity. The SRS-22 HRQL questionnaire may be useful in choosing nonsurgical versus surgical treatment in borderline cases."," Spine (Phila Pa 1976) 28(1999): 74-78.","USA",2003,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","Tool Validation","Observational","USA","Adolescents","Spinal Deformity","Surgical","Tool Validation","Observational","SRS-HRQOL","2000:2004"]
[23,"Asher,M.,et al. (2003). \"The reliability and concurrent validity of the scoliosis research society-22 patient questionnaire for idiopathic scoliosis.\" Spine (Phila Pa 1976) 28(1999): 63-69.",null,"Asher,M.,et al.","The reliability and concurrent validity of the scoliosis research society-22 patient questionnaire for idiopathic scoliosis","STUDY DESIGN: Outcome study to determine response distribution,internal consistency,reproducibility,and concurrent validity of the Scoliosis Research Society-22 (SRS-22) health-related quality-of-life (HRQL) questionnaire. OBJECTIVES: Further refinement of an HRQL questionnaire specific for idiopathic scoliosis. SUMMARY OF BACKGROUND DATA: Previous experience with the original and modified SRS HRQL questionnaires suggested a need for further refinement and more complete validation. METHODS: The SRS-22 and Short Form 36 (SF-36) HRQL questionnaires were mailed to 83 previously surveyed postoperative idiopathic scoliosis patients. RESULTS: Fifty-eight (70%) patients returned the first set of questionnaires. Their average age at surgery was 14.6 years,and their average follow-up interval since surgery was 10.8 years. Fifty-one (88%) of the 58 returned the second set of questionnaires an average of 28 days later. The psychometric attributes of the instruments were comparable: score distribution,SRS-22 56.9% ceiling and 1.7% floor,SF-36 79.3% ceiling and 1.7% floor; internal consistency (Cronbach alpha),SRS-22 0.92 to 0.75,SF-36 0.91 to 0.36; and reproducibility (intraclass correlation coefficient),SRS-22 0.96 to 0.85,SF-36 0.92 to 0.61. Concurrent validity,determined by Pearson Correlation Coefficients between SRS-22 and SF-36 domains,was 0.70 or greater ( < 0.0001) for 17 relevant comparisons. CONCLUSION: The SRS-22 HRQL questionnaire is reliable with internal consistency and reproducibility comparable to SF-36. In addition,it demonstrated concurrent validity when compared to SF-36. It is shorter and more focused on the health issues related to idiopathic scoliosis than SF-36."," Spine (Phila Pa 1976) 28(1999): 63-69.","USA",2003,"Spinal Deformity","Surgical","SRS-HRQOL","Unknown","Tool Validation","Observational","USA","Unknown","Spinal Deformity","Surgical","Tool Validation","Observational","SRS-HRQOL","2000:2004"]
[24,"Asher,M.,et al. (2004). \"The influence of spine and trunk deformity on preoperative idiopathic scoliosis patients' health-related quality of life questionnaire responses.\" Spine (Phila Pa 1976) 29(8): 861-868.",null,"Asher,M.,et al.","The influence of spine and trunk deformity on preoperative idiopathic scoliosis patients' health-related quality of life questionnaire responses","STUDY DESIGN: Retrospective case series. OBJECTIVES: To determine the influence of spine and trunk deformity on preoperative idiopathic scoliosis patients' health-related quality of life questionnaire responses. SUMMARY OF BACKGROUND DATA: Management recommendations for patients with idiopathic scoliosis during adolescence are based heavily on spine deformity and to some extent trunk deformity magnitude. However,the manner in which these objective measures influence the patients' perception of their condition is unclear. METHODS: Of 67 consecutive preoperative patients,61 (91%) had completed the Scoliosis Research Society-22 health-related quality of life questionnaire and had been studied with posterior exposure surface topography. Their average age was 15 years,6 months (range 10 years,10 months-20 years,10 months),and the average maximum Cobb was 63 degrees (range 40-137 degrees). Correlations between spine and trunk deformity measures and Scoliosis Research Society-22 scores were determined by the Pearson correlation coefficient,with P < 0.01 considered significant. RESULTS: For the study group,spine deformity (Cobb) correlated significantly only with Scoliosis Research Society-22 function (r = -0.39,P = 0.0022) domain. Neither coronal nor transverse plane trunk deformity composite scores correlated with any Scoliosis Research Society-22 scores. The Hump Index component of the transverse plane Suzuki Hump Sum composite score was the only trunk measurement to correlate significantly (function r = -0.45,P = 0.003; self image,r = -0.36,P = 0.0040). The strongest correlations occurred when the single thoracic curves,King classifications III and IV,were combined: Cobb versus function r = -0.53,P = 0.0027; Cobb versus self-image r = -0.46,P = 0.0099; and Hump Index versus function r = -0.60,P = 0.0005. There were no significant correlations between either spine deformity or any trunk deformity measure with Scoliosis Research Society-22 responses for either the double or thoracolumbar curve pattern groups. CONCLUSION: Both spine and upper thoracic transverse plane trunk deformity significantly influenced preoperative idiopathic scoliosis patients' perception of function and self-image,but not pain or mental health. However,in spite of a fairly rigorous standard of proof,P < or = 0.01,the significant r values ranged from -0.33 to -0.68,suggesting that there are factors other than spine and trunk deformity influencing the idiopathic scoliosis patients' health-related quality of life questionnaire responses. Future studies are necessary to define these factors."," Spine (Phila Pa 1976) 29(8): 861-868.","USA",2004,"Spinal Deformity","Surgical","SRS-HRQOL","Unknown","PRO study","Observational","USA","Unknown","Spinal Deformity","Surgical","PRO study","Observational","SRS-HRQOL","2000:2004"]
[25,"Atalay,N. S.,et al. (2013). \"Comparison of efficacy of neural therapy and physical therapy in chronic low back pain.\" Afr J Tradit Complement Altern Med 10(3): 431-435.",null,"Atalay,N. S.,et al.","Comparison of efficacy of neural therapy and physical therapy in chronic low back pain","The aim of this prospective study was to evaluate the effects of neural therapy,and physical therapy on level of pain,disability,quality of life,and psychological status in patients with chronic low back pain. Patients admitted to the physical therapy and rehabilitation outpatient clinic with the complaint of low back pain of at least 3 months duration. Group 1 (n=27),physical therapy (PT,hotpack,ultrasound,TENS 15 sessions),group 2 (n=33),neural therapy (NT,1:1 mixture of 20 mg/mL Lidocaine HCl (Jetokain simplex(R)) and saline for 5 sessions. For pain,Visual Analogue Scale (VAS),for disability Roland Morris Disability Questionnaire (RMDQ),for quality-of-life Nottingham-Health-Profile (NHP),for depression,and anxiety,Hospital Anxiety-Depression Scale (HADS) were used before and after the treatment. Mean age was 47.3+/-11.32 years,symptom time was 13.78+/-11.98 months. There were no differences for demographic variables between groups. Significant improvements were detected for VAS,RMDQ,NHP-Pain,NHP-Physical activity,HADS for both of two groups after treatment. In addition to these findings,significant improvements were found for NHP-Energy,NHP-Social isolation in NT group. The differences of pre- and post-treatment values of parameters were evaluated for each group. Although there were no differences for VAS,NHP-sleep,NHP-Emotional reaction,HADS between groups,RMDQ,NHP-Pain,NHP-Physical activity,NHP-Social isolation were higher in NT than PT before treatment,the improvements for these parameters were better in NT than PT. In conclusion both of NT and PT are effective on pain,function,quality of life,anxiety,and depression in patients with chronic low back pain."," Afr J Tradit Complement Altern Med 10(3): 431-435.","Turkey",2013,"Back Pain","Physical Therapy","RMDQ","Adults","PRO study","Observational","Turkey","Adults","Back Pain","Physical Therapy","PRO study","Observational","RMDQ","2010:2014"]
[26,"Atlas,S. J.,et al. (2003). \"The Maine-Seattle back questionnaire: a 12-item disability questionnaire for evaluating patients with lumbar sciatica or stenosis: results of a derivation and validation cohort analysis.\" Spine (Phila Pa 1976) 28(16): 1869-1876.",null,"Atlas,S. J.,et al.","The Maine-Seattle back questionnaire: a 12-item disability questionnaire for evaluating patients with lumbar sciatica or stenosis: results of a derivation and validation cohort analysis","STUDY DESIGN: Analysis of health-related quality of life data obtained from a prospective cohort study of patients with sciatica due to an intervertebral disc herniation or lumbar spinal stenosis. OBJECTIVE: To derive and validate a shortened version of a previously validated 23-item modification of the Roland-Morris Disability Questionnaire. SUMMARY OF BACKGROUND DATA: For patients with low back pain,improving health-related quality of life is often the main goal of therapy. The Roland-Morris Disability Questionnaire is one of the best validated and most frequently used back-specific functional status measures. A shortened version may permit more widespread use in clinical and research settings. METHODS: Data from 507 patients with sciatica enrolled in the Maine Lumbar Spine Study were used to derive a shortened version of a 23-item modification of the original Roland-Morris Disability Questionnaire using qualitative and cluster analysis techniques. The internal consistency,construct validity,reproducibility,and responsiveness in detecting change over a 3-month period for a new 12-item scale was compared to the original 23-item scale. The 12-item scale was then validated in an independent cohort of 148 patients with lumbar spinal stenosis. RESULTS: Internal consistency was very good but modestly lower for the 12-item instrument compared to the 23-item original scale. Reproducibility over a 3-month interval was good and did not differ between the 12-item and original scale. Findings from the validation cohort were similar or better than the derivation cohort. A high degree of construct validity with patient-reported symptoms was demonstrated for the 12-item and original scales. The responsiveness and interpretability of the 12-item scale over 3 months was excellent and comparable to the original scale. Responsiveness assessed in patients with lumbar spinal stenosis in the independent validation cohort showed consistent findings compared to patients with a disc herniation in the derivation cohort. CONCLUSIONS: This short,simple,self-administered 12-item back-specific functional status questionnaire performed extremely well in comparison with the original 23-item scale. If validated in additional study populations,this new questionnaire may be useful in the clinical setting as a way for providers to prospectively compare their outcomes of care to other patient populations,and to study treatment effectiveness."," Spine (Phila Pa 1976) 28(16): 1869-1876.","USA",2003,"Back Pain,Degenerative Disk Disease","Not Specified","Maine","Unknown","Tool Validation","Observational","USA","Unknown","Back Pain,Degenerative Disk Disease","Not Specified","Tool Validation","Observational","Maine","2000:2004"]
[27,"Auffinger,B.,et al. (2013). \"Usefulness of minimum clinically important difference for assessing patients with subaxial degenerative cervical spine disease: statistical versus substantial clinical benefit.\" Acta Neurochir (Wien) 155(12): 2345-2354; discussion 2355.",null,"Auffinger,B.,et al.","Usefulness of minimum clinically important difference for assessing patients with subaxial degenerative cervical spine disease: statistical versus substantial clinical benefit","BACKGROUND: The measurement of the therapeutic outcome of cervical spine surgeries commonly relies on four main patient reported outcomes (PROs): Neck Disability Index (NDI),Visual Analog Scale (VAS) for pain,and Short Form-36 (SF-36) Physical (PCS) and Mental (MCS) Component Summary. However,the clinical impact of such scores and how they could effectively measure therapeutic efficacy remains unclear. In this context,the concept of minimum clinically important difference (MCID) is developing into the standard by which to evaluate treatments,patient satisfaction and cost-effectiveness. METHODS: Eighty-eight consecutive patients undergoing surgery for subaxial degenerative cervical spine disease were selected from a prospective blinded database. PROs (NDI,PCS,MCS and VAS) were collected preoperatively,and together with blinded Surgeon Ratings (SR) at 3 months and 6 months post-surgery. Four anchor-based approaches were used to calculate different MCIDs. Three anchors (VAS,HTI (Health Transition Item of the SF-36) and SR) were used to evaluate surgery outcome. The best clinically and statistically relevant MCID was chosen. RESULTS: On average,all patients presented with a statistically significant improvement (p < 0.001) postoperatively for NDI (27.42 to 19.42),PCS (33.02 to 42.03),MCS (44 to 50.74) and VAS (2.85 to 1.93). The four MCID anchor-based approaches yielded a range of values for each PRO: 2.23-16.59 for PCS,0.11-16.27 for MCS and 2.72-12.08 for NDI. When compared to the VAS and HTI anchors,the area under the ROC curve was greater for SR. This finding suggests that SR may be a more reliable anchor for MCID calculation. CONCLUSION: The MDC (minimum detectable change) approach together with the SR anchor appears to be the most appropriate MCID method. It offers the greatest area under the ROC curve (threshold above the 95 % CI),and the choice of the anchor did not significantly affect this result. MCID values for this dataset were 5.6 for PCS,5.12 for MCS and 2.41 for NDI."," Acta Neurochir (Wien) 155(12): 2345-2354; discussion 2355.","USA",2013,"Spine Disease","Surgical","NDI","Unknown","Cost-Effectiveness","Observational","USA","Unknown","Spine Disease","Surgical","Cost-Effectiveness","Observational","NDI","2010:2014"]
[28,"Ayvaz,M.,et al. (2014). \"Posterior all-pedicle screw instrumentation combined with multiple chevron and concave rib osteotomies in the treatment of adolescent congenital kyphoscoliosis.\" Spine J 14(1999): 11-19.",null,"Ayvaz,M.,et al.","Posterior all-pedicle screw instrumentation combined with multiple chevron and concave rib osteotomies in the treatment of adolescent congenital kyphoscoliosis","BACKGROUND CONTEXT: Congenital kyphoscoliosis is a disorder that often requires surgical treatment. Although many methods of surgical treatment exist,posterior-only vertebral column resection with instrumentation and fusion seem to have become the gold standard for very severe and very rigid curves. Multiple chevron and concave rib osteotomies have been previously reported to be effective in the treatment of neglected severe idiopathic curves. We hypothesized that this method may also be used successfully in the treatment of congenital kyphoscoliosis. PURPOSE: To evaluate the effectiveness and safety of multiple chevron osteotomies combined with concave rib osteotomy and posterior pedicle screw instrumentation. STUDY DESIGN: Retrospective chart review in the spine service of a large university hospital. PATIENT SAMPLE: Adolescent patients undergoing a specific surgical treatment for the indication of rigid congenital kyphoscoliotic deformity. OUTCOME MEASURES: Radiographic images were used for the measurement of deformity correction. The Turkish version of the Scoliosis Research Society 22 (SRS-22) Patient Questionnaire has been used as a clinical outcome measure in the patient population. METHODS: A retrospective chart review was performed. Patients admitted to Hacettepe Hospital Spine Center during the period of 2005 to 2009 were included. Criteria for inclusion were as follows: adolescent age group (10-16 years); congenital kyphoscoliosis; formation and/or segmentation defect of at least two vertebral motion segments; surgical treatment of deformity by posterior all-pedicle screw instrumentation,multiple chevron osteotomies,and multiple concave rib osteotomies; follow-up of at least 24 months; and a complete set of preoperative,postoperative,and follow-up standing posteroanterior and lateral full spinal radiographs. The patients' hospital records and X-rays were reviewed. Duration of surgery,intraoperative blood loss,postoperative transfusion requirements,postoperative stay in postanesthesia care unit (PACU),time of hospitalization,and complications were recorded. Deformity in both coronal and sagittal planes was analyzed for correction and maintenance of the correction in preoperative,postoperative,and follow-up radiographs. Patients' health-related quality of life was assessed using the SRS-22 questionnaire at the final follow-up. RESULTS: Eighteen patients met the inclusion criteria. Their average age was 13.6 years (range,11-16 years). Chevron osteotomies were performed at apical segments (three to seven levels) and concave rib osteotomies at Cobb-to-Cobb (five to eight levels). No patient had preoperative cord compression because of the sharply angulated deformity or neurologic deficit. The average preoperative scoliosis was 66.0 degrees (range,31 degrees -116 degrees ),52.4 degrees (range,22 degrees -85 degrees ) on flexibility X-rays,and became 24.9 degrees (range,12 degrees -52 degrees ) postoperatively. The average preoperative global kyphosis (T2-T12) of 75.9 degrees (range,50 degrees -106 degrees ) became 49.5 degrees (range,18 degrees -66 degrees ). The average preoperative local kyphosis of 71.9 degrees (range,35 degrees -114 degrees ) became 31.4 degrees (range,-44 degrees to 64 degrees ). The average intraoperative bleeding was 989 cc,surgical time was 292 minutes,and intraoperative transfusion was 2.3 units. The maximum PACU stay was overnight. There were no neurologic complications except one pneumothorax and one pneumonia. The average follow-up was 34.3 months. At follow-up,average scoliosis was 27.5 degrees (range,10 degrees -50 degrees ),global kyphosis was 50.3 degrees (range,28 degrees -73 degrees ),and local kyphosis was 36.9 degrees (range,-36 degrees to 58 degrees ). Performed on the last follow-up,the average scores for the five domains of SRS-22 were 4.3,4.4,4.2,4.1,and 4.8 for function,pain,self-image,mental health,satisfaction,and total,respectively. CONCLUSIONS: Multiple chevron and concave rib osteotomies with posterior instrumentation provide an acceptable rate of deformity correction and maintenance of correction at 2 years with acceptable intraoperative bleeding,surgical time,postoperative morbidity,and rate of complications. It can be considered as an alternative in the treatment of rigid congenital curves involving more than three levels or multiple curves separated by at least two segments that would otherwise require multiple vertebral resections."," Spine J 14(1999): 11-19.","Turkey",2014,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Retrospective review","Turkey","Adolescents","Spinal Deformity","Surgical","PRO study","Retrospective review","SRS-HRQOL","2010:2014"]
[29,"Azad,T. D.,et al. (2016). \"Building an electronic health record integrated quality of life outcomes registry for spine surgery.\" J Neurosurg Spine 24(1999): 176-185.",null,"Azad,T. D.,et al.","Building an electronic health record integrated quality of life outcomes registry for spine surgery","OBJECTIVE: Demonstrating the value of spine care requires adequate outcomes assessment. Long-term outcomes are best measured as overall improvement in quality of life (QOL) after surgical intervention. Present registries often require parallel data entry,introducing inefficiencies and limiting compliance. The authors detail the methodology of constructing an integrated electronic health record (EHR) system to collect QOL metrics and demonstrate the effect of data collection on routine clinical workflow. A streamlined approach to collecting QOL data can capture patient data without requiring dual data entry and without increasing clinic visit times. METHODS: Through extensive literature review,a combination of QOL assessments was selected,consisting of the Patient Health Questionnaire-2 and -9,Oswestry Disability Index,Neck Disability Index,and visual analog scale for pain. These metrics were used to provide assessment of QOL following spine surgery and were incorporated into standard clinic workflow by a multidisciplinary team of surgeons,advanced practice providers,and health care information technology specialists. A clinical dashboard tracking more than 25 patient variables was developed. Clinic flow was assessed and opportunities for improvement reviewed. Duration of clinic visits before and after initiation of QOL measure capture was recorded,with assessment of mean clinic visit times for the 12 months before and the 12 months after implementation. RESULTS: The integrated QOL capture was instituted for 3 spine surgeons in a tertiary care academic center. In the 12-month period prior to initiating collection of QOL data,806 new patient visits were completed with an average visit time of 127.9 +/- 51.5 minutes. In the 12 months after implementation,1013 new patient visits were recorded,with 791 providing QOL measures with an average visit time of 117.0 +/- 45.7 minutes. Initially the primary means of collecting patient outcome data was via paper form,with gradual transition to collection via entry into the electronic medical records system. To improve electronic data capture,paper forms were eliminated and an online portal used as part of the patient rooming process. This improved electronic capture to nearly 98% without decreasing the number of patients enrolled in the process. CONCLUSIONS: A systematic approach to collecting spine-related QOL data within an EHR system is feasible and offers distinct advantages over registries that require dual data entry. The process of data collection does not impact patients' clinical visit or providers' clinical workflow. This approach is scalable,and may form the foundation for a decentralized outcomes registry network."," J Neurosurg Spine 24(1999): 176-185.","USA",2016,"Back Pain","Surgical","ODI,NDI","Unknown","PRO study","Observational","USA","Unknown","Back Pain","Surgical","PRO study","Observational","ODI,NDI","2015:2018"]
[30,"Bago,J.,et al. (2004). \"The Spanish version of the SRS-22 patient questionnaire for idiopathic scoliosis: transcultural adaptation and reliability analysis.\" Spine (Phila Pa 1976) 29(15): 1676-1680.",null,"Bago,J.,et al.","The Spanish version of the SRS-22 patient questionnaire for idiopathic scoliosis: transcultural adaptation and reliability analysis","STUDY DESIGN: Validation of the transcultural adaptation of a questionnaire for measuring health-related quality of life. OBJECTIVES: To translate and culturally adapt the SRS-22 questionnaire to Spanish. To determine the metric qualities (internal consistency and test-retest reproducibility) of this questionnaire. SUMMARY OF BACKGROUND DATA: The SRS-22 Patient Questionnaire has proven to be a valid instrument for clinical assessment of patients with idiopathic scoliosis. The widespread use of the SRS-22 in non-English-speaking countries requires its transcultural adaptation. METHODS: Transcultural adaptation of the SRS-22 was carried out according to the International Quality of Life Assessment Project guidelines and included two translations and two back-translations of the material. A committee of experts decided on the final version. The questionnaire was administered to 175 individuals (152 women and 23 men) with idiopathic scoliosis. The mean age of the participants at the time they received the questionnaire was 18.9 years,thoracic curve magnitude was 28.8 degrees,and lumbar curve magnitude was 28.1 degrees. At this time,85 patients had been treated surgically,45 had been treated with orthesis,and 45 were under observation. A subgroup of 30 patients completed the questionnaire a second time 1 week later. Internal consistency was determined with Cronbach's alpha coefficient and test-retest reliability with the intraclass correlation coefficient. RESULTS: The overall alpha coefficient of the questionnaire was 0.89. Coefficients for individual domains were as follows: function/activity,0.67; pain,0.81; mental health,0.83; self-image,0.73; and satisfaction,0.78. The questionnaire as a whole had an intraclass correlation coefficient of 0.96. Intraclass correlation coefficients for individual domains were as follows: pain,0.93; function,0.82; self-image,0.94; mental health,0.94; and satisfaction,0.98. CONCLUSIONS: The Spanish version of the SRS-22 Patient Questionnaire demonstrated adequate internal consistency for the majority of domains and excellent reproducibility. These results suggest that the process of adaptation has produced an instrument that is apparently equivalent to the original and suitable for clinical research."," Spine (Phila Pa 1976) 29(15): 1676-1680.","Spain",2004,"Spinal Deformity","Surgical","SRS-HRQOL","Unknown","Tool Validation","Observational","Spain","Unknown","Spinal Deformity","Surgical","Tool Validation","Observational","SRS-HRQOL","2000:2004"]
[31,"Bailey,C. S.,et al. (2014). \"Orthosis versus no orthosis for the treatment of thoracolumbar burst fractures without neurologic injury: a multicenter prospective randomized equivalence trial.\" Spine J 14(11): 2557-2564.",null,"Bailey,C. S.,et al.","Orthosis versus no orthosis for the treatment of thoracolumbar burst fractures without neurologic injury: a multicenter prospective randomized equivalence trial","BACKGROUND CONTEXT: Thoracolumbar burst fractures have good outcomes when treated with early ambulation and orthosis (TLSO). If equally good outcomes could be achieved with early ambulation and no brace,resource utilization would be decreased,especially in developing countries where prolonged bed rest is the default option because bracing is not available or affordable. PURPOSE: To determine whether TLSO is equivalent to no orthosis (NO) in the treatment of acute AO Type A3 thoracolumbar burst fractures with respect to their functional outcome at 3 months. STUDY DESIGN: A multicentre,randomized,nonblinded equivalence trial involving three Canadian tertiary spine centers. Enrollment began in 2002 and 2-year follow-up was completed in 2011. PATIENT SAMPLE: Inclusion criteria included AO-A3 burst fractures between T11 and L3,skeletally mature and older than 60 years,72 hours from their injury,kyphotic deformity lower than 35 degrees,no neurologic deficit. One hundred ten patients were assessed for eligibility for the study; 14 patients were not recruited because they resided outside the country (3),refused participation (8),or were not consented before independent ambulation (3). OUTCOME MEASURES: Roland Morris Disability Questionnaire score (RMDQ) assessed at 3 months postinjury. The equivalence margin was set at delta=5 points. METHODS: The NO group was encouraged to ambulate immediately with bending restrictions for 8 weeks. The TLSO group ambulated when the brace was available and weaned from the brace after 8 to 10 weeks. The following competitive grants supported this work: VHHSC Interdisciplinary Research Grant,Zimmer/University of British Columbia Research Fund,and Hip Hip Hooray Research Grant. Aspen Medical provided the TLSOs used in this study. The authors have no financial or personal relationships that could inappropriately influence this work. RESULTS: Forty-seven patients were enrolled into the TLSO group and 49 patients into the NO group. Forty-six participants per group were available for the primary outcome. The RMDQ score at 3 months postinjury was 6.8 +/- 5.4 (standard deviation [SD]) for the TLSO group and 7.7 +/- 6.0 (SD) in the NO group. The 95% confidence interval (-1.5 to 3.2) was within the predetermined margin of equivalence. Six patients required surgical stabilization,five of them before initial discharge. CONCLUSIONS: Treating these fractures using early ambulation without a brace avoids the cost and patient deconditioning associated with a brace and complications and costs associated with long-term bed rest if a TLSO or body cast is not available."," Spine J 14(11): 2557-2564.","Canada",2014,"Trauma","Surgical","RMDQ","Adults","PRO study","Clinical trial","Canada","Adults","Trauma","Surgical","PRO study","Clinical trial","RMDQ","2010:2014"]
[32,"Bakhsheshian,J.,et al. (2017). \"Impact of poor mental health in adult spinal deformity patients with poor physical function: a retrospective analysis with a 2-year follow-up.\" J Neurosurg Spine 26(1999): 116-124.",null,"Bakhsheshian,J.,et al.","Impact of poor mental health in adult spinal deformity patients with poor physical function: a retrospective analysis with a 2-year follow-up","OBJECTIVE Mental disease burden can have a significant impact on levels of disability and health-related quality of life (HRQOL) measures. Therefore,the authors investigated the significance of mental health status in adults with spinal deformity and poor physical function. METHODS A retrospective analysis of a prospective multicenter database of 365 adult spinal deformity (ASD) patients who had undergone surgical treatment was performed. Health-related QOL variables were examined preoperatively and at the 2-year postoperative follow-up. Patients were grouped by their 36-Item Short Form Health Survey mental component summary (MCS) and physical component summary (PCS) scores. Both groups had PCS scores </= 25th percentile for matched norms; however,the low mental health (LMH) group consisted of patients with an MCS score </= 25th percentile,and the high mental health (HMH) group included patients with an MCS score >/= 75th percentile. RESULTS Of the 264 patients (72.3%) with a 2-year follow-up,104 (28.5%) met the inclusion criteria for LMH and 40 patients (11.0%) met those for HMH. The LMH group had a significantly higher overall rate of comorbidities,specifically leg weakness,depression,hypertension,and self-reported neurological and psychiatric disease processes,and were more likely to be unemployed as compared with the HMH group (p < 0.05 for all). The 2 groups had similar 2-year postoperative improvements in HRQOL (p > 0.05) except for the greater improvements in the MCS and the Scoliosis Research Society-22r questionnaire (SRS-22r) mental domain (p < 0.05) in the LMH group and greater improvements in PCS and SRS-22r satisfaction and back pain domains (p < 0.05) in the HMH group. The LMH group had a higher rate of reaching a minimal clinically important difference (MCID) on the SRS-22r mental domain (p < 0.01),and the HMH group had a higher rate of reaching an MCID on the PCS and SRS-22r activity domain (p < 0.05). On multivariable logistic regression,having LMH was a significant independent predictor of failure to reach an MCID on the PCS (p < 0.05). At the 2-year postoperative follow-up,14 LMH patients (15.1%) were categorized as HMH. Two LMH patients (2.2%),and 3 HMH patients (7.7%) transitioned to a PCS score >/= 75th percentile for age- and sex-matched US norms (p < 0.01). CONCLUSIONS While patients with poor mental and physical health,according to their MCS and PCS scores,have higher medical comorbidity and unemployment rates,they still demonstrate significant improvements in HRQOL measurements postoperatively. Both LMH and HMH patient groups demonstrated similar improvements in most HRQOL domains,except that the LMH patients had difficulties in obtaining improvements in the PCS domain."," J Neurosurg Spine 26(1999): 116-124.","USA",2017,"Spinal Deformity","Surgical","SRS-HRQOL","Adults","PRO study","Retrospective review","USA","Adults","Spinal Deformity","Surgical","PRO study","Retrospective review","SRS-HRQOL","2015:2018"]
[33,"Baldus,C.,et al. (2008). \"Age-gender matched comparison of SRS instrument scores between adult deformity and normal adults: are all SRS domains disease specific?\" Spine (Phila Pa 1976) 33(20): 2214-2218.",null,"Baldus,C.,et al.","Age-gender matched comparison of SRS instrument scores between adult deformity and normal adults: are all SRS domains disease specific?","STUDY DESIGN: Prospective,observational study. OBJECTIVE: To further validate the Scoliosis Research Society (SRS) instrument by comparing scores of adult deformity patients with no prior history of spine surgery to the scores of normal adult volunteers in age-gender matched groups. SUMMARY OF BACKGROUND DATA: Efforts have been made to validate the SRS questionnaire in adolescent and adult deformity patients. An important psychometric attribute of any quality of life tool is its ability to discriminate between subjects with and without the condition of interest. Discriminate validity of the SRS questionnaire has not been established in the primary (no prior surgical treatment) adult deformity population. METHODS: The SRS questionnaire was issued prospectively to 935 primary adult deformity patients with a diagnosis of idiopathic or de novo scoliosis and minimum Cobb angle of 30 degrees (average Cobb angle: 54 degrees; range: 30 degrees-132 degrees). Five hundred forty-three patients were treated nonsurgically while 392 patients underwent surgical intervention. Baseline SRS scores of the deformity population were compared to 1222 volunteers with no history of spine disease randomly sampled from the US population. Analysis between the 2 populations was broken down into 6 age-gender groups: male/female; 20-40,41-60,61-80 years of age. RESULTS: SRS domain scores of the deformity subgroups demonstrated significant statistical differences from their corresponding age-gender matched normative group. The only exceptions were the mental health domain in the older males,61-80 years of age. The average SRS subscore for each age-gender subgroup was less than the tenth percentile in the corresponding normative population,indicating substantial limitations in these patients. CONCLUSION: Our findings confirm the SRS instrument has excellent discriminate validity in the adult population. It appears to be disease-specific in the domains of pain,appearance and activity in adult spinal deformity patients who have not had prior surgery."," Spine (Phila Pa 1976) 33(20): 2214-2218.","USA",2008,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","Tool Validation","Prospective Observation","USA","Adolescents","Spinal Deformity","Surgical","Tool Validation","Prospective Observation","SRS-HRQOL","2005:2009"]
[34,"Baldus,C.,et al. (2011). \"The Scoliosis Research Society Health-Related Quality of Life (SRS-30) age-gender normative data: an analysis of 1346 adult subjects unaffected by scoliosis.\" Spine (Phila Pa 1976) 36(14): 1154-1162.",null,"Baldus,C.,et al.","The Scoliosis Research Society Health-Related Quality of Life (SRS-30) age-gender normative data: an analysis of 1346 adult subjects unaffected by scoliosis","STUDY DESIGN: Prospective,cross-sectional study. OBJECTIVE: To determine Scoliosis Research Society (SRS)-30 health-related quality of life (HRQOL) reference values by age and gender in an adult population unaffected by scoliosis thereby allowing clinicians and investigators to compare individual and/or groups of spinal deformity patients to their generational peers. SUMMARY OF BACKGROUND DATA: Normative data are collected to establish means and standard deviations of health-related quality of life outcomes representative of a population. The SRS HRQOL questionnaire has become the standard for determining and comparing treatment outcomes in spinal deformity practices. With the establishment of adult SRS-30 HRQOL population values,clinicians,and investigators now have a reference for interpretation of individual scores and/or the scores of subgroups of adult patients with spinal deformities. METHODS: The SRS-30 HRQOL was issued prospectively to 1346 adult volunteers recruited from across the United States. Volunteers self-reported no history of scoliosis or prior spine surgery. Domain medians,means,confidence intervals,percentiles,and minimum/maximum values were calculated for six generational age-gender groups: male/female; 20-39,40-59,and 60-80 years of age. RESULTS: Median and mean domain values ranged from 4.1 to 4.6 for all age-gender groups. The older the age-gender group,the lower (worse) the reported domain median and mean scores. The only exception was the mental health domain scores in the female groups which improved slightly. Males reported higher (better) scores than females but only the younger males were significantly higher in all domains than their female counterparts. In addition,all male groups reported higher Mental Health domain scores than their female counterparts (P=0.003). CONCLUSION: This study reports population medians,means,standard deviations,percentiles,and confidence intervals for the domains of the SRS-30 HRQOL instrument. Clinicians must be mindful of age-gender differences when assessing deformity populations. Generational decreases noted in the older adult volunteer scores may provide a basis for future investigators to interpret observed score decreases in patient cohorts at long-term follow-up."," Spine (Phila Pa 1976) 36(14): 1154-1162.","USA",2011,"Spinal Deformity","Surgical","SRS-HRQOL","Adults","PRO study","Observational","USA","Adults","Spinal Deformity","Surgical","PRO study","Observational","SRS-HRQOL","2010:2014"]
[35,"Barton, M., et al. (2014). \"Invasive candidiasis in low birth weight preterm infants: risk factors, clinical course and outcome in a prospective multicenter study of cases and their matched controls.\" BMC Infect Dis 14: 327.",null,"Barton, M., et al.","Invasive candidiasis in low birth weight preterm infants: risk factors, clinical course and outcome in a prospective multicenter study of cases and their matched controls","BACKGROUND: This multicenter prospective study of invasive candidiasis (IC) was carried out to determine the risk factors for, incidence of, clinical and laboratory features, treatment and outcome of IC in infants of birth weight <1250 g. METHODS: Neonates <1250 g with IC and their matched controls (2:1) were followed longitudinally and descriptive analysis was performed. Survivors underwent neurodevelopmental assessment at 18 to 24 months corrected age. Neurodevelopmental impairment (NDI) was defined as blindness, deafness, moderate to severe cerebral palsy, or a score <70 on the Bayley Scales of Infant Development 2nd edition. Multivariable analyses were performed to determine risk factors for IC and predictors of mortality and NDI. RESULTS: Cumulative incidence rates of IC were 4.2%, 2.2% and 1.5% for birth-weight categories <750 g, <1000 g, <1500 g, respectively. Forty nine infants with IC and 90 controls were enrolled. Necrotizing enterocolitis (NEC) was the only independent risk factor for IC (p=0.03). CNS candidiasis occurred in 50% of evaluated infants, while congenital candidiasis occurred in 31%. Infants with CNS candidiasis had a higher mortality rate (57%) and incidence of deafness (50%) than the overall cohort of infants with IC. NDI (56% vs. 33%; p=0.017) and death (45% vs. 7%; p=0.0001) were more likely in cases than in controls, respectively. IC survivors were more likely to be deaf (28% vs. 7%; p=0.01). IC independently predicted mortality (p=0.0004) and NDI (p=0.018). CONCLUSION: IC occurred in 1.5% of VLBW infants. Preceding NEC increased the risk of developing IC. CNS candidiasis is under-investigated and difficult to diagnose, but portends a very poor outcome. Mortality, deafness and NDI were independently significantly increased in infants with IC compared to matched controls."," BMC Infect Dis 14: 327.","USA",2014,"Low Birth Weight","Not Specified","NDI","Infants","PRO study","Prospective Observation","USA","Infants","Low Birth Weight","Not Specified","PRO study","Prospective Observation","NDI","2010:2014"]
[36,"Bastrom, T. P., et al. (2013). \"Prevalence of postoperative pain in adolescent idiopathic scoliosis and the association with preoperative pain.\" Spine (Phila Pa 1976) 38(21): 1848-1852.",null,"Bastrom, T. P., et al.","Prevalence of postoperative pain in adolescent idiopathic scoliosis and the association with preoperative pain","STUDY DESIGN: Review of a prospective database registry of surgical patients with adolescent idiopathic scoliosis (AIS). OBJECTIVE: The purpose of this study was to examine the prevalence of postoperative pain and its impact on patient-reported postoperative outcomes using the Scoliosis Research Society (SRS)-22 outcomes questionnaire. SUMMARY OF BACKGROUND DATA: Although reportedly rare, postoperative pain can be a devastating situation for the patient with AIS. Most recent studies examining outcomes in AIS surgical treatment use the SRS Pain domain score to assess pain in this population. METHODS: A prospectively enrolled multicenter database was queried. Patients with minimum 2-year follow-up and 2-year SRS scores were included. Postoperative pain after the acute phase of recovery when reported by the patient to the treating surgeon/clinical team in follow-up is recorded as a complication in the database. Patients included in this series were grouped as either reporting pain or not to the surgeon/clinical team postoperatively. Pre- and postoperative SRS scores were then compared between these 2 groups using analysis of variance (P < 0.05). RESULTS: Five hundred and eighty-four patients meeting the inclusion criteria were identified. Sixty-one (11%) reported pain at sometime between 2 weeks and 2 years postoperatively. Thirteen were within the 6-month postoperative period. Of the remaining 48 reporting pain between 6 and 24 months postoperatively, 41 (7% of the total cohort) had no obvious cause for their pain. More than half of these patients (26/41) were referred for further treatment (physical therapy, referral to pain specialist, further imaging). These 41 patients had significantly decreased 2-year SRS scores in the domains of Pain, Self-image, Mental health, and Total score (P < 0.05). The patients with postoperative pain were found to have significantly lower preoperative Pain domain scores (P < 0.001), indicative of greater pain preoperatively, yet there were no other domains effected preoperatively. For this group the pre- to postoperative SRS pain scores did not show significant change (P > 0.05). CONCLUSION: Unexplained pain after the 6-month postoperative period occurred in 7% of the cohort. The results indicate that patients reporting pain to their surgeons/clinical team postoperatively have lower pain scores on a subjective outcome instrument thus further validating the SRS-22 outcome tool. This reported pain seems to be associated with decreases in other SRS-22 domains. Interestingly, these patients also have lower preoperative pain scores than those without postoperative pain. Study into causes of pain in AIS and whether preoperative education and expectations targeted at this population would positively impact outcomes is warranted, especially because on average patients after AIS surgery have less pain. LEVEL OF EVIDENCE: 3."," Spine (Phila Pa 1976) 38(21): 1848-1852.","USA",2013,"Spinal Deformity","Surgical,Physical Therapy","SRS-HRQOL","Adolescents","PRO study","Observational","USA","Adolescents","Spinal Deformity","Surgical,Physical Therapy","PRO study","Observational","SRS-HRQOL","2010:2014"]
[37,"Beausejour, M., et al. (2009). \"Reliability and validity of adapted French Canadian version of Scoliosis Research Society Outcomes Questionnaire (SRS-22) in Quebec.\" Spine (Phila Pa 1976) 34(6): 623-628.",null,"Beausejour, M., et al.","Reliability and validity of adapted French Canadian version of Scoliosis Research Society Outcomes Questionnaire (SRS-22) in Quebec","STUDY DESIGN: Prospective validation study of a cross-cultural adaptation of the Scoliosis Research Society (SRS) Outcomes Questionnaire. OBJECTIVE: To provide a French Canadian version of the SRS Outcomes Questionnaire and to empirically test its response in healthy adolescents and adolescent idiopathic scoliosis (AIS) patients in Quebec. SUMMARY OF BACKGROUND DATA: The SRS Outcomes Questionnaire is widely used for the assessment of health-related quality of life in AIS patients. METHODS: French translation and back-translation of the SRS-22 (SRS-22-fv) were done by an expert committee. Its reliability was measured using the coefficient of internal consistency, construct validity with a factorial analysis, concurrent validity by using the short form-12 and discriminant validity using ANOVA and multivariate linear regression, on 145 AIS patients, 44 patients with non clinically significant scoliosis (NCSS), and 64 healthy patients. RESULTS: The SRS-22-fv showed a good global internal consistency (AIS: Cronbach alpha = 0.86, NCSS: 0.81, and controls: 0.79) and in all of its domains for AIS patients. The factorial structure was coherent with the original questionnaire (47.4% of explained variance). High correlation coefficients were obtained between SRS-22-fv and short form-12 corresponding domains. Boys had higher scores than girls, scores worsened with age, and with increasing body mass index. Mean Total, Pain, Self-image, and Satisfaction scores, were correlated with Cobb angle. Adjusted regression models showed statistically significant differences between the AIS, NCSS, and control groups in the Total, Pain, and Function scores. CONCLUSION: The SRS-22-fv showed satisfactory reliability, factorial, concurrent, and discriminant validity. This study provides scores in a significant group of healthy adolescents and demonstrates a clear gradient in response between subjects with AIS, NCSS, and controls."," Spine (Phila Pa 1976) 34(6): 623-628.","Canada",2009,"Spinal Deformity","Not Specified","SRS-HRQOL,QBPD","Unknown","Tool Validation","Prospective Observation","Canada","Unknown","Spinal Deformity","Not Specified","Tool Validation","Prospective Observation","SRS-HRQOL,QBPD","2005:2009"]
[38,"Begerow, B., et al. (1999). \"Time since vertebral fracture: an important variable concerning quality of life in patients with postmenopausal osteoporosis.\" Osteoporos Int 10(1999): 26-33.",null,"Begerow, B., et al.","Time since vertebral fracture: an important variable concerning quality of life in patients with postmenopausal osteoporosis","The aim of the study was to identify factors affecting patients with postmenopausal osteoporosis who had experienced one or more vertebral fractures. The overall hypothesis was that time after fracture would influence patients' perception of pain and well-being. The sample (50 patients) was split into two groups (group A, time after fracture < or > 24 months; group B, time after fracture >24 months). A fracture was defined as a vertebral height reduction of more than 20% or at least 4 mm. The assessment was carried out using the Spine Deformity Index and was confirmed by an experienced radiologist. To assess quality of life (QoL) the following measures were used: 'well-being scale' including social extroversion as a subscale, pain scale, and limitations in everyday life. The Sense of Coherence questionnaire developed by Antonovsky measures the ability of a person to see life meaningful, manageable and explicable. This questionnaire may reflect patients' coping abilities and was introduced to establish whether these influence the perception of pain and well-being after vertebral fracture. Variance and covariance analysis was carried out using SPSS (version 6.1). Differences between groups A and B were found for perception of average pain (p = 0.017), social extroversion (p = 0.003) and well-being (p = 0.024). No differences were found for limitations in everyday life (p = 0.607), Sense of Coherence (p = 0.638), the Spine Deformity Index (p = 0.171) and loss of height (p = 0.619). All analyses were corrected for age. Concurrent medication was not found to influence the results. Findings suggest that time after fracture is an important variable when considering QoL and well-being after vertebral fracture and should, therefore, be considered in future studies."," Osteoporos Int 10(1999): 26-33.","Germany",1999,"Osteoporosis","Not Specified","SDI","Adults","PRO study","Observational","Germany","Adults","Osteoporosis","Not Specified","PRO study","Observational","SDI","1995:1999"]
[39,"Berenguera, A., et al. (2011). \"Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial.\" BMC Musculoskelet Disord 12: 194.",null,"Berenguera, A., et al.","Study protocol of cost-effectiveness and cost-utility of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial","BACKGROUND: Low back pain (LBP), with high incidence and prevalence rate, is one of the most common reasons to consult the health system and is responsible for a significant amount of sick leave, leading to high health and social costs. The objective of the study is to assess the cost-effectiveness and cost-utility analysis of a multidisciplinary biopsychosocial educational group intervention (MBEGI) of non-specific sub-acute LBP in comparison with the usual care in the working population recruited in primary healthcare centres. METHODS/DESIGN: The study design is a cost-effectiveness and cost-utility analysis of a MBEGI in comparison with the usual care of non-specific sub-acute LBP.Measures on effectiveness and costs of both interventions will be obtained from a cluster randomised controlled clinical trial carried out in 38 Catalan primary health care centres, enrolling 932 patients between 18 and 65 years old with a diagnosis of non-specific sub-acute LBP. Effectiveness measures are: pharmaceutical treatments, work sick leave (% and duration in days), Roland Morris disability, McGill pain intensity, Fear Avoidance Beliefs (FAB) and Golberg Questionnaires. Utility measures will be calculated from the SF-12. The analysis will be performed from a social perspective. The temporal horizon is at 3 months (change to chronic LBP) and 12 months (evaluate the outcomes at long term).Assessment of outcomes will be blinded and will follow the intention-to-treat principle. DISCUSSION: We hope to demonstrate the cost-effectiveness and cost-utility of MBEGI, see an improvement in the patients' quality of life, achieve a reduction in the duration of episodes and the chronicity of non-specific low back pain, and be able to report a decrease in the social costs. If the intervention is cost-effectiveness and cost-utility, it could be applied to Primary Health Care Centres. TRIAL REGISTRATION: ISRCTN: ISRCTN58719694."," BMC Musculoskelet Disord 12: 194.","Spain",2011,"Back Pain","Psychosocial","RMDQ","Unknown","Cost-Effectiveness","Clinical trial","Spain","Unknown","Back Pain","Psychosocial","Cost-Effectiveness","Clinical trial","RMDQ","2010:2014"]
[40,"Bishop, F. L., et al. (2010). \"A within-subjects trial to test the equivalence of online and paper outcome measures: the Roland Morris disability questionnaire.\" BMC Musculoskelet Disord 11: 113.",null,"Bishop, F. L., et al.","A within-subjects trial to test the equivalence of online and paper outcome measures: the Roland Morris disability questionnaire","BACKGROUND: Augmenting validated paper versions of existing outcome measures with an equivalent online version may offer substantial research advantages (cost, rapidity and reliability). However, equivalence of online and paper questionnaires cannot be assumed, nor can acceptability to respondents. The aim was to test whether online and written versions of the Roland Morris Disability Questionnaire (RMDQ), a standard measure of functional disability in back pain, are equivalent at both group and individual levels to establish whether they can be used interchangeably. METHODS: This is a within-participants equivalence study. 167 participants with back pain fully completed both the paper and online versions of the RMDQ in random order. Participants were recruited from a chiropractic clinic and patient support groups in Southern England. Limits of equivalence were pre-defined as 0.5 RMDQ points, the Bland-Altman range was calculated, and participants' comments were examined using content analysis. RESULTS: The mean score difference was 0.03 (SD = 1.43), with the 95% Confidence Interval falling entirely within our limits of equivalence (-0.19 to 0.25). The Bland-Altman range was -2.77 to 2.83 RMDQ points. Participants identified unique advantages and disadvantages associated with each version of the RMDQ. CONCLUSIONS: The group and individual level data suggest that online and paper versions of the RMDQ are equivalent and can be used interchangeably. The Bland-Altman range appears to reflect the known measurement properties of the RMDQ. Furthermore, participants' comments confirmed the potential value to be had from offering them the choice of completing the RMDQ online or on paper."," BMC Musculoskelet Disord 11: 113.","UK",2010,"Back Pain","Not Specified","RMDQ","Unknown","PRO study","Clinical trial","UK","Unknown","Back Pain","Not Specified","PRO study","Clinical trial","RMDQ","2010:2014"]
[41,"Borgstrom, F., et al. (2013). \"The impact of different health dimensions on overall quality of life related to kyphoplasty and non-surgical management.\" Osteoporos Int 24(7): 1991-1.",null,"Borgstrom, F., et al.","The impact of different health dimensions on overall quality of life related to kyphoplasty and non-surgical management","UNLABELLED: This study uses data from a previously published randomised trial where balloon kyphoplasty was compared to non-surgical management. Of the improved overall quality of life, 60 % was caused by decreased pain. However, ignoring other dimensions of quality of life would underestimate the procedure's effect. INTRODUCTION: Acute back pain has been viewed as the most important factor lowering quality of life (QoL) for patients suffering vertebral fractures. The objective of this study was to quantify the impact of different health dimensions on overall QoL using patient-reported outcome measurements (PROMs) collected in Fracture Reduction Evaluation (FREE) trial. METHODS: The analysis was based on patients included in the 2-year-long randomised controlled FREE trial studying the efficacy and safety of balloon kyphoplasty procedure (BKP) compared to non-surgical management (NSM). The PROMs included were EQ-5D, Short Form (SF)-36, visual analogue scale (VAS) pain and the Roland-Morris Disability Questionnaire (RMDQ). The health dimensional contribution to the overall QoL improvements was analysed by isolating the impact of each dimension on QoL in the SF-36 and EQ-5D, respectively. A correlation analysis of the QoL improvement was performed to investigate the relationships between the four instruments. RESULTS: Changes in pain explained 60 % of the quality-adjusted life years (QALY) gained in BKP vs. NSM followed by self-care (17 %), mobility (16 %) and usual activities (10 %) (EQ-5D). Health dimensions capturing the mental state had little impact on the QALY gained. The SF-36 dimensional analysis showed similar results. The correlation analysis showed that the correlation between VAS pain, RMDQ and QALY improvement was fairly weak. CONCLUSIONS: Changes in the pain dimension of health are the most important drivers for changes of overall QoL in patients treated with BKP or NSM. However, ignoring the impact of other dimensions would lead to an underestimation of the actual improvement in overall QoL."," Osteoporos Int 24(7): 1991-1.","Sweden",2013,"Spinal Fracture","Surgical","RMDQ","Adults","PRO study","Clinical trial","Sweden","Adults","Spinal Fracture","Surgical","PRO study","Clinical trial","RMDQ","2010:2014"]
[42,"Boucher, M., et al. (2001). \"Health-related quality of life after short segment instrumentation of lumbar burst fractures.\" J Spinal Disord 14(5): 417-426.",null,"Boucher, M., et al.","Health-related quality of life after short segment instrumentation of lumbar burst fractures","Management of lumbar burst fractures remains controversial. Surgical reduction/stabilization is becoming more popular; however, the functional impact of operative intervention is not clear. The purpose of this study was to assess health-related quality of life and functional outcome after posterior fixation of lumbar burst fractures with either posterolateral or intrabody bone grafting. Twenty-four subjects were included. Radiographs and computed tomography scans were evaluated for deformity (kyphosis, vertebral compression, lateral angulation, lateral body height, and canal compromise) postoperatively, at 1 year, and at final follow-up (mean 3.2 years). Patients completed the SF 36 Health Survey and the Oswestry Low Back Pain Disability Questionnaire at final follow-up. Significant improvement was noted in midsagittal diameter compromise, vertebral compression, and kyphosis. The difference observed between the respondents mean scores on the SF 36 was not significantly different from those presented as the U.S. national average (p = 0.053). Data from the Oswestry questionnaire indicated a similarly high level of function. Overall, we found posterior spinal instrumentation to correlate with positive functional outcome based on both general health (SF 36) and joint-specific outcome scales (Oswestry). Posterior instrumentation provides sound canal decompression, kyphotic reduction, and maintains vertebral height with minimal transgression and long-term sequelae. In cases of severe initial deformity and neurologic compromise, intrabody bone grafting is most certainly indicated; the additional support provided by a posterolateral graft may also prove beneficial as an adjunct."," J Spinal Disord 14(5): 417-426.","Canada",2001,"Back Pain","Surgical","ODI","Adults","PRO study","Observational","Canada","Adults","Back Pain","Surgical","PRO study","Observational","ODI","2000:2004"]
[43,"Braun, M., et al. (2011). \"Effectiveness of traditional Chinese \"gua sha\" therapy in patients with chronic neck pain: a randomized controlled trial.\" Pain Med 12(3): 362-369.",null,"Braun, M., et al.","Effectiveness of traditional Chinese \"gua sha\" therapy in patients with chronic neck pain: a randomized controlled trial","OBJECTIVE: Gua sha is a traditional East Asian healing technique where the body surface is press-stroked with a smooth-edged instrument to intentionally raise therapeutic petechiae. A traditional indication of Gua sha is neck pain; no data from controlled trials exist to support this claim. The researchers aimed to investigate the effectiveness of Gua sha in the symptomatic treatment of chronic neck pain. DESIGN: The study was designed as an open randomized controlled clinical trial. SETTING: The study was set in Kliniken Essen-Mitte, Academic Teaching Hospital of the University Duisburg-Essen, Germany. SUBJECTS: Forty-eight outpatients (58.5+/-8.0 years; 41 female) with chronic mechanical neck pain were the subjects of the study. INTERVENTION: Patients were randomized into Gua sha (N=24) or control groups (N=24) and followed up for 7 days. Gua sha patients were treated once with Gua sha, while control patients were treated with a local thermal heat pad. OUTCOME MEASURES: Primary outcome was change of neck pain severity after 1 week as assessed by visual analog scale. Secondary outcomes included pain at motion, the neck disability index (NDI) and quality-of-life (Short-Form [36] Health Survey). RESULTS: Neck pain severity after 1 week improved significantly better in the Gua sha group compared with the control group (group difference -29.9 mm, 95% confidence interval: -43.3; -16.6 mm; P<0.001). Significant treatment effects were also found for pain at motion, scores on the NDI, and dimensions of quality-of-life. The treatment was safe and well tolerated. CONCLUSION: Gua sha has beneficial short-term effects on pain and functional status in patients with chronic neck pain. The value of Gua sha in the long-term management of neck pain and related mechanisms remains to be clarified."," Pain Med 12(3): 362-369.","Germany",2011,"Neck Pain","Other","NDI","Adults","PRO study","Clinical trial","Germany","Adults","Neck Pain","Other","PRO study","Clinical trial","NDI","2010:2014"]
[44,"Bridwell, K. H., et al. (2007). \"Is the SRS-22 instrument responsive to change in adult scoliosis patients having primary spinal deformity surgery?\" Spine (Phila Pa 1976) 32(20): 2220-2225.",null,"Bridwell, K. H., et al.","Is the SRS-22 instrument responsive to change in adult scoliosis patients having primary spinal deformity surgery?","STUDY DESIGN: Multicenter study. OBJECTIVE: The purpose of this study is to prospectively analyze responsiveness of the SRS-22 to change at 1 and 2 years following primary surgery. SUMMARY OF BACKGROUND DATA: A number of efforts have been directed at validation of the SRS-22 instrument in the setting of adolescent and adult spinal deformity. However, few have extensively analyzed the ability of the instrument to detect change (brought on by surgical treatment) in adult scoliosis patients. METHODS: A multicenter prospective series of consecutive adult scoliosis patients (all primary/no revisions) were administered SRS-22, Oswestry Disability Index (ODI)and Short Form-12 (SF-12) questionnaires preoperation and 1 and 2 years postoperation. Fifty-six patients had preoperative, 1-year postoperative, and 2-year postoperative data. RESULTS: The greatest changes from preoperation to 2-year postoperation were the SRS self-image domain followed by SRS total, SRS pain, and ODI scores. SRS pain and function scores significantly (P < 0.05) improved from 1-year to 2-year postoperation. There were not substantial differences in the outcome measures according to age or curve type. All outcome measures except SF-12 mental health showed statistically significant (P < 0.05) improvement from baseline to 2-year follow-up. CONCLUSION: Based on these 3 outcome tools, the greatest responsiveness to change was demonstrated by the SRS self-image domain followed by SRS total, then SRS pain, then ODI. This suggests that the SRS tool is more responsive than ODI, which is more responsive than SF-12 to change brought on by primary surgical treatment of adult scoliosis patients. Surgical treatment in adult scoliosis significantly improved pain, self-image, and function based on the health-related quality of life measures used in this study."," Spine (Phila Pa 1976) 32(20): 2220-2225.","USA",2007,"Spinal Deformity","Surgical","ODI,SRS-HRQOL","Adults","Tool Validation","Prospective Observation","USA","Adults","Spinal Deformity","Surgical","Tool Validation","Prospective Observation","ODI,SRS-HRQOL","2005:2009"]
[45,"Briggs, A. M., et al. (2013). \"Low back pain-related beliefs and likely practice behaviours among final-year cross-discipline health students.\" Eur J Pain 17(5): 766-775.",null,"Briggs, A. M., et al.","Low back pain-related beliefs and likely practice behaviours among final-year cross-discipline health students","BACKGROUND: Evidence points to clinicians' beliefs and practice behaviours related to low back pain (LBP), which are discordant with contemporary evidence. While interventions to align beliefs and behaviours with evidence among clinicians have demonstrated effectiveness, a more sustainable and cost-effective approach to positively developing workforce capacity in this area may be to target the emerging workforce. The aim of this study was to investigate beliefs and clinical recommendations for LBP, and their alignment to evidence, in Australian university allied health and medical students. METHODS: Final-year students in chiropractic, medicine, occupational therapy, pharmacy and physiotherapy disciplines in three Western Australian universities responded to a survey. Demographic data, LBP-related beliefs data [modified Health Care Providers Pain and Impact Relationship Scale (HC-PAIRS) and the Back Pain Beliefs Questionnaire (BBQ)] and activity, rest and work clinical recommendations for an acute LBP clinical vignette were collected. RESULTS: Six hundred two students completed the survey (response rate 74.6%). Cross-discipline differences in beliefs and clinical recommendations were observed (p > 0.001). Physiotherapy and chiropractic students reported significantly more helpful beliefs compared with the other disciplines, while pharmacy students reported the least helpful beliefs. A greater proportion of chiropractic and physiotherapy students reported guideline-consistent recommendations compared with other disciplines. HC-PAIRS and BBQ scores were strongly associated with clinical recommendations, independent to the discipline of study and prior experience of LBP. CONCLUSIONS: Aligning cross-discipline university curricula with current evidence may provide an opportunity to facilitate translation of this evidence into practice with a focus on a consistent, cross-discipline approach to LBP management."," Eur J Pain 17(5): 766-775.","Australia",2013,"Back Pain","Physical Therapy","BBQ","Unknown","Cost-Effectiveness","Observational","Australia","Unknown","Back Pain","Physical Therapy","Cost-Effectiveness","Observational","BBQ","2010:2014"]
[46,"Broekema, A. E., et al. (2017). \"Study protocol for a randomised controlled multicentre study: the Foraminotomy ACDF Cost-Effectiveness Trial (FACET) in patients with cervical radiculopathy.\" BMJ Open 7(1999): e012829.",null,"Broekema, A. E., et al.","Study protocol for a randomised controlled multicentre study: the Foraminotomy ACDF Cost-Effectiveness Trial (FACET) in patients with cervical radiculopathy","INTRODUCTION: Cervical radiculopathy due to discogenic or spondylotic stenosis of the neuroforamen can be surgically treated by an anterior discectomy with fusion (ACDF) or a posterior foraminotomy (FOR). Most surgeons prefer ACDF, although there are indications that FOR is as effective as ACDF, has a lower complication rate and is less expensive. A head-to-head comparison of the 2 surgical techniques in a randomised controlled trial has not yet been performed. The study objectives of the Foraminotomy ACDF Cost-Effectiveness Trial (FACET) study are to compare clinical outcomes, complication rates and cost-effectiveness of FOR to ACDF. METHODS AND ANALYSIS: The FACET study is a prospective randomised controlled trial conducted in 7 medical centres in the Netherlands. The follow-up period is 2 years. The main inclusion criterion is a radiculopathy of the C4, C5, C6 or C7 nerve root, due to a single-level isolated cervical foraminal stenosis caused by a soft disc and/or osteophytic component, requiring operative decompression. A sample size of 308 patients is required to test the hypothesis of clinical non-inferiority of FOR versus ACDF. Primary outcomes are: 'operative success', the measured decrease in radiculopathy assessed by the visual analogue scale and 'patient success', assessed by the modified Odom's criteria. Secondary outcomes are: Work Ability Index (single-item WAI), quality of life (EuroQol 5 Dimensions 5 level Survey, EQ-5D-5L), Neck Disability Index (NDI) and complications. An economic evaluation will assess cost-effectiveness. In addition, a budget impact analysis will be performed. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Institutional Ethics Committee of the University Medical Center Groningen. Results of this study will be disseminated through national and international papers. The participants and relevant patient support groups will be informed about the results of the study. TRIAL REGISTRATION NUMBER: NTR5536, pre-results."," BMJ Open 7(1999): e012829.","Netherlands",2017,"Radiculopathy,Spondylosis","Surgical","NDI,Odom","Unknown","Cost-Effectiveness","RCT","Netherlands","Unknown","Radiculopathy,Spondylosis","Surgical","Cost-Effectiveness","RCT","NDI,Odom","2015:2018"]
[47,"Brouwer, P. A., et al. (2009). \"Effectiveness of percutaneous laser disc decompression versus conventional open discectomy in the treatment of lumbar disc herniation; design of a prospective randomized controlled trial.\" BMC Musculoskelet Disord 10: 49.",null,"Brouwer, P. A., et al.","Effectiveness of percutaneous laser disc decompression versus conventional open discectomy in the treatment of lumbar disc herniation; design of a prospective randomized controlled trial","BACKGROUND: The usual surgical treatment of refractory sciatica caused by lumbar disc herniation, is open discectomy. Minimally invasive procedures, including percutaneous therapies under local anesthesia, are increasingly gaining attention. One of these treatments is Percutaneous Laser Disc Decompression (PLDD). This treatment can be carried out in an outpatient setting and swift recovery and return to daily routine are suggested. Thus far, no randomized trial into cost-effectiveness of PLDD versus standard surgical procedure has been performed. We present the design of a randomized controlled trial, studying the cost-effectiveness of PLDD versus conventional open discectomy in patients with sciatica from lumbar disc herniation. METHODS/DESIGN: The study is a randomized prospective multi-center trial, in which two treatment strategies are compared in a parallel group design. Patients (age 18-70 years) visiting the neurosurgery department of the participating hospitals, are considered for inclusion in the trial when sciatica due to lumbar disc herniation has lasted more than 8 weeks. Patients with disc herniation smaller than 1/3 of the spinal canal diameter, without concomitant lateral recess stenosis or sequestration, are eligible for participation, and are randomized into one of two treatment arms; either Percutaneous Laser Disc Decompression or conventional discectomy. The functional outcome of the patient, as assessed by the Roland Disability Questionnaire for Sciatica at 8 weeks and 1 year after treatment, is the primary outcome measure. The secondary outcome parameters are recovery as perceived by the patient, leg and back pain, incidence of re-intervention, complications, quality of life, medical consumption, absence of work and secondary costs. DISCUSSION: Open discectomy is still considered to be the golden standard in the surgical treatment of lumbar disc herniation. Whether Percutaneous Laser Disc Decompression has at least as much efficacy as the standard surgical procedure, and is more cost-effective, will be determined by this trial."," BMC Musculoskelet Disord 10: 49.","Netherlands",2009,"Degenerative Disk Disease","Surgical","RMDQ","Adults","Cost-Effectiveness","RCT","Netherlands","Adults","Degenerative Disk Disease","Surgical","Cost-Effectiveness","RCT","RMDQ","2005:2009"]
[48,"Buchbinder, R., et al. (2001). \"2001 Volvo Award Winner in Clinical Studies: Effects of a media campaign on back pain beliefs and its potential influence on management of low back pain in general practice.\" Spine (Phila Pa 1976) 26(23): 2535-2542.",null,"Buchbinder, R., et al.","2001 Volvo Award Winner in Clinical Studies: Effects of a media campaign on back pain beliefs and its potential influence on management of low back pain in general practice","STUDY DESIGN: Quasi-experimental, nonrandomized, nonequivalent, parallel group-controlled study involving before and after telephone surveys of the general population and postal surveys of general practitioners was conducted, with an adjacent state used as a control group. OBJECTIVES: To evaluate the effectiveness of a population-based intervention designed to alter beliefs about back pain, influence medical management, and reduce disability and workers' compensation-related costs. SUMMARY OF BACKGROUND DATA: A multimedia campaign begun during 1997 in Victoria, Australia, positively advised patients with back pain to stay active and exercise, not to rest for prolonged periods, and to remain at work. METHODS: The campaign's impact on population beliefs about back pain and fear-avoidance beliefs was measured in telephone surveys, and the effect of the campaign on the potential management of low back pain by general practitioners was assessed by eliciting their likely approach to two hypothetical scenarios in mailed surveys. Demographically identical population groups in Victoria and the control state, New South Wales, were surveyed at three times: before, during, and after intervention in Victoria. RESULTS: The studies were completed by 4730 individuals in the general population and 2556 general practitioners. There were large statistically significant improvements in back pain beliefs over time in Victoria (mean scores on the Back Beliefs Questionnaire, 26.5, 28.4, and 29.7), but not in New South Wales (26.3, 26.2, and 26.3, respectively). Among those who reported back pain during the previous year, fear-avoidance beliefs about physical activity improved significantly in Victoria (mean scores on the Fear-Avoidance Beliefs Questionnaire for physical activity, 14, 12.5, and 11.6), but not in New South Wales (13.3, 13.6, and 12.7, respectively). General practitioners in Victoria reported significant improvements over time in beliefs about back pain management, as compared with their interstate colleagues. There were statistically significant interactions between state and time for 7 of 10 responses on management of acute low back pain, and for 6 of 10 responses on management of subacute low back pain. CONCLUSION: A population-based strategy of providing positive messages about back pain improves the beliefs of the general population and general practitioners about back pain and appears to influence medical management."," Spine (Phila Pa 1976) 26(23): 2535-2542.","Australia",2001,"Back Pain","Exercise","BBQ","Unknown","PRO study","Clinical trial","Australia","Unknown","Back Pain","Exercise","PRO study","Clinical trial","BBQ","2000:2004"]
[49,"Buchbinder, R., et al. (2001). \"Population based intervention to change back pain beliefs and disability: three part evaluation.\" Bmj 322(7301): 1516-1520.",null,"Buchbinder, R., et al.","Population based intervention to change back pain beliefs and disability: three part evaluation","OBJECTIVE: To evaluate the effectiveness of a population based, state-wide public health intervention designed to alter beliefs about back pain, influence medical management, and reduce disability and costs of compensation. DESIGN: Quasi-experimental, non-randomised, non-equivalent, before and after telephone surveys of the general population and postal surveys of general practitioners with an adjacent state as control group and descriptive analysis of claims database. SETTING: Two states in Australia. PARTICIPANTS: 4730 members of general population before and two and two and a half years after campaign started, in a ratio of 2:1:1; 2556 general practitioners before and two years after campaign onset. MAIN OUTCOME MEASURES: Back beliefs questionnaire, knowledge and attitude statements about back pain, incidence of workers' financial compensation claims for back problems, rate of days compensated, and medical payments for claims related to back pain and other claims. RESULTS: In the intervention state beliefs about back pain became more positive between successive surveys (mean improvement in questionnaire score 1.9 (95% confidence interval 1.3 to 2.5), P<0.001 and 3.2 (2.6 to 3.9), P<0.001, between baseline and the second and third survey, respectively). Beliefs about back pain also improved among doctors. There was a clear decline in number of claims for back pain, rates of days compensated, and medical payments for claims for back pain over the duration of the campaign. CONCLUSIONS: A population based strategy of provision of positive messages about back pain improves population and general practitioner beliefs about back pain and seems to influence medical management and reduce disability and workers' compensation costs related to back pain."," Bmj 322(7301): 1516-1520.","Australia",2001,"Back Pain","Not Specified","BBQ","Adults","PRO study","Clinical trial","Australia","Adults","Back Pain","Not Specified","PRO study","Clinical trial","BBQ","2000:2004"]
[50,"Bunge, E. M., et al. (2007). \"Health-related quality of life in patients with adolescent idiopathic scoliosis after treatment: short-term effects after brace or surgical treatment.\" Eur Spine J 16(1999): 83-89.",null,"Bunge, E. M., et al.","Health-related quality of life in patients with adolescent idiopathic scoliosis after treatment: short-term effects after brace or surgical treatment","For treatment of teenagers with progressive adolescent idiopathic scoliosis in an early stage, two options are generally considered: treatment with a brace or observation followed by surgery if necessary. Many doctors and patients prefer conservative treatment (i.e. brace treatment) to surgical treatment, because surgery of the spine is generally considered a drastic intervention. Because potential differences in health-related quality of life (HRQoL) after treatment between braced and surgically treated patients are not well explored, this study aimed to determine whether short-term differences exist in HRQoL between adolescents treated with a brace or treated surgically. A cross-sectional analysis of HRQoL was made of 109 patients with adolescent idiopathic scoliosis who, after completing treatment, filled out the Dutch SRS-22 Patient Questionnaire. All patients had been treated either with a brace or surgery, or with a brace followed by surgery. Patients treated surgically had significantly higher mean scores in the satisfaction with management domain than those treated with a brace. No other consistent differences in HRQoL were found between patients treated with a brace and patients treated surgically. Gender, curve type and curve size had no relevant effect on HRQoL. We conclude that short-term differences in HRQoL after treatment in adolescent patients with idiopathic scoliosis are negligible and cannot support preference of one treatment above the other."," Eur Spine J 16(1999): 83-89.","Netherlands",2007,"Spinal Deformity","Surgical","SRS-HRQOL","Unknown","PRO study","Narrative review","Netherlands","Unknown","Spinal Deformity","Surgical","PRO study","Narrative review","SRS-HRQOL","2005:2009"]
[51,"Burgstaller, J. M., et al. (2016). \"The Impact of Obesity on the Outcome of Decompression Surgery in Degenerative Lumbar Spinal Canal Stenosis: Analysis of the Lumbar Spinal Outcome Study (LSOS): A Swiss Prospective Multicenter Cohort Study.\" Spine (Phila Pa 1976) 41(1999): 82-89.",null,"Burgstaller, J. M., et al.","The Impact of Obesity on the Outcome of Decompression Surgery in Degenerative Lumbar Spinal Canal Stenosis: Analysis of the Lumbar Spinal Outcome Study (LSOS): A Swiss Prospective Multicenter Cohort Study","STUDY DESIGN: Prospective, multicenter cohort study including 8 medical centers of the Cantons Zurich, Lucerne, and Thurgau, Switzerland. OBJECTIVE: The aim of the study was to assess whether obese patients benefit after decompression surgery for degenerative lumbar spinal stenosis (DLSS). SUMMARY AND BACKGROUND DATA: Lumbar decompression surgery has been shown to improve quality of life in patients with DLSS. In the existing literature, the efficacy of lumbar decompression in the obese population remains controversial. METHODS: Baseline patient characteristics and outcomes were analyzed at 6 and 12 months follow-up with the Spinal Stenosis Measure (SSM), the Numeric Rating Scale (NRS), Feeling Thermometer (FT), the EQ-5D-EL, and the Roland and Morris Disability Questionnaire (RMDQ). Body mass index (BMI) was classified into 3 categories according to the WHO. Minimal clinically important differences (MCIDs) in SSM for different BMI categories were considered as main outcome. RESULTS: Of the 656 patients in the Lumbar Spinal Outcome Study database as of end of October 2014, 166 patients met the inclusion criteria. Fifty (30.1%) had a BMI less than 25 (underweight and normal weight group), 72 (43.4%) had a BMI between 25 and less than 30 (preobesity group), and 44 (26.5%) patients had a BMI at least 30 (obese group). We found for the main outcome that in obese patients 36% reached MCID at 6 months, and 48% at 12 months. The estimated odds ratios for MCID in the obese group were 0.78 (0.34-1.82) at 6 months and 0.99 (0.44-2.23) at 12 months in a logistic regression model adjusting for levels of laminectomy. In the additional outcomes, SSM, NRS, FT, and RMDQ showed statistically significant mean improvements in the 6 and 12 months follow-up. CONCLUSION: Obese patients can expect clinical improvement after lumbar decompression for DLSS, but the percentage of patients with a meaningful improvement is lower than in the group of patients with underweight, normal weight, and preobese weight at 6 and 12 months."," Spine (Phila Pa 1976) 41(1999): 82-89.","Switzerland",2016,"Spinal Deformity","Surgical","RMDQ,SSM","Unknown","PRO study","Prospective Observation","Switzerland","Unknown","Spinal Deformity","Surgical","PRO study","Prospective Observation","RMDQ,SSM","2015:2018"]
[52,"Cairns, M. C., et al. (2006). \"Randomized controlled trial of specific spinal stabilization exercises and conventional physiotherapy for recurrent low back pain.\" Spine (Phila Pa 1976) 31(19): E670-681.",null,"Cairns, M. C., et al.","Randomized controlled trial of specific spinal stabilization exercises and conventional physiotherapy for recurrent low back pain","STUDY DESIGN: Pragmatic, multicentered randomized controlled trial, with 12-month follow-up. OBJECTIVE: To evaluate the effect of adding specific spinal stabilization exercises to conventional physiotherapy for patients with recurrent low back pain (LBP) in the United Kingdom. SUMMARY OF BACKGROUND DATA: Spinal stabilization exercises are a popular form of physiotherapy management for LBP, and previous small-scale studies on specific LBP subgroups have identified improvement in outcomes as a result. METHODS: A total of 97 patients (18-60 years old) with recurrent LBP were recruited. Stratified randomization was undertaken into 2 groups: \"conventional,\" physiotherapy consisting of general active exercise and manual therapy; and conventional physiotherapy plus specific spinal stabilization exercises. Stratifying variables used were laterality of symptoms, duration of symptoms, and Roland Morris Disability Questionnaire score at baseline. Both groups received The Back Book, by Roland et al. Back-specific functional disability (Roland Morris Disability Questionnaire) at 12 months was the primary outcome. Pain, quality of life, and psychologic measures were also collected at 6 and 12 months. Analysis was by intention to treat. RESULTS: A total of 68 patients (70%) provided 12-month follow-up data. Both groups showed improved physical functioning, reduced pain intensity, and an improvement in the physical component of quality of life. Mean change in physical functioning, measured by the Roland Morris Disability Questionnaire, was -5.1 (95% confidence interval -6.3 to -3.9) for the specific spinal stabilization exercises group and -5.4 (95% confidence interval -6.5 to -4.2) for the conventional physiotherapy group. No statistically significant differences between the 2 groups were shown for any of the outcomes measured, at any time. CONCLUSIONS: Patients with LBP had improvement with both treatment packages to a similar degree. There was no additional benefit of adding specific spinal stabilization exercises to a conventional physiotherapy package for patients with recurrent LBP."," Spine (Phila Pa 1976) 31(19): E670-681.","UK",2006,"Back Pain","Exercise","RMDQ","Adults","PRO study","RCT","UK","Adults","Back Pain","Exercise","PRO study","RCT","RMDQ","2005:2009"]
[53,"Cameron, I. D., et al. (2011). \"A randomized trial comparing acupuncture and simulated acupuncture for subacute and chronic whiplash.\" Spine (Phila Pa 1976) 36(26): E1659-1665.",null,"Cameron, I. D., et al.","A randomized trial comparing acupuncture and simulated acupuncture for subacute and chronic whiplash","STUDY DESIGN: A randomized controlled trial with 3 and 6 months follow-up. OBJECTIVE: To compare the effectiveness of acupuncture with simulated acupuncture in patients with subacute and chronic whiplash-associated disorders. SUMMARY OF BACKGROUND DATA: Acupuncture is widely used for the treatment of neck and other musculoskeletal pain, and there is some evidence supporting its effectiveness for short-term pain relief. The effectiveness of acupuncture in the treatment of whiplash-associated disorders is not clear. METHODS: A total of 124 patients between 18 and 65 years with chronic (85%) or subacute whiplash-associated disorders (Grade I or II) were randomly allocated to real or simulated electroacupuncture treatment for 12 sessions during a 6-week period. Both treatments involved skin penetration with acupuncture needles and were provided by a single university-trained acupuncturist in a University Clinic in Sydney, Australia. Primary outcome measures were pain intensity (10-cm visual analog scale), disability (Neck Disability Index), and health-related quality of life (SF-36). Secondary outcomes were patient-specific activity scales, and the McGill Pain Rating Index. RESULTS: Mean initial pain intensity for all participants was 5.6 cm. Participants receiving the real electroacupuncture treatment had significantly greater reduction in pain intensity at 3 and 6 months, 0.9 cm (P = 0.05) and 1.3 cm (P = 0.007), respectively, in comparison to the sham electro-acupuncture group. After adjustment for baseline status, there was no significant reduction in disability, or improvement in health-related quality of life. There was an improvement in the activity scales of a similar size to the reduction in pain, but no difference in the McGill Index. CONCLUSION: Real electroacupuncture was associated with a significant reduction in pain intensity over at least 6 months. This reduction was probably not clinically significant. There was no improvement in disability or quality of life."," Spine (Phila Pa 1976) 36(26): E1659-1665.","Australia",2011,"Trauma","Acupuncture","NDI","Adults","PRO study","RCT","Australia","Adults","Trauma","Acupuncture","PRO study","RCT","NDI","2010:2014"]
[54,"Campbell, L., et al. (2015). \"Trauma-focused cognitive behaviour therapy and exercise for chronic whiplash: protocol of a randomised, controlled trial.\" J Physiother 61(4): 218.",null,"Campbell, L., et al.","Trauma-focused cognitive behaviour therapy and exercise for chronic whiplash: protocol of a randomised, controlled trial","INTRODUCTION: As a consequence of a road traffic crash, persistent pain and disability following whiplash injury are common and incur substantial personal and economic costs. Up to 50% of people who experience a whiplash injury will never fully recover and up to 30% will remain moderately to severely disabled by the condition. The reason as to why symptoms persist past the acute to sub-acute stage and become chronic is unclear, but likely results from complex interactions between structural injury, physical impairments, and psychological and psychosocial factors. Psychological responses related to the traumatic event itself are becoming an increasingly recognised factor in the whiplash condition. Despite this recognition, there is limited knowledge regarding the effectiveness of psychological interventions, either delivered alone or in combination with physiotherapy, in reducing the physical and pain-related psychological factors of chronic whiplash. Pilot study results have shown positive results for the use of trauma-focused cognitive behaviour therapy to treat psychological factors, pain and disability in individuals with chronic whiplash. The results have indicated that a combined approach could not only reduce psychological symptoms, but also pain and disability. AIMS: The primary aim of this randomised, controlled trial is to investigate the effectiveness of combined trauma-focused cognitive behavioural therapy, delivered by a psychologist, and physiotherapy exercise to decrease pain and disability of individuals with chronic whiplash and post-traumatic stress disorder (PTSD). The trial also aims to investigate the effectiveness of the combined therapy in decreasing post-traumatic stress symptoms, anxiety and depression. PARTICIPANTS AND SETTING: A total of 108 participants with chronic whiplash-associated disorder (WAD) grade II of > 3 months and < 5 years duration and PTSD (diagnosed with the Clinician Administered PTSD Scale (CAPS) according to the DSM-5) will be recruited for the study. Participants will be assessed via phone screening and in person at a university research laboratory. Interventions will take place in southeast Queensland, Australia and southern Denmark. INTERVENTION: Psychological therapy will be delivered once a week over 10 weeks, with participants randomly assigned to either trauma-focused cognitive behavioural therapy or supportive therapy, both delivered by a clinical psychologist. Participants will then receive ten sessions of evidence-based physiotherapy exercise delivered over a 6-week period. OUTCOME MEASURES: The primary outcome measure is neck disability (Neck Disability Index). Secondary outcomes focus on: pain intensity; presence and severity of PTSD (CAPS V and PTSD Checklist 5); psychological distress (Depression, Anxiety Stress Scale 21); patient perceived functionality (SF-12, Tampa Scale of Kinesiophobia, and Patient-Specific Functional Scale); and pain-specific self-efficacy and catastrophising (Pain Self-Efficacy Questionnaire and Pain Catastrophizing Scale). After psychotherapy (10 weeks after randomisation) and physiotherapy (16 weeks after randomisation), as well as at the 6-month and 12-month follow-ups, a blind assessor will measure the outcomes. ANALYSIS: All analyses will be conducted on an intention-to-treat basis. The primary and secondary outcomes that are measured will be analysed using linear mixed and logistic regression models. Any effect of site (Australia or Denmark) will be evaluated by including a site-by-treatment group-by-time interaction term in the mixed models analyses. Effect modification will only be assessed for the primary outcome of the Neck Disability Index. DISCUSSION: This study will provide a definitive evaluation of the effects of adding trauma-focused cognitive behaviour therapy to physiotherapy exercise for individuals with chronic WAD and PTSD. This study is likely to influence the clinical management of whiplash injury and will have immediate clinical applicability in Australia, Denmark and the wider international community. The study will also have implications for both health and insurance policy makers in their decision-making regarding treatment options and funding."," J Physiother 61(4): 218.","Australia,Denmark",2015,"Trauma","CBT","NDI","Adults","Cost and Resource Use","Narrative review","Australia,Denmark","Adults","Trauma","CBT","Cost and Resource Use","Narrative review","NDI","2015:2018"]
[55,"Carreon, L. Y., et al. (2011). \"Predicting SF-6D utility scores from the neck disability index and numeric rating scales for neck and arm pain.\" Spine (Phila Pa 1976) 36(6): 490-494.",null,"Carreon, L. Y., et al.","Predicting SF-6D utility scores from the neck disability index and numeric rating scales for neck and arm pain","STUDY DESIGN: Cross-sectional cohort. OBJECTIVE: This study aims to provide an algorithm to estimate Short Form-6D (SF-6D) utilities using data from the Neck Disability Index (NDI), neck pain, and arm pain scores. SUMMARY OF BACKGROUND DATA: Although cost-utility analysis is increasingly used to provide information about the relative value of alternative interventions, health state values or utilities are rarely available from clinical trial data. The Neck Disability Index (NDI) and numerical rating scales for neck and arm pain are widely used disease-specific measures in patients with cervical degenerative disorders. The purpose of this study is to provide an algorithm to allow estimation of SF-6D utilities using data from the NDI, and numerical rating scales for neck and arm pain. METHODS: SF-36, NDI, neck and arm pain rating scale scores were prospectively collected before surgery, at 12 and 24 months after surgery in 2080 patients undergoing cervical fusion for degenerative disorders. SF-6D utilities were computed, and Spearman correlation coefficients were calculated for paired observations from multiple time points between NDI, neck and arm pain scores, and SF-6D utility scores. SF-6D scores were estimated from the NDI, neck and arm pain scores were estimated using a linear regression model. Using a separate, independent dataset of 396 patients in which NDI scores were available, SF-6D was estimated for each subject and compared to their actual SF-6D. RESULTS: The mean age for those in the development sample was 50.4 +/- 11.0 years and 33% were male. In the validation sample, the mean age was 53.1 +/- 9.9 years and 35% were male. Correlations between the SF-6D and the NDI, neck and arm pain scores were statistically significant (P < 0.0001) with correlation coefficients of 0.82, 0.62, and 0.50, respectively. The regression equation using NDI aloneto predict SF-6D had an R of 0.66 and a root mean square error of 0.056. In the validation analysis, there was no statistically significant difference (P 5 0.961) between actual mean SF-6D (0.49 6 0.08) and the estimated mean SF-6D score (0.49 6 0.08), using the NDI regression model. CONCLUSION: This regression-based algorithm may be a useful tool to predict SF-6D scores in studies of cervical degenerative disease that have collected NDI but not utility scores."," Spine (Phila Pa 1976) 36(6): 490-494.","USA",2011,"Neck Pain,Spondylosis","Surgical","NDI","Adults","Tool Validation","Prospective Observation","USA","Adults","Neck Pain,Spondylosis","Surgical","Tool Validation","Prospective Observation","NDI","2010:2014"]
[56,"Carreon, L. Y., et al. (2014). \"Estimating EQ-5D values from the Neck Disability Index and numeric rating scales for neck and arm pain.\" J Neurosurg Spine 21(3): 394-399.",null,"Carreon, L. Y., et al.","Estimating EQ-5D values from the Neck Disability Index and numeric rating scales for neck and arm pain","OBJECT: The Neck Disability Index (NDI) and numeric rating scales (0 to 10) for neck pain and arm pain are widely used cervical spine disease-specific measures. Recent studies have shown that there is a strong relationship between the SF-6D and the NDI such that using a simple linear regression allows for the estimation of an SF-6D value from the NDI alone. Due to ease of administration and scoring, the EQ-5D is increasingly being used as a measure of utility in the clinical setting. The purpose of this study is to determine if the EQ-5D values can be estimated from commonly available cervical spine disease-specific health-related quality of life measures, much like the SF-6D. METHODS: The EQ-5D, NDI, neck pain score, and arm pain score were prospectively collected in 3732 patients who presented to the authors' clinic with degenerative cervical spine disorders. Correlation coefficients for paired observations from multiple time points between the NDI, neck pain and arm pain scores, and EQ-5D were determined. Regression models were built to estimate the EQ-5D values from the NDI, neck pain, and arm pain scores. RESULTS: The mean age of the 3732 patients was 53.3 +/- 12.2 years, and 43% were male. Correlations between the EQ-5D and the NDI, neck pain score, and arm pain score were statistically significant (p < 0.0001), with correlation coefficients of -0.77, -0.62, and -0.50, respectively. The regression equation 0.98947 + (-0.00705 x NDI) + (-0.00875 x arm pain score) + (-0.00877 x neck pain score) to predict EQ-5D had an R-square of 0.62 and a root mean square error (RMSE) of 0.146. The model using NDI alone had an R-square of 0.59 and a RMSE of 0.150. The model using the individual NDI items had an R-square of 0.46 and an RMSE of 0.172. The correlation coefficient between the observed and estimated EQ-5D scores was 0.79. There was no statistically significant difference between the actual EQ-5D score (0.603 +/- 0.235) and the estimated EQ-5D score (0.603 +/- 0.185) using the NDI, neck pain score, and arm pain score regression model. However, rounding off the coefficients to fewer than 5 decimal places produced less accurate results. CONCLUSIONS: The regression model estimating the EQ-5D from the NDI, neck pain score, and arm pain score accounted for 60% of the variability of the EQ-5D with a relatively large RMSE. This regression model may not be sufficient to accurately or reliably estimate actual EQ-5D values."," J Neurosurg Spine 21(3): 394-399.","USA",2014,"Spine Disease,Neck Pain","Not Specified","NDI","Adults","PRO study","Prospective Observation","USA","Adults","Spine Disease,Neck Pain","Not Specified","PRO study","Prospective Observation","NDI","2010:2014"]
[57,"Carrico, G., et al. (2012). \"Cross-cultural adaptation and validity of an adapted Brazilian Portuguese version of Scoliosis Research Society-30 questionnaire.\" Spine (Phila Pa 1976) 37(1999): E60-63.",null,"Carrico, G., et al.","Cross-cultural adaptation and validity of an adapted Brazilian Portuguese version of Scoliosis Research Society-30 questionnaire","STUDY DESIGN: Prospective clinical study developed at a tertiary teaching facility to test an adapted Brazilian Portuguese version of the Scoliosis Research Society-30 (SRS-30) questionnaire. OBJECTIVE: To perform cross-cultural adaptation and evaluate the validity of the adapted Brazilian Portuguese version of SRS-30 questionnaire. SUMMARY OF BACKGROUND DATA: Quality-of-life measurement is a common practice to assess spine diseases. The SRS questionnaires have been proven to be a valid tool in the clinical evaluation of patients diagnosed with idiopathic scoliosis in United States. However, adaptation into languages other than the source language is necessary to allow multinational use respecting cultural and lingual differences. METHODS: A translation/retranslation of the English version of the SRS-30 into Brazilian Portuguese was conducted, and all steps for cross-cultural adaptation process were performed, including a pretest with 20 patients. Sixty-four postoperative patients were submitted to the final version of the Brazilian SRS-30 questionnaire, through oral interviews. The average age of all patients who joined the study was 18.5 years. Internal consistency of the instrument was determined with Cronbach alpha coefficient. RESULTS: The study demonstrated high Cronbach alpha values for 4 of the corresponding domains (pain, 0.68; self-image, 0.75; mental health, 0.78; and function/activity, 0.57). However, the Cronbach alpha value for satisfaction domain (0.28) was considerably lower than the original English questionnaire. The overall Cronbach alpha values achieved 0.85 for all domains. CONCLUSION: The adapted Brazilian version of the SRS-30 questionnaire can be used to assess the outcome of treatment for Brazilian Portuguese-speaking patients with idiopathic scoliosis."," Spine (Phila Pa 1976) 37(1999): E60-63.","Brazil",2012,"Spinal Deformity","Surgical","SRS-HRQOL","Adults","Tool Validation","Prospective Observation","Brazil","Adults","Spinal Deformity","Surgical","Tool Validation","Prospective Observation","SRS-HRQOL","2010:2014"]
[58,"Castro-Sanchez, A. M., et al. (2016). \"Benefits of Craniosacral Therapy in Patients with Chronic Low Back Pain: A Randomized Controlled Trial.\" J Altern Complement Med 22(8): 650-657.",null,"Castro-Sanchez, A. M., et al.","Benefits of Craniosacral Therapy in Patients with Chronic Low Back Pain: A Randomized Controlled Trial","OBJECTIVES: To evaluate the effects of craniosacral therapy on disability, pain intensity, quality of life, and mobility in patients with low back pain. DESIGN: A single-blinded randomized controlled trial. PATIENTS: Sixty-four patients with chronic nonspecific low back pain (mean age +/- SD, 50 +/- 12 years; 66% female) who were referred for physical therapy at a clinical unit of the Health Science School of the University of Almeria (Spain). INTERVENTIONS: Participants were randomly assigned to an experimental group (10 sessions of craniosacral therapy) or a control group (10 sessions of classic massage). OUTCOME MEASURES: Disability (Roland Morris Disability Questionnaire [RMQ, primary outcome] and Oswestry Disability Index), pain intensity (10-point numeric pain rating scale), kinesiophobia (Tampa Scale of Kinesiophobia), isometric endurance of trunk flexor muscles (McQuade test), lumbar mobility in flexion, hemoglobin oxygen saturation, systolic blood pressure, diastolic blood pressure, hemodynamic measures (cardiac index), and biochemical estimation of interstitial fluid. These outcomes were registered at baseline, after treatment, and 1-month follow-up. RESULTS: No statistically significant differences were seen between groups for the main outcome of the study, the RMQ (p = 0.060). However, patients receiving craniosacral therapy experienced greater improvement in pain intensity (p </= 0.008), hemoglobin oxygen saturation (p </= 0.028), and systolic blood pressure (p </= 0.029) at immediate- and medium-term and serum potassium (p = 0.023) level and magnesium (p = 0.012) at short-term than those receiving classic massage. CONCLUSIONS: Ten sessions of craniosacral therapy resulted in a statistically greater improvement in pain intensity, hemoglobin oxygen saturation, systolic blood pressure, serum potassium, and magnesium level than did 10 sessions of classic massage in patients with low back pain."," J Altern Complement Med 22(8): 650-657.","Spain",2016,"Back Pain","Physical Therapy","ODI,RMDQ","Adults","PRO study","RCT","Spain","Adults","Back Pain","Physical Therapy","PRO study","RCT","ODI,RMDQ","2015:2018"]
[59,"Celenay, S. T., et al. (2016). \"A Comparison of the Effects of Stabilization Exercises Plus Manual Therapy to Those of Stabilization Exercises Alone in Patients With Nonspecific Mechanical Neck Pain: A Randomized Clinical Trial.\" J Orthop Sports Phys Ther 46(2): 44-55.",null,"Celenay, S. T., et al.","A Comparison of the Effects of Stabilization Exercises Plus Manual Therapy to Those of Stabilization Exercises Alone in Patients With Nonspecific Mechanical Neck Pain: A Randomized Clinical Trial","STUDY DESIGN: Randomized clinical trial. BACKGROUND: Little is known about the efficacy of providing manual therapy in addition to cervical and scapulothoracic stabilization exercises in people with mechanical neck pain (MNP). Objectives To compare the effects of stabilization exercises plus manual therapy to those of stabilization exercises alone on disability, pain, range of motion (ROM), and quality of life in patients with MNP. METHODS: One hundred two patients with MNP (18-65 years of age) were recruited and randomly allocated into 2 groups: stabilization exercise without (n = 51) and with (n = 51) manual therapy. The program was carried out 3 days per week for 4 weeks. The Neck Disability Index, visual analog pain scale, digital algometry of pressure pain threshold, goniometric measurements, and Medical Outcomes Study 36-Item Short-Form Health Survey were used to assess participants at baseline and after 4 weeks. RESULTS: Improvements in Neck Disability Index score, night pain, rotation ROM, and the Medical Outcomes Study 36-Item Short-Form Health Survey score were greater in the group that received stabilization exercise with manual therapy compared to the group that only received stabilization exercise. Between-group differences (95% confidence interval) were 2.2 (0.1, 4.3) points for the Neck Disability Index, 1.1 (0.0, 2.3) cm for pain at night measured on the visual analog scale, -4.3 degrees (-8.1 degrees , -0.5 degrees ) and -5.0 degrees (-8.2 degrees , -1.7 degrees ) for right and left rotation ROM, respectively, and -2.9 (-5.4, -0.4) points and -3.1 (-6.2, 0.0) points for the Medical Outcomes Study 36-Item Short-Form Health Survey physical and mental components, respectively. Changes in resting and activity pain, pressure pain threshold, and cervical extension or lateral flexion ROM did not differ significantly between the groups. Pressure pain threshold increased only in those who received stabilization exercise with manual therapy (P<.05). CONCLUSION: The results of this study suggest that stabilization exercises with manual therapy may be superior to stabilization exercises alone for improving disability, pain intensity at night, cervical rotation motion, and quality of life in patients with MNP. LEVEL OF EVIDENCE: Therapy, level 1b."," J Orthop Sports Phys Ther 46(2): 44-55.","Unknown",2016,"Neck Pain","Exercise","NDI","Adults","PRO study","RCT","Unknown","Adults","Neck Pain","Exercise","PRO study","RCT","NDI","2015:2018"]
[60,"Challier, B., et al. (2001). \"Is quality of life affected by season and weather conditions in ankylosing spondylitis?\" Clin Exp Rheumatol 19(3): 277-281.",null,"Challier, B., et al.","Is quality of life affected by season and weather conditions in ankylosing spondylitis?","OBJECTIVE: To examine the links between the quality of life (QOL) and season and weather conditions in ankylosing spondylitis (AS) patients. METHODS: A cohort of 146 AS patients (67% males), with a mean age of 47.3 years and a mean disease duration of 12.8 years, answered a self-administered questionnaire, the AS-AIMS2 validated for AS, 4 times over a period of one year in a postal survey. Clinical measures were assessed in a subsample of the cohort. Meterological data including daily temperature, hygrometry, wind speed and atmospheric pressure were collected over the same period. RESULTS: In this cohort, 106 patients completed the follow-up. A higher lumbar spine flexibility (Schober index) was associated with a higher climatic temperature and lower wind speed. Physical QOL improved in the summer, as did Social Interaction in the summer and fall, while Role QOL decreased in winter. A lower perceived QOL was significantly associated with a higher temperature and wind speed over the past 4 weeks, and with a higher hygrometry and atmospheric pressure over the past 2 days prior to completion of the questionnaire. CONCLUSION: This study provides some support to the popular belief and frequent patient complaints of a link between health status and perceived quality of life, as assessed by a specific questionnaire, with season and weather conditions."," Clin Exp Rheumatol 19(3): 277-281.","France",2001,"Spondylosis","Not Specified","Schober","Adults","PRO study","Prospective Observation","France","Adults","Spondylosis","Not Specified","PRO study","Prospective Observation","Schober","2000:2004"]
[61,"Chamorro Comesana, A., et al. (2017). \"Effect of myofascial induction therapy on post-c-section scars, more than one and a half years old. Pilot study.\" J Bodyw Mov Ther 21(1999): 197-204.",null,"Chamorro Comesana, A., et al.","Effect of myofascial induction therapy on post-c-section scars, more than one and a half years old. Pilot study","Myofascial Induction Therapy (MIT) is a manually-applied method used in physiotherapy and focused on restoring altered fascial tissue. In a healthy body, the fascial system maintains elasticity and coordination of movements. However, injuries and their after-effects, such as scars, may reduce this tissue role, causing a dysfunction. The aim of this study is to ascertain the effect of MIT on scars which have completed the repair process in healthy individuals without any associated pathology that might affect the healing process. In all 10 cases studied, changes were observed after applying MIT on the structure of the scar fold, both at deep (shown by ultrasound) and at superficial (shown by scar fold measurement) levels. Eight weekly MIT sessions were applied, establishing this number as a reference for future studies. Functional improvement was determined using Schober's Test and patient quality of life was measured with a specific questionnaire. These outcomes lay the groundwork for future research."," J Bodyw Mov Ther 21(1999): 197-204.","Spain",2017,"Unspecified","Physical Therapy","Schober","Unknown","PRO study","Prospective Observation","Spain","Unknown","Unspecified","Physical Therapy","PRO study","Prospective Observation","Schober","2015:2018"]
[62,"Chapman, J. R., et al. (2011). \"Evaluating common outcomes for measuring treatment success for chronic low back pain.\" Spine (Phila Pa 1976) 36(21 Suppl): S54-68.",null,"Chapman, J. R., et al.","Evaluating common outcomes for measuring treatment success for chronic low back pain","STUDY DESIGN: Systematic review. OBJECTIVE: To identify, describe, and evaluate common outcome measures in patients with chronic low back pain (CLBP). SUMMARY OF BACKGROUND DATA: The treatment of CLBP has been associated with multiple clinical challenges. Further complicating this is the myriad of outcome scores used to assess treatment of CLBP. These scores have been used to examine different domains of patient satisfaction and quality of life in the literature. Critical assessment of the frequency, parity, and the quality of these outcomes are essential to improve our understanding of CLBP. METHODS: A systematic review of the English-language literature was undertaken for articles published from January 2001 through December 31, 2010. Electronic databases and reference lists of key articles were searched to identify measures used to evaluate outcomes in six different domains in patients with CLBP. The titles and abstracts of the peer-reviewed literature of LBP were searched to determine which of these measures were most commonly reported in the literature and which have been validated in populations with CLBP. RESULTS: We identified 75 outcome measures cited to evaluate CLBP. Twenty-nine of these outcome measures were excluded because of only a single citation leaving 46 measures for the evaluation. The most commonly used functional outcomes were the Oswestry Disability Index, Roland Morris Disability Index, and range of motion. For pain, the Numeric Pain Rating Scale, Brief Pain Inventory, Pain Disability Index, McGill Pain Questionnaire, and visual analog scale were most commonly cited. For psychosocial function, the Fear Avoidance Beliefs Questionnaire, Tampa Scale for Kinesiophobia, and Beck Depression Inventory were most commonly used. For generic quality of life, short form 36, Nottingham Health Profile, short form 12, and Sickness Impact Profile were the most common measures. For objective measures, the work status/return to work, complications or adverse events, and medications used were the most commonly cited. For preference-based measures, the Euro-Quol 5 dimensions and short form 6 dimensions were most commonly cited. The validity, reliability, responsiveness, universality, and potential proprietary requirements are summarized for each. CONCLUSION: Outcome measures should be routinely assessed in patients with CLBP. The choice of appropriate outcome measure should be influenced by the study objectives and design, as well as properties of the particular measure within the context of CLBP. CLINICAL RECOMMENDATIONS: Recommendation 1: When selecting the appropriate outcome measures for clinical or research purposes, consider domains that best measure what are most important to patients. Measures that are valid, reliable, and responsive to change should be considered first. Other considerations include the number of items required (especially in the context of multiple measures), whether the measure is validated in the relevant language, and the associated costs or fees. Strength: Strong Recommendation 2: Domains of greatest importance include pain, function, and quality of life. If cost utilization is a priority, then preference-based measures should be considered. For pain, we recommend the VAS and NRPS because of their ease of administration and responsiveness. For function, we recommend the ODI and RMDQ. The SF-36 and its shorter versions are most commonly used and should be considered if quality of life is important. If cost utility is important, consider the EQ-5D or SF-6D. Psychosocial tests are best used as screening tools prior to surgery because of their lack of responsiveness. Complications should always be assessed as a standard of clinical practice. Return to work and medication use are complicated outcome measures and not recommended unless the specific study question is focused on these domains. Consider staff and patient burden when prioritizing one's battery of measures."," Spine (Phila Pa 1976) 36(21 Suppl): S54-68.","USA",2011,"Back Pain","Surgical","ODI,RMDQ","Unknown","PRO study","Systematic review","USA","Unknown","Back Pain","Surgical","PRO study","Systematic review","ODI,RMDQ","2010:2014"]
[63,"Checchia, G. A., et al. (2017). \"Observational multicentric study on chronic sciatic pain: clinical data from 44 Italian centers.\" Eur Rev Med Pharmacol Sci 21(7): 1653-1664.",null,"Checchia, G. A., et al.","Observational multicentric study on chronic sciatic pain: clinical data from 44 Italian centers","OBJECTIVE: To provide information on the clinical presentation of sciatic neuropathy and its management in a real-world setting, and to analyze the effects of a multimodal approach based on the association of physical and pharmacological therapy. PATIENTS AND METHODS: A multicentric observational prospective study was conducted in 44 Italian tertiary centers specialized in Physical Medicine and Rehabilitation, Orthopedics, Neurology, Neurosurgery, and Rheumatology. To develop a shared management of LPB with sciatica, a dedicated clinical record was proposed to collect data about diagnosis, treatment, and outcomes. Pain, disability, and quality of life were recorded trough validated questionnaires at baseline and after a two-month follow-up. RESULTS: 394 patients (age, mean +/- SD 55.7 +/- 14.1 years, 57.1% females) with chronic LBP and sciatica were enrolled in the study. The characteristics of the selected group showed a certain variability in the clinical presentation. At baseline, patients received several different therapeutic options among physical, pharmacological and neurotrophic treatments. A subgroup of 312 patients was treated with a combination of neurotrophic agents containing alpha-lipoic acid (ALA). After a two-month follow-up, a general improvement in both perceived pain and functional disabilities was observed. A significant improvement (p < 0.001) in the Pain Numeric Rating Scale (NRS), Roland e Morris Disability Questionnaire (RMDQ) and Brief Pain Inventory (BPI) Italian short version was observed. CONCLUSIONS: Sciatic neuropathy is a multifaceted condition managed by means of a wide spectrum of therapeutic options. The results of this study suggest that a multimodal approach based on the association of ALA with physical and pharmacological therapies can be beneficial in the treatment of LBP with sciatica."," Eur Rev Med Pharmacol Sci 21(7): 1653-1664.","Italy",2017,"Degenerative Disk Disease","Surgical","RMDQ","Adults","PRO study","Narrative review","Italy","Adults","Degenerative Disk Disease","Surgical","PRO study","Narrative review","RMDQ","2015:2018"]
[64,"Chen, C. Y., et al. (2015). \"Is rehabilitation intervention during hospitalization enough for functional improvements in patients undergoing lumbar decompression surgery? A prospective randomized controlled study.\" Clin Neurol Neurosurg 129 Suppl 1: S41-46.",null,"Chen, C. Y., et al.","Is rehabilitation intervention during hospitalization enough for functional improvements in patients undergoing lumbar decompression surgery? A prospective randomized controlled study","OBJECTIVE: Rehabilitation has been reported to improve pain and disability for patients after lumbar surgery. However, studies to investigate the rehabilitation intervention for lumbar decompression surgery during hospitalization are scarce. The aim of this study was to examine outcomes of perioperative rehabilitation intervention for patients who underwent lumbar decompression surgery (LDS). METHODS: Patients aged 18-65 years old who received their first LDS were randomized into the perioperative rehabilitation group (PG) or control group (CG). The PG received rehabilitation intervention during hospitalization for lumbar decompression surgery. Pain, functional capacity, Roland-Morris Disability Questionnaire (RMDQ), and Short-Form Health Survey (SF-12) were assessed on admission, at discharge, and at follow-ups one month, three months, and six months after surgery. Two-way repeated measures ANOVAs were used for statistical analysis. RESULTS: A total of 60 patients scheduled for decompression surgery for lumbar stenosis were enrolled into the study. After surgery, the PG showed significant pain relief and improvement of disability as well as quality of life, but there were no significant functional improvements compared with the CG. CONCLUSIONS: The findings of this study indicate that the rehabilitation intervention during hospitalization improves pain intensity as well as disability and quality of life, yet has limited effects on the functional performance over time up to six months post-surgery in patients who received LDS. The study suggest that rehabilitation interventions during hospitalization must include regular support for patient adherence to the intervention program and focus on task-oriented programs for lower extremities such as closed-chain exercises in functional postures."," Clin Neurol Neurosurg 129 Suppl 1: S41-46.","Taiwan",2015,"Spine Disease","Surgical","RMDQ","Adults","PRO study","RCT","Taiwan","Adults","Spine Disease","Surgical","PRO study","RCT","RMDQ","2015:2018"]
[65,"Cheng, I., et al. (2005). \"Apical sublaminar wires versus pedicle screws--which provides better results for surgical correction of adolescent idiopathic scoliosis?\" Spine (Phila Pa 1976) 30(18): 2104-2112.",null,"Cheng, I., et al.","Apical sublaminar wires versus pedicle screws--which provides better results for surgical correction of adolescent idiopathic scoliosis?","STUDY DESIGN: The results of correction for adolescent idiopathic scoliosis (AIS) were compared using apical sublaminar wires versus pedicle screws. OBJECTIVE: To compare comprehensively the 2-year minimum postoperative results of posterior correction and spinal fusion using translational correction through either hybrid hook/sublaminar wire/pedicle screw constructs versus in situ rod-contouring correction with pedicle screw constructs in the treatment of AIS at 2 institutions. SUMMARY OF BACKGROUND DATA: Despite the reports of satisfactory correction of scoliotic curves by both apical (sublaminar wire) instrumentation and apical pedicle screw instrumentation, to our knowledge, no reports on the comprehensive comparison of hybrid (hook/sublaminar wire/pedicle screw) instrumentation versus segmental pedicle screw instrumentation exist. METHODS: A total of 50 patients with AIS at 2 institutions who underwent posterior spinal fusion with sublaminar wire (25 patients) or pedicle screw (25) constructs were sorted and matched according to 4 criteria: (1999) similar age at surgery (14.2 years in the sublaminar wire and 14.4 in the pedicle screw group, P = 0.72); (2) similar number of fused vertebrae (11.4 in the sublaminar wire and 11.8 in the pedicle screw group, P = 0.36); (3) similar operative methods; and (4) identical Lenke curve types and similar preoperative major curve measurements (63.5 degrees in the sublaminar wire and 59.5 degrees in the pedicle screw group, P = 0.42). Patients were evaluated preoperatively, immediately postoperatively, and at 2-year follow-up according to radiographic changes in curve correction, operating time, intraoperative blood loss, implant costs, and the Scoliosis Research Society patient questionnaire (SRS-24) scores. RESULTS: After surgery, average major curve correction was 67.4% in the sublaminar wire and 68.1% in the pedicle screw group (P = 0.56). At 2-year follow-up, loss of the major curve correction was 4.6% in the sublaminar wire compared to 5.1% in the pedicle screw group (P = 0.79). Postoperative global coronal and sagittal balance were similar in both groups. No significant difference was found in the average number of levels fused from the distal end vertebra (1.48 in the sublaminar wire and 0.64 in the pedicle screw group, P = 0.21). Operating time averaged 350 minutes in the sublaminar wire and 357 in the pedicle screw group (P = 0.86). Intraoperative blood loss was significantly different in both groups (1791 +/- 816 mL in the sublaminar wire and 824 +/- 440 mL in the pedicle screw group) (P = 0.0003). Average implant cost in the sublaminar wire group (16.0 fixation points; 8,341 US dollars) was significantly lower than that of the pedicle screw group (17.1 fixation points; 13,462 US dollars) (P < 0.0001). Postoperative 2-year SRS-24 scores were similar in both groups (sublaminar wire = 107.3, pedicle screw = 103.5, P = 0.19). There were no neurologic or visceral complications related to sublaminar wire or pedicle screw instrumentation and no reoperations at a minimum 2-year follow-up. CONCLUSIONS: Apical sublaminar wire and pedicle screw instrumentation both offer similar major curve correction with similar fusion lengths without neurologic problems in the operative treatment of AIS. Although more expensive, pedicle screw constructs had significantly less blood loss and slightly shorter fusion lengths than the sublaminar wire constructs."," Spine (Phila Pa 1976) 30(18): 2104-2112.","USA",2005,"Spinal Deformity,Spinal Fusion","Surgical","SRS-HRQOL","Adolescents","Tool Validation","Prospective Observation","USA","Adolescents","Spinal Deformity,Spinal Fusion","Surgical","Tool Validation","Prospective Observation","SRS-HRQOL","2005:2009"]
[66,"Cherkin, D. C., et al. (2014). \"Comparison of complementary and alternative medicine with conventional mind-body therapies for chronic back pain: protocol for the Mind-body Approaches to Pain (MAP) randomized controlled trial.\" Trials 15: 211.",null,"Cherkin, D. C., et al.","Comparison of complementary and alternative medicine with conventional mind-body therapies for chronic back pain: protocol for the Mind-body Approaches to Pain (MAP) randomized controlled trial","BACKGROUND: The self-reported health and functional status of persons with back pain in the United States have declined in recent years, despite greatly increased medical expenditures due to this problem. Although patient psychosocial factors such as pain-related beliefs, thoughts and coping behaviors have been demonstrated to affect how well patients respond to treatments for back pain, few patients receive treatments that address these factors. Cognitive-behavioral therapy (CBT), which addresses psychosocial factors, has been found to be effective for back pain, but access to qualified therapists is limited. Another treatment option with potential for addressing psychosocial issues, mindfulness-based stress reduction (MBSR), is increasingly available. MBSR has been found to be helpful for various mental and physical conditions, but it has not been well-studied for application with chronic back pain patients. In this trial, we will seek to determine whether MBSR is an effective and cost-effective treatment option for persons with chronic back pain, compare its effectiveness and cost-effectiveness compared with CBT and explore the psychosocial variables that may mediate the effects of MBSR and CBT on patient outcomes. METHODS/DESIGN: In this trial, we will randomize 397 adults with nonspecific chronic back pain to CBT, MBSR or usual care arms (99 per group). Both interventions will consist of eight weekly 2-hour group sessions supplemented by home practice. The MBSR protocol also includes an optional 6-hour retreat. Interviewers masked to treatment assignments will assess outcomes 5, 10, 26 and 52 weeks postrandomization. The primary outcomes will be pain-related functional limitations (based on the Roland Disability Questionnaire) and symptom bothersomeness (rated on a 0 to 10 numerical rating scale) at 26 weeks. DISCUSSION: If MBSR is found to be an effective and cost-effective treatment option for patients with chronic back pain, it will become a valuable addition to the limited treatment options available to patients with significant psychosocial contributors to their pain. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT01467843."," Trials 15: 211.","USA",2014,"Back Pain","CBT","RMDQ,Bothersomeness","Unknown","PRO study","Narrative review","USA","Unknown","Back Pain","CBT","PRO study","Narrative review","RMDQ,Bothersomeness","2010:2014"]
[67,"Cheung, K. M., et al. (2007). \"Outcome assessment of bracing in adolescent idiopathic scoliosis by the use of the SRS-22 questionnaire.\" Int Orthop 31(4): 507-511.",null,"Cheung, K. M., et al.","Outcome assessment of bracing in adolescent idiopathic scoliosis by the use of the SRS-22 questionnaire","The SRS-22 questionnaire is specifically designed for the assessment of quality of life in spinal deformity patients. This study is the first to use it to assess the quality of life of adolescent idiopathic scoliosis patients under brace treatment and compares the results with an observational group matched by age and curve magnitude. Forty-six patients were enrolled into each group. Overall, it was found that patients under observation had a significantly better quality of life than braced patients. Specifically, the domains for function/activity and self-image were most affected. This effect was most apparent in those with a curve magnitude of under 20 degrees . The scores did not improve significantly with the duration of brace wear, suggesting little adaptation. This study has implications for treatment, and more attention will need to be given to those with mild but progressive curves to help improve patients' understanding of their treatment and hence their compliance and satisfaction."," Int Orthop 31(4): 507-511.","China",2007,"Spinal Deformity","Brace","SRS-HRQOL","Adolescents","PRO study","Prospective Observation","China","Adolescents","Spinal Deformity","Brace","PRO study","Prospective Observation","SRS-HRQOL","2005:2009"]
[68,"Cheung, K. M., et al. (2007). \"Reliability and concurrent validity of the adapted Chinese version of Scoliosis Research Society-22 (SRS-22) questionnaire.\" Spine (Phila Pa 1976) 32(10): 1141-1145.",null,"Cheung, K. M., et al.","Reliability and concurrent validity of the adapted Chinese version of Scoliosis Research Society-22 (SRS-22) questionnaire","STUDY DESIGN: Validation study to define validity and reliability of an adapted and translated questionnaire. OBJECTIVE: Assessment of the concurrent validity and reliability of a Chinese version of SRS-22 outcome instrument. SUMMARY OF BACKGROUND DATA: No valid health-related quality of life (HRQL) outcome instrument exists for patients with spinal deformity in Chinese. The modified SRS-22 questionnaire was proven to be an appropriate outcome instrument in English, and has already been translated and validated in several other languages. METHODS: The English version of the SRS-22 questionnaire was adapted to Chinese according to the International Quality of Life Assessment Project guidelines. To assess reliability, 48 subjects with adolescent idiopathic scoliosis (mean age, 16.5 years) filled the questionnaire on 2 separate occasions (Group 1). To assess concurrent validity, 50 subjects (mean age, 21 years) filled in the same questionnaire and a previously validated Chinese version of the Short Form-36 (SF36) questionnaire (Group 2). Internal consistency, reproducibility and concurrent validity were determined with Cronbach's alpha coefficient, interclass correlation coefficient and Pearson correlation coefficient, respectively. RESULTS: Cronbach's alpha coefficient for the 4 major domains (function/activity, pain, self-image/appearance and mental health) were high. Intraclass correlation was also excellent for all domains. For concurrent validity, excellent correlation was found in 1 domain, good in 12 domains, moderate in 3 domains, and poor in 1 domain of the 17 relevant domains. DISCUSSION: Both cultural adaptation and linguistic translation are essential in any attempt to use a HRQL questionnaire across cultures. The Chinese version of the SRS-22 outcome instrument has satisfactory internal consistency and excellent reproducibility. It is ready for use in clinical studies on idiopathic scoliosis in Chinese-speaking societies."," Spine (Phila Pa 1976) 32(10): 1141-1145.","China",2007,"Spinal Deformity","Not Specified","SRS-HRQOL","Adolescents","Tool Validation","Observational","China","Adolescents","Spinal Deformity","Not Specified","Tool Validation","Observational","SRS-HRQOL","2005:2009"]
[69,"Chien, A., et al. (2014). \"Translation, cross-cultural adaptation, and validation of a Chinese version of the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire.\" Spine (Phila Pa 1976) 39(12): 963-970.",null,"Chien, A., et al.","Translation, cross-cultural adaptation, and validation of a Chinese version of the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire","STUDY DESIGN: Translation and psychometric testing of a questionnaire. OBJECTIVE: To adapt the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ) cross-culturally to Chinese language and to investigate the psychometric properties of the translated Chinese JOACMEQ. SUMMARY OF BACKGROUND DATA: The recently developed JOACMEQ is a self-reported questionnaire used to assess the severity of the cervical spondylotic myelopathy. Despite its acceptance in the literature, the JOACMEQ has not been translated and validated for Chinese-speaking patients. METHODS: Translation and cross-cultural adaptation of the original JOACMEQ was performed according to published guidelines. A total of 105 patients with a predominant complain of neck pain that included but not limited to patients with a clinically confirmed cervical spondylotic myelopathy were included. Psychometric testing of the responses included construct validity (factor analysis), internal consistency (Cronbach alpha), test-retest reproducibility (intraclass correlation coefficient), and concurrent validity (Spearman rho). The discriminatory power of differentiating those with myelopathy from those without was assessed by the area under the receiver operating characteristic curve and with the optimal cutoff points determined. RESULTS: Construct validity testing revealed a comparable factorial structure of the Chinese JOACMEQ with the original JOACMEQ. The Cronbach alpha of the Chinese JOACMEQ was 0.88, indicating good internal consistency. Good to excellent test-retest reliability was demonstrated for all 5 domain scores (intraclass correlation coefficient range = 0.79-0.90). A significant strong association between the Chinese Neck Disability Index and the quality of life domain of the Chinese JOACMEQ (Spearman rho= -0.76, P < 0.01) was identified. The upper and lower extremity function domain scores were found to be significant, with the area under the receiver operating characteristic curve found to be 0.75 (P = 0.04) and 0.82 (P = 0.02), respectively. CONCLUSION: The results indicated that the Chinese JOACMEQ successfully retained the psychometric properties of the original JOACMEQ and support the usefulness of the Chinese JOACMEQ as an appropriate supplementary diagnostic and outcome measure for Chinese patients suspected of cervical spondylotic myelopathy."," Spine (Phila Pa 1976) 39(12): 963-970.","Taiwan",2014,"Spondylosis,Cervical Myelopathy,Neck Pain","Not Specified","JOACMEQ","Unknown","Tool Validation","Observational","Taiwan","Unknown","Spondylosis,Cervical Myelopathy,Neck Pain","Not Specified","Tool Validation","Observational","JOACMEQ","2010:2014"]
[70,"Chino, B., et al. (2009). \"Subjective assessments of the quality of life, well-being and self-efficacy in patients with schizophrenia.\" Psychiatry Clin Neurosci 63(4): 521-528.",null,"Chino, B., et al.","Subjective assessments of the quality of life, well-being and self-efficacy in patients with schizophrenia","AIM: The present study examined three kinds of subjective assessment scales in the same patient group with schizophrenia to analyze the correlations among scores obtained in relation to the background data. METHOD: Thirty-six patients with schizophrenia were examined with the 26-item short form of the World Health Organization Quality of Life (WHO-QOL 26), Subjective Well-being under Neuroleptic drug treatment: Short Japanese version (SWNS) and Self-Efficacy for Community Life scale (SECL) for subjective assessment scales, five kinds of neurocognitive tests, Positive and Negative Syndrome Scale (PANSS) for clinical symptom, Social Functioning Scale (SFS), and Global Assessment of Functioning (GAF) scale for social functioning. RESULT: The scores for delusions (components of positive syndrome), anxiety and depression (components of general psychopathology) on the PANSS significantly correlated with QoL and subjective well-being scores. In contrast, the scores for components of negative syndrome were not correlated with the subjective assessment scores. Furthermore, none of the clinical symptom scores were correlated with the score in self-efficacy scale. The SFS and GAF scores were significantly correlated with the subjective assessment scores. There were significant correlations among the scores on the three subjective assessment scales. CONCLUSION: Each scale has different features and should be utilized depending upon the expected effect of treatment or the purpose of assessment. The treatments provided to patients must be directed at improving both psychological and social impairments, in order to enhance the social functioning and QoL of patients."," Psychiatry Clin Neurosci 63(4): 521-528.","Japan",2009,"Schizophrenia","Psychosocial","SWNS","Unknown","PRO study","Observational","Japan","Unknown","Schizophrenia","Psychosocial","PRO study","Observational","SWNS","2005:2009"]
[71,"Chotai, S., et al. (2015). \"Quality of Life and General Health After Elective Surgery for Cervical Spine Pathologies: Determining a Valid and Responsive Metric of Health State Utility.\" Neurosurgery 77(4): 553-560; discussion 560.",null,"Chotai, S., et al.","Quality of Life and General Health After Elective Surgery for Cervical Spine Pathologies: Determining a Valid and Responsive Metric of Health State Utility","BACKGROUND: As part of the Affordable Care Act, health utility metrics are being investigated to define a cost-effective, value-based health care model. EuroQOL-5D (EQ-5D) and Short Form-6D (SF-6D) are commonly used quality-of-life instruments. Domains in the EQ-5D questionnaire are thought to be less responsive in measuring quality of life after cervical surgery. OBJECTIVE: To evaluate the validity and responsiveness of SF-6D and EQ-5D in determining health and quality of life after elective cervical spine surgery. METHODS: A total of 420 patients undergoing elective cervical spine surgery over a period of 2 years were enrolled in a prospective longitudinal registry. Patient-reported outcomes Neck Disability Index (NDI), EQ-5D, and SF-12 were recorded. Based on previously published equations, SF-6D was calculated using NDI and SF-12 scores. Patients were asked whether \"surgery met their expectations\" (meaningful improvement). The validity and relative responsiveness of SF-6D (NDI), SF-6D (SF-12), and EQ-5D to discriminate between meaningful and nonmeaningful improvement were calculated. RESULTS: Sixty-six percent of patients (277) reported a level of improvement after surgery that met their expectations (meaningful improvement). SF-6D (NDI) (area under the curve [AUC] = 0.69) was a more valid discriminator of meaningful improvement compared with the SF-6D (SF-12) (AUC = 0.65) and EQ-5D (AUC = 0.62). SF-6D (NDI) was also a more responsive measure compared with SF-6D (SF-12) and EQ-5D (standardized response mean difference: 0.66, 0.48, and 0.44, respectively). CONCLUSION: SF-6D is a more valid and responsive measure of general health and quality of life compared with EQ-5D. SF-6D derived from disease-specific disability scores was more valid and responsive than that derived from the generic preference-based SF-12. Cost-effective studies should use SF-6D as a measure of QALY after cervical spine surgery."," Neurosurgery 77(4): 553-560; discussion 560.","USA",2015,"Unspecified","Surgical","NDI","Unknown","Cost-Effectiveness","Observational","USA","Unknown","Unspecified","Surgical","Cost-Effectiveness","Observational","NDI","2015:2018"]
[72,"Chotai, S., et al. (2016). \"Effect of obesity on cost per quality-adjusted life years gained following anterior cervical discectomy and fusion in elective degenerative pathology.\" Spine J 16(11): 1342-1350.",null,"Chotai, S., et al.","Effect of obesity on cost per quality-adjusted life years gained following anterior cervical discectomy and fusion in elective degenerative pathology","BACKGROUND: Obese patients have greater comorbidities along with higher risk of complications and greater costs after spine surgery, which may result in increased cost and lower quality of life compared with their non-obese counterparts. PURPOSE: The aim of the present study was to determine cost-utility following anterior cervical discectomy and fusion (ACDF) in obese patients. STUDY DESIGN: This study analyzed prospectively collected data. PATIENT SAMPLE: Patients undergoing elective ACDF for degenerative cervical pathology at a single academic institution were included in the study. OUTCOME MEASURES: Cost and quality-adjusted life years (QALYs) were the outcome measures. METHODS: One- and two-year medical resource utilization, missed work, and health state values (QALYs) were assessed. Two-year resource use was multiplied by unit costs based on Medicare national payment amounts (direct cost). Patient and caregiver workday losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). Total cost (direct+indirect) was used to compute cost per QALY gained. Patients were defined as obese for body mass index (BMI) >/=35 based on the WHO definition of class II obesity. A subgroup analysis was conducted in morbidly obese patients (BMI>/=40). RESULTS: There were significant improvements in pain (neck pain or arm pain), disability (Neck Disability Index), and quality of life (EuroQol-5D and Short Form-12) at 2 years after surgery (p<.001). There was no significant difference in post-discharge health-care resource utilization, direct cost, indirect cost, and total cost between obese and non-obese patients at postoperative 1-year and 2-year follow-up. Mean 2-year direct cost for obese patients was $19,225+/-$8,065 and $17,635+/-$6,413 for non-obese patients (p=.14). There was no significant difference in the mean total 2-year cost between obese ($23,144+/-$9,216) and non-obese ($22,183+/-$10,564) patients (p=.48). Obese patients had a lower mean cumulative gain in QALYs versus non-obese patients at 2-years (0.34 vs. 0.42, p=.32). Two-year cost-utility in obese ($68,070/QALY) versus non-obese patients ($52,816/QALY) was not significantly different (p=.11). Morbidly obese patients had lower QALYs gained (0.17) and higher cost per QALYs gained ($138,094/QALY) at 2 years. CONCLUSIONS: Anterior cervical discectomy and fusion provided a significant gain in health state utility in obese patients, with a mean 2-year cost-utility of $68,070 per QALYs gained, which can be considered moderately cost-effective. Morbidly obese patients had lower cost-effectiveness; however, surgery does provide a significant improvement in outcomes. Obesity, and specifically morbid obesity, should to be taken into consideration as physician and hospital reimbursements move toward a bundled model."," Spine J 16(11): 1342-1350.","USA",2016,"Neck Pain","Surgical","NDI","Adults","Cost and Resource Use","Observational","USA","Adults","Neck Pain","Surgical","Cost and Resource Use","Observational","NDI","2015:2018"]
[73,"Chow, R. T., et al. (2006). \"The effect of 300 mW, 830 nm laser on chronic neck pain: a double-blind, randomized, placebo-controlled study.\" Pain 124(1-2): 201-210.",null,"Chow, R. T., et al.","The effect of 300 mW, 830 nm laser on chronic neck pain: a double-blind, randomized, placebo-controlled study","A randomized, double-blind, placebo-controlled study of low-level laser therapy (LLLT) in 90 subjects with chronic neck pain was conducted with the aim of determining the efficacy of 300 mW, 830 nm laser in the management of chronic neck pain. Subjects were randomized to receive a course of 14 treatments over 7 weeks with either active or sham laser to tender areas in the neck. The primary outcome measure was change in a 10 cm Visual Analogue Scale (VAS) for pain. Secondary outcome measures included Short-Form 36 Quality-of-Life questionnaire (SF-36), Northwick Park Neck Pain Questionnaire (NPNQ), Neck Pain and Disability Scale (NPAD), the McGill Pain Questionnaire (MPQ) and Self-Assessed Improvement (SAI) in pain measured by VAS. Measurements were taken at baseline, at the end of 7 weeks' treatment and 12 weeks from baseline. The mean VAS pain scores improved by 2.7 in the treated group and worsened by 0.3 in the control group (difference 3.0, 95% CI 3.8-2.1). Significant improvements were seen in the active group compared to placebo for SF-36-Physical Score (SF36 PCS), NPNQ, NPAD, MPQVAS and SAI. The results of the SF-36 - Mental Score (SF36 MCS) and other MPQ component scores (afferent and sensory) did not differ significantly between the two groups. Low-level laser therapy (LLLT), at the parameters used in this study, was efficacious in providing pain relief for patients with chronic neck pain over a period of 3 months."," Pain 124(1-2): 201-210.","Australia",2006,"Neck Pain","Laser Therapy","NPDS,Northwick","Unknown","PRO study","RCT","Australia","Unknown","Neck Pain","Laser Therapy","PRO study","RCT","NPDS,Northwick","2005:2009"]
[74,"Cleland, J. A., et al. (2009). \"Does continuing education improve physical therapists' effectiveness in treating neck pain? A randomized clinical trial.\" Phys Ther 89(1999): 38-47.",null,"Cleland, J. A., et al.","Does continuing education improve physical therapists' effectiveness in treating neck pain? A randomized clinical trial","BACKGROUND AND PURPOSE: Physical therapists often attend continuing education (CE) courses to improve their overall clinical performance and patient outcomes. However, evidence suggests that CE courses may not improve the outcomes for patients receiving physical therapy for the management of neck pain. The purpose of this study was to investigate the effectiveness of an ongoing educational intervention for improving the outcomes for patients with neck pain. PARTICIPANTS: The study participants were 19 physical therapists who attended a 2-day CE course focusing on the management of neck pain. All patients treated by the therapists in this study completed the Neck Disability Index (NDI) and a pain rating scale at the initial examination and at their final visit. METHODS: Therapists from 11 clinics were invited to attend a 2-day CE course on the management of neck pain. After the CE course, the therapists were randomly assigned to receive either ongoing education consisting of small group sessions and an educational outreach session or no further education. Clinical outcomes achieved by therapists who received ongoing education and therapists who did not were compared for both pretraining and posttraining periods. The effects of receiving ongoing education were examined by use of linear mixed-model analyses with time period and group as fixed factors; improvements in disability and pain as dependent variables; and age, sex, and the patient's initial NDI and pain rating scores as covariates. RESULTS: Patients treated by therapists who received ongoing education experienced significantly greater reductions in disability during the study period (pretraining to posttraining) than those treated by therapists who did not receive ongoing training (mean difference=4.2 points; 95% confidence interval [CI]=0.69, 7.7). Changes in pain did not differ for patients treated by the 2 groups of therapists during the study period (mean difference=0.47 point; 95% CI=-0.11, 1.0). Therapists in the ongoing education group also used fewer visits during the posttraining period (mean difference=1.5 visits; 95% CI=0.81, 2.3). DISCUSSION AND CONCLUSION: The results of this study demonstrated that ongoing education for the management of neck pain was beneficial in reducing disability for patients with neck pain while reducing the number of physical therapy visits. However, changes in pain did not differ for patients treated by the 2 groups of therapists. Although it appears that a typical CE course does not improve the overall outcomes for patients treated by therapists attending that course, more research is needed to evaluate other educational strategies to determine the most clinically effective and cost-effective interventions."," Phys Ther 89(1999): 38-47.","USA",2009,"Neck Pain","Physical Therapy","NDI","Therapists","PRO study","Clinical trial","USA","Therapists","Neck Pain","Physical Therapy","PRO study","Clinical trial","NDI","2005:2009"]
[75,"Cleland, J., et al. (2011). \"Assessing dimensionality and responsiveness of outcomes measures for patients with low back pain.\" Pain Pract 11(1999): 57-69.",null,"Cleland, J., et al.","Assessing dimensionality and responsiveness of outcomes measures for patients with low back pain","OBJECTIVE: To provide a systematic literature review of the responsiveness of patient-reported health outcomes measures for the evaluation of low back pain (LBP). METHODS AND DESIGN: Searches of MEDLINE and EMBASE were performed for articles published in English through June 29, 2009 using the search terms \"back pain\" or \"low back pain\" and \"questionnaires\" or \"instrument\" or \"survey\" or \"measure\" or \"patient report outcome.\" Information on responsiveness was gathered through additional measure-specific searches that included the measure name, first author of the original paper, and \"respons*\" or \"sensit*.\" Responsiveness was determined based on use of a receiver operating characteristics curve or effect size statistics. RESULTS: Of 43 identified measures, 31 were reported as being responsive to treatment or clinical change, 25 of which were evaluated for responsiveness using methods considered adequate. When considering both the responsiveness evaluation and the underlying factor structure, 13 measures were identified as being adequately validated for use in evaluating responsiveness in the research or clinical practice setting. The majority of the LBP outcome assessment studies were comprised of patients undergoing physical and interventional therapies from clinical practice and clinical trials. The Roland Morris Disability Questionnaire and the Oswestry Disability Index were the most comprehensively validated measures with respect to responsiveness. CONCLUSIONS: We identified 13 measures of LBP that can be used to evaluate responsiveness to change. Choice of a measure warrants careful evaluation of its construct and responsiveness properties in order to maximize the observed impact on pain and functional improvement in subjects with LBP."," Pain Pract 11(1999): 57-69.","USA",2011,"Back Pain","Physical Therapy","ODI,RMDQ","Unknown","PRO study","Systematic review","USA","Unknown","Back Pain","Physical Therapy","PRO study","Systematic review","ODI,RMDQ","2010:2014"]
[76,"Climent, J. M. and J. Sanchez (1999). \"Impact of the type of brace on the quality of life of Adolescents with Spine Deformities.\" Spine (Phila Pa 1976) 24(18): 1903-1908.",null,"Climent, J. M. and J. Sanchez","Impact of the type of brace on the quality of life of Adolescents with Spine Deformities","STUDY DESIGN: A group of 102 brace-treated adolescents, aged 10-19 years with spine deformities participated in a cross-sectional study. OBJECTIVES: To determine the effect of various types of orthoses on self-perceived health status. SUMMARY OF BACKGROUND DATA: Spinal orthosis is an effective means of controlling progressive scoliosis, but bracing has shown a considerable impact on several aspects of adolescent functioning. METHODS: Skeletally immature patients with spine deformities (75% with idiopathic scoliosis) who visited consecutively for routine biannual follow-up evaluations of orthotic treatment were studied. Twenty-five patients used the Milwaukee brace, 30 the Boston brace, 13 the thoracolumbosacral orthosis (TLSO), and 34 the Charleston bending orthosis. Patients completed the Quality of Life Profile for Spine Deformities (QLPSD), a specific instrument that measures quality of life in five areas labeled psychosocial functioning, sleep disturbances, back pain, body image, and back flexibility. Higher QLPSD scores mean a high level of impairment of quality of life. RESULTS: Milwaukee brace-treated patients scored significantly higher than Boston brace-treated and TLSO-braced patients and patients with Charleston bending orthosis in the overall QLPSD score (mean +/- SD, 53.60 +/- 13.26 vs. 45.65 +/- 12.81 and 42.79 +/- 12.99, respectively) and in back flexibility and psychosocial functioning. Other quality-of-life-related variables selected in multivariate analysis were the Risser sign, clinical diagnosis, duration of brace treatment, and degrees of correction. CONCLUSION: In cases of different orthoses of proven similar effectiveness in controlling the scoliotic curves, the use of bracing with the lowest impact on the quality of life should be recommended."," Spine (Phila Pa 1976) 24(18): 1903-1908.","Spain",1999,"Spinal Deformity","Psychosocial","QLPSD,BrQ","Adolescents","PRO study","Observational","Spain","Adolescents","Spinal Deformity","Psychosocial","PRO study","Observational","QLPSD,BrQ","1995:1999"]
[77,"Climent, J. M., et al. (1995). \"Construction and validation of a specific quality of life instrument for adolescents with spine deformities.\" Spine (Phila Pa 1976) 20(18): 2006-2011.",null,"Climent, J. M., et al.","Construction and validation of a specific quality of life instrument for adolescents with spine deformities","STUDY DESIGN: The development and construction of a specific instrument for measuring quality of life in adolescents with spine deformities was investigated. OBJECTIVES: To assess the validity and reliability of the Quality of Life Profile for Spine Deformities. SUMMARY OF BACKGROUND DATA: An 88-item questionnaire was self-administered to 174 patients ranging in age from 10 to 20 years with spine deformities. Items were rated on a five-point Likert scale. Higher scores means high level of impairment in quality of life. Age, gender, menarche or voice change, salient symptoms in the medical record, ordinary parameters on physical examination, and measurements on standard anteroposterior and lateral radiographs were recorded. The retest was done 10 days after the initial administration in a subsample of 35 patients. METHODS: The test-retest reliability was analyzed calculating the intraclass correlation coefficient. Internal consistency was measured with the Cronbach's alpha method. Factor analysis was used to obtain a reduced number of variables. Construct validity was assessed using the principal components model of factor analysis based on the correlation matrix and using the varimax computer algorithm for orthogonal rotation. Discriminant validity was assessed using the Kruskal-Wallis test. RESULTS: The Quality of Life Profile for Spine Deformities contained 21 items and five factors in conceptual terms labeled psychosocial functioning, sleep disturbances, back pain, body image, and back flexibility. The overall questionnaire score showed an internal consistency of 0.88 and a test-retest correlation of 0.91. Patients with structural curves showed significantly higher scores in all dimensions of the Quality of Life Profile for Spine Deformities except for the subscale of body image than patients with postural curves. When patients were grouped according to the symptom of back pain, those with backache had a significantly higher quality of life overalls score and scores in the dimensions of sleep disturbances and pain. Brace-treated patients showed statistically significant differences in the quality of life overall score and scores in the dimensions of psychosocial functioning and back flexibility. CONCLUSIONS: The instrument developed for measuring quality of life in patients with spine deformities during the period of bone growth has validity, internal consistency, and high test-retest reliability. The conceptualization of quality of life of the Quality of Life Profile for Spine Deformity includes psychosocial dimensions and pain and function."," Spine (Phila Pa 1976) 20(18): 2006-2011.","Spain",1995,"Spinal Deformity","Psychosocial","QLPSD","Adolescents","Tool Validation","Observational","Spain","Adolescents","Spinal Deformity","Psychosocial","Tool Validation","Observational","QLPSD","1995:1999"]
[78,"Climent, J. M., et al. (2005). \"Validity of the Spanish version of the Scoliosis Research Society-22 (SRS-22) Patient Questionnaire.\" Spine (Phila Pa 1976) 30(6): 705-709.",null,"Climent, J. M., et al.","Validity of the Spanish version of the Scoliosis Research Society-22 (SRS-22) Patient Questionnaire","STUDY DESIGN: A cross-sectional multicenter study was performed to validate the Spanish version of the Scoliosis Research Society-22 (SRS-22) Patient Questionnaire. OBJECTIVES: To determine the construct validity and convergent validity of the instrument. METHODS: The Spanish version of the SRS-22 was given to 175 patients with scoliosis (mean age, 19 years old and 86% women). A subgroup of 31 patients also received the Quality of Life for Spine Deformities Profile (QLSDP). Construct validity was studied by factor analysis. Discriminant validity was assessed analyzing the relation between SRS-22 scores and the variables of deformity severity. Convergent validity as related to the QLSDP was studied with a multitrait-multimethod matrix analysis. RESULTS: Factor analysis offered a solution of four factors coherent with the dimensions of the original instrument. SRS-22 scores were worse in older patients (r = -0.34); patients using analgesics demonstrated lower scores (P < 0.001). Patients treated with a brace had a poorer self-image and were less satisfied with their treatment (P < 0.001) than the other treatment groups. Angular improvement of the curves was associated with better self-image scores (r = 0.34). The SRS-22 and QLSDP demonstrated high correlation coefficients in the convergent validity tests (r = 0.84). CONCLUSION: The Spanish version of the SRS-22 is valid. It has a factorial structure similar to that of the original questionnaire. Moreover, it relates to known severity characteristics of the disease, distinguishes among scoliosis patient groups, and shows concordant values with another valid instrument for measuring self-perceived health."," Spine (Phila Pa 1976) 30(6): 705-709.","Spain",2005,"Spinal Deformity","Brace","SRS-HRQOL,QLSDP","Adults","Tool Validation","Observational","Spain","Adults","Spinal Deformity","Brace","Tool Validation","Observational","SRS-HRQOL,QLSDP","2005:2009"]
[79,"Cohen, M., et al. (2011). \"Acupuncture as analgesia for low back pain, ankle sprain and migraine in emergency departments: study protocol for a randomized controlled trial.\" Trials 12: 241.",null,"Cohen, M., et al.","Acupuncture as analgesia for low back pain, ankle sprain and migraine in emergency departments: study protocol for a randomized controlled trial","BACKGROUND: Pain is the most common reason that patients present to an emergency department (ED) and is often inadequately managed. Evidence suggests that acupuncture is effective for pain relief, yet it is rarely practiced in the ED. The current study aims to assess the efficacy of acupuncture for providing effective analgesia to patients presenting with acute low back pain, migraine and ankle sprain at the EDs of four hospitals in Melbourne, Australia. METHOD: The study is a multi-site, randomized, assessor-blinded, controlled trial of acupuncture analgesia in patients who present to an ED with low back pain, migraine or ankle sprain. Patients will be block randomized to receive either acupuncture alone, acupuncture as an adjunct to pharmacotherapy or pharmacotherapy alone. Acupuncture will be applied according to Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). Pain after one hour, measured using a visual analogue scale (VAS), is the primary outcome. Secondary outcomes measures include the following instruments; the Oswestry low back pain disability questionnaire, 24-hour Migraine Quality of Life questionnaire and Patient's Global Assessment of Ankle Injury Scale. These measures will be recorded at baseline, 1 hour after intervention, each hour until discharge and 48+/-12 hours of ED discharge. Data will also be collected on the safety and acceptability of acupuncture and health resource utilization. DISCUSSION: The results of this study will determine if acupuncture, alone or as an adjunct to pharmacotherapy provides effective, safe and acceptable pain relief for patients presenting to EDs with acute back pain, migraine or ankle sprain. The results will also identify the impact that acupuncture treatment may have upon health resource utilisation in the ED setting. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000989246."," Trials 12: 241.","Australia",2011,"Back Pain","Acupuncture","ODI","Unknown","PRO study","RCT","Australia","Unknown","Back Pain","Acupuncture","PRO study","RCT","ODI","2010:2014"]
[80,"Constant, F., et al. (1998). \"Use of spa therapy to improve the quality of life of chronic low back pain patients.\" Med Care 36(9): 1309-1314.",null,"Constant, F., et al.","Use of spa therapy to improve the quality of life of chronic low back pain patients","OBJECTIVES: This study assessed the effectiveness of adding spa therapy to usual drug treatment in chronic low back pain patients. METHODS: A total of 224 patients were assigned randomly to either a treatment (n=128) or a control (n=96) group. Subjects in both groups received usual drug therapy. Those in the treatment group also underwent spa therapy in Vittel, France, for 6 days a week for 3 consecutive weeks. Effectiveness was assessed using a quality-of-life scale (the Duke Health Profile), clinical measures, and the Roland and Morris disability questionnaire. Groups were compared using an analysis of variance with repeated measures. RESULTS: At both 3 weeks and 3 months, patients in the treatment group exhibited significant improvement in measures of: physical and mental dimensions of quality of life, anxiety, depression, pain duration, pain intensity, and functional disability. CONCLUSION: This study suggests that spa therapy is an effective treatment for chronic low back pain patients."," Med Care 36(9): 1309-1314.","France",1998,"Back Pain","Other","RMDQ","Unknown","PRO study","RCT","France","Unknown","Back Pain","Other","PRO study","RCT","RMDQ","1995:1999"]
[81,"Corniola, M. V., et al. (2016). \"Correlation of pain, functional impairment, and health-related quality of life with radiological grading scales of lumbar degenerative disc disease.\" Acta Neurochir (Wien) 158(3): 499-505.",null,"Corniola, M. V., et al.","Correlation of pain, functional impairment, and health-related quality of life with radiological grading scales of lumbar degenerative disc disease","BACKGROUND: It is generally believed that radiological signs of lumbar degenerative disc disease (DDD) are associated with increased pain and functional impairment as well as lower health-related quality of life (HRQoL). Our aim was to assess the association of the Modic and Pfirrmann grading scales with established outcome questionnaires and the timed-up-and-go (TUG) test. METHODS: In a prospective two-center study with patients scheduled for lumbar spine surgery, visual analogue scale (VAS) for back and leg pain, Roland-Morris Disability Index, Oswestry Disability Index and HRQoL, as determined by the Short-Form (SF)-12 and the Euro-Qol, were recorded. Functional mobility was measured with the TUG test. Modic type (MOD) and Pfirrmann grade (PFI) of the affected lumbar segment were assessed with preoperative imaging. Uni- and multivariate logistic regression analysis was performed to estimate the effect size of the relationship between clinical and radiological findings. RESULTS: Two hundred eighty-four patients (mean age 58.5, 119 (42 %) females) were enrolled. None of the radiological grading scales were significantly associated with any of the subjective or objective clinical tests. There was a tendency for higher VAS back pain (3.48 vs. 4.14, p = 0.096) and lower SF-12 physical component scale (31.2 vs. 29.4, p = 0.065) in patients with high PFI (4-5) as compared to patients with low PFI (0-3). In the multivariate analysis, patients with MOD changes of the vertebral endplates were 100 % as likely as patients without changes to show an impaired TUG test performance (odds ratio (OR) 1.00, 95 % confidence interval (CI) 0.56-1.80, p = 0.982). Patients with high PFI were 145 % as likely as those with low PFI to show an impaired TUG test performance (OR 1.45, 95 % CI 0.79-2.66, p = 0.230). CONCLUSIONS: There was no association between established outcome questionnaires of symptom severity and two widely used radiological classifications in patients undergoing surgery for lumbar DDD."," Acta Neurochir (Wien) 158(3): 499-505.","Switzerland,Australia",2016,"Spine Disease","Surgical","ODI,RMDQ","Unknown","PRO study","Prospective Observation","Switzerland,Australia","Unknown","Spine Disease","Surgical","PRO study","Prospective Observation","ODI,RMDQ","2015:2018"]
[82,"Corona, J., et al. (2011). \"Measuring quality of life in children with early onset scoliosis: development and initial validation of the early onset scoliosis questionnaire.\" J Pediatr Orthop 31(2): 180-185.",null,"Corona, J., et al.","Measuring quality of life in children with early onset scoliosis: development and initial validation of the early onset scoliosis questionnaire","BACKGROUND: Treatment of children with early onset scoliosis (EOS) seeks to improve natural history and health related quality of life (QOL). QOL measurement presents a significant challenge given the young age, comorbidities, and heterogeneity of this population. The purpose of this study is to develop a disease specific measure reflecting issues of importance to EOS patients and caretakers that is responsive to clinical and treatment changes. METHODS: Review of the literature and relevant measures informed development of semistructured qualitative interviews. Interviews of caregivers of EOS patients were interpreted through the framework technique. A masterlist of 75 items was created and responses were scaled on a 5-point Likert scale. Psychometric analysis was carried out to group items into domains, to maintain score distribution, to create a responsive instrument, and to identify question redundancy. RESULTS: Content validation showed 8 items with low content validity indices (<0.70). Item distribution analysis showed 19 items with skewed distribution. Item reliability showed redundant items within domains (r>/=0.5). Construct validity showed unique domains measuring intended issues of interest. The resulting Early Onset Scoliosis Questionnaire (EOSQ) includes 33 items in 13 domains: General Health, Pain, Physical Function, Pulmonary Function, Daily Living, Fatigue, Emotion, Surgical Concerns, Satisfaction, Transfer, Financial Burden, Parental Burden, and Treatment Outcomes. CONCLUSIONS: The EOSQ reflects QOL and caregiver burden in the EOS population. The EOSQ will expand options for outcome assessment in this unique population."," J Pediatr Orthop 31(2): 180-185.","USA",2011,"Spinal Deformity","Surgical","EOSQ","Infants","PRO study","Narrative review","USA","Infants","Spinal Deformity","Surgical","PRO study","Narrative review","EOSQ","2010:2014"]
[83,"Coste, J., et al. (2004). \"Prognosis and quality of life in patients with acute low back pain: insights from a comprehensive inception cohort study.\" Arthritis Rheum 51(2): 168-176.",null,"Coste, J., et al.","Prognosis and quality of life in patients with acute low back pain: insights from a comprehensive inception cohort study","OBJECTIVE: To investigate the respective contribution of various biologic and psychosocial factors, especially initial health-related quality of life (HRQOL), in the natural history of acute low back pain (LBP) and to evaluate the impact of this condition on HRQOL. METHODS: For 3 months, we assessed 113 patients consulting for nonspecific acute LBP of <72 hours duration at inclusion and treated with acetaminophen. Endpoints included pain, disability assessed by the Roland Disability Questionnaire, and HRQOL assessed by the Short Form 36 health survey (SF-36). RESULTS: Seventy-three percent of patients recovered within 2 weeks and 5% of patients developed chronic LBP. Prior low back surgery, higher initial disability questionnaire score, lower SF-36 score, and temporary compensation status were independently associated with delayed recovery. The impact of the acute LBP episode on HRQOL was brief and moderate, except for patients with comorbidity, psychiatric disorders, those of foreign origin, unemployed, or with job dissatisfaction. The impact of compensation status, sick leave, and bed rest was more profound and lasting. CONCLUSIONS: This study highlights the large contribution of work-related factors, but also initial HRQOL, to the prognosis of LBP. It also suggests that LBP impairs HRQOL mainly through compensation and inappropriate medical care, and that, in turn, impaired HRQOL favors the condition becoming chronic. These findings have implications for future research into the management of LBP."," Arthritis Rheum 51(2): 168-176.","France",2004,"Back Pain","Surgical","RMDQ","Unknown","Cost-Effectiveness","Prospective Observation","France","Unknown","Back Pain","Surgical","Cost-Effectiveness","Prospective Observation","RMDQ","2000:2004"]
[84,"Coulombe, B. J., et al. (2017). \"Core Stability Exercise Versus General Exercise for Chronic Low Back Pain.\" J Athl Train 52(1999): 71-72.",null,"Coulombe, B. J., et al.","Core Stability Exercise Versus General Exercise for Chronic Low Back Pain","Reference: Wang XQ, Zheng JJ, Yu ZW, et al. A meta-analysis of core stability exercise versus general exercise for chronic low back pain. PLoS One. 2012;7(12):e52082. Clinical Questions: Is core stability exercise more effective than general exercise in the treatment of patients with nonspecific low back pain (LBP)? DATA SOURCES: The authors searched the following databases: China Biological Medicine disc, Cochrane Library, Embase, and PubMed from 1970 through 2011. The key medical subject headings searched were chronic pain, exercise, LBP, lumbosacral region, and sciatica. STUDY SELECTION: Randomized controlled trials comparing core stability exercise with general exercise in the treatment of chronic LBP were investigated. Participants were male and female adults with LBP for at least 3 months that was not caused by a specific known condition. A control group receiving general exercise and an experimental group receiving core stability exercise were required for inclusion in the meta-analysis. Core stability was defined as the ability to ensure a stable neutral spine position, but the type of exercise was not specified. Outcome measures of pain intensity, back-specific functional status, quality of life, and work absenteeism were recorded at 3-, 6-, and 12-month intervals. DATA EXTRACTION: The study design, participant information, description of interventions in the control and experimental groups, outcome measures, and follow-up period were extracted. The mean difference (MD) and 95% confidence interval (CI) were calculated to evaluate statistical significance. Risk of bias was assessed using the Cochrane Collaboration Recommendations, and all articles were rated as high risk for other bias with no further explanation given. MAIN RESULTS: Five studies involving 414 patients were included. Four studies assessed pain intensity using the visual analog scale or numeric rating scale. In the core stability exercise group, the reduction in pain was significant at 3 months (MD = -1.29, 95% CI = -2.47, -0.11; P = .003) but not at 6 months (MD = -0.50, 95% CI = -1.36, 0.35; P = .26). Functional status was improved at 3 months (MD = -7.14, 95% CI = -11.64, -2.65; P = .002) but not at 6 months (MD = -0.50, 95% CI = 0.36, 0.35; P = .26) or 12 months (MD = -0.32, 95% CI = -0.87, 0.23; P = .25). All of the included studies assessed back-specific functional status: 4 used the Oswestry Disability Index and 1 used the Roland-Morris Disability Questionnaire. Patients in the core stability exercise groups experienced improved functional status versus the general exercise group at 3 months (MD = -7.14, 95% CI = -11.64, -2.65; P = .002); no results were recorded at 6 or 12 months. CONCLUSIONS: In the short term, core stability exercise was more effective than general exercise for decreasing pain and increasing back-specific functional status in patients with LBP."," J Athl Train 52(1999): 71-72.","USA",2017,"Back Pain","Exercise","ODI,RMDQ","Unknown","PRO study","Systematic review","USA","Unknown","Back Pain","Exercise","PRO study","Systematic review","ODI,RMDQ","2015:2018"]
[85,"Cramer, H., et al. (2011). \"Randomized controlled trial of pulsating cupping (pneumatic pulsation therapy) for chronic neck pain.\" Forsch Komplementmed 18(6): 327-334.",null,"Cramer, H., et al.","Randomized controlled trial of pulsating cupping (pneumatic pulsation therapy) for chronic neck pain","BACKGROUND: Pneumatic pulsation therapy may combine the effects of cupping therapy and massage. This study investigated the effect of pneumatic pulsation therapy on chronic neck pain compared to standard medical care. METHODS: 50 patients (79.15% female; 46.17 +/- 12.21 years) with chronic nonspecific neck pain were randomized to treatment group (TG; n = 25) or control group (CG; n = 25). The TG received 5 pneumatic pulsation treatments over a period of 2 weeks utilizing a mechanical device. Treatment was applied as a combination of moving and stationary pulsating cupping. Main outcome measure was pain intensity in pain diaries (numerical rating scale). Secondary outcome measures included functional disability (NDI), quality of life (SF-36), and pain at motion. Sensory thresholds, including pressure pain threshold, were measured at pain-related sites. RESULTS: After the intervention, significant group differences occurred regarding pain intensity (baseline: 4.12 +/- 1.45 in TG and 4.20 +/- 1.57 in CG; post-intervention: 2.72 +/- 1.62 in TG and 4.44 +/- 1.96 in CG; analysis of covariance: p = 0.001), NDI (baseline: 25.92 +/- 8.23 and 29.83; post-intervention: 20.44 +/- 10.17 and 28.83; p = 0.025), and physical quality of life (baseline: 43.85 +/- 7.65 and 41.66 +/- 7.09; post-intervention: 47.60 +/- 7.93 and 40.49 +/- 8.03; p = 0.002). Further significant group differences were found for pain at motion (p = 0.004) and pressure pain threshold (p = 0.002). No serious adverse events were reported. CONCLUSION: Pneumatic pulsation therapy appears to be a safe and effective method to relieve pain and to improve function and quality of life in patients with chronic neck pain."," Forsch Komplementmed 18(6): 327-334.","Germany",2011,"Neck Pain","Other,Massage","NDI","Adults","PRO study","RCT","Germany","Adults","Neck Pain","Other,Massage","PRO study","RCT","NDI","2010:2014"]
[86,"Cramer, H., et al. (2013). \"Randomized-controlled trial comparing yoga and home-based exercise for chronic neck pain.\" Clin J Pain 29(3): 216-223.",null,"Cramer, H., et al.","Randomized-controlled trial comparing yoga and home-based exercise for chronic neck pain","OBJECTIVES: Chronic neck pain is a significant public health problem with only very few evidence-based treatment options. There is growing evidence for the effectiveness of yoga for relieving musculoskeletal disorders. The aim of this study was to evaluate the effect of Iyengar yoga compared with exercise on chronic nonspecific neck pain. METHODS: Patients were randomly assigned to either yoga or exercise. The yoga group attended a 9-week yoga course and the exercise group received a self-care manual on home-based exercises for neck pain relief. The main outcome measure was the present neck pain intensity (100 mm visual analog scale). Secondary outcome measures included functional disability (Neck Disability Index), pain at motion (visual analog scale), health-related quality of life (Short Form-36 questionnaire), cervical range of motion, proprioceptive acuity, and pressure pain threshold. RESULTS: Fifty-one patients (mean age 47.8 y ; 82.4% female) were randomized to yoga (n=25) and exercise (n=26) intervention. After the study period, patients in the yoga group reported significantly less neck pain intensity compared with the exercise group [mean difference: -13.9 mm (95% CI, -26.4 to -1.4), P=0.03]. The yoga group reported less disability and better mental quality of life. Range of motion and proprioceptive acuity were improved and the pressure pain threshold was elevated in the yoga group. DISCUSSION: Yoga was more effective in relieving chronic nonspecific neck pain than a home-based exercise program. Yoga reduced neck pain intensity and disability and improved health-related quality of life. Moreover, yoga seems to influence the functional status of neck muscles, as indicated by improvement of physiological measures of neck pain."," Clin J Pain 29(3): 216-223.","Germany",2013,"Neck Pain","Yoga","NDI","Unknown","PRO study","RCT","Germany","Unknown","Neck Pain","Yoga","PRO study","RCT","NDI","2010:2014"]
[87,"Cramer, H., et al. (2013). \"Yoga for chronic neck pain: a 12-month follow-up.\" Pain Med 14(4): 541-548.",null,"Cramer, H., et al.","Yoga for chronic neck pain: a 12-month follow-up","OBJECTIVES: To assess the effects of a 9-week yoga intervention on chronic nonspecific neck pain 12 months after completion. DESIGN: Twelve-month follow-up of the pooled data of both arms of a randomized, controlled trial. SETTING: Department of Internal and Integrative Medicine at an academic teaching hospital. SUBJECTS: Fifty-one patients with chronic nonspecific neck pain (mean age 47.8 years; 82.4% female). INTERVENTIONS: A 9-week yoga group intervention. OUTCOME MEASURES: Neck pain intensity (100-mm visual analog scale), functional disability (neck disability index), health-related quality of life (short-form 36 questionnaire, SF-36), generic disability (days with restricted activities), and global improvement. RESULTS: From baseline to 12-month follow-up, pain intensity improved from 48.81 +/- 17.71 to 32.31 +/- 20.68 (P < 0.001), neck-related disability decreased from 25.26 +/- 9.02 to 19.49 +/- 11.52 (P = 0.001), and bodily pain in the SF-36 improved from 49.37 +/- 12.40 to 59.26 +/- 17.57 (P = 0.005). Improvements in pain intensity were predicted by weekly minutes of yoga practice during the past 4 weeks (r(2) = 0.12, P = 0.028); improved neck-related disability (r(2) = 0.24, P = 0.001) and bodily pain (r(2) = 0.26, P = 0.006) were predicted by regular yoga practice during the past 12 months. Generic disability did not decrease significantly. Twenty-four patients (68.6%) rated their health as at least somewhat improved. CONCLUSIONS: A 9-week yoga intervention improved pain and neck-related disability for at least 12 months after completion. Sustained yoga practice seems to be the most important predictor of long-term effectiveness."," Pain Med 14(4): 541-548.","Germany",2013,"Neck Pain","Yoga","NDI","Adults","PRO study","RCT","Germany","Adults","Neck Pain","Yoga","PRO study","RCT","NDI","2010:2014"]
[88,"Cramer, H., et al. (2014). \"Validation of the German version of the Neck Disability Index (NDI).\" BMC Musculoskelet Disord 15: 91.",null,"Cramer, H., et al.","Validation of the German version of the Neck Disability Index (NDI)","BACKGROUND: The Neck Disability Index (NDI) is the most commonly used outcome measure for neck pain. This study aimed to determine the psychometric properties of a German version of the NDI. Cross-cultural translation and psychometric testing of the NDI were performed. METHODS: The 10-item NDI was translated into German and administered to 558 patients with chronic unspecific neck pain (Mean age 49.9 +/- 11.4 years, 76% female). The factor structure and reliability of the NDI were assessed using factor analysis, Cronbach's alpha, split-half reliability (Spearman-Brown coefficient), and intra-class correlation (ICC2,1). To determine convergent validity, pain intensity (visual analog scale; VAS), pain on movement (VAS), and quality of life (Short Form 36 Health Survey Questionnaire; SF-36) were correlated with the NDI. Correlation with range of motion and sensitivity to change were also assessed in a subsample of 49 patients. RESULTS: The mean NDI score was 32.75 +/- 13.09. Factor analysis revealed a single factor that explained 39.8% of the variance. Cronbach's alpha was 0.81; Spearman-Brown coefficient was 0.80; and intra-class correlation was 0.81 (95% confidence interval = 0.78, 0.83). Significant correlations were found for pain intensity (r = 0.22, p < 0.01), pain on movement (r = 0.39, p < 0.01), quality of life (r = -0.30 to -0.45, p < 0.01), and range of motion (r = -0.34, p = 0.02). Patients who reported global improvement of health after an exercise or yoga intervention showed a higher decrease on the NDI than patients who reported no global improvement (p < 0.01). CONCLUSIONS: The German version of the NDI has a comparable factor structure as the original version, acceptable psychometric properties, and is sensitive to change after physical activity. Neck disability is associated with other measures of neck pain."," BMC Musculoskelet Disord 15: 91.","Germany",2014,"Neck Pain","Exercise","NDI","Adults","Tool Validation","Observational","Germany","Adults","Neck Pain","Exercise","Tool Validation","Observational","NDI","2010:2014"]
[89,"Critchley, D. J., et al. (2007). \"Effectiveness and cost-effectiveness of three types of physiotherapy used to reduce chronic low back pain disability: a pragmatic randomized trial with economic evaluation.\" Spine (Phila Pa 1976) 32(14): 1474-1481.",null,"Critchley, D. J., et al.","Effectiveness and cost-effectiveness of three types of physiotherapy used to reduce chronic low back pain disability: a pragmatic randomized trial with economic evaluation","STUDY DESIGN: Pragmatic, randomized, assessor blinded, clinical trial with economic analysis. OBJECTIVE: To compare the effectiveness and cost-effectiveness of three kinds of physiotherapy commonly used to reduce disability in chronic low back pain. SUMMARY OF BACKGROUND DATA: Physiotherapy reduces disability in chronic back pain, but there are several forms of physiotherapy and it is unclear which is most effective or cost effective. METHODS: A total of 212 patients referred to physiotherapy with chronic low back pain were randomized to receive usual outpatient physiotherapy, spinal stabilization classes, or physiotherapist-led pain management classes. Primary outcome was Roland Disability Questionnaire score 18 months from baseline; secondary measures were pain, health-related quality of life, and time off work. Healthcare costs associated with low back pain and quality-adjusted life years (QALYs) were also measured. RESULTS.: A total of 71 participants were assigned to usual outpatient physiotherapy, 72 to spinal stabilization, and 69 to physiotherapist-led pain management. A total of 160 (75%) provided follow-up data at 18 months, showing similar improvements with all interventions: mean (95% confidence intervals) Roland Disability Questionnaire score improved from 11.1 (9.6-12.6) to 6.9 (5.3-8.4) with usual outpatient physiotherapy, 12.8 (11.4-14.2) to 6.8 (4.9-8.6) with spinal stabilization, and 11.5 (9.8-13.1) to 6.5 (4.5-8.6) following pain management classes. Pain, quality of life, and time off work also improved within all groups with no between-group differences. Mean (SD) healthcare costs and QALY gain were pound474 (840) and 0.99 (0.27) for individual physiotherapy, pound379 (1040) and 0.90 (0.37) for spinal stabilization, and pound165 (202) and 1.00 (0.28) for pain management. CONCLUSIONS: For chronic low back pain, all three physiotherapy regimens improved disability and other relevant health outcomes, regardless of their content. Physiotherapist-led pain management classes offer a cost-effective alternative to usual outpatient physiotherapy and are associated with less healthcare use. A more widespread adoption of physiotherapist-led pain management could result in considerable cost savings for healthcare providers."," Spine (Phila Pa 1976) 32(14): 1474-1481.","UK",2007,"Back Pain","Physical Therapy","RMDQ","Adults","Cost-Effectiveness","RCT","UK","Adults","Back Pain","Physical Therapy","Cost-Effectiveness","RCT","RMDQ","2005:2009"]
[90,"Cuesta-Vargas, A. I. and C. P. Gabel (2014). \"Validation of a Spanish version of the Spine Functional Index.\" Health Qual Life Outcomes 12: 96.",null,"Cuesta-Vargas, A. I. and C. P. Gabel","Validation of a Spanish version of the Spine Functional Index","BACKGROUND: The Spine Functional Index (SFI) is a recently published, robust and clinimetrically valid patient reported outcome measure. OBJECTIVES: The purpose of this study was the adaptation and validation of a Spanish-version (SFI-Sp) with cultural and linguistic equivalence. METHODS: A two stage observational study was conducted. The SFI was cross-culturally adapted to Spanish through double forward and backward translation then validated for its psychometric characteristics. Participants (n = 226) with various spine conditions of >12 weeks duration completed the SFI-Sp and a region specific measure: for the back, the Roland Morris Questionnaire (RMQ) and Backache Index (BADIX); for the neck, the Neck Disability Index (NDI); for general health the EQ-5D and SF-12. The full sample was employed to determine internal consistency, concurrent criterion validity by region and health, construct validity and factor structure. A subgroup (n = 51) was used to determine reliability at seven days. RESULTS: The SFI-Sp demonstrated high internal consistency (alpha = 0.85) and reliability (r = 0.96). The factor structure was one-dimensional and supported construct validity. Criterion specific validity for function was high with the RMQ (r = 0.79), moderate with the BADIX (r = 0.59) and low with the NDI (r = 0.46). For general health it was low with the EQ-5D and inversely correlated (r = -0.42) and fair with the Physical and Mental Components of the SF-12 and inversely correlated (r = -0.56 and r = -0.48), respectively. The study limitations included the lack of longitudinal data regarding other psychometric properties, specifically responsiveness. CONCLUSIONS: The SFI-Sp was demonstrated as a valid and reliable spine-regional outcome measure. The psychometric properties were comparable to and supported those of the English-version, however further longitudinal investigations are required."," Health Qual Life Outcomes 12: 96.","Spain",2014,"Unspecified","Not Specified","NDI,SFI","Unknown","Tool Validation","Prospective Observation","Spain","Unknown","Unspecified","Not Specified","Tool Validation","Prospective Observation","NDI,SFI","2010:2014"]
[91,"Cuesta-Vargas, A. I. and M. Gonzalez-Sanchez (2014). \"Ability to discriminate between healthy and low back pain sufferers using ultrasound during maximum lumbar extension.\" Arch Phys Med Rehabil 95(6): 1093-1099.",null,"Cuesta-Vargas, A. I. and M. Gonzalez-Sanchez","Ability to discriminate between healthy and low back pain sufferers using ultrasound during maximum lumbar extension","OBJECTIVE: To analyze the ability to discriminate between healthy individuals and individuals with chronic nonspecific low back pain (CNLBP) by measuring the relation between patient-reported outcomes and objective clinical outcome measures of the erector spinae (ES) muscles using an ultrasound during maximal isometric lumbar extension. DESIGN: Cross-sectional study with screening and diagnostic tests with no blinded comparison. SETTING: University laboratory. PARTICIPANTS: Healthy individuals (n=33) and individuals with CNLBP (n=33). INTERVENTIONS: Each subject performed an isometric lumbar extension. With the variables measured, a discriminate analysis was performed using a value >/= 6 in the Roland and Morris disability questionnaire (RMDQ) as the grouping variable. Then, a logistic regression with the functional and architectural variables was performed. A new index was obtained from each subject value input in the discriminate multivariate analysis. MAIN OUTCOME MEASURES: Morphologic muscle variables of the ES muscle were measured through ultrasound images. The reliability of the measures was calculated through intraclass correlation coefficients (ICCs). The relation between patient-reported outcomes and objective clinical outcome measures was analyzed using a discriminate function from standardized values of the variables and an analysis of the reliability of the ultrasound measurement. RESULTS: The reliability tests show an ICC value >.95 for morphologic and functional variables. The independent variables included in the analysis explained 42% (P=.003) of the dependent variable variance. CONCLUSIONS: The relation between objective variables (electromyography, thickness, pennation angle) and a subjective variable (RMDQ >/= 6) and the capacity of this relation to identify CNLBP within a group of healthy subjects is moderate. These results should be considered by clinicians when treating this type of patient in clinical practice."," Arch Phys Med Rehabil 95(6): 1093-1099.","Spain",2014,"Back Pain","Not Specified","RMDQ","Unknown","PRO study","Observational","Spain","Unknown","Back Pain","Not Specified","PRO study","Observational","RMDQ","2010:2014"]
[92,"Cuesta-Vargas, A. I. and M. Gonzalez-Sanchez (2015). \"Changes in disability, physical/mental health states and quality of life during an 8-week multimodal physiotherapy programme in patients with chronic non-specific neck pain: a prospective cohort study.\" PLoS One 10(2): e0118395.",null,"Cuesta-Vargas, A. I. and M. Gonzalez-Sanchez","Changes in disability, physical/mental health states and quality of life during an 8-week multimodal physiotherapy programme in patients with chronic non-specific neck pain: a prospective cohort study","AIM: The aim of this study was to analyse the effect of an 8-week multimodal physiotherapy programme (MPP), integrating physical land-based therapeutic exercise (TE), adapted swimming and health education, as a treatment for patients with chronic non-specific neck pain (CNSNP), on disability, general health/mental states and quality of life. METHODS: 175 CNSNP patients from a community-based centre were recruited to participate in this prospective study. INTERVENTION: 60-minute session (30 minutes of land-based exercise dedicated to improving mobility, motor control, resistance and strengthening of the neck muscles, and 30 minutes of adapted swimming with aerobic exercise keeping a neutral neck position using a snorkel). Health education was provided using a decalogue on CNSNP and constant repetition of brief advice by the physiotherapist during the supervision of the exercises in each session. STUDY OUTCOMES: primary: disability (Neck Disability Index); secondary: physical and mental health states and quality of life of patients (SF-12 and EuroQoL-5D respectively). Differences between baseline data and that at the 8-week follow-up were calculated for all outcome variables. RESULTS: Disability showed a significant improvement of 24.6% from a mean (SD) of 28.2 (13.08) at baseline to 16.88 (11.62) at the end of the 8-week intervention. All secondary outcome variables were observed to show significant, clinically relevant improvements with increase ranges between 13.0% and 16.3% from a mean of 0.70 (0.2) at baseline to 0.83 (0.2), for EuroQoL-5D, and from a mean of 40.6 (12.7) at baseline to 56.9 (9.5), for mental health state, at the end of the 8-week intervention. CONCLUSION: After 8 weeks of a MPP that integrated land-based physical TE, health education and adapted swimming, clinically-relevant and statistically-significant improvements were observed for disability, physical and mental health states and quality of life in patients who suffer CNSNP. The clinical efficacy requires verification using a randomised controlled study design. TRIAL REGISTRATION: ClinicalTrials.gov NCT02046876."," PLoS One 10(2): e0118395.","Spain",2015,"Neck Pain","Exercise","NDI","Unknown","PRO study","Prospective Observation","Spain","Unknown","Neck Pain","Exercise","PRO study","Prospective Observation","NDI","2015:2018"]
[93,"Cui, X. J., et al. (2017). \"Shi-style cervical manipulations for cervical radiculopathy: A multicenter randomized-controlled clinical trial.\" Medicine (Baltimore) 96(31): e7276.",null,"Cui, X. J., et al.","Shi-style cervical manipulations for cervical radiculopathy: A multicenter randomized-controlled clinical trial","BACKGROUND: There is a lack of high-quality evidence supporting the use of manipulation therapy for patients with cervical radiculopathy (CR). This study aimed to evaluate the effectiveness of Shi-style cervical manipulations (SCMs) versus mechanical cervical traction (MCT) for CR. METHODS: This was a randomized, open-label, controlled trial carried out at 5 hospitals in patients with CR for at least 2 weeks and neck pain. The patients received 6 treatments of SCM (n = 179) or MCT (n = 180) over 2 weeks. The primary outcome was participant-rated disability (neck disability index), measured 2 weeks after randomization. The secondary outcomes were participant-rated pain (visual analog scale) and health-related quality of life (36-Item Short Form Health Survey [SF-36]). Assessments were performed before, during, and after (2, 4, 12, and 24 weeks) intervention. RESULTS: After 2 weeks of treatment, the SCM group showed a greater improvement in participant-rated disability compared with the control group (P = .018). The SCM group reported less disability compared with the control group (P < .001) during the 26-week follow-up. The difference was particularly important at 6 months (mean -28.91 +/- 16.43, P < .001). Significant improvements in SF-36 were noted in both groups after 2 weeks of treatment, but there were no differences between the 2 groups. CONCLUSION: SCM could be a better option than MCT for the treatment of CR-related pain and disability."," Medicine (Baltimore) 96(31): e7276.","China",2017,"Radiculopathy,Neck Pain","Manipulations","NDI","Unknown","PRO study","RCT","China","Unknown","Radiculopathy,Neck Pain","Manipulations","PRO study","RCT","NDI","2015:2018"]
[94,"Dalton, J. E., et al. (2017). \"Accuracy of Cardiovascular Risk Prediction Varies by Neighborhood Socioeconomic Position: A Retrospective Cohort Study.\" Ann Intern Med 167(7): 456-464.",null,"Dalton, J. E., et al.","Accuracy of Cardiovascular Risk Prediction Varies by Neighborhood Socioeconomic Position: A Retrospective Cohort Study","Background: Inequality in health outcomes in relation to Americans' socioeconomic position is rising. Objective: First, to evaluate the spatial relationship between neighborhood disadvantage and major atherosclerotic cardiovascular disease (ASCVD)-related events; second, to evaluate the relative extent to which neighborhood disadvantage and physiologic risk account for neighborhood-level variation in ASCVD event rates. Design: Observational cohort analysis of geocoded longitudinal electronic health records. Setting: A single academic health center and surrounding neighborhoods in northeastern Ohio. Patients: 109 793 patients from the Cleveland Clinic Health System (CCHS) who had an outpatient lipid panel drawn between 2007 and 2010. The date of the first qualifying lipid panel served as the study baseline. Measurements: Time from baseline to the first occurrence of a major ASCVD event (myocardial infarction, stroke, or cardiovascular death) within 5 years, modeled as a function of a locally derived neighborhood disadvantage index (NDI) and the predicted 5-year ASCVD event rate from the Pooled Cohort Equations Risk Model (PCERM) of the American College of Cardiology and American Heart Association. Outcome data were censored if no CCHS encounters occurred for 2 consecutive years or when state death data were no longer available (that is, from 2014 onward). Results: The PCERM systematically underpredicted ASCVD event risk among patients from disadvantaged communities. Model discrimination was poorer among these patients (concordance index [C], 0.70 [95% CI, 0.67 to 0.74]) than those from the most affluent communities (C, 0.80 [CI, 0.78 to 0.81]). The NDI alone accounted for 32.0% of census tract-level variation in ASCVD event rates, compared with 10.0% accounted for by the PCERM. Limitations: Patients from affluent communities were overrepresented. Outcomes of patients who received treatment for cardiovascular disease at Cleveland Clinic were assumed to be independent of whether the patients came from a disadvantaged or an affluent neighborhood. Conclusion: Neighborhood disadvantage may be a powerful regulator of ASCVD event risk. In addition to supplemental risk models and clinical screening criteria, population-based solutions are needed to ameliorate the deleterious effects of neighborhood disadvantage on health outcomes. Primary Funding Source: The Clinical and Translational Science Collaborative of Cleveland and National Institutes of Health."," Ann Intern Med 167(7): 456-464.","USA",2017,"Cardiovascular Disease","Not Specified","NDI","Adults","Tool Validation","Retrospective review","USA","Adults","Cardiovascular Disease","Not Specified","Tool Validation","Retrospective review","NDI","2015:2018"]
[95,"Damian, M. and C. Zalpour (2011). \"Trigger point treatment with radial shock waves in musicians with nonspecific shoulder-neck pain: data from a special physio outpatient clinic for musicians.\" Med Probl Perform Art 26(4): 211-217.",null,"Damian, M. and C. Zalpour","Trigger point treatment with radial shock waves in musicians with nonspecific shoulder-neck pain: data from a special physio outpatient clinic for musicians","Musicians often suffer from disorders of the musculoskeletal system that are related to their instrument playing. Among the most frequent symptoms are complaints in the shoulder-neck area. Radial shock wave therapy is increasingly used in trigger point treatment, but only few high-level studies have examined of shock wave therapy used together with physical therapy in the treatment of musicians. METHODS: This randomized blinded study in musicians (n = 26) with nonspecific shoulder-neck problems was done to examine the effect of shock wave therapy in addition to current physical therapy on the symptoms and quality of life of the musicians as well as their habits of playing musical instruments (intervention group shock wave vs reference group placebo). The effects were documented by a pain VAS and other instruments. A questionnaire designed specifically for musicians (with initial and final questions) recorded intensity and manifestation of pain and handicaps in daily life, especially when practicing and playing. The Shoulder Pain and Disability Index (SPADI) and the Neck Pain Disability Index Questionnaire (NPDIQ) were also used. RESULTS: Both groups reported subjective improvement in pain, but significance was found only for the intervention group for the SPADI and NPDIQ. CONCLUSIONS: Trigger point treatment with radial shock wave used in combination with physical therapy makes the subjects feel temporarily relieved of neck and shoulder pains. The effects of radial shock wave without physical therapy will need to be examined in further studies."," Med Probl Perform Art 26(4): 211-217.","Germany",2011,"Back Pain,Neck Pain","Physical Therapy","NPDIQ","Unknown","PRO study","RCT","Germany","Unknown","Back Pain,Neck Pain","Physical Therapy","PRO study","RCT","NPDIQ","2010:2014"]
[96,"Danielsson, A. J. and K. Romberg (2013). \"Reliability and validity of the Swedish version of the Scoliosis Research Society-22 (SRS-22r) patient questionnaire for idiopathic scoliosis.\" Spine (Phila Pa 1976) 38(21): 1875-1884.",null,"Danielsson, A. J. and K. Romberg","Reliability and validity of the Swedish version of the Scoliosis Research Society-22 (SRS-22r) patient questionnaire for idiopathic scoliosis","STUDY DESIGN: Two quality-of-life questionnaires were completed, once or twice, by patients with idiopathic scoliosis from 3 centers for scoliosis care in Sweden. These patients were under observation, during brace treatment, or after treatment with either a brace or surgery. OBJECTIVE: The aim of the study was to translate and validate the revised version of the Scoliosis Research Society Questionnaire (SRS-22r) for use in Sweden. SUMMARY OF BACKGROUND DATA: In modern outcome research, the patient's own view of outcome is of great importance. The SRS-22 Questionnaire has been specially designed to measure quality of life in patients with scoliosis and has been used in a number of recent studies. This questionnaire had not previously been used in Sweden. METHODS: The SRS-22r was translated into Swedish according to accepted methods for the translation of quality-of-life questionnaires. One hundred and forty one patients answered the questionnaire together with the SF-36. Statistical analyses were performed and revealed a somewhat low internal consistency (Cronbach alpha) of the Function domain/SRS-22, which was found to originate in question number 18. After retranslation, another 52 patients completed the improved questionnaire. Analyses were repeated, and the results improved. When suitable, all 193 patients were therefore analyzed together. RESULTS: Descriptive statistics, distributions, test-retest, and test for concurrent validity showed satisfactory results. After retranslation, the Cronbach alpha for all domain scores was at least 0.72. Discriminant validity was only shown for self-image and management satisfaction/dissatisfaction. CONCLUSION: The SRS-22r Questionnaire was found to be appropriate for use in our language. Further testing for discriminant validity will be performed. LEVEL OF EVIDENCE: N/A."," Spine (Phila Pa 1976) 38(21): 1875-1884.","Sweden",2013,"Spinal Deformity","Surgical","SRS-HRQOL","Unknown","Tool Validation","Observational","Sweden","Unknown","Spinal Deformity","Surgical","Tool Validation","Observational","SRS-HRQOL","2010:2014"]
[97,"Danielsson, A. J., et al. (2012). \"Body appearance and quality of life in adult patients with adolescent idiopathic scoliosis treated with a brace or under observation alone during adolescence.\" Spine (Phila Pa 1976) 37(9): 755-762.",null,"Danielsson, A. J., et al.","Body appearance and quality of life in adult patients with adolescent idiopathic scoliosis treated with a brace or under observation alone during adolescence","STUDY DESIGN: The Scoliosis Research Society (SRS) brace study (published in the JBJS-A, 1995) was comprised of patients with adolescent idiopathic scoliosis with moderate curve sizes (25 degrees -35 degrees ). Forty observed and 37 braced patients (77% of the original group) attended a follow-up, a mean of 16 years after onset of maturity. OBJECTIVE: To analyze whether the subjectively evaluated present body appearance affects outcome as measured by quality of life in adult patients, previously treated by observation alone (nonbraced) or with a brace during adolescence. SUMMARY OF BACKGROUND DATA: Few reports exist where validated outcome measures for body appearance have been used. METHODS: Two quality-of-life questionnaires, the Scoliosis Research Society-22 (SRS-22) questionnaire and the 36-Item Short-Form Survey Instrument (SF-36), were answered. The patient's opinion on body appearance was evaluated pictorially (i.e., sketches) using the spinal appearance questionnaire, in which 7 aspects of asymmetry are graded. These scores were compared with curve sizes, scoliometer measurements for grading trunk asymmetry, and quality-of-life measures. RESULTS: At follow-up, both groups were similar in terms of age (mean = 32 years) and curve size (mean = 35 degrees ). Distortion was inversely related to SRS-22 total score and satisfaction/dissatisfaction with management subscore, but not related to the SRS-22 function subscore. No difference was found between the groups in terms of trunk rotation, where the means were 10.7 degrees and 10.8 degrees for the nonbraced and braced patients, respectively. The nonbraced patients estimated that their body appearance was significantly less distorted than the braced patients (mean = 12.9 and 15.0, respectively; P = 0.0028). CONCLUSION: Patients who experienced less body asymmetry were more satisfied with treatment and had a better quality of life. In spite of similar curve sizes and trunk rotation in both groups, the nonbraced patients felt that their body appearance was less distorted than that of the braced patients."," Spine (Phila Pa 1976) 37(9): 755-762.","Sweden",2012,"Spinal Deformity","Brace","SRS-HRQOL","Adults","PRO study","Retrospective review","Sweden","Adults","Spinal Deformity","Brace","PRO study","Retrospective review","SRS-HRQOL","2010:2014"]
[98,"DeBerard, M. S., et al. (2001). \"Outcomes of posterolateral lumbar fusion in Utah patients receiving workers' compensation: a retrospective cohort study.\" Spine (Phila Pa 1976) 26(7): 738-746; discussion 747.",null,"DeBerard, M. S., et al.","Outcomes of posterolateral lumbar fusion in Utah patients receiving workers' compensation: a retrospective cohort study","STUDY DESIGN: A retrospective cohort study consisting of a medical record review and a follow-up telephone survey of patients with lumbar fusion, at least 2 years after their surgery, was performed. OBJECTIVE: To identify presurgical correlates and long-term outcomes from posterolateral lumbar fusion in Utah patients receiving workers' compensation. SUMMARY OF BACKGROUND DATA: Lumbar fusion has been criticized for its highly variable outcomes, and compensated workers are at particular risk for poor outcomes. Evidence suggests that presurgical psychosocial factors may be important modifiers of back pain reporting and back surgery outcomes. METHODS: The patients in this study were 185 compensated workers in Utah who underwent posterolateral lumbar fusion. Patient medical records were independently reviewed, and medical and sociodemographic variables were coded. A telephone outcome survey was completed with 130 patients (70%) an average of 4.6 years after their surgery. RESULTS: Reported solid fusion, reoperation, and disability rates for the follow-up sample were 74%, 24%, and 25%, respectively. As reported by the patients, 41% experienced no change or a worsened quality of life. Mean scores from the Roland and Morris Back Pain Disability Questionnaire, the Stauffer-Coventry-Index, and the Short-Form 20 Multidimensional Health Survey indicate that many patients experienced postsurgical dysfunction. Presurgical predictors of outcomes were number of prior low back operations, income at time of injury, age, litigation, and depression. CONCLUSIONS: Outcomes of posterolateral lumbar fusion among compensated workers in Utah are inconsistent. Outcomes can be predicted by presurgical sociodemographic variables. Screening for such presurgical risk factors may be important for prudent surgical decisions and rehabilitation planning."," Spine (Phila Pa 1976) 26(7): 738-746; discussion 747.","USA",2001,"Back Pain","Surgical","RMDQ,SCI","Adults","PRO study","Retrospective review","USA","Adults","Back Pain","Surgical","PRO study","Retrospective review","RMDQ,SCI","2000:2004"]
[99,"del Pozo-Cruz, B., et al. (2012). \"An occupational, internet-based intervention to prevent chronicity in subacute lower back pain: a randomised controlled trial.\" J Rehabil Med 44(7): 581-587.",null,"del Pozo-Cruz, B., et al.","An occupational, internet-based intervention to prevent chronicity in subacute lower back pain: a randomised controlled trial","OBJECTIVE: To investigate whether an online occupational postural and exercise intervention reduced patients' overall risk status for chronicity in subacute non-specific low back pain compared with conventional treatment, and to determine whether changes in risk of chronicity correlate with changes in specific outcomes (i.e. Functional Status and QoL) for low back pain. DESIGN: Prospective, single-blinded randomized intervention study. SUBJECTS: University office workers with subacute non-specific low back pain (n=100) were randomized 1:1 to an intervention group, who received an online occupational postural and exercise intervention, and a control group. METHODS: Exercise and education materials used in the intervention were developed as an online resource, and included video demonstrations recorded in a laboratory. All sessions included exercises combining postural stability (for abdominal, lumbar, hip and thigh muscles) strengthening, flexibility, mobility, and stretching. Outcome measures included STarT Back Screening Tool (SBST), Roland Morris score, and European Quality of Life Questionnaire -5 dimensions - 3 levels. At 9 months, SBST was analysed and compared with the baseline and controls. RESULTS: Significant positive effects were found on mean scores recorded in the online occupational exercise intervention group for risk of chronicity (p<0.019). A correlation between functional disability, health-related quality of life and risk of chronicity of low back pain was observed. CONCLUSION: This study supports the potential utility of a real-time occupational internet-based intervention for preventing progression to chronicity of subacute non-specific low back pain among office workers."," J Rehabil Med 44(7): 581-587.","Spain",2012,"Back Pain","Exercise","RMDQ","Unknown","PRO study","Observational","Spain","Unknown","Back Pain","Exercise","PRO study","Observational","RMDQ","2010:2014"]
[100,"del Pozo-Cruz, B., et al. (2013). \"Musculoskeletal fitness and health-related quality of life characteristics among sedentary office workers affected by sub-acute, non-specific low back pain: a cross-sectional study.\" Physiotherapy 99(3): 194-200.",null,"del Pozo-Cruz, B., et al.","Musculoskeletal fitness and health-related quality of life characteristics among sedentary office workers affected by sub-acute, non-specific low back pain: a cross-sectional study","OBJECTIVES: To establish the level of musculoskeletal fitness and health-related quality of life (HRQoL) in sedentary office workers with sub-acute, non-specific low back pain, and compare the results with reference data for healthy sedentary office workers. DESIGN: Cross-sectional study. SETTING: Occupational secondary prevention setting. PARTICIPANTS: One-hundred and ninety sedentary office workers: 118 suffering from sub-acute, non-specific low back pain (47 men and 71 women) and 72 age-matched healthy controls (30 men and 42 women). MAIN OUTCOME MEASURES: Participants were assessed using a musculoskeletal fitness battery (sit-and-reach test, hand grip strength, lumbar and abdominal trunk muscle endurance, and back scratch test), the EuroQol-5D-3L, Oswestry Disability Questionnaire, and Roland Morris Disability Questionnaire. Data for both genders and conditions were compared. RESULTS: Subjects with low back pain achieved lower scores in most of the fitness tests compared with healthy, age-matched controls. Trunk flexor and extensor endurance demonstrated the greatest difference in both men {flexion: median difference 59 [95% confidence interval (CI) 26 to 90]seconds; extension: median difference 24 [95% CI 20 to 68]} and women [flexion: median difference 59 (95% CI 5 to 85.50)seconds; extension: median difference 41 (95% CI 30 to 55)seconds]. Differences in HRQoL were also demonstrated between groups for both men and women, with the exception of the pain/discomfort dimension in women. CONCLUSIONS: Sedentary office workers with sub-acute, non-specific low back pain had lower musculoskeletal fitness than healthy, age-matched controls, with the main difference found in endurance of the trunk muscles. HRQoL was also lower in workers with low back pain."," Physiotherapy 99(3): 194-200.","Spain",2013,"Back Pain","Not Specified","ODI,RMDQ","Unknown","PRO study","Observational","Spain","Unknown","Back Pain","Not Specified","PRO study","Observational","ODI,RMDQ","2010:2014"]
[101,"Drury, T., et al. (2009). \"Degenerative spondylolisthesis in patients with neurogenic claudication effects functional performance and self-reported quality of life.\" Spine (Phila Pa 1976) 34(25): 2812-2817.",null,"Drury, T., et al.","Degenerative spondylolisthesis in patients with neurogenic claudication effects functional performance and self-reported quality of life","STUDY DESIGN: The effect of degenerative spondylolisthesis on functional performance and self reported quality of life in patients with lumbar spinal stenosis was compared to patients with lumbar spinal stenosis and no degenerative spondylolisthesis. OBJECTIVE: To define the relationship degenerative spondylolisthesis shares with functional performance and self reported quality of life in patients with symptomatic lumbar spinal stenosis. SUMMARY OF BACKGROUND DATA: Neurogenic claudication is a clinical syndrome that reflects symptoms caused by anatomic spinal stenosis. This condition limits functional status and impacts overall health satisfaction. Degenerative spondylolisthesis is one cause of spinal stenosis and is present to different degrees in patients with neurogenic claudication. METHODS: Thirty-eight women and 39 men diagnosed with lumbar spinal stenosis and neurogenic claudication were prospectively enrolled in the study. All underwent routine, screening side-lying, lateral flexion and extension radiographs. The evaluation included a shuttle walking test, as well as patient self-assessment using the Swiss Spinal Stenosis Questionnaire, and Short Form 36. RESULTS: The overall walking distance did not differ based on the presence of degenerative spondylolisthesis. No correlation between magnitude of deformity and decreased walking distance was identified. Men walked on average 231.3 m (SD: 159.2) and women walked 251.3 m (SD: 138.4). No statistical difference was noted between men and women and their walking ability (P < 0.56). The Swiss Spinal Stenosis Questionnaire and the Short Form 36 were both strongly correlated with decreased walking ability (P < 0.05). CONCLUSION: The presence and magnitude of degenerative spondylolisthesis does not correlate with decreased functional capacity. The Swiss Spinal Stenosis Questionnaire and Short Form 36 are accurate in defining the functional status of a patient. Comprehensive evaluation of patients with symptomatic lumbar spinal stenosis using functional assessment and self-assessment questionnaires are helpful in determining the severity of a patient's disability. Plain radiographs may be valuable adjuncts for surgical decision-making, but are not useful in quantifying the degree to which a patient is impaired."," Spine (Phila Pa 1976) 34(25): 2812-2817.","USA",2009,"Spondylosis","Surgical","SSSQ","Unknown","PRO study","Prospective Observation","USA","Unknown","Spondylosis","Surgical","PRO study","Prospective Observation","SSSQ","2005:2009"]
[102,"Duffy, S. A., et al. (2002). \"Effect of smoking, alcohol, and depression on the quality of life of head and neck cancer patients.\" Gen Hosp Psychiatry 24(3): 140-147.",null,"Duffy, S. A., et al.","Effect of smoking, alcohol, and depression on the quality of life of head and neck cancer patients","This pilot study examined the relationship between smoking, alcohol intake, depressive symptoms and quality of life (QoL) in head and neck cancer patients. A questionnaire on smoking, alcohol, depressive symptoms and QoL was distributed to head and neck cancer patients (N=81). Over one-third (35%) of the respondents had smoked within the last 6 months, 46% had drunk alcohol within the last 6 months and 44% screened positive for significant depressive symptoms. About one-third (32%) of smokers were interested in smoking cessation services and 37% of patients with depressive symptoms were interested in depression services. However, only 9% of those who drank alcohol expressed interest in alcohol services. Smoking was negatively associated with five scales of the SF-36V including Physical Functioning, General Health, Vitality, Social Functioning, and Role-Emotional Health. Depressive symptoms were negatively associated with all eight scales on the SF-36V and all four scales of the Head and Neck Quality of Life instrument. Surprisingly, alcohol was not found to be associated with any of the QoL scales. While smoking, alcohol intake and depression may be episodically treated, standardized protocols and aggressive intervention strategies for systematically addressing these highly prevalent disorders are needed in this population."," Gen Hosp Psychiatry 24(3): 140-147.","USA",2002,"Cancer","Not Specified","HNQOL","Unknown","PRO study","Observational","USA","Unknown","Cancer","Not Specified","PRO study","Observational","HNQOL","2000:2004"]
[103,"Dundar, U., et al. (2009). \"Clinical effectiveness of aquatic exercise to treat chronic low back pain: a randomized controlled trial.\" Spine (Phila Pa 1976) 34(14): 1436-1440.",null,"Dundar, U., et al.","Clinical effectiveness of aquatic exercise to treat chronic low back pain: a randomized controlled trial","STUDY DESIGN: This study was a prospective, randomized, controlled study. OBJECTIVE: To compare the effectiveness of aquatic exercise interventions with land-based exercises in the treatment of chronic low back pain (CLBP). SUMMARY OF BACKGROUND DATA: Land-based exercise and physiotherapy are the main treatment tools used for CLBP. Clinical experience indicates that aquatic exercise may have advantages for patients with musculoskeletal disorders. METHODS: A total of 65 patients with CLBP were included in this study. Patients were randomly assigned to receive aquatic exercise or land-based exercise treatment protocol. Aquatic exercise program consisted of 20 sessions, 5 x per week for 4 weeks in a swimming pool at 33 degrees C. Land-based exercise (home-based exercise) program were demonstrated by a physiotherapist on one occasion and then they were given written advice The patients were assessed for spinal mobility, pain, disability, and quality of life. Evaluations were performed before treatment (week 0) and after treatment (week 4 and week 12). RESULTS: In both groups, statistically significant improvements were detected in all outcome measures (except modified Schober test) compared with baseline. However, improvement in modified Oswestry Low Back Pain Disability questionnaire and physical function and role limitations due to physical functioning subpart of Short-Form 36 Health Survey were better in aquatic exercise group (P < 0.05). CONCLUSION: It is concluded that a water-based exercises produced better improvement in disability and quality of life of the patients with CLBP than land-based exercise."," Spine (Phila Pa 1976) 34(14): 1436-1440.","Turkey",2009,"Back Pain","Exercise","ODI","Unknown","PRO study","Prospective Observation","Turkey","Unknown","Back Pain","Exercise","PRO study","Prospective Observation","ODI","2005:2009"]
[104,"Dundar, U., et al. (2014). \"Effect of aquatic exercise on ankylosing spondylitis: a randomized controlled trial.\" Rheumatol Int 34(11): 1505-1511.",null,"Dundar, U., et al.","Effect of aquatic exercise on ankylosing spondylitis: a randomized controlled trial","Ankylosing spondylitis (AS) is a chronic systemic inflammatory disease that affects mainly the axial skeleton and causes significant pain and disability. Aquatic (water-based) exercise may have a beneficial effect in various musculoskeletal conditions. The aim of this study was to compare the effectiveness of aquatic exercise interventions with land-based exercises (home-based exercise) in the treatment of AS. Patients with AS were randomly assigned to receive either home-based exercise or aquatic exercise treatment protocol. Home-based exercise program was demonstrated by a physiotherapist on one occasion and then, exercise manual booklet was given to all patients in this group. Aquatic exercise program consisted of 20 sessions, 5x per week for 4 weeks in a swimming pool at 32-33 degrees C. All the patients in both groups were assessed for pain, spinal mobility, disease activity, disability, and quality of life. Evaluations were performed before treatment (week 0) and after treatment (week 4 and week 12). The baseline and mean values of the percentage changes calculated for both groups were compared using independent sample t test. Paired t test was used for comparison of pre- and posttreatment values within groups. A total of 69 patients with AS were included in this study. We observed significant improvements for all parameters [pain score (VAS) visual analog scale, lumbar flexion/extension, modified Schober test, chest expansion, bath AS functional index, bath AS metrology index, bath AS disease activity index, and short form-36 (SF-36)] in both groups after treatment at week 4 and week 12 (p < 0.05). Comparison of the percentage changes of parameters both at week 4 and week 12 relative to pretreatment values showed that improvement in VAS (p < 0.001) and bodily pain (p < 0.001), general health (p < 0.001), vitality (p < 0.001), social functioning (p < 0.001), role limitations due to emotional problems (p < 0.001), and general mental health (p < 0.001) subparts of SF-36 were better in aquatic exercise group. It is concluded that a water-based exercises produced better improvement in pain score and quality of life of the patients with AS compared with home-based exercise."," Rheumatol Int 34(11): 1505-1511.","Turkey",2014,"Spondylosis","Exercise","Schober","Unknown","PRO study","RCT","Turkey","Unknown","Spondylosis","Exercise","PRO study","RCT","Schober","2010:2014"]
[105,"Dundar, U., et al. (2015). \"Effect of high-intensity laser therapy in the management of myofascial pain syndrome of the trapezius: a double-blind, placebo-controlled study.\" Lasers Med Sci 30(1999): 325-332.",null,"Dundar, U., et al.","Effect of high-intensity laser therapy in the management of myofascial pain syndrome of the trapezius: a double-blind, placebo-controlled study","Myofascial pain syndrome (MPS) of the trapezius muscle is one of the main causes of neck pain. In this randomized, double-blind study, we evaluated the effects of high-intensity laser therapy (HILT) in female patients with chronic MPS of the trapezius muscle. The patients were assigned to two groups. The HILT group was treated with HILT and exercise, and the sham therapy group was treated with placebo HILT and exercise. The patients were assessed for pain, cervical active range of motion, disability, and quality of life. Evaluations were performed before treatment (week 0) and after treatment (weeks 4 and 12). Both groups showed significant improvement in all parameters at weeks 4 and 12. However, in a comparison of the percentage changes in the parameters at weeks 4 and 12 relative to pretreatment values, the HILT group showed greater improvement in pain scores, the neck disability index, and several subparts of the short-form 36 health survey (SF-36) (physical functioning, role limitations due to physical functioning, bodily pain, general health perceptions, social functioning, and role limitations due to emotional problems) than did the sham therapy group. We conclude that HILT is an effective therapeutic method in the treatment of patients with chronic MPS of the trapezius muscle."," Lasers Med Sci 30(1999): 325-332.","Turkey",2015,"Neck Pain","Laser Therapy","NDI","Unknown","PRO study","RCT","Turkey","Unknown","Neck Pain","Laser Therapy","PRO study","RCT","NDI","2015:2018"]
[106,"Dvorak, M. F., et al. (2007). \"Clinical outcomes of 90 isolated unilateral facet fractures, subluxations, and dislocations treated surgically and nonoperatively.\" Spine (Phila Pa 1976) 32(26): 3007-3013.",null,"Dvorak, M. F., et al.","Clinical outcomes of 90 isolated unilateral facet fractures, subluxations, and dislocations treated surgically and nonoperatively","STUDY DESIGN: A retrospective outcomes study. OBJECTIVE: The purposes of this study were 1) to identify plausible patient and interventional variables that influence the outcome of unilateral facet injuries and 2) to determine if patients return to normal general health status after unilateral facet injuries. SUMMARY OF BACKGROUND DATA: The management of unilateral subaxial cervical facet fractures and dislocations lacks agreement on treatment options and the variables that influence outcome. METHODS: Injury data, radiographs, and outcomes (North American Spine Society Cervical Follow-up Questionnaire and Short Form-36) were collected from 9 centers and 13 surgeons, members of the Spine Trauma Study Group. RESULTS: Causally motor vehicle accidents (49%) and sports (31%) predominated. The C6-C7 level accounted for 60% of injuries and C5-C6 represented 17%. The mean SF-36 PCS score of the operative patients with follow-up >18 months was 6.70 points higher than the mean of the nonoperative patients (P = 0.017). The SF-36 Bodily Pain mean of all patients was 67.2 (SD = 27.6), significantly lower (more pain) than the normative mean of 75.2 (SD = 23.7) (P = 0.014). Nonoperative patients also reported a mean Bodily Pain score of 63.0 (SD = 30.5) that was significantly worse than normative values (P = 0.031). Similarly, the NASS PD mean score for all patients was 84.8 (SD = 17.9), significantly lower than the normative mean of 89.1 (SD = 15.5) (P = 0.014). CONCLUSION: To our knowledge this is the largest reported series of facet injuries to date and the only one using health-related quality of life instruments. Unilateral facet injuries of the subaxial cervical spine led to reported levels of pain and disability that are significantly worse than those of the healthy population. Although further study is required, we suggest that nonoperatively treated patients report worse outcomes than operatively treated patients, particularly at longer follow-up despite having a more benign fracture pattern. The presence of comorbidities, associated injuries, and advanced age adversely impact clinical outcomes."," Spine (Phila Pa 1976) 32(26): 3007-3013.","Canada",2007,"Spinal Fracture","Surgical","NASS-L","Unknown","PRO study","Retrospective review","Canada","Unknown","Spinal Fracture","Surgical","PRO study","Retrospective review","NASS-L","2005:2009"]
[107,"Ehrlich, G. E. (2003). \"Back pain.\" J Rheumatol Suppl 67: 26-31.",null,"Ehrlich, G. E.","Back pain","Back pain is ubiquitous and probably plagues almost everyone in all cultures and ethnic groups at some time (around 20% annually), and in up to 50% of these at least once a year. The WHO-COPCORD epidemiologic investigations have established its prevalence even in countries that had been unaware of its frequency in their populace, and factors involving type of work and training probably accounted for this misperception. Medical journals are replete with articles addressing diagnosis and treatment, but the majority fail to meet the standards needed for metaanalysis or comparison. A task force of the Agency for Health Care Policy and Research of the United States Department of Health and Human Services screened more than 10,000 abstracts, eliminated the majority of these studies and papers, and still was unable to recommend the best approach even to acute back pain; the problem of subacute and chronic back pain is even more formidable. Yet back pain has been identified as perhaps the major cause of disability and absenteeism from the workplace worldwide. WHO chiefly addressed subacute back pain, as most acute back pain is self-limited and ends spontaneously, almost regardless of the treatment. Subacute pain is the intermediate stage toward chronic pain, which defies most treatments. Specific causes for back pain, such as infections, tumors, osteoporosis, spondyloarthropathies, and trauma, actually represent a minority of such pain syndromes, qualifying for specific therapeutic approaches. A major problem in defining the burden of disease for back pain has been a dearth of agreed-upon outcome measures by which to judge the various interventions, and this was the task that the WHO Low Back Pain Initiative took upon itself. Among measures recommended to be included in all studies, so that valid comparisons could be made, were measurement of pain by visual analog scales, somatic perception, the Oswestry disability and modified Zung questionnaires, and a modified Schober test of spinal mobility. These measures are needed for studies, not for diagnosis or treatment of individual patients. They have been translated into various major languages and validated by back-translations, and applied in comparative studies in various cultures to medical, chiropractic, and other common interventions. The importance of such scientifically sound studies cannot be overemphasized, as the costs of health care are mounting everywhere and it therefore becomes imperative to develop cost-effective approaches. All the more so as conversion of acute back pain to chronic back pain is often iatrogenic, with strong psychosocial factors as well, so that not only what to do but also what not to do become important public health issues. The general lack of attention to back pain by governments and organizations probably results from the fact that it is perceived as a syndromic presentation with myriad causes rather than as a specific disease entity. Even if the \"disease\" names classify like presentations but are not necessarily etiologically discrete, syndromic diagnoses that subsume a variety of causes receive less attention; international rankings of common disabilities and public health problems tend to emphasize the named disorders rather than the grouped disorders. Moreover, back pain is often self-treated with nonprescription medications or alternative therapies, and by nonmedical practitioners or treatments in many parts of the world. Validation of outcomes therefore not only reduces invalidism and direct costs but also reduces the indirect costs of absenteeism and medical care."," J Rheumatol Suppl 67: 26-31.","USA",2003,"Back Pain,Spondylosis","Psychosocial","ODI","Unknown","Tool Validation","Narrative review","USA","Unknown","Back Pain,Spondylosis","Psychosocial","Tool Validation","Narrative review","ODI","2000:2004"]
[108,"Eklund, A., et al. (2014). \"Prevention of low back pain: effect, cost-effectiveness, and cost-utility of maintenance care - study protocol for a randomized clinical trial.\" Trials 15: 102.",null,"Eklund, A., et al.","Prevention of low back pain: effect, cost-effectiveness, and cost-utility of maintenance care - study protocol for a randomized clinical trial","BACKGROUND: Low back pain (LBP) is a prevalent condition and a socioeconomic problem in many countries. Due to its recurrent nature, the prevention of further episodes (secondary prevention), seems logical. Furthermore, when the condition is persistent, the minimization of symptoms and prevention of deterioration (tertiary prevention), is equally important. Research has largely focused on treatment methods for symptomatic episodes, and little is known about preventive treatment strategies. METHODS/DESIGN: This study protocol describes a randomized controlled clinical trial in a multicenter setting investigating the effect and cost-effectiveness of preventive manual care (chiropractic maintenance care) in a population of patients with recurrent or persistent LBP.Four hundred consecutive study subjects with recurrent or persistent LBP will be recruited from chiropractic clinics in Sweden. The primary outcome is the number of days with bothersome pain over 12 months. Secondary measures are self-rated health (EQ-5D), function (the Roland Morris Disability Questionnaire), psychological profile (the Multidimensional Pain Inventory), pain intensity (the Numeric Rating Scale), and work absence.The primary utility measure of the study is quality-adjusted life years and will be calculated using the EQ-5D questionnaire. Direct medical costs as well as indirect costs will be considered.Subjects are randomly allocated into two treatment arms: 1) Symptom-guided treatment (patient controlled), receiving care when patients feel a need. 2) Preventive treatment (clinician controlled), receiving care on a regular basis. Eligibility screening takes place in two phases: first, when assessing the primary inclusion/exclusion criteria, and then to only include fast responders, i.e., subjects who respond well to initial treatment. Data are collected at baseline and at follow-up as well as weekly, using SMS text messages. DISCUSSION: This study investigates a manual strategy (chiropractic maintenance care) for recurrent and persistent LBP and aims to answer questions regarding the effect and cost-effectiveness of this preventive approach. Strict inclusion criteria should ensure a suitable target group and the use of frequent data collection should provide an accurate outcome measurement. The study utilizes normal clinical procedures, which should aid the transferability of the results. TRIAL REGISTRATION: Clinical trials.gov; NCT01539863, February 22, 2012. The first patient was randomized into the study on April 13th 2012."," Trials 15: 102.","Sweden",2014,"Back Pain","Psychosocial","RMDQ","Adults","Cost-Effectiveness","RCT","Sweden","Adults","Back Pain","Psychosocial","Cost-Effectiveness","RCT","RMDQ","2010:2014"]
[109,"el Barzouhi, A., et al. (2014). \"Reliability of gadolinium-enhanced magnetic resonance imaging findings and their correlation with clinical outcome in patients with sciatica.\" Spine J 14(11): 2598-2607.",null,"el Barzouhi, A., et al.","Reliability of gadolinium-enhanced magnetic resonance imaging findings and their correlation with clinical outcome in patients with sciatica","BACKGROUND CONTEXT: Gadolinium-enhanced magnetic resonance imaging (Gd-MRI) is often performed in the evaluation of patients with persistent sciatica after lumbar disc surgery. However, correlation between enhancement and clinical findings is debated, and limited data are available regarding the reliability of enhancement findings. PURPOSE: To evaluate the reliability of Gd-MRI findings and their correlation with clinical findings in patients with sciatica. STUDY DESIGN: Prospective observational evaluation of patients who were enrolled in a randomized trial with 1-year follow-up. PATIENTS SAMPLE: Patients with 6- to 12-week sciatica, who participated in a multicentre randomized clinical trial comparing an early surgery strategy with prolonged conservative care with surgery if needed. In total 204 patients underwent Gd-MRI at baseline and after 1 year. OUTCOME MEASURES: Patients were assessed by means of the Roland Disability Questionnaire (RDQ) for sciatica, visual analog scale (VAS) for leg pain, and patient-reported perceived recovery at 1 year. Kappa coefficients were used to assess interobserver reliability. METHODS: In total, 204 patients underwent Gd-MRI at baseline and after 1 year. Magnetic resonance imaging findings were correlated to the outcome measures using the Mann-Whitney U test for continuous data and Fisher exact tests for categorical data. RESULTS: Poor-to-moderate agreement was observed regarding Gd enhancement of the herniated disc and compressed nerve root (kappa<0.41), which was in contrast with excellent interobserver agreement of the disc level of the herniated disc and compressed nerve root (kappa>0.95). Of the 59 patients with an enhancing herniated disc at 1 year, 86% reported recovery compared with 100% of the 12 patients with nonenhancing herniated discs (p=.34). Of the 12 patients with enhancement of the most affected nerve root at 1 year, 83% reported recovery compared with 85% of the 192 patients with no enhancement (p=.69). Patients with and without enhancing herniated discs or nerve roots at 1 year reported comparable outcomes on RDQ and VAS-leg pain. CONCLUSIONS: Reliability of Gd-MRI findings was poor-to-moderate and no correlation was observed between enhancement and clinical findings at 1-year follow-up."," Spine J 14(11): 2598-2607.","Netherlands",2014,"Degenerative Disk Disease","Surgical","RMDQ","Unknown","PRO study","RCT","Netherlands","Unknown","Degenerative Disk Disease","Surgical","PRO study","RCT","RMDQ","2010:2014"]
[110,"Fakurnejad, S., et al. (2015). \"The likelihood of reaching minimum clinically important difference and substantial clinical benefit at 2 years following a 3-column osteotomy: analysis of 140 patients.\" J Neurosurg Spine 23(3): 340-348.",null,"Fakurnejad, S., et al.","The likelihood of reaching minimum clinically important difference and substantial clinical benefit at 2 years following a 3-column osteotomy: analysis of 140 patients","OBJECT: Three-column osteotomies (3COs) are technically challenging techniques for correcting severe rigid spinal deformities. The impact of these interventions on outcomes reaching minimum clinically important difference (MCID) or substantial clinical benefit (SCB) is unclear. The objective of this study was to determine the rates of MCID and SCB in standard health-related quality of life (HRQOL) measures after 3COs in patients with adult spinal deformity (ASD). The impacts of location of the uppermost instrumented vertebra (UIV) on clinical outcomes and of maintenance on sagittal correction at 2 years postoperatively were also examined. METHODS: The authors conducted a retrospective multicenter analysis of the records from adult patients who underwent 3CO with complete 2-year radiographic and clinical follow-ups. Cases were categorized according to established radiographic thresholds for pelvic tilt (> 22 degrees ), sagittal vertical axis (> 4.7 cm), and the mismatch between pelvic incidence and lumbar lordosis (> 11 degrees ). The cases were also analyzed on the basis of a UIV in the upper thoracic (T1-6) or thoracolumbar (T9-L1) region. Patient-reported outcome measures evaluated preoperatively and 2 years postoperatively included Oswestry Disability Index (ODI) scores, the Physical Component Summary and Mental Component Summary (MCS) scores of the 36-Item Short Form Health Survey, and Scoliosis Research Society-22 questionnaire (SRS-22) scores. The percentages of patients whose outcomes for these measures met MCID and SCB were compared among the groups. RESULTS: Data from 140 patients (101 women and 39 men) were included in the analysis; the average patient age was 57.3 +/- 12.4 years (range 20-82 years). Of these patients, 94 had undergone only pedicle subtraction osteotomy (PSO) and 42 only vertebral column resection (VCR); 113 patients had a UIV in the upper thoracic (n = 63) orthoracolumbar region (n = 50). On average, 2 years postoperatively the patients had significantly improved in all HRQOL measures except the MCS score. For the entire patient cohort, the improvements ranged from 57.6% for the SRS-22 pain score MCID to 24.4% for the ODI score SCB. For patients undergoing PSO or VCR, the likelihood of their outcomes reaching MCID or SCB ranged from 24.3% to 62.3% and from 16.2% to 47.8%, respectively. The SRS-22 self-image score of patients who had a UIV in the upper thoracic region reached MCID significantly more than that of patients who had a UIV in the thoracolumbar region (70.6% vs 41.9%, p = 0.0281). All other outcomes were similar for UIVs of upper thoracic and thoracolumbar regions. Comparison of patients whose spines were above or below the radiographic thresholds associated with disability indicated similar rates of meeting MCID and SCB for HRQOL at the 2-year follow-up. CONCLUSIONS: Outcomes for patients having UIVs in the upper thoracic region were no more likely to meet MCID or SCB than for those having UIVs in the thoracolumbar region, except for the MCID in the SRS-22 self-image measure. The HRQOL outcomes in patients who had optimal sagittal correction according to radiographic thresholds determined preoperatively were not significantly more likely to reach MCID or SCB at the 2-year follow-up. Future work needs to determine whether the Schwab preoperative radiographic thresholds for severe disability apply in postoperative settings."," J Neurosurg Spine 23(3): 340-348.","USA",2015,"Spinal Deformity","Surgical","ODI,SRS-HRQOL","Adults","PRO study","Retrospective review","USA","Adults","Spinal Deformity","Surgical","PRO study","Retrospective review","ODI,SRS-HRQOL","2015:2018"]
[111,"Fallah, A., et al. (2012). \"Anterior cervical discectomy with arthroplasty versus arthrodesis for single-level cervical spondylosis: a systematic review and meta-analysis.\" PLoS One 7(8): e43407.",null,"Fallah, A., et al.","Anterior cervical discectomy with arthroplasty versus arthrodesis for single-level cervical spondylosis: a systematic review and meta-analysis","OBJECTIVE: To estimate the effectiveness of anterior cervical discectomy with arthroplasty (ACDA) compared to anterior cervical discectomy with fusion (ACDF) for patient-important outcomes for single-level cervical spondylosis. DATA SOURCES: Electronic databases (MEDLINE, EMBASE, Cochrane Register for Randomized Controlled Trials, BIOSIS and LILACS), archives of spine meetings and bibliographies of relevant articles. STUDY SELECTION: We included RCTs of ACDF versus ACDA in adult patients with single-level cervical spondylosis reporting at least one of the following outcomes: functionality, neurological success, neck pain, arm pain, quality of life, surgery for adjacent level degeneration (ALD), reoperation and dysphonia/dysphagia. We used no language restrictions. We performed title and abstract screening and full text screening independently and in duplicate. DATA SYNTHESIS: We used random-effects model to pool data using mean difference (MD) for continuous outcomes and relative risk (RR) for dichotomous outcomes. We used GRADE to evaluate the quality of evidence for each outcome. RESULTS: Of 2804 citations, 9 articles reporting on 9 trials (1778 participants) were eligible. ACDA is associated with a clinically significant lower incidence of neurologic failure (RR = 0.53, 95% CI = 0.37-0.75, p = 0.0004) and improvement in the Neck pain visual analogue scale (VAS) (MD = 6.56, 95% CI = 3.22-9.90, p = 0.0001; Minimal clinically important difference (MCID) = 2.5. ACDA is associated with a statistically but not clinically significant improvement in Arm pain VAS and SF-36 physical component summary. ACDA is associated with non-statistically significant higher improvement in the Neck Disability Index Score and lower incidence of ALD requiring surgery, reoperation, and dysphagia/dysphonia. CONCLUSIONS: There is no strong evidence to support the routine use of ACDA over ACDF in single-level cervical spondylosis. Current trials lack long-term data required to assess safety as well as surgery for ALD. We suggest that ACDA in patients with single level cervical spondylosis is an option although its benefits and indication over ACDF remain in question."," PLoS One 7(8): e43407.","Canada",2012,"Neck Pain,Spondylosis","Surgical","NDI","Unknown","PRO study","Systematic review","Canada","Unknown","Neck Pain,Spondylosis","Surgical","PRO study","Systematic review","NDI","2010:2014"]
[112,"Fan, H., et al. (2016). \"Comparison of Functional Outcome and Quality of Life in Patients With Idiopathic Scoliosis Treated by Spinal Fusion.\" Medicine (Baltimore) 95(19): e3289.",null,"Fan, H., et al.","Comparison of Functional Outcome and Quality of Life in Patients With Idiopathic Scoliosis Treated by Spinal Fusion","Longer spinal fusions have been shown to result in improved deformity correction; however, loss of normal flexibility in the fusion area should not be ignored. Current consensus was to achieve a shorter fusion in primary surgery, with the goal of preserving as much of the distal motion segment as possible. However, the correlation between the length of fusion and functional outcome remains controversial. To the best of our knowledge, a previous study has demonstrated the function outcomes and the differences in HRQoL with specific fusion levels.In this cross-sectional study, 172 patients (mean age, 17.8 y) with idiopathic scoliosis treated by spinal fusion (mean time since surgery, 29.7 mo) were included to measure lumbar spine mobility and quality of life using validated outcome instruments in the study population. Patients were assigned to 5 groups according to the lower instrumented vertebra (LIV) level: group A (fusion above L2) 26 patients; group B (fusion to L2) 21 patients; group C (fusion to L3) 46 patients; group D (fusion to L4) 53 patients; and group E (fusion to L5) 26 patients. At each follow-up, patients were asked to complete the Scoliosis Research Society 22 (SRS-22) Questionnaire. Lumbar mobility was assessed using a dual digital inclinometer.Average spinal range of motion (ROM) was 41.4 degrees (SD, 20.7), forward flexion was 29.2 degrees (SD, 15.0), and backward extension was 12.2 degrees (SD, 9.5). The total spinal range of motion and forward flexion dropped noticeably as the LIV got more distal. Statistically significant between-group differences (1-way ANOVA) were found for ROM (P < 0.001), forward flexion (P < 0.001), or backward extension (P < 0.001). The motion segments preserved significantly correlated with ROM (r = 0.76, P < 0.001), ROMF (r = 0.76, P < 0.001), and ROME (r = 0.39, P < 0.001). However, no significant between-group differences was found for each domain of SRS-22 questionnaire.The motion segments preserved strongly correlated with lumbar mobility. Less fusion levels can preserve better lumbar flexibility by keeping more motion segments."," Medicine (Baltimore) 95(19): e3289.","China",2016,"Spinal Fusion,Spinal Deformity","Surgical","SRS-HRQOL","Unknown","Tool Validation","Observational","China","Unknown","Spinal Fusion,Spinal Deformity","Surgical","Tool Validation","Observational","SRS-HRQOL","2015:2018"]
[113,"Fehlings, M. G., et al. (2013). \"Efficacy and safety of surgical decompression in patients with cervical spondylotic myelopathy: results of the AOSpine North America prospective multi-center study.\" J Bone Joint Surg Am 95(18): 1651-1658.",null,"Fehlings, M. G., et al.","Efficacy and safety of surgical decompression in patients with cervical spondylotic myelopathy: results of the AOSpine North America prospective multi-center study","BACKGROUND: Cervical spondylotic myelopathy is the leading cause of spinal cord dysfunction worldwide. The objective of this study was to evaluate the impact of surgical decompression on functional, quality-of-life, and disability outcomes at one year after surgery in a large cohort of patients with this condition. METHODS: Adult patients with symptomatic cervical spondylotic myelopathy and magnetic resonance imaging evidence of spinal cord compression were enrolled at twelve North American centers from 2005 to 2007. At enrollment, the myelopathy was categorized as mild (modified Japanese Orthopaedic Association [mJOA] score >/= 15), moderate (mJOA = 12 to 14), or severe (mJOA < 12). Patients were followed prospectively for one year, at which point the outcomes of interest included the mJOA score, Nurick grade, Neck Disability Index (NDI), and Short Form-36 version 2 (SF-36v2). All outcomes at one year were compared with the preoperative values with use of univariate paired statistics. Outcomes were also compared among the severity classes with use of one-way analysis of variance. Finally, a multivariate analysis that adjusted for baseline differences among the severity groups was performed. Treatment-related complication data were collected and the overall complication rate was calculated. RESULTS: Eighty-five (30.6%) of the 278 enrolled patients had mild cervical spondylotic myelopathy, 110 (39.6%) had moderate disease, and 83 (29.9%) had severe disease preoperatively. One-year follow-up data were available for 222 (85.4%) of 260 patients. There was a significant improvement from baseline to one year postoperatively (p < 0.05) in the mJOA score, Nurick grade, NDI score, and all SF-36v2 health dimensions (including the mental and physical health composite scores) except general health. With the exception of the change in the mJOA, the degree of improvement did not depend on the severity of the preoperative symptoms. These results remained unchanged after adjusting for relevant confounders in the multivariate analysis. Fifty-two patients experienced complications (prevalence, 18.7%), with no significant differences among the severity groups. CONCLUSIONS: Surgical decompression for the treatment of cervical spondylotic myelopathy was associated with improvement in functional, disability-related, and quality-of-life outcomes at one year of follow-up for all disease severity categories. Furthermore, complication rates observed in the study were commensurate with those in previously reported cervical spondylotic myelopathy series."," J Bone Joint Surg Am 95(18): 1651-1658.","Canada",2013,"Spondylosis","Surgical","NDI,Nurick","Unknown","PRO study","Prospective Observation","Canada","Unknown","Spondylosis","Surgical","PRO study","Prospective Observation","NDI,Nurick","2010:2014"]
[114,"Fehlings, M. G., et al. (2013). \"Predictors of treatment outcomes in geriatric patients with odontoid fractures: AOSpine North America multi-centre prospective GOF study.\" Spine (Phila Pa 1976) 38(11): 881-886.",null,"Fehlings, M. G., et al.","Predictors of treatment outcomes in geriatric patients with odontoid fractures: AOSpine North America multi-centre prospective GOF study","STUDY DESIGN: Multicenter prospective cohort study. OBJECTIVE: To identify patient and treatment characteristics associated with treatment success or failure in the management of odontoid fractures. SUMMARY OF BACKGROUND DATA: Odontoid fractures are the most common cervical spine fractures in the elderly and represent a significant management challenge with widely divergent views regarding operative versus nonoperative management. METHODS: A total of 159 patients 65 years and older with radiographically confirmed type II odontoid fractures were enrolled at 10 sites in the United States and 1 site in Canada between January 2006 and May 2009. Subjects were followed at 6 and 12 months post-initial treatment with Neck Disability Index and SF-36v2 scores. Final treatment outcome was classified as failure or success. Treatment failure was defined as death by any cause, decline in Neck Disability Index by more than 9.5 absolute points, or occurrence of a major treatment-related complication. Baseline characteristics between the groups were compared using t test for the continuous variables and chi2 test for the categorical variables. Baseline characteristics associated with treatment outcomes were identified by multiple logistic stepwise regression analysis. RESULTS: A total of 101 (63.5%) patients were treated surgically and 58 (36.5%) conservatively. Forty-four (27.7%) patients had a successful outcome and 86 (54.1%) had a treatment failure; for 29 patients (18.2%), treatment status could not be determined (3 withdrew; 26 were lost to follow-up). Twenty-nine (18.2%) patients expired before the 12-month follow-up. Follow-up information was available for 103 of 127 surviving (81.1%) patients. Twelve-month SF-36v2 scores were worse in the failure group. The characteristics associated with treatment failure were older age (odds ratio [OR] = 1.08 for each year of age); initial nonsurgical treatment (OR = 3.09); male sex (OR = 4.33), and baseline neurological system comorbidity (OR = 4.13). CONCLUSION: Older age, initial nonsurgical treatment, and male sex are associated with failure of treatment in patients with geriatric odontoid fractures."," Spine (Phila Pa 1976) 38(11): 881-886.","Canada",2013,"Spinal Fracture","Surgical","NDI","Elderly","PRO study","Prospective Observation","Canada","Elderly","Spinal Fracture","Surgical","PRO study","Prospective Observation","NDI","2010:2014"]
[115,"Fehlings, M. G., et al. (2017). \"Laminectomy and fusion versus laminoplasty for the treatment of degenerative cervical myelopathy: results from the AOSpine North America and International prospective multicenter studies.\" Spine J 17(1999): 102-108.",null,"Fehlings, M. G., et al.","Laminectomy and fusion versus laminoplasty for the treatment of degenerative cervical myelopathy: results from the AOSpine North America and International prospective multicenter studies","BACKGROUND CONTEXT: It remains unclear whether cervical laminoplasty (LP) offers advantages over cervical laminectomy and fusion (LF) in patients undergoing posterior decompression for degenerative cervical myelopathy (DCM). PURPOSE: The objective of this study is to compare outcomes of LP and LF. STUDY DESIGN/SETTING: This is a multicenter international prospective cohort study. PATIENT SAMPLE: A total of 266 surgically treated symptomatic DCM patients undergoing cervical decompression using LP (N=100) or LF (N=166) were included. OUTCOME MEASURES: The outcome measures were the modified Japanese Orthopaedic Association score (mJOA), Nurick grade, Neck Disability Index (NDI), Short-Form 36v2 (SF36v2), length of hospital stay, length of stay in the intensive care unit, treatment complications, and reoperations. METHODS: Differences in outcomes between the LP and LF groups were analyzed by analysis of variance and analysis of covariance. The dependent variable in all analyses was the change score between baseline and 24-month follow-up, and the independent variable was surgical procedure (LP or LF). In the analysis of covariance, outcomes were compared between cohorts while adjusting for gender, age, smoking, number of operative levels, duration of symptoms, geographic region, and baseline scores. RESULTS: There were no differences in age, gender, smoking status, number of operated levels, and baseline Nurick, NDI, and SF36v2 scores between the LP and LF groups. Preoperative mJOA was lower in the LP compared with the LF group (11.52+/-2.77 and 12.30+/-2.85, respectively, p=.0297). Patients in both groups showed significant improvements in mJOA, Nurick grade, NDI, and SF36v2 physical and mental health component scores 24 months after surgery (p<.0001). At 24 months, mJOA scores improved by 3.49 (95% confidence interval [CI]: 2.84, 4.13) in the LP group compared with 2.39 (95% CI: 1.91, 2.86) in the LF group (p=.0069). Nurick grades improved by 1.57 (95% CI: 1.23, 1.90) in the LP group and 1.18 (95% CI: 0.92, 1.44) in the LF group (p=.0770). There were no differences between the groups with respect to NDI and SF36v2 outcomes. After adjustment for preoperative characteristics, surgical factors and geographic region, the differences in mJOA between surgical groups were no longer significant. The rate of treatment-related complications in the LF group was 28.31% compared with 21.00% in the LP group (p=.1079). CONCLUSIONS: Both LP and LF are effective at improving clinical disease severity, functional status, and quality of life in patients with DCM. In an unadjusted analysis, patients treated with LP achieved greater improvements on the mJOA at 24-month follow-up than those who received LF; however, these differences were insignificant following adjustment for relevant confounders."," Spine J 17(1999): 102-108.","Canada",2017,"Cervical Myelopathy","Surgical","NDI,Nurick","Unknown","PRO study","Prospective Observation","Canada","Unknown","Cervical Myelopathy","Surgical","PRO study","Prospective Observation","NDI,Nurick","2015:2018"]
[116,"Feise, R. J., et al. (2005). \"Construction and validation of the scoliosis quality of life index in adolescent idiopathic scoliosis.\" Spine (Phila Pa 1976) 30(11): 1310-1315.",null,"Feise, R. J., et al.","Construction and validation of the scoliosis quality of life index in adolescent idiopathic scoliosis","STUDY DESIGN: A prospective cross-sectional design was used to evaluate the Scoliosis Quality of Life Index (SQLI). SQLI is a 22-item self-reporting health-related quality-of-life questionnaire for idiopathic scoliosis patients. OBJECTIVE: The goal of this study was to evaluate the psychometric qualities of SQLI. SUMMARY OF BACKGROUND DATA: SQLI, a modification of the Scoliosis Research Society-22 (SRS-22) questionnaire, is intended to be more applicable to patients with adolescent idiopathic scoliosis (AIS) between 10 and 18 years of age. METHODS: Eighty-four subjects with a mean age of 14.9 years participated. We determined reliability, validity, distribution of scores, and clinical utility of SQLI in a hospital setting. Seventy patients were AIS patients (16 postsurgical, 30 braced, 24 unbraced) with a mean Cobb angle of 30.7 degrees, and 14 patients were sibling controls. RESULTS: Reliability: Intraclass correlation coefficient for test-retest reliability of the global index was very good (ICC 2,1 = 0.80); Spearman's rho correlations between items and domains was 0.39 to 0.89 and between domains and global index was 0.55 to 0.78; Cronbach's alpha scores were more than 0.80 (0.82-0.89). VALIDITY: construct validity was established by correlations between SQLI's global index and Quality of Life Profile for Spine Deformities (QLPSD) global index (Spearman's rho, 0.79) and between SQLI domains and QLPSD domains (0.46-0.81); discriminate validity was established by SQLI's global index successfully partitioned controls and AIS subjects (Kruskal-Wallis test, P = 0.0013). Time required by the patient averaged 2.5 minutes per administration. CONCLUSIONS: SQLI is reliable and valid and demonstrates satisfactory distribution of scores. SQLI is a promising instrument in the assessment of AIS patients."," Spine (Phila Pa 1976) 30(11): 1310-1315.","USA",2005,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Observational","USA","Adolescents","Spinal Deformity","Surgical","PRO study","Observational","SRS-HRQOL","2005:2009"]
[117,"Fernandez-Fairen, M., et al. (2012). \"Is anterior cervical fusion with a porous tantalum implant a cost-effective method to treat cervical disc disease with radiculopathy?\" Spine (Phila Pa 1976) 37(20): 1734-1741.",null,"Fernandez-Fairen, M., et al.","Is anterior cervical fusion with a porous tantalum implant a cost-effective method to treat cervical disc disease with radiculopathy?","STUDY DESIGN: Retrospective cost-effectiveness analysis. OBJECTIVE: To determine the relative cost-effectiveness of anterior cervical discectomy with fusion (ACDF) using a porous tantalum implant compared with autograft with plating, for single-level cervical disc disease with radiculopathy. SUMMARY OF BACKGROUND DATA: ACDF with autograft as an interbody spacer is a generally accepted method to treat degenerated cervical discs with radiculopathy. Concerns about donor site morbidity and the structural characteristics of autograft stimulated investigations of alternative materials. Techniques may differ in their operative risks, complications, outcomes, and resource use. METHODS: A retrospective review of clinical outcomes and total cost of illness for 5 years postsurgery was performed for 61 consecutive patients enrolled for this study. Twenty-eight patients were treated with single-level ACDF using either a stand-alone, porous tantalum implant, without graft inside the implant, and 33 patients received autograft and plating. A cost-effectiveness analysis comparing the 2 ACDF treatment methods was conducted. This article reports clinical assessments, quality adjusted life years gained, and an incremental cost-effectiveness ratio analysis. RESULTS: Patients in both cohorts reported improved clinical outcomes, including neck disability index, visual analogue scale, Short-Form 36, Odom's clinical assessment, and patient satisfaction at 5 years postindex surgery. The mean cost of illness for the study period, including preoperative through 5 years postoperative assessments, was 6806 per patient treated with tantalum and 10,143 per patient receiving autograft and plate. Quality-adjusted life years (QALY) gained were 9.41 and 7.14 for the tantalum and control cohorts, respectively. The cost per QALY for the tantalum group was 723 and 1420 for the control group. The incremental cost-effectiveness ratio of ACDF with a porous tantalum implant compared with ACDF with autograft and plate was -1473 per patient per year for the duration of this study. CONCLUSION: This cost-effectiveness analysis reports favorable results for ACDF procedures utilizing a tantalum implant. The data reported suggest that using porous tantalum as a stand-alone device is less costly and more effective than autograft and plate in ACDF procedures."," Spine (Phila Pa 1976) 37(20): 1734-1741.","Spain",2012,"Radiculopathy","Surgical","NDI,Odom","Unknown","Cost-Effectiveness","retrospective review","Spain","Unknown","Radiculopathy","Surgical","Cost-Effectiveness","Retrospective review","NDI,Odom","2010:2014"]
[118,"Filiz, M., et al. (2005). \"The effectiveness of exercise programmes after lumbar disc surgery: a randomized controlled study.\" Clin Rehabil 19(1999): 4-11.",null,"Filiz, M., et al.","The effectiveness of exercise programmes after lumbar disc surgery: a randomized controlled study","OBJECTIVE: To compare two different exercise programmes versus a control group, after lumbar disc surgery. DESIGN: A prospective, single-blind, randomized controlled study. SETTING: Outpatient clinic of Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation. SUBJECTS: Sixty patients diagnosed as having single level lumbar disc herniation with clinical examination and MRI evaluation and who had undergone lumbar discectomy (post-operative first month) at a single level. Patients with serious pathologies involving the cardiac and respiratory systems that could prevent them from doing exercises were excluded. INTERVENTION: The patients were randomly split into three groups. The first group received an intensive exercise programme and back school education while the second group received a home exercise programme and back school education. The third group was defined as the control group and did not receive education or exercise. MAIN MEASURES: The patients were evaluated at the beginning and end of the treatment with clinical parameters, pain levels, endurance tests and weight-lifting tests, modified Oswestry Disability Index, Beck Depression Inventory, Low Back Pain Rating Scale and return to work. RESULTS: The groups doing exercises experienced a decrease in the severity of pain and disability, also functional parameters showed better improvement than the control group. The intensive exercise programme was better than the home exercise programme. CONCLUSIONS: It seems that intensive exercise is more effective in reduction of pain and disability, but whether it is cost-effective is not clear."," Clin Rehabil 19(1999): 4-11.","Turkey",2005,"Back Pain,Degenerative Disk Disease","Surgical","ODI","Unknown","PRO study","RCT","Turkey","Unknown","Back Pain,Degenerative Disk Disease","Surgical","PRO study","RCT","ODI","2005:2009"]
[119,"Fisher, C., et al. (2004). \"Outcome evaluation of the operative management of lumbar disc herniation causing sciatica.\" J Neurosurg 100(4 Suppl Spine): 317-324.",null,"Fisher, C., et al.","Outcome evaluation of the operative management of lumbar disc herniation causing sciatica","OBJECT: The authors conducted a study to assess health-related quality of life (HRQOL) and the appropriateness of surgery in patients who have undergone elective lumbar discectomy. METHODS: The study involved a prospective cohort of 82 surgically treated patients with lumbar disc herniation causing lower-extremity radiculopathy. An independent study coordinator recorded demographic data and administered the North American Spine Society (NASS) lumbar spine instrument and the Short Form-36 (SF-36) before treatment, and at 6 months and 1 year after surgery. The HRQOL results were also compared with normative data for the NASS and SF-36. The influence of baseline variables on HRQOL was determined using regression modeling. The InterQual Indicators for Surgery and Procedures (ISP) were used to compare surgeon practice patterns with standardized indications for surgery. The NASS neurogenic symptom (NSS) and pain/disability scores (PDSs) showed very significant improvement at 6 months and little change between 6 months and 1 year. The SF-36 physical function and bodily pain scale scores were associated with the greatest improvement. Interestingly, the 1-year NASS (NSS and PDS) and SF-36 (only PCS) scores remained lower than those of age-matched normative data. Other than preoperative HRQOL scores, the only other variable that inversely influenced HRQOL was the duration of time between symptom onset and surgery. Ninety-five percent of ISP forms were completed, and 97% of the indications recorded by the surgeon matched the criteria. CONCLUSIONS: The reporting of standardized outcomes in association with indications for surgery is feasible and may help elucidate the ideal rate for discectomy."," J Neurosurg 100(4 Suppl Spine): 317-324.","Canada",2004,"Degenerative Disk Disease","Surgical","NASS-L","Unknown","PRO study","Prospective Observation","Canada","Unknown","Degenerative Disk Disease","Surgical","PRO study","Prospective Observation","NASS-L","2000:2004"]
[120,"Foletti, A. and J. Pokorny (2015). \"Biophysical approach to low back pain: a pilot report.\" Electromagn Biol Med 34(2): 156-159.",null,"Foletti, A. and J. Pokorny","Biophysical approach to low back pain: a pilot report","Since biophysical treatment has been reported to be effective in the general management of pain, we decided to assess the specific effect and treatment duration of this therapeutic strategy in low back pain. We were interested in verifying the possibility that a single clinical procedure could reduce pain and improve patients' quality of life within a period of three months. An Electromagnetic Information Transfer Through Aqueous System was employed to record endogenous therapeutic signals from each individual using an electromagnetic recording device (Med Select 729). A highly significant reduction in the Roland Morris low back pain and disability questionnaire score was observed after 3 months following a single biophysical intervention (11.83 +/- 6 at baseline versus 2.3 +/- 3.25 at 3 months, p < 0.0001). This preliminary report provides further evidence of the theoretical implications and clinical applications of Quantum Electro Dynamic concepts in biology and medicine."," Electromagn Biol Med 34(2): 156-159.","Italy",2015,"Back Pain","Not Specified","RMDQ","Unknown","PRO study","Observational","Italy","Unknown","Back Pain","Not Specified","PRO study","Observational","RMDQ","2015:2018"]
[121,"Forestier, R., et al. (2007). \"French version of the Copenhagen neck functional disability scale.\" Joint Bone Spine 74(2): 155-159.",null,"Forestier, R., et al.","French version of the Copenhagen neck functional disability scale","We conducted a study to validate the French version of the Copenhagen Neck Functional Disability Scale (CNFDS). METHODS: We used the CNFDS on data generated by a previous randomized controlled trial comparing pulsed electromagnetic field therapy (PEMFT), spa therapy, and standard therapy in patients with neck pain. Patients were recruited locally and examined by a physician who was unaware of the treatment group and independent from the trial. Treatment efficacy was evaluated based on a visual analog scale (VAS) for pain, the short-form-36 quality-of-life instrument (SF36), payments by public healthcare insurance, and overall assessments by the patients and physicians. Efficacy was evaluated at baseline, at treatment completion, and after 3 and 6 months. In addition, the patients completed the CNFDS at these time points. RESULTS: CNFDS scores were normally distributed. CNFDS scores and their variations correlated well with the other efficacy criteria. CNFDS scores were less sensitive to change than the VAS pain scores and more sensitive to change than the other efficacy criteria. CONCLUSION: The CNFDS holds promise as a tool for evaluating neck pain. Score reproducibility needs to be studied. The CNFDS can be added to the other instruments that have been translated in recent years to serve as tools for clinical research. However, the ease of completion of the CNFDS is consistent with use in clinical practice."," Joint Bone Spine 74(2): 155-159.","France",2007,"Neck Pain","Other","CNFDS","Adults","Tool Validation","RCT","France","Adults","Neck Pain","Other","Tool Validation","RCT","CNFDS","2005:2009"]
[122,"Foster, N. E., et al. (2014). \"Effect of stratified care for low back pain in family practice (IMPaCT Back): a prospective population-based sequential comparison.\" Ann Fam Med 12(2): 102-111.",null,"Foster, N. E., et al.","Effect of stratified care for low back pain in family practice (IMPaCT Back): a prospective population-based sequential comparison","PURPOSE: We aimed to determine the effects of implementing risk-stratified care for low back pain in family practice on physician's clinical behavior, patient outcomes, and costs. METHODS: The IMPaCT Back Study (IMplementation to improve Patient Care through Targeted treatment) prospectively compared separate patient cohorts in a preintervention phase (6 months of usual care) and a postintervention phase (12 months of stratified care) in family practice, involving 64 family physicians and linked physical therapy services. A total of 1,647 adults with low back pain were invited to participate. Stratified care entailed use of a risk stratification tool to classify patients into groups at low, medium, or high risk for persistent disability and provision of risk-matched treatment. The primary outcome was 6-month change in disability as assessed with the Roland-Morris Disability Questionnaire. Process outcomes captured physician behavior change in risk-appropriate referral to physical therapy, diagnostic tests, medication prescriptions, and sickness certifications. A cost-utility analysis estimated incremental quality-adjusted life-years and back-related health care costs. Analysis was by intention to treat. RESULTS: The 922 patients studied (368 in the preintervention phase and 554 in the postintervention phase) had comparable baseline characteristics. At 6 months follow-up, stratified care had a small but significant benefit relative to usual care as seen from a mean difference in Roland-Morris Disability Questionnaire scores of 0.7 (95% CI, 0.1-1.4), with a large, clinically important difference in the high risk group of 2.3 (95% CI, 0.8-3.9). Mean time off work was 50% shorter (4 vs 8 days, P = .03) and the proportion of patients given sickness certifications was 30% lower (9% vs 15%, P = .03) in the postintervention cohort. Health care cost savings were also observed. CONCLUSIONS: Stratified care for back pain implemented in family practice leads to significant improvements in patient disability outcomes and a halving in time off work, without increasing health care costs. Wider implementation is recommended."," Ann Fam Med 12(2): 102-111.","UK",2014,"Back Pain","Physical Therapy","RMDQ","Unknown","PRO study","Prospective Observation","UK","Unknown","Back Pain","Physical Therapy","PRO study","Prospective Observation","RMDQ","2010:2014"]
[123,"Froud, R., et al. (2015). \"Primary outcome measure use in back pain trials may need radical reassessment.\" BMC Musculoskelet Disord 16: 88.",null,"Froud, R., et al.","Primary outcome measure use in back pain trials may need radical reassessment","BACKGROUND: The answers to patient reported outcome measures and global transition questions for back pain can be discordant. For example, the most commonly used outcome measure in back pain trials, the Roland Morris Disability Questionnaire (RMDQ), can show improvement even though participants say that their back pain is worse. This gives cause for concern as transition questions are used as anchors to estimate minimally important change (MIC) thresholds on patient reported outcome measures such as the RMDQ. We aimed to explore and compare what people with back pain think when they respond to a transition question and when they complete the RMDQ. METHODS: We purposively sampled people enrolled on a back pain randomised controlled trial who completed the RMDQ and two transition questions. One enquired about change in ability to perform tasks, the other about change in back pain. We sampled participants with discordance (in both directions), and participants with concordant scores. We explored participants' thought processes using in-depth interviews. RESULTS: We completed 35 in-depth interviews. People with discordant RMDQ change and transition question responses attend to different factors when responding to transition questions compared to people with concordant scores. In particular, those for whom the RMDQ change indicated greater improvement than transition questions, prioritised their pain ahead of functional disability. When completing the RMDQ, participants' thought processes were comparatively more objective, and specific to each statement. CONCLUSION: Approaches to primary outcome assessment in back pain needs re-assessment. The RMDQ may be unsuitable for use as a primary outcome measure since patients may not attend to thinking about their back pain when completing it: patients' abilities to cope with tasks can be independent of the change in their back pain. Some participants who improve on the RMDQ consider themselves globally worse. As transition questions can be driven by pain and other physical factors, transition questions should not be used to anchor minimally important change thresholds on the RMDQ."," BMC Musculoskelet Disord 16: 88.","UK",2015,"Back Pain","Not Specified","RMDQ","Unknown","PRO study","RCT","UK","Unknown","Back Pain","Not Specified","PRO study","RCT","RMDQ","2015:2018"]
[124,"Froum, S. J., et al. (2007). \"Narrow-diameter implants: a restorative option for limited interdental space.\" Int J Periodontics Restorative Dent 27(5): 449-455.",null,"Froum, S. J., et al.","Narrow-diameter implants: a restorative option for limited interdental space","The present study reports on the results of the use of a screw-retained narrow-diameter implant (NDI) system as an option for implant placement in areas of limited bone volume. This retrospective report followed 48 NDIs in 27 patients for 1 to 5 years postloading. No implant failures were reported, yielding a 100% survival rate. The screw-retained attribute of this system allows retrievability of the restorations, which may require replacement because of porcelain fracture, chipping, or a desire to change color. The three diameters available--1.8 mm, 2.2 mm, and 2.4 mm--allow flexibility for a variety of narrow edentulous spaces. These NDIs present a cost-effective alternative for restoring limited spaces with implant restorations, without the bone augmentation or orthodontic procedures required for conventional fixed restorations. The NDI system is approved by the U.S. Food and Drug Administration for long-term use."," Int J Periodontics Restorative Dent 27(5): 449-455.","USA",2007,"Spinal Fracture","Not Specified","NDI","Unknown","PRO study","Retrospective review","USA","Unknown","Spinal Fracture","Not Specified","PRO study","Retrospective review","NDI","2005:2009"]
[125,"Fuchs, S., et al. (2005). \"Intraarticular hyaluronic acid versus glucocorticoid injections for nonradicular pain in the lumbar spine.\" J Vasc Interv Radiol 16(11): 1493-1498.",null,"Fuchs, S., et al.","Intraarticular hyaluronic acid versus glucocorticoid injections for nonradicular pain in the lumbar spine","PURPOSE: To investigate the efficacy and safety of intraarticular sodium hyaluronate (SH) compared with intraarticular glucocorticoids (triamcinolone acetonide; TA) in the treatment of chronic nonradicular lumbar pain. MATERIALS AND METHODS: Sixty patients were included in this randomized, controlled, blind-observer clinical study and randomly assigned to two groups to receive 10 mg SH or 10 mg TA per facet joint. The facet joints on both sides at levels S1-L5, L5-L4, and L4-L3 were treated once per week under computed tomographic guidance. The study visits were timed to permit assessment of the immediate effect as well as possible carryover effects at 3 and 6 months after completion of treatment. Changes in pain were assessed with a visual analog scale (VAS) and changes in function and quality of life were assessed by the Roland Morris Questionnaire (RMQ), the Oswestry Disability Questionnaire (ODQ), the Low Back Outcome Score (LBOS), and the Short Form 36 (SF-36) questionnaire. RESULTS: Patients reported lasting pain relief, better function, and improved quality of life with both treatments. Mann-Whitney analyses of the patient questionnaires (RMQ, ODQ, and LBOS) very consistently showed that SH is not inferior to TA. In addition, the efficacy of SH was largely comparable with that of TA on the VAS and SF-36. No adverse effects were reported after administration of the test products. The intraarticular treatment of facet joints (levels S1-L5, L5-L4, and L4-L3) with SH in patients with chronic nonradicular pain in the lumbar spine resulted in a marked reduction in pain with improved function and better quality of life, which was at least equal to the effect of a course of TA injections. SH-treated patients showed greater benefits in the long term. CONCLUSION: Intraarticular SH is a very promising new option for the treatment of patients with chronic nonradicular lumbar symptoms."," J Vasc Interv Radiol 16(11): 1493-1498.","Germany",2005,"Back Pain","Glucocorticoids","ODI,RMDQ,LBOS","Unknown","PRO study","RCT","Germany","Unknown","Back Pain","Glucocorticoids","PRO study","RCT","ODI,RMDQ,LBOS","2005:2009"]
[126,"Fujiwara, H., et al. (2016). \"Correlations and time-dependent changes of upper arm performance tests, the Japanese Orthopaedic Association score, and a newly developed patient-based outcome measure : the Japanese Orthopaedic Cervical Myelopathy Questionnaire.\" Bone Joint J 98-b(7): 990-996.",null,"Fujiwara, H., et al.","Correlations and time-dependent changes of upper arm performance tests, the Japanese Orthopaedic Association score, and a newly developed patient-based outcome measure : the Japanese Orthopaedic Cervical Myelopathy Questionnaire","AIMS: In this prospective observational study, we investigated the time-dependent changes and correlations of upper arm performance tests (ten-second test and Simple Test for Evaluating Hand Function (STEF), the Japanese Orthopaedic Association (JOA) score, and the JOA Cervical Myelopathy Evaluation Questionnaire (JOACMEQ) in 31 patients with cervical myelopathy who had undergone surgery. PATIENTS AND METHODS: We hypothesised that all the indices correlate with each other, but show slightly different recovery patterns, and that the newly described JOACMEQ is a sensitive outcome measure. RESULTS: Peak recoveries were achieved one month post-operatively in the ten-second test and JOACMEQ upper extremity function (UEF) subscale, and at three months in the JOA and STEF scores. The recoveries of all indices were maintained until six months post-operatively. The upper extremity function (UEF) subscale in the JOACMEQ showed the strongest correlation with STEF although all the indices correlated with each other. Patients with >/= 20 and < 20 acquired points in the UEF subscale were classified into the UEF-improved and UEF-unimproved groups. Comparisons between the groups showed that pre-operative evaluation of \"coordinated motion\" of the STEF was significantly low in the UEF-unimproved group. CONCLUSION: These results indicate that the JOACMEQ is a concise, sensitive, patient-based outcome measure for evaluating functional recovery in patients with cervical myelopathy who have undergone surgery. Cite this article: Bone Joint J 2016;98-B:990-6."," Bone Joint J 98-b(7): 990-996.","Japan",2016,"Cervical Myelopathy","Surgical","JOACMEQ","Unknown","PRO study","Prospective Observation","Japan","Unknown","Cervical Myelopathy","Surgical","PRO study","Prospective Observation","JOACMEQ","2015:2018"]
[127,"Fukui, M., et al. (2007). \"An outcome measure for patients with cervical myelopathy: Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ): Part 1.\" J Orthop Sci 12(3): 227-240.",null,"Fukui, M., et al.","An outcome measure for patients with cervical myelopathy: Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ): Part 1","BACKGROUND: An outcome measure to evaluate the neurological function of cervical myelopathy was proposed by the Japanese Orthopaedic Association in 1975 (JOA score), and has been widely used in Japan. However, the JOA score does not include patients' satisfaction, disability, handicaps, or general health, which can be affected by cervical myelopathy. The purpose of this study was to develop a new outcome measure for patients with cervical myelopathy. METHODS: This study was conducted in eight university hospitals and their affiliated hospitals from February to May 2002. The questionnaire included 77 items. Forty-one questions, which were originally listed by the authors, were for evaluation of the physical function of the cervical spine and spinal cord. The Medical Outcome Study Short-Form 36-Item Health Survey (SF-36) was used to examine health-related quality of life (QOL). Patients with cervical myelopathy and healthy volunteers were recruited at each institution. After analysis of the answers from patients and volunteers, irrelevant questions using the following criteria were excluded: (1999) a question 80% of answers for which were concentrated on one choice, (2) a question whose answer was highly correlated with that of other questions, (3) a question that could be explained by other questions, and (4) a question for which the distribution of the answers obtained from the patients was not different from that obtained from the normal volunteers. RESULTS: The patients comprised 164 men and 86 women, and the healthy volunteers 96 men and 120 women. Thirteen items from the questions about the physical functions of the cervical spine and the spinal cord and 11 items from SF-36 remained as candidates that should be included in the final outcome measure questionnaire. CONCLUSION: Twenty-four questions remained as candidates for the final questionnaire. This new self-administered questionnaire might be used to evaluate the outcomes in patients with cervical myelopathy more efficiently."," J Orthop Sci 12(3): 227-240.","Japan",2007,"Cervical Myelopathy","Not Specified","JOACMEQ","Unknown","Tool Validation","Observational","Japan","Unknown","Cervical Myelopathy","Not Specified","Tool Validation","Observational","JOACMEQ","2005:2009"]
[128,"Fukui, M., et al. (2007). \"JOA back pain evaluation questionnaire: initial report.\" J Orthop Sci 12(5): 443-450.",null,"Fukui, M., et al.","JOA back pain evaluation questionnaire: initial report","BACKGROUND: There is no widely accepted objective evaluation for lumbar spine disorders. New outcome measures should be patient-oriented and should measure symptoms and self-reported functional status in multiple dimensions. The aim of this study was to identify items to be included in the disease-specific quality of life (QOL) questionnaire for the assessments of patients with lumbar spine disorders. METHODS: The draft of the QOL questionnaire that consisted of a total of 60 items, including 24 items derived from the Japanese version of the Roland Morris Disability Questionnaire (RDQ) and 36 items derived from the Japanese version of Short Form 36 (SF-36), were administered to patients and controls. After obtaining written informed consent, the following data were collected from the patient group (n = 328) and the control group (n = 213): (1999) background characteristics, including age, diagnosis, Japanese Orthopaedic Association (JOA) score, and finger to floor distance; (2) responses to the questionnaire; (3) the identification rate by discrimination analysis to select the candidates for adoption and by adopting explanatory variables. The items to be excluded were determined by examining the explanatory variables, which were selected after the discrimination analysis, by setting the candidate to-be-excluded items as an objective variable. RESULTS: Based on the distribution of the responses, two items, RDQ-15 and RDQ-19, were excluded. From the results of the correlation coefficient calculation for each question in the patient group, 33 items were excluded and 27 candidate items were adopted. Based on the adoption explanatory variable used in the discrimination analysis, 25 of the 27 candidate items for adoption were accepted. CONCLUSIONS: This study identified the 25 specific questionnaire items that should be included in the questionnaire to evaluate QOL of patients with various lumbar spine disorders."," J Orthop Sci 12(5): 443-450.","Unknown",2007,"Spinal Deformity","Not Specified","RMDQ","Unknown","PRO study","Clinical trial","Unknown","Unknown","Spinal Deformity","Not Specified","PRO study","Clinical trial","RMDQ","2005:2009"]
[129,"Fukui, M., et al. (2008). \"Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ): part 4. Establishment of equations for severity scores. Subcommittee on low back pain and cervical myelopathy, evaluation of the clinical outcome committee of the Japanese Orthopaedic Association.\" J Orthop Sci 13(1999): 25-31.",null,"Fukui, M., et al.","Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ): part 4. Establishment of equations for severity scores. Subcommittee on low back pain and cervical myelopathy, evaluation of the clinical outcome committee of the Japanese Orthopaedic Association","BACKGROUND: To establish a patient-oriented outcome measure for cervical myelopathy, a subcommittee of the Japanese Orthopaedic Association (JOA) developed a new scoring system to evaluate the overall clinical status of patients, which could be completed by patients themselves. The subcommittee completed three large-scale studies to select and modify questions derived from various preexisting outcome measures including Short Form-36, and then finalized and validated the questionnaire, which comprised 24 questions. METHODS: The finalized questionnaire was administered to 369 patients with cervical myelopathy due to disc herniation, spondylosis, or ossification of posterior longitudinal ligament by randomly selected board-certified spine surgeons. Patients with different severities of myelopathy were included to insure accuracy and responsiveness of this questionnaire against patients' different neurological status. RESULTS: Data of 236 patients were employed and were subjected to rigorous statistical analyses. There was no question that was difficult to answer and distribution of answers for each question was not concentrated to one choice, indicating the appropriateness of all 24 questions. Results of factor analysis suggested that the 24 questions could be divided into five different factors or functional domains. The factors were defined as follows: factor 1, lower extremity function; factor 2, quality of life; factor 3, cervical spine function; factor 4, bladder function; and factor 5, upper extremity function. Finally, equations that would yield scores for the five factors were assembled. The score to be used to represent the degree of patients' disability or status in each domain can be calculated by multiplying prefixed numbers of selected answers to questions by preassigned coefficients. Coefficients were defined to make the minimum score 0 and the maximum score 100. CONCLUSIONS: We have successfully established a questionnaire that is able to demonstrate the status of patients suffering cervical myelopathy from five different aspects represented by five intuitive numerical scores. The final issue to be confirmed is the responsiveness of this questionnaire to changes in patients' status after various surgical and nonsurgical treatments."," J Orthop Sci 13(1999): 25-31.","Japan",2008,"Degenerative Disk Disease,Spondylosis","Surgical","JOACMEQ","Unknown","PRO study","Observational","Japan","Unknown","Degenerative Disk Disease,Spondylosis","Surgical","PRO study","Observational","JOACMEQ","2005:2009"]
[130,"Fukui, M., et al. (2008). \"Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ): part 4. Establishment of equations for severity scores. Subcommittee on low back pain and cervical myelopathy, evaluation of the clinical outcome committee of the Japanese Orthopaedic Association.\" J Orthop Sci 13(1999): 25-31.",null,"Fukui, M., et al.","Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ): part 4. Establishment of equations for severity scores. Subcommittee on low back pain and cervical myelopathy, evaluation of the clinical outcome committee of the Japanese Orthopaedic Association","BACKGROUND: To establish a patient-oriented outcome measure for cervical myelopathy, a subcommittee of the Japanese Orthopaedic Association (JOA) developed a new scoring system to evaluate the overall clinical status of patients, which could be completed by patients themselves. The subcommittee completed three large-scale studies to select and modify questions derived from various preexisting outcome measures including Short Form-36, and then finalized and validated the questionnaire, which comprised 24 questions. METHODS: The finalized questionnaire was administered to 369 patients with cervical myelopathy due to disc herniation, spondylosis, or ossification of posterior longitudinal ligament by randomly selected board-certified spine surgeons. Patients with different severities of myelopathy were included to insure accuracy and responsiveness of this questionnaire against patients' different neurological status. RESULTS: Data of 236 patients were employed and were subjected to rigorous statistical analyses. There was no question that was difficult to answer and distribution of answers for each question was not concentrated to one choice, indicating the appropriateness of all 24 questions. Results of factor analysis suggested that the 24 questions could be divided into five different factors or functional domains. The factors were defined as follows: factor 1, lower extremity function; factor 2, quality of life; factor 3, cervical spine function; factor 4, bladder function; and factor 5, upper extremity function. Finally, equations that would yield scores for the five factors were assembled. The score to be used to represent the degree of patients' disability or status in each domain can be calculated by multiplying prefixed numbers of selected answers to questions by preassigned coefficients. Coefficients were defined to make the minimum score 0 and the maximum score 100. CONCLUSIONS: We have successfully established a questionnaire that is able to demonstrate the status of patients suffering cervical myelopathy from five different aspects represented by five intuitive numerical scores. The final issue to be confirmed is the responsiveness of this questionnaire to changes in patients' status after various surgical and nonsurgical treatments."," J Orthop Sci 13(1999): 25-31.","Japan",2008,"Degenerative Disk Disease,Spondylosis","Surgical","JOACMEQ","Unknown","PRO study","Observational","Japan","Unknown","Degenerative Disk Disease,Spondylosis","Surgical","PRO study","Observational","JOACMEQ","2005:2009"]
[131,"Gadjradj, P. S., et al. (2016). \"Clinical outcomes after percutaneous transforaminal endoscopic discectomy for lumbar disc herniation: a prospective case series.\" Neurosurg Focus 40(2): E3.",null,"Gadjradj, P. S., et al.","Clinical outcomes after percutaneous transforaminal endoscopic discectomy for lumbar disc herniation: a prospective case series","OBJECTIVE Throughout the last decades, full-endoscopic techniques to treat lumbar disc herniation (LDH) have gained popularity in clinical practice. To date, however, no Class I evidence on the efficacy of percutaneous transforaminal endoscopic discectomy (PTED) has been published, and studies describing its safety and short- and long-term efficacy are scarce. In this study the authors aimed to evaluate the clinical outcomes and safety in patients undergoing PTED for LDH. METHODS Patients who underwent PTED for LDH between January 2009 and December 2012 were prospectively followed. The primary outcomes were the visual analog scale (VAS) score for leg pain and the score on the Quebec Back Pain Disability Scale (QBPDS). Secondary outcomes were the perceived experience with the local anesthesia used and satisfaction with the results after 1 year using Likert-type scales. The pretreatment means were compared with the means obtained 6 and 52 weeks after surgery using paired t-tests. RESULTS A total of 166 patients underwent surgery for a total of 167 LDHs. The mean duration of surgery (+/- SD) was 51.0 +/- 9.0 minutes. The 1-year follow-up rate was 95.2%. The mean reported scores on the VAS and QBPDS were 82.5 +/- 17.3 mm and 60.0 +/- 18.4 at baseline, respectively. Six weeks after surgery, the scores on the VAS and QBPDS were significantly reduced to 28.8 +/- 24.5 mm and 26.7 +/- 20.6, respectively (p < 0.001). After 52 weeks of follow-up, the scores were further reduced compared with baseline scores (p < 0.001) to 19.6 +/- 23.5 mm on the VAS and 20.2 +/- 18.1 on the QBPDS. A total of 4 complications were observed, namely 1 dural tear, 1 deficit of ankle dorsiflexion, and 2 cases of transient paresis in the foot due to the use of local anesthetics. CONCLUSIONS PTED appears to be a safe and effective intervention for LDH and has similar clinical outcomes compared to conventional open microdiscectomy. High-quality randomized controlled trials are required to study the efficacy and cost-effectiveness of PTED."," Neurosurg Focus 40(2): E3.","USA",2016,"Degenerative Disk Disease","Surgical","QBPD","Unknown","PRO study","RCT","USA","Unknown","Degenerative Disk Disease","Surgical","PRO study","RCT","QBPD","2015:2018"]
[132,"Garner, M. J., et al. (2007). \"Chiropractic care of musculoskeletal disorders in a unique population within Canadian community health centers.\" J Manipulative Physiol Ther 30(3): 165-170.",null,"Garner, M. J., et al.","Chiropractic care of musculoskeletal disorders in a unique population within Canadian community health centers","OBJECTIVE: This study was part of a larger demonstration project integrating chiropractic care into publicly funded Canadian community health centers. This pre/post study investigated the effectiveness of chiropractic care in reducing pain and disability as well as improving general health status in a unique population of urban, low-income, and multiethnic patients with musculoskeletal (MSK) complaints. METHODS: All patients who presented to one of two community health center-based chiropractic clinics with MSK complaints between August 2004 and December 2005 were recruited to participate in this study. Outcomes were assessed by a general health measure (Short Form-12), a pain scale (VAS), and site-specific disability indexes (Roland-Morris Questionnaire and Neck Disability Index), which were administered before and after a 12-week treatment period. RESULTS: Three hundred twenty-four patients with MSK conditions were recruited into the study, and 259 (80.0%) of them were followed to the study's conclusion. Clinically important and statistically significant positive changes were observed for all outcomes (Short Form-12: physical composite score mean change = 4.9, 95% confidence interval [CI] = 3.8-6.0; VAS: current pain mean change = 2.3, 95% CI = 1.9-2.6; Neck Disability Index: mean change = 6.8, 95% CI = 5.4-8.1; Roland-Morris Questionnaire: mean change = 4.3, 95% CI = 3.6-5.1). No adverse events were reported. CONCLUSIONS: Patients of low socioeconomic status face barriers to accessing chiropractic services. This study suggests that chiropractic care reduces pain and disability as well as improves general health status in patients with MSK conditions. Further studies using a more robust methodology are needed to investigate the efficacy and cost-effectiveness of introducing chiropractic care into publicly funded health care facilities."," J Manipulative Physiol Ther 30(3): 165-170.","Canada",2007,"Unspecified","Not Specified","RMDQ,NDI","Unknown","PRO study","Clinical trial","Canada","Unknown","Unspecified","Not Specified","PRO study","Clinical trial","RMDQ,NDI","2005:2009"]
[133,"Gautschi, O. P., et al. (2016). \"Influence of age on pain intensity, functional impairment and health-related quality of life before and after surgery for lumbar degenerative disc disease.\" Clin Neurol Neurosurg 150: 33-39.",null,"Gautschi, O. P., et al.","Influence of age on pain intensity, functional impairment and health-related quality of life before and after surgery for lumbar degenerative disc disease","BACKGROUND: Demographic changes will lead to an increase of elderly people in our population and consecutively to a higher prevalence of patients suffering from degenerative disc disease (DDD). The goal of this study was to investigate age-related differences in pain intensity, subjective and objective functional impairment and health-related quality of life (HRQoL) in patients with lumbar DDD. METHODS: In a prospective two-center study, back and leg pain intensity (visual analogue scale (VAS)), functional impairment (Oswestry Disability Index (ODI), Roland-Morris Disability Index (RMDI)) and HRQoL (EuroQol-5D (EQ-5D), Short-Form (SF12)) were collected for consecutive patients undergoing lumbar spine surgery. Objective functional impairment (OFI) was measured using the Timed Up and Go (TUG) test. Adjusted partial correlation was used to correlate age to each scale preoperatively, as well as to the postoperative improvement at six weeks. RESULTS: A total of n=377 patients (161 females, 42.7%) with a mean age of 58.5 years (SD 15.7, range 18.0-93.7) were included. Unadjusted TUG test raw times naturally increased with age, whereas the age-effect on standardized OFI T-scores was close to zero in patients with a lumbar disc herniation (LDH; r=-0.0666, p=0.367) or lumbar spinal stenosis (LSS; r=-0.0134, p=0.879). There was a weak correlation between age and higher ODI (LDH: r=0.1289, p=0.089; LSS: r=0.1975; p=0.027), lower EQ-5D (LSS: r=-0.1824, p=0.042) and higher RMDI by trend (LSS: r=0.1679, p=0.061). The correlation between age and postoperative improvement was negative on the VAS for back pain (LDH: r=-0.3189, p=0.026), VAS for leg pain (LDH: r=-0.3656, p=0.009) and RMDI by trend (LSS: r=-0.2004, p=0.069), as well as positive on the EQ-5D index (r=0.2412, p=0.011), indicating that younger patients showed better improvement. Due to in-group heterogeneity, no age-effect could be calculated for patients scheduled for surgical fusion. CONCLUSIONS: The influence of age on subjective and objective measures of pain, functional impairment and HRQoL is limited for patients with LDH and LSS, but suggests an age-dependent increase of functional disability. Younger patients generally showed greater postoperative improvement at six weeks than older patients."," Clin Neurol Neurosurg 150: 33-39.","Switzerland,Australia",2016,"Degenerative Disk Disease","Surgical","ODI,RMDQ","Elderly","PRO study","Prospective Observation","Switzerland,Australia","Elderly","Degenerative Disk Disease","Surgical","PRO study","Prospective Observation","ODI,RMDQ","2015:2018"]
[134,"Gautschi, O. P., et al. (2016). \"Sex differences in lumbar degenerative disc disease.\" Clin Neurol Neurosurg 145: 52-57.",null,"Gautschi, O. P., et al.","Sex differences in lumbar degenerative disc disease","OBJECTIVES: A growing number of studies focus on sex differences in the pre- and postoperative setting in patients with degenerative disc disease (DDD). The exact pathomechanism behind this phenomenon, however, remains unclear. The objective of this study was to investigate pre- and postoperative sex differences in patients with lumbar DDD. PATIENTS AND METHODS: In a prospective two-center study, back and leg pain (Visual Analogue Scale (VAS)), functional disability (Oswestry Disability Index (ODI) and Roland-Morris Disability Index) and health-related quality of life (HRQoL) (EuroQol 5D and Short-Form (SF12)) were collected for patients scheduled for lumbar spine surgery. In addition to the subjective functional impairment (SFI), objective functional impairment (OFI) was estimated using age- and sex-adjusted cut-off values for the timed-up-and-go (TUG) test. The 6-week responder status was defined using minimally clinically important differences of the ODI, SF12 PCS, VAS back and leg pain in all patients. Six months and one year follow-up (FU) was available in n=127 and n=87 patients, respectively. RESULTS: The patient cohort comprised of n=214 patients (41.6% females). Preoperatively, female patients scored significantly worse on VAS back and leg pain, ODI and SF12 PCS (p<0.033), while OFI was similar (p=0.334). At the 6 week FU, sex-related differences had resolved for SFI and OFI was similar as well (p=0.333). There were no sex differences in the mean improvement after 6 weeks for all measures of pain intensity, functional impairment and HRQoL (p>0.182). Male and female patients profited equally on measures of SFI and HRQoL up to six months and one year after surgery (p>0.091). CONCLUSION: Preoperatively, female patients scored worse in terms of SFI, while OFI was similar. Consecutively, OFI appears to be less prone to sex bias and may thus serve as a valuable surrogate-marker of disability. The disadvantageous preoperative SFI-status did not translate into worse postoperative results, as no sex differences were present at the 6-week, 6-months and 1-year follow-up."," Clin Neurol Neurosurg 145: 52-57.","Switzerland,Australia",2016,"Spine Disease","Surgical","ODI,RMDQ","Unknown","Tool Validation","Prospective Observation","Switzerland,Australia","Unknown","Spine Disease","Surgical","Tool Validation","Prospective Observation","ODI,RMDQ","2015:2018"]
[135,"Gautschi, O. P., et al. (2016). \"Sex differences in subjective and objective measures of pain, functional impairment, and health-related quality of life in patients with lumbar degenerative disc disease.\" Pain 157(5): 1065-1071.",null,"Gautschi, O. P., et al.","Sex differences in subjective and objective measures of pain, functional impairment, and health-related quality of life in patients with lumbar degenerative disc disease","Sex differences in pain perception are known to exist; however, the exact pathomechanism remains unclear. This work aims to elucidate sex differences in subjective and objective measures of pain, functional impairment, and health-related quality of life (HRQoL) in patients with lumbar degenerative disc disease. In a prospective 2-center study, back and leg pain (visual analogue scale [VAS]), functional disability (Oswestry Disability Index and Roland-Morris Disability Index), and HRQoL (EuroQol-5D and Short Form [SF12]) were collected for consecutive patients undergoing lumbar spine surgery. Objective functional impairment (OFI) was estimated using age-adjusted and sex-adjusted cutoff values for the timed-up-and-go (TUG) test. A healthy cohort of n = 110 subjects served as the control group. Univariate and multivariate analyses were performed to test the association between sex and pain, subjective and OFIs, and HRQoL. The study comprised n = 305 patients (41.6% females). Female patients had more VAS back pain (P = 0.002) and leg pain (P = 0.014). They were more likely to report higher functional impairment in terms of Oswestry Disability Index (P = 0.005). Similarly, HRQoL measured with the EuroQol-5D index (P = 0.012) and SF12 physical composite score (P = 0.005) was lower in female patients. Female patients reported higher VAS back and leg pain, functional impairment, and reduced HRQoL than male patients. However, there were no sex differences with respect to the presence and degree of OFI measured by the TUG test using age-adjusted and sex-adjusted cutoff values. As such, the TUG may be a good test to overcome sex bias for the clinical assessment of patients with degenerative disc disease."," Pain 157(5): 1065-1071.","Switzerland",2016,"Spine Disease","Surgical","ODI,RMDQ","Unknown","PRO study","Prospective Observation","Switzerland","Unknown","Spine Disease","Surgical","PRO study","Prospective Observation","ODI,RMDQ","2015:2018"]
[136,"Ghogawala, Z., et al. (2014). \"Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 2: assessment of functional outcome following lumbar fusion.\" J Neurosurg Spine 21(1999): 7-13.",null,"Ghogawala, Z., et al.","Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 2: assessment of functional outcome following lumbar fusion","Assessment of functional patient-reported outcome following lumbar spinal fusion continues to be essential for comparing the effectiveness of different treatments for patients presenting with degenerative disease of the lumbar spine. When assessing functional outcome in patients being treated with lumbar spinal fusion, a reliable, valid, and responsive outcomes instrument such as the Oswestry Disability Index should be used. The SF-36 and the SF-12 have emerged as dominant measures of general health-related quality of life. Research has established the minimum clinically important difference for major functional outcomes measures, and this should be considered when assessing clinical outcome. The results of recent studies suggest that a patient's pretreatment psychological state is a major independent variable that affects the ability to detect change in functional outcome."," J Neurosurg Spine 21(1999): 7-13.","USA",2014,"Spinal Fusion","Psychosocial","ODI","Unknown","PRO study","Narrative review","USA","Unknown","Spinal Fusion","Psychosocial","PRO study","Narrative review","ODI","2010:2014"]
[137,"Gilbert, F. J., et al. (2004). \"Low back pain: influence of early MR imaging or CT on treatment and outcome--multicenter randomized trial.\" Radiology 231(2): 343-351.",null,"Gilbert, F. J., et al.","Low back pain: influence of early MR imaging or CT on treatment and outcome--multicenter randomized trial","PURPOSE: To establish whether early use of magnetic resonance (MR) imaging or computed tomography (CT) influences treatment and outcome of patients with low back pain (LBP) and whether it is cost-effective. MATERIALS AND METHODS: In a multicenter randomized study, two imaging policies for LBP were compared in 782 participants with symptomatic lumbar spine disorders who were referred to orthopedists or neurosurgeons. Participants were randomly allocated to early (393 participants; mean age, 43.9 years; range, 16-82 years) or delayed selective (389 participants; mean age, 42.8 years; range, 14-82 years) imaging groups. Delayed selective imaging referred to imaging restricted to patients in whom a clear clinical need subsequently developed. Main outcome measures were Aberdeen Low Back Pain (ALBP) score, Short Form 36 (SF-36) score (for multidimensional health status), EuroQol (EQ-5D) score (for quality-adjusted life-year [QALY] estimates), and healthcare resource use at 8 and 24 months after randomization. Data were evaluated with analysis of covariance, ordinal logistic regression analysis, and chi(2) and Mann-Whitney tests. RESULTS: Both groups showed improvement in ALBP score, but this was greater in the early group (adjusted mean difference between groups, -3.05 points [95% CI: -5.16, -0.95; P =.005] and -3.62 points [95% CI: -5.92, -1.32; P =.002] at 8 and 24 months, respectively). Scores for SF-36 (bodily pain domain) and EQ-5D were also significantly better at 24 months. Clinical treatment was similar in both groups. Differences in total costs reflected cost of imaging. Imaging provided an adjusted mean additional QALY of 0.041 during 24 months at a mean incremental cost per QALY of $2,124. CONCLUSION: Early use of imaging does not appear to affect treatment overall. Decisions about the use of imaging depend on judgments concerning whether the small observed improvement in outcome justifies additional cost."," Radiology 231(2): 343-351.","UK",2004,"Back Pain","Not Specified","Aberdeen LBP","Adults","Cost-Effectiveness","RCT","UK","Adults","Back Pain","Not Specified","Cost-Effectiveness","RCT","Aberdeen LBP","2000:2004"]
[138,"Glassman, S. D., et al. (2007). \"The impact of perioperative complications on clinical outcome in adult deformity surgery.\" Spine (Phila Pa 1976) 32(24): 2764-2770.",null,"Glassman, S. D., et al.","The impact of perioperative complications on clinical outcome in adult deformity surgery","STUDY DESIGN: Retrospective case-control series. OBJECTIVE: The purpose of this study is to determine whether perioperative complications alter subsequent clinical outcome measures in adult spinal deformity surgery. SUMMARY OF BACKGROUND DATA: Increasingly, the benefit of surgical intervention is being evaluated based on patient reported outcomes and standardized health related quality of life (HRQOL) measures. As improvement or deterioration in HRQOL scores becomes a standard for clinical evaluation in adult spinal deformity, the correlation between HRQOL outcome scores and historic benchmarks, such as curve correction, sagittal balance, fusion healing, or the occurrence of a complication, must be clarified. METHODS: This study analyzes a prospective multicenter data base for adult spinal deformity. Patients with major, minor, and no complications were matched using a logistic regression technique producing 46 patients in each group. Standardized outcome measures at baseline and at 1 year postop were compared. RESULTS: Forty-seven major complications were reported in 46 patients. Sixty-two minor complications were noted in 46 patients. Comparison between the 3 complication groups revealed that 1-year postoperative outcome measures were not statistically different for the Scoliosis Research Society Outcomes Instrument, Medical Outcomes Short Form-36 (SF-12), Oswestry Disability Index, or Numerical Pain Scales. The only significant interaction was in the rate of change from preop to 1-year postop for the SF-12 general health subscale. For the group with major complications, SF-12 general health deteriorated by 2.1 points from preop to 1-year postop. During the same period, the group with minor complications experienced an improvement of 4.2 points and the group with no complications experienced an improvement of 1.5 points. CONCLUSION: This study suggests that risk for minor complications may be a less substantial obstacle than previously assumed for surgical treatment in adult spinal deformity. In contrast, major complications were reported in approximately 10% of cases and adversely affected outcome as evidenced by the deterioration in SF-12 general health scores at 1 year after surgery."," Spine (Phila Pa 1976) 32(24): 2764-2770.","USA",2007,"Spinal Deformity","Surgical","ODI,SRS-HRQOL","Unknown","PRO study","Prospective Observation","USA","Unknown","Spinal Deformity","Surgical","PRO study","Prospective Observation","ODI,SRS-HRQOL","2005:2009"]
[139,"Glassman, S. D., et al. (2009). \"Do 1-year outcomes predict 2-year outcomes for adult deformity surgery?\" Spine J 9(4): 317-322.",null,"Glassman, S. D., et al.","Do 1-year outcomes predict 2-year outcomes for adult deformity surgery?","BACKGROUND CONTEXT: Health-related quality-of-life (HRQOL) measures are being used more frequently in the evaluation of the adult deformity patient. This is due in part to the validation of the deformity-specific Scolios Research Society-22 (SRS-22). Hence, relationships between HRQOL outcomes and traditional measures of success such as deformity correction, fusion healing, and complications are being established. PURPOSE: To examine the pattern of HRQOL outcome responses after adult deformity surgery. STUDY DESIGN: Analysis of prospective multicenter cohort. PATIENT SAMPLE: Two hundred and eighty-three adult deformity patients with preoperative, 1-, and 2-year postoperative outcome measures. OUTCOME MEASURES: SRS-22, Short Form-12 (SF-12), Oswestry Disability Index (ODI), and back and leg pain numeric rating scale scores. METHODS: Preoperative versus postoperative health status measures were evaluated by matched-pairs sample t test statistics and post hoc analysis of variance (ANOVA) findings. RESULTS: SRS-22 improved from a mean 3.03 points at baseline to 3.21 points at 6 months, 3.71 points at 1 year, and 3.70 points at 2 years post-op. Mean ODI score was 37.0 points pre-op and improved to 27.0 points at 6 months, and 22.8 points at 1 and 2 years post-op. Mean SF-12 physical component score was 33.7 points at baseline, improving to 36.9 points at 6 months, 40.6 points at 1 year, and 40.5 points at 2 years post-op. Paired samples analysis comparing 6-month and 1-year post-op scores showed deterioration for numeric rating scale leg pain (p=0.05). There was a trend for improvement in SF-12 physical component score (p=0.06). Significant improvement between 6 months and 1 year post-op was noted for ODI (p=0.02) and SRS total score (p<0.0001). Comparison of 1- versus 2-year postoperative scores revealed no statistically significant differences for any of the HRQOL parameters. CONCLUSIONS: This study supports the application of HRQOL measures, including the deformity-specific SRS-22, as a valuable tool in the assessment of adult deformity patients. Change in outcome score stabilized after the 1-year postoperative interval, for most patients."," Spine J 9(4): 317-322.","USA",2009,"Spinal Deformity","Surgical","ODI,SRS-HRQOL","Unknown","PRO study","Prospective Observation","USA","Unknown","Spinal Deformity","Surgical","PRO study","Prospective Observation","ODI,SRS-HRQOL","2005:2009"]
[140,"Glassman, S. D., et al. (2010). \"The costs and benefits of nonoperative management for adult scoliosis.\" Spine (Phila Pa 1976) 35(5): 578-582.",null,"Glassman, S. D., et al.","The costs and benefits of nonoperative management for adult scoliosis","STUDY DESIGN: A prospective cohort of adult scoliosis patients treated nonoperatively had a minimum of 2-year follow-up during which time data were collected on the type and quantity of nonoperative treatment used. OBJECTIVE: To quantify the use, cost, and effectiveness of nonoperative treatment for adult scoliosis. SUMMARY OF BACKGROUND DATA: A 2007 systematic review of nonsurgical treatment in adult scoliosis revealed minimal data, and concluded that evidence for nonoperative care was lacking. METHODS: Duration of use and frequency of visits were collected for 8 specific treatment methods: medication, physical therapy, exercise, injections/blocks, chiropractic care, pain management, bracing, and bed rest. Costs for each intervention were determined using the Medicare Fee schedule. Outcome measures were the SRS-22, SF-12, and ODI. Analysis was performed for the entire group, and for subsets of high (ODI, >40), mid (ODI = 21-40) and low (ODI, <or=20) symptom patients. RESULTS: A total of 123 patients (111 females, 12 males) with a mean age of 53.3 (18-79) years were evaluated. In 55 scoliosis patients who received no treatment, the only significant change in HRQOL measures over the 2-year period was in SRS satisfaction subscore (0.3 points, P = 0.014). Among the 68 adult scoliosis patients who used nonoperative resources, there was no significant change in any of the HRQOL outcome parameters. Mean treatment cost over the 2-year period was $10,815. Mean cost over the 2-year period averaged $9704 in the low symptom patients, $11,116 in the mid symptom, and $14,022 in the high symptom patients. CONCLUSION: This study questions the value of nonoperative treatment commonly used for adult scoliosis patients. Documented costs are substantial and no improvement in health status was observed. An important caveat is that treatment was not randomized and therefore the treatment group might have deteriorated if not for the treatment they received."," Spine (Phila Pa 1976) 35(5): 578-582.","USA",2010,"Spinal Deformity","Surgical,Physical Therapy","SRS-HRQOL","Adults","Cost and Resource Use","Clinical trial","USA","Adults","Spinal Deformity","Surgical,Physical Therapy","Cost and Resource Use","Clinical trial","SRS-HRQOL","2010:2014"]
[141,"Glattes, R. C., et al. (2007). \"The reliability and concurrent validity of the Scoliosis Research Society-22r patient questionnaire compared with the Child Health Questionnaire-CF87 patient questionnaire for adolescent spinal deformity.\" Spine (Phila Pa 1976) 32(16): 1778-1784.",null,"Glattes, R. C., et al.","The reliability and concurrent validity of the Scoliosis Research Society-22r patient questionnaire compared with the Child Health Questionnaire-CF87 patient questionnaire for adolescent spinal deformity","STUDY DESIGN: This is a clinic-based cross-sectional study involving 2 health-related quality-of-life (HRQL) questionnaires. OBJECTIVES: To compare the score distribution and reliability of the spinal deformity specific Scoliosis Research Society-22r (SRS-22r) questionnaire and the established generic Child Health Questionnaire-CF87 (CHQ-CF87), and to assess the concurrent validity of the SRS-22r using the CHQ-CF87 in an adolescent spine deformity population. SUMMARY OF BACKGROUND DATA: Different questionnaires are commonly thought to be necessary to assess the HRQL of adolescent and adult populations. But since spinal deformities usually begin in the second decade of life, longitudinal follow-up with the same HRQL is desirable. The SRS-22r HRQL has recently been validated for score distribution and internal consistency in a spinal deformity population ranging in age from 7 to 78 years. METHODS: The SRS-22r and CHQ-CF87 HRQLs were completed by 70 orthopedic spinal deformity outpatients 8 to 18 years of age, of whom 54 returned mailed retest questionnaires at an average of 24 days later. RESULTS: The ceiling effect averaged 27% for the SRS-22r and 36% for the CHQ-CF87. Respective values for internal consistency (Cronbach alpha) were 0.81 and 0.82, and for test-retest reproducibility the intraclass correlations (ICC) were 0.73 and 0.61. Concurrent validity was r > or = 0.68 or more for relevant function, pain, and mental health domains. The SRS Self-Image and particularly the Satisfaction/Dissatisfaction with Management domains did not correlate well with any CHQ-CF87 domains (r = 0.50 and 0.30, respectively). CONCLUSION: In a spinal deformity population 8 to 18 years of age, the score distribution and reliability, internal consistency, and reproducibility of the SRS-22r were at least as good as the CHQ-CF87. The SRS-22r function, pain, and mental health domains were concurrently valid in comparison to relevant CHQ-CF87 domains, but the SRS-22r self-image and satisfaction/dissatisfaction domains were not, thereby providing health-related quality-of-life information not provided for by the CHQ-CF87."," Spine (Phila Pa 1976) 32(16): 1778-1784.","USA",2007,"Spinal Deformity","Not Specified","SRS-HRQOL","Adolescents","PRO study","Observational","USA","Adolescents","Spinal Deformity","Not Specified","PRO study","Observational","SRS-HRQOL","2005:2009"]
[142,"Gnanenthiran, S. R., et al. (2012). \"Nonoperative versus operative treatment for thoracolumbar burst fractures without neurologic deficit: a meta-analysis.\" Clin Orthop Relat Res 470(2): 567-577.",null,"Gnanenthiran, S. R., et al.","Nonoperative versus operative treatment for thoracolumbar burst fractures without neurologic deficit: a meta-analysis","BACKGROUND: Decision-making regarding nonoperative versus operative treatment of patients with thoracolumbar burst fractures in the absence of neurologic deficits is controversial. Lack of evidence-based practice may result in patients being treated inappropriately and being exposed to unnecessary adverse consequences. PURPOSE: Using meta-analysis, we therefore compared pain (VAS) and function (Roland Morris Disability Questionnaire) in patients with thoracolumbar burst fractures without neurologic deficit treated nonoperatively and operatively. Secondary outcomes included return to work, radiographic progression of kyphosis, radiographic progression of spinal canal stenosis, complications, cost, and length of hospitalization. METHODS: We searched MEDLINE, EMBASE((R)), and the Cochrane Central Register of Controlled Trials for 'thoracic fractures', 'lumbar fractures', 'non-operative', 'operative' and 'controlled clinical trials'. We established five criteria for inclusion. Data extraction and quality assessment were in accordance with Cochrane Collaboration guidelines. The main analyses were performed on individual patient data from randomized controlled trials. Sensitivity analyses were performed on VAS pain, Roland Morris Disability Questionnaire score, kyphosis, and return to work, including data from nonrandomized controlled trials and using fixed effects meta-analysis. We identified four trials, including two randomized controlled trials consisting of 79 patients (41 with operative treatment and 38 with nonoperative treatment). The mean followups ranged from 24 to 118 months. RESULTS: We found no between-group differences in baseline pain, kyphosis, and Roland Morris Disability Questionnaire scores. At last followup, there were no between-group differences in pain, Roland Morris Disability Questionnaire scores, and return to work rates. We found an improvement in kyphosis ranging from means of 12.8 masculine to 11 masculine in the operative group, but surgery was associated with higher complication rates and costs. CONCLUSIONS: Operative management of thoracolumbar burst fractures without neurologic deficit may improve residual kyphosis, but does not appear to improve pain or function at an average of 4 years after injury and is associated with higher complication rates and costs. LEVEL OF EVIDENCE: Level II, therapeutic study. See the Guidelines for Authors for a complete description of level of evidence."," Clin Orthop Relat Res 470(2): 567-577.","Australia",2012,"Trauma","Surgical","RMDQ","Adults","Cost and Resource Use","Systematic review","Australia","Adults","Trauma","Surgical","Cost and Resource Use","Systematic review","RMDQ","2010:2014"]
[143,"Godfrey, E., et al. (2016). \"Physiotherapy informed by Acceptance and Commitment Therapy (PACT): protocol for a randomised controlled trial of PACT versus usual physiotherapy care for adults with chronic low back pain.\" BMJ Open 6(6): e011548.",null,"Godfrey, E., et al.","Physiotherapy informed by Acceptance and Commitment Therapy (PACT): protocol for a randomised controlled trial of PACT versus usual physiotherapy care for adults with chronic low back pain","INTRODUCTION: Chronic low back pain (CLBP) is a common condition and source of significant suffering, disability and healthcare costs. Current physiotherapy treatment is moderately effective. Combining theory-based psychological methods with physiotherapy could improve outcomes for people with CLBP. The primary aim of this randomised controlled trial (RCT) is to evaluate the efficacy of Physiotherapy informed by Acceptance and Commitment Therapy (PACT) on functioning in patients with CLBP. METHODS AND ANALYSIS: The PACT trial is a two-armed, parallel-group, multicentre RCT to assess the efficacy of PACT in comparison with usual physiotherapy care (UC). 240 patients referred to physiotherapy with CLBP will be recruited from three National Health Service (NHS) hospitals trusts. Inclusion criteria are: age >/=18 years, CLBP >/=12-week duration, scoring >/=3 points on the Roland-Morris Disability Questionnaire (RMDQ) and adequate understanding of spoken and written English to participate. Patients will be randomised to PACT or UC (120 per arm stratified by centre) by an independent randomisation service and followed up at 3 and 12 months post randomisation. The sample size of 240 will provide adequate power to detect a standardised mean difference of 0.40 in the primary outcome (RMDQ; 5% significance, 80% power) assuming attrition of 20%. Analysis will be by intention to treat conducted by the trial statistician, blind to treatment group, following a prespecified analysis plan. Estimates of treatment effect at the follow-up assessments will use an intention-to-treat framework, implemented using a linear mixed-effects model. ETHICS AND DISSEMINATION: This trial has full ethical approval (14/SC/0277). It will be disseminated via peer-reviewed publications and conference presentations. The results will enable clinicians, patients and health service managers to make informed decisions regarding the efficacy of PACT for patients with CLBP. TRIAL REGISTRATION NUMBER: ISRCTN95392287; Pre-results."," BMJ Open 6(6): e011548.","UK",2016,"Back Pain","Physical Therapy","RMDQ","Adults","PRO study","Clinical trial","UK","Adults","Back Pain","Physical Therapy","PRO study","Clinical trial","RMDQ","2015:2018"]
[144,"Godil, S. S., et al. (2013). \"Accurately measuring outcomes after surgery for adult Chiari I malformation: determining the most valid and responsive instruments.\" Neurosurgery 72(5): 820-827; discussion 827.",null,"Godil, S. S., et al.","Accurately measuring outcomes after surgery for adult Chiari I malformation: determining the most valid and responsive instruments","BACKGROUND: There has been a transition to using patient-reported outcome instruments (PROi) to assess surgical effectiveness. However, none of these instruments have been validated for outcomes of adult Chiari I malformation (CMI). OBJECTIVE: The aim of this study was to determine the relative validity and responsiveness of various PROi in measuring outcomes after surgery for CMI. METHODS: Fifty patients undergoing suboccipital craniotomy for adult CMI were prospectively followed for 1 year. Baseline and 1-year patient-reported outcomes (visual analog scale for head pain and visual analog scale for neck pain, Neck Disability Index [NDI], Headache Disability Index, SF-12, Zung Self-Rating Depression Scale, and EuroQol-5D [EQ-5D]) were assessed. A level of improvement in general health after surgery was defined as meaningful improvement. Receiver-operating characteristic curves were generated to assess the validity of PROi to discriminate between meaningful improvement and not. The difference between standardized response means (SRMs) in patients reporting meaningful improvement vs not as calculated to determine the relative responsiveness of each outcome instrument. RESULTS: For pain and disability, the NDI was the most accurate discriminator of meaningful effectiveness (area under the curve: 0.90) and also most responsive to postoperative improvement (standardized response means difference: 1.87). For general health and quality of life, the SF-12 PCS, EQ-5D, and Zung Self-Rating Depression Scale were all accurate discriminators; however, SF-12 Physical Component Scale (SF-12 PCS) and EQ-5D were most accurate. SF-12 PCS was also most responsive. CONCLUSION: For pain and disability, NDI is the most valid and responsive measure of improvement after surgery for CMI. For health-related quality of life, SF-12 PCS and EQ-5D are the most valid and responsive measures. NDI with SF-12 or EQ-5D is the most valid in patients with CMI and should be considered in cost-effectiveness studies."," Neurosurgery 72(5): 820-827; discussion 827.","USA",2013,"Neck Pain","Surgical","NDI","Unknown","Cost and Resource Use","Prospective Observation","USA","Unknown","Neck Pain","Surgical","Cost and Resource Use","Prospective Observation","NDI","2010:2014"]
[145,"Gordon, A., et al. (2010). \"Buprenorphine transdermal system for opioid therapy in patients with chronic low back pain.\" Pain Res Manag 15(3): 169-178.",null,"Gordon, A., et al.","Buprenorphine transdermal system for opioid therapy in patients with chronic low back pain","OBJECTIVE: The present randomized, double-blinded, crossover study compared the efficacy and safety of a seven-day buprenorphine transdermal system (BTDS) and placebo in patients with low back pain of moderate or greater severity for at least six weeks. METHODS: Prestudy analgesics were discontinued the evening before random assignment to 5 microg/h BTDS or placebo, with acetaminophen 300 mg/codeine 30 mg, one to two tablets every 4 h to 6 h as needed, for rescue analgesia. The dose was titrated to effect weekly, if tolerated, to 10 microg/h and 20 microg/h BTDS. Each treatment phase was four weeks. RESULTS: Fifty-three patients (28 men, 25 women, mean [+/- SD] age 54.5+/-12.7 years) were evaluable for efficacy (completed two weeks or more in each phase). Baseline pain was 62.1+/-15.5 mm (100 mm visual analogue scale) and 2.5+/-0.6 (five-point ordinal scale). BTDS resulted in lower mean daily pain scores than in the placebo group (37.6+/-20.7 mm versus 43.6+/-21.2 mm on a visual analogue scale, P=0.0487; and 1.7+/-0.6 versus 2.0+/-0.7 on the ordinal scale, P=0.0358). Most patients titrated to the highest dose of BTDS (59% 20 microg/h, 31% 10 microg/h and 10% 5 microg/h). There were improvements from baseline in pain and disability (Pain Disability Index), Pain and Sleep (visual analogue scale), Quebec Back Pain Disability Scale and Short-Form 36 Health Survey scores for both BTDS and placebo groups, without significant differences between treatments. While there were more opioid-related side effects with BTDS treatment than with placebo, there were no serious adverse events. A total of 82% of patients chose to continue BTDS in a long-term open-label evaluation, in whom improvements in pain intensity, functionality and quality of life were sustained for up to six months without analgesic tolerance. CONCLUSION: BTDS (5 microg/h to 20 microg/h) represents a new treatment option for initial opioid therapy in patients with chronic low back pain."," Pain Res Manag 15(3): 169-178.","Canada",2010,"Back Pain","Opioid","QBPD","Adults","PRO study","Clinical trial","Canada","Adults","Back Pain","Opioid","PRO study","Clinical trial","QBPD","2010:2014"]
[146,"Gornet, M. F., et al. (2016). \"The Effect of Workers' Compensation Status on Outcomes of Cervical Disc Arthroplasty: A Prospective, Comparative, Observational Study.\" J Bone Joint Surg Am 98(2): 93-99.",null,"Gornet, M. F., et al.","The Effect of Workers' Compensation Status on Outcomes of Cervical Disc Arthroplasty: A Prospective, Comparative, Observational Study","BACKGROUND: Receiving Workers' Compensation benefits has been associated with inferior outcomes after lumbar fusion. The purpose of our study was to compare the outcomes of cervical disc arthroplasty between patients receiving and those not receiving Workers' Compensation. METHODS: Patient-reported outcomes, reoperations, complications, and return-to-work status were analyzed at one year after surgery in an observational cohort of consecutive patients who underwent single-level or multilevel cervical disc arthroplasty for symptomatic cervical disc conditions, including radiculopathy or discogenic pain with or without radiculopathy, exclusive of myelopathy. RESULTS: Of the 189 patients who underwent cervical disc arthroplasty, 144 received Workers' Compensation and forty-five did not. The mean scores on all patient-reported measures improved significantly from preoperative baseline to one year after surgery (p < 0.001), and the improvement in patient-reported outcomes did not differ significantly between the Workers' Compensation and the non-Workers' Compensation group (respectively, 22.7 compared with 25.0 for the Neck Disability Index; 8.3 compared with 9.6 for the Short Form (SF)-36 physical component summary; 7.9 compared with 9.6 for the SF-36 mental component summary; 3.5 compared with 3.7 for neck pain; and 2.6 compared with 2.8 for arm pain). The two groups also did not differ significantly in the rate of reoperations (7.6% for those receiving Workers' Compensation compared with 13.3% for those not receiving Workers' Compensation) and complications (2.8% compared with 4.4%, respectively). At one year after surgery, the proportion of patients who had returned to work was comparable (77.7% in the Workers' Compensation group and 79.4% in the non-Workers' Compensation group); however, the patients receiving Workers' Compensation had significantly more days off before returning to work (a mean of 145.2 compared with 61.9 days; p = 0.001). CONCLUSIONS: After cervical disc arthroplasty, patients receiving Workers' Compensation had outcomes that were similar to those of patients not receiving Workers' Compensation in terms of patient-reported outcomes, surgery-related complications, reoperations, and return-to-work status. Patients receiving Workers' Compensation remained off work for a longer interval than did patients not receiving Workers' Compensation. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence."," J Bone Joint Surg Am 98(2): 93-99.","USA",2016,"Neck Pain","Surgical","NDI","Unknown","PRO study","Prospective Observation","USA","Unknown","Neck Pain","Surgical","PRO study","Prospective Observation","NDI","2015:2018"]
[147,"Gorton, G. E., 3rd, et al. (2012). \"Accuracy, reliability, and validity of a 3-dimensional scanner for assessing torso shape in idiopathic scoliosis.\" Spine (Phila Pa 1976) 37(11): 957-965.",null,"Gorton, G. E., 3rd, et al.","Accuracy, reliability, and validity of a 3-dimensional scanner for assessing torso shape in idiopathic scoliosis","STUDY DESIGN: Prospective cohort with concurrent controls. OBJECTIVE: To establish accuracy, reliability, and validity of the Vitronic 3D Body Scanner for the evaluation of torso asymmetry in patients with idiopathic scoliosis. SUMMARY OF BACKGROUND DATA: Improved appearance is an important expectation of treatment for patients with scoliosis and their parents. Despite being the \"gold standard\" for quantifying outcomes, Cobb angles do not explain perception of appearance or quality of life. Surface topography is an attractive noninvasive alternative to radiography but has not been studied in the context of patient-centered outcomes. METHODS: Thirty-six adolescents with idiopathic scoliosis undergoing surgical correction had pre- and postoperative radiographs and evaluation of standing posture, torso surface shape, and responses to the Scoliosis Research Society-22 and Spinal Appearance Questionnaire. Twenty-one adolescents without scoliosis were evaluated for comparison. Scanner accuracy was assessed by scanning an object of known dimensions. Within-session reliability of body shape measures constructed from scan data was assessed. Discriminant validity was assessed by examining pre- to postoperative differences. Concurrent validity was examined through correlations of scan measures with radiographs, optoelectronic measures of posture, and self-report responses to the Scoliosis Research Society-22 and Spinal Appearance Questionnaire. RESULTS: Scan system measurement error was 1.74 +/- 1.56 mm. Within-session reliability was excellent for the control (intraclass correlation coefficient = 0.83) and scoliosis (intraclass correlation coefficient = 0.94) groups. Medial/lateral torso shift, rotation, and right/left asymmetry differed significantly among the preoperative, postoperative, and control groups (analysis of variance, P < 0.05). Torso asymmetry measures correlated with radiographical measures (r = 0.43-0.51), optoelectronical measures of posture and symmetry (r = 0.33-0.75), and appearance and quality-of-life domains of the Scoliosis Research Society-22 (r = 0.35-0.64) and the Spinal Appearance Questionnaire (r = 0.48-0.67). CONCLUSION: The Vitronic 3D Body Scanner has sufficient accuracy, reliability, and validity to monitor torso asymmetry due to scoliosis. Scan-based measures differentiate between normal and pathological and between preoperative and postoperative body shape and show good correlation with measures of appearance and quality of life."," Spine (Phila Pa 1976) 37(11): 957-965.","USA",2012,"Spinal Deformity","Surgical","SRS-HRQOL,SAQ","Adolescents","PRO study","Prospective Observation","USA","Adolescents","Spinal Deformity","Surgical","PRO study","Prospective Observation","SRS-HRQOL,SAQ","2010:2014"]
[148,"Gorzkowicz, B. and M. Kolban (2012). \"The influence of the degree of spine curvature on the quality of life assessment among patients treated surgically with the Cotrel-Dubousset method.\" Stud Health Technol Inform 176: 423-427.",null,"Gorzkowicz, B. and M. Kolban","The influence of the degree of spine curvature on the quality of life assessment among patients treated surgically with the Cotrel-Dubousset method","Physical appearance and psychomotor ability rank high in the hierarchy of values accepted by children and teenagers. Therefore Idiopathic Scoliosis (IS), which is accompanied by the dysfunction of locomotive organ and often requires troublesome treatment, may lead to poor body image and frustration. Other common effects are a low self-esteem, identity problems and depressive symptoms. METHOD: Prospective examination was done in two independent groups of IS patients treated in one of Szczecin's clinic. The first group of 35 patients was examined twice: after being selected for surgery and 12 months after surgery. The second group of 52 patients was examined after a minimum of two years from operation. Research tools consisted of: personal data questionnaire, the assessment form of the clinical state and the Scoliosis Research Society (SRS)-22. The results were statistically analyzed using STATISTICA 5 software. Pearson's linear correlation coefficients and Spearman's rank correlation coefficients were calculated to determine the relationship between the pairs of variables. RESULTS/FINDINGS: Preoperatively, the Cobb angle of thoracic curves was found to significantly correlate only with the Physical Activity (rs = -0.41, p<0.02) and Self-Image (rs = - 0.51, p<0.002). Postoperatively, a positive correlation with statistical significance was observed only with correction values in thoracic section with total scores of the SRS-22 (p<0.03) in the 24-month period. CONCLUSIONS: 1. Clinical assessment appears insufficient to decide how advanced the disease is and what the treatment results are. 2. The degree of spinal curvature, especially in the postoperative period, have little effect on quality of patients' lives. 3. Studies with the use of the SRS-22 HRQL instrument suggest that other non-clinical factors may affect the quality of life assessment."," Stud Health Technol Inform 176: 423-427.","Poland",2012,"Spinal Deformity","Surgical","SRS-HRQOL","Infants","PRO study","Prospective Observation","Poland","Infants","Spinal Deformity","Surgical","PRO study","Prospective Observation","SRS-HRQOL","2010:2014"]
[149,"Green, A., et al. (2016). \"Physiotherapeutic Rehabilitation Following Lumbar Total Disc Replacement: A Retrospective Study.\" Physiother Res Int 21(3): 155-163.",null,"Green, A., et al.","Physiotherapeutic Rehabilitation Following Lumbar Total Disc Replacement: A Retrospective Study","BACKGROUND AND PURPOSE: This study sought to answer the following questions: What are the outcomes of physiotherapy post lumbar total disc replacement (LTDR) compared with patient self-mediated rehabilitation? Is a difference in outcomes related to the number of physiotherapy sessions? METHODS: This is a retrospective observational study of 600 patients post TDR. Patient outcomes for self-mediated rehabilitation (Group 1), 1-3 sessions of clinic-based physiotherapy (Group 2) and >/=4 sessions of clinic-based physiotherapy (Group 3) were analysed. Outcomes measures included the Oswestry Disability Index (ODI), Roland Morris Disability Questionnaire (RMQ), Short Form-36 Physical (SF-36 PCS) and Mental Subscale Components (SF-36 MCS), Visual Analogue Scale (VAS) for back and leg pain intensity. Patient's pre-operative baseline measures and post-operative follow-up measures at 3, 6, 12 and 24 months post-operatively were analysed. RESULTS: Oswestry Disability Index and RMQ had significantly lower scores in Group 3 compared with Group 1 at 3, 6, 12 and 24 months follow-up. Significantly lower scores for Group 2 compared with Group 1 were observed for the ODI at 3 months follow-up and for the RMQ at 3 and 6 months follow-up. Significantly lower scores were observed in Group 3 compared with Group 1 for VAS back pain at 3 months and VAS leg pain at 6 months follow-up. Significantly higher scores in Group 3 compared with Group 1 were also observed in the SF-36 PCS at 6, 12 and 24 months. Significantly higher scores in Group 2 compared with Group 1 were observed at 6 months follow up. These trends were also observed when investigating the percentage of patients with a greater 50% improvement in the outcome measure. CONCLUSIONS: Physiotherapy post-LTDR produces statistically significant and possibly clinically important improvements in functional disability, pain and quality of life outcomes compared with self-mediated rehabilitation. Copyright (c) 2015 John Wiley & Sons, Ltd."," Physiother Res Int 21(3): 155-163.","Australia,Sweden",2016,"Degenerative Disk Disease","Physical Therapy","ODI,RMDQ","Unknown","PRO study","Retrospective review","Australia,Sweden","Unknown","Degenerative Disk Disease","Physical Therapy","PRO study","Retrospective review","ODI,RMDQ","2015:2018"]
[150,"Groeneweg, R., et al. (2010). \"The effectiveness and cost-evaluation of manual therapy and physical therapy in patients with sub-acute and chronic non specific neck pain. Rationale and design of a Randomized Controlled Trial (RCT).\" BMC Musculoskelet Disord 11: 14.",null,"Groeneweg, R., et al.","The effectiveness and cost-evaluation of manual therapy and physical therapy in patients with sub-acute and chronic non specific neck pain. Rationale and design of a Randomized Controlled Trial (RCT)","BACKGROUND: Manual Therapy applied to patients with non specific neck pain has been investigated several times. In the Netherlands, manual therapy as applied according to the Utrecht School of Manual Therapy (MTU) has not been the subject of a randomized controlled trial. MTU differs in diagnoses and treatment from other forms of manual therapy. METHODS/DESIGN: This is a single blind randomized controlled trial in patients with sub-acute and chronic non specific neck pain. Patients with neck complaints existing for two weeks (minimum) till one year (maximum) will participate in the trial. 180 participants will be recruited in thirteen primary health care centres in the Netherlands.The experimental group will be treated with MTU during a six week period. The control group will be treated with physical therapy (standard care, mainly active exercise therapy), also for a period of six weeks.Primary outcomes are Global Perceived Effect (GPE) and functional status (Neck Disability Index (NDI-DV)). Secondary outcomes are neck pain (Numeric Rating Scale (NRS)), Eurocol, costs and quality of life (SF36). DISCUSSION: This paper presents details on the rationale of MTU, design, methods and operational aspects of the trial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00713843."," BMC Musculoskelet Disord 11: 14.","Netherlands",2010,"Neck Pain","Exercise","NDI","Unknown","Cost and Resource Use","RCT","Netherlands","Unknown","Neck Pain","Exercise","Cost and Resource Use","RCT","NDI","2010:2014"]
[151,"Groessl, E. J., et al. (2016). \"Yoga for veterans with chronic low back pain: Design and methods of a randomized clinical trial.\" Contemp Clin Trials 48: 110-118.",null,"Groessl, E. J., et al.","Yoga for veterans with chronic low back pain: Design and methods of a randomized clinical trial","Chronic low back pain (CLBP) afflicts millions of people worldwide, with particularly high prevalence in military veterans. Many treatment options exist for CLBP, but most have limited effectiveness and some have significant side effects. In general populations with CLBP, yoga has been shown to improve health outcomes with few side effects. However, yoga has not been adequately studied in military veteran populations. In the current paper we will describe the design and methods of a randomized clinical trial aimed at examining whether yoga can effectively reduce disability and pain in US military veterans with CLBP. A total of 144 US military veterans with CLBP will be randomized to either yoga or a delayed treatment comparison group. The yoga intervention will consist of 2x weekly yoga classes for 12weeks, complemented by regular home practice guided by a manual. The delayed treatment group will receive the same intervention after six months. The primary outcome is the change in back pain-related disability measured with the Roland-Morris Disability Questionnaire at baseline and 12-weeks. Secondary outcomes include pain intensity, pain interference, depression, anxiety, fatigue/energy, quality of life, self-efficacy, sleep quality, and medication usage. Additional process and/or mediational factors will be measured to examine dose response and effect mechanisms. Assessments will be conducted at baseline, 6-weeks, 12-weeks, and 6-months. All randomized participants will be included in intention-to-treat analyses. Study results will provide much needed evidence on the feasibility and effectiveness of yoga as a therapeutic modality for the treatment of CLBP in US military veterans."," Contemp Clin Trials 48: 110-118.","USA",2016,"Back Pain","Yoga","RMDQ","Unknown","PRO study","Clinical trial","USA","Unknown","Back Pain","Yoga","PRO study","Clinical trial","RMDQ","2015:2018"]
[152,"Gudavalli, M. R., et al. (2015). \"Development of an attention-touch control for manual cervical distraction: a pilot randomized clinical trial for patients with neck pain.\" Trials 16: 259.",null,"Gudavalli, M. R., et al.","Development of an attention-touch control for manual cervical distraction: a pilot randomized clinical trial for patients with neck pain","BACKGROUND: Manual cervical distraction (MCD) is a traction-based therapy performed with a manual contact over the cervical region producing repeating cycles while patients lie prone. This study evaluated a traction force-based minimal intervention for use as an attention-touch control in clinical trials of MCD for patients with chronic neck pain. METHODS: We conducted a mixed-methods, pilot randomized clinical trial in adults with chronic neck pain. Participants were allocated to three traction force ranges of MCD: low force/minimal intervention (0-20 N), medium force (21-50 N), or high force (51-100 N). Clinicians delivered five treatments over two weeks consisting of three sets of five cycles of MCD at the C5 vertebra and occiput. Traction forces were measured at each treatment. Patient-reported outcomes included a pain visual analogue scale (VAS), Neck Disability Index (NDI), Credibility and Expectancy Questionnaire (CEQ), and adverse effects. A qualitative interview evaluated treatment group allocation perceptions. RESULTS: We randomized 48 participants, allocating an average of five each month. Forty-five participants completed the trial with three participants lost to follow-up. Most participants were women (65%) and white (92%) with a mean (SD) age of 46.8 (12.5) years. Mean traction force values were within the prescribed force ranges for each group at the C5 and occiput levels. Neck pain VAS demonstrated a benefit for high traction force MCD compared to the low force group [adjusted mean difference 15.6; 95% confidence interval (CI) 1.6 to 29.7]. Participants in the medium traction force group demonstrated improvements in NDI compared to the low force group (adjusted mean difference 3.0; 95% CI 0.1 to 5.9), as did participants in the high traction force group (adjusted mean difference 2.7; 95% CI -0.1 to 5.6). CEQ favored the high force group. Most low force participants correctly identified their treatment allocation in the qualitative interview. No serious adverse events were documented. CONCLUSIONS: This pilot study demonstrated the feasibility of a clinical trial protocol and the utility of a traction-based, minimal intervention as an attention-touch control for future efficacy trials of MCD for patients with neck pain. TRIAL REGISTRATION: ClinicalTrials.gov NCT01765751 (Registration Date 30 May 2012)."," Trials 16: 259.","USA",2015,"Neck Pain","Manipulations","NDI","Adults","PRO study","RCT","USA","Adults","Neck Pain","Manipulations","PRO study","RCT","NDI","2015:2018"]
[153,"Gugliotta, M., et al. (2016). \"Surgical versus conservative treatment for lumbar disc herniation: a prospective cohort study.\" BMJ Open 6(12): e012938.",null,"Gugliotta, M., et al.","Surgical versus conservative treatment for lumbar disc herniation: a prospective cohort study","OBJECTIVES: Evidence comparing the effectiveness of surgical and conservative treatment of symptomatic lumbar disc herniation is controversial. We sought to compare short-term and long-term effectiveness of surgical and conservative treatment in sciatica symptom severity and quality of life in patients with lumbar disc herniation in a routine clinical setting. METHODS: A prospective cohort study of a routine clinical practice registry consisting of 370 patients. Outcome measures were the North American Spine Society questionnaire and the 36-Item Short-Form Health Survey to assess patient-reported back pain, physical function, neurogenic symptoms and quality of life. Primary outcomes were back pain at 6 and 12 weeks. Standard open discectomy was assessed versus conservative interventions at 6, 12, 52 and 104 weeks. We filled in missing outcome variable values with multiple imputation, accounted for repeated measures within patients with mixed-effects models and adjusted baseline group differences in relevant prognostic indicators by inverse probability of treatment weighting. RESULTS: Surgical treatment patients reported less back pain at 6 weeks than those receiving conservative therapy (-0.97; 95% CI -1.89 to -0.09), were more likely to report >/=50% decrease in back pain symptoms from baseline to 6 weeks (48% vs 17%, risk difference: 0.34; 95% CI 0.16 to 0.47) and reported less physical function disability at 52 weeks (-3.7; 95% CI -7.4 to -0.1). The other assessments showed minimal between-group differences with CIs, including the null effect. CONCLUSIONS: Compared with conservative therapy, surgical treatment provided faster relief from back pain symptoms in patients with lumbar disc herniation, but did not show a benefit over conservative treatment in midterm and long-term follow-up."," BMJ Open 6(12): e012938.","Switzerland,Canada,UK",2016,"Degenerative Disk Disease","Surgical","NASS-L","Unknown","PRO study","Prospective Observation","Switzerland,Canada,UK","Unknown","Degenerative Disk Disease","Surgical","PRO study","Prospective Observation","NASS-L","2015:2018"]
[154,"Gurden, M., et al. (2012). \"Evaluation of a general practitioner referral service for manual treatment of back and neck pain.\" Prim Health Care Res Dev 13(3): 204-210.",null,"Gurden, M., et al.","Evaluation of a general practitioner referral service for manual treatment of back and neck pain","AIM: To describe and evaluate a community-based musculoskeletal service, commissioned by National Health Services North East Essex Primary Care Trust (PCT), in terms of patient-reported outcomes and satisfaction. BACKGROUND: Persistent musculoskeletal conditions, including back and neck pain, are costly in terms of primary and secondary healthcare resources. Most patients are assessed and managed by general practitioners (GPs), with referral when necessary to secondary care services. METHOD: Patients consulting for at least four weeks for back or neck pain were referred by their GP according to patient preference to either a chiropractor or osteopath or physiotherapist working in the independent sector. Patients completed questionnaires at baseline and at discharge from the service. RESULTS: Questionnaire data were obtained from 696 patients, 97% of whom were seen within two weeks. About half (51%) had had their pain for less than three months, and of the remainder 49% for more than 12 months. Patients received on average six treatments. Using the Bournemouth Questionnaire, the Bothersomeness scale and the Global Improvement Scale, approximately two-thirds (64.6%, 67.8% and 69.9%, respectively) reported improvement at discharge, and approximately 65% a significant reduction in medication. Almost all (99.5%) patients were satisfied with the service. Similarly, almost all (97%) patients were discharged from the service with advice on self-management; the remainder were recommended for secondary care referral. CONCLUSION: This service improved patient access and choice resulting in shorter waiting times and effective outcomes. An impact analysis of the first 12 months of the service by the PCT showed a reduction in primary care consultations and in inappropriate referrals to secondary care."," Prim Health Care Res Dev 13(3): 204-210.","UK",2012,"Back Pain,Neck Pain","Not Specified","Bournemouth,Bothersomeness","Unknown","PRO study","Prospective Observation","UK","Unknown","Back Pain,Neck Pain","Not Specified","PRO study","Prospective Observation","BOURNEMOUTH,Bothersomeness","2010:2014"]
[155,"Guzman, J. Z., et al. (2016). \"Patient-Reported Outcome Instruments in Spine Surgery.\" Spine (Phila Pa 1976) 41(5): 429-437.",null,"Guzman, J. Z., et al.","Patient-Reported Outcome Instruments in Spine Surgery","STUDY DESIGN: A critical review of the current literature. OBJECTIVE: The purpose of this study was to determine frequency, trends, and methods of utilization of spine-related PROIs over the last 10 years. SUMMARY OF BACKGROUND DATA: Patient-reported outcome instruments (PROIs) have become the gold standard to assess the efficacy of various medical and surgical treatments. Currently, however, there is an expansive range of PROIs without a clear consensus or guideline addressing which PROIs should be used for a particular diagnosis or surgical intervention. METHODS: A PubMed search was conducted from 2004 to 2013 of 5 orthopedic journals (The Journal of Bone and Joint Surgery, The Bone and Joint Journal, The Spine Journal, The European Spine Journal, and Spine) that publish spine articles, chosen on the basis of readership and impact factor. Journal abstracts were inspected for spine surgery and inclusion of at least 1 PROI. All articles containing PROIs and investigating a surgical intervention with a level of evidence (LOE) 1 to 4 were included for analysis. Article title, LOE, journal, and chosen PROI were recorded for selected articles. RESULTS: Out of 19,736 articles published in our selected time frame, 1,079 utilized PROIs. Most studies were LOE 4 (32.7%). Nearly half (48.9%) of all articles addressed degenerative thoracolumbar conditions. In total, there were 206 unique PROIs in the studies chosen for inclusion. The top 6 instruments utilized were the (1999) visual analog scale, (2) Oswestry disability index, (3) Short Form-36, (4) Japanese Orthopaedic Association Outcome Questionnaire, (5) Neck Disability Index, and (6) Scoliosis Research Society-22. CONCLUSION: The breadth of PROIs in spine surgery is extensive. Although there are preferred patient-reported outcome measures, a consensus or guideline addressing which instruments should be used for a particular diagnosis or procedure may be warranted. LEVEL OF EVIDENCE: 4."," Spine (Phila Pa 1976) 41(5): 429-437.","USA",2016,"Spinal Deformity","Surgical","ODI,JOACMEQ,NDI,SRS-HRQOL","Unknown","PRO study","Systematic review","USA","Unknown","Spinal Deformity","Surgical","PRO study","Systematic review","ODI,JOACMEQ,NDI,SRS-HRQOL","2015:2018"]
[156,"Haher, T. R., et al. (1999). \"Results of the Scoliosis Research Society instrument for evaluation of surgical outcome in adolescent idiopathic scoliosis. A multicenter study of 244 patients.\" Spine (Phila Pa 1976) 24(14): 1435-1440.",null,"Haher, T. R., et al.","Results of the Scoliosis Research Society instrument for evaluation of surgical outcome in adolescent idiopathic scoliosis. A multicenter study of 244 patients","STUDY DESIGN: An outcome questionnaire was constructed to evaluate patient satisfaction and performance and to discriminate among patients with adolescent idiopathic scoliosis. OBJECTIVES: To determine reliability and validity in a new quality-of-life instrument for measuring progress among scoliosis patients. SUMMARY OF BACKGROUND DATA: Meta-analysis of the surgical treatment of adolescent idiopathic scoliosis determined that a uniform assessment of outcome did not exist. In addition, patient measures of well-being as opposed to process measures (e.g., radiographs) were not consistently reported. This established the need for a standardized questionnaire to assess patient measures in conjunction with process measures. METHODS: The instrument consists of 24 questions divided into seven equally weighted domains as determined by factor analysis: pain, general self-image, postoperative self-image, general function, overall level of activity, postoperative function, and satisfaction. The questionnaire takes approximately 5 minutes to complete and is taken at predetermined time intervals. A total of 244 of patients from three different sites responded to the questionnaire. RESULTS: The reliability based on internal consistency was confirmed with a Cronbach's alpha coefficient greater than 0.6 for each domain. In addition, acceptable correlation coefficient values greater than 0.68 were obtained for each domain by the test-retest method on normal controls. Similarly; to establish validity of the questionnaire, responses of normal high school students were compared with that of the patients. Consistent differences were noted in the domains between the two groups with P < 0.003. The largest differences were in pain (control, 29.96 +/- 0.20; patient, 13.23 +/- 5.55) and general level of activity (control, 14.96 +/- 0.20; patient, 12.16 +/- 3.23). Examination of the relationship between the domains and patient satisfaction showed that pain correlates with satisfaction to the greatest degree (Pearson's correlation co-efficient, r = -0.511; P < 0.001), followed by self-image (r = 0.412; P < 0.001). CONCLUSIONS: This questionnaire addresses patient measures for evaluation of outcome in adolescent idiopathic scoliosis surgery by examining several domains. It also allows for dynamic monitoring of scoliosis patients as they become adults. This is a validated instrument with good reliability measures."," Spine (Phila Pa 1976) 24(14): 1435-1440.","USA",1999,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Systematic review","USA","Adolescents","Spinal Deformity","Surgical","PRO study","Systematic review","SRS-HRQOL","1995:1999"]
[157,"Hahne, A. J., et al. (2011). \"Specific treatment of problems of the spine (STOPS): design of a randomised controlled trial comparing specific physiotherapy versus advice for people with subacute low back disorders.\" BMC Musculoskelet Disord 12: 104.",null,"Hahne, A. J., et al.","Specific treatment of problems of the spine (STOPS): design of a randomised controlled trial comparing specific physiotherapy versus advice for people with subacute low back disorders","BACKGROUND: Low back disorders are a common and costly cause of pain and activity limitation in adults. Few treatment options have demonstrated clinically meaningful benefits apart from advice which is recommended in all international guidelines. Clinical heterogeneity of participants in clinical trials is hypothesised as reducing the likelihood of demonstrating treatment effects, and sampling of more homogenous subgroups is recommended. We propose five subgroups that allow the delivery of specific physiotherapy treatment targeting the pathoanatomical, neurophysiological and psychosocial components of low back disorders. The aim of this article is to describe the methodology of a randomised controlled trial comparing specific physiotherapy treatment to advice for people classified into five subacute low back disorder subgroups. METHODS/DESIGN: A multi-centre parallel group randomised controlled trial is proposed. A minimum of 250 participants with subacute (6 weeks to 6 months) low back pain and/or referred leg pain will be classified into one of five subgroups and then randomly allocated to receive either physiotherapy advice (2 sessions over 10 weeks) or specific physiotherapy treatment (10 sessions over 10 weeks) tailored according to the subgroup of the participant. Outcomes will be assessed at 5 weeks, 10 weeks, 6 months and 12 months following randomisation. Primary outcomes will be activity limitation measured with a modified Oswestry Disability Index as well as leg and back pain intensity measured on separate 0-10 Numerical Rating Scales. Secondary outcomes will include a 7-point global rating of change scale, satisfaction with physiotherapy treatment, satisfaction with treatment results, the Sciatica Frequency and Bothersomeness Scale, quality of life (EuroQol-5D), interference with work, and psychosocial risk factors (Orebro Musculoskeletal Pain Questionnaire). Adverse events and co-interventions will also be measured. Data will be analysed according to intention to treat principles, using linear mixed models for continuous outcomes, Mann Whitney U tests for ordinal outcomes, and Chi-square, risk ratios and risk differences for dichotomous outcomes. DISCUSSION: This trial will determine the difference in outcomes between specific physiotherapy treatment tailored to each of the five subgroups versus advice which is recommended in guidelines as a suitable treatment for most people with a low back disorder. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000834257."," BMC Musculoskelet Disord 12: 104.","Australia",2011,"Back Pain","Physical Therapy","ODI,Bothersomeness","Unknown","PRO study","Clinical trial","Australia","Unknown","Back Pain","Physical Therapy","PRO study","Clinical trial","ODI,Bothersomeness","2010:2014"]
[158,"Hallett, A., et al. (2007). \"Foraminal stenosis and single-level degenerative disc disease: a randomized controlled trial comparing decompression with decompression and instrumented fusion.\" Spine (Phila Pa 1976) 32(13): 1375-1380.",null,"Hallett, A., et al.","Foraminal stenosis and single-level degenerative disc disease: a randomized controlled trial comparing decompression with decompression and instrumented fusion","STUDY DESIGN: A randomized controlled trial with 5-year outcome data. OBJECTIVE: To compare clinical outcomes following spinal decompression (Group 1) with those following decompression and instrumented posterolateral fusion (Group 2) and decompression and instrumented posterolateral fusion plus transforaminal interbody fusion (TLIF) (Group 3). SUMMARY OF BACKGROUND DATA: Decompression is frequently advocated for the relief of nerve root stenosis in the presence of degenerate disc disease. It is uncertain if spinal fusion is also necessary. MATERIALS AND METHODS: Following completion of a standardized physiotherapy program, 44 patients with single-level disc disease were randomly assigned to 1 of 3 surgical groups. In those patients undergoing instrumentation, segmental pedicle screw fixation was used to stabilize the spine. Titanium interbody cages filled with autologous bone were inserted into patients in Group 3. Spinal disability, quality of life, and pain were assessed before surgery, and then at 1, 2, and 5 years by an independent researcher. RESULTS: At 2 years, 82% of the patients were pain free or moderately improved. Disability (Low Back Outcome Score and Roland Morris index) were both better in Group 1, but only Low Back Outcome Score was better in Group 2 (P < 0.05). By 5 years, although patients in all 3 groups showed some improvements in all the ratings used (Low Back Outcome Score, SF-36 Physical Functioning, and Roland Morris score), only Group 1 patients showed significant changes in all 3 outcomes (P < 0.05). There was no difference in any score between groups (P > 0.05). Two had secondary surgery for adjacent level stenosis (Group 2 and 3). One patient (Group 1) underwent subsequent lateral mass fusion for chronic pain. No patient required revision surgery for instrumentation failure, cage displacement, or pseudarthrosis. Evidence of at least unilateral lateral mass bone graft incorporation was evident in 95% of Groups 2 and 3. CONCLUSIONS: The results are encouraging in that almost all patients had improved by 5 years. However, it is a concern that no significant additional benefit has been noted from the more complex surgery. This suggests that patients are optimally treated by decompression alone, with the proviso that further operations may be required."," Spine (Phila Pa 1976) 32(13): 1375-1380.","UK",2007,"Back Pain,Spinal Fusion","Surgical","RMDQ,LBOS","Adults","PRO study","Clinical trial","UK","Adults","Back Pain,Spinal Fusion","Surgical","PRO study","Clinical trial","RMDQ,LBOS","2005:2009"]
[159,"Hansen, I. R., et al. (2011). \"Neck exercises, physical and cognitive behavioural-graded activity as a treatment for adult whiplash patients with chronic neck pain: design of a randomised controlled trial.\" BMC Musculoskelet Disord 12: 274.",null,"Hansen, I. R., et al.","Neck exercises, physical and cognitive behavioural-graded activity as a treatment for adult whiplash patients with chronic neck pain: design of a randomised controlled trial","BACKGROUND: Many patients suffer from chronic neck pain following a whiplash injury. A combination of cognitive, behavioural therapy with physiotherapy interventions has been indicated to be effective in the management of patients with chronic whiplash-associated disorders. The objective is to present the design of a randomised controlled trial (RCT) aimed at evaluating the effectiveness of a combined individual physical and cognitive behavioural-graded activity program on self-reported general physical function, in addition to neck function, pain, disability and quality of life in patients with chronic neck pain following whiplash injury compared with a matched control group measured at baseline and 4 and 12 months after baseline. METHODS/DESIGN: The design is a two-centre, RCT-study with a parallel group design. Included are whiplash patients with chronic neck pain for more than 6 months, recruited from physiotherapy clinics and an out-patient hospital department in Denmark. Patients will be randomised to either a pain management (control) group or a combined pain management and training (intervention)group. The control group will receive four educational sessions on pain management, whereas the intervention group will receive the same educational sessions on pain management plus 8 individual training sessions for 4 months, including guidance in specific neck exercises and an aerobic training programme. Patients and physiotherapists are aware of the allocation and the treatment, while outcome assessors and data analysts are blinded. The primary outcome measures will be Medical Outcomes Study Short Form 36 (SF36), Physical Component Summary (PCS). Secondary outcomes will be Global Perceived Effect (-5 to +5), Neck Disability Index (0-50), Patient Specific Functioning Scale (0-10), numeric rating scale for pain bothersomeness (0-10), SF-36 Mental Component Summary (MCS), TAMPA scale of Kinesiophobia (17-68), Impact of Event Scale (0-45), EuroQol (0-1), craniocervical flexion test (22 mmHg - 30 mmHg), joint position error test and cervical range of movement. The SF36 scales are scored using norm-based methods with PCS and MCS having a mean score of 50 with a standard deviation of 10. DISCUSSION: The perspectives of this study are discussed, in addition to the strengths and weaknesses. TRIAL REGISTRATION: The study is registered in http://www.ClinicalTrials.gov identifier NCT01431261."," BMC Musculoskelet Disord 12: 274.","Denmark",2011,"Trauma,Neck Pain","Exercise","NDI,Bothersomeness","Unknown","PRO study","RCT","Denmark","Unknown","Trauma,Neck Pain","Exercise","PRO study","RCT","NDI,Bothersomeness","2010:2014"]
[160,"Harms, M. C., et al. (2010). \"Low back pain: what determines functional outcome at six months? An observational study.\" BMC Musculoskelet Disord 11: 236.",null,"Harms, M. C., et al.","Low back pain: what determines functional outcome at six months? An observational study","BACKGROUND: The rise in disability due to back pain has been exponential with escalating medical and societal costs. The relative contribution of individual prognostic indicators to the pattern of recovery remains unclear. The objective of this study was to determine the prognostic value of demographic, psychosocial, employment and clinical factors on outcome in patients with low back pain METHODS: A prospective cohort study with six-month follow-up was undertaken at a multidisciplinary back pain clinic in central London employing physiotherapists, osteopaths, clinical psychologists and physicians, receiving referrals from 123 general practitioners. Over a twelve-month period, 593 consecutive patients referred from general practice with simple low back pain were recruited. A baseline questionnaire was developed to elicit information on potential prognostic variables. The primary outcome measures were change in 24-item Roland Morris disability questionnaire score at six months as a measure of low back related functional disability and the physical functioning scale of the SF-36, adjusted for baseline scores. RESULTS: Roland Morris scores improved by 3.8 index points (95% confidence interval 3.23 to 4.32) at six months and SF-36 physical functioning score by 10.7 points (95% confidence interval 8.36 to 12.95). Ten factors were linked to outcome yet in a multiple regression model only two remained predictive. Those with episodic rather than continuous pain were more likely to have recovered at six months (odds ratio 2.64 confidence interval 1.25 to 5.60), while those that classified themselves as non-white were less likely to have recovered (0.41 confidence interval 0.18 to 0.96). CONCLUSIONS: Analysis controlling for confounding variables, demonstrated that participants showed greater improvement if their episodes of pain during the previous year were short-lived while those with Middle Eastern, North African and Chinese ethnicity demonstrated minimal improvement. The study did not support previous findings that a wide range of factors could predict outcome."," BMC Musculoskelet Disord 11: 236.","UK",2010,"Back Pain","Psychosocial","RMDQ","Unknown","Cost and Resource Use","Prospective Observation","UK","Unknown","Back Pain","Psychosocial","Cost and Resource Use","Prospective Observation","RMDQ","2010:2014"]
[161,"Hart, R. A., et al. (2013). \"Lumbar Stiffness Disability Index: pilot testing of consistency, reliability, and validity.\" Spine J 13(2): 157-161.",null,"Hart, R. A., et al.","Lumbar Stiffness Disability Index: pilot testing of consistency, reliability, and validity","BACKGROUND CONTEXT: The primary goal of surgical arthrodesis is to eliminate the motion of spinal segments in an effort to alleviate pain, improve deformity, and reduce disability. However, decreased spinal mobility may impair performance of activities of daily living (ADLs) due to the resulting stiffness or the lack of mobility of the fused segment. Current clinical outcome instruments do not seek information regarding the impact of spinal stiffness on functional ability. Therefore, a patient-reported outcome questionnaire measuring the impact of lumbar stiffness on functional abilities was devised and assessed for internal consistency, retest repeatability, and external validity. PURPOSE: To develop and validate an outcome instrument to measure the collateral effect of stiffness after lumbar fusion on functional ability. STUDY DESIGN: Cross-sectional pilot study. PATIENT SAMPLE: Consecutive cohort of lumbar spine fusion patients from a single surgeon's practice. OUTCOME MEASURES: Lumbar Stiffness Disability Index (LSDI) and Cobb angle measurements from digital radiographs. METHODS: We developed and evaluated a 10-item questionnaire, referred to as the LSDI, which seeks information on the impact of spinal stiffness on ADLs after lumbar spinal arthrodesis. The questionnaire yields a score from 0 to 100, with higher scores indicating greater difficulty resulting from lumbar spinal stiffness in performing 10 different ADLs. The study sample comprised 32 lumbar arthrodesis patients at a minimum of 1 year postoperatively. All patients completed the questionnaire twice via telephone interviews conducted 4 weeks apart. Internal consistency was assessed using the Cronbach alpha, and retest reliability was measured using an intraclass correlation coefficient (ICC). External validity of the questionnaire was evaluated by correlating the scores with lumbar range of motion (LROM) as measured from the angular change between the inferior end plate of T12 and the superior end plate of S1 on standardized digital flexion and extension lateral radiographs. RESULTS: The study sample included 22 women (69%) and 10 men (31%) with an average age of 63 years. The questionnaire demonstrated high internal consistency (Cronbach alpha=0.89). Retest reliability was also high (ICC=0.87). External validity was demonstrated by a statistically significant inverse relationship between LROM and LSDI scores (r=-0.71; p<.001). CONCLUSIONS: This pilot study demonstrates that the LSDI questionnaire is a reliable and valid instrument for assessing functional limitations due to lumbar stiffness among spinal arthrodesis patients. The questionnaire is proposed for use in prospective evaluation of lumbar stiffness impacts after arthrodesis."," Spine J 13(2): 157-161.","USA",2013,"Spine Disease","Surgical","LSDI","Adults","Tool Validation","Observational","USA","Adults","Spine Disease","Surgical","Tool Validation","Observational","LSDI","2010:2014"]
[162,"Hasegawa, T. M., et al. (2014). \"Acupuncture for acute non-specific low back pain: a randomised, controlled, double-blind, placebo trial.\" Acupunct Med 32(2): 109-115.",null,"Hasegawa, T. M., et al.","Acupuncture for acute non-specific low back pain: a randomised, controlled, double-blind, placebo trial","OBJECTIVE: To assess the efficacy of Yamamoto's acupuncture method on pain, drug intake, functional capacity and quality of life for the treatment of acute non-specific low back pain (ANLBP). METHODS: A prospective, randomised, parallel-group, double-blind, placebo-controlled trial was performed in 80 men and women with ANLBP who were randomly assigned to five acupuncture sessions (intervention group (IG), n=40) and to five non-penetrating acupuncture sessions (sham group (SG), n=40). Patients were evaluated at baseline and at 3, 7, 14, 21 and 28 days. The measurements used were: visual analogue scale (VAS) for cumulative pain (before intervention, VAS1) and immediate pain (after intervention, VAS2); function (Roland-Morris Disability Questionnaire (RM)); quality of life (SF-36); improvement rating; and number of anti-inflammatory tablets taken. The primary endpoint was a decrease of at least 2 cm in VAS1. RESULTS: Pain VAS improved significantly in the IG from day 14 onwards compared with the SG, but the difference did not reach the prespecified clinically relevant value of 2 cm. The IG was significantly superior to the SG in the following outcomes: cumulative pain, function, pain (SF-36) and vitality (SF-36) at days 14, 21 and 28 (p<0.05); limitation in physical aspects (SF-36) at all times (p=0.007 and p=0.02); and functional capacity (SF-36) at days 21 and 28 (p<0.05). The IG also took significantly fewer anti-inflammatory tablets than the SG (p=0.004) at all evaluation times and the improvement rating was better than the SG (p<0.001). CONCLUSIONS: Yamamoto's new scalp acupuncture was more effective than sham treatment with regard to decrease in pain and anti-inflammatory intake as well as improving functional status and quality of life for patients with ANLBP. CLINICALTRIALSGOV: NCT 01124955."," Acupunct Med 32(2): 109-115.","Brazil",2014,"Back Pain","Acupuncture","RMDQ","Unknown","PRO study","RCT","Brazil","Unknown","Back Pain","Acupuncture","PRO study","RCT","RMDQ","2010:2014"]
[163,"Hashash, J. G., et al. (2008). \"Clinical trial: a randomized controlled cross-over study of flupenthixol + melitracen in functional dyspepsia.\" Aliment Pharmacol Ther 27(11): 1148-1155.",null,"Hashash, J. G., et al.","Clinical trial: a randomized controlled cross-over study of flupenthixol + melitracen in functional dyspepsia","BACKGROUND: Functional dyspepsia is a prevalent condition associated with diminished quality of life (QoL) and high economic burden. AIM: To study the efficacy of a combination of flupenthixol and melitracen (F + M) with anxiolytic and antidepressant properties in functional dyspepsia using a randomized controlled cross-over design. METHODS: Patients met the Rome III criteria for functional dyspepsia and a validated questionnaire was used to exclude those with anxiety or depression. Moreover, patients had to have failed a trial of acid-suppressive therapy and Helicobacter pylori eradication when positive. End points included subjective global symptom relief and QoL assessed by the Nepean Dyspepsia Index (NDI). RESULTS: Twenty-five patients (14 females, 11 males; mean age = 34.3 +/- 9.9 years) were enrolled and 24 completed the 8-week study. There was a significant improvement in subjective global symptom relief with F + M vs. placebo (ITT: 73.9% vs. 26.1%, P = 0.001) and a significant drop in the NDI score vs. placebo (ITT: -9.0 +/- 11.9 vs. -2.4 +/- 8.9, P = 0.03). No difference was noted whether the initial treatment was F + M or placebo. No significant side effects were noted. CONCLUSIONS: A combination of F and M is safe and effective in the short-term treatment of functional dyspepsia. F + M is associated with significant improvement in QoL independent of the presence of anxiety or depression."," Aliment Pharmacol Ther 27(11): 1148-1155.","Lebanon",2008,"Functional Dyspepsia","Not Specified","NDI","Adults","PRO study","RCT","Lebanon","Adults","Functional Dyspepsia","Not Specified","PRO study","RCT","NDI","2005:2009"]
[164,"Hayakawa, M., et al. (2015). \"Outcome in VLBW infants with surgical intestinal disorder at 18 months of corrected age.\" Pediatr Int 57(4): 633-638.",null,"Hayakawa, M., et al.","Outcome in VLBW infants with surgical intestinal disorder at 18 months of corrected age","BACKGROUND: Surgical intestinal disorders, such as necrotizing enterocolitis (NEC), focal intestinal perforation (FIP), and meconium-related ileus (MRI), are serious morbidities in very low-birthweight infants (VLBWI). The aim of this study was to compare the composite outcomes of death or neurodevelopmental impairment (NDI) in VLBWI with surgical intestinal disorders and assess independent risk factors for death and NDI at 18 months of corrected age. METHODS: A retrospective matched-cohort study was conducted at 11 institutes. We included VLBWI who had undergone laparotomy for NEC, FIP, and MRI. Two control subjects were chosen for every surgical patient and matched for gestational age and birthweight to form the comparison group. Death and neurodevelopmental outcome at 18 months of corrected age were evaluated. RESULTS: The number of infants in the NEC, FIP, MRI, and control groups was 44, 47, 42, and 261, respectively. In-hospital mortality was higher in infants with NEC and MRI relative to those in the control group (P < 0.001). The incidence rate for NDI at 18 months of corrected age was higher in infants with MRI relative to those in the control group (P = 0.021). On logistic regression analysis, low gestational age, male sex, small for gestational age, intraventricular hemorrhage, and MRI were associated with increased risk of death or NDI at 18 months of corrected age. CONCLUSIONS: NEC and MRI were associated with in-hospital mortality, and MRI was associated with NDI or death at 18 months of corrected age."," Pediatr Int 57(4): 633-638.","Japan",2015,"Low Birth Weight","Surgical","NDI","Infants","PRO study","Retrospective review","Japan","Infants","Low Birth Weight","Surgical","PRO study","Retrospective review","NDI","2015:2018"]
[165,"Helenius, I., et al. (2008). \"Long-term health-related quality of life after surgery for adolescent idiopathic scoliosis and spondylolisthesis.\" J Bone Joint Surg Am 90(6): 1231-1239.",null,"Helenius, I., et al.","Long-term health-related quality of life after surgery for adolescent idiopathic scoliosis and spondylolisthesis","BACKGROUND: The aim of surgical treatment for adolescent idiopathic scoliosis is primarily to prevent progression and secondarily to correct the deformity, whereas the goal of surgical treatment of pediatric spondylolisthesis is mainly to relieve pain and, in patients with a high-grade slip, to prevent progression. The aim of this study was to compare the long-term health-related quality of life after surgery for idiopathic scoliosis and spondylolisthesis in adolescence. METHODS: One hundred and ninety patients, with a mean age of fifteen years, who were treated surgically for adolescent idiopathic scoliosis and 270 patients, with a mean age of sixteen years, who were treated surgically for low-grade or high-grade spondylolisthesis participated in the present study. The mean duration of follow-up was 14.8 years for the scoliosis group and 17.0 years for the spondylolisthesis group. Radiographs were made preoperatively, at the time of the two-year follow-up, and at the time of the final follow-up. Additionally, a physical examination was performed, and the Scoliosis Research Society-24 and Short Form-36 questionnaires were completed at the final follow-up evaluation. RESULTS: The median total score on the Scoliosis Research Society questionnaire was 102 (range, 63 to 118) for the scoliosis group and 95 (range, 42 to 115) for the spondylolisthesis group (p < 0.001). After adjusting for age at the time of surgery, gender, and duration of follow-up, the patients with scoliosis had a significantly higher odds ratio for a good total score (> or = 90 points) on the Scoliosis Research Society questionnaire than did patients with spondylolisthesis (odds ratio, 2.65 [95% confidence interval, 1.58 to 4.44]; p = 0.0002). Patients in the scoliosis group had better values for general self-image, postoperative self-image, and postoperative function than did patients in the spondylolisthesis group (p < 0.001). Sixteen patients in both groups reported that they had back pain often or very often at rest. The standardized physical component scale on the Short Form-36 yielded slightly but significantly better values for the scoliosis group (median, 53.8 points; range, 32 to 61 points) compared with the spondylolisthesis group (median, 53.4 points; range, 27 to 59 points) (p = 0.01). CONCLUSIONS: Patients have good long-term health-related quality of life after surgery for idiopathic scoliosis and spondylolisthesis in adolescence. Patients who have surgery for idiopathic scoliosis are likely to have better long-term outcomes than are patients who have surgery for spondylolisthesis. It is possible that back pain in adolescence may affect quality of life more than spinal deformity does."," J Bone Joint Surg Am 90(6): 1231-1239.","Finland",2008,"Spinal Deformity,Spondylosis","Surgical","SRS-HRQOL","Adolescents","PRO study","Clinical trial","Finland","Adolescents","Spinal Deformity,Spondylosis","Surgical","PRO study","Clinical trial","SRS-HRQOL","2005:2009"]
[166,"Hidalgo Ovejero, A. M., et al. (2015). \"Cross-cultural adaptation of the Zurich Claudication Questionnaire.Validation study of the Spanish version.\" An Sist Sanit Navar 38(1999): 41-52.",null,"Hidalgo Ovejero, A. M., et al.","Cross-cultural adaptation of the Zurich Claudication Questionnaire.Validation study of the Spanish version","BACKGROUND: In the last few years, instruments that measure outcomes and quality of life as perceived by the patient have become tools of great clinical value. The Zurich Claudication Questionnaire is one of the main instruments for the assessment of patients suffering from lumbar spinal stenosis. Nonetheless, no valid version has been published for use in the Spanish population. METHODS: The Zurich Claudication Questionnaire was translated and cross-culturally adapted to Spanish and the psychometric characteristics of the new version were then studied. Seventy-six patients were selected who were to undergo epidural steroid injection or were seen in the Hospital Complex of Navarre Spinal Unit. RESULTS: The Spanish version of the Zurich Claudication Questionnaire shows high Cronbach alpha internal consistency values, high reproducibility, a good correlation with the most important low back condition questionnaires used worldwide and good sensitivity for detecting clinical change in patients who undergo epidural steroid injection. CONCLUSION: This study resulted in a version of the Zurich Claudication Questionnaire or Swiss Spinal Stenosis Questionnaire translated and cross-culturally adapted to Spanish, with highly reliable, valid and sensitive psychometric characteristics. These proven properties make the Zurich Claudication Questionnaire available for the Spanish population, to evaluate outcomes and health status as perceived by patients with spinal stenosis and claudication syndrome."," An Sist Sanit Navar 38(1999): 41-52.","Spain",2015,"Unspecified","Not Specified","SSSQ","Unknown","Tool Validation","Observational","Spain","Unknown","Unspecified","Not Specified","Tool Validation","Observational","SSSQ","2015:2018"]
[167,"Highsmith, J. M., et al. (2011). \"Treatment of cervical stenotic myelopathy: a cost and outcome comparison of laminoplasty versus laminectomy and lateral mass fusion.\" J Neurosurg Spine 14(5): 619-625.",null,"Highsmith, J. M., et al.","Treatment of cervical stenotic myelopathy: a cost and outcome comparison of laminoplasty versus laminectomy and lateral mass fusion","OBJECT: Cervical stenotic myelopathy due to spondylosis or ossification of the posterior longitudinal ligament is often treated with laminoplasty or cervical laminectomy (with fusion). The goal of this study was to compare outcomes, radiographic results, complications, and implant costs associated with these 2 treatments. METHODS: The authors analyzed the records of 56 patients (age range 42-81 years) who were surgically treated for cervical stenosis. Of this group, 30 underwent laminoplasty and 26 underwent laminectomy with fusion. Patients who had cervical kyphosis or spondylolisthesis were excluded. An average of 4 levels were instrumented in the laminoplasty group and 5 levels in the fusion group (p < 0.01). Forty-two percent of the fusions crossed the cervicothoracic junction, but no laminoplasty instrumentation crossed the cervicothoracic junction, and it only reached C-7 in one-third of the cases. Preoperative and postoperative Nurick grades and modified Japanese Orthopaedic Association (mJOA) scores were obtained. Outcomes were also assessed with neck pain visual analog scale (VAS) scores and the Odom outcome criteria. Postoperative length of stay, complications, and implant costs were calculated. RESULTS: The mean duration of follow-up, average patient age, and length of hospital stay were similar for both groups. The mean Nurick scores were also similar in the 2 groups and improved an average of 1.4 points in both (p < 0.01 for preoperative-postoperative comparison in each group). The mean mJOA scores improved 2.7 points in laminoplasty patients and 2.8 points in fusion patients (p < 0.01 for each group). The mean VAS scores for neck pain did not change significantly in the laminoplasty cohort (3.2 +/- 2.8 [SD] preoperatively vs 3.4 +/- 2.6 postoperatively, p = 0.50). In the fusion cohort, the mean VAS scores improved from 5.8 +/- 3.2 to 3.0 +/- 2.3 (p < 0.01). Excellent or good Odom outcomes were observed in 76.7% of the patients in the laminoplasty cohort and 80.8% of those in the fusion cohort (p = 0.71). In the fusion group, complications were twice as common and implant costs were nearly 3 times as high as in the laminoplasty group. When cases involving fusions crossing the cervicothoracic junction were excluded, analysis showed similar complication rates in the 2 groups. CONCLUSIONS: Patients treated with laminoplasty and patients treated with laminectomy and fusion had similar improvements in Nurick scores, mJOA scores, and Odom outcomes. Patients who underwent fusion typically had higher preoperative neck pain scores, but their neck pain improved significantly after surgery. There was no significant change in the neck pain scores of patients treated with laminoplasty. Our series suggests cervical fusion significantly reduces neck pain in patients with stenotic myelopathy, but that the cost of the implant and rate of reoperation are greater than in laminoplasty."," J Neurosurg Spine 14(5): 619-625.","USA",2011,"Neck Pain,Spondylosis","Surgical","Odom,Nurick","Adults","Cost and Resource Use","Observational","USA","Adults","Neck Pain,Spondylosis","Surgical","Cost and Resource Use","Observational","Odom,Nurick","2010:2014"]
[168,"Hill, J. C., et al. (2011). \"Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial.\" Lancet 378(9802): 1560-1571.",null,"Hill, J. C., et al.","Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial","BACKGROUND: Back pain remains a challenge for primary care internationally. One model that has not been tested is stratification of the management according to the patient's prognosis (low, medium, or high risk). We compared the clinical effectiveness and cost-effectiveness of stratified primary care (intervention) with non-stratified current best practice (control). METHODS: 1573 adults (aged >/=18 years) with back pain (with or without radiculopathy) consultations at ten general practices in England responded to invitations to attend an assessment clinic. Eligible participants were randomly assigned by use of computer-generated stratified blocks with a 2:1 ratio to intervention or control group. Primary outcome was the effect of treatment on the Roland Morris Disability Questionnaire (RMDQ) score at 12 months. In the economic evaluation, we focused on estimating incremental quality-adjusted life years (QALYs) and health-care costs related to back pain. Analysis was by intention to treat. This study is registered, number ISRCTN37113406. FINDINGS: 851 patients were assigned to the intervention (n=568) and control groups (n=283). Overall, adjusted mean changes in RMDQ scores were significantly higher in the intervention group than in the control group at 4 months (4.7 [SD 5.9] vs 3.0 [5.9], between-group difference 1.81 [95% CI 1.06-2.57]) and at 12 months (4.3 [6.4] vs 3.3 [6.2], 1.06 [0.25-1.86]), equating to effect sizes of 0.32 (0.19-0.45) and 0.19 (0.04-0.33), respectively. At 12 months, stratified care was associated with a mean increase in generic health benefit (0.039 additional QALYs) and cost savings ( pound240.01 vs pound274.40) compared with the control group. INTERPRETATION: The results show that a stratified approach, by use of prognostic screening with matched pathways, will have important implications for the future management of back pain in primary care. FUNDING: Arthritis Research UK."," Lancet 378(9802): 1560-1571.","UK",2011,"Radiculopathy","Not Specified","RMDQ","Adults","PRO study","Clinical trial","UK","Adults","Radiculopathy","Not Specified","PRO study","Clinical trial","RMDQ","2010:2014"]
[169,"Ho, L. F., et al. (2017). \"Efficacy of abdominal acupuncture for neck pain: A randomized controlled trial.\" PLoS One 12(7): e0181360.",null,"Ho, L. F., et al.","Efficacy of abdominal acupuncture for neck pain: A randomized controlled trial","OBJECTIVE: This study aims to provide evidence regarding the clinical efficacy of abdominal acupuncture for neck pain. METHODS: This randomized, patient and assessor-blind, sham-controlled trial was conducted at a Chinese medicine center in Hong Kong between November 2014 and March 2016. A total of 154 eligible participants (age range, 18-65 years) with neck pain were randomly assigned to receive abdominal (n = 77) or non-penetrating sham abdominal (sham group; n = 77) acupuncture. Each participant was administered treatment over six sessions by Registered Chinese Medicine Practitioners, in accordance with a standardized protocol. The primary outcome was mean improvement in neck pain disability scores evaluated by the Northwick Park Neck Pain Questionnaire (NPQ). Secondary outcomes included intensity of neck pain and health-related quality-of-life measures. The outcomes were assessed at baseline and at 2 and 6 weeks from baseline. Patients in the abdominal acupuncture group received additional follow-up evaluation at 14 weeks from baseline. Outcomes were evaluated by intention-to-treat analysis. RESULTS: All participants provided informed consent for treatment and follow-up evaluation. Patients who received abdominal acupuncture exhibited greater improvement in NPQ scores than those who received sham treatment at both 2 and 6 weeks from baseline (intergroup mean differences, -5.75; 95% confidence interval [CI], -9.48 to -2.03; P = 0.008 and -8.65; 95% CI, -12.13 to -5.16; P < 0.001, respectively). The improvement in NPQ scores in the abdominal acupuncture group was even more significant at 14 weeks from baseline. Patients in the abdominal acupuncture group also exhibited significantly greater improvements in intensity of neck pain and a few quality-of-life measures than those in the sham abdominal acupuncture group, without any serious adverse events. CONCLUSION: These findings suggest that abdominal acupuncture is an effective alternative treatment for neck pain. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR-TRC-14004932."," PLoS One 12(7): e0181360.","China",2017,"Neck Pain","Acupuncture","Northwick","Adults","PRO study","Clinical trial","China","Adults","Neck Pain","Acupuncture","PRO study","Clinical trial","Northwick","2015:2018"]
[170,"Hoekstra, C. J., et al. (2014). \"Criterion validity, reliability and clinical responsiveness of the CareConnections Functional Index.\" Physiother Theory Pract 30(6): 429-437.",null,"Hoekstra, C. J., et al.","Criterion validity, reliability and clinical responsiveness of the CareConnections Functional Index","This study established the criterion validity, test-retest reliability and responsiveness of the CareConnections Functional Index (CCFI). The CCFI is composed of four body-region specific subscales, measuring functional ability. Reference standards included the Neck Disability Index; Modified Oswestry Disability Index; Quick Disabilities of the Arm, Shoulder and Hand and the Lower Extremity Functional Scale. One hundred subjects per body region were enrolled. Subject's rated their perceived improvement based on the 15-point Global Rating of Change questionnaire. Minimal clinically important differences (MCID) were calculated via receiver operator characteristic curve. Test-retest reliability coefficients were good to excellent. Validity correlations with the reference standard measures were acceptable (r > 0.7) for all subscales. MCID for the cervical subscale = 7 points, lumbar = 8 points, upper extremity = 16 points and lower extremity = 11 points. The results of this study support the use of the CCFI in outpatient physical therapy practice as a responsive tool with good reliability and validity. The results also indicate that future work should focus on the impact of baseline patient factors that may affect future outcome."," Physiother Theory Pract 30(6): 429-437.","USA",2014,"Unspecified","Physical Therapy","ODI,NDI","Unknown","PRO study","Clinical trial","USA","Unknown","Unspecified","Physical Therapy","PRO study","Clinical trial","ODI,NDI","2010:2014"]
[171,"Horng, Y. S., et al. (2005). \"Predicting health-related quality of life in patients with low back pain.\" Spine (Phila Pa 1976) 30(5): 551-555.",null,"Horng, Y. S., et al.","Predicting health-related quality of life in patients with low back pain","STUDY DESIGN: Cross-sectional surveys of health-related quality of life (HRQOL) in patients with low back pain at ambulatory clinics plus 8 weeks of follow-up. OBJECTIVE: The objective of this study is to predict the HRQOL in patients with low back pain. SUMMARY OF BACKGROUND DATA: There is disagreement on the relative contribution of pain, physical impairment, functional status, and psychological factors on the disability and HRQOL in patients with low back pain. METHODS: Data were collected from 232 patients with low back pain who were consecutively recruited from several clinics of physical medicine and rehabilitation. Every patient received physical examination and completed a set of questionnaire, including the Taiwan version of the Brief Questionnaire of the World Health Organization on quality of life (WHOQOL-BREF), Modified Roland and Morris Disability Questionnaire, and visual analogue scale for pain intensity and for HRQOL. These patients were observed with a mail questionnaire 8 weeks later. The results of WHOQOL-BREF were also compared to those obtained from another 213 healthy volunteers who were accompanied persons with patients, volunteer workers in hospitals, and hospital employees. RESULTS: Results showed that there were significant correlations of HRQOL with pain intensity, disability scale, and disability days. Among the results of physical examination, lumbosacral radiculopathy was the only factor with moderate correlation with HRQOL. The significant predictors for HRQOL included physical domain, psychological domain, pain intensity, and family income. Among all the 232 study patients, 100 of them responded to the follow-up questionnaire. Changes in environmental domain, disability days, educational level, receiving herb drugs, and physiotherapy were the significant predictors for the changes of HRQOL. CONCLUSIONS: The HRQOL of patients with low back pain depended on functional status and psychological factors more than simple physical impairment. Future intervention may need to put more emphasis on improving functional status and psychological stress for these patients."," Spine (Phila Pa 1976) 30(5): 551-555.","Taiwan",2005,"Back Pain","Physical Therapy","RMDQ","Unknown","PRO study","Observational","Taiwan","Unknown","Back Pain","Physical Therapy","PRO study","Observational","RMDQ","2005:2009"]
[172,"Hurley, D. A., et al. (2004). \"A randomized clinical trial of manipulative therapy and interferential therapy for acute low back pain.\" Spine (Phila Pa 1976) 29(20): 2207-2216.",null,"Hurley, D. A., et al.","A randomized clinical trial of manipulative therapy and interferential therapy for acute low back pain","STUDY DESIGN: A multicenter assessor-blinded randomized clinical trial was conducted. OBJECTIVES: To investigate the difference in effectiveness of manipulative therapy and interferential therapy for patients with acute low back pain when used as sole treatments and in combination. SUMMARY OF BACKGROUND DATA: Both manipulative therapy and interferential therapy are commonly used treatments for low back pain. Evidence for the effectiveness of manipulative therapy is available only for the short-term. There is limited evidence for interferential therapy, and no study has investigated the effectiveness of manipulative therapy combined with interferential therapy. METHODS: Consenting subjects (n = 240) recruited following referral by physicians to physiotherapy departments in the (government-funded) National Health Service in Northern Ireland were randomly assigned to receive a copy of the Back Book and either manipulative therapy (MT; n = 80), interferential therapy (IFT; n = 80), or a combination of manipulative therapy and interferential therapy (CT; n = 80). The primary outcome was a change in functional disability on the Roland Morris Disability Questionnaire. Follow-up questionnaires were posted at discharge and at 6 and 12 months. RESULTS: The groups were balanced at baseline for low back pain and demographic characteristics. At discharge all interventions significantly reduced functional disability (Roland Morris scale, MT: -4.53; 95% CI, -5.7 to -3.3 vs. IFT: -3.56; 95% CI, -4.8 to -2.4 vs. CT: -4.65; 95% CI, -5.8 to -3.5; P = 0.38) and pain (McGill questionnaire, MT: -5.12; 95% CI, -7.7 to -2.5 vs. IFT: -5.87; 95% CI, -8.5 to -3.3 vs. CT: -6.64; 95% CI, -9.2 to -4.1; P = 0.72) and increased quality of life (SF-36 Role-Physical, MT: 28.6; 95% CI, 18.3 to 38.9 vs. IFT: 31.4; 95% CI, 21.2 to 41.5 vs. CT: 30; 95% CI, 19.9 to 40; P = 0.93) to the same degree and maintained these improvements at 6 and 12 months. No significant differences were found between groups for reported LBP recurrence, work absenteeism, medication consumption, exercise participation, or healthcare use at 12 months (P > 0.05). CONCLUSIONS: For acute low back pain, there was no difference between the effects of a combined manipulative therapy and interferential therapy package and either manipulative therapy or interferential therapy alone."," Spine (Phila Pa 1976) 29(20): 2207-2216.","Ireland",2004,"Back Pain","Exercise","RMDQ","Unknown","PRO study","RCT","Ireland","Unknown","Back Pain","Exercise","PRO study","RCT","RMDQ","2000:2004"]
[173,"Itoh, K., et al. (2004). \"Trigger point acupuncture treatment of chronic low back pain in elderly patients--a blinded RCT.\" Acupunct Med 22(4): 170-177.",null,"Itoh, K., et al.","Trigger point acupuncture treatment of chronic low back pain in elderly patients--a blinded RCT","OBJECTIVE: There is some evidence for the efficacy of acupuncture in chronic low back pain, but it remains unclear which acupuncture modes are most effective. Our objective was to evaluate the effects of two different modes of trigger point acupuncture on pain and quality of life in chronic low back pain patients compared to standard acupuncture treatment. METHODS: Thirty five consecutive out-patients (25 women, 10 men; age range: 65-81 years) from the Department of Orthopaedic Surgery, Meiji University of Oriental Medicine, with non-radiating low back pain for at least six months and normal neurological examination, were randomised to one of three groups over 12 weeks. Each group received two phases of acupuncture treatment with an interval between them. Nine patients dropped out during the course of the study. The standard acupuncture group (n=9) received treatment at traditional acupuncture points for low back pain, while the other acupuncture groups received superficial (n=9) or deep (n=9) treatments on trigger points. Outcome measures were VAS pain intensity and Roland Morris Questionnaire. RESULTS: After treatment, the group that received deep needling to trigger points reported less pain intensity and improved quality of life compared to the standard acupuncture group or the group that received superficial needling to trigger points, but the differences were not statistically significant. There was a significant reduction in pain intensity between the treatment and interval in the group that received deep needling to trigger points (P<0.01), but not in the standard acupuncture group or the group that received superficial needling to trigger points. CONCLUSION: These results suggest that deep needling to trigger points may be more effective in the treatment of low back pain in elderly patients than either standard acupuncture therapy, or superficial needling to trigger points."," Acupunct Med 22(4): 170-177.","Japan",2004,"Back Pain","Acupuncture,Surgical","RMDQ","Elderly","PRO study","Clinical trial","Japan","Elderly","Back Pain","Acupuncture,Surgical","PRO study","Clinical trial","RMDQ","2000:2004"]
[174,"Itoh, K., et al. (2006). \"Effects of trigger point acupuncture on chronic low back pain in elderly patients--a sham-controlled randomised trial.\" Acupunct Med 24(1999): 5-12.",null,"Itoh, K., et al.","Effects of trigger point acupuncture on chronic low back pain in elderly patients--a sham-controlled randomised trial","INTRODUCTION: There is some evidence for the efficacy of acupuncture, but it remains unclear whether trigger point acupuncture is effective. Our objective was to evaluate the effects of trigger point acupuncture on pain and quality of life in chronic low back pain patients compared with sham acupuncture. METHODS: Twenty-six consecutive out-patients (17 women, 9 men; age range: 65-91 years) from the Department of Orthopaedic Surgery, Meiji University of Oriental Medicine, with non-radiating low back pain for at least six months and normal neurological examination, were randomised to two groups. Each group received one phase of trigger point acupuncture and one of sham acupuncture with a three week washout period between them, over 12 weeks. Group A (n = 13) received trigger point acupuncture in the first phase and sham acupuncture in the second. Group B (n = 13) received the same interventions in the reverse order. Outcome measures were pain intensity (visual analogue scale, VAS) and Roland Morris Questionnaire. RESULTS: Nineteen patients were included in the analysis. At the end of the first treatment phase, group A receiving trigger point acupuncture scored significantly lower VAS (P < 0.001) and Roland Morris Questionnaire scores (P < 0.01) than the sham control group. There were significant within-group reductions in pain in both groups during the trigger point acupuncture phase but not in the sham treatment phase. However, the beneficial effects were not sustained. CONCLUSION: These results suggest that trigger point acupuncture may have greater short term effects on low back pain in elderly patients than sham acupuncture."," Acupunct Med 24(1999): 5-12.","Japan",2006,"Back Pain","Acupuncture,Surgical","RMDQ","Elderly","PRO study","Prospective Observation","Japan","Elderly","Back Pain","Acupuncture,Surgical","PRO study","Prospective Observation","RMDQ","2005:2009"]
[175,"Itoh, K., et al. (2007). \"Randomised trial of trigger point acupuncture compared with other acupuncture for treatment of chronic neck pain.\" Complement Ther Med 15(3): 172-179.",null,"Itoh, K., et al.","Randomised trial of trigger point acupuncture compared with other acupuncture for treatment of chronic neck pain","INTRODUCTION: There is some evidence for the efficacy of acupuncture in chronic neck pain (CNP) treatment, but it remains unclear which acupuncture modes are most effective. Objective was to evaluate the effects of trigger point acupuncture on pain and quality of life (QOL) in CNP patients compared to three other acupuncture treatments (acupoints, non-trigger point and sham treatment). METHODS: Forty out-patients (29 women, 11 men; age range: 47-80 years) from the Department of Orthopaedic Surgery, Meiji University of Oriental Medicine, with non-radiating CNP for at least 6 months and normal neurological examination were randomised to one of four groups over 13 weeks. Each group received two phases of acupuncture treatment with an interval between them. The acupoint group (standard acupuncture; SA, n=10) received treatment at traditional acupoints for neck pain, the trigger point (TrP, n=10) and non-trigger point (non-TrP, n=10) groups received treatment at tenderness points for the same muscle, while the other acupuncture group received sham treatments on the trigger point (SH, n=10). Outcome measures were pain intensity (visual analogue scale; VAS 0-100mm) and disease specific questionnaire (neck disability index; NDI, 60-point scale). RESULTS: After treatment, the TrP group reported less pain intensity and improved QOL compared to the SA or non-TrP group. There was significant reduction in pain intensity between the treatment and the interval for the TrP group (p<0.01, Dunnett's multiple test), but not for the SA or non-TrP group. CONCLUSION: These results suggest that trigger point acupuncture therapy may be more effective on chronic neck pain in aged patients than the standard acupuncture therapy."," Complement Ther Med 15(3): 172-179.","Japan",2007,"Neck Pain","Acupuncture,Surgical","NDI","Adults","PRO study","RCT","Japan","Adults","Neck Pain","Acupuncture,Surgical","PRO study","RCT","NDI","2005:2009"]
[176,"Janssen, M. E., et al. (2015). \"ProDisc-C Total Disc Replacement Versus Anterior Cervical Discectomy and Fusion for Single-Level Symptomatic Cervical Disc Disease: Seven-Year Follow-up of the Prospective Randomized U.S. Food and Drug Administration Investigational Device Exemption Study.\" J Bone Joint Surg Am 97(21): 1738-1747.",null,"Janssen, M. E., et al.","ProDisc-C Total Disc Replacement Versus Anterior Cervical Discectomy and Fusion for Single-Level Symptomatic Cervical Disc Disease: Seven-Year Follow-up of the Prospective Randomized U.S. Food and Drug Administration Investigational Device Exemption Study","BACKGROUND: In patients with single-level cervical degenerative disc disease, total disc arthroplasty can relieve radicular pain and preserve functional motion between two vertebrae. We compared the efficacy and safety of cervical total disc arthroplasty with that of anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical degenerative disc disease between C3-C4 and C6-C7. METHODS: Two hundred and nine patients at thirteen sites were randomly treated with either total disc arthroplasty with ProDisc-C (n = 103) or with ACDF (n = 106). Patients were assessed preoperatively; at six weeks and three, six, twelve, eighteen, and twenty-four months postoperatively; and then annually until seven years postoperatively. Outcome measures included the Neck Disability Index (NDI), the Short Form-36 (SF-36), postoperative neurologic parameters, secondary surgical procedures, adverse events, neck and arm pain, and satisfaction scores. RESULTS: At seven years, the overall follow-up rate was 92% (152 of 165). There were no significant differences in demographic factors, follow-up rate, or patient-reported outcomes between groups. Both procedures were effective in reducing neck and arm pain and improving and maintaining function and health-related quality of life. Neurologic status was improved or maintained in 88% and 89% of the patients in the ProDisc-C and ACDF groups, respectively. After seven years of follow-up, thirty secondary surgical procedures had been performed in nineteen (18%) of 106 patients in the ACDF group compared with seven secondary surgical procedures in seven (7%) of 103 patients in the ProDisc-C group (p = 0.0099). There were no significant differences in the rates of any device-related adverse events between the groups. CONCLUSIONS: Total disc arthroplasty with ProDisc-C is a safe and effective surgical treatment of single-level symptomatic cervical degenerative disc disease. Clinical outcomes after total disc arthroplasty with ProDisc-C were similar to those after ACDF. Patients treated with ProDisc-C had a lower probability of subsequent surgery, suggesting that total disc arthroplasty provides durable results and has the potential to slow the rate of adjacent-level disease. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence."," J Bone Joint Surg Am 97(21): 1738-1747.","USA",2015,"Radiculopathy","Surgical","NDI","Unknown","PRO study","RCT","USA","Unknown","Radiculopathy","Surgical","PRO study","RCT","NDI","2015:2018"]
[177,"Jarvik, J. G., et al. (2014). \"Back pain in seniors: the Back pain Outcomes using Longitudinal Data (BOLD) cohort baseline data.\" BMC Musculoskelet Disord 15: 134.",null,"Jarvik, J. G., et al.","Back pain in seniors: the Back pain Outcomes using Longitudinal Data (BOLD) cohort baseline data","BACKGROUND: Back pain represents a substantial burden globally, ranking first in a recent assessment among causes of years lived with disability. Though back pain is widely studied among working age adults, there are gaps with respect to basic descriptive epidemiology among seniors, especially in the United States. Our goal was to describe how pain, function and health-related quality of life vary by demographic and geographic factors among seniors presenting to primary care providers with new episodes of care for back pain. METHODS: We examined baseline data from the Back pain Outcomes using Longitudinal Data (BOLD) registry, the largest inception cohort to date of seniors presenting to a primary care provider for back pain. The sample included 5,239 patients >/= 65 years old with a new primary care visit for back pain at three integrated health systems (Northern California Kaiser-Permanente, Henry Ford Health System [Detroit], and Harvard Vanguard Medical Associates [Boston]). We examined differences in patient characteristics across healthcare sites and associations of patient sociodemographic and clinical characteristics with baseline patient-reported measures of pain, function, and health-related quality of life. RESULTS: Patients differed across sites in demographic and other characteristics. The Detroit site had more African-American patients (50%) compared with the other sites (7-8%). The Boston site had more college graduates (68%) compared with Detroit (20%). Female sex, lower educational status, African-American race, and older age were associated with worse functional disability as measured by the Roland-Morris Disability Questionnaire. Except for age, these factors were also associated with worse pain. CONCLUSIONS: Baseline pain and functional impairment varied substantially with a number of factors in the BOLD cohort. Healthcare site was an important factor. After controlling for healthcare site, lower education, female sex, African-American race, and older age were associated with worse physical disability and all of these factors except age were associated with worse pain. TRIAL REGISTRATION: Clinical Trials.gov NCT01776242; Registration date: June 13, 2012."," BMC Musculoskelet Disord 15: 134.","USA",2014,"Back Pain","Not Specified","RMDQ","Adults","PRO study","Retrospective review","USA","Adults","Back Pain","Not Specified","PRO study","Retrospective review","RMDQ","2010:2014"]
[178,"Jarvik, J. G., et al. (2015). \"Association of early imaging for back pain with clinical outcomes in older adults.\" Jama 313(11): 1143-1153.",null,"Jarvik, J. G., et al.","Association of early imaging for back pain with clinical outcomes in older adults","IMPORTANCE: In contrast to the recommendations for younger adults, many guidelines allow for older adults with back pain to undergo imaging without waiting 4 to 6 weeks. However, early imaging may precipitate interventions that do not improve outcomes. OBJECTIVE: To compare function and pain at the 12-month follow-up visit among older adults who received early imaging with those who did not receive early imaging after a new primary care visit for back pain without radiculopathy. DESIGN, SETTING, AND PARTICIPANTS: Prospective cohort of 5239 patients 65 years or older with a new primary care visit for back pain (2011-2013) in 3 US health care systems. We matched controls 1:1 using propensity score matching of demographic and clinical characteristics, including diagnosis, pain severity, pain duration, functional status, and prior resource use. EXPOSURES: Diagnostic imaging (plain films, computed tomography [CT], magnetic resonance imaging [MRI]) of the lumbar or thoracic spine within 6 weeks of the index visit. MAIN OUTCOME AND MEASURES: PRIMARY OUTCOME: back or leg pain-related disability measured by the modified Roland-Morris Disability Questionnaire (score range, 0-24; higher scores indicate greater disability) 12 months after enrollment. RESULTS: Among the 5239 patients, 1174 had early radiographs and 349 had early MRI/CT. At 12 months, neither the early radiograph group nor the early MRI/CT group differed significantly from controls on the disability questionnaire. The mean score for patients who underwent early radiography was 8.54 vs 8.74 among the control group (difference, -0.10 [95% CI, -0.71 to 0.50]; mixed model, P = .36). The mean score for the early MRI/CT group was 9.81 vs 10.50 for the control group (difference,-0.51 [-1.62 to 0.60]; mixed model, P = .18). CONCLUSIONS AND RELEVANCE: Among older adults with a new primary care visit for back pain, early imaging was not associated with better 1-year outcomes. The value of early diagnostic imaging in older adults for back pain without radiculopathy is uncertain."," Jama 313(11): 1143-1153.","USA",2015,"Back Pain","Not Specified","RMDQ","Unknown","PRO study","Observational","USA","Unknown","Back Pain","Not Specified","PRO study","Observational","RMDQ","2015:2018"]
[179,"Jensen, C. E., et al. (2014). \"Study protocol of an economic evaluation of an extended implementation strategy for the treatment of low back pain in general practice: a cluster randomised controlled trial.\" Implement Sci 9: 140.",null,"Jensen, C. E., et al.","Study protocol of an economic evaluation of an extended implementation strategy for the treatment of low back pain in general practice: a cluster randomised controlled trial","BACKGROUND: In Denmark, guidelines on low back pain management are currently being implemented; in association with this, a clinical trial is conducted. A health economic evaluation is carried out alongside the clinical trial to assess the cost-effectiveness of an extended implementation strategy to increase the general practitioners' adherence to the guidelines. In addition to usual dissemination, the extended implementation strategy is composed of visits from a guideline facilitator, stratification tools, and feedback on guideline adherence. The aim of this paper is to provide the considerations on the design of the health economic evaluation. METHODS/DESIGN: The economic evaluation is carried out alongside a cluster randomised controlled trial consisting of 60 general practices in the North Denmark Region. An expected 1,200 patients between the age of 18 and 65 years with a low back pain diagnosis will be enrolled. The economic evaluation comprises both a cost-effectiveness analyses and a cost-utility analysis. Effectiveness measures include referral to secondary care, health-related quality of life measured by EQ-5D-5L, and disability measured by the Roland Morris disability questionnaire. Cost measures include all relevant additional costs of the extended implementation strategy compared to usual implementation. The economic evaluation will be performed from both a societal perspective and a health sector perspective with a 12-month time horizon. DISCUSSION: It is expected that the extended implementation strategy will reduce the number of patients referred to secondary care. It is hypothesised that the additional upfront cost of extended implementation will be counterbalanced by improvements in clinical practice and patient-related outcomes, thereby rendering the extended implementation strategy cost-effective. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01699256."," Implement Sci 9: 140.","Denmark",2014,"Back Pain","Not Specified","RMDQ","Adults","Cost-Effectiveness","Clinical trial","Denmark","Adults","Back Pain","Not Specified","Cost-Effectiveness","Clinical trial","RMDQ","2010:2014"]
[180,"Joslin, C. C., et al. (2004). \"Long-term disability after neck injury. a comparative study.\" J Bone Joint Surg Br 86(7): 1032-1034.",null,"Joslin, C. C., et al.","Long-term disability after neck injury. a comparative study","Claims for personal injury after whiplash injury cost the economy of the United Kingdom more than pound 3 billion per year, yet only very few patients have radiologically demonstrable pathology. Those sustaining fractures of the cervical spine have been subjected to greater force and may reasonably be expected to have worse symptoms than those with whiplash injuries. Using the neck disability index as the outcome measure, we compared pain and functional disability in four groups of patients who had suffered injury to the cervical spine. After a mean follow-up of 3.5 years, patients who had sustained fractures of the cervical spine had significantly lower levels of pain and disability than those who had received whiplash injuries and were pursuing compensation (p < 0.01), but had similar levels to those whiplash sufferers who had settled litigation or had never sought compensation. Functional recovery after neck injury was unrelated to the physical insult. The increased morbidity in whiplash patients is likely to be psychological and is associated with litigation."," J Bone Joint Surg Br 86(7): 1032-1034.","UK",2004,"Trauma","Psychosocial","NDI","Unknown","PRO study","Clinical trial","UK","Unknown","Trauma","Psychosocial","PRO study","Clinical trial","NDI","2000:2004"]
[181,"Joswig, H., et al. (2017). \"Effects of Smoking on Subjective and Objective Measures of Pain Intensity, Functional Impairment, and Health-Related Quality of Life in Lumbar Degenerative Disk Disease.\" World Neurosurg 99: 6-13.",null,"Joswig, H., et al.","Effects of Smoking on Subjective and Objective Measures of Pain Intensity, Functional Impairment, and Health-Related Quality of Life in Lumbar Degenerative Disk Disease","BACKGROUND: Numerous studies assessed the effects of smoking on lumbar degenerative disk disease (DDD); they focused on patient-reported outcome measures (PROMs) and yielded conflicting results. METHODS: In this 2-center study on consecutive patients receiving surgical treatment for lumbar DDD, subjective functional impairment (SFI) in terms of PROMs including visual analog scale back and leg pain, Roland-Morris, Oswestry Disability Index, Euro-Qol-5D, and a Short-Form 12 physical component summary was determined at baseline, 3 days, 6 weeks, 6 months, and 1 year postoperatively. Age- and sex-adjusted T-scores of objective functional impairment (OFI) were determined using the Timed Up and Go test up to 6 weeks postoperatively. The responder status was defined by the minimal clinically important difference. RESULTS: We analyzed 375 patients (n = 96 [25.6%] smokers and n = 279 [74.4%] nonsmokers). SFI on any of the PROMs before treatment was similar in smokers and nonsmokers. Smokers were more likely to have OFI in univariate logistic regression analysis (95% confidence interval 1.31-3.37, P = 0.002). In multivariate analysis, however, this relationship became insignificant (95% confidence interval 0.85-2.38, P = 0.184). The smoking status had no predictive capacity on the 6-week SFI or OFI responder status, and there were no differences in any of the PROMs until the 1-year follow-up. CONCLUSIONS: PROMs measuring SFI for pain intensity, functional impairment, and health-related quality of life were similar in smokers and nonsmokers before surgery for lumbar DDD, as well as postoperatively. The smoking status has negligible impact on the Timed Up and Go test, which appears to be a robust assessment tool for OFI."," World Neurosurg 99: 6-13.","Switzerland,Australia",2017,"Degenerative Disk Disease","Surgical","ODI,RMDQ","Unknown","PRO study","Observational","Switzerland,Australia","Unknown","Degenerative Disk Disease","Surgical","PRO study","Observational","ODI,RMDQ","2015:2018"]
[182,"Joswig, H., et al. (2017). \"Patients' Preference of the Timed Up and Go Test or Patient-Reported Outcome Measures Before and After Surgery for Lumbar Degenerative Disk Disease.\" World Neurosurg 99: 26-30.",null,"Joswig, H., et al.","Patients' Preference of the Timed Up and Go Test or Patient-Reported Outcome Measures Before and After Surgery for Lumbar Degenerative Disk Disease","BACKGROUND: The Timed Up and Go (TUG) test, as a measure of objective functional impairment in lumbar degenerative disk disease (DDD), complements patient-reported outcome measures (PROMs) of subjective functional impairment. METHODS: Prospective 2-center study on consecutive patients scheduled for surgical treatment for lumbar DDD who underwent an objective (TUG test) and subjective (PROMs) functional assessment before and 1 and 3 days after surgery. PROMs included the visual analog scale (VAS), Roland-Morris Disability Index (RMDI), Oswestry Disability Index (ODI), Euro-Qol (EQ-5D), and Short Form 12 (SF-12) questionnaires. On completion of each assessment, patients were asked whether they would prefer performing the TUG test or completing the PROMs questionnaires. RESULTS: A total of 109 of 125 patients (87.2%) completed the assessments. Preoperatively, patients were 2.18 times as likely to prefer the TUG test to the PROMs (odds ratio [OR], 2.18; 95% confidence interval [CI], 1.27-3.75). On postoperative days 1 and 3, patients were 5.79 (OR, 5.79; 95% CI, 3.23-10.37) and 6.33 times as likely to prefer the TUG test to the PROMs, respectively (OR, 6.33; 95% CI, 3.51-11.41). There were no statistical differences in baseline characteristics, TUG t scores, VAS, RMDI, ODI, SF-12, and EQ-5D index between patients preferring either the TUG test or the PROMs questionnaires. CONCLUSIONS: The TUG test is preferred over a battery of PROMs by 60%-70% of patients with lumbar DDD not only in the preoperative, but also in the postoperative, setting. High functional disability does not result in avoidance of the TUG test, and repeated assessments lead to higher preference."," World Neurosurg 99: 26-30.","Switzerland,Australia",2017,"Degenerative Disk Disease","Surgical","ODI,RMDQ","Unknown","PRO study","Prospective Observation","Switzerland,Australia","Unknown","Degenerative Disk Disease","Surgical","PRO study","Prospective Observation","ODI,RMDQ","2015:2018"]
[183,"Kang, D. G., et al. (2017). \"Neurologic Deficits Have a Negative Impact on Patient-Related Outcomes in Primary Presentation Adult Symptomatic Lumbar Scoliosis Surgical Treatment at One-Year Follow-up.\" Spine (Phila Pa 1976) 42(7): 479-489.",null,"Kang, D. G., et al.","Neurologic Deficits Have a Negative Impact on Patient-Related Outcomes in Primary Presentation Adult Symptomatic Lumbar Scoliosis Surgical Treatment at One-Year Follow-up","STUDY DESIGN: A retrospective analysis of prospective, multicenter National Institute of Health clinical trial. OBJECTIVE: The aim of this study was to assess the rate of neurologic complications and impact of new neurologic deficits on 1-year postoperative patient-reported outcomes (PROs). SUMMARY OF BACKGROUND DATA: There are limited studies evaluating the impact of new neurologic deficits on PROs following surgery for primary presentation adult lumbar scoliosis. METHODS: Patients were divided into two groups: new postoperative neurological deficit (Def) or no deficit (NoDef). Preoperative and 1-year follow-up PROs were analyzed [Scoliosis Research Society (SRS) Questionnaire, Oswestry Disability Index (ODI), Short Form-12 Physical/Mental Health Composite Scores (PCS/MCS), and back/leg pain Numerical Rating Scale (NRS)]. RESULTS: One hundred forty-one patients: 14 Def (9.9%), 127 NoDef (90.1%). No differences were observed in demographic, radiographic, or PRO data between groups preoperatively. Def group had longer surgical procedures (8.3 vs. 6.9 hours, P = 0.030), greater blood loss (2832 vs. 2606 mL, P = 0.022), and longer hospitalizations (10.6 vs. 7.8 days, P = 0.004). NoDef group reported significant improvement in all PROs from preop to 1-year postoperative. Def group only had improvement in SRS Pain (2.7 preop to 3.4 postop, P = 0.037) and self-image domains (2.7 to 3.6, p = 0.004), and NRS back pain (6.6 to 3.2, P = 0.004) scores with significant worsening of NRS leg pain (4.1 to 6.1, P = 0.045). Group comparisons of 1-year postop PROs found that Def group reported more NRS leg pain (6.1 vs. 1.7, P < 0.001) and worse outcomes than NoDef group for ODI (35.7 vs. 23.1, P = 0.016) and PCS (32.6 vs. 41.9, P = 0.007). CONCLUSION: We found a 9.9% rate of new neurologic deficits following surgery for symptomatic primary presentation adult lumbar scoliosis, much higher than previous studies. Most neurologic deficits improved by 1-year follow-up, but appeared to have a dramatic negative impact on PROs, with increased postoperative leg pain and greater patient-perceived pathology reported in patients experiencing neurological deficits compared with those who did not. LEVEL OF EVIDENCE: 3."," Spine (Phila Pa 1976) 42(7): 479-489.","USA",2017,"Spinal Deformity","Surgical","ODI,SRS-HRQOL","Unknown","PRO study","Clinical trial","USA","Unknown","Spinal Deformity","Surgical","PRO study","Clinical trial","ODI,SRS-HRQOL","2015:2018"]
[184,"Karstens, S., et al. (2015). \"Validation of the German version of the STarT-Back Tool (STarT-G): a cohort study with patients from primary care practices.\" BMC Musculoskelet Disord 16: 346.",null,"Karstens, S., et al.","Validation of the German version of the STarT-Back Tool (STarT-G): a cohort study with patients from primary care practices","BACKGROUND: Current research emphasizes the high prevalence and costs of low back pain (LBP). The STarT Back Tool was designed to support primary care decision making for treatment by helping to determine the treatment prognosis of patients with non-specific low back pain. The German version is the STarT-G. The cross-cultural translation of the tool followed a structured and widely accepted process but to date it was only partially validated with a small sample. The aim of the study was to test the psychometric properties construct validity, discriminative ability, internal consistency and test-retest-reliability of the STarT-G and to compare them with values given for the original English version. METHODS: A consecutive cohort study with a two-week retest was conducted among patients with non-specific LBP, aged 18 to 60 years, from primary care practices. Questionnaires were collected before the first consultation, and two weeks later by post, using the following reference standards: the Roland and Morris disability questionnaire, the Tampa Scale of Kinesiophobia, the Pain Catastrophizing Scale and the Hospital Anxiety and Depression Scale. Psychometric properties examined included the tool's discriminative abilities, whether the psychosocial subscale was one factor, internal consistency, item redundancy, test-retest reliability and floor and ceiling effects. RESULTS: There were 228 patients recruited with a mean age of 42.2 (SD 11.0) years, and 53 % were female. The areas under the curve (AUC) for discriminative ability ranged from 0.70 (STarT-G Subscale - Pain Catastrophizing Scale; CI95 0.63, 0.78) to 0.77 (STarT-G Total - Composite reference standard, CI95 0.60, 0.94). Factor loadings ranged from 0.49 to 0.74. Cronbach's alpha testing the internal consistency and redundancy for the total/subscale scores were alpha = 0.52/0.55 respectively. The STarT-G test-retest reliability Kappa values for the total/subscale scores were 0.67/0.68 respectively. No floor or ceiling effects were present. CONCLUSIONS: The STarT-G shows acceptable psychometric properties although not in exact agreement with the original English version. The items previously regarded as a psychosocial subscale may be better seen as an index of different individual psychosocial constructs. The relevance of using the tool at the point of consultation should be further examined."," BMC Musculoskelet Disord 16: 346.","Germany",2015,"Back Pain","Psychosocial","RMDQ","Adults","Tool Validation","Observational","Germany","Adults","Back Pain","Psychosocial","Tool Validation","Observational","RMDQ","2015:2018"]
[185,"Kato, S., et al. (2015). \"Comparison of the Japanese Orthopaedic Association (JOA) score and modified JOA (mJOA) score for the assessment of cervical myelopathy: a multicenter observational study.\" PLoS One 10(4): e0123022.",null,"Kato, S., et al.","Comparison of the Japanese Orthopaedic Association (JOA) score and modified JOA (mJOA) score for the assessment of cervical myelopathy: a multicenter observational study","OBJECTIVES: The Japanese Orthopaedic Association (JOA) score is widely used to assess the severity of clinical symptoms in patients with cervical compressive myelopathy, particularly in East Asian countries. In contrast, modified versions of the JOA score are currently accepted as the standard tool for assessment in Western countries. The objective of the present study is to compare these scales and clarify their differences and interchangeability and verify their validity by comparing them to other outcome measures. MATERIALS AND METHODS: Five institutions participated in this prospective multicenter observational study. The JOA and modified JOA (mJOA) proposed by Benzel were recorded preoperatively and at three months postoperatively in patients with cervical compressive myelopathy who underwent decompression surgery. Patient reported outcome (PRO) measures, including Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ), the Short Form-12 (SF-12) and the Neck Disability Index (NDI), were also recorded. The preoperative JOA score and mJOA score were compared to each other and the PRO values. A Bland-Altman analysis was performed to investigate their limits of agreement. RESULTS: A total of ninety-two patients were included. The correlation coefficient (Spearman's rho) between the JOA and mJOA was 0.87. In contrast, the correlations between JOA/mJOA and the other PRO values were moderate (|rho| = 0.03 - 0.51). The correlation coefficient of the recovery rate between the JOA and mJOA was 0.75. The Bland-Altman analyses showed that limits of agreement were 3.6 to -1.2 for the total score, and 55.1% to -68.8% for the recovery rates. CONCLUSIONS: In the present study, the JOA score and the mJOA score showed good correlation with each other in terms of their total scores and recovery rates. Previous studies using the JOA can be interpreted based on the mJOA; however it is not ideal to use them interchangeably. The validity of both scores was demonstrated by comparing these values to the PRO values."," PLoS One 10(4): e0123022.","Japan",2015,"Cervical Myelopathy","Surgical","NDI","Unknown","PRO study","Prospective Observation","Japan","Unknown","Cervical Myelopathy","Surgical","PRO study","Prospective Observation","NDI","2015:2018"]
[186,"Katzman, W. B., et al. (2016). \"Study of Hyperkyphosis, Exercise and Function (SHEAF) Protocol of a Randomized Controlled Trial of Multimodal Spine-Strengthening Exercise in Older Adults With Hyperkyphosis.\" Phys Ther 96(3): 371-381.",null,"Katzman, W. B., et al.","Study of Hyperkyphosis, Exercise and Function (SHEAF) Protocol of a Randomized Controlled Trial of Multimodal Spine-Strengthening Exercise in Older Adults With Hyperkyphosis","BACKGROUND: Hyperkyphosis negatively affects health status, physical mobility, and quality of life, but there is no standard protocol for treating people with hyperkyphosis. Treatment options include targeted exercise. OBJECTIVES: This single-site randomized controlled trial (RCT) will determine the efficacy of a targeted multimodal spine-strengthening exercise program, compared with no exercise intervention, among community-dwelling men and women aged >/=60 years. DESIGN: The RCT is a parallel-group design, with 1:1 randomization to exercise and attentional control groups. SETTING: The study will be conducted at one primary site (one academic medical center partnered with one local community medical center). PARTICIPANTS: One hundred men and women, aged >/=60 years, with thoracic kyphosis >/=40 degrees will be randomized. INTERVENTION: The targeted multimodal spine-strengthening exercise intervention includes exercise and postural training delivered by a physical therapist in a group of 10 participants, 3 times a week for 6 months. Controls receive monthly health education meetings in a group of 10 participants and monthly calls from the study coordinator to monitor physical activity and any adverse events. MEASUREMENTS: The primary outcome is change in Cobb angle of kyphosis measured from lateral spine radiographs at baseline and 6 months. Secondary outcomes include change in physical function (assessed with the modified Physical Performance Test, Timed \"Up & Go\" Test, timed loaded standing, 4-m walk, and Six-Minute Walk Test) and health-related quality of life (assessed with the modified Scoliosis Research Society instrument [SRS-30] self-image domain and Patient Reported Outcomes Measurement Information System [PROMIS] global health and physical function indexes). Additional secondary outcomes include pain, physical activity level, spinal flexion and extension muscle strength, paraspinal extensor muscle density, and adverse events. LIMITATIONS: Blinding of the participants and instructors providing the intervention is not possible. CONCLUSIONS: The efficacy of a high-quality, adequately powered exercise intervention in men and women with kyphosis >/=40 degrees will be evaluated to determine whether targeted multimodal spine-strengthening exercise reduces hyperkyphosis in older adults and improves important secondary outcomes of physical function and health-related quality of life."," Phys Ther 96(3): 371-381.","USA",2016,"Spinal Deformity","Exercise","SRS-HRQOL","Adults","PRO study","RCT","USA","Adults","Spinal Deformity","Exercise","PRO study","RCT","SRS-HRQOL","2015:2018"]
[187,"Kelly, R. E., Jr., et al. (2008). \"Surgical repair of pectus excavatum markedly improves body image and perceived ability for physical activity: multicenter study.\" Pediatrics 122(6): 1218-1222.",null,"Kelly, R. E., Jr., et al.","Surgical repair of pectus excavatum markedly improves body image and perceived ability for physical activity: multicenter study","OBJECTIVE: This study evaluated changes in both physical and psychosocial quality of life reported by the parent and child after surgical repair of pectus excavatum. METHODS: As part of a multicenter study of pectus excavatum, a previously validated tool called the Pectus Excavatum Evaluation Questionnaire was administered by the research coordinator, via telephone, to parents and patients (8-21 years of age) before and 1 year after surgery. Eleven North American children's hospitals participated. From 2001 to 2006, 264 patients and 291 parents completed the initial questionnaire, and 247 patients and 274 parents completed the postoperative questionnaire. Responses used a Likert-type scale of 1 to 4, reflecting the extent or frequency of a particular experience, with higher values conveying less-desirable experience. RESULTS: Preoperative psychosocial functioning was unrelated to objective pectus excavatum severity (computed tomographic index). Patients and their parents reported significant positive postoperative changes. Improvements occurred in both physical and psychosocial functioning, including less social self-consciousness and a more-favorable body image. For children, the body image component improved from 2.30+/-0.62 (mean+/-SD) to 1.40+/-0.42 after surgery and the physical difficulties component improved from 2.11+/-0.82 to 1.37+/-0.44. For the parent questionnaire, the child's emotional difficulties improved from 1.81+/-0.70 to 1.24+/-0.36, social self-consciousness improved from 2.86+/-1.03 to 1.33+/-0.68, and physical difficulties improved from 2.14+/-0.75 to 1.32+/-0.39. Ninety-seven percent of patients thought that surgery improved how their chest looked. CONCLUSIONS: Surgical repair of pectus excavatum can significantly improve the body image difficulties and limitations on physical activity experienced by patients. These results should prompt physicians to consider the physiologic and psychological implications of pectus excavatum just as they would any other physical deformity known to have such consequences."," Pediatrics 122(6): 1218-1222.","USA",2008,"Unspecified","Surgical","Pectus","Infants","PRO study","Clinical trial","USA","Infants","Unspecified","Surgical","PRO study","Clinical trial","Pectus","2005:2009"]
[188,"Khan, K. A., et al. (2014). \"Mapping between the Roland Morris Questionnaire and generic preference-based measures.\" Value Health 17(6): 686-695.",null,"Khan, K. A., et al.","Mapping between the Roland Morris Questionnaire and generic preference-based measures","OBJECTIVES: The Roland Morris Questionnaire (RMQ) is a widely used health status measure for low back pain (LBP). It is not preference-based, and there are currently no established algorithms for mapping between the RMQ and preference-based health-related quality-of-life measures. Using data from randomized controlled trials of treatment for LBP, we sought to develop algorithms for mapping between RMQ scores and health utilities derived using either the EuroQol five-dimensional questionnaire (EQ-5D) or the six-dimensional health state short form (derived from Medical Outcomes Study 36-Item Short-Form Health Survey) (SF-6D). METHODS: This study is based on data from the Back Skills Training Trial in which data were collected from 701 patients at baseline and subsequently at 3, 6, and 12 months postrandomization using a range of outcome measures, including the RMQ, the EQ-5D, and the Short Form 12 item Health Survey (SF-12) (from which SF-6D utilities can be derived). We used baseline trial data to estimate models using both direct and response mapping approaches to predict EQ-5D and SF-6D health utilities and dimension responses. A multistage model selection process was used to assess the predictive accuracy of the models. We then explored different techniques and mapping models that made use of repeated follow-up observations in the data. The estimated mapping algorithms were validated using external data from the UK Back Pain Exercise and Manipulation trial. RESULTS: A number of models were developed that accurately predict health utilities in this context. The best performing model for RMQ to EQ-5D mapping was a beta regression with Bayesian quasi-likelihood estimation that included 24 dummy variables for RMQ responses, age, and sex as covariates (mean squared error 0.0380) based on repeated data. The model selected for RMQ to SF-6D mapping was a finite mixture model that included the overall RMQ score, age, sex, RMQ score squared, age squared, and an interaction term for age and RMQ score as covariates (mean squared error 0.0114) based on repeated data. CONCLUSIONS: It is possible to reasonably predict EQ-5D and SF-6D health utilities from RMQ scores and responses using regression methods. Our regression equations provide an empirical basis for estimating health utilities when EQ-5D or SF-6D data are not available. They can be used to inform future economic evaluations of interventions targeting LBP."," Value Health 17(6): 686-695.","UK",2014,"Back Pain","Exercise","RMDQ","Unknown","PRO study","Retrospective review","UK","Unknown","Back Pain","Exercise","PRO study","Retrospective review","RMDQ","2010:2014"]
[189,"Kienapfel, H., et al. (2004). \"Integrated outcome assessment after anterior cervical discectomy and fusion: myelocompression but not adjacent instability affect patient-reported quality of life and cervical spine symptoms.\" Spine (Phila Pa 1976) 29(22): 2501-2509.",null,"Kienapfel, H., et al.","Integrated outcome assessment after anterior cervical discectomy and fusion: myelocompression but not adjacent instability affect patient-reported quality of life and cervical spine symptoms","STUDY DESIGN: The authors conducted a cross-sectional study. OBJECTIVE: Integrated assessment of adjacent instability (AI), myelocompression (MC), magnetic resonance imaging (MRI) signs of myelopathy (MRISM), physician-assessed clinical signs and symptoms, including clinical signs of myelopathy (CSM), patients' self-reported symptoms and quality of life after anterior cervical discectomy and fusion (ACDF). MATERIALS AND METHODS: Fifty-four patients who had ACDF between 1986 and 1995 received MRI scans, conventional and flexion/extension radiographs to assess myelocompression, MRISM, fusion, and AI. Clinical outcome was assessed using signs and symptoms based on selected items of Odom's criteria, Oswestry low back pain disability questionnaire, and the neck disability index. Patients reported their quality of life (QL) on a standardized instrument (Profiles of QL of Chronically Ill [PLC]) and by a specific validated Cervical Spine Symptom Scale (CSSS). RESULTS: Myelocompression was found more frequently than expected (24%). MRISM were seen in 2 patients (4%). One of the 2 patients developed CSM. Fusion was achieved in 94% (with kyphosis in 17%). AI was found in 30%. However, only myelocompression but not AI was associated with statistically significant decreases in most QL scores (i.e., everyday capabilities, positive mood) and high cervical spine symptom burden (all P's < 0.05). CONCLUSIONS: The study results underline the need for a better understanding of the biomechanical changes in the adjacent unfused segments. Consensus is needed on postoperative follow-up guidelines, including pain management strategies. Future studies on the outcome of ACDF will profit from an integrated outcome approach, including assessments based on imaging, physicians, and patients."," Spine (Phila Pa 1976) 29(22): 2501-2509.","Germany",2004,"Cervical Myelopathy,Back Pain","Surgical","ODI,Odom,CSSS","Unknown","Tool Validation","Observational","Germany","Unknown","Cervical Myelopathy,Back Pain","Surgical","Tool Validation","Observational","ODI,Odom,CSSS","2000:2004"]
[190,"Kinel, E., et al. (2012). \"Polish validation of Brace Questionnaire.\" Eur Spine J 21(8): 1603-1608.",null,"Kinel, E., et al.","Polish validation of Brace Questionnaire","PURPOSE: The aim of the study was to undertake the process of cultural adaptation of the Brace Questionnaire (BrQ) into Polish. METHODS: The BrQ is an instrument for measuring the quality of life of scoliotic adolescents who are being treated conservatively with wearing a corrective brace. The BrQ consists of 34 Likert-scale items related to eight domains. The translation from the original Greek into Polish was performed. The process of cultural adaptation of the questionnaire was in accordance with the guidelines of the International Quality of Life Assessment Project. It involved 35 adolescents, aged between 10.0 and 16.0 years, all with adolescent idiopathic scoliosis with mean Cobb angle of 35.1 +/- 10.6 degrees, and all wearing the same kind of brace (Cheneau orthosis) for more than 3 months. Statistical analysis calculated the reliability (internal consistency), floor and ceiling effects of the BrQ. RESULTS: The internal consistency was satisfactory; Cronbach's alpha coefficient was 0.94. There was no floor or ceiling effects. CONCLUSIONS: Polish version of the BrQ is reliable and can be used in adolescents with idiopathic scoliosis wearing the brace to assess their quality of life."," Eur Spine J 21(8): 1603-1608.","Poland",2012,"Spinal Deformity","Brace","BrQ","Adolescents","Tool Validation","Observational","Poland","Adolescents","Spinal Deformity","Brace","Tool Validation","Observational","BrQ","2010:2014"]
[191,"Klaber Moffett, J. A., et al. (2005). \"Randomised trial of a brief physiotherapy intervention compared with usual physiotherapy for neck pain patients: outcomes and patients' preference.\" Bmj 330(7482): 75.",null,"Klaber Moffett, J. A., et al.","Randomised trial of a brief physiotherapy intervention compared with usual physiotherapy for neck pain patients: outcomes and patients' preference","OBJECTIVES: Firstly, to compare the effectiveness of a brief physiotherapy intervention with \"usual\" physiotherapy for patients with neck pain. Secondly, to evaluate the effect of patients' preferences on outcome. DESIGN: Non-inferiority randomised controlled trial eliciting preferences independently of randomisation. SETTING: Physiotherapy departments in a community setting in Yorkshire and north Lincolnshire. PARTICIPANTS: 268 patients (mean age 48 years) with subacute and chronic neck pain, who were referred by their general practitioner and randomly assigned to a brief physiotherapy intervention (one to three sessions) using cognitive behaviour principles to encourage self management and return to normal function or usual physiotherapy, at the discretion of the physiotherapist concerned. MAIN OUTCOME MEASURES: The Northwick Park neck pain questionnaire (NPQ), a specific measure of functional disability resulting from neck pain. Also, the short form 36 (SF-36) questionnaire, a generic, health related, quality of life measure; and the Tampa scale for kinesophobia, a measure of fear and avoidance of movement. RESULTS: At 12 months, patients allocated to usual physiotherapy had a small but significant improvement in NPQ scores compared with patients in the brief intervention group (mean difference 1.99, 95% confidence interval 0.45 to 3.52; P = 0.01). Although the result shows a significant inferiority of the intervention, the confidence interval shows that the effect could be in the non-inferiority range for the brief intervention (below 1.2 points of NPQ score). Patients who preferred the brief intervention and received this treatment had similar outcomes to patients receiving usual physiotherapy. CONCLUSIONS: Usual physiotherapy may be only marginally better than a brief physiotherapy intervention for neck pain. Patients with a preference for the brief intervention may do at least as well with this approach. Additional training for the physiotherapists in cognitive behaviour techniques might improve this approach further."," Bmj 330(7482): 75.","UK",2005,"Neck Pain","Physical Therapy","Northwick","Adults","PRO study","RCT","UK","Adults","Neck Pain","Physical Therapy","PRO study","RCT","Northwick","2005:2009"]
[192,"Kofotolis, N., et al. (2016). \"Effects of Pilates and trunk strengthening exercises on health-related quality of life in women with chronic low back pain.\" J Back Musculoskelet Rehabil 29(4): 649-659.",null,"Kofotolis, N., et al.","Effects of Pilates and trunk strengthening exercises on health-related quality of life in women with chronic low back pain","BACKGROUND: Pilates programs are widely used as a form of regular exercise in a broad range of populations investigating their effectiveness for chronic low back pain (CLBP) treatment. OBJECTIVE: The aim of this study was to compare the effects of a Pilates program and a trunk strengthening exercise program on functional disability and health-related quality of life (HRQOL) in women with nonspecific CLBP. METHODS: A total of 101 volunteer women with CLBP provided data with a 3-month follow-up. They were randomized to either a Pilates (n= 37), trunk strengthening exercise (n= 36) or a control group (n= 28), exercising for a period of 8 weeks, three times a week. Data were collected on HRQOL using the Short-Form 36 Health Survey (SF-36v2), and functional disability using the Roland Morris Disability Questionnaire prior to program initiation, mid-intervention, immediately after program termination, and three months post-intervention. RESULTS: The Pilates participants reported greater improvements on self-reported functional disability and HRQOL compared with participants in the trunk strengthening exercise and control groups (p < 0.05). The effects were retained for a period of three months after program termination for the Pilates group and to a lesser extent for the trunk strengthening exercise group. CONCLUSIONS: An 8-week Pilates program improved HRQOL and reduced functional disability more than either a trunk strengthening exercise program or controls among women with CLBP."," J Back Musculoskelet Rehabil 29(4): 649-659.","Greece",2016,"Back Pain","Exercise","RMDQ","Unknown","PRO study","Clinical trial","Greece","Unknown","Back Pain","Exercise","PRO study","Clinical trial","RMDQ","2015:2018"]
[193,"Konstantinovic, L. M., et al. (2010). \"Acute low back pain with radiculopathy: a double-blind, randomized, placebo-controlled study.\" Photomed Laser Surg 28(4): 553-560.",null,"Konstantinovic, L. M., et al.","Acute low back pain with radiculopathy: a double-blind, randomized, placebo-controlled study","OBJECTIVE: The aim of this study was to investigate the clinical effects of low-level laser therapy (LLLT) in patients with acute low back pain (LBP) with radiculopathy. BACKGROUND DATA: Acute LBP with radiculopathy is associated with pain and disability and the important pathogenic role of inflammation. LLLT has shown significant anti-inflammatory effects in many studies. MATERIALS AND METHODS: A randomized, double-blind, placebo-controlled trial was performed on 546 patients. Group A (182 patients) was treated with nimesulide 200 mg/day and additionally with active LLLT; group B (182 patients) was treated only with nimesulide; and group C (182 patients) was treated with nimesulide and placebo LLLT. LLLT was applied behind the involved spine segment using a stationary skin-contact method. Patients were treated 5 times weekly, for a total of 15 treatments, with the following parameters: wavelength 904 nm; frequency 5000 Hz; 100-mW average diode power; power density of 20 mW/cm(2) and dose of 3 J/cm(2); treatment time 150 sec at whole doses of 12 J/cm(2). The outcomes were pain intensity measured with a visual analog scale (VAS); lumbar movement, with a modified Schober test; pain disability, with Oswestry disability score; and quality of life, with a 12-item short-form health survey questionnaire (SF-12). Subjects were evaluated before and after treatment. Statistical analyses were done with SPSS 11.5. RESULTS: Statistically significant differences were found in all outcomes measured (p < 0.001), but were larger in group A than in B (p < 0.0005) and C (p < 0.0005). The results in group C were better than in group B (p < 0.0005). CONCLUSIONS: The results of this study show better improvement in acute LBP treated with LLLT used as additional therapy."," Photomed Laser Surg 28(4): 553-560.","Serbia",2010,"Back Pain,Radiculopathy","Laser Therapy","ODI","Unknown","PRO study","RCT","Serbia","Unknown","Back Pain,Radiculopathy","Laser Therapy","PRO study","RCT","ODI","2010:2014"]
[194,"Kopec, J. A., et al. (2008). \"Computerized adaptive testing in back pain: validation of the CAT-5D-QOL.\" Spine (Phila Pa 1976) 33(12): 1384-1390.",null,"Kopec, J. A., et al.","Computerized adaptive testing in back pain: validation of the CAT-5D-QOL","STUDY DESIGN: We have conducted an outcome instrument validation study. OBJECTIVE: Our objective was to develop a computerized adaptive test (CAT) to measure 5 domains of health-related quality of life (HRQL) and assess its feasibility, reliability, validity, and efficiency. SUMMARY OF BACKGROUND DATA: Kopec and colleagues have recently developed item response theory based item banks for 5 domains of HRQL relevant to back pain and suitable for CAT applications. The domains are Daily Activities (DAILY), Walking (WALK), Handling Objects (HAND), Pain or Discomfort (PAIN), and Feelings (FEEL). METHODS: An adaptive algorithm was implemented in a web-based questionnaire administration system. The questionnaire included CAT-5D-QOL (5 scales), Modified Oswestry Disability Index (MODI), Roland-Morris Disability Questionnaire (RMDQ), SF-36 Health Survey, and standard clinical and demographic information. Participants were outpatients treated for mechanical back pain at a referral center in Vancouver, Canada. RESULTS: A total of 215 patients completed the questionnaire and 84 completed a retest. On average, patients answered 5.2 items per CAT-5D-QOL scale. Reliability ranged from 0.83 (FEEL) to 0.92 (PAIN) and was 0.92 for the MODI, RMDQ, and Physical Component Summary (PCS-36). The ceiling effect was 0.5% for PAIN compared with 2% for MODI and 5% for RMQ. The CAT-5D-QOL scales correlated as anticipated with other measures of HRQL and discriminated well according to the level of satisfaction with current symptoms, duration of the last episode, sciatica, and disability compensation. The average relative discrimination index was 0.87 for PAIN, 0.67 for DAILY and 0.62 for WALK, compared with 0.89 for MODI, 0.80 for RMDQ, and 0.59 for PCS-36. CONCLUSION: The CAT-5D-QOL is feasible, reliable, valid, and efficient in patients with back pain. This methodology can be recommended for use in back pain research and should improve outcome assessment, facilitate comparisons across studies, and reduce patient burden."," Spine (Phila Pa 1976) 33(12): 1384-1390.","Canada",2008,"Back Pain","Not Specified","ODI,RMDQ","Unknown","Tool Validation","Observational","Canada","Unknown","Back Pain","Not Specified","Tool Validation","Observational","ODI,RMDQ","2005:2009"]
[195,"Korovessis, P., et al. (2007). \"Comparative multifactorial analysis of the effects of idiopathic adolescent scoliosis and Scheuermann kyphosis on the self-perceived health status of adolescents treated with brace.\" Eur Spine J 16(4): 537-546.",null,"Korovessis, P., et al.","Comparative multifactorial analysis of the effects of idiopathic adolescent scoliosis and Scheuermann kyphosis on the self-perceived health status of adolescents treated with brace","Bracing is the most effective non-operative treatment for mild progressive spinal deformities in adolescence but it has shown a considerable impact on several aspects of adolescents' functioning. This cross-sectional study investigated the self-perceived health status of adolescents with the two most common deformities, treated with body orthosis. Seventy-nine adolescents with spinal deformities (idiopathic adolescent scoliosis, thoracic Scheuermann kyphosis) and 62 adolescents without spinal deformities were asked to complete the Quality of Life profile for Spine Deformities Instrument. This study showed that adolescents with deformities are significantly less likely to have back pain in training than controls, but more likely to have difficulty in forward bending, and in the most common daily activities while in brace. These individuals claim they wake up because of back pain and feel quite nervous with the external appearance of their body. These patients face often problems with their relations with friends, while they reported difficulties in getting up from bed and sleep at night more often than their counterparts without deformities. As they grow older, patients feel increasing ashamed of their body, as they are more concerned about the future effect of the deformity on their body. As the bracing time increases, patients have much more probability than controls to get low back pain. Girls with deformity have a higher probability than boys to get low back pain while working in the house and while training. Individuals with larger spinal curvatures have more difficulties in bending and increased incidence of back pain than their counterparts with smaller curvatures. Psychological reasons associated mainly with relations at school and back pain are the main causes for low compliance in adolescents with spinal deformities treated with body orthosis. Careful instructions for all individuals who will undergo brace therapy, psychological support for all patients who develop psychological reactions and physical training particularly for older girls should be recommended to increase bracing compliance."," Eur Spine J 16(4): 537-546.","Greece",2007,"Back Pain,Spinal Deformity","Not Specified","QLSDP","Adolescents","PRO study","Observational","Greece","Adolescents","Back Pain,Spinal Deformity","Not Specified","PRO study","Observational","QLSDP","2005:2009"]
[196,"Kotil, K. and R. Tari (2011). \"Two level cervical corpectomy with iliac crest fusion and rigid plate fixation: a retrospective study with a three-year follow-up.\" Turk Neurosurg 21(4): 606-612.",null,"Kotil, K. and R. Tari","Two level cervical corpectomy with iliac crest fusion and rigid plate fixation: a retrospective study with a three-year follow-up","AIM: There is no clear knowlegde in the literature about two-level vertebral corpectomy using the iliac bone crest for fusion and rigid plate fixation. We present our experience with two-vertebral level cervical corpectomy and reconstruction. MATERIAL AND METHODS: Each patient was graded according to the Nuricks Grade (1972) and the modified Japanese Orthopaedic Association (mJOA) Scale (1991), and the recovery rates were calculated. All patients had two-level vertabral corpectomy. Anterior iliac crest bone graft with titanium plate fixation was applied to all patients. RESULTS: Postoperatively the mJOA score raised up to 15.5. Mean recovery rate was 69%. Average 25.2 degrees correction of kyphosis was achieved in 21 patients. Among the postoperative complications, three cases (12%) had temporary C5 nerve palsy that was resolved in three weeks, two cases had (8 %) graft malposition and infection, and three cases (%12) had temporary donor site pain. CONCLUSION: Excellent fusion rates can be achieved following two-level corpectomy with iliac bone graft repacement. This techique is easy, cost effective and safe. If the bone graft is harvested from the iliac crest by standart approach and between anatomical landmarks, most patients do not experience persistent pain at the donor site."," Turk Neurosurg 21(4): 606-612.","Turkey",2011,"Spinal Deformity","Surgical","JOACMEQ,Nurick","Unknown","PRO study","Observational","Turkey","Unknown","Spinal Deformity","Surgical","PRO study","Observational","JOACMEQ,Nurick","2010:2014"]
[197,"Kovacs, F. M., et al. (2008). \"Psychometric characteristics of the Spanish version of instruments to measure neck pain disability.\" BMC Musculoskelet Disord 9: 42.",null,"Kovacs, F. M., et al.","Psychometric characteristics of the Spanish version of instruments to measure neck pain disability","BACKGROUND: The NDI, COM and NPQ are evaluation instruments for disability due to NP. There was no Spanish version of NDI or COM for which psychometric characteristics were known. The objectives of this study were to translate and culturally adapt the Spanish version of the Neck Disability Index Questionnaire (NDI), and the Core Outcome Measure (COM), to validate its use in Spanish speaking patients with non-specific neck pain (NP), and to compare their psychometric characteristics with those of the Spanish version of the Northwick Pain Questionnaire (NPQ). METHODS: Translation/re-translation of the English versions of the NDI and the COM was done blindly and independently by a multidisciplinary team. The study was done in 9 primary care Centers and 12 specialty services from 9 regions in Spain, with 221 acute, subacute and chronic patients who visited their physician for NP: 54 in the pilot phase and 167 in the validation phase. Neck pain (VAS), referred pain (VAS), disability (NDI, COM and NPQ), catastrophizing (CSQ) and quality of life (SF-12) were measured on their first visit and 14 days later. Patients' self-assessment was used as the external criterion for pain and disability. In the pilot phase, patients' understanding of each item in the NDI and COM was assessed, and on day 1 test-retest reliability was estimated by giving a second NDI and COM in which the name of the questionnaires and the order of the items had been changed. RESULTS: Comprehensibility of NDI and COM were good. Minutes needed to fill out the questionnaires [median, (P25, P75)]: NDI. 4 (2.2, 10.0), COM: 2.1 (1.0, 4.9). Reliability: [ICC, (95%CI)]: NDI: 0.88 (0.80, 0.93). COM: 0.85 (0.75,0.91). Sensitivity to change: Effect size for patients having worsened, not changed and improved between days 1 and 15, according to the external criterion for disability: NDI: -0.24, 0.15, 0.66; NPQ: -0.14, 0.06, 0.67; COM: 0.05, 0.19, 0.92. VALIDITY: Results of NDI, NPQ and COM were consistent with the external criterion for disability, whereas only those from NDI were consistent with the one for pain. Correlations with VAS, CSQ and SF-12 were similar for NDI and NPQ (absolute values between 0.36 and 0.50 on day 1, between 0.38 and 0.70 on day 15), and slightly lower for COM (between 0.36 and 0.48 on day 1, and between 0.33 and 0.61 on day 15). Correlation between NDI and NPQ: r = 0.84 on day 1, r = 0.91 on day 15. Correlation between COM and NPQ: r = 0.63 on day 1, r = 0.71 on day 15. CONCLUSION: Although most psychometric characteristics of NDI, NPQ and COM are similar, those from the latter one are worse and its use may lead to patients' evolution seeming more positive than it actually is. NDI seems to be the best instrument for measuring NP-related disability, since its results are the most consistent with patient's assessment of their own clinical status and evolution. It takes two more minutes to answer the NDI than to answer the COM, but it can be reliably filled out by the patient without assistance. TRIAL REGISTRATION: Clinical Trials Register NCT00349544."," BMC Musculoskelet Disord 9: 42.","Spain",2008,"Neck Pain","Not Specified","NDI,Northwick","Unknown","Tool Validation","Prospective Observation","Spain","Unknown","Neck Pain","Not Specified","Tool Validation","Prospective Observation","NDI,Northwick","2005:2009"]
[198,"Kovacs, F., et al. (2007). \"Fear avoidance beliefs do not influence disability and quality of life in Spanish elderly subjects with low back pain.\" Spine (Phila Pa 1976) 32(19): 2133-2138.",null,"Kovacs, F., et al.","Fear avoidance beliefs do not influence disability and quality of life in Spanish elderly subjects with low back pain","STUDY DESIGN: Correlation between previously validated questionnaires. OBJECTIVE: To assess the association of fear avoidance beliefs (FAB) with disability and quality of life in elderly Spanish subjects. SUMMARY OF BACKGROUND DATA: As opposed to Anglo-Saxon and Northern European patients, in Spanish low back pain (LBP) patients of working age, the influence of FAB on disability and quality of life is sparse and much less than that of pain. The influence of FAB on LBP-related disability and quality of life in the elderly is unknown. METHODS: A visual analogue scale (VAS), the Roland Morris Questionnaire (RMQ), the FAB-Phys questionnaire (FABQ), and the SF-12 questionnaire were used to assess LBP, disability, fear avoidance beliefs, and quality of life in 661 institutionalized elderly in Spain, 439 of whom had LBP. RESULTS: In all subjects, FAB correlated with LBP (r = 0.477), disability (r = 0.458), the Physical Component Summary of SF-12 (PCS SF-12) (r = -0.389), and the Mental Component Summary of SF-12 (MCS SF-12) (r = -0.165). In subjects with LBP, FABs only correlated weakly with disability (r = -0.110). The stronger correlations were found between LBP and disability, both in all subjects (r = 0.803) and LBP patients (r = 0.445). Regression models including all the participants showed that the influence of FABs on physical quality of life was sparse and that FABs were not associated with either disability or mental quality of life. In elderly subjects with LBP, FABs were not associated with either disability or quality of life. CONCLUSION: In Spanish institutionalized elderly subjects, FABs only have a minor influence on physical quality of life, and none on disability or mental quality of life. In elderly subjects with LBP, differences in FABs are not associated with differences in disability or quality of life. Further studies should explore the potential value of FABs in the elderly in other settings."," Spine (Phila Pa 1976) 32(19): 2133-2138.","Spain",2007,"Back Pain","Not Specified","RMDQ","Elderly","PRO study","Observational","Spain","Elderly","Back Pain","Not Specified","PRO study","Observational","RMDQ","2005:2009"]
[199,"Krein, S. L., et al. (2013). \"Pedometer-based internet-mediated intervention for adults with chronic low back pain: randomized controlled trial.\" J Med Internet Res 15(8): e181.",null,"Krein, S. L., et al.","Pedometer-based internet-mediated intervention for adults with chronic low back pain: randomized controlled trial","BACKGROUND: Chronic pain, especially back pain, is a prevalent condition that is associated with disability, poor health status, anxiety and depression, decreased quality of life, and increased health services use and costs. Current evidence suggests that exercise is an effective strategy for managing chronic pain. However, there are few clinical programs that use generally available tools and a relatively low-cost approach to help patients with chronic back pain initiate and maintain an exercise program. OBJECTIVE: The objective of the study was to determine whether a pedometer-based, Internet-mediated intervention can reduce chronic back pain-related disability. METHODS: A parallel group randomized controlled trial was conducted with 1:1 allocation to the intervention or usual care group. 229 veterans with nonspecific chronic back pain were recruited from one Department of Veterans Affairs (VA) health care system. Participants randomized to the intervention received an uploading pedometer and had access to a website that provided automated walking goals, feedback, motivational messages, and social support through an e-community (n=111). Usual care participants (n=118) also received the uploading pedometer but did not receive the automated feedback or have access to the website. The primary outcome was measured using the Roland Morris Disability Questionnaire (RDQ) at 6 months (secondary) and 12 months (primary) with a difference in mean scores of at least 2 considered clinically meaningful. Both a complete case and all case analysis, using linear mixed effects models, were conducted to assess differences between study groups at both time points. RESULTS: Baseline mean RDQ scores were greater than 9 in both groups. Primary outcome data were provided by approximately 90% of intervention and usual care participants at both 6 and 12 months. At 6 months, average RDQ scores were 7.2 for intervention participants compared to 9.2 for usual care, an adjusted difference of 1.6 (95% CI 0.3-2.8, P=.02) for the complete case analysis and 1.2 (95% CI -0.09 to 2.5, P=.07) for the all case analysis. A post hoc analysis of patients with baseline RDQ scores >/=4 revealed even larger adjusted differences between groups at 6 months but at 12 months the differences were no longer statistically significant. CONCLUSIONS: Intervention participants, compared with those receiving usual care, reported a greater decrease in back pain-related disability in the 6 months following study enrollment. Between-group differences were especially prominent for patients reporting greater baseline levels of disability but did not persist over 12 months. Primarily, automated interventions may be an efficient way to assist patients with managing chronic back pain; additional support may be needed to ensure continuing improvements. TRIAL REGISTRATION: ClinicalTrials.gov NCT00694018; http://clinicaltrials.gov/ct2/show/NCT00694018 (Archived by WebCite at http://www.webcitation.org/6IsG4Y90E)."," J Med Internet Res 15(8): e181.","USA",2013,"Back Pain","Exercise","RMDQ","Unknown","PRO study","RCT","USA","Unknown","Back Pain","Exercise","PRO study","RCT","RMDQ","2010:2014"]
[200,"Krousel-Wood, M. A., et al. (1994). \"Predicting work status for patients in an occupational medicine setting who report back pain.\" Arch Fam Med 3(4): 349-355.",null,"Krousel-Wood, M. A., et al.","Predicting work status for patients in an occupational medicine setting who report back pain","OBJECTIVE: To determine the ability of patient-reported health status information to predict physician-determined fit-for-work status for patients reporting complaints of low back pain. DESIGN: Cross-sectional study using survey methods. SETTING: Occupational medicine section of a large multispecialty private clinic. PATIENTS: Four hundred sixty-two questionnaire packets were distributed to patients who were seen for work-related conditions or disorders over a 13-week period; 235 questionnaires were returned (51% response rate). One hundred seven responders reported low back pain and completed the Low Back Pain TyPE (Technology of Patient Experience) Tool. The mean (+/- SD) age of respondents was 39 (+/- 12) years; 67% of respondents were male, 70% were white, 87% were receiving worker's compensation, 58% were married, and 55% had a high school education or less. INTERVENTIONS: Questionnaire packets for self-administration containing health/functional status questions (short form [SF]-36, COOP Charts) and the Low Back Pain TyPE Tool were distributed to the patients. Other variables were abstracted from the medical records and administrative databases. MAIN OUTCOME MEASURES: The primary study outcome measured was fitness for work; patients were examined and categorized as fit or not fit for work by physicians who were unaware of the questionnaire results. RESULTS: Logistic regression analysis consisted of variables from 107 patients who reported low back pain. The final model contained the physical functioning scale (SF-36), employment status, smoking status, and physical functioning (SF-36) by gender interaction. Seventy-seven percent of the fit-for-work cases and 90% of the not-fit-for-work cases were correctly classified. CONCLUSION: Patient-reported physical function (as modified by gender), smoking status, and employment status predicted physician-determined work status for patients reporting low back pain in this study. Larger studies will be required to confirm this finding."," Arch Fam Med 3(4): 349-355.","USA",1994,"Back Pain","Not Specified","TyPE","Adults","PRO study","Observational","USA","Adults","Back Pain","Not Specified","PRO study","Observational","TyPE","1990:1994"]
[201,"Kumar, K., et al. (2005). \"Vertebroplasty in osteoporotic spine fractures: a quality of life assessment.\" Can J Neurol Sci 32(4): 487-495.",null,"Kumar, K., et al.","Vertebroplasty in osteoporotic spine fractures: a quality of life assessment","OBJECTIVE: Our goal was to perform a quantitative evaluation of the improvement in functional capacity, quality of life, mental function, reduction in drug intake and impact on hospital admissions after vertebroplasty in the treatment of osteoporotic compression fractures. The efficacy of vertebroplasty in relief of pain has been addressed in previous publications but the quantitative evaluation of improvement in quality of life has not been addressed before. METHODS: This is a prospective study of 42 patients with 83 symptomatic vertebral fractures treated by vertebroplasty with a mean follow-up of 9.1 months. The outcome was measured by pre and postoperatively utilizing the Visual Analogue Scale, the Oswestry Disability Index, the Rolland Morris Scale for Back Pain and EuroQol-5D questionnaire (EQ-5D). The postoperative evaluations were performed at one week, one month, three month, and six month intervals thereafter. RESULTS: In 34 out of 39 active patients, marked pain relief was noted (87%). The Visual Analogue Scale score improved from a mean preoperative score of 8.2 to a mean postoperative score of 2.9 (p=0.0000003) at one week follow up and 3.9 at the last follow-up. The Rolland Morris Scale for Back Pain showed a drop from a mean preoperative rating of 13 to a mean postoperative rating of 10, showing a 25% improvement (p= 0.0207). The Oswestry Disability Index preoperatively was 64.4 which improved to 43.8 postoperatively, showing a 32% improvement (p= 0.0207). The EQ-5D showed a mean preoperative index value of 0.097 and mean postoperative index value of 0.592 (p = 0.0000003). All p-values were determined by the Willcoxin sign-ranked test. CONCLUSION: Vertebroplasty is a safe and efficacious procedure with a resulting improvement in pain and quality of life."," Can J Neurol Sci 32(4): 487-495.","Canada",2005,"Spinal Fracture","Surgical","ODI,RMDQ","Unknown","PRO study","Prospective Observation","Canada","Unknown","Spinal Fracture","Surgical","PRO study","Prospective Observation","ODI,RMDQ","2005:2009"]
[202,"Kumar, S., et al. (2017). \"Effectiveness of Ayurvedic Massage (Sahacharadi Taila) in Patients with Chronic Low Back Pain: A Randomized Controlled Trial.\" J Altern Complement Med 23(2): 109-115.",null,"Kumar, S., et al.","Effectiveness of Ayurvedic Massage (Sahacharadi Taila) in Patients with Chronic Low Back Pain: A Randomized Controlled Trial","OBJECTIVES: Ayurveda is one of the oldest comprehensive healthcare systems worldwide. Ayurvedic massage and physical therapy are frequently used to treat patients with chronic pain syndromes and disorders of the musculoskeletal system. This study aimed to evaluate the effectiveness of Ayurvedic massage in nonspecific chronic low back pain by means of a randomized clinical trial. DESIGN: Sixty-four patients (mean age, 54.8 years; 49 women and 15 men) with chronic low back pain who scored >40 mm on a 100-mm visual analogue scale (VAS) were randomly assigned to a 2-week massage group with 6 hours of Ayurvedic massage and external treatment (n = 32) or to a 2-week local thermal therapy group (n = 32). The study observation period was 4 weeks, consisting of a 2-week intervention phase followed by a 2-week follow-up phase. OUTCOME MEASURES: Primary outcome measure was the change of mean pain (VAS) from baseline to week 4. Secondary outcomes included pain-related bothersomeness, the Roland Disability Questionnaire, quality of life (Medical Outcomes Study 36-Item Short Form), the Hanover Functional Ability Questionnaire for measuring back pain-related disability, and psychological outcomes. Outcomes were assessed at baseline and after 2 and 4 weeks. RESULTS: Mean back pain (primary outcome) at week 2 was significantly reduced from 53.4 +/- 18.5 to 21.6 +/- 18.2 in the massage group and from 55.3 +/- 12.9 to 41.8 +/- 19.8 in the standard thermal therapy group (mean group difference, -18.7; 95% confidence interval, -28.7 to -8.7; p < 0.001). While beneficial effects on pain-related bothersomeness and psychological well-being were also apparent, the Ayurvedic intervention did not improve function or disability in the short-term observation period. Both programs were safe and well tolerated. CONCLUSIONS: Ayurvedic external treatment is effective for pain-relief in chronic low back pain in the short term. Further studies with longer observation periods are needed to evaluate the long-term effects of the Ayurvedic external treatment approach on function and disability."," J Altern Complement Med 23(2): 109-115.","Germany",2017,"Back Pain","Massage,Physical Therapy","RMDQ,Bothersomeness","Adults","PRO study","RCT","Germany","Adults","Back Pain","Massage,Physical Therapy","PRO study","RCT","RMDQ,Bothersomeness","2015:2018"]
[203,"Kyrola, K., et al. (2017). \"Reliability and Validity Study of the Finnish Adaptation of Scoliosis Research Society Questionnaire Version SRS-30.\" Spine (Phila Pa 1976) 42(12): 943-949.",null,"Kyrola, K., et al.","Reliability and Validity Study of the Finnish Adaptation of Scoliosis Research Society Questionnaire Version SRS-30","STUDY DESIGN: A prospective clinical study to test and adapt a Finnish version of the Scoliosis Research Society 30 (SRS-30) questionnaire. OBJECTIVE: The aim of this study was to perform cross-cultural adaptation and evaluate the validity of the adapted Finnish version of the SRS-30 questionnaire. SUMMARY OF BACKGROUND DATA: The SRS-30 questionnaire has proved to be a valid instrument in evaluating health-related quality of life (HRQoL) in adolescent and adult population with spine deformities in the United States. Multinational availability requires cross-cultural and linguistic adaptation and validation of the instrument. METHODS: The SRS-30 was translated into Finnish using accepted methods for translation of quality-of-life questionnaires. A total of 274 adult patients with degenerative radiographic sagittal spinal disorder answered the questionnaire with sociodemographic data, RAND 36-item health survey questionnaire (RAND Corp. Health, Santa Monica, CA, US), Oswestry disability index, DEPS depression scale, and Visual Analog Scale (VAS) back and leg pain scales within 2 weeks' interval. The cohort included patients with and without previous spine surgery. Internal consistency and validity were tested with Cronbach alpha, intraclass correlation (ICC), standard error of measurement, and Spearman correlation coefficient with 95% confidence intervals (CIs). RESULTS: The internal consistency of SRS-30 was good in both surgery and nonsurgery groups, with Cronbach alpha 0.853 (95% CI, 0.670 to 0.960) and 0.885 (95% CI, 0.854 to 0.911), respectively. The test-retest reproducibility ICC of the SRS-30 total and subscore domains of patients with stable symptoms was 0.905 (95% CI, 0.870-0.930) and 0.904 (95% CI, 0.871-0.929), respectively. The questionnaire had discriminative validity in the pain, self-image, and satisfaction with management domains compared with other questionnaires. CONCLUSION: The SRS-30 questionnaire proved to be valid and applicable in evaluating HRQoL in Finnish adult spinal deformity patients. It has two domains related to deformity that are not covered by other generally used questionnaires. LEVEL OF EVIDENCE: 3."," Spine (Phila Pa 1976) 42(12): 943-949.","Finland",2017,"Spinal Deformity","Surgical","SRS-HRQOL,ODI","Adolescents","Tool Validation","Prospective Observation","Finland","Adolescents","Spinal Deformity","Surgical","Tool Validation","Prospective Observation","SRS-HRQOL,ODI","2015:2018"]
[204,"Lafage, V., et al. (2009). \"Pelvic tilt and truncal inclination: two key radiographic parameters in the setting of adults with spinal deformity.\" Spine (Phila Pa 1976) 34(17): E599-606.",null,"Lafage, V., et al.","Pelvic tilt and truncal inclination: two key radiographic parameters in the setting of adults with spinal deformity","STUDY DESIGN: Prospective radiographic and clinical analysis. OBJECTIVE: Investigate the relationship between spino-pelvic parameters and patient self reported outcomes on adult subjects with spinal deformities. SUMMARY OF BACKGROUND DATA: It is becoming increasingly recognized that the study of spinal alignment should include pelvic position. While pelvic incidence determines lumbar lordosis, pelvic tilt (PT) is a positional parameter reflecting compensation to spinal deformity. Correlation between plumbline offset (sagittal vertical axis [SVA]) and Health Related Quality of Life (HRQOL) measures has been demonstrated, but such a study is lacking for PT. METHODS: This prospective study was carried out on 125 adult patients suffering from spinal deformity (mean age: 57 years). Full-length free-standing radiographs including the spine and pelvis were available for all patients. HRQOL instruments included: Oswestry Disability Index, Short Form-12, Scoliosis Research Society. Correlation analysis between radiographic spinopelvic parameters and HRQOL measures was pursued. RESULTS: Correlation analysis revealed no significance pertaining to coronal plane parameters. Significant sagittal plane correlations were identified. SVA and truncal inclination measured by T1 spinopelvic inclination (T1-SPI) (angle between T1-hip axis and vertical) correlated with: Scoliosis Research Society (appearance, activity, total score), Oswestry Disability Index, and Short Form-12 (physical component score). Correlation coefficients ranged from 0.42 < r < 0.55 (P < 0.0001). T1-SPI revealed greater correlation with HRQOL compared to SVA. PT showed correlation with HRQOL (0.28 < r < 0.42) and with SVA (r = 0.64, P < 0.0001). CONCLUSION: This study confirms that pelvic position measured via PT correlates with HRQOL in the setting of adult deformity. High values of PT express compensatory pelvic retroversion for sagittal spinal malalignment. This study also demonstrates significant T1-SPI correlation with HRQOL measures and outperforms SVA. This parameter carries the advantage of being an angular measurement which avoids the error inherent in measuring offsets in noncalibrated radiographs."," Spine (Phila Pa 1976) 34(17): E599-606.","USA",2009,"Spinal Deformity","Not Specified","ODI,SRS-HRQOL","Adults","PRO study","Prospective Observation","USA","Adults","Spinal Deformity","Not Specified","PRO study","Prospective Observation","ODI,SRS-HRQOL","2005:2009"]
[205,"Lai, S. M., et al. (2006). \"Estimating SRS-22 quality of life measures with SF-36: application in idiopathic scoliosis.\" Spine (Phila Pa 1976) 31(4): 473-478.",null,"Lai, S. M., et al.","Estimating SRS-22 quality of life measures with SF-36: application in idiopathic scoliosis","STUDY DESIGN: Comparison of a generic- with a disorder-specific health-related quality of life (HRQL) questionnaire. OBJECTIVES: To determine the association between generic- and disorder-specific questionnaire domains of similar construct. SUMMARY OF BACKGROUND DATA: Short Form-36 (SF-36), a general HRQL questionnaire, has been widely used to evaluate patients with scoliosis and related spine deformity. How it relates to the disorder-specific Scoliosis Research Society-22 (SRS-22) questionnaire is currently unknown. METHODS: Seventy-eight patients, operated at a mean age 14.5 years for idiopathic scoliosis with a mean largest Cobb of 60 degrees , completed both questionnaires at a mean of 9.25 years after surgery. RESULTS: The predictability of the SRS-22 Mental Health domain is excellent using the SF-36 Mental Health domain, from which it was adapted (R2 = 0.81). The SRS-22 Pain domain predictability using the SF-36 Bodily Pain domain is also excellent (R2 = 0.79). The SRS-22 Function domain predictability using the SF-36 Physical Component Summary domain is good (R2 = 0.64). The SRS-22 Self-Image and Management Satisfaction/Dissatisfaction domains are poorly predicted by the SF-36 General Health and Physical Component Summary domains, respectively, R2 = 0.52 and 0.54. CONCLUSION: SRS-22 Mental Health and Pain domain scores can be accurately calculated from correlating SF-36 domain scores. SRS-22 Function scores can be fairly well predicted from correlated SF-36 domain scores. Self-Image and Management Satisfaction/Dissatisfaction domain scores cannot be approximated from SF-36 domain scores."," Spine (Phila Pa 1976) 31(4): 473-478.","USA",2006,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Prospective Observation","USA","Adolescents","Spinal Deformity","Surgical","PRO study","Prospective Observation","SRS-HRQOL","2005:2009"]
[206,"Lai, S. M., et al. (2010). \"Identification of Scoliosis Research Society-22r Health-Related Quality of Life questionnaire domains using factor analysis methodology.\" Spine (Phila Pa 1976) 35(12): 1236-1240.",null,"Lai, S. M., et al.","Identification of Scoliosis Research Society-22r Health-Related Quality of Life questionnaire domains using factor analysis methodology","STUDY DESIGN: Cross-sectional mail questionnaire. OBJECTIVE: Examination of the underlying construct validity of the Scoliosis Research Society-22r (SRS-22r) Health-Related Quality of Life (HRQoL) Questionnaire using factor analysis. SUMMARY OF BACKGROUND DATA: The original SRS-24 HRQoL questionnaire has undergone a series of modifications in an effort to further improve its psychometric properties and validate its use in patients from 10 years of age until well into adulthood. The SRS-22r questionnaire is the result of this effort. To date, the underlying construct validity of the original English version has not been analyzed by factor analysis. METHODS: A questionnaire including all questions on the SRS-24, -23, -22, and -22r questionnaires (49 total questions) was mailed to a consecutive series of 235 patients who had received primary posterior or anterior instrumentation and arthrodesis. Domain structure of the SRS-22r questions was analyzed using iterated principal factor analysis with orthogonal rotation. RESULTS: One hundred twenty-one (51%) of the patients, age 23.34 +/- 4.52 years (range, 14.16-34.57 years), returned the questionnaire at 8.63 +/- 4.00 years (range, 2.32-15.94 years) following surgery. Factor analysis using all 22 questions resulted in 3 factors with many shared items because of significant collinearity of the satisfaction/dissatisfaction with management questions with the others. After 18 iterations, factor analysis using the 20 nonmanagement questions revealed 4 factors that explained 98% of the variance. These factors parallel the assigned domains of the SRS-22r questionnaire. Three questions (2 self-image and 1 function) were identified that had high loading in 2 factors. However, internal consistency was best when 2 of the questions (1 self-image and 1 function) were retained in their assigned SRS-22r domains and the third decreased self-image internal consistency by only 0.01%. The internal consistencies (Cronbach alpha) of the assigned SRS-22r nonmanagement domains were excellent or very good: function 0.83, pain 0.87, self-image 0.80, and mental health 0.90. For the management domain it was good: 0.73. CONCLUSION: Factor analysis of the SRS-22r HRQoL confirms placement of the 20 nonmanagement domain questions in the assigned 4 domains, all with excellent or very good internal consistency."," Spine (Phila Pa 1976) 35(12): 1236-1240.","USA",2010,"Spinal Deformity","Surgical","SRS-HRQOL","Adults","Tool Validation","Observational","USA","Adults","Spinal Deformity","Surgical","Tool Validation","Observational","SRS-HRQOL","2010:2014"]
[207,"Lake, W. B., et al. (2013). \"Comparative effectiveness research in spine surgery.\" J Comp Eff Res 2(1999): 45-51.",null,"Lake, W. B., et al.","Comparative effectiveness research in spine surgery","Degenerative spine disorders are a significant cause of patient morbidity and are a prominent factor in healthcare costs in many countries. Pressure for healthcare cost control and the desire for improved outcomes have led to an expanding emphasis on evidence-based medicine methodologies in spine research. Determination of the optimal treatment paradigm for many common degenerative spinal disorders has proven difficult and comparative effectiveness research is increasingly being employed to examine these clinical dilemmas. The Swedish Spine Registry and the Registry of the Scoliosis Research Society are two of the long-standing databases compiling data for spine patients. Spine surgery professional organizations have recently taken a prominent role in assembling procedural- and diagnosis-based registries, specifically addressing therapeutic outcomes for spine patients. As healthcare systems continue to evolve, comparative effectiveness research driven by spine registries may better elucidate the appropriate clinical choices for patients with these challenging illnesses."," J Comp Eff Res 2(1999): 45-51.","USA",2013,"Spinal Deformity","Surgical","SRS-HRQOL","Unknown","PRO study","Narrative review","USA","Unknown","Spinal Deformity","Surgical","PRO study","Narrative review","SRS-HRQOL","2010:2014"]
[208,"Lam, M. W., et al. (2008). \"Quality-of-life outcomes after surgical correction of pectus excavatum: a comparison of the Ravitch and Nuss procedures.\" J Pediatr Surg 43(5): 819-825.",null,"Lam, M. W., et al.","Quality-of-life outcomes after surgical correction of pectus excavatum: a comparison of the Ravitch and Nuss procedures","PURPOSE: The purpose of this study was to compare clinical and health-related quality-of-life (HRQL) outcomes within a group of patients treated for pectus excavatum (PE). METHODS: A retrospective 3-year review of patients undergoing Nuss or Ravitch correction of PE was performed. Health-related quality-of-life assessment was performed using the Child Health Questionnaire (CHQ-CF87) and the 17-item Pectus Excavatum Evaluation Questionnaire, and results were compared between groups and with age-matched CHQ-CF87 normative data. RESULTS: Forty-three patients (39 males; 91%) underwent surgery; 19 (44%) by Nuss procedure. Duration of postoperative opioid analgesia and length of hospital stay (LOS) were significantly longer in Nuss patients. The overall survey response rate was 53%. The groups differed significantly in the CHQ on one item (Change in Health). On the Pectus Excavatum Evaluation Questionnaire, Nuss patients reported being \"less bothered\" by the appearance of their chest. Compared to Australian age-matched norms, the aggregate PE sample showed better scores for family activity domain and worse scores in mental health, general health perceptions, change in health, bodily pain, and self-esteem. CONCLUSIONS: Patients undergoing surgery for PE by either Nuss or Ravitch procedure have similar clinical and HRQL outcomes, but as a group have poorer HRQL scores than age-matched population norms."," J Pediatr Surg 43(5): 819-825.","Canada",2008,"Pectus Excavatum","Surgical","Pectus","Unknown","PRO study","Retrospective review","Canada","Unknown","Pectus Excavatum","Surgical","PRO study","Retrospective review","Pectus","2005:2009"]
[209,"Lamb, S. E., et al. (2007). \"Managing Injuries of the Neck Trial (MINT): design of a randomised controlled trial of treatments for whiplash associated disorders.\" BMC Musculoskelet Disord 8: 7.",null,"Lamb, S. E., et al.","Managing Injuries of the Neck Trial (MINT): design of a randomised controlled trial of treatments for whiplash associated disorders","BACKGROUND: A substantial proportion of patients with whiplash injuries develop chronic symptoms. However, the best treatment of acute injuries to prevent long-term problems is uncertain. A stepped care treatment pathway has been proposed, in which patients are given advice and education at their initial visit to the emergency department (ED), followed by review at three weeks and physiotherapy for those with persisting symptoms. MINT is a two-stage randomised controlled trial to evaluate two components of such a pathway: 1. use of The Whiplash Book versus usual advice when patients first attend the emergency department; 2. referral to physiotherapy versus reinforcement of advice for patients with continuing symptoms at three weeks. METHODS: Evaluation of the Whiplash Book versus usual advice uses a cluster randomised design in emergency departments of eight NHS Trusts. Eligible patients are identified by clinicians in participating emergency departments and are sent a study questionnaire within a week of their ED attendance. Three thousand participants will be included. Patients with persisting symptoms three weeks after their ED attendance are eligible to join an individually randomised study of physiotherapy versus reinforcement of the advice given in ED. Six hundred participants will be randomised. Follow-up is at 4, 8 and 12 months after their ED attendance. Primary outcome is the Neck Disability Index (NDI), and secondary outcomes include quality of life and time to return to work and normal activities. An economic evaluation is being carried out. CONCLUSION: This paper describes the protocol and operational aspects of a complex intervention trial based in NHS emergency and physiotherapy departments, evaluating two components of a stepped-care approach to the treatment of whiplash injuries. The trial uses two randomisations, with the first stage being cluster randomised and the second individually randomised."," BMC Musculoskelet Disord 8: 7.","UK",2007,"Trauma","Physical Therapy","NDI","Unknown","PRO study","Clinical trial","UK","Unknown","Trauma","Physical Therapy","PRO study","Clinical trial","NDI","2005:2009"]
[210,"Lamb, S. E., et al. (2010). \"A multicentred randomised controlled trial of a primary care-based cognitive behavioural programme for low back pain. The Back Skills Training (BeST) trial.\" Health Technol Assess 14(41): 1-253, iii-iv.",null,"Lamb, S. E., et al.","A multicentred randomised controlled trial of a primary care-based cognitive behavioural programme for low back pain. The Back Skills Training (BeST) trial","OBJECTIVES: To estimate the clinical effectiveness of active management (AM) in general practice versus AM plus a group-based, professionally led cognitive behavioural approach (CBA) for subacute and chronic low back pain (LBP) and to measure the cost of each strategy over a period of 12 months and estimate cost-effectiveness. DESIGN: Pragmatic multicentred randomised controlled trial with investigator-blinded assessment of outcomes. SETTING: Fifty-six general practices from seven English regions. PARTICIPANTS: People with subacute and chronic LBP who were experiencing symptoms that were at least moderately troublesome. INTERVENTIONS: Participants were randomised (in a ratio of 2:1) to receive either AM+CBA or AM alone. MAIN OUTCOME MEASURES: Primary outcomes were the Roland Morris Disability Questionnaire (RMQ) and the Modified Von Korff Scale (MVK), which measure LBP and disability. Secondary outcomes included mental and physical health-related quality of life (Short Form 12-item health survey), health status, fear avoidance beliefs and pain self-efficacy. Cost-utility of CBA was considered from both the UK NHS perspective and a broader health-care perspective, including both NHS costs and costs of privately purchased goods and services related to LBP. Quality-adjusted life-years (QALYs) were calculated from the five-item EuroQoL. RESULTS: Between April 2005 and April 2007, 701 participants were randomised: 233 to AM and 468 to AM+CBA. Of these, 420 were female. The mean age of participants was 54 years and mean baseline RMQ was 8.7. Outcome data were obtained for 85% of participants at 12 months. Benefits were seen across a range of outcome measures in favour of CBA with no evidence of group or therapist effects. CBA resulted in at least twice as much improvement as AM. Mean additional improvement in the CBA arm was 1.1 [95% confidence interval (CI) 0.4 to 1.7], 1.4 (95% CI 0.7 to 2.1) and 1.3 (95% CI 0.6 to 2.1) change points in the RMQ at 3, 6 and 12 months respectively. Additional improvement in MVK pain was 6.8 (95% CI 3.5 to 10.2), 8.0 (95% CI 4.3 to 11.7) and 7.0 (95% CI 3.2 to 10.7) points, and in MVK disability was 4.3 (95% CI 0.4 to 8.2), 8.1 (95% CI 4.1 to 12.0) and 8.4 (95% CI 4.4 to 12.4) points at 3, 6 and 12 months respectively. At 12 months, 60% of the AM+CBA arm and 31% of the AM arm reported some or complete recovery. Mean cost of attending a CBA course was 187 pounds per participant with an additional benefit in QALYs of 0.099 and an additional cost of 178.06 pounds. Incremental cost-effectiveness ratio was 1786.00 pounds. Probability of CBA being cost-effective reached 90% at about 3000 pounds and remained at that level or above; at a cost-effectiveness threshold of 20,000 pounds the CBA group had an almost 100% probability of being considered cost-effective. User perspectives on the acceptability of group treatments were sought through semi-structured interviews. Most were familiar with key messages of AM; most who had attended any group sessions had retained key messages from the sessions and two-thirds talked about a reduction in fear avoidance and changes in their behaviour. Group sessions appeared to provide reassurance, lessen isolation and enable participants to learn strategies from each other. CONCLUSIONS: Long-term effectiveness and cost-effectiveness of CBA in treating subacute and chronic LBP was shown, making this intervention attractive to patients, clinicians and purchasers. Short-term (3-month) clinical effects were similar to those found in high-quality studies of other therapies and benefits were maintained and increased over the long term (12 months). Cost per QALY was about half that of competing interventions for LBP and because the intervention can be delivered by existing NHS staff following brief training, the back skills training programme could be implemented within the NHS with relative ease. TRIAL REGISTRATION: Current Controlled Trials ISRCTN37807450. FUNDING: The National Institute for Health Research Health Technology Assessment programme."," Health Technol Assess 14(41): 1-253, iii-iv.","UK",2010,"Back Pain","CBT","RMDQ","Adults","Cost-Effectiveness","RCT","UK","Adults","Back Pain","CBT","Cost-Effectiveness","RCT","RMDQ","2010:2014"]
[211,"Lamb, S. E., et al. (2010). \"Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis.\" Lancet 375(9718): 916-923.",null,"Lamb, S. E., et al.","Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis","BACKGROUND: Low-back pain is a common and costly problem. We estimated the effectiveness of a group cognitive behavioural intervention in addition to best practice advice in people with low-back pain in primary care. METHODS: In this pragmatic, multicentre, randomised controlled trial with parallel cost-effectiveness analysis undertaken in England, 701 adults with troublesome subacute or chronic low-back pain were recruited from 56 general practices and received an active management advisory consultation. Participants were randomly assigned by computer-generated block randomisation to receive an additional assessment and up to six sessions of a group cognitive behavioural intervention (n=468) or no further intervention (control; n=233). Primary outcomes were the change from baseline in Roland Morris disability questionnaire and modified Von Korff scores at 12 months. Assessment of outcomes was blinded and followed the intention-to-treat principle, including all randomised participants who provided follow-up data. This study is registered, number ISRCTN54717854. FINDINGS: 399 (85%) participants in the cognitive behavioural intervention group and 199 (85%) participants in the control group were included in the primary analysis at 12 months. The most frequent reason for participant withdrawal was unwillingness to complete questionnaires. At 12 months, mean change from baseline in the Roland Morris questionnaire score was 1.1 points (95% CI 0.39-1.72) in the control group and 2.4 points (1.89-2.84) in the cognitive behavioural intervention group (difference between groups 1.3 points, 0.56-2.06; p=0.0008). The modified Von Korff disability score changed by 5.4% (1.99-8.90) and 13.8% (11.39-16.28), respectively (difference between groups 8.4%, 4.47-12.32; p<0.0001). The modified Von Korff pain score changed by 6.4% (3.14-9.66) and 13.4% (10.77-15.96), respectively (difference between groups 7.0%, 3.12-10.81; p<0.0001). The additional quality-adjusted life-year (QALY) gained from cognitive behavioural intervention was 0.099; the incremental cost per QALY was 1786 pound sterling, and the probability of cost-effectiveness was greater than 90% at a threshold of 3000 pound sterling per QALY. There were no serious adverse events attributable to either treatment. INTERPRETATION: Over 1 year, the cognitive behavioural intervention had a sustained effect on troublesome subacute and chronic low-back pain at a low cost to the health-care provider. FUNDING: National Institute for Health Research Health Technology Assessment Programme."," Lancet 375(9718): 916-923.","UK",2010,"Back Pain","CBT","RMDQ","Adults","Cost-Effectiveness","RCT","UK","Adults","Back Pain","CBT","Cost-Effectiveness","RCT","RMDQ","2010:2014"]
[212,"Lamb, S. E., et al. (2012). \"Group cognitive behavioural interventions for low back pain in primary care: extended follow-up of the Back Skills Training Trial (ISRCTN54717854).\" Pain 153(2): 494-501.",null,"Lamb, S. E., et al.","Group cognitive behavioural interventions for low back pain in primary care: extended follow-up of the Back Skills Training Trial (ISRCTN54717854)","Group cognitive behavioural intervention (CBI) is effective in reducing low back pain and disability over a 12-month period, in comparison to best practice advice in primary care. The aim was to study the effects of this CBI beyond 12 months. We undertook an extended follow-up of our original randomised, controlled trial of a group CBI and best practice advice in primary care, in comparison to best practice advice alone. Participants were mailed a questionnaire including measures of disability, pain, health services resource use, and health-related quality of life. The time of extended follow-up ranged between 20 and 50 months (mean 34 months). Fifty-six percent (395 of 701) of the original cohort provided extended follow-up. Those who responded were older and had less disability and pain at baseline than did the original trial cohort. After 12 months, the improvements in pain and disability observed with CBI were sustained. For disability measures, the treatment difference in favour of CBI persisted (mean difference 1.3 Roland and Morris Disability Questionnaire points, 95% confidence interval 0.27 to 2.26; 5.5 Modified von Korff Scale disability points, 95% confidence interval 0.27 to 10.64). There was no between-group difference in Modified von Korff Scale pain outcomes. The results suggest that the effects of a group CBI are maintained up to an average of 34 months. Although pain improves in response to best practice advice, longer-term recovery of disability remains substantially less."," Pain 153(2): 494-501.","UK",2012,"Back Pain","CBT","RMDQ","Unknown","PRO study","RCT","UK","Unknown","Back Pain","CBT","PRO study","RCT","RMDQ","2010:2014"]
[213,"Lamb, S. E., et al. (2012). \"Managing Injuries of the Neck Trial (MINT): a randomised controlled trial of treatments for whiplash injuries.\" Health Technol Assess 16(49): iii-iv, 1-141.",null,"Lamb, S. E., et al.","Managing Injuries of the Neck Trial (MINT): a randomised controlled trial of treatments for whiplash injuries","OBJECTIVES: To examine the clinical effectiveness of a stepped care approach over a 12-month period after an acute whiplash injury; to estimate the costs and cost-effectiveness of each strategy including treatments and subsequent health-care costs; and to gain participants' perspective on experiencing whiplash injury, NHS treatment, and recovery within the context of the Managing Injuries of the Neck Trial (MINT). DESIGN: Two linked, pragmatic, randomised controlled trials. In Step 1, emergency departments (EDs) were cluster randomised to usual care advice (UCA) or The Whiplash Book advice (WBA)/active management advice. In Step 2, participants were individually randomised to either a single session of advice from a physiotherapist or a physiotherapy package of up to six sessions. An economic evaluation and qualitative study were run in parallel with the trial. SETTING: Twelve NHS trusts in England comprising 15 EDs. PARTICIPANTS: People who attended EDs with an acute whiplash injury of whiplash-associated disorder grades I-III were eligible for Step 1. People who had attended EDs with whiplash injuries and had persistent symptoms 3 weeks after ED attendance were eligible for Step 2. INTERVENTIONS: In Step 1, the control intervention was UCA and the experimental intervention was a psycho-educational intervention (WBA/active management advice). In Step 2 the control treatment was reinforcement of the advice provided in Step 1 and the experimental intervention was a package of up to six physiotherapy treatments. MAIN OUTCOME: The primary outcome was the Neck Disability Index (NDI), which measures severity and frequency of pain and symptoms, and a range of activities including self-care, driving, reading, sleeping and recreation. Secondary outcomes included the mental and physical health-related quality-of-life (HRQoL) subscales of the Short Form questionnaire-12 items (SF-12) and the number of work days lost. RESULTS: A total of 3851 patients were recruited to Step 1 of the trial. 1598 patients attending EDs were randomised to UCA, and 2253 were randomised to WBA/active management. Outcome data were obtained at 12 months for 70% and 80% of participants at Step 1 and Step 2, respectively. The majority of people recovered from the injury. Eighteen per cent of the Step 1 cohort had late whiplash syndrome. There was no statistically or clinically significant difference observed in any of the outcomes for participants attending EDs randomised to UCA or active management advice [difference in NDI 0.5, 95% confidence interval (CI) -1.8 to 2.8]. In Step 2 the physiotherapy package resulted in improvements in neck disability at 4 months compared with a single advice session, but these effects were small at the population level (difference in NDI -3.2, 95% CI -5.8 to -0.7). The physiotherapy package was accompanied by a significant reduction in the number of work days lost at 4-month follow-up (difference -40.2, 95% CI -44.3 to -35.8). CONCLUSIONS: MINT suggests that enhanced psycho-educational interventions in EDs are no more effective than UCA in reducing the burden of acute whiplash injuries. A physiotherapy package provided to people who have persisting symptoms within the first 6 weeks of injury produced additional short-term benefits in neck disability compared with a single physiotherapy advice session. However, from a health-care perspective, the physiotherapy package was not cost-effective at current levels of willingness to pay. Both experimental treatments were associated with increased cost with no discernible gain in health-related quality of life. However, an important benefit of the physiotherapy package was a reduction in work days lost; consequently, the intervention may prove cost-effective at the societal level. TRIAL REGISTRATION: Current Controlled Trials ISRCTN33302125. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 16, No. 49. See the HTA programme website for further project information."," Health Technol Assess 16(49): iii-iv, 1-141.","UK",2012,"Trauma","Physical Therapy","NDI","Unknown","Cost-Effectiveness","RCT","UK","Unknown","Trauma","Physical Therapy","Cost-Effectiveness","RCT","NDI","2010:2014"]
[214,"Lamb, S. E., et al. (2013). \"Emergency department treatments and physiotherapy for acute whiplash: a pragmatic, two-step, randomised controlled trial.\" Lancet 381(9866): 546-556.",null,"Lamb, S. E., et al.","Emergency department treatments and physiotherapy for acute whiplash: a pragmatic, two-step, randomised controlled trial","BACKGROUND: Little is known about the effectiveness of treatments for acute whiplash injury. We aimed to estimate whether training of staff in emergency departments to provide active management consultations was more effective than usual consultations (Step 1) and to estimate whether a physiotherapy package was more effective than one additional physiotherapy advice session in patients with persisting symptoms (Step 2). METHODS: Step 1 was a pragmatic, cluster randomised trial of 12 NHS Trust hospitals including 15 emergency departments who treated patients with acute whiplash associated disorder of grades I-III. The hospitals were randomised by clusters to either active management or usual care consultations. In Step 2, we used a nested individually randomised trial. Patients were randomly assigned to receive either a package of up to six physiotherapy sessions or a single advice session. Randomisation in Step 2 was stratified by centre. Investigator-masked outcomes were obtained at 4, 8, and 12 months. Masking of clinicians and patients was not possible in all steps of the trial. The primary outcome was the Neck Disability Index (NDI). Analysis was intention to treat, and included an economic evaluation. The study is registered ISRCTN33302125. FINDINGS: Recruitment ran from Dec 5, 2005 to Nov 30, 2007. Follow-up was completed on Dec 19, 2008. In Step 1, 12 NHS Trusts were randomised, and 3851 of 6952 eligible patients agreed to participate (1598 patients were assigned to usual care and 2253 patients were assigned to active management). 2704 (70%) of 3851 patients provided data at 12 months. NDI score did not differ between active management and usual care consultations (difference at 12 months 0.5, 95% CI -1.5 to 2.5). In Step 2, 599 patients were randomly assigned to receive either advice (299 patients) or a physiotherapy package (300 patients). 479 (80%) patients provided data at 12 months. The physiotherapy package at 4 months showed a modest benefit compared to advice (NDI difference -3.7, -6.1 to -1.3), but not at 8 or 12 months. Active management consultations and the physiotherapy package were more expensive than usual care and single advice session. No treatment-related serious adverse events or deaths were noted. INTERPRETATION: Provision of active management consultation did not show additional benefit. A package of physiotherapy gave a modest acceleration to early recovery of persisting symptoms but was not cost effective from a UK NHS perspective. Usual consultations in emergency departments and a single physiotherapy advice session for persistent symptoms are recommended. FUNDING: NIHR Health Technology Assessment programme."," Lancet 381(9866): 546-556.","UK",2013,"Trauma","Physical Therapy","NDI","Unknown","PRO study","RCT","UK","Unknown","Trauma","Physical Therapy","PRO study","RCT","NDI","2010:2014"]
[215,"Lan, L., et al. (2014). \"Acupuncture for functional dyspepsia.\" Cochrane Database Syst Rev(10): Cd008487.",null,"Lan, L., et al.","Acupuncture for functional dyspepsia","BACKGROUND: Functional dyspepsia (FD) has been a worldwide complaint. More effective therapies are needed with fewer adverse effects than are seen with conventional medications. Acupuncture, as a traditional therapeutic method, has been widely used for functional gastrointestinal disorders in the East. Manual acupuncture and electroacupuncture have been recognized treatments for FD, but to date, no robust evidence has been found for the effectiveness and safety of these interventions in the treatment of this condition. OBJECTIVES: This review was conducted to assess the efficacy and safety of manual acupuncture and electroacupuncture in the treatment of FD. SEARCH METHODS: Trials meeting the inclusion criteria were identified through electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Allied and Complementary Medicine Database (AMED), Chinese Biology Medicine Disc (CBMdisc), China National Knowledge Infrastructure (CNKI), the Wanfang Database, the VIP Database, and six trial registries. Handsearching was done to screen the reference sections of potential trials and reviews. SELECTION CRITERIA: Randomized controlled trials (RCTs) were included if investigators reported efficacy and safety of manual acupuncture or electroacupuncture for patients with FD diagnosed by Rome II or Rome III criteria, compared with medications, blank control, or sham acupuncture. DATA COLLECTION AND ANALYSIS: Data were extracted by independent review authors. Study limitations were assessed by using the tool of The Cochrane Collabration for assessing risk of bias. For dichotomous data, risk ratios (RRs) and 95% confidence intervals (95% CIs) would be applied, and for continuous data, mean differences (MDs) and 95% CIs. A fixed-effect model was applied in the meta-analysis, or a descriptive analysis was performed. The quality of evidence for the outcome measure was assessed by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methods. MAIN RESULTS: Seven studies were included in the review, involving 542 participants with FD (212 males and 330 females). These studies generally had an unclear risk of bias based on inadequate descriptions of allocation concealment and a high risk of bias based on lack of blinding. None of the studies reported on outcomes of the Functional Digestive Disorder Quality of Life questionnaire (FDDQL), the Satisfaction With Dyspepsia Related Health scale (SODA), the Digestive Health Status Instrument (DHSI), or effective/inefficient rate and symptom recurrence six months from completion of acupuncture treatment.Four RCTs of acupuncture versus medications (cisapride, domperidone, and itopride) were included in the review. No statistically significant difference was noted in the reduction in FD symptom scores and the frequency of FD attack by manual acupuncture, manual-electroacupuncture, or electroacupuncture compared with medications. In three trials of acupuncture versus sham acupuncture, all descriptive or quantitative analysis results implied that acupuncture could improve FD symptom scores and scores on the Neck Disability Index (NDI), the 36-Item Short Form Health Survey (SF-36), the Self-Rating Anxiety Scale (SAS), and the Self-Rating Depression Scale (SDS) more or as significantly as sham acupuncture. With regard to adverse effects, acupuncture was superior to cisapride treatment (one study; all minor events), but no statistically significant difference was reported between acupuncture and sham acupuncture. No adverse effects data were reported in studies examining manual acupuncture versus domperidone, manual-electroacupuncture versus domperidone, or electroacupuncture versus itopride.Nevertheless, all evidence was of low or very low quality. The body of evidence identified cannot yet permit a robust conclusion regarding the efficacy and safety of acupuncture for FD. AUTHORS' CONCLUSIONS: It remains unknown whether manual acupuncture or electroacupuncture is more effective or safer than other treatments for patients with FD."," Cochrane Database Syst Rev(10): Cd008487.","China",2014,"Functional Dyspepsia","Acupuncture","NDI","Unknown","PRO study","Systematic review","China","Unknown","Functional Dyspepsia","Acupuncture","PRO study","Systematic review","NDI","2010:2014"]
[216,"Landen Ludvigsson, M., et al. (2017). \"Cost-effectiveness of neck-specific exercise with or without a behavioral approach versus physical activity prescription in the treatment of chronic whiplash-associated disorders: Analyses of a randomized clinical trial.\" Medicine (Baltimore) 96(25): e7274.",null,"Landen Ludvigsson, M., et al.","Cost-effectiveness of neck-specific exercise with or without a behavioral approach versus physical activity prescription in the treatment of chronic whiplash-associated disorders: Analyses of a randomized clinical trial","BACKGROUND: Fifty percent of people injured by whiplash still report neck pain after 1 year and costs associated with whiplash associated disorders (WAD) are mostly attributed to health service and sick-leave costs in chronic conditions. With increasing health care expenditures the economic impact of interventions needs to be considered. OBJECTIVE: To analyze the cost-effectiveness of physiotherapist-led neck-specific exercise without (NSE) or with a behavioral approach (NSEB), or prescription of physical activity (PPA) in chronic WAD, grade 2 to 3. METHODS: This is a secondary cost-effectiveness analysis of a multicenter randomized clinical trial of 216 participants with chronic WAD grade 2 to 3. The interventions were physiotherapist-led neck-specific exercise without or with a behavioral approach, or prescription of physical activity for 12 weeks. Incremental cost-effectiveness ratios (ICERs) were determined after 1 year and bootstrapped cost-effectiveness planes and sensitivity analyses of physiotherapy visits were performed. Health care and production loss costs were included and quality-adjusted life years (QALYs) were estimated, using the Euroqol-5D questionnaire. Comparisons with the Short Form-6D, and neck disability index (NDI) were also made. RESULTS: The 1-year follow-up was completed by 170 participants (79%). Both physiotherapist-led groups improved in health related quality of life. The intervention cost alone, per quality-adjusted life year (QALY) gain in the NSE group was US$ 12,067. A trend for higher QALY gains were observed in the NSEB group but the costs were also higher. The ICERs varied depending on questionnaire used, but the addition of a behavioral approach to neck-specific exercise alone was not cost-effective from a societal perspective (ICER primary outcome $127,800 [95% confidence interval [CI], 37,816-711,302]). The sensitivity analyses confirmed the results. The prescription of physical activity did not result in any QALY gain and the societal costs were not lower. CONCLUSION: Neck-specific exercise was cost-effective from a societal perspective in the treatment of chronic WAD compared with the other exercise interventions. ICERS varied depending on health-related quality of life questionnaires used, but the addition of a behavioral approach was not cost-effective from a societal perspective. The prescription of physical activity did not result in any QALY gain and was thus not considered a relevant option."," Medicine (Baltimore) 96(25): e7274.","Sweden",2017,"Neck Pain","Exercise","NDI","Unknown","Cost-Effectiveness","RCT","Sweden","Unknown","Neck Pain","Exercise","Cost-Effectiveness","RCT","NDI","2015:2018"]
[217,"Lara-Palomo, I. C., et al. (2013). \"Short-term effects of interferential current electro-massage in adults with chronic non-specific low back pain: a randomized controlled trial.\" Clin Rehabil 27(5): 439-449.",null,"Lara-Palomo, I. C., et al.","Short-term effects of interferential current electro-massage in adults with chronic non-specific low back pain: a randomized controlled trial","OBJECTIVES: To analyse the effectiveness of a combined procedure of massage and electrotherapy with interferential current in individuals with chronic non-specific low back pain of mechanical aetiology. DESIGN: A single blinded randomized controlled trial. SETTING: Clinical setting. PARTICIPANTS: Sixty-two individuals with chronic non-specific low back pain were randomly assigned to an experimental or control group. For 10 weeks the experimental group underwent treatment comprising 20 sessions (twice a week) of massage with interferential current in the lumbar and dorsal-lumbar area, and the control group received superficial lower back massage (effleurage, superficial pressure and skin rolling). MAIN OUTCOME VARIABLES: Oswestry Disability Index, pain visual analogue scale, Tampa Scale for Kinesiophobia, Roland Morris Disability Questionnaire, McQuade Test, Side Bridge Test, quality of life scores and the range of trunk anteflexion motion, which were all assessed before the treatment and immediately after the last treatment session. RESULTS: The 2 x 2 mixed model ANOVA with repeated measurements showed statistically significant group * time interactions for the visual analogue scale (F = 12.839; P = 0.001), Oswestry Disability Index (F = 5.850; P = 0.019), Roland Morris Disability Questionnaire (F = 8.237; P = 0.006) and quality of life (physical function (F = 16.792; P = 0.001), physical role (F = 14.839; P = 0.001) and body pain (F = 11.247; P = 0.001)). CONCLUSIONS: In individuals with chronic non-specific low back pain, interferential current electro-massage achieved a significantly greater improvement in disability, pain and quality of life in comparison to superficial massage after 20 treatment sessions."," Clin Rehabil 27(5): 439-449.","Spain",2013,"Back Pain","Massage,Electrotherapy","ODI,RMDQ","Unknown","PRO study","RCT","Spain","Unknown","Back Pain","Massage,Electrotherapy","PRO study","RCT","ODI,RMDQ","2010:2014"]
[218,"Lark, R. K., et al. (2013). \"Adding thoracic fusion levels in Lenke 5 curves: risks and benefits.\" Spine (Phila Pa 1976) 38(2): 195-200.",null,"Lark, R. K., et al.","Adding thoracic fusion levels in Lenke 5 curves: risks and benefits","STUDY DESIGN: Multicenter; review of prospectively collected data. OBJECTIVE: To determine the risks and potential benefits of nonselective versus selective fusion in a matched set of patients with Lenke 5 curves. SUMMARY OF BACKGROUND DATA: The Lenke classification suggests a limited thoracolumbar/lumbar fusion for type 5 curves, although many experienced adolescent idiopathic scoliosis surgeons, at times, include a fusion of the thoracic curve. METHODS.: Prospectively collected cases from a multicenter database were analyzed. Patients with Lenke type 5 scoliosis curves were divided into 2 groups: 109 selective or short (only thoracolumbar/lumbar curve fused), and 41 nonselective or long (both thoracolumbar/lumbar and thoracic curves fused). Patients were then matched on the basis of the preoperative radiographical and clinical measures. Two-year postoperative radiographical and clinical outcomes were compared, using analysis of variance, with Bonferroni correction (P < 0.008). RESULTS: Twenty-nine matched pairs (58 patients) with Lenke 5 curves were identified. There were no preoperative differences between groups in age, thoracic or lumbar Cobb angle, curve flexibility, thoracic kyphosis, clinical trunk flexibility, or Scoliosis Research Society outcomes questionnaire scores. Postoperatively, patients in the nonselective group exhibited greater coronal correction for thoracic (residual Cobb; 22 degrees vs. 12 degrees ) and lumbar curves (residual Cobb; 19 degrees vs. 13 degrees ). However, the longer fusions had significantly less thoracic kyphosis (27 degrees vs. 18 degrees ), truncal side bending (14 vs. 10 cm), and rotational flexibility (53 degrees vs. 42 degrees ). There was no difference in clinical balance or Scoliosis Research Society questionnaire, version 22, scores. CONCLUSION: Adolescent idiopathic scoliosis surgeons attempt to achieve balanced correction with the fewest motion segments fused. Our data suggest that fusion of the thoracic curve in primary thoracolumbar scoliosis may improve coronal correction, but at the cost of decreased thoracic kyphosis and clinical flexibility 2 years postoperatively."," Spine (Phila Pa 1976) 38(2): 195-200.","USA",2013,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","Cost and Resource Use","Prospective Observation","USA","Adolescents","Spinal Deformity","Surgical","Cost and Resource Use","Prospective Observation","SRS-HRQOL","2010:2014"]
[219,"Larson, A. N., et al. (2014). \"Does higher anchor density result in increased curve correction and improved clinical outcomes in adolescent idiopathic scoliosis?\" Spine (Phila Pa 1976) 39(7): 571-578.",null,"Larson, A. N., et al.","Does higher anchor density result in increased curve correction and improved clinical outcomes in adolescent idiopathic scoliosis?","STUDY DESIGN: Retrospective review of prospectively collected data. OBJECTIVE: To determine whether anchor density is associated with curve correction and patient-reported outcomes. SUMMARY OF BACKGROUND DATA: There is limited information as to whether anchor density affects the results of adolescent idiopathic scoliosis surgery. METHODS: A total of 952 patients with adolescent idiopathic scoliosis met inclusion criteria (Lenke 1, 2, and 5 curves) with predominantly screw constructs (no. of screws/no. of total anchors >75%). Anchor density was defined as the number of screws, hooks, and wires per level fused, with less than 1.54 considered low density. Analysis of covariance was undertaken to determine association of anchor density with percent curve correction, Scoliosis Research Society (SRS), and Spinal Appearance Questionnaire (SAQ) scores, controlling for flexibility, fusion length, demographics, and surgeon. RESULTS: High- compared with low-anchor density was associated with increased percent curve correction in Lenke 1 curves at 1 year (69% vs. 66% correction, P = 0.0022), controlling for percent preoperative curve flexibility, length of fusion, and sex (model, P < 0.0001). Similar associations held at 2-year follow-up and for Lenke 2 curves. Decreased thoracic kyphosis was found with increased anchor density for Lenke 1 and 2 curve patterns. There were no associations found between anchor density and Lenke 5 curves. For Lenke 1 curve patterns at 2 years postoperatively, in the high- versus low-anchor density cohorts, there were statistically higher SRS Activity (4.3 vs. 4.2, P = 0.019), Appearance (4.3 vs. 4.1, P = 0.0005), Satisfaction (4.5 vs. 4.3, P = 0.028), and Total scores (4.3 vs. 4.2; P = 0.024). Similarly, the SAQ Appearance score at 1 year similarly was improved in the high-anchor density group (high: 14.1 vs. low: 15.0, P = 0.03) for Lenke 1 curve patterns only. CONCLUSION: For Lenke 1 and 2 curve patterns, improved percent correction of major coronal curve was noted in the high-screw density cohort. Although statistical significance was reached, it is unclear whether screw density resulted in clinically significant differences in patient-reported outcomes."," Spine (Phila Pa 1976) 39(7): 571-578.","USA",2014,"Spinal Deformity","Surgical","SRS-HRQOL,SAQ","Adolescents","PRO study","Prospective Observation","USA","Adolescents","Spinal Deformity","Surgical","PRO study","Prospective Observation","SRS-HRQOL,SAQ","2010:2014"]
[220,"Lau, D., et al. (2016). \"The Clinical Correlation of the Hart-ISSG Proximal Junctional Kyphosis Severity Scale With Health-Related Quality-of-life Outcomes and Need for Revision Surgery.\" Spine (Phila Pa 1976) 41(3): 213-223.",null,"Lau, D., et al.","The Clinical Correlation of the Hart-ISSG Proximal Junctional Kyphosis Severity Scale With Health-Related Quality-of-life Outcomes and Need for Revision Surgery","STUDY DESIGN: Retrospective analysis of prospective data. OBJECTIVE: Evaluate the utility of the Hart-International Spine Study Group proximal junctional kyphosis severity scale (Hart-ISSG PJKSS). SUMMARY OF BACKGROUND DATA: Proximal junctional kyphosis (PJK) and failure (PJF) are well-described complications after long-segment instrumentation. The Hart-ISSG PJKSS was recently developed and incorporates neurological deficit, pain, instrumentation issues, degree of kyphosis, presence of fracture, and level of upper-most instrumented vertebrae. METHODS: All adult spinal deformity patients with PJK or PJF were identified from two academic centers over a 7-year period. Health-related quality-of-life (HRQOL) outcomes were prospectively collected: Oswestry Disability Index (ODI), visual analogue scale (VAS) pain, SF-36 questionnaire, and SRS-30 questionnaire. Patients were retrospectively assigned Hart-ISSG PJKSS scores. Correlation between the Hart-ISSG PJKSS and outcomes was assessed with linear regression, Pearson correlation coefficients, and chi(2) analysis. RESULTS: A total of 184 cases were included; 21.2% were men and mean age was 65.0 years. Weakness and/or myelopathy were present in 11.4% of patients and 88.6% had pain. Instrumentation issues occurred in 44.0% and 64.1% had PJK-associated fractures. PJK occurred in the upper thoracic spine in 21.7% of cases. Mean PJKSS score was 5.9. The Hart-ISSG PJKSS was significantly and strongly associated with ODI (P < 0.001, r = 0.611), VAS pain (P < 0.001, r = 0.676), SRS-30 function (P < 0.001, r = -0.401), SRS-30 mental health (P < 0.001, r = -0.592), SRS-30 self-image (P < 0.001, r = -0.511), SRS-30 satisfaction (P < 0.001, r = -0.531), and SRS-30 pain (P < 0.001, r = -0.445). Higher scores were associated with higher proportion of patients undergoing revision surgery (P < 0.001); scores of 9 to 11 and 12 to 15 underwent revision 96.0% and 100.0% of the time, respectively. CONCLUSION: The Hart-ISSG PJKSS was strongly correlated with validated functional outcomes and higher scores were associated with higher rates of revision surgery. The Hart-ISSG PJKSS may be a useful clinical tool in the treatment of patient with PJK. LEVEL OF EVIDENCE: 3."," Spine (Phila Pa 1976) 41(3): 213-223.","USA",2016,"Cervical Myelopathy","Surgical","ODI,SRS-HRQOL","Adults","PRO study","Observational","USA","Adults","Cervical Myelopathy","Surgical","PRO study","Observational","ODI,SRS-HRQOL","2015:2018"]
[221,"Lau, H. M., et al. (2011). \"The effectiveness of thoracic manipulation on patients with chronic mechanical neck pain - a randomized controlled trial.\" Man Ther 16(2): 141-147.",null,"Lau, H. M., et al.","The effectiveness of thoracic manipulation on patients with chronic mechanical neck pain - a randomized controlled trial","The aim of our study was to assess the effectiveness of thoracic manipulation (TM) on patients with chronic neck pain. 120 patients aged between 18 and 55 were randomly allocated into two groups: an experimental group which received TM and a control group without the manipulative procedure. Both groups received infrared radiation therapy (IRR) and a standard set of educational material. TM and IRR were given twice weekly for 8 sessions. Outcome measures included craniovertebral angle (CV angle), neck pain (Numeric Pain Rating Scale; NPRS), neck disability (Northwick Park Neck Disability Questionnaire; NPQ), health-related quality of life status (SF36 Questionnaire) and neck mobility. These outcome measures were assessed immediately after 8 sessions of treatment, 3-months and at a 6-month follow-up. Patients that received TM showed significantly greater improvement in pain intensity (p = 0.043), CV angle (p = 0.049), NPQ (p = 0.018), neck flexion (p = 0.005), and the Physical Component Score (PCS) of the SF36 Questionnaire (p = 0.002) than the control group immediately post-intervention. All these improvements were maintained at the 6-month follow-ups. This study shows that TM was effective in reducing neck pain, improving dysfunction and neck posture and neck range of motion (ROM) for patients with chronic mechanical neck pain up to a half-year post-treatment."," Man Ther 16(2): 141-147.","China",2011,"Neck Pain","Manipulations","Northwick","Adults","PRO study","RCT","China","Adults","Neck Pain","Manipulations","PRO study","RCT","Northwick","2010:2014"]
[222,"Lauche, R., et al. (2011). \"The influence of a series of five dry cupping treatments on pain and mechanical thresholds in patients with chronic non-specific neck pain--a randomised controlled pilot study.\" BMC Complement Altern Med 11: 63.",null,"Lauche, R., et al.","The influence of a series of five dry cupping treatments on pain and mechanical thresholds in patients with chronic non-specific neck pain--a randomised controlled pilot study","BACKGROUND: In this preliminary trial we investigated the effects of dry cupping, an ancient method for treating pain syndromes, on patients with chronic non-specific neck pain. Sensory mechanical thresholds and the participants' self-reported outcome measures of pain and quality of life were evaluated. METHODS: Fifty patients (50.5 +/- 11.9 years) were randomised to a treatment group (TG) or a waiting-list control group (WL). Patients in the TG received a series of 5 cupping treatments over a period of 2 weeks; the control group did not. Self-reported outcome measures before and after the cupping series included the following: Pain at rest (PR) and maximal pain related to movement (PM) on a 100-mm visual analogue scale (VAS), pain diary (PD) data on a 0-10 numeric rating scale (NRS), Neck Disability Index (NDI), and health-related quality of life (SF-36). In addition, the mechanical-detection thresholds (MDT), vibration-detection thresholds (VDT), and pressure-pain thresholds (PPT) were determined at pain-related and control areas. RESULTS: Patients of the TG had significantly less pain after cupping therapy than patients of the WL group (PR: Delta-22.5 mm, p = 0.00002; PM: Delta-17.8 mm, p = 0.01). Pain diaries (PD) revealed that neck pain decreased gradually in the TG patients and that pain reported by the two groups differed significantly after the fifth cupping session (Delta-1.1, p = 0.001). There were also significant differences in the SF-36 subscales for bodily pain (Delta13.8, p = 0.006) and vitality (Delta10.2, p = 0.006). Group differences in PPT were significant at pain-related and control areas (all p < 0.05), but were not significant for MDT or VDT. CONCLUSIONS: A series of five dry cupping treatments appeared to be effective in relieving chronic non-specific neck pain. Not only subjective measures improved, but also mechanical pain sensitivity differed significantly between the two groups, suggesting that cupping has an influence on functional pain processing. TRIAL REGISTRATION: The trial was registered at clinicaltrials.gov (NCT01289964)."," BMC Complement Altern Med 11: 63.","Germany",2011,"Neck Pain","Not Specified","NDI","Unknown","PRO study","RCT","Germany","Unknown","Neck Pain","Not Specified","PRO study","RCT","NDI","2010:2014"]
[223,"Lauche, R., et al. (2013). \"Clinically meaningful differences in pain, disability and quality of life for chronic nonspecific neck pain - a reanalysis of 4 randomized controlled trials of cupping therapy.\" Complement Ther Med 21(4): 342-347.",null,"Lauche, R., et al.","Clinically meaningful differences in pain, disability and quality of life for chronic nonspecific neck pain - a reanalysis of 4 randomized controlled trials of cupping therapy","OBJECTIVES: The assessment of clinically meaningful differences in patients' self-reported outcomes has become increasingly important when interpreting the results of clinical studies. Although these assessments have become quite common there are hardly any data for nonspecific neck pain, especially in the context of complementary and alternative medicine. The aim of this analysis is the determination of minimal clinically important differences (MCID) and substantial clinical benefits (SCB) in patients with chronic nonspecific neck pain after cupping treatment. METHODS: The data set comprised a total of 200 patients with chronic nonspecific neck pain participating in clinical trials on cupping therapy. The MCID and SCB for pain intensity (VAS), neck disability index (NDI) and the subscale bodily pain (SF-36-BP) as well as physical component summary (SF-36-PCS) of the SF-36 were determined using receiver operating characteristic (ROC) curve analysis with an adapted assessment of change in health status (SF-36), i.e. a 5-point Likert scale ranging from \"much better\" to \"much worse\", as anchor. MCID derived from the ROC was the score to distinguish \"somewhat better\" from \"about the same\", and the SCB was the score to distinguish \"much better\" from \"somewhat better\". RESULTS: The calculated MCIDs were: -8mm (-21%) for VAS, -3 points (-10.2%) for NDI, +10 points (+20.5%) for SF-36-BP and +2.6 points (+7.7%) for SF-36-PCS. The SCBs were: -26.5mm (-66.8%) for VAS, -8.4 points (-29%) for NDI, +15.5 points (+43.1%) for SF-36-BP and +5.1 points (+12.9%) for SF-36-PCS. Accuracy of the estimations was good for MCID in general and for SCB regarding VAS and NDI. CONCLUSIONS: The results support the assumption that patients' perceptions of treatment benefits measured by VAS in these trials might be comparable to others in conventional therapies. For NDI and SF-36-PCS the estimated differences were smaller than in previous reports indicating that context factors such as patient characteristics and specific treatment conditions might play an important role. Further studies on MCIDS and SCBs for chronic nonspecific neck pain seem warranted."," Complement Ther Med 21(4): 342-347.","Germany",2013,"Neck Pain","Other","NDI","Unknown","PRO study","Clinical trial","Germany","Unknown","Neck Pain","Other","PRO study","Clinical trial","NDI","2010:2014"]
[224,"Lauche, R., et al. (2014). \"Reliability and validity of the pain on movement questionnaire (POM) in chronic neck pain.\" Pain Med 15(11): 1850-1856.",null,"Lauche, R., et al.","Reliability and validity of the pain on movement questionnaire (POM) in chronic neck pain","OBJECTIVE: This analysis aimed to determine reliability, validity, and responsiveness of the pain on movement (POM) questionnaire, an instrument developed to determine pain intensity induced by head movement. DESIGN: Data from nine randomized controlled trials for the treatment of chronic nonspecific neck pain were reanalyzed to determine reliability and validity of the POM questionnaire. METHODS: POM was assessed as ratings of pain intensity induced by head movement in six different directions. The instrument's structure was assessed using a factor analysis. Reliability (internal consistency) was determined using Cronbach's alpha, and validity (convergent validity) was determined by correlating the POM with pain at rest on a visual analog scale (VAS), the neck disability index (NDI), quality of life (short-form 36 health survey questionnaire [SF-36]) and range of motion. Responsiveness was indicated by sensitivity to changes over time in a subsample of 49 patients. RESULTS: Overall, 482 patients (mean age 50.3 +/- 12.4 years, 72.3% female) were included in the analysis, and 458 of them provided complete data set for the POM. Average POM was 43.9 +/- 20.8 mm on the VAS. The POM showed very good reliability as indicated by high internal consistency and moderate validity as indicated by significant correlations with the pain at rest, the NDI, and the SF-36. No correlations were found for POM with range of motion. The POM further proved to be responsive as it was sensitive to changes over time, and those changes were correlated to changes in pain intensity and NDI. CONCLUSIONS: The POM seems to be a reliable and valid instrument to assess POM in patients with chronic nonspecific neck pain."," Pain Med 15(11): 1850-1856.","Germany",2014,"Neck Pain","Not Specified","NDI","Adults","PRO study","RCT","Germany","Adults","Neck Pain","Not Specified","PRO study","RCT","NDI","2010:2014"]
[225,"Lee, S., et al. (2016). \"Efficacy and safety of Myofascial-meridian Release Acupuncture (MMRA) for chronic neck pain: a study protocol for randomized, patient- and assessor-blinded, sham controlled trial.\" BMC Complement Altern Med 16: 45.",null,"Lee, S., et al.","Efficacy and safety of Myofascial-meridian Release Acupuncture (MMRA) for chronic neck pain: a study protocol for randomized, patient- and assessor-blinded, sham controlled trial","BACKGROUND: The purpose of this study is to evaluate the efficacy and safety of myofascial-meridian release acupuncture (MMRA) in the treatment of chronic neck pain compared with sham acupuncture. METHODS/DESIGN: A protocol for a randomized, patient- and assessor-blinded, sham controlled parallel trial is presented. Seventy-four participants with a >/=3 month history of neck pain and a score of >/=4 on the 11-point pain intensity numerical rating scale (PI-NRS) will be randomly assigned to the MMRA group (n = 37) or sham acupuncture group (n = 37). The participants will receive the MMRA treatment or sham acupuncture treatment twice per week for 4 weeks. The primary outcome is the mean change in the PI-NRS (0 = no pain and 10 = worst possible pain, 11-point Likert scale) from baseline to 4 weeks. The secondary outcomes are the mean change from baseline on the clinical relevance of the pain (ratio of changes greater than 1.5 or with percentiles greater than 30 % and 50 % in the PI-NRS), function (Neck Disability Index and Cervical Range of Motion), autonomic and psychometric measurements (Heart Rate Variability and Perceived Stress Scale), quality of life (EuroQol), global assessment (Patient Global Impression of Change), semi-objective outcomes (pressure pain threshold, consumption of rescue medicine and days of restricted activity) and immunologic/stress biomarkers. Adverse events will be evaluated at every visit. DISCUSSION: The results of this trial will provide evidence to confirm the efficacy and safety of acupuncture for chronic neck pain. TRIAL REGISTRATION: The trial is registered with the Clinical Research Information Service (CRiS), Republic of Korea: KCT0001573 ."," BMC Complement Altern Med 16: 45.","Republic of Korea",2016,"Neck Pain","Acupuncture","NDI","Unknown","Protocol","RCT","Republic of Korea","Unknown","Neck Pain","Acupuncture","Protocol","RCT","NDI","2015:2018"]
[226,"Leferink, V. J., et al. (2003). \"Functional outcome in patients with thoracolumbar burst fractures treated with dorsal instrumentation and transpedicular cancellous bone grafting.\" Eur Spine J 12(3): 261-267.",null,"Leferink, V. J., et al.","Functional outcome in patients with thoracolumbar burst fractures treated with dorsal instrumentation and transpedicular cancellous bone grafting","The aim of the study was to develop an insight into the impairments in spinal fracture patients, operatively treated with an internal fixator, and also into their ability to participate in daily living, return to work and quality of life as defined by the World Health Organization. Nineteen patients operated for a type A fracture of the thoracolumbar spine (T9-L4) between 1993 and 1998 in the University Hospital Groningen, the Netherlands, aged between 18 and 60 years, without neurological deficit were included in the study. Operative treatment consisted of fracture reduction and internal fixation using the Universal Spine System, combined with transpedicular cancellous bone grafting and dorsal spondylodesis. No ventral fusion operations, laminectomies or discectomies were done. Restrictions in body function and structure were measured on radiographs and in functional capacity tests, such as lifting tests and ergometry. Restrictions in activities were studied with the Visual Analogue Scale (VAS) Spine Score and the Roland Morris Disability Questionnaire (RMDQ). Restrictions in participation/quality of life were analysed with the Short Form 36 (SF36) and described in the return to work status. The radiological results are comparable to the literature. The reduction of the anterior wedge angle was followed by a gradual partial loss of intervertebral angle and regional angle. The maximum oxygen uptake (VO2-max) was reduced in only 8.3% of the patients. Arm and trunk lift was within the normal range in 87% and 80% of the patients respectively, but only 53% of the patients were able to perform a leg lift within the normal range. A mean RMDQ score of 4.0 positive items (SD 6.0) was found, and the mean VAS Spinal Score was 79.4 (SD 25.0), both better than in other series. No significant differences compared to the values of a comparable (healthy) age group could be identified in any variable of the SF36. A high correlation was seen between RMDQ, VAS Spine Score and the SF36 categories. No correlation was found between the anterior wedge angle and the regional angle on the one hand, and functional capacity tests or questionnaire scores on the other. Of the patients in paid employment before the trauma, 87% had returned to work at follow-up. About 50% of the patients had been obliged to change the intensity of their work or the kind of work they performed after the injury and treatment. In this matter, leg (muscle) performance seems a more important factor than overall condition (VO2-max). The results of the study indicate that patients with thoracolumbar spinal fractures without neurological deficit, treated with dorsal instrumentation, perform like healthy people 3-8 years after injury, according to the RMDQ, VAS Spine Score and SF36 results. Physical capacity tests reveal that leg (muscle) performance seems a more important factor in impairment than arm lift or overall condition."," Eur Spine J 12(3): 261-267.","Netherlands",2003,"Spondylosis,Trauma","Bone Grafting","RMDQ","Adults","PRO study","Observational","Netherlands","Adults","Spondylosis,Trauma","Bone Grafting","PRO study","Observational","RMDQ","2000:2004"]
[227,"Leidig, G., et al. (1990). \"A study of complaints and their relation to vertebral destruction in patients with osteoporosis.\" Bone Miner 8(3): 217-229.",null,"Leidig, G., et al.","A study of complaints and their relation to vertebral destruction in patients with osteoporosis","Patients with spinal osteoporosis suffer from vertebral deformation, loss of height and back pain, as well as from functional limitations and alterations of mood. So far little is known about the extent of these clinical symptoms at all and whether they are related in a predictable manner to the fractures or damages of bone structure. In the present study we investigated the relation between vertebral deformation and clinical symptoms in 70 patients with osteoporosis. Clinical data like pain, functional limitations and parameters of mood were examined by a standardized questionnaire. The numbers of vertebral fractures were determined, and the vertebral destruction was quantified using the Spine Deformity Index (SDI). The symptoms and functional limitations were graded and correlated to the SDI and the number of fractures. Our results underline a relation between the extent of vertebral deformation and the reduction in quality of life by pain, functional limitations and alterations of mood. This relationship was absent or less evident, if the number of fractures was taken into account. Besides the difficulties concerning the grading and quantification of clinical symptoms and outcome of disease, our study revealed that there is a causal relation between the extent of vertebral destruction measured by the SDI and the extent of these clinical parameters."," Bone Miner 8(3): 217-229.","Germany",1990,"Osteoporosis","Not Specified","SDI","Unknown","PRO study","Narrative review","Germany","Unknown","Osteoporosis","Not Specified","PRO study","Narrative review","SDI","1990:1994"]
[228,"Lerner, T. and U. Liljenqvist (2013). \"Silicate-substituted calcium phosphate as a bone graft substitute in surgery for adolescent idiopathic scoliosis.\" Eur Spine J 22 Suppl 2: S185-194.",null,"Lerner, T. and U. Liljenqvist","Silicate-substituted calcium phosphate as a bone graft substitute in surgery for adolescent idiopathic scoliosis","STUDY DESIGN AND OBJECTIVE: The purpose of this prospective clinical study is to evaluate the clinical and radiographic outcomes using a silicate-substituted calcium phosphate (Si-CaP) as a bone graft substitute in surgery for adolescent idiopathic scoliosis (AIS). In posterior corrective surgery for AIS, harvesting autologous bone from the iliac crest still represents the gold standard to augment the local bone graft though it is comparatively invasive and associated with donor site morbidity. Si-CaP enriched with bone marrow aspirate (BMA) might be an appropriate bone graft extender to overcome these difficulties. METHODS: Eighteen female and three male patients with AIS who underwent corrective posterior instrumentation were observed clinically and radiographically for a minimum of 24 months. In all cases, 20-40 ml Si-CaP granules (ACTIFUSE) mixed with BMA from vertebral bodies was used to extend the local bone graft. Fusion was assessed by standardized conventional radiographs regarding loss of correction and implant failure. Clinical outcome was evaluated with use of the Scoliosis Research Society-22 patient Questionnaire (SRS-22) and a Visual Analog Scale (VAS) for back pain. RESULTS: Cobb angle of major curves averaged 63 degrees preoperatively, 22 degrees after surgery, and 24 degrees at final follow-up, with a maximum loss of correction of 7 degrees recorded after 4 months. No adverse effects related to the study material had been observed. In all patients, there was no evidence of implant failure, and formation of an increasingly densifying 'fusion mass' was visible, as assessed by conventional radiography. VAS score for back pain averaged 1.7 before surgery, 2.3 at discharge, and 1.5 at final follow-up. Outcome assessment using the SRS-22 revealed a significantly enhanced overall health-related quality of life (84 vs. 74 % before surgery; P = 0.0005) due to a significant improvement of the domains 'self image' (77 vs. 59 %; P = 0.0002) and 'pain' (88 vs. 80 %; P = 0.02). Patients' management satisfaction averaged 93 %. CONCLUSIONS: Si-CaP augmented with BMA from vertebral bodies seems to prove an effective, safe, and easy to handle bone graft extender in scoliosis surgery and thus a suitable alternative to bone harvesting procedures."," Eur Spine J 22 Suppl 2: S185-194.","Germany",2013,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Prospective Observation","Germany","Adolescents","Spinal Deformity","Surgical","PRO study","Prospective Observation","SRS-HRQOL","2010:2014"]
[229,"Lewis, M., et al. (2007). \"An economic evaluation of three physiotherapy treatments for non-specific neck disorders alongside a randomized trial.\" Rheumatology (Oxford) 46(11): 1701-1708.",null,"Lewis, M., et al.","An economic evaluation of three physiotherapy treatments for non-specific neck disorders alongside a randomized trial","OBJECTIVES: Cost-effectiveness and cost-utility analyses were conducted to compare advice and exercise plus manual therapy (MT) and advice and exercise plus pulsed shortwave diathermy (PSWD) with advice and exercise alone (A&E) in the treatment of non-specific neck disorders by experienced physiotherapists. METHODS: Between July 2000 and June 2002, 350 participants with neck disorders from 15 physiotherapy departments were randomized to: A&E (n = 115); MT (n = 114) and PSWD (n = 121). Outcome and resource-use data were collected using physiotherapist case report forms and participant self-complete questionnaires. Outcome measures were the Northwick Park Neck Pain Questionnaire (NPQ) and EuroQoL EQ-5D [used to derive quality-adjusted-life-year (QALY) utility scores]. Two economic viewpoints were considered (health care and societal). Cost-effectiveness acceptability curves were used to assess the probabilities of the interventions being cost-effective at different willingness-to-pay threshold values. RESULTS: Mean improvement in NPQ at 6 months was 11.5 in the A&E group, 10.2 in the MT group and 10.3 in the PSWD group; mean QALY scores were 0.362, 0.342 and 0.360, respectively. Mean health care costs were pound sterling105, pound sterling119 and pound sterling123 in the A&E, MT and PSWD groups, respectively. Mean societal costs were pound sterling373, pound sterling303 and pound sterling 338 in each group, respectively. Depending on the viewpoint and the outcome measure, A&E or MT were most likely to be the cost-effective interventions. PSWD was consistently the least cost-effective intervention. CONCLUSIONS: The cost-effective intervention is likely to be A&E or MT, depending on the economic perspective and preferred outcome, but not PSWD."," Rheumatology (Oxford) 46(11): 1701-1708.","UK",2007,"Neck Pain","Exercise","Northwick","Unknown","Cost-Effectiveness","Retrospective review","UK","Unknown","Neck Pain","Exercise","Cost-Effectiveness","Retrospective review","Northwick","2005:2009"]
[230,"Lewis, M., et al. (2015). \"Should General Practitioners Issue a Sick Certificate to Employees Who Consult for Low Back Pain in Primary Care?\" J Occup Rehabil 25(3): 577-588.",null,"Lewis, M., et al.","Should General Practitioners Issue a Sick Certificate to Employees Who Consult for Low Back Pain in Primary Care?","PURPOSE: Back pain is a common problem and has significant societal impact. Sickness certification is commonly issued to patients consulting their general practitioner with low back pain. The aim of this study was to investigate the association of certification for low back pain with clinical outcomes and cost consequences. METHODS: A prospective cohort study using linked questionnaire and medical record data from 806 low back pain patients in 8 UK general practices: comparison of 116 (14.4%) who received a sickness certificate versus 690 who did not receive certification. The primary clinical measure was the Roland and Morris Disability Questionnaire (RMDQ). Data on back pain consultation and work absenteeism were used to calculate healthcare and societal costs. RESULTS: Participants issued a sickness certificate had higher back-related disability at baseline consultation and 6-month follow-up [mean difference 3.1 (95% CI 1.8, 4.4) on the RMDQ], indicating worse health status. After fully adjusting for baseline differences, most changes in clinical outcomes at 6 months were not significantly different between study groups. Productivity losses were significantly higher for the certification group, with most absence occurring after the expected end of certification; mean difference in costs due to absenteeism over 6 months was pound1,956 (95% CI pound941, pound3040). CONCLUSIONS: There was no clear evidence of a difference in clinical outcomes between individuals issued a sickness certificate and those not issued a certification for their back pain. With little overall contrast in clinical outcomes, policy makers and care providers may wish to draw on the likely difference in societal costs alongside issues in ethical and moral care in their consideration of patient care for low back pain."," J Occup Rehabil 25(3): 577-588.","UK",2015,"Back Pain","Not Specified","RMDQ","Unknown","PRO study","Prospective Observation","UK","Unknown","Back Pain","Not Specified","PRO study","Prospective Observation","RMDQ","2015:2018"]
[231,"Li, G., et al. (2009). \"Adult scoliosis in patients over sixty-five years of age: outcomes of operative versus nonoperative treatment at a minimum two-year follow-up.\" Spine (Phila Pa 1976) 34(20): 2165-2170.",null,"Li, G., et al.","Adult scoliosis in patients over sixty-five years of age: outcomes of operative versus nonoperative treatment at a minimum two-year follow-up","STUDY DESIGN: Retrospective case-control study. OBJECTIVE: The purpose of this study was to compare the self-reported outcomes between operatively and nonoperatively treated patients over the age of 65 with adult scoliosis, using 4 distinct self-assessment questionnaires (SRS-22, SF-12, EQ5D, and Oswestry disability index [ODI]) and standard radiographic measurement parameters. SUMMARY OF BACKGROUND DATA: The current spine literature contains no studies that directly compare the self-reported and radiographic outcomes of operatively and nonoperatively treated patients over the age of 65 years with adult scoliosis. METHODS: We retrospectively analyzed the self-reported outcomes of 83 adult scoliosis in patients over the age of 65 years. A total of 34 patients were treated operatively, whereas 49 patients were managed nonoperatively. For each of these patients, standard radiographic measurements were recorded both before and after treatment, and each patient received 4 questionnaires (SRS-22, SF-12, EQ5D, and ODI) that were completed with a minimum of 2-year follow-up from the time the treatment was initiated. The outcomes of both groups were then statistically compared. RESULTS: As compared to the nonoperative group, the operative group reported significantly better self-assessment scores for the EQ5D index, EQ5D Visual Analogue Score, and SRS-22 questionnaires. However, no statistically significant difference between the groups was detected for the ODI, SF-12 Mental Health Component Summary, and SF-12 PCS. Furthermore, the operative group also had a significant improvement in radiographic measurements. CONCLUSION: Adult scoliosis patients over the age of 65 years treated operatively had significantly less pain, a better health-related quality of life, self image, mental health, and were more satisfied with their treatment than patients treated conservatively. However, we found no statistically significant differences in their degree of disability as measured by the ODI as well as physical and mental health by the SF-12 instrument. Preoperative radiographic deformity was not determined to be a significant factor for predicting whether an operative or nonoperative treatment course was chosen."," Spine (Phila Pa 1976) 34(20): 2165-2170.","USA",2009,"Spinal Deformity","Surgical","ODI,SRS-HRQOL","Adults","PRO study","Retrospective review","USA","Adults","Spinal Deformity","Surgical","PRO study","Retrospective review","ODI,SRS-HRQOL","2005:2009"]
[232,"Li, M., et al. (2009). \"Adapted simplified Chinese (mainland) version of Scoliosis Research Society-22 questionnaire.\" Spine (Phila Pa 1976) 34(12): 1321-1324.",null,"Li, M., et al.","Adapted simplified Chinese (mainland) version of Scoliosis Research Society-22 questionnaire","STUDY DESIGN: Validation study to define validity and reliability of an adapted and translated questionnaire. OBJECTIVE: This study attempted to validate the traditional Chinese (Hong Kong) version of the modified Scoliosis Research Society (SRS) Outcomes Instrument, SRS-22, into simplified Chinese for use in mainland China. SUMMARY OF BACKGROUND DATA: Although a traditional Chinese (Hong Kong) adaptation of the SRS-22 has been previously validated, no culturally adapted, validated SRS-22 exists for use in mainland China. METHODS: Adhering to International Quality of Life Assessment Project guidelines, the adapted traditional Chinese SRS-22 was translated into simplified Chinese while referencing the original English questionnaire. To examine the psychometric properties and clinical application of the adapted simplified Chinese SRS-22, a survey was conducted in a group of randomly selected 87 patients previously surgically treated at an outpatient clinic. Reliability assessment of the simplified Chinese version of the SRS-22 was determined by calculating Cronbach's alpha and intraclass coefficient (ICC) values. Concurrent validity was evaluated by comparing SRS-22 domains with relevant domains of the simplified Short-Form-36 questionnaire; correlation was made using Pearson correlation coefficients. RESULTS: Cronbach's alpha, applied to each of the 22 questions of the adapted SRS-22, revealed very satisfactory internal consistency (Cronbach's alpha = 0.80-0.89) for function/activity and pain, and good consistency (Cronbach's alpha = 0.50-0.79) for the remaining domains. The test/retest reproducibility was found to be good (ICC > or =0.40-0.75) in the function/activity domain, and excellent (ICC > or =0.75) in the remaining domains. In terms of concurrent validity, 3 domains had excellent correlation, while 10 had good correlation, and 21 had moderate correlation. DISCUSSION: The authors report the validation of a simplified Chinese SRS-22 for use in mainland China, which is culturally relevant, reliable, repeatable, psychometrically sound, and suitable for immediate clinical use."," Spine (Phila Pa 1976) 34(12): 1321-1324.","China",2009,"Spinal Deformity","Surgical","SRS-HRQOL","Unknown","Tool Validation","RCT","China","Unknown","Spinal Deformity","Surgical","Tool Validation","RCT","SRS-HRQOL","2005:2009"]
[233,"Liang, Z., et al. (2011). \"Assessment of a traditional acupuncture therapy for chronic neck pain: a pilot randomised controlled study.\" Complement Ther Med 19 Suppl 1: S26-32.",null,"Liang, Z., et al.","Assessment of a traditional acupuncture therapy for chronic neck pain: a pilot randomised controlled study","OBJECTIVE: This study is aimed to assess the efficacy of traditional acupuncture for chronic neck pain in patients by comparing the differences in symptoms, dysfunctions and quality of life. METHODS: The study used a two-arm, single-blinded, randomised controlled design. The patients were randomised to the study group and control group, who respectively received traditional acupuncture and placebo treatment. The Northwick Park Neck Pain Questionnaire (NPQ), visual analogue scale (VAS), Short Form (36) Health Survey (SF-36) and doctor's judgement were applied for measuring effectiveness. The patients' effectiveness outcome was assessed, respectively, before the intervention, immediately after the intervention, at the end of the first month of follow-up and at the end of the third month of follow-up. The statistical analysis was done on Statistical Package for Social Sciences (SPSS) v13, which included comparison of demographic and clinical homogeneity, the repeated measures approach based on the general linear model (GLM) for effectiveness assessment and the sum rank test for doctors' subjective efficacy judgement. RESULTS: Totally, 190 patients were recruited and 178 patients (88 in the study group and 90 in the control group) completed the intervention and follow-up assessment. The scores of NPQ, VAS and SF-36 were improved after the intervention and during follow-up (P<0.01 vs. before the intervention). The patients in the study group had better effectiveness outcome in NPQ, VAS and in the VT, SF and MH domains of SF-36 (P<0.05). CONCLUSION: Traditional acupuncture can relieve pain intensity and improve the quality of daily life with a relative long-term clinical efficacy in patients with chronic neck pain."," Complement Ther Med 19 Suppl 1: S26-32.","China",2011,"Neck Pain","Acupuncture","Northwick","Unknown","PRO study","RCT","China","Unknown","Neck Pain","Acupuncture","PRO study","RCT","Northwick","2010:2014"]
[234,"Licciardone, J. C. and S. Aryal (2013). \"Prevention of progressive back-specific dysfunction during pregnancy: an assessment of osteopathic manual treatment based on Cochrane Back Review Group criteria.\" J Am Osteopath Assoc 113(10): 728-736.",null,"Licciardone, J. C. and S. Aryal","Prevention of progressive back-specific dysfunction during pregnancy: an assessment of osteopathic manual treatment based on Cochrane Back Review Group criteria","CONTEXT: Back pain during pregnancy may be associated with deficits in physical functioning and disability. Research indicates that osteopathic manual treatment (OMT) slows the deterioration of back-specific functioning during pregnancy. OBJECTIVE: To measure the treatment effects of OMT in preventing progressive back-specific dysfunction during the third trimester of pregnancy using criteria established by the Cochrane Back Review Group. DESIGN: A randomized sham-controlled trial including 3 parallel treatment arms: usual obstetric care and OMT (UOBC+OMT), usual obstetric care and sham ultrasound therapy (UOBC+SUT), and usual obstetric care (UOBC). SETTING: The Osteopathic Research Center within the University of North Texas Health Science Center in Fort Worth. PARTICIPANTS: A total of 144 patients were randomly assigned and included in intention-to-treat analyses. MAIN OUTCOME MEASURES: Progressive back-specific dysfunction was defined as a 2-point or greater increase in the Roland-Morris Disability Questionnaire (RMDQ) score during the third trimester of pregnancy. Risk ratios (RRs) and 95% confidence intervals (CIs) were used to compare progressive back-specific dysfunction in patients assigned to UOBC+OMT relative to patients assigned to UOBC+SUT or UOBC. Numbers needed to treat (NNTs) and 95% CIs were also used to assess UOBC+OMT vs each comparator. Subgroup analyses were performed using median splits of baseline scores on a numerical rating scale for back pain and the RMDQ. RESULTS: Overall, 68 patients (47%) experienced progressive back-specific dysfunction during the third trimester of pregnancy. Patients who received UOBC+OMT were significantly less likely to experience progressive back-specific dysfunction (RR, 0.6; 95% CI, 0.3-1.0; P=.046 vs UOBC+SUT; and RR, 0.4; 95% CI, 0.2-0.7; P<.0001 vs UOBC). The effect sizes for UOBC+OMT vs UOBC+SUT and for UOBC+OMT vs UOBC were classified as medium and large, respectively. The corresponding NNTs for UOBC+OMT were 5.1 (95% CI, 2.7-282.2) vs UOBC+SUT; and 2.5 (95% CI, 1.8-4.9) vs UOBC. There was no statistically significant interaction between subgroups in response to OMT. CONCLUSION: Osteopathic manual treatment has medium to large treatment effects in preventing progressive back-specific dysfunction during the third trimester of pregnancy. The findings are potentially important with respect to direct health care expenditures and indirect costs of work disability during pregnancy."," J Am Osteopath Assoc 113(10): 728-736.","USA",2013,"Back Pain","Ultrasound","RMDQ","Unknown","PRO study","Systematic review","USA","Unknown","Back Pain","Ultrasound","PRO study","Systematic review","RMDQ","2010:2014"]
[235,"Lim, J. B., et al. (2015). \"Comparison of patient quality of life scores and satisfaction after common orthopedic surgical interventions.\" Eur J Orthop Surg Traumatol 25(6): 1007-1012.",null,"Lim, J. B., et al.","Comparison of patient quality of life scores and satisfaction after common orthopedic surgical interventions","Patient quality of life scores are commonly used to assess patient-reported satisfaction following orthopedic interventions. Our main aim was to review the satisfaction scores of four common orthopedic interventions in our tertiary institution, primary hallux valgus (HV) corrective surgery, primary single-level transforaminal lumbar interbody fusion (TLIF), primary unilateral total knee arthroplasty (TKA) and primary total hip arthroplasty (THA). We retrospectively reviewed prospectively collected data on patients who underwent four different types of orthopedic surgeries using the SF-36 score and two questions adopted from North American Spine Society Questionnaire. The database of a tertiary hospital between January 2007 and December 2009 was reviewed. There were 3488, 374, 184 and 73 patients who underwent TKA, THA, TLIF and HV surgery, respectively. Patients who underwent primary TLIF, TKA and THA had significant degree of improvement in all aspects of SF-36 scores at 6 months and 2 years of follow-up (p < 0.001). Postoperatively at 2 years, the most satisfied postoperative patients were those who underwent THA (91.9 %), followed by TKA (90.5 %), TLIF (86.1 %) and HV (77.4 %). This study shows a significant degree of postoperative improvement in terms of SF-36 scores for common orthopedic interventions in particular to primary TKA, THA and TLIF at 6 months and 2 years of follow-up. With a significant degree of improvement in SF-36 scores postoperatively, this also translated into patient satisfaction and meeting their expectations of surgery."," Eur J Orthop Surg Traumatol 25(6): 1007-1012.","Singapore",2015,"Unspecified","Surgical","NASS-L","Unknown","Tool Validation","Prospective Observation","Singapore","Unknown","Unspecified","Surgical","Tool Validation","Prospective Observation","NASS-L","2015:2018"]
[236,"Lochting, I., et al. (2017). \"The impact of psychological factors on condition-specific, generic and individualized patient reported outcomes in low back pain.\" Health Qual Life Outcomes 15(1999): 40.",null,"Lochting, I., et al.","The impact of psychological factors on condition-specific, generic and individualized patient reported outcomes in low back pain","BACKGROUND: An individualized patient reported outcome (PRO) has recently been recommended within LBP research, but no study has evaluated this instrument with commonly applied PROs. Moreover, the impact of psychological factors has mostly been assessed for disease-specific instruments. The objective of this study was to assess the predictive value of illness perceptions, pain catastrophizing and psychological distress on 12 month outcomes assessed by specific, generic and individualized PROs recommended in low back pain (LBP). METHODS: Secondary analysis of patients with sub-acute or chronic LBP recruited for a cluster randomized controlled trial in primary care who completed a self-administered questionnaire at baseline and 12 months. 12 month scores for the Roland Morris Disability Questionnaire (RMDQ), the EuroQol (EQ-5D), and the Patient Generated Index (PGI) were dependent variables in hierarchical regression analysis. Independent variables included baseline scores for the Brief Illness Perceptions Questionnaire (Brief IPQ), Hopkins Symptom Check List (HSCL-25), Pain Catastrophizing Scale (PCS), health/clinical and sociodemographic variables. RESULTS: Of the 216 eligible patients included, 203 patients responded to the baseline questionnaire and 150 (74%) responded at 12 months. The mean age was 38.3 (SD 10.2) years and 57.6% were female. The Brief IPQ showed a statistically significant variation in the 12-months score of all the PROs, explaining 2.5% in RMDQ, 7.9% in EQ-5D, and 3.6% in PGI. Most of the explained variation for EQ-5D scores related to illness perceptions. The PCS explained 3.7% of the RMDQ and 2.5% in the EQ-5D scores. The HSCL-25 did not make a significant contribution. CONCLUSION: Illness perceptions and pain catastrophizing were associated with 12-month outcomes as assessed by condition-specific, generic and individualized PROs. The Brief IPQ and PCS have relevance to applications in primary care that include interventions designed to enhance psychological aspects of health and where the contribution of such variables to outcomes is of interest. Further studies should assess whether the Brief IPQ perform similarly in LBP populations in other health care settings."," Health Qual Life Outcomes 15(1999): 40.","Norway",2017,"Back Pain","Psychosocial","RMDQ","Adults","PRO study","RCT","Norway","Adults","Back Pain","Psychosocial","PRO study","RCT","RMDQ","2015:2018"]
[237,"Luo, M., et al. (2017). \"Comparison of Consecutive, Interval, and Skipped Pedicle Screw Techniques in Moderate Lenke Type 1 Adolescent Idiopathic Scoliosis.\" World Neurosurg 98: 563-570.",null,"Luo, M., et al.","Comparison of Consecutive, Interval, and Skipped Pedicle Screw Techniques in Moderate Lenke Type 1 Adolescent Idiopathic Scoliosis","OBJECTIVE: To compare perioperative, radiographic, and Scoliosis Research Society-22 (SRS-22) outcomes of consecutive, interval, and skipped pedicle screw techniques in patients with moderate Lenke type 1 adolescent idiopathic scoliosis (AIS). METHODS: We retrospectively reviewed 65 consecutive moderate Lenke type 1 AIS patients at a single institution using all-pedicle screw constructs, with a minimum of 2 years of follow-up. In the consecutive group (C group, n = 22), pedicle screws were instrumented at consecutive levels bilaterally. In the interval group (I group, n = 18), pedicle screws were placed at every level on the concave side while skipping levels on the convex side. In the skipped group (S group, n = 25), pedicle screws were instrumented by skipping levels bilaterally. Perioperative, radiographic, and SRS-22 measurements were analyzed with a 1-way analysis of variance. RESULTS: No significant differences were found in length of hospital stay, fused levels, coronal correction, and SRS-22 scores among the 3 groups. Increased surgery time was found in the C group compared with the I and S groups (P = 0.001 and P = 0.005, respectively). Decreased blood loss and blood transfusions were found in the S group compared with the C group (P = 0.04 and P = 0.047, respectively). Decreased implant costs were found in the S group compared with the C and I groups (P < 0.001 and P = 0.03, respectively). CONCLUSIONS: Consecutive, interval, and skipped pedicle screw techniques all provide satisfactory deformity correction and SRS-22 outcomes with few complications. With better perioperative outcomes, interval and skipped pedicle screw techniques are the more cost-effective options for patients with moderate Lenke type 1 AIS."," World Neurosurg 98: 563-570.","China",2017,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Retrospective review","China","Adolescents","Spinal Deformity","Surgical","PRO study","Retrospective review","SRS-HRQOL","2015:2018"]
[238,"Machado, D., et al. (2016). \"Abobotulinum Toxin A in the Treatment of Chronic Low Back Pain.\" Toxins (Basel) 8(12).",null,"Machado, D., et al.","Abobotulinum Toxin A in the Treatment of Chronic Low Back Pain","Chronic low back pain is a debilitating condition with a complex and multifactorial pathophysiology. Botulinum neurotoxins (BoNTs) have strong analgesic effects, as shown in both animal models of pain and in human beings. A randomized, double-blind, placebo-controlled, parallel format study to investigate the efficacy of abobotulinum toxin A (aboA) in chronic low back pain was conducted. The study cohort consisted of 18 patients who received 100 units of aboA into each of the five lumbar extensor spinae muscles unilaterally or bilaterally (total dose 500 to 1000 units), and 19 who received normal saline of the same volume. The level of pain and quality of life were assessed using the visual analogue scale (VAS) and three questionnaires including the Oswestry Low Back Pain Disability Questionnaire (OLBPDQ). Patients' perception of improvement was recorded via patient global impression of change (PGIC). The primary outcome measure, the proportion of responders with VAS of <4 at 6 weeks, was not met, but the data was significantly in favor of aboA at 4 weeks (p = 0.008). The total Oswestry score representing quality of life improved in the aboA group compared to the placebo group (p = 0.0448). Moreover, significantly more patients reported their low back pain as \"much improved\" in the abobotulinum toxin A group (0.0293)."," Toxins (Basel) 8(12).","USA",2016,"Back Pain","Abobotulinum toxin A","ODI","Unknown","PRO study","RCT","USA","Unknown","Back Pain","Abobotulinum toxin A","PRO study","RCT","ODI","2015:2018"]
[239,"MacPherson, H., et al. (2013). \"Alexander Technique Lessons, Acupuncture Sessions or usual care for patients with chronic neck pain (ATLAS): study protocol for a randomised controlled trial.\" Trials 14: 209.",null,"MacPherson, H., et al.","Alexander Technique Lessons, Acupuncture Sessions or usual care for patients with chronic neck pain (ATLAS): study protocol for a randomised controlled trial","BACKGROUND: Chronic neck pain is a common condition in the adult population. More research is needed to evaluate interventions aiming to facilitate beneficial long-term change. We propose to evaluate the effect of Alexander Technique lessons and acupuncture in a rigorously conducted pragmatic trial with an embedded qualitative study. METHODS/DESIGN: We will recruit 500 patients who have been diagnosed with neck pain in primary care, who have continued to experience neck pain for at least three months with 28% minimum cut-off score on the Northwick Park Neck Pain Questionnaire (NPQ). We will exclude patients with serious underlying pathology, prior cervical spine surgery, history of psychosis, rheumatoid arthritis, ankylosing spondylitis, osteoporosis, haemophilia, cancer, HIV or hepatitis, or with alcohol or drug dependency currently or in the last 12 months, or actively pursuing compensation or with pending litigation.The York Trials Unit will randomly allocate participants using a secure computer-based system. We will use block randomisation with allocation to each intervention arm being unambiguously concealed from anyone who might subvert the randomisation process.Participants will be randomised in equal proportions to Alexander Technique lessons, acupuncture or usual care alone. Twenty 30-minute Alexander Technique lessons will be provided by teachers registered with the Society of Teachers of the Alexander Technique and twelve 50-minute sessions of acupuncture will be provided by acupuncturists registered with the British Acupuncture Council. All participants will continue to receive usual GP care.The primary outcome will be the NPQ at 12 months, with the secondary time point at 6 months, and an area-under-curve analysis will include 3, 6 and 12 month time-points. Adverse events will be documented. Potential intervention effect modifiers and mediators to be explored include: self-efficacy, stress management, and the incorporation of practitioner advice about self-care and lifestyle. Qualitative material will be used to address issues of safety, acceptability and factors that impact on longer term outcomes. DISCUSSION: This study will provide robust evidence on whether there are significant clinical benefits to patients, economic benefits demonstrating value for money, and sufficient levels of acceptability and safety. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15186354."," Trials 14: 209.","UK",2013,"Neck Pain,Cancer,Spondylosis","Acupuncture,Surgical","Northwick","Unknown","Protocol","RCT","UK","Unknown","Neck Pain,Cancer,Spondylosis","Acupuncture,Surgical","Protocol","RCT","Northwick","2010:2014"]
[240,"MacPherson, H., et al. (2015). \"Alexander Technique Lessons or Acupuncture Sessions for Persons With Chronic Neck Pain: A Randomized Trial.\" Ann Intern Med 163(9): 653-662.",null,"MacPherson, H., et al.","Alexander Technique Lessons or Acupuncture Sessions for Persons With Chronic Neck Pain: A Randomized Trial","BACKGROUND: Management of chronic neck pain may benefit from additional active self-care-oriented approaches. OBJECTIVE: To evaluate clinical effectiveness of Alexander Technique lessons or acupuncture versus usual care for persons with chronic, nonspecific neck pain. DESIGN: Three-group randomized, controlled trial. (Current Controlled Trials: ISRCTN15186354). SETTING: U.K. primary care. PARTICIPANTS: Persons with neck pain lasting at least 3 months, a score of at least 28% on the Northwick Park Questionnaire (NPQ) for neck pain and associated disability, and no serious underlying pathology. INTERVENTION: 12 acupuncture sessions or 20 one-to-one Alexander lessons (both 600 minutes total) plus usual care versus usual care alone. MEASUREMENTS: NPQ score (primary outcome) at 0, 3, 6, and 12 months (primary end point) and Chronic Pain Self-Efficacy Scale score, quality of life, and adverse events (secondary outcomes). RESULTS: 517 patients were recruited, and the median duration of neck pain was 6 years. Mean attendance was 10 acupuncture sessions and 14 Alexander lessons. Between-group reductions in NPQ score at 12 months versus usual care were 3.92 percentage points for acupuncture (95% CI, 0.97 to 6.87 percentage points) (P = 0.009) and 3.79 percentage points for Alexander lessons (CI, 0.91 to 6.66 percentage points) (P = 0.010). The 12-month reductions in NPQ score from baseline were 32% for acupuncture and 31% for Alexander lessons. Participant self-efficacy improved for both interventions versus usual care at 6 months (P < 0.001) and was significantly associated (P < 0.001) with 12-month NPQ score reductions (acupuncture, 3.34 percentage points [CI, 2.31 to 4.38 percentage points]; Alexander lessons, 3.33 percentage points [CI, 2.22 to 4.44 percentage points]). No reported serious adverse events were considered probably or definitely related to either intervention. LIMITATION: Practitioners belonged to the 2 main U.K.-based professional associations, which may limit generalizability of the findings. CONCLUSION: Acupuncture sessions and Alexander Technique lessons both led to significant reductions in neck pain and associated disability compared with usual care at 12 months. Enhanced self-efficacy may partially explain why longer-term benefits were sustained. PRIMARY FUNDING SOURCE: Arthritis Research UK."," Ann Intern Med 163(9): 653-662.","Unknown",2015,"Neck Pain","Acupuncture","Northwick","Adults","PRO study","RCT","Unknown","Adults","Neck Pain","Acupuncture","PRO study","RCT","Northwick","2015:2018"]
[241,"Mannion, A. F., et al. (2012). \"Reliability and validity of the cross-culturally adapted Italian version of the Core Outcome Measures Index.\" Eur Spine J 21 Suppl 6: S737-749.",null,"Mannion, A. F., et al.","Reliability and validity of the cross-culturally adapted Italian version of the Core Outcome Measures Index","Patient-orientated outcome questionnaires are essential for the assessment of treatment success in spine care. Standardisation of the instruments used is necessary for comparison across studies and in registries. The Core Outcome Measures Index (COMI) is a short, multidimensional outcome instrument validated for patients with spinal disorders and is the recommended outcome instrument in the Spine Society of Europe Spine Tango Registry; currently, no validated Italian version exists. A cross-cultural adaptation of the COMI into Italian was carried out using established guidelines. 96 outpatients with chronic back problems (>3 months) were recruited from five practices in Switzerland and Italy. They completed the newly translated COMI, the Roland Morris disability (RM), adjectival pain rating, WHO Quality of Life (WHOQoL), EuroQoL-5D, and EuroQoL-VAS scales. Reproducibility was assessed in a subgroup of 63 patients who returned a second questionnaire within 1 month and indicated no change in back status on a 5-point Likert-scale transition question. The COMI scores displayed no floor or ceiling effects. On re-test, the responses for each individual domain of the COMI were within one category in 100% patients for \"function\", 92% for \"symptom-specific well-being\", 100% for \"general quality of life\", 90% for \"social disability\", and 98% for \"work disability\". The intraclass correlation coefficients (ICC(2,1)) for the COMI back and leg pain items were 0.78 and 0.82, respectively, and for the COMI summary index, 0.92 (95% CI 0.86-0.95); this compared well with 0.84 for RM, 0.87 for WHOQoL, 0.79 for EQ-5D, and 0.77 for EQ-VAS. The standard error of measurement (SEM) for COMI was 0.54 points, giving a ''minimum detectable change'' for the COMI of 1.5 points. The scores for most of the individual COMI domains and the COMI summary index correlated to the expected extent (0.4-0.8) with the corresponding full-length reference questionnaires (r = 0.45-0.72). The reproducibility of the Italian version of the COMI was comparable to that published for the German and Spanish versions. The COMI scores correlated in the expected manner with existing but considerably longer questionnaires suggesting adequate convergent validity for the COMI. The Italian COMI represents a practical, reliable, and valid tool for use with Italian-speaking patients and will be of value for international studies and surgical registries."," Eur Spine J 21 Suppl 6: S737-749.","Switzerland",2012,"Spine Disease","Surgical","RMDQ","Unknown","Tool Validation","Prospective Observation","Switzerland","Unknown","Spine Disease","Surgical","Tool Validation","Prospective Observation","RMDQ","2010:2014"]
[242,"Markman, J. D., et al. (2015). \"Screening for neuropathic characteristics in failed back surgery syndromes: challenges for guiding treatment.\" Pain Med 16(3): 520-530.",null,"Markman, J. D., et al.","Screening for neuropathic characteristics in failed back surgery syndromes: challenges for guiding treatment","OBJECTIVE: Neuropathic pain screening tools have shown promise in identifying common neuropathic pain characteristics that derive from diverse etiologies (e.g., diabetic peripheral neuropathy, postherpetic neuralgia). However, no prior studies have specifically assessed whether these tools are capable of discerning the underlying pain mechanisms in the vast, heterogeneous group of patients diagnosed with failed back surgery syndrome (FBSS). DESIGN: In this clinical observational study, two tests for neuropathic pain characteristics, the Douleur Neuropathique en 4 (DN4) and Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) questionnaires, were performed on 43 subjects with FBSS. Subjects underwent physical or neurosensory exam components of the DN4 and LANSS in the region of most severe pain (e.g., axial low back or lower extremities). DN4 and LANSS scores were correlated with clinical history and neurologic exam, pain-related quality of life questionnaires, and compared to an independent assessment of pain distribution. RESULTS: The presence of neuropathic characteristics, determined by the DN4 (62% sensitivity, 44% specificity), LANSS (38% sensitivity, 75% specificity; cut-offs of 4 and 12, respectively), or their combination (20% sensitivity, 58% specificity) was associated with higher pain intensity as measured by the visual analog scale (DN4 > 4, P = 0.001; LANSS >/= 12, P = 0.042), modified Brief Pain Inventory-Short Form (DN4 > 4, P = 0.001; LANSS >/= 12, P = 0.082), and Neuropathic Pain Symptom Inventory (DN4 > 4, P = 0.001; LANSS >/= 12, P = 0.001), and greater pain-related functional impairment as measured by the Roland-Morris Disability Questionnaire (DN4 > 4, P = 0.006; LANSS >/= 12, P = 0.018). The percentage of subjects characterized as neuropathic by the DN4 and LANSS lacked concordance (67.4 vs. 25.6), and the distribution of most severe symptoms (i.e., axial vs radicular) did not correlate with subjects determined to have neuropathic pain. CONCLUSIONS: Unlike other neuropathic syndromes, the neuropathic component of FBSS is less reliably identified by the LANSS and DN4."," Pain Med 16(3): 520-530.","USA",2015,"Neuropathic Pain,Radiculopathy","Surgical","RMDQ","Unknown","PRO study","Observational","USA","Unknown","Neuropathic Pain,Radiculopathy","Surgical","PRO study","Observational","RMDQ","2015:2018"]
[243,"Martel, J., et al. (2011). \"A randomised controlled trial of preventive spinal manipulation with and without a home exercise program for patients with chronic neck pain.\" BMC Musculoskelet Disord 12: 41.",null,"Martel, J., et al.","A randomised controlled trial of preventive spinal manipulation with and without a home exercise program for patients with chronic neck pain","BACKGROUND: Evidence indicates that supervised home exercises, combined or not with manual therapy, can be beneficial for patients with non-specific chronic neck pain (NCNP). The objective of the study is to investigate the efficacy of preventive spinal manipulative therapy (SMT) compared to a no treatment group in NCNP patients. Another objective is to assess the efficacy of SMT with and without a home exercise program. METHODS: Ninety-eight patients underwent a short symptomatic phase of treatment before being randomly allocated to either an attention-group (n = 29), a SMT group (n = 36) or a SMT + exercise group (n = 33). The preventive phase of treatment, which lasted for 10 months, consisted of meeting with a chiropractor every two months to evaluate and discuss symptoms (attention-control group), 1 monthly SMT session (SMT group) or 1 monthly SMT session combined with a home exercise program (SMT + exercise group). The primary and secondary outcome measures were represented by scores on a 10-cm visual analog scale (VAS), active cervical ranges of motion (cROM), the neck disability index (NDI) and the Bournemouth questionnaire (BQ). Exploratory outcome measures were scored on the Fear-avoidance Behaviour Questionnaire (FABQ) and the SF-12 Questionnaire. RESULTS: Our results show that, in the preventive phase of the trial, all 3 groups showed primary and secondary outcomes scores similar to those obtain following the non-randomised, symptomatic phase. No group difference was observed for the primary, secondary and exploratory variables. Significant improvements in FABQ scores were noted in all groups during the preventive phase of the trial. However, no significant change in health related quality of life (HRQL) was associated with the preventive phase. CONCLUSIONS: This study hypothesised that participants in the combined intervention group would have less pain and disability and better function than participants from the 2 other groups during the preventive phase of the trial. This hypothesis was not supported by the study results. Lack of a treatment specific effect is discussed in relation to the placebo and patient provider interactions in manual therapies. Further research is needed to delineate the specific and non-specific effects of treatment modalities to prevent unnecessary disability and to minimise morbidity related to NCNP. Additional investigation is also required to identify the best strategies for secondary and tertiary prevention of NCNP. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00566930."," BMC Musculoskelet Disord 12: 41.","Canada",2011,"Neck Pain","Exercise","NDI","Unknown","PRO study","Clinical trial","Canada","Unknown","Neck Pain","Exercise","PRO study","Clinical trial","NDI","2010:2014"]
[244,"Matamalas, A., et al. (2014). \"Body image in idiopathic scoliosis: a comparison study of psychometric properties between four patient-reported outcome instruments.\" Health Qual Life Outcomes 12: 81.",null,"Matamalas, A., et al.","Body image in idiopathic scoliosis: a comparison study of psychometric properties between four patient-reported outcome instruments","BACKGROUND: Four patient-reported outcome (PRO) instruments are commonly used to assess body image in idiopathic scoliosis (IS): the Quality of Life Profile for Spinal Deformities (QLPSD), SRS-22 Self-Image scale, Spinal Appearance Questionnaire (SAQ), and Trunk Appearance Perception Scale (TAPS). The aim of this study is to compare the psychometric properties of these instruments in patients with IS and report the translational/cultural adaptation of the SAQ to Spanish. METHODS: The four instruments in a Spanish version were administered to 80 patients with IS aged 10 to 40 years old. The sample was stratified according to scoliosis magnitude (less and more than 45 masculine). Analysis was also conducted for age groups. The psychometric properties studied included convergent and divergent construct validity, as well as internal consistency. Convergent validity was evaluated by correlation analysis between the self-image instruments and Cobb angle. Divergent validity was assessed with correlation analysis between PRO scores and SRS-22 dimensions scores such as Function, Pain and Mental Health. RESULTS: In the overall sample, each of the PRO instruments demonstrated high internal consistency (QLPSD Body Image, alpha = 0.80; SRS-22 Self Image, alpha = 0.78; SAQ, alpha = 0.89; TAPS, alpha = 0.87), also both for younger and adult patients subgroups. Correlation with curve magnitude was significant for each of the four scales. However, the correlation was higher for the pictorial scales (SAQ Appearance r = 0.61, TAPS r = -0.62) than for the textual scales (QLPSD-bi r = 0.36, SRS-22 Self-Image scale r = -0.41). In the younger group, correlation between Cobb angle and textual scales (QLPSD-bi and SRS-22 Self-Image Scale) was not significant. Body Image scales showed significant correlations with SRS-22 Pain, Function and Mental Health dimensions. CONCLUSIONS: All four instruments tested have good psychometric properties. Pictorial scales (SAQ Appearance and TAPS) correlated better with the radiological magnitude of the curve and this correlation is independent of age. Unexpectedly, all four scales demonstrated significant correlations with non-body image dimensions and the divergent hypothesis was not confirmed. Globally, pictorial scales showed slightly better construct validity to test body image perception than textual scales."," Health Qual Life Outcomes 12: 81.","Spain",2014,"Spinal Deformity","Not Specified","SRS-HRQOL,SAQ","Adults","Tool Validation","Observational","Spain","Adults","Spinal Deformity","Not Specified","Tool Validation","Observational","SRS-HRQOL,SAQ","2010:2014"]
[245,"McMorland, G. and E. Suter (2000). \"Chiropractic management of mechanical neck and low-back pain: a retrospective, outcome-based analysis.\" J Manipulative Physiol Ther 23(5): 307-311.",null,"McMorland, G. and E. Suter","Chiropractic management of mechanical neck and low-back pain: a retrospective, outcome-based analysis","BACKGROUND: Evidence suggests that spinal manipulation is an effective treatment for mechanical neck and low-back pain (LBP). Treatment efficacy is important to establish for these symptoms because combined they account for a considerable amount of disability and substantial associated direct and indirect costs to society. OBJECTIVE: The purpose of this study was to examine the outcome of patients undergoing chiropractic treatment for mechanical neck or LBP. DESIGN AND SETTING: A retrospective, outcome-based analysis was done for patients seeking care at a private chiropractic practice over a 1-year period. A total of 512 files were reviewed, with 119 patients selected for inclusion. Patients were included if their chief symptom was uncomplicated mechanical neck or LBP. Diagnoses included cervical, lumbar, or sacroiliac joint sprain/strain (International Code of Diagnostics version 9 [ICD-9] code: 847.1, 847.3, 846.1, respectively), discogenic LBP (ICD-9: 722.1), and headaches (ICD-9: 784.0) because many patients with neck pain presented with concomitant headaches. Disability and pain were measured with the modified Oswestry scale (for the patients with LBP), Neck Disability Index, and an 11-box visual analogue pain scale before and after treatment. Treatment consisted of spinal manipulation, various soft-tissue techniques, home-care instructions, and ergonomic and return-to-activity advice, including rehabilitative exercises. Patients received an average of 12 treatments over a 4-week period. Statistical analysis was performed on pretreatment and posttreatment values for both disability and pain. Stratification was based on duration (acute/subacute, chronic, acute exacerbation of a chronic condition) and severity (mild, moderate, or severe) of symptoms. RESULTS: Statistically significant reductions in disability and pain scores were achieved in all groups. An average 52.5% and 52.9% reduction in pain and disability, respectively, was achieved in the low-back group. The chronic LBP group realized a less statistically significant reduction of pain and disability (19.7% and 19.8%, respectively) than the acute/subacute (66.8% and 62.5%) or the chronic/recurrent group (56. 5% and 63.4%). The differences were statistically significant. Patients with neck pain had an average 53.8% and 48.4% reduction in their pain and disability, respectively. Patients with concomitant neck pain and headaches had statistically significant higher pretreatment and posttreatment disability and pain scores than those with only neck pain. There was no statistically significant difference in outcomes between groups stratified according to pain intensity. CONCLUSIONS: Patients attending a private chiropractic clinic for treatment of mechanical neck pain or LBP had statistically significant reductions in their pain-related disability after treatment. These results indicate that chiropractic manipulation is beneficial for the treatment of mechanical neck pain and LBP. However, care must be taken when drawing conclusions from these outcomes. The study design does not account for the natural history of low back- or neck pain-related disability and therefore does not allow for claims of treatment efficacy. In addition, it has been suggested that patients presenting to medical doctors with these symptoms have significant overlying comorbidity when compared with patients presenting to a chiropractor."," J Manipulative Physiol Ther 23(5): 307-311.","Canada",2000,"Back Pain,Neck Pain","Exercise","ODI,NDI","Unknown","PRO study","Retrospective review","Canada","Unknown","Back Pain,Neck Pain","Exercise","PRO study","Retrospective review","ODI,NDI","2000:2004"]
[246,"Mekhail, N., et al. (2012). \"Functional and patient-reported outcomes in symptomatic lumbar spinal stenosis following percutaneous decompression.\" Pain Pract 12(6): 417-425.",null,"Mekhail, N., et al.","Functional and patient-reported outcomes in symptomatic lumbar spinal stenosis following percutaneous decompression","BACKGROUND: Neurogenic claudication due to symptomatic lumbar spinal stenosis (LSS) is a painful condition causing significant functional disability. While the cause of LSS is multifactorial, thickened ligamentum flavum (LF) accounts for up to 85% of spinal canal narrowing. mild percutaneous lumbar decompression allows debulking of the hypertrophic LF while avoiding the morbidities frequently associated with more invasive surgical procedures. METHODS: In this prospective case series study, consecutive LSS patients presenting with neurogenic claudication were treated with percutaneous lumbar decompression. Efficacy was evaluated using the Pain Disability Index (PDI) and Roland-Morris Disability Questionnaire. Pre- and postprocedure Standing Time, Walking Distance, and Visual Analog Score (VAS) were also monitored. Significant device- or procedure-related adverse events were reported. RESULTS: The mild procedure was successfully performed on forty patients. At twelve months, both PDI and Roland-Morris showed significant improvement of 22.6 points (ANOVA, P<0.0001) and 7.7 points (ANOVA, P<0.0001), respectively. Walking Distance, Standing Time, and VAS improvements were also statistically significant, increasing from 246 to 3,956 feet (ANOVA, P<0.0001), 8 to 56 minutes (ANOVA, P<0.0001), and 7.1 to 3.6 points (ANOVA, P<0.0001), respectively. Tukey HSD test found improvement in all 5-outcome measures to be significant from baseline at each follow-up interval. No significant device- or procedure-related adverse events were reported. CONCLUSION: This study demonstrated significant functional improvement as well as decreased disability secondary to neurogenic claudication after mild procedure. Safety, cost-effectiveness, and quality-of-life outcomes are best compared with comprehensive medical management in a randomized controlled fashion and, where ethical, to open lumbar decompression surgery."," Pain Pract 12(6): 417-425.","USA",2012,"Spine Disease","Surgical","RMDQ","Unknown","PRO study","RCT","USA","Unknown","Spine Disease","Surgical","PRO study","RCT","RMDQ","2010:2014"]
[247,"Miekisiak, G., et al. (2014). \"Reliability and validity of the Polish version of the Core Outcome Measures Index for the neck.\" Eur Spine J 23(4): 898-903.",null,"Miekisiak, G., et al.","Reliability and validity of the Polish version of the Core Outcome Measures Index for the neck","PURPOSE: Patient reported outcome measures play an increasingly important role in the outcomes research. The Core Outcome Measures Index (COMI) is a short, multidimensional instrument initially developed for the use by patients with low back pain. This study is an evaluation of a Polish version of COMI adapted for neck pain. METHODS: One hundred twenty-three patients complaining of neck pain were enrolled. All of them completed a questionnaire booklet containing COMI-neck, Neck Disability Index and Likert-type questions regarding the frequency of use of pain medications and pain frequency. Ninety-eight patients returned the retest questionnaire. Data quality was also assessed. Assessment of psychometric properties included examination of data quality, construct validity, test-retest reliability and factor analysis. RESULTS: The quality of data was good with no missing answers and a little floor effect. Exploratory factor analysis revealed a single-factor structure. Reliability expressed as intraclass correlation coefficient was 0.88 (95% CI 0.84-0.92) for the overall COMI score and was generally good for most of individual core items. The minimum detectable change (MDC95%) was 1.97. CONCLUSION: This version of the COMI-neck is a valid and reliable instrument, with good psychometric properties. It can be recommended for Polish-speaking patients."," Eur Spine J 23(4): 898-903.","Poland",2014,"Back Pain,Neck Pain","Not Specified","NDI","Unknown","PRO study","Prospective Observation","Poland","Unknown","Back Pain,Neck Pain","Not Specified","PRO study","Prospective Observation","NDI","2010:2014"]
[248,"Miller, L. E. and J. E. Block (2011). \"Safety and effectiveness of bone allografts in anterior cervical discectomy and fusion surgery.\" Spine (Phila Pa 1976) 36(24): 2045-2050.",null,"Miller, L. E. and J. E. Block","Safety and effectiveness of bone allografts in anterior cervical discectomy and fusion surgery","STUDY DESIGN: Systematic review. OBJECTIVE: The primary aim of this review was to evaluate clinical and radiographic outcomes in studies of anterior cervical discectomy and fusion (ACDF) using allograft versus ACDF with autograft, ACDF with cage devices, and cervical disc arthroplasty for the treatment of symptomatic cervical disc disease. SUMMARY OF BACKGROUND DATA: ACDF remains the standard of care for patients with cervical radiculopathy who are unresponsive to conservative medical care. However, no known study has compared patient outcomes after ACDF with allograft, ACDF with autograft, ACDF with cage, and disc arthroplasty. METHODS: After applying strict inclusion criteria, 21 comparisons from 20 studies formed the basis for this review. Patient outcomes included neck and arm pain, neck disability index (NDI), physical component summary (PCS), and mental component summary (MCS) scores from the SF-36, radiographic fusion rate, and select adverse events (e.g., wound infection, dysphagia, and adjacent segment degeneration). RESULTS: The four treatment groups included ACDF with allograft (allograft, n = 1341), ACDF with autograft (autograft, n = 568), ACDF with cage (cage, n = 87), and cervical disc arthroplasty (arthroplasty, n = 603). Neck pain was reduced similarly by 63% to 69% in all groups. Comparable improvements were realized in arm pain after ACDF with allograft (75%) or arthroplasty (73%) that were greater than other treatment groups (62-68%). There was notable improvement in neck disability (61-65%) with allograft and arthroplasty after treatment. PCS scores improved with allograft (42%) and arthroplasty (44%). MCS scores improved modestly (16-21%) with allograft and arthroplasty. Fusion rates were 91% for allograft and autograft and 97% for cage. Adverse events were uncommon in all groups. CONCLUSION: ACDF with allograft, ACDF with autograft, ACDF with cage, and cervical disc arthroplasty show similar improvements in pain, function, and quality of life with correspondingly low adverse event rates. All ACDF procedures result in high fusion rates."," Spine (Phila Pa 1976) 36(24): 2045-2050.","USA",2011,"Neck Pain,Radiculopathy","Surgical","NDI","Unknown","PRO study","Retrospective review","USA","Unknown","Neck Pain,Radiculopathy","Surgical","PRO study","Retrospective review","NDI","2010:2014"]
[249,"Moffett, J. K., et al. (1999). \"Randomised controlled trial of exercise for low back pain: clinical outcomes, costs, and preferences.\" Bmj 319(7205): 279-283.",null,"Moffett, J. K., et al.","Randomised controlled trial of exercise for low back pain: clinical outcomes, costs, and preferences","OBJECTIVE: To evaluate effectiveness of an exercise programme in a community setting for patients with low back pain to encourage a return to normal activities. DESIGN: Randomised controlled trial of progressive exercise programme compared with usual primary care management. Patients' preferences for type of management were elicited independently of randomisation. PARTICIPANTS: 187 patients aged 18-60 years with mechanical low back pain of 4 weeks to 6 months' duration. INTERVENTIONS: Exercise classes led by a physiotherapist that included strengthening exercises for all main muscle groups, stretching exercises, relaxation session, and brief education on back care. A cognitive-behavioural approach was used. MAIN OUTCOME MEASURES: Assessments of debilitating effects of back pain before and after intervention and at 6 months and 1 year later. Measures included Roland disability questionnaire, Aberdeen back pain scale, pain diaries, and use of healthcare services. RESULTS: At 6 weeks after randomisation, the intervention group improved marginally more than the control group on the disability questionnaire and reported less distressing pain. At 6 months and 1 year, the intervention group showed significantly greater improvement in the disability questionnaire score (mean difference in changes 1.35, 95% confidence interval 0.13 to 2.57). At 1 year, the intervention group also showed significantly greater improvement in the Aberdeen back pain scale (4.44, 1.01 to 7.87) and reported only 378 days off work compared with 607 in the control group. The intervention group used fewer healthcare resources. Outcome was not influenced by patients' preferences. CONCLUSIONS: The exercise class was more clinically effective than traditional general practitioner management, regardless of patient preference, and was cost effective."," Bmj 319(7205): 279-283.","UK",1999,"Back Pain","Exercise","Aberdeen LBP","Adults","Cost and Resource Use","RCT","UK","Adults","Back Pain","Exercise","Cost and Resource Use","RCT","Aberdeen LBP","1995:1999"]
[250,"Moffett, J. K., et al. (2006). \"Randomized trial of two physiotherapy interventions for primary care neck and back pain patients: 'McKenzie' vs brief physiotherapy pain management.\" Rheumatology (Oxford) 45(12): 1514-1521.",null,"Moffett, J. K., et al.","Randomized trial of two physiotherapy interventions for primary care neck and back pain patients: 'McKenzie' vs brief physiotherapy pain management","OBJECTIVES: Interventions that take psychosocial factors into account are recommended for patients with persistent back or neck pain. We compared the effectiveness of a brief physiotherapy pain management approach using cognitive-behavioural principles (Solution-Finding Approach-SFA) with a commonly used method of physical therapy (McKenzie Approach-McK). METHODS: Eligible patients referred by GPs to physiotherapy departments with neck or back pain lasting at least 2 weeks were randomized to McK (n= 161) or to SFA (n= 154). They were further randomized to receive an educational booklet or not. The primary outcome was the Tampa Scale of Kinesiophobia (TSK) (Activity-Avoidance scale used as a proxy for coping) at 6 weeks, and 6 and 12 months. RESULTS: Of 649 patients assessed for eligibility, 315 were recruited (219 with back pain, 96 with neck pain). There were no statistically significant differences in outcomes between the groups, except that at any time point SFA patients supported by a booklet reported less reliance on health professionals (Multidimensional Health Locus of Control Powerful Others Scale), while at 6 months McK patients showed slightly more improvement on activity-avoidance (TSK). At 6 weeks, patient satisfaction was greater for McK (median 90% compared with 70% for SFA). Both interventions resulted in modest but clinically important improvements over time on the Roland Disability Questionnaire Scores and Northwick Park Neck Pain Scores. CONCLUSIONS: The McK approach resulted in higher patient satisfaction overall but the SFA could be more cost-effective, as fewer (three vs four) sessions were needed."," Rheumatology (Oxford) 45(12): 1514-1521.","UK",2006,"Neck Pain","Physical Therapy","RMDQ,Northwick","Unknown","PRO study","RCT","UK","Unknown","Neck Pain","Physical Therapy","PRO study","RCT","RMDQ,Northwick","2005:2009"]
[251,"Monticone, M., et al. (2010). \"Development of the Italian version of the revised Scoliosis Research Society-22 Patient Questionnaire, SRS-22r-I: cross-cultural adaptation, factor analysis, reliability, and validity.\" Spine (Phila Pa 1976) 35(24): E1412-1417.",null,"Monticone, M., et al.","Development of the Italian version of the revised Scoliosis Research Society-22 Patient Questionnaire, SRS-22r-I: cross-cultural adaptation, factor analysis, reliability, and validity","STUDY DESIGN: Evaluation of the psychometric properties of a translated and culturally adapted questionnaire. OBJECTIVE: Translating, culturally adapting, and validating the Italian version of the revised Scoliosis Research Society-22 Patient Questionnaire (SRS-22r-I) in order to allow its use with Italian-speaking patients with adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: Increasing attention is being given to health-related quality of life measures as a means of adding information about the evaluation of AIS. A translated form of the revised SRS-22 has never been validated in Italian patients with AIS. METHODS: The development of the SRS-22 questionnaire involved its translation and back-translation, a final review by an Expert Committee, and testing of the prefinal version to establish its correspondence to the original English version. Psychometric testing included factor analysis, reliability by internal consistency (Cronbach alpha) and test-retest repeatability (Intraclass Coefficient Correlation), and concurrent validity (Pearson correlation) by comparing the SRS-22r-I domains with the Short-Form Health Survey (SF-36) subscales. RESULTS: It took 4 months to develop a shared version of the SRS-22r-I, which proved to be satisfactorily acceptable when administered to 223 subjects with AIS. Factor analysis indicated a 4-factor solution (54% of the explained variance), and the questionnaire had an acceptable level of internal consistency (alpha = 0.77) and a high level of test-retest reliability (intraclass correlation coefficient = 0.957). In terms of concurrent validity, the correlations with the related Short-Form-36 subscales were moderate to good in the case of the Pain and Mental Health domains, and moderate in the case of the Function and Self-Image domains. CONCLUSION: The Italian translation of the SRS-22r has a good factorial structure and psychometric properties, and replicates the results of existing English versions of the questionnaire. Its use for research purposes can therefore be recommended."," Spine (Phila Pa 1976) 35(24): E1412-1417.","Italy",2010,"Spinal Deformity","Psychosocial","SRS-HRQOL","Adolescents","Tool Validation","Observational","Italy","Adolescents","Spinal Deformity","Psychosocial","Tool Validation","Observational","SRS-HRQOL","2010:2014"]
[252,"Monticone, M., et al. (2014). \"Active self-correction and task-oriented exercises reduce spinal deformity and improve quality of life in subjects with mild adolescent idiopathic scoliosis. Results of a randomised controlled trial.\" Eur Spine J 23(6): 1204-1214.",null,"Monticone, M., et al.","Active self-correction and task-oriented exercises reduce spinal deformity and improve quality of life in subjects with mild adolescent idiopathic scoliosis. Results of a randomised controlled trial","PURPOSE: To evaluate the effect of a programme of active self-correction and task-oriented exercises on spinal deformities and health-related quality of life (HRQL) in patients with mild adolescent idiopathic scoliosis (AIS) (Cobb angle <25 degrees ). METHODS: This was a parallel-group, randomised, superiority-controlled study in which 110 patients were randomly assigned to a rehabilitation programme consisting of active self-correction, task-oriented spinal exercises and education (experimental group, 55 subjects) or traditional spinal exercises (control group, 55 subjects). Before treatment, at the end of treatment (analysis at skeletal maturity), and 12 months later (follow-up), all of the patients underwent radiological deformity (Cobb angle), surface deformity (angle of trunk rotation) and HRQL evaluations (SRS-22 questionnaire). A linear mixed model for repeated measures was used for each outcome measure. RESULTS: There were main effects of time (p < 0.001), group (p < 0.001) and time by group interaction (p < 0.001) on radiological deformity: training in the experimental group led to a significant improvement (decrease in Cobb angle of >5 degrees ), whereas the control group remained stable. Analysis of all of the secondary outcome measures revealed significant effects of time, group and time by group interaction in favour of the experimental group. CONCLUSIONS: The programme of active self-correction and task-oriented exercises was superior to traditional exercises in reducing spinal deformities and enhancing the HRQL in patients with mild AIS. The effects lasted for at least 1 year after the intervention ended."," Eur Spine J 23(6): 1204-1214.","Italy",2014,"Spinal Deformity","Exercise","SRS-HRQOL","Adolescents","PRO study","RCT","Italy","Adolescents","Spinal Deformity","Exercise","PRO study","RCT","SRS-HRQOL","2010:2014"]
[253,"Moorthy, R. K., et al. (2005). \"Quantitative changes in gait parameters after central corpectomy for cervical spondylotic myelopathy.\" J Neurosurg Spine 2(4): 418-424.",null,"Moorthy, R. K., et al.","Quantitative changes in gait parameters after central corpectomy for cervical spondylotic myelopathy","OBJECT: In this study, quantitative gait analysis is used to describe the changes in the kinematic and kinetic parameters of gait after central corpectomy in patients with cervical spondylotic myelopathy (CSM). METHODS: Six men with CSM that was categorized preoperatively as Nurick Grade 3 or 4 were assessed using quantitative gait analysis. The values of various kinematic and kinetic parameters, physiological cost index, and range of motion (ROM) in the lower-limb joints were computed preoperatively as well as at follow-up review 12 months or more postoperatively. Patients also received scores based on the Nurick and Japanese Orthopaedic Association (JOA) lower-limb functional scales pre- and postoperatively. The mean Nurick grade improved from 3.3 to 2 (p = 0.02) and the mean JOA lower-limb score improved from 4.2 to 6 (p = 0.02). The forward ground reaction force showed a statistically significant increase from 10.8+/-4.1% body weight to 12.1+/-3.6% body weight (p = 0.04). There was a significant improvement in the ROM at the knees, from 48.6+/-7.7 degrees to 54.2+/-5.2 degrees (p = 0.03). There was an increase in the mean walking speed, stride length, percentage of single-limb support time, vertical and backward ground reaction forces, and ROM at the hips in the postoperative gait analysis. These results indicate an improved stability of gait as well as greater flexibility in the knee after decompression of the spinal cord. These changes correlated with an improvement in the functional status of patients with CSM after central corpectomy. CONCLUSIONS: Gait analysis can be used as a quantitative tool in the pre- and postoperative evaluation of patients with CSM."," J Neurosurg Spine 2(4): 418-424.","India",2005,"Spondylosis","Surgical","Nurick","Unknown","PRO study","Observational","India","Unknown","Spondylosis","Surgical","PRO study","Observational","Nurick","2005:2009"]
[254,"Morone, G., et al. (2011). \"Quality of life improved by multidisciplinary back school program in patients with chronic non-specific low back pain: a single blind randomized controlled trial.\" Eur J Phys Rehabil Med 47(4): 533-541.",null,"Morone, G., et al.","Quality of life improved by multidisciplinary back school program in patients with chronic non-specific low back pain: a single blind randomized controlled trial","STUDY DESIGN: A three and six months follow-up in a randomized controlled trial. BACKGROUND: Back School has become a widespread exercise program for low back pain (LBP), since its introduction in 1969. Back School could improve quality of life (QoL), but there are controversial data regarding its effectiveness. AIM: To evaluate the effects of the Back School program on quality of life (primary outcome), disability and pain perceptions (secondary outcomes) in patients with chronic and non-specific low back pain. SETTING: Rehabilitative specialized centre. POPULATION: Seventy four patients with chronic non-specific LBP. METHODS: Patients were randomly placed in a 3:2 form and were allocated into 2 groups (treated-control). Treatment group participated in a intensive multidisciplinary Back School program including brief education and active back exercises (BSG, N.=41), while the control group received medical assistance (CG, N.=29). Medication was the same in both groups. The Short Form 36 Health Status Survey, Waddel Index, Oswestry Disability Index and Visual Analogue Scale were collected at baseline, at the end of treatment, and at the three and six month follow-up. RESULTS: Quality of life significantly improved along time more in BSG, both in Physical and Mental Composite Score (repeated measure Anova: interaction time per group: P<0.001 and P=0.002, respectively). We also observed a significant improvement in disability scores along time (P<0.001) in BSG with significant differences between groups at three and at six months for Waddell Index (P=0.006 and P=0.009 respectively) and for Oswestry Disability Index (P=0.018 and 0.011 respectively). Moreover, pain perception score VAS showed a reduction in both groups, but it was significantly lower in BSG at end of treatment and both follow-ups (P<0.001). CONCLUSION: Our Back School program can be considered an effective treatment in people with chronic non-specific LBP."," Eur J Phys Rehabil Med 47(4): 533-541.","Italy",2011,"Back Pain","Exercise","ODI,RMDQ,WADDEL","Unknown","PRO study","RCT","Italy","Unknown","Back Pain","Exercise","PRO study","RCT","ODI,RMDQ,WADDEL","2010:2014"]
[255,"Morone, N. E., et al. (2016). \"A Mind-Body Program for Older Adults With Chronic Low Back Pain: A Randomized Clinical Trial.\" JAMA Intern Med 176(3): 329-337.",null,"Morone, N. E., et al.","A Mind-Body Program for Older Adults With Chronic Low Back Pain: A Randomized Clinical Trial","IMPORTANCE: Treatment of chronic low back pain (LBP) in older adults is limited by the adverse effects of analgesics. Effective nonpharmacologic treatment options are needed. OBJECTIVE: To determine the effectiveness of a mind-body program at increasing function and reducing pain in older adults with chronic LBP. DESIGN, SETTING, AND PARTICIPANTS: This single-blind, randomized clinical trial compared a mind-body program (n = 140) with a health education program (n = 142). Community-dwelling older adults residing within the Pittsburgh metropolitan area were recruited from February 14, 2011, to June 30, 2014, with 6-month follow-up completed by April 9, 2015. Eligible participants were 65 years or older with functional limitations owing to their chronic LBP (>/=11 points on the Roland and Morris Disability Questionnaire) and chronic pain (duration >/=3 months) of moderate intensity. Data were analyzed from March 1 to July 1, 2015. INTERVENTIONS: The intervention and control groups received an 8-week group program followed by 6 monthly sessions. The intervention was modeled on the Mindfulness-Based Stress Reduction program; the control program, on the \"10 Keys\" to Healthy Aging. MAIN OUTCOMES AND MEASURES: Follow-up occurred at program completion and 6 months later. The score on the Roland and Morris Disability Questionnaire was the primary outcome and measured functional limitations owing to LBP. Pain (current, mean, and most severe in the past week) was measured with the Numeric Pain Rating Scale. Secondary outcomes included quality of life, pain self-efficacy, and mindfulness. Intent-to-treat analyses were conducted. RESULTS: Of 1160 persons who underwent screening, 282 participants enrolled in the trial (95 men [33.7%] and 187 women [66.3%]; mean [SD] age,74.5 [6.6] years). The baseline mean (SD) Roland and Morris Disability Questionnaire scores for the intervention and control groups were 15.6 (3.0) and 15.4 (3.0), respectively. Compared with the control group, intervention participants improved an additional -1.1 (mean, 12.1 vs 13.1) points at 8 weeks and -0.04 (mean, 12.2 vs 12.6) points at 6 months (effect sizes, -0.23 and -0.08, respectively) on the Roland and Morris Disability Questionnaire. By 6 months, the intervention participants improved on the Numeric Pain Rating Scale current and most severe pain measures an additional -1.8 points (95% CI, -3.1 to -0.05 points; effect size, -0.33) and -1.0 points (95% CI, -2.1 to 0.2 points; effect size, -0.19), respectively. The changes in Numeric Pain Rating Scale mean pain measure after the intervention were not significant (-0.1 [95% CI, -1.1 to 1.0] at 8 weeks and -1.1 [95% CI, -2.2 to -0.01] at 6 months; effect size, -0.01 and -0.22, respectively). CONCLUSIONS AND RELEVANCE: A mind-body program for chronic LBP improved short-term function and long-term current and most severe pain. The functional improvement was not sustained, suggesting that future development of the intervention could focus on durability. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01405716."," JAMA Intern Med 176(3): 329-337.","USA",2016,"Back Pain","Psychosocial","RMDQ","Adults","PRO study","RCT","USA","Adults","Back Pain","Psychosocial","PRO study","RCT","RMDQ","2015:2018"]
[256,"Morr, S., et al. (2015). \"Skipped versus consecutive pedicle screw constructs for correction of Lenke 1 curves.\" Eur Spine J 24(7): 1473-1480.",null,"Morr, S., et al.","Skipped versus consecutive pedicle screw constructs for correction of Lenke 1 curves","PURPOSE: Thoracic pedicle screws provide superior curve correction to hook and wire constructs in adolescent idiopathic scoliosis, while increasing cost. The number of implants required for best correction and outcome has not yet been determined. METHODS: We retrospectively reviewed pre- and post-operative radiographs and self-reported outcome measures in an age- and curve-matched cohort of 40 patients with Lenke I AIS who underwent selective fusions between T3/4 and L1. Twenty patients were treated with thoracic pedicle screws at every level bilaterally (CON) and 20 patients with screws at every level on the concave side and skipped levels on the convex side of the curve (SKP). All patients had a minimum 2-year follow-up. Radiographs were assessed for coronal and sagittal curvatures, as well as thoracic torsion and vertebral rotation. Health-related quality of life was assessed using the SRS-22 instrument. Instrumentation cost data were collected for each case. RESULTS: Postoperative follow-up averaged 28 months for the CON group and 29 months for the SKP group. No statistically significant differences were found between groups with respect to age and pre- and post-operative radiographic parameters. Both constructs provided acceptable correction of the main thoracic curves (66.9 vs. 66.6 %, CON group and SKP group, respectively; p = 0.92), and spontaneous correction of the proximal thoracic (41.5 vs. 41.1 %; p = 0.92) and thoracolumbar/lumbar curves (54.8 vs. 54.3 %; p = 0.92). No significant difference was found in postoperative SRS-22 scores (96 vs. 94.3; p = 0.34). The CON group cost for instrumentation was significantly higher than the SKP group ($19,500 vs. $13,300; p = 0.002). There was no statistically significant difference in operating room times between groups. CONCLUSION: Both construct types provide excellent coronal correction and sagittal balance, with no significant differences in radiographic findings or clinical outcomes. A significant decrease in cost was found with use of skipped screw constructs."," Eur Spine J 24(7): 1473-1480.","USA",2015,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Retrospective review","USA","Adolescents","Spinal Deformity","Surgical","PRO study","Retrospective review","SRS-HRQOL","2015:2018"]
[257,"Morris, T., et al. (2015). \"Can we convert between outcome measures of disability for chronic low back pain?\" Spine (Phila Pa 1976) 40(10): 734-739.",null,"Morris, T., et al.","Can we convert between outcome measures of disability for chronic low back pain?","STUDY DESIGN: Retrospective database analysis. OBJECTIVE: A range of patient-reported outcomes were used to measure disability due to low back pain. There is not a single back pain disability measurement commonly used in all randomized controlled trials. We report here our assessment as to whether different disability measures are sufficiently comparable to allow data pooling across trials. SUMMARY OF BACKGROUND DATA: We used individual patient data from a repository of data from back pain trials of therapist-delivered interventions. METHODS: We used data from 11 trials (n=6089 patients) that had at least 2 of the following 7 measurements: Roland-Morris Disability Questionnaire, Chronic Pain Grade disability score, Physical Component Summary of the 12- or 36-Item Short Form Health Survey, Patient Specific Functional Scale, Pain Disability Index, Oswestry Disability Index, and Hannover Functional Ability Questionnaire. Within each trial, the change score between baseline and short-term follow-up was computed for each outcome and this was used to calculate the correlation between the change scores and the Cohen's kappa for the 3-level outcome of change score of less than, equal to, and more than zero. It was considered feasible to pool 2 measures if they were at least moderately correlated (correlation>0.5) and have at least moderately similar responsiveness (kappa>0.4). RESULTS: Although all pairs of measures were found to be positively correlated, most correlations were less than 0.5, with only 1 pair of outcomes in 1 trial having a correlation of more than 0.6. All kappa statistics were less than 0.4 so that in no cases were the criteria for acceptability of pooling measures satisfied. CONCLUSION: The lack of agreement between different outcome measures means that pooling of data on these different disability measurements in a meta-analysis is not recommended. LEVEL OF EVIDENCE: 2."," Spine (Phila Pa 1976) 40(10): 734-739.","UK",2015,"Back Pain","Not Specified","ODI,RMDQ","Unknown","PRO study","Retrospective review","UK","Unknown","Back Pain","Not Specified","PRO study","Retrospective review","ODI,RMDQ","2015:2018"]
[258,"Mousavi, S. J., et al. (2010). \"Reliability and validity of the persian version of the scoliosis research society-22r questionnaire.\" Spine (Phila Pa 1976) 35(7): 784-789.",null,"Mousavi, S. J., et al.","Reliability and validity of the persian version of the scoliosis research society-22r questionnaire","STUDY DESIGN: Cross-sectional validation study to investigate psychometric properties of adapted Persian version of the Scoliosis Research Society-22r (SRS-22r) questionnaire. OBJECTIVES.: To translate the SRS-22r into Persian and to evaluate the internal consistency, reliability, and validity of the Persian SRS-22r. SUMMARY OF BACKGROUND DATA: The SRS-22r has not been translated and validated for Persian-speaking patients with idiopathic scoliosis. This was to provide a validated instrument to measure health-related quality of life in patients with idiopathic scoliosis in Iran. METHODS: The translation and cultural adaptation of the original questionnaire were carried out in accordance with the published guidelines. About 84 patients with adolescent idiopathic scoliosis were participated in the study. The Short Form Health Survey (SF-36) was used to test convergent validity of the Persian SRS-22r. RESULTS: Moderate to high correlations were found between the SRS-22r domains and SF-36 subscales. The correlations ranged from 0.54 to 0.67 (function/activity domain), 0.48 to 0.74 (pain domain), 0.45 to 0.55 (self image domain), 0.66 to 0.85 (mental health domain), and 0.35 to 0.55 (satisfaction domain) (P < 0.01). One-way analysis of variance showed that the Persian questionnaire successfully discriminated between patients undergoing observation, brace, and surgical treatments (P < 0.05). Cronbach alpha coefficient for the Persian SRS-22r domains ranged from 0.68 to 0.78. The Persian SRS-22rdomains showed satisfactory test-retest reliability with Intraclass Correlation Coefficient ranged from 0.79 to 0.87 (P < 0.01). CONCLUSION: The Persian version of the SRS-22r has satisfactory reliability, convergent validity, and discriminant validity to measure health-related quality of life in adolescent patients with scoliosis in Iran. It is simple and easy to use and now can be applied in clinical settings and future outcome studies in Iran."," Spine (Phila Pa 1976) 35(7): 784-789.","USA",2010,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","Tool Validation","Observational","USA","Adolescents","Spinal Deformity","Surgical","Tool Validation","Observational","SRS-HRQOL","2010:2014"]
[259,"Muehlbacher, M., et al. (2006). \"Topiramate in treatment of patients with chronic low back pain: a randomized, double-blind, placebo-controlled study.\" Clin J Pain 22(6): 526-531.",null,"Muehlbacher, M., et al.","Topiramate in treatment of patients with chronic low back pain: a randomized, double-blind, placebo-controlled study","OBJECTIVE: Chronic low back pain (CLBP) is a widespread ailment. The aim of this study was to assess the efficacy of topiramate in the treatment of CLBP and the changes in anger status and processing, body weight, subjective pain-related disability and health-related quality of life during the course of treatment. METHODS: We conducted a 10-week, randomized, double-blind, placebo-controlled study of topiramate in 96 (36 women) patients with CLBP. The subjects were randomly assigned to topiramate (n=48) or placebo (n=48). Primary outcome measures were changes on the McGill Pain Questionnaire, State-Trait Anger Expression Inventory, Oswestry Low Back Pain Disability Questionnaire and SF-36 Health Survey scales, and in body weight. RESULTS: In comparison with the placebo group (according to the intent-to-treat principle), significant changes on the pain rating index of McGill Pain Questionnaire (Ps<0.001), State-Trait Anger Expression Inventory Scales (all Ps<0.001), Oswestry Low Back Pain Disability Questionnaire (P<0.001), and SF-36 Health Survey scales (all P<0.001, except on the role-emotional scale) were observed after 10 weeks in the patients treated with topiramate. Weight loss was also observed and was significantly more pronounced in the group treated with topiramate than in those treated with placebo (P<0.001). Most patients tolerated topiramate relatively well but 2 patients dropped out because of side effects. DISCUSSION: Topiramate seems to be a relatively safe and effective agent in the treatment of CLBP. Significantly positive changes in pain sensitivity, anger status and processing, subjective disability, health-related quality of life, and loss of weight were observed."," Clin J Pain 22(6): 526-531.","Austria",2006,"Back Pain","Topiramate","ODI","Unknown","PRO study","RCT","Austria","Unknown","Back Pain","Topiramate","PRO study","RCT","ODI","2005:2009"]
[260,"Muller, C., et al. (2011). \"Prospective evaluation of physical activity in patients with idiopathic scoliosis or kyphosis receiving brace treatment.\" Eur Spine J 20(7): 1127-1136.",null,"Muller, C., et al.","Prospective evaluation of physical activity in patients with idiopathic scoliosis or kyphosis receiving brace treatment","Bracing is an established method of conservative treatment for adolescent idiopathic scoliosis and kyphosis. Compliance among adolescents is frequently inadequate due to the discomfort of wearing a brace, cosmetic issues, and fear on the part of patients and parents that bracing may reduce everyday physical activities. The aim of this prospective, controlled study was to objectify the impact of spinal bracing on daily step activity in patients receiving conservative treatment for adolescent idiopathic scoliosis (AIS) or adolescent kyphosis (AK). Forty-eight consecutive patients (mean age 13.4 +/- 2.3 years), consisting of 38 AIS patients (33 girls, 5 boys) and 10 AK patients (6 girls, 4 boys) were included. Once the decision to carry out bracing had been taken and while the patients were waiting for the individual brace to be built, step activity was assessed without braces by means of step activity monitoring (SAM) for seven consecutive days. After 8 weeks of brace wearing, step activity was assessed during regular brace treatment, again for seven consecutive days. In addition, brace-wearing times were simultaneously recorded using temperature probes implanted in the braces to measure compliance. Before and during brace treatment, patients completed the Scoliosis Research Society (SRS-22) questionnaire. The SAM was worn for an average of 12.7 +/- 1.5 h/day during the first measurement and 12.3 +/- 1.9 h on average during the second measurement. The mean gait cycles (GCs) per day and per hour before treatment were 5,036 +/- 1,465 and 395 +/- 105, respectively. No significant reduction in step activity was found at the follow-up measurement during bracing, at 4,880 +/- 1,529 GCs/day and 403 +/- 144 GCs/h. Taking the 23-h recommended time for brace wearing as a basis (100%), patients wore the brace for 72.7 +/- 27.6% of the prescribed time, indicating an acceptable level of compliance. Girls showed a higher compliance level (75.6 +/- 25.6%) in comparison with boys (56.7 +/- 31.9%), although the difference was not significant (P = 0.093). The SRS-22 total score showed no differences between the two measurements (2.57 +/- 0.23 vs. 2.56 +/- 0.28). Implementing a simultaneous and objective method of assessing step activity and brace-wearing times in everyday life proved to be feasible, and it expands the information available regarding the impact of bracing on patients' quality of life. The results clearly show that brace treatment does not negatively interfere with daily step activity in AIS and AK patients. This is an important finding that should help reduce patients' and parents' worries concerning bracing."," Eur Spine J 20(7): 1127-1136.","Germany",2011,"Spinal Deformity","Brace","SRS-HRQOL","Adolescents","PRO study","Prospective Observation","Germany","Adolescents","Spinal Deformity","Brace","PRO study","Prospective Observation","SRS-HRQOL","2010:2014"]
[261,"Murphy, S. E., et al. (2013). \"The effectiveness of a stratified group intervention using the STarTBack screening tool in patients with LBP--a non randomised controlled trial.\" BMC Musculoskelet Disord 14: 342.",null,"Murphy, S. E., et al.","The effectiveness of a stratified group intervention using the STarTBack screening tool in patients with LBP--a non randomised controlled trial","BACKGROUND: Low back pain (LBP) is costly to society and improving patient outcomes is a priority. Stratifying LBP patients into more homogenous groups is advocated to improve patient outcome. The STarT Back tool, a prognostic screening tool has demonstrated efficacy and greater cost effectiveness in physiotherapy settings. The management of LBP patients in groups is common but to date the utility of the STarT Back tool in group settings has not been explored. The aim of this study is to determine if the implementation of 'stratified care' when delivered in a group setting will lead to significantly better physical and psychological outcomes and greater cost effectiveness in LBP patients compared to a bestcare historical control group. METHODS/DESIGN: This study is a non randomised controlled trial. Low back pain patients recruited from the Waterford Primary Care area (population = 47,000) will be stratified into low, medium or high risk of persisting symptoms using the STarT Back Tool. Low risk patients will be offered a single one off education/exercise class offering positive messages on LBP management in line with recommended guidelines. Medium risk patients will be offered a 12 week group exercise/education intervention addressing their dominant physical obstacles to recovery. A 12 week group cognitive behavioural approach will be delivered to the high risk patients, characterised by the presence of high levels of psychosocial prognostic factors. These patients will be compared with a historical control group where therapists were blinded as to the risk stratification of patients and a generic group intervention was delivered to all patients, irrespective of their initial risk stratification. The primary outcome measure will be disability (Roland Morris Disability Questionnaire). Secondary outcomes will include back pain intensity (Visual Analogue Scale), distress (Distress and Risk Assessment Method), back beliefs (Back Beliefs Questionnaire), health status (Euroqol), global benefit (7 point likert scale), satisfaction (7 point likert scale), cost effectiveness and functional status. Outcome will be measured at baseline, 12 weeks and 6 months. DISCUSSION: This paper details the rationale, design, methods, planned analysis and operational aspects of a study examining the utility of the STarT Back Tool as a 'stratification tool for targeted treatment' in a group intervention. TRIAL REGISTRATION: Current controlled trials: ACTRN12613000431729."," BMC Musculoskelet Disord 14: 342.","USA",2013,"Back Pain","Exercise","RMDQ","Unknown","Cost-Effectiveness","RCT","USA","Unknown","Back Pain","Exercise","Cost-Effectiveness","RCT","RMDQ","2010:2014"]
[262,"Murphy, S. E., et al. (2016). \"Comparison of a Stratified Group Intervention (STarT Back) With Usual Group Care in Patients With Low Back Pain: A Nonrandomized Controlled Trial.\" Spine (Phila Pa 1976) 41(8): 645-652.",null,"Murphy, S. E., et al.","Comparison of a Stratified Group Intervention (STarT Back) With Usual Group Care in Patients With Low Back Pain: A Nonrandomized Controlled Trial","STUDY DESIGN: A nonrandomized controlled trial. OBJECTIVE: This study aims to explore the effectiveness of group-based stratified care in primary care. SUMMARY OF BACKGROUND DATA: Stratified care based on psychosocial screening (STarT Back) has demonstrated greater clinical and cost-effectiveness in patients with low back pain. However, low back pain interventions are often delivered in groups and evaluating this system of care in a group setting is important. METHODS: Patients were recruited from 60 general practices and linked physiotherapy services. A new group stratified intervention was compared with a historical nonstratified control group. Patients stratified as low, medium and high risk were offered risk-matched group care. Consenting participants completed self-report measures of functional disability (primary outcome measure), pain, psychological distress, and beliefs. The historical control received a generic group intervention. Analysis was by intention to treat. RESULTS: In total, 251 patients in the new stratified intervention and 332 in the historical control were included in the primary analysis at 12 weeks. The mean age of patients was 43 +/- 10.98 years. Overall adjusted mean changes in the RMDQ scores were higher in the stratified intervention than in the control arm at 12-week follow-up (P = 0.028). Exploring the risk groups, individually the high-risk stratified group, demonstrated better outcome over the controls (P = 0.031). The medium-risk stratified intervention demonstrated equally good outcomes (P = 0.125), and low-risk stratified patients, despite less intervention, did as well as the historical controls (P = 0.993). CONCLUSION: Stratified care delivered in a group setting demonstrated superior outcomes in the high-risk patients, and equally good outcomes for the medium and low-risk groups. This model, embedded in primary care, provides an early and effective model of chronic disease management and adds another dimension to the utility of the STarT Back system of care. LEVEL OF EVIDENCE: 2."," Spine (Phila Pa 1976) 41(8): 645-652.","Ireland",2016,"Back Pain","Physical Therapy","RMDQ","Adults","Cost-Effectiveness","RCT","Ireland","Adults","Back Pain","Physical Therapy","Cost-Effectiveness","RCT","RMDQ","2015:2018"]
[263,"Murphy, S., et al. (2013). \"The role of clinical specialist physiotherapists in the management of low back pain in a spinal triage clinic.\" Ir J Med Sci 182(4): 643-650.",null,"Murphy, S., et al.","The role of clinical specialist physiotherapists in the management of low back pain in a spinal triage clinic","BACKGROUND: Traditional care pathways for patients with low back pain (LBP) where general practitioners (GPs) refer to consultant specialists can lead to excessive waiting times for patients and questionable use of health care resources. The evaluation of more cost effective pathways is a priority. AIMS: The study aims to determine if clinical specialist physiotherapists can allocate patients into the three distinct diagnostic triage categories in line with international guidelines. A secondary aim is to examine the utility of baseline domains to inform clinical decision making. METHODS: A review of LBP patients (n = 1,532) consecutively referred between 2008 and 2010 to a physiotherapy led spinal triage clinic was undertaken. Baseline demographics, pain severity (Visual Analogue Scale), disability (Roland Morris Disability Questionnaire), distress (Distress and Risk Assessment Method), mobility and function were assessed. Relationships between these factors were analysed. RESULTS: Eighty-five percent of the population were deemed suitable for conservative management and were referred for either group exercise intervention (n = 1,125, 73 %) or individual treatment (n = 178, 12 %), in line with clinical guidelines. Fourteen percent were discharged and only 1 % required a specialist opinion. Patients allocated to the three management streams could be clearly discriminated by baseline measures of pain, distress, disability and function (p < 0.01). CONCLUSION: Clinical Specialist physiotherapists are effective in assessing and selecting appropriate care pathways for LBP patients in line with international LBP clinical guidelines. The utility of the physical and psychological measures to differentiate between groups of varying clinical severity has important implications for treatment selection and management."," Ir J Med Sci 182(4): 643-650.","USA",2013,"Back Pain","Exercise","RMDQ","Unknown","Cost and Resource Use","Observational","USA","Unknown","Back Pain","Exercise","Cost and Resource Use","Observational","RMDQ","2010:2014"]
[264,"Nagoshi, N., et al. (2017). \"Risk Factors for and Clinical Outcomes of Dysphagia After Anterior Cervical Surgery for Degenerative Cervical Myelopathy: Results from the AOSpine International and North America Studies.\" J Bone Joint Surg Am 99(13): 1069-1077.",null,"Nagoshi, N., et al.","Risk Factors for and Clinical Outcomes of Dysphagia After Anterior Cervical Surgery for Degenerative Cervical Myelopathy: Results from the AOSpine International and North America Studies","BACKGROUND: Although dysphagia is a common complication after anterior cervical decompression and fusion, important risk factors have not been rigorously evaluated. Furthermore, the impact of dysphagia on neurological and quality-of-life outcomes is not fully understood. The aim of this study was to determine the prevalence of and risk factors for dysphagia, and the impact of this complication on short and long-term clinical outcomes, in patients treated with anterior cervical decompression and fusion. METHODS: Four hundred and seventy patients undergoing a 1-stage anterior or 2-stage anteroposterior cervical decompression and fusion were enrolled in the prospective AOSpine CSM (Cervical Spondylotic Myelopathy) North America or International study at 26 global sites. Logistic regression analyses were conducted to determine important clinical and surgical predictors of perioperative dysphagia. Preoperatively and at each follow-up visit, patients were evaluated using the modified Japanese Orthopaedic Association scale (mJOA), Nurick score, Neck Disability Index (NDI), and Short Form-36 Health Survey (SF-36). A 2-way repeated-measures analysis of covariance was used to evaluate differences in outcomes at 6 and 24 months between patients with and those without dysphagia, while controlling for relevant baseline characteristics and surgical factors. RESULTS: The overall prevalence of dysphagia was 6.2%. Bivariate analysis showed the major risk factors for perioperative dysphagia to be a higher comorbidity score, older age, a cardiovascular or endocrine disorder, a lower SF-36 Physical Component Summary score, 2-stage surgery, and a greater number of decompressed levels. Multivariable analysis showed patients to be at an increased risk of perioperative dysphagia if they had an endocrine disorder, a greater number of decompressed segments, or 2-stage surgery. Both short and long-term improvements in functional, disability, and quality-of-life scores were comparable between patients with and those without dysphagia. CONCLUSIONS: The most important predictors of dysphagia are an endocrine disorder, a greater number of decompressed levels, and 2-stage surgery. At the time of both short and long-term follow-up, patients with perioperative dysphagia exhibited improvements in functional, disability, and quality-of life scores that were similar to those of patients without dysphagia. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence."," J Bone Joint Surg Am 99(13): 1069-1077.","Japan,Canada,USA,Italy",2017,"Spondylosis","Surgical","NDI,Nurick","Unknown","PRO study","Prospective Observation","Japan,Canada,USA,Italy","Unknown","Spondylosis","Surgical","PRO study","Prospective Observation","NDI,Nurick","2015:2018"]
[265,"Nakashima, H., et al. (2016). \"Comparison of Outcomes of Surgical Treatment for Ossification of the Posterior Longitudinal Ligament Versus Other Forms of Degenerative Cervical Myelopathy: Results from the Prospective, Multicenter AOSpine CSM-International Study of 479 Patients.\" J Bone Joint Surg Am 98(5): 370-378.",null,"Nakashima, H., et al.","Comparison of Outcomes of Surgical Treatment for Ossification of the Posterior Longitudinal Ligament Versus Other Forms of Degenerative Cervical Myelopathy: Results from the Prospective, Multicenter AOSpine CSM-International Study of 479 Patients","BACKGROUND: Degenerative cervical myelopathy (DCM) is an all-encompassing term that includes cervical spondylotic myelopathy (CSM), ossification of the posterior longitudinal ligament (OPLL), and other spinal abnormalities that cause cervical cord compression. It is unclear whether surgery is equally effective and safe for patients with OPLL as it is for those with other forms of DCM. The purpose of this study was to compare surgical outcomes of patients with OPLL and those with other forms of DCM. METHODS: Four hundred and seventy-nine patients with symptomatic DCM were prospectively enrolled in the CSM-International study at sixteen sites. Patients' functional status was evaluated using the modified Japanese Orthopaedic Association scale (mJOA) and the Nurick score. Quality of life was assessed using patient-reported outcome measures, including the Neck Disability Index (NDI) and the Short Form (SF)-36. Postoperative functional and quality-of-life outcomes were assessed at two years of follow-up, and scores were compared between patients with and without OPLL. RESULTS: Of 479 patients, 135 (28.2%) had radiographic evidence of OPLL, and 344 (71.8%) had other forms of DCM. The two groups did not differ significantly in demographics, surgical approach, or baseline myelopathy severity. Patients with OPLL achieved similar functional outcomes by two years following surgery compared with patients with other forms of DCM. With respect to quality of life, the NDI and most of the subscales of the SF-36 were not different between the two diagnostic groups. There was a higher risk of perioperative complications in the OPLL group (p = 0.054), although this relationship did not reach statistical significance. Rates of neurological complications did not differ significantly between diagnostic groups. CONCLUSIONS: Surgical decompression for the treatment of OPLL resulted in improvements in functional status and quality of life comparable to those seen in patients with other forms of DCM. Patients with OPLL were at a higher risk of perioperative complications than patients with other forms of DCM."," J Bone Joint Surg Am 98(5): 370-378.","Canada,Japan,China",2016,"Cervical Myelopathy,Spondylosis","Surgical","NDI,Nurick","Unknown","PRO study","Prospective Observation","Canada,Japan,China","Unknown","Cervical Myelopathy,Spondylosis","Surgical","PRO study","Prospective Observation","NDI,Nurick","2015:2018"]
[266,"Negrini, S., et al. (2012). \"Is the SRS-22 able to detect Quality of Life (QoL) changes during conservative treatments ?\" Stud Health Technol Inform 176: 433-436.",null,"Negrini, S., et al.","Is the SRS-22 able to detect Quality of Life (QoL) changes during conservative treatments ?","BACKGROUND: The SRS-22 has been developed to monitor QoL in scoliosis. Only a few studies have evaluated its effects on therapies. Consequently, doubts exist on its utility in conservative treatment. AIM: To evaluate if SRS-22 is able to detect changes in patients treated conservatively. MATERIAL AND METHODS: Study design. Retrospective controlled cohort study nested in a prospective clinical database. Population. One hundred and thirty six consecutive adolescents at their first evaluation, age 12.8 +/- 2.7, divided into 5 groups according to treatment: 30 brace for 18 hours/day, 7 for 21 h/d, 33 for 23 h/d, 48 exercises and 14 observed (controls). Methods. All patients completed SRS-22 before the first and at the 6 months follow-up evaluations. Statistical analysis. ANOVA and Kruskall-Wallis tests. RESULTS: Controls did not show changes with time, while all treated patients had increase of satisfaction with treatment. Aesthetic improvement was perceived by patients treated with exercises, while brace treated patients showed a negative psychological impact: these statistical changes were not clinically significant (0.2-0.3 points out of 5), excluding satisfaction (1.15-1.8). Between the groups, the 23 h/d showed worst start but best results in functioning, aesthetics, pain and satisfaction. CONCLUSION: SRS-22 appears to detect changes in populations, but its clinical everyday use appears less reliable."," Stud Health Technol Inform 176: 433-436.","Italy",2012,"Spinal Deformity","Exercise","SRS-HRQOL","Adolescents","PRO study","Prospective Observation","Italy","Adolescents","Spinal Deformity","Exercise","PRO study","Prospective Observation","SRS-HRQOL","2010:2014"]
[267,"Nitikman, M., et al. (2017). \"Internet-administered Health-related Quality of Life Questionnaires Compared With Pen and Paper in an Adolescent Scoliosis Population: A Randomized Crossover Study.\" J Pediatr Orthop 37(2): e75-e79.",null,"Nitikman, M., et al.","Internet-administered Health-related Quality of Life Questionnaires Compared With Pen and Paper in an Adolescent Scoliosis Population: A Randomized Crossover Study","BACKGROUND: Modern technology puts into question the effectiveness of using pen and paper as a means of collecting information from web-enabled patients. This study aimed to validate and test the reliability of using the Internet as a method of administering health-related quality of life questionnaires in a pediatric spine population. METHODS: A prospective randomized crossover study was conducted. Patients aged 11 to 18 with idiopathic scoliosis were invited to participate, and informed consent was obtained from a scoliosis outpatient clinic setting. Participants were randomized to one of 4 groups determining the method of questionnaire administration [Scoliosis Research Society 30 (SRS-30) and Pediatric Outcomes Data Collection Instrument (PODCI)]. Both questionnaires were completed at 2 separate timepoints and 2 weeks apart to prevent recall bias. Groups included: Paper/Paper, Paper/Internet, Internet/Paper, and Internet/Internet. Paired-samples t tests were used to determine the test-retest reliability of each group. Analysis was stratified for surveys returned within or outside of the allotted 4-week timeframe following enrollment. RESULTS: Of the 96 participants who completed and returned both sets of questionnaires, 26 were allocated to the Paper/Paper group (27%), 20 to the Paper/Internet group (21%), 26 to the Internet/Paper group (27%), and 24 to the Internet/Internet group (25%). The second iteration of questionnaires was returned on time by 69 of the participants (71.2%). Of the late questionnaires, 18 (67%) were paper forms. Overall, no differences were observed between Internet-administered compared with pen and paper-administered questionnaires (P=0.206). No differences were observed within any group individually for either the SRS-30 or PODCI questionnaire. In addition, no significant differences were observed within groups for surveys returned within or outside of the 4-week timeframe. Eighty-four percent of the participants who completed both paper and Internet versions of the questionnaires reported a preference of the Internet. CONCLUSION: Internet administration of both the SRS-30 and PODCI questionnaires is a valid and reliable method of acquiring health-related quality of life information in this population LEVEL OF EVIDENCE:: Level II-therapeutic study."," J Pediatr Orthop 37(2): e75-e79.","Canada",2017,"Spinal Deformity","Not Specified","SRS-HRQOL","Unknown","PRO study","Prospective Observation","Canada","Unknown","Spinal Deformity","Not Specified","PRO study","Prospective Observation","SRS-HRQOL","2015:2018"]
[268,"Nordin, M., et al. (2003). \"Measures for low back pain: a proposal for clinical use.\" Rev Lat Am Enfermagem 11(2): 152-155.",null,"Nordin, M., et al.","Measures for low back pain: a proposal for clinical use","Low back pain represents a serious public health problem. Therefore, great efforts have been made in order to improve and assess the efficacy of its treatment. Reports in international literature have presented important studies concerning instruments to assess pain and functional incapacity in patients with low back pain. This study presents a clinical protocol which was developed by a multidisciplinary team. This protocol consists of the evaluation and distribution of pain, The Spitzer Quality of Life, The Oswestry Low Back Pain Disability Questionnaire, and The Center for Epidemiological Studies Depression Scale. Instruments must be urgently developed or adapted in order to be used according to the Brazilian reality."," Rev Lat Am Enfermagem 11(2): 152-155.","USA",2003,"Back Pain","Not Specified","ODI","Unknown","Protocol","Narrative review","USA","Unknown","Back Pain","Not Specified","Protocol","Narrative review","ODI","2000:2004"]
[269,"Oestergaard, L. G., et al. (2012). \"The effect of early initiation of rehabilitation after lumbar spinal fusion: a randomized clinical study.\" Spine (Phila Pa 1976) 37(21): 1803-1809.",null,"Oestergaard, L. G., et al.","The effect of early initiation of rehabilitation after lumbar spinal fusion: a randomized clinical study","STUDY DESIGN: A multicenter randomized clinical trial including 82 patients. OBJECTIVE: To examine the effect of early initiation of rehabilitation after instrumented lumbar spinal fusion. SUMMARY OF BACKGROUND DATA: Lumbar spinal fusion has been performed for more than 70 years. Yet, few studies have examined patients' subsequent rehabilitation. Group-based rehabilitation is both efficient and cost-effective in rehabilitation of lumbar spinal fusion patients. METHODS: Patients with degenerative disc diseases undergoing instrumented lumbar spinal fusion were randomly assigned to initiate their rehabilitation 6 weeks (6-wk group) or 12 weeks after lumbar spinal fusion (12-wk group). Both groups received the same group-based rehabilitation. Primary outcome was the Oswestry Disability Index. Secondary outcome was the Dallas Pain Questionnaire, the Low Back Pain Rating Scale, and absence from work. Wilcoxon rank-sum test was used to compare the groups in terms of differences from baseline to 6 months and 1-year follow-up. Results are presented in median with 25th and 75th percentiles. RESULTS: According to the Oswestry Disability Index, at 1-year follow-up, the 6-week-group had a median reduction of -6 (-19; 4) compared with -20 (-30;-7) in the 12-week group (P, 0.05). The Dallas Pain Questionnaire showed overall the same tendency, and within daily activities were significantly reduced in favor of the 12-week group (P, 0.05). For back pain, the 6-week group had a median reduction of -2.2 (-3.0; -0.7) similar with -3.3 (-4.7; -1.7) in the 12-week group (P, 0.05). The results at 6 months of follow-up were similar. No difference was found according to return to work 1 year postsurgery. CONCLUSION: Early start of rehabilitation (6 wk vs. 12 wk) after lumbar spinal fusion resulted in inferior outcomes. The improvements in the 12-week group were 4 times better than that in the 6-week group, indicating that the start-up time of rehabilitation is an important contributing factor for the overall outcome."," Spine (Phila Pa 1976) 37(21): 1803-1809.","Denmark",2012,"Back Pain,Spinal Fusion","Surgical","ODI,ICF","Unknown","Cost-Effectiveness","RCT","Denmark","Unknown","Back Pain,Spinal Fusion","Surgical","Cost-Effectiveness","RCT","ODI,ICF","2010:2014"]
[270,"Oner, F. C., et al. (2016). \"Toward the Development of a Universal Outcome Instrument for Spine Trauma: A Systematic Review and Content Comparison of Outcome Measures Used in Spine Trauma Research Using the ICF as Reference.\" Spine (Phila Pa 1976) 41(4): 358-367.",null,"Oner, F. C., et al.","Toward the Development of a Universal Outcome Instrument for Spine Trauma: A Systematic Review and Content Comparison of Outcome Measures Used in Spine Trauma Research Using the ICF as Reference","STUDY DESIGN: A systematic literature review. OBJECTIVE: The aim of this study was (1999) to identify patient-reported and clinician-based outcome measures most frequently used to evaluate the function and health of spine trauma patients, (2) to identify and quantify the concepts of these measures using the International Classification of Functioning, Disability, and Health (ICF) as reference, and (3) to describe their clinimetric properties. SUMMARY OF BACKGROUND DATA: There is a real need for a disease-specific outcome instrument to measure the effect size of various treatment options in a variety of traumatic spinal column injuries. METHODS: A systematic literature search was conducted in several databases. From the included studies, outcome measures were extracted. The items and underlying concepts of the identified outcome measures were specified and linked to the ICF categories. Finally, as far as available in literature, the clinimetric properties of the obtained measures were analyzed. RESULTS: Out of 5117 screened references, 245 were included, and 17 different frequently used outcome measures were identified. Meaningful concepts of the items and response options of the retrieved outcome measures were linked to a total of 105 different ICF categories, aggregated to 57 first- or second-level categories. The categories were linked to the components activities and participation (n = 31), body functions (n = 17), environmental factors (n = 8), and body structures (n = 1). Overall, there is only limited evidence on the measurement properties, except for some disease-specific questionnaires, such as Oswestry Disability Index, Roland-Morris Disability Questionnaire, Neck Disability Index, and Cervical Spine Outcome Questionnaire. CONCLUSION: The current systematic literature review revealed great diversity in the use and content of outcome measures to evaluate the functioning and health of spine trauma patients, with 17 different outcome measures linked to 57 unique ICF categories. This study creates an evidence base for a consensus meeting during which a core set of ICF categories for outcome measurement in spine trauma will be decided. LEVEL OF EVIDENCE: 2."," Spine (Phila Pa 1976) 41(4): 358-367.","USA",2016,"Unspecified","Not Specified","ODI,RMDQ,NDI,Oswestry,ICF","Unknown","PRO study","Systematic review","USA","Unknown","Unspecified","Not Specified","PRO study","Systematic review","ODI,RMDQ,NDI,Oswestry,ICF","2015:2018"]
[271,"Orgera, G., et al. (2014). \"Percutaneous vertebroplasty for pain management in patients with multiple myeloma: is radiofrequency ablation necessary?\" Cardiovasc Intervent Radiol 37(1999): 203-210.",null,"Orgera, G., et al.","Percutaneous vertebroplasty for pain management in patients with multiple myeloma: is radiofrequency ablation necessary?","PURPOSE: This study was designed to investigate the added role of radiofrequency ablation (RFA) to vertebroplasty on the pain management of patients with multiple myeloma (MM). METHODS: Thirty-six patients (51-82 years) with vertebral localization of MM were randomly divided into two groups: 18 patients (group A) who underwent RFA and then vertebroplasty, and 18 patients (group B) who underwent only vertebroplasty. Primary endpoints were technical success and pain relief score rate measured by the visual analogue pain scores (VAS) and Roland-Morris Questionnaire (RMQ); secondary endpoint was the amount of administered analgesia. Survival and complications were compared. RESULTS: Technical success was 100 % in both groups. The VAS score (at 24 h and 6 weeks postprocedure) decreased in equal manner for both groups from a mean of 9.1-3.4 and 2.0 for group A and from a mean of 9.3-3.0 and 2.3 for group B; RMQ mean score was 19.8 for group A and 19.9 for group B and decreased to a mean of 9.6 and 8.2 for group A and 9.5 and 8.7 for group B. The amount of medication was equally decreased in the two groups. No statistically significant difference was noted. No major complication occurred and two patients died from other causes. CONCLUSIONS: The use of percutaneous vertebroplasty alone appears to be effective for the pain management of the patients with vertebral involvement of multiple myeloma. The use of RFA that includes cost and time does not offer any clear added benefit on the midterm pain management of such patients."," Cardiovasc Intervent Radiol 37(1999): 203-210.","Italy",2014,"Cancer","Surgical","RMDQ","Adults","PRO study","Clinical trial","Italy","Adults","Cancer","Surgical","PRO study","Clinical trial","RMDQ","2010:2014"]
[272,"Ortancil, O., et al. (2009). \"The effect(s) of a six-week home-based exercise program on the respiratory muscle and functional status in ankylosing spondylitis.\" J Clin Rheumatol 15(2): 68-70.",null,"Ortancil, O., et al.","The effect(s) of a six-week home-based exercise program on the respiratory muscle and functional status in ankylosing spondylitis","BACKGROUND: Ankylosing spondylitis (AS) is a chronic, inflammatory rheumatic disease. Involvement of costovertebral and costotransverse joints results in rigidity of the chest wall and inability to expand the chest fully on inspiration. Also significant reduction in exercise capacity in the AS patients was reported. OBJECTIVES: To determine the effects of a 6-week home-based exercise program on the respiratory muscle and energy cost in AS. METHODS: Twenty-two AS patients were included. Chest expansion, tragus-wall distance, modified Schober test, maximal inspiratory pressure, maximal expiratory pressure, 6-minute walking distance, physiologic cost index and functional status Bath Ankylosing Spondylitis Functional Index of patients were measured at baseline and repeated at the end of an open 6-week home-based exercise program. Breathing exercises and upper extremity exercises were taught to all the patients. The patients were then asked to practice these exercises at home individually for 6 weeks. RESULTS: Chest expansion, maximal inspiratory pressure, and maximal expiratory pressure values and Bath Ankylosing Spondylitis Functional Index scores of patients significantly increased after 6 weeks (P < 0.001). Six-minute walking distance and physiologic cost index values did not change at the end of the 6 weeks (P > 0.05). CONCLUSIONS: A home-based exercise program can have an effect on some measures respiratory muscle and functional status. Greater emphasis should be placed on maintaining cardiorespiratory fitness as well as spinal mobility to encourage patients with AS."," J Clin Rheumatol 15(2): 68-70.","Turkey",2009,"Spondylosis","Exercise","Schober","Unknown","PRO study","Clinical trial","Turkey","Unknown","Spondylosis","Exercise","PRO study","Clinical trial","Schober","2005:2009"]
[273,"Ostelo, R. W. and H. C. de Vet (2005). \"Clinically important outcomes in low back pain.\" Best Pract Res Clin Rheumatol 19(4): 593-607.",null,"Ostelo, R. W. and H. C. de Vet","Clinically important outcomes in low back pain","Four important domains directly related to low back pain are: pain intensity, low-back-pain-specific disability, patient satisfaction with treatment outcome, and work disability. Within each of the domains, different questionnaires have been proposed. This chapter focuses on validated and widely used questionnaires. Details of the background and the measurement properties, and of the minimally clinically important change (MCIC) using these questionnaires, are described. The MCIC can be estimated using various methods and there is no consensus in the literature on what the most appropriate technique is. This chapter focuses primarily on two adequate and frequently used methods for estimating the MCIC. We argue that the MCIC should not be considered as a fixed value and that the MCIC values presented in this chapter are used as indications. For patients with subacute or chronic low back pain, the MCIC for pain on a visual analogue scale (VAS) should at least be 20mm and for acute low back pain it seems reasonable to suggest that the MCIC should at least be at the level of approximately 35mm. If a numerical rating scale (NRS) is used it seems reasonable to suggest that the MCIC should at least be 3.5 and 2.5 for patients with acute and chronic low back pain, respectively. For functional disability as measured with the Roland Disability Questionnaire it seems reasonable that the MCIC should at least be 3.5 points, whereas an MCIC of at least 10 points when the Oswestry Disability Index is used. For global perceived effect, we argue that the MCIC is most appropriately defined in terms of at least 'much improved' or 'very satisfied', instead of including 'slightly improved'. Finally, we argue that, from the point of view of cost effectiveness, every day of earlier return to work is important. The exact value for the MCIC can be determined, taking into account the aim of the measurement, the initial scores, the target population and the method used to assess MCIC."," Best Pract Res Clin Rheumatol 19(4): 593-607.","Netherlands",2005,"Back Pain","Not Specified","ODI,RMDQ","Unknown","PRO study","Narrative review","Netherlands","Unknown","Back Pain","Not Specified","PRO study","Narrative review","ODI,RMDQ","2005:2009"]
[274,"Padua, R., et al. (2001). \"Patient outcomes after Harrington instrumentation for idiopathic scoliosis: a 15- to 28-year evaluation.\" Spine (Phila Pa 1976) 26(11): 1268-1273.",null,"Padua, R., et al.","Patient outcomes after Harrington instrumentation for idiopathic scoliosis: a 15- to 28-year evaluation","STUDY DESIGN: A retrospective study was performed, using the Short Form-36 Health Survey and the Roland and Morris Disability Questionnaire, to investigate patient outcomes after fusion for adolescent idiopathic scoliosis using Harrington rod instrumentation. OBJECTIVE: To evaluate health-related quality of life and low back pain in a long-term follow-up study of surgery for adolescent idiopathic scoliosis. SUMMARY OF BACKGROUND DATA: The commonly accepted surgical treatment for idiopathic evolutive scoliosis is vertebral fusion. It has been suggested that this procedure may cause low back pain and a poor quality of life over the long term. Outcome measures after surgery for adolescent idiopathic scoliosis have focused mainly on objective parameters such as radiographic measures. However, this information has proved to be correlated only weakly with outcomes that are more relevant to patients, such as functional status and symptoms. Until recently, only a few long-term outcome studies have used standardized and validated patient-oriented tools to evaluate surgically treated patients with scoliosis. METHODS: In this study, 70 patients treated with a standard Harrington technique were recontacted and evaluated by means of self-administered questionnaires (Short Form-36 Health Survey and Roland and Morris Disability, clinical examination, and radiographic analysis. Preoperative and follow-up radiographic findings were registered. Relations between radiographic and patient-oriented data were evaluated. RESULTS: A comparison between the current sample and the Italian age-matched normative data for the Short Form-36 Health Survey showed them to have a similar pattern. Findings showed the patient-oriented outcome to be correlated inversely with the extension of vertebral fusion and the preoperative Cobb angle. CONCLUSION: Long-term follow-up evaluation of Harrington rod fusion for adolescent idiopathic scoliosis showed no important impairment of health-related quality of life, as measured by patient-oriented evaluation."," Spine (Phila Pa 1976) 26(11): 1268-1273.","Italy",2001,"Spinal Deformity","Surgical","RMDQ","Adolescents","PRO study","Retrospective review","Italy","Adolescents","Spinal Deformity","Surgical","PRO study","Retrospective review","RMDQ","2000:2004"]
[275,"Paleri, V., et al. (2001). \"Quality of life in laryngectomees: a post-treatment comparison of laryngectomy alone versus combined therapy.\" J Laryngol Otol 115(6): 450-454.",null,"Paleri, V., et al.","Quality of life in laryngectomees: a post-treatment comparison of laryngectomy alone versus combined therapy","Patients with advanced and recurrent laryngeal and hypopharyngeal cancer often need combined therapy, which is associated with greater morbidity than single modality treatment. The aim of this study was to assess the quality of life in laryngectomees and to assess whether differences exist between the irradiated and the non-irradiated patients. The University of Michigan Head and Neck Quality of Life questionnaire, a validated instrument for assessing the head and neck cancer related functional status and well-being, was used for this purpose. Subjects for the study included patients who had undergone total laryngectomy for laryngeal or hypophyarngeal squamous cancer. No significant difference between the groups was evident in the various domain scores, although a trend towards higher scores was seen in the combined therapy group. This study suggests that long-term side effects induced by radiotherapy do not adversely affect the quality of life in laryngectomised patients."," J Laryngol Otol 115(6): 450-454.","UK",2001,"Cancer","Surgical","HNQOL","Unknown","PRO study","Clinical trial","UK","Unknown","Cancer","Surgical","PRO study","Clinical trial","HNQOL","2000:2004"]
[276,"Pallay, R. M., et al. (2004). \"Etoricoxib reduced pain and disability and improved quality of life in patients with chronic low back pain: a 3 month, randomized, controlled trial.\" Scand J Rheumatol 33(4): 257-266.",null,"Pallay, R. M., et al.","Etoricoxib reduced pain and disability and improved quality of life in patients with chronic low back pain: a 3 month, randomized, controlled trial","BACKGROUND: Chronic low back pain (LBP) is a growing health problem. Non-steroidal anti-inflammatory drugs (NSAIDs) are used to treat this condition, but have not demonstrated efficacy beyond 2 weeks, and no studies have shown that NSAIDs produce durable improvements in disability. METHODS: To evaluate the efficacy and durability of effect of etoricoxib for chronic LBP, a randomized, double blind, placebo-controlled trial was conducted at 46 centres. Three hundred and twenty-five patients with chronic LBP requiring treatment with an NSAID or paracetamol were randomized 1:1:1 to etoricoxib 60 mg (n=109), 90 mg (n=106), or placebo (n=110), daily for 3 months. Pre-specified endpoints over 3 months included LBP intensity scale (visual analog scale 0-100 mm) time-weighted average change from baseline, the Roland-Morris Disability Questionnaire (RMDQ), the LBP bothersomeness scale, patient and investigator global assessments, and measures of quality of life. RESULTS: Both etoricoxib groups experienced significant reductions in LBP intensity at 4 weeks versus placebo [-15.15 mm and -13.03 mm for 60 and 90 mg, respectively, probability (p)<0.001 for each], which was maintained over 3 months. Treatment resulted in significant improvement from baseline compared to placebo in RMDQ scores (etoricoxib 60 mg, -2.82 and 90 mg, -2.38, p<0.001 for each) over 12 weeks and most other efficacy endpoints. There were no significant differences between treatments in incidence of adverse events (AEs) or discontinuations due to AEs. CONCLUSION: Etoricoxib provided significant relief of symptoms and disability associated with chronic LBP detected at 1 week, confirmed at 4 weeks, and maintained over 3 months. Reductions in chronic LBP severity corresponded to improvements in physical functioning and quality of life. All treatments were generally well tolerated."," Scand J Rheumatol 33(4): 257-266.","USA",2004,"Back Pain","NSAID","RMDQ,Bothersomeness","Unknown","PRO study","RCT","USA","Unknown","Back Pain","NSAID","PRO study","RCT","RMDQ,Bothersomeness","2000:2004"]
[277,"Paolucci, T., et al. (2012). \"Psychological features and outcomes of the Back School treatment in patients with chronic non-specific low back pain. A randomized controlled study.\" Eur J Phys Rehabil Med 48(2): 245-253.",null,"Paolucci, T., et al.","Psychological features and outcomes of the Back School treatment in patients with chronic non-specific low back pain. A randomized controlled study","BACKGROUND: Low back pain is a worldwide health problem, affecting up to 80% of adult population. Psychological factors are involved in its development and maintenance. Many clinical trials have evaluated the efficacy of different interventions for chronic non-specific low back pain. In this field, Back School program has been demonstrated effective for people with chronic non-specific low back. AIM: To evaluate the relationship between the effects of the Back School treatment and psychological features measured by MMPI-II of patients with chronic non-specific low back pain. DESIGN: A randomised controlled trial with three and six-month follow-up. SETTING: Ambulatory rehabilitative university centre. POPULATION: Fifty patients with chronic non-specific low back pain out of 77 screened patients. METHODS: Patients were randomly placed in a 3:2 form and were allocated into two groups (Treatment versus Control). The Treatment Group participated to an intensive multidisciplinary Back School program (BSG, N.=29), while the Control Group received medical assistance (CG, N.=21). Medication was the same in both groups. Then, patients were subgrouped in those with at least an elevation in one scale of MMPI-II, and those without it. The Short Form 36 Health Status Survey for the assessment of quality of life (primary outcome measure), pain Visual Analogue Scale, Waddel Index and Oswestry Disability Index were collected at baseline, at the end of treatment, and at the three and six-month follow-up. RESULTS: Only the two treated subgroups showed a significant improvements in terms of quality of life, disability and pain. Among treated subjects, only those with at least one scale elevation in MMPI-II showed also a significant improvement in terms of Short Form 36 mental composite score and relevant subscores. CONCLUSION: These results suggest that Back School program has positive effects, even in terms of mental components of quality of life in patients with scale elevations of MMPI-II. Probably these findings are due to its educational and cognitive-behavioural characteristics. CLINICAL REHABILITATION IMPACT: Because of its educational purposes, the Back School treatment can have positive effects also on the mental status of patients with low back pain when it affects their psychological features."," Eur J Phys Rehabil Med 48(2): 245-253.","Italy",2012,"Back Pain","Psychosocial","ODI,Waddel","Unknown","PRO study","RCT","Italy","Unknown","Back Pain","Psychosocial","PRO study","RCT","ODI,WADDEL","2010:2014"]
[278,"Parent, E. C., et al. (2010). \"The association between Scoliosis Research Society-22 scores and scoliosis severity changes at a clinically relevant threshold.\" Spine (Phila Pa 1976) 35(3): 315-322.",null,"Parent, E. C., et al.","The association between Scoliosis Research Society-22 scores and scoliosis severity changes at a clinically relevant threshold","STUDY DESIGN: Cross-sectional correlation study. OBJECTIVE: To determine the threshold in spinal deformity severity measurements beyond which there is a progressive decline in health-related quality-of-life (HRQOL). SUMMARY OF BACKGROUND DATA: The associations between HRQOL and scoliosis deformity measures are at best moderate when assessed using linear regressions. This may be because HRQOL is not affected until a severity threshold is reached. Identifying the thresholds in deformity beyond which HRQOL deteriorates could assist in treatment recommendations. METHODS: The Scoliosis Research Society-22 (SRS-22) questionnaire was completed by 101 females with adolescent idiopathic scoliosis (age, 15.0 +/- 1.8; largest Cobb angle, 36.9 degrees +/- 14.6 degrees). Radiographs and surface topography were used to quantify the severity of the internal (largest Cobb angle) and external deformity (cosmetic score, decompensation, trunk twist), respectively. Segmented linear regression models were estimated to determine the association between SRS-22 domains and spinal deformity measures. This analysis also identifies deformity thresholds beyond which HRQOL is more affected. The percentage of variance explained (R2) by linear and segmented models were compared (alpha = 0.05) to identify the best models. RESULTS: Cobb angle predicted significantly more variance in all SRS-22 domains except mental health using segmented models (R2: 0.09-0.30) than linear models (R2: 0.02-0.21). Segmented models with a single threshold estimated at a Cobb angle between 43 degrees and 48 degrees predicted between 3% and 11% more variance compared to corresponding linear model using the same variables. Surface topography parameters were not strongly associated with SRS-22 variables with linear and segmented models explaining less than 10% of the variance. CONCLUSION: Deterioration in SRS-22 scores is mildly associated with increases in the severity of the internal deformity. HRQOL is stable until the curve reaches a maximal Cobb angle threshold at approximately 45 degrees where HRQOL declines linearly with increasing internal deformity. The association between HRQOL and scoliosis severity is low, but is better explained by segmented rather than linear models."," Spine (Phila Pa 1976) 35(3): 315-322.","Canada",2010,"Spinal Deformity","Not Specified","SRS-HRQOL","Adolescents","PRO study","Observational","Canada","Adolescents","Spinal Deformity","Not Specified","PRO study","Observational","SRS-HRQOL","2010:2014"]
[279,"Passias, P. G., et al. (2015). \"Magnitude of preoperative cervical lordotic compensation and C2-T3 angle are correlated to increased risk of postoperative sagittal spinal pelvic malalignment in adult thoracolumbar deformity patients at 2-year follow-up.\" Spine J 15(8): 1756-1763.",null,"Passias, P. G., et al.","Magnitude of preoperative cervical lordotic compensation and C2-T3 angle are correlated to increased risk of postoperative sagittal spinal pelvic malalignment in adult thoracolumbar deformity patients at 2-year follow-up","BACKGROUND CONTEXT: Cervical deformity (CD) is prevalent among patients with adult spinal deformity (ASD). The effect of baseline cervical alignment on achieving optimal thoracolumbar alignment in ASD surgery is unclear. PURPOSE: This study assesses the relationship between preoperative (preop) cervical spinal parameters and global alignment after thoracolumbar ASD surgery at 2-year follow-up. STUDY DESIGN/SETTING: This study is a retrospective review of a multicenter, prospective database. PATIENT SAMPLE: Surgical ASD patients with 2-year follow-up and cervical X-rays were included. OUTCOME MEASURES: The outcome measures were radiographic parameters and self-reported health-related quality-of-life measures (Short-Form 36 [SF-36], Oswestry Disability Index [ODI], and Scoliosis Research Society 22 [SRS-22]). METHODS: Surgical ASD patients of 18 years and older with scoliosis greater than or equal to 20 degrees and one of the following radiographic parameters were included: sagittal vertical axis (SVA) greater than or equal to 5 cm, pelvic tilt (PT) greater than or equal to 25 degrees , or thoracic kyphosis (TK) greater than 60 degrees . The SRS-Schwab sagittal modifiers (PT, global alignment, and pelvic incidence and lumbar lordosis [PI-LL]) were assessed at 2-year postoperatively as either normal (\"0\") or abnormal (\"+\" or \"++\"). Patients were classified in the aligned group (AG) or malaligned group (MG) at 2-year follow-up if all three sagittal modifiers were normal or abnormal, respectively. Patients were assessed for CD based on the following criteria: C2-C7 SVA greater than 4 cm, C2-C7 SVA less than 4 cm, cervical kyphosis (CL greater than 0), cervical lordosis (CL less than 0), any deformity (C2-C7 SVA greater than 4 cm or CL greater than 0), and both CD (C2-C7 SVA greater than 4 cm and CL greater than 0). Univariate testing was performed using t or chi-square test, looking at the following preop parameters: CD, C2-C7 SVA, C2-T3 SVA, CL, T1 slope (T1S), T1S-CL, C2-T3 angle, LL, TK, PT, C7-S1 SVA, and PI-LL. RESULTS: One hundred four patients met the initial inclusion criteria with 70 in the AG and 34 in MG. Preoperative, patients in the MG had a higher CL (11.7 vs. 4.9, p=.03), higher C2-T3 angle (13.59 vs 4.9 p=.01), higher PT (p<.0001), higher SVA (p<.0001), and higher PI-LL (p<.0001) compared with the AG. Interestingly, the prevalence of CD at baseline was similar for both groups. There was no statistically significant difference among groups in the amount of improvement more than 2 years on the ODI or the Physical Component Summary of SF-36. CONCLUSIONS: Patients with sagittal spinal malalignment associated with significant cervical compensatory lordosis are at increased risk of realignment failure at 2-year follow-up. Assessment of the degree of cervical compensation may be helpful in preop evaluation to assist in realignment outcome prediction."," Spine J 15(8): 1756-1763.","USA",2015,"Spinal Deformity","Surgical","SRS-HRQOL","Unknown","PRO study","Prospective Observation","USA","Unknown","Spinal Deformity","Surgical","PRO study","Prospective Observation","SRS-HRQOL","2015:2018"]
[280,"Passias, P. G., et al. (2015). \"Postoperative cervical deformity in 215 thoracolumbar patients with adult spinal deformity: prevalence, risk factors, and impact on patient-reported outcome and satisfaction at 2-year follow-up.\" Spine (Phila Pa 1976) 40(5): 283-291.",null,"Passias, P. G., et al.","Postoperative cervical deformity in 215 thoracolumbar patients with adult spinal deformity: prevalence, risk factors, and impact on patient-reported outcome and satisfaction at 2-year follow-up","STUDY DESIGN: Retrospective review of prospective multicenter database. OBJECTIVE: Quantify the incidence of new onset cervical deformity (CD) after adult spinal deformity surgery of the thoracolumbar spine, identify predictors of development, and determine the impact on outcomes. SUMMARY OF BACKGROUND DATA: High prevalence of residual CD has been identified after surgical treatment of adult spinal deformity. Development of new onset CD is less understood and its clinical impact unclear. METHODS: A total of 215 patients with complete 2-year follow-up and full-length radiographs met inclusion criteria. CD was defined by T1 slope minus Cervical Lordosis (CL) more than 20 degrees , C2-C7 sagittal vertical axis more than 40 mm, or C2-C7 kyphosis more than 10 degrees . Univariate analysis was performed using t tests or tests of proportion. Multivariate logistic regression was used to determine independent predictors of new onset CD. The impact of CD on health-related quality of life and satisfaction was measured using repeated measures mixed models or logistic regression as appropriate, accounting for potential confounders. RESULTS: The overall rate of CD at 2 years after surgery was 63%. Univariate analysis revealed that patients who developed new onset CD postoperatively had higher incidence of diabetes (7.35% vs. 1.28%, P = 0.05), increased preoperative C2-C7 sagittal vertical axis (P = 0.04) and C2 slope (P = 0.038), and smaller diameter rods used at surgery (P = 0.032). Independent predictors of new onset CD at 2 years included: diabetes (odds ratio, 10.49; P = 0.046) and increased preoperative T1 slope minus cervical lordosis (odds ratio, 1.08/ masculine; P = 0.022). Ending instrumentation below T4 was a negative predictor (odds ratio, 0.31; P = 0.019). Patients with and without CD experienced improvements in 2-year 36-Item Short Form Health Survey (P = 0.0001), Oswestry Disability Index (P = 0.0001), and Scoliosis Research Society (P = 0.0001). Rates and overall improvement were similar. CD was not associated with decreased satisfaction (P = 0.28). CONCLUSION: A total of 47.7% of patients without preoperative CD developed new onset postoperative CD after thoracolumbar surgery. Independent predictors of new onset CD at 2 years included diabetes, higher preoperative T1 slope minus cervical lordosis, and ending instrumentation above T4. Significant improvements in health-related quality of life scores occurred despite the development of postoperative CD. LEVEL OF EVIDENCE: 2."," Spine (Phila Pa 1976) 40(5): 283-291.","USA",2015,"Spinal Deformity","Surgical","ODI,SRS-HRQOL","Unknown","PRO study","Retrospective review","USA","Unknown","Spinal Deformity","Surgical","PRO study","Retrospective review","ODI,SRS-HRQOL","2015:2018"]
[281,"Patel, S., et al. (2014). \"Primum non nocere: shared informed decision making in low back pain--a pilot cluster randomised trial.\" BMC Musculoskelet Disord 15: 282.",null,"Patel, S., et al.","Primum non nocere: shared informed decision making in low back pain--a pilot cluster randomised trial","BACKGROUND: Low back pain is a common and disabling condition leading to large health service and societal costs. Although there are several treatment options for back pain little is known about how to improve patient choice in treatment selection. The purpose of this study was to pilot a decision support package to help people choose between low back pain treatments. METHODS: This was a single-centred pilot cluster randomised controlled trial conducted in a community physiotherapy service. We included adults with non-specific low back pain referred for physiotherapy. Intervention participants were sent an information booklet prior to their first consultation. Intervention physiotherapists were trained to enhance their skills in shared informed decision making. Those in the control arm received care as usual. The primary outcome was satisfaction with the treatment received at four months using a five-point Likert Scale dichotomised into \"satisfaction\" (very satisfied or somewhat satisfied) and \"non-satisfaction\" (neither satisfied nor dissatisfied, somewhat dissatisfied or very dissatisfied). RESULTS: We recruited 148 participants. In the control arm 67% of participants were satisfied with their treatment and in the intervention arm 53%. The adjusted relative risk of being satisfied was 1.28 (95% confidence interval 0.79 to 2.09). For most secondary outcomes the trend was towards worse outcomes in the intervention group. For one measure; the Roland Morris Disability Questionnaire, this difference was clinically important (2.27, 95% confidence interval 0.08 to 4.47). Mean healthcare costs were slightly lower ( pound38 saving per patient) within the intervention arm but health outcomes were also less favourable (0.02 fewer QALYs); the estimated probability that the intervention would be cost-effective at an incremental threshold of pound20,000 per QALY was 16%. CONCLUSION: We did not find that this decision support package improved satisfaction with treatment; it may have had a substantial negative effect on clinical outcome, and is very unlikely to prove cost-effective. That a decision support package might have a clinically important detrimental effect is of concern. To our knowledge this has not been observed previously. Decision support packages should be formally tested for clinical and cost-effectiveness, and safety before implementation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN46035546 registered on 11/02/10."," BMC Musculoskelet Disord 15: 282.","UK",2014,"Back Pain","Physical Therapy","RMDQ","Adults","PRO study","RCT","UK","Adults","Back Pain","Physical Therapy","PRO study","RCT","RMDQ","2010:2014"]
[282,"Paulus, M. C., et al. (2014). \"Cost and value of spinal deformity surgery.\" Spine (Phila Pa 1976) 39(5): 388-393.",null,"Paulus, M. C., et al.","Cost and value of spinal deformity surgery","STUDY DESIGN: Literature review. OBJECTIVE: To assess (1999) quality of life in patients with adult scoliosis who underwent nonoperative and/or surgical treatment, and (2) cost-effectiveness of different scoliosis treatment modalities. SUMMARY OF BACKGROUND DATA: Recently, there has been an interest in examining quality of life of patients undergoing treatment for adult scoliosis, comparing the value of nonoperative versus operative management. This article reviews the current literature on treatment of adult scoliosis, in the hopes of drawing conclusions for the best approach to these patients. METHODS: MEDLINE and PubMed databases were searched to identify articles. Health-related quality of life measures included Oswestry Disability Index scores, Scoliosis Research Society (SRS) instrument scores, 12-Item Short Form Health Survey, and numerical rating scale for leg and/or back pain. Studies included were those involving patients with adult scoliosis who underwent primary surgery or nonoperative management. The studies that focused on the change in validated outcome scores from the onset of the study to final follow-up were found to be valuable. Studies on predominantly adolescent scoliosis and those that only measured postoperative outcomes scores were excluded. RESULTS: The SRS-22, Oswestry Disability Index, 12-Item Short Form Health Survey, and numerical rating scale were found to be validated for measuring quality of life in patients with scoliosis. Thirteen studies were included, which evaluated changes in health-related quality of life outcomes from baseline in surgical and nonsurgical treatment of adult scoliosis. There was a trend toward improved quality of life measures in patients undergoing surgical treatment for adult scoliosis. CONCLUSION: Adults with painful and disabling scoliosis may benefit from surgical treatment compared with nonsurgical treatment, given the proper indications. Nonsurgical treatment does not seem to be cost-effective and has not shown to have a positive impact on quality of life, although there is a possibility that patients' health may have deteriorated if they did not receive the nonsurgical treatment. Future prospective studies focusing on the cost-effectiveness of adult scoliosis treatment and improvement of quality of life are needed to confirm the assertion of the current retrospective literature that surgery provides better quality of life than nonoperative treatment. LEVEL OF EVIDENCE: N/A."," Spine (Phila Pa 1976) 39(5): 388-393.","USA",2014,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","Cost-Effectiveness","Observational","USA","Adolescents","Spinal Deformity","Surgical","Cost-Effectiveness","Observational","SRS-HRQOL","2010:2014"]
[283,"Pawar, S. G., et al. (2017). \"Software version of Roland Morris Disability questionnaire for outcome assessment in low back pain.\" Neurol Res 39(4): 292-297.",null,"Pawar, S. G., et al.","Software version of Roland Morris Disability questionnaire for outcome assessment in low back pain","BACKGROUND: Developing and using the software version of existing validated paper version of patient-related outcome can go a long way in saving cost, time and effort. However, the equivalence of paper version and software versions cannot be assumed. The aim of the study is to test the equivalence between paper version and software version of Roland Morris Disability Questionnaire and its acceptability among patients. METHODS: This is a within-subject cross over equivalence study. Fifty-five patients with back pain were asked to complete the paper and software version of RMDQ in random order. Patients were included from the Neuro Spinal surgery outpatient department of Lilavati Hospital and Research Center. RESULTS: Statistical analysis of 52 patients who completed the study showed high agreement between the paper and software version of the questionnaire (intraclass correlation coefficient 0.994, 95% confidence interval (0.989-0.996)). High sensitivity and specificity of 84 and 88% of the software version was noted. About 69.2% patients preferred software version over paper version. CONCLUSION: Our study shows that software version is comparable to the paper version. It may prove to be a useful tool for epidemiological studies and patient follow-up over longer period."," Neurol Res 39(4): 292-297.","India",2017,"Back Pain","Surgical","RMDQ","Unknown","PRO study","Observational","India","Unknown","Back Pain","Surgical","PRO study","Observational","RMDQ","2015:2018"]
[284,"Pellegrino, L. N. and O. Avanzi (2014). \"Prospective evaluation of quality of life in adolescent idiopathic scoliosis before and after surgery.\" J Spinal Disord Tech 27(8): 409-414.",null,"Pellegrino, L. N. and O. Avanzi","Prospective evaluation of quality of life in adolescent idiopathic scoliosis before and after surgery","STUDY DESIGN: Prospective observational study. OBJECTIVE: To assess patient quality of life before and after surgical treatment of adolescent idiopathic scoliosis (AIS) and determine whether an association exists between quality of life and curve magnitude, curve correction, and type of instrumentation. SUMMARY OF BACKGROUND DATA: Assessment of AIS surgery outcomes has always been based on analysis of radiographic measurements and postoperative curve correction. However, there is a current trend toward greater emphasis on patient-centered outcomes. Assessment of treatment success on the basis of these outcomes requires prospective use of quality-of-life surveys before and after AIS treatment. METHODS: Prospective study of 33 patients undergoing surgical treatment of AIS. Mean age was 15.6 years and mean Cobb angle was 70.5 degrees. Patients were randomly allocated into one of 2 instrumentation groups (hybrid and pedicle screws alone), and the Scoliosis Research Society-30 questionnaire (SRS-30) and Short Form-36 Health Survey (SF-36) questionnaires were administered preoperatively and at 3-, 6-, and 12-month follow-up. Statistical testing was performed to determine whether survey scores correlated with Cobb angle, curve correction, or type of instrumentation. RESULTS: SRS-30 and SF-36 scores improved significantly. The greatest changes occurred in the self-image and satisfaction with management domains of the SRS-30 survey. SRS-30 and SF-36 scores showed worsening pain and decreased function at 3-month follow-up, but significant improvement from baseline at 12 months. Total SRS-30 scores were significantly improved at 6- and 12-month follow-up, as were subscores in the general health, vitality, and social functioning domains of SF-36. Curve magnitude, percent curve correction, and type of instrumentation had no significant influence on final SRS-30 and SF-36 scores. CONCLUSIONS: Surgical treatment of AIS improved patient quality of life, as shown by significant improvement on all SRS-30 and SF-36 domains. Questionnaire scores did not correlate with Cobb angle, curve correction, or type of instrumentation."," J Spinal Disord Tech 27(8): 409-414.","Brazil",2014,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Prospective Observation","Brazil","Adolescents","Spinal Deformity","Surgical","PRO study","Prospective Observation","SRS-HRQOL","2010:2014"]
[285,"Peloso, P. M., et al. (2004). \"Analgesic efficacy and safety of tramadol/ acetaminophen combination tablets (Ultracet) in treatment of chronic low back pain: a multicenter, outpatient, randomized, double blind, placebo controlled trial.\" J Rheumatol 31(12): 2454-2463.",null,"Peloso, P. M., et al.","Analgesic efficacy and safety of tramadol/ acetaminophen combination tablets (Ultracet) in treatment of chronic low back pain: a multicenter, outpatient, randomized, double blind, placebo controlled trial","OBJECTIVE: To evaluate the analgesic efficacy and safety of tramadol 37.5 mg/acetaminophen 325 mg (tramadol/APAP) combination tablets for treatment of chronic low back pain (LBP). METHODS: This 91 day, multicenter, outpatient, randomized, double blind, placebo controlled study enrolled 338 patients with chronic LBP requiring daily medication for > or = 3 months. Patients with at least moderate pain [pain visual analog scale (VAS) with scores > or = 40/100 mm] after washout were randomized to tramadol/APAP or placebo. After a 10 day titration, patients received 1 or 2 tablets QID. Primary outcome measure was final pain VAS score. Secondary measures included pain relief, quality of life and physical functioning, efficacy failure, and overall medication assessments. RESULTS: In total, 336 intent-to-treat patients received tramadol/APAP (n = 167) or placebo (n = 169). Mean baseline pain VAS score was 67.8. Intent-to-treat analysis showed significantly better mean final pain VAS scores (47.4 vs 62.9; p < 0.001) and mean final pain relief scores (1.8 vs 0.7; p < 0.001) for tramadol/APAP than for placebo. Roland Disability Questionnaire scores and physical-related subcategories of the McGill Pain Questionnaire and the Medical Outcome Study Short Form-36 Health Survey were significantly better for tramadol/APAP patients. More patients rated tramadol/APAP as \"very good\" or \"good\" than placebo (63.6 vs 25.2%; p < 0.001). Kaplan-Meier estimates of cumulative discontinuation rates due to efficacy failures were 22.9% (tramadol/APAP) vs 54.7% (placebo; p < 0.001). The most common treatment related adverse events with tramadol/APAP were nausea (12.0%), dizziness (10.8%), and constipation (10.2%). Average daily dose of tramadol/APAP was 4.2 tablets (tramadol 158 mg/APAP 1369 mg). CONCLUSION: Tramadol 37.5 mg/APAP 325 mg combination tablets show efficacy in pain reduction, in measures of physical functioning and quality of life, and in overall medication assessments, with a tolerability profile comparable with other opioids used for the treatment of chronic LBP."," J Rheumatol 31(12): 2454-2463.","USA",2004,"Back Pain","Tramadol","RMDQ","Unknown","PRO study","RCT","USA","Unknown","Back Pain","Tramadol","PRO study","RCT","RMDQ","2000:2004"]
[286,"Peolsson, A., et al. (2013). \"Effects of neck-specific exercise with or without a behavioural approach in addition to prescribed physical activity for individuals with chronic whiplash-associated disorders: a prospective randomised study.\" BMC Musculoskelet Disord 14: 311.",null,"Peolsson, A., et al.","Effects of neck-specific exercise with or without a behavioural approach in addition to prescribed physical activity for individuals with chronic whiplash-associated disorders: a prospective randomised study","BACKGROUND: Up to 50% of chronic whiplash associated disorders (WAD) patients experience considerable pain and disability and remain on sick-leave. No evidence supports the use of physiotherapy treatment of chronic WAD, although exercise is recommended. Previous randomised controlled studies did not evaluate the value of adding a behavioural therapy intervention to neck-specific exercises, nor did they compare these treatments to prescription of general physical activity. Few exercise studies focus on patients with chronic WAD, and few have looked at patients' ability to return to work and the cost-effectiveness of treatments. Thus, there is a great need to develop successful evidence-based rehabilitation models. The study aim is to investigate whether neck-specific exercise with or without a behavioural approach (facilitated by a single caregiver per patient) improves functioning compared to prescription of general physical activity for individuals with chronic WAD. METHODS/DESIGN: The study is a prospective, randomised, controlled, multi-centre study with a 2-year follow-up that includes 216 patients with chronic WAD (> 6 months and < 3 years). The patients (aged 18 to 63) must be classified as WAD grade 2 or 3. Eligibility will be determined with a questionnaire, telephone interview and clinical examination. The participants will be randomised into one of three treatments: (A) neck-specific exercise followed by prescription of physical activity; (B) neck-specific exercise with a behavioural approach followed by prescription of physical activity; or (C) prescription of physical activity alone without neck-specific exercises. Treatments will be performed for 3 months. We will examine physical and psychological function, pain intensity, health care consumption, the ability to resume work and economic health benefits. An independent, blinded investigator will perform the measurements at baseline and 3, 6, 12 and 24 months after inclusion. The main study outcome will be improvement in neck-specific disability as measured with the Neck Disability Index. All treatments will be recorded in treatment diaries and medical records. DISCUSSION: The study findings will help improve the treatment of patients with chronic WAD. TRIALS REGISTRATION: ClinicalTrials.gov identifier: NCT01528579."," BMC Musculoskelet Disord 14: 311.","Sweden",2013,"Trauma","Exercise","NDI","Adults","Cost-Effectiveness","RCT","Sweden","Adults","Trauma","Exercise","Cost-Effectiveness","RCT","NDI","2010:2014"]
[287,"Peolsson, A., et al. (2016). \"Effects of Neck-Specific Exercises Compared to Waiting List for Individuals With Chronic Whiplash-Associated Disorders: A Prospective, Randomized Controlled Study.\" Arch Phys Med Rehabil 97(2): 189-195.",null,"Peolsson, A., et al.","Effects of Neck-Specific Exercises Compared to Waiting List for Individuals With Chronic Whiplash-Associated Disorders: A Prospective, Randomized Controlled Study","OBJECTIVE: To determine whether 3 months of neck-specific exercises (NSEs) could benefit individuals with chronic whiplash-associated disorder (WAD) who were on a waiting list (WL) for treatment. DESIGN: A prospective, randomized controlled study. SETTING: Primary health care. PARTICIPANTS: Individuals (N=41; 31 women, 10 men; mean age +/- SD, 38+/-11.2y) with chronic (6-36mo) WAD, grades 2 and 3, were analyzed. INTERVENTIONS: Patients were randomly assigned to NSEs or no treatment for 3 months. MAIN OUTCOME MEASURES: Neck-specific disability (Neck Disability Index [NDI]), neck pain (visual analog scale), general pain-related disability (Pain Disability Index [PDI]), self-perceived performance ability (Self-Efficacy Scale [SES]), and health-related quality of life (EuroQol 5 dimensions [EQ-5D]) were measured. RESULTS: NSEs significantly improved the NDI, SES, and EQ-5D compared with WL (P<.01). There was significant improvement (P<.0001) over time in all outcomes for NSEs, and apart from the PDI, significant worsening (P=.002-.0002) over time for the untreated group. CONCLUSIONS: NSEs were more beneficial than no intervention while on a WL for individuals with chronic WAD."," Arch Phys Med Rehabil 97(2): 189-195.","Sweden",2016,"Neck Pain","Exercise","NDI","Unknown","PRO study","RCT","Sweden","Unknown","Neck Pain","Exercise","PRO study","RCT","NDI","2015:2018"]
[288,"Perez-Grueso, F. S., et al. (2000). \"The low lumbar spine below Cotrel-Dubousset instrumentation: long-term findings.\" Spine (Phila Pa 1976) 25(18): 2333-2341.",null,"Perez-Grueso, F. S., et al.","The low lumbar spine below Cotrel-Dubousset instrumentation: long-term findings","STUDY DESIGN: Retrospective review of long instrumented fusions down to the low lumbar spine for the treatment of adolescent idiopathic scoliosis. OBJECTIVES: To evaluate whether the use of instrumentation systems that preserve the sagittal profile could reduce the incidence of early degenerative changes. SUMMARY OF BACKGROUND DATA: Long fusions and distractive Harrington instrumentation in the surgical treatment of adolescent idiopathic scoliosis (AIS) are known to produce pain and degenerative changes in the free lumbar segments. Reports on the use of Cotrel-Dubousett instrumentation (CDI) confirm that the instrumentation maintains physiologic lumbar lordosis, but the evolution of the spine below the fusion is not addressed. METHOD: Thirty-five patients with AIS and CDI were studied. Their spines were fused to L3 or lower, and they had a minimum follow-up of 10 years. Radiologic measurements were recorded from frontal and lateral radiographs. At the time of last examination, lateral flexion-extension dynamic radiographs and magnetic resonance imaging evaluated the health of the disks below the fusion. Clinical outcome was assessed with the Scoliosis Research Society instrument. A control group consisting of 35 peers without scoliosis served as a reference for the outcome questionnaire. RESULTS: Surgery kept the sagittal profile in a physiologic range. All but two patients were satisfied with the results of surgery. There were no differences between patients and control group insofar as pain, self-image, general function, and daily activity were concerned. Eleven patients showed instability signs in dynamic radiographs and more than half of patients showed incipient degeneration on magnetic resonance images. These findings are similar to those found in the general population, according to the literature, and could evidence normal aging processes. CONCLUSIONS: Cotrel-Dubousset instrumentation maintains the physiologic sagittal contour. Although there are some degenerative changes in magnetic resonance images and dynamic radiographs, the quality of life and daily activities of the patients after surgery are similar to those of a normal population of the same age."," Spine (Phila Pa 1976) 25(18): 2333-2341.","Spain",2000,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Retrospective review","Spain","Adolescents","Spinal Deformity","Surgical","PRO study","Retrospective review","SRS-HRQOL","2000:2004"]
[289,"Perillo, M. and R. Bulbulian (2003). \"Responsiveness of the Bournemouth and Oswestry questionnaires: a prospective pilot study.\" J Manipulative Physiol Ther 26(2): 77-86.",null,"Perillo, M. and R. Bulbulian","Responsiveness of the Bournemouth and Oswestry questionnaires: a prospective pilot study","BACKGROUND: The assessment of health-related quality-of-life outcome information has become an essential feature in the delivery of quality health care. Outcome assessment and increased clinical research capacity have been identified as recommended areas of priority for chiropractic research, chiropractic colleges, and the profession. OBJECTIVE: This article reports the results of a multisite pilot project utilizing New York Chiropractic College's 3 off-campus health centers. In the project, we sought to examine generic issues related to research infrastructure and feasibility, perform pilot testing of the responsiveness of the revised Oswestry Disability Index (ODI) and the Bournemouth Questionnaire (BQ), and develop estimates of change and population size for the possible future projects. METHODS: We describe the infrastructure created to conduct the project, including an on-site clinician research manager; on-site student research assistants; identification, recruitment, and patient flow; demographic and clinical characteristics; and abstraction instruments. Responsiveness study subjects completed 3 health-related quality-of-life assessments at baseline, 15 days, and 30 days. At 45 days, or at discharge, subjects completed the same questionnaires and a global rating of change. Responsiveness is reported by analysis of standardized estimates of change, relative efficiency, and receiver operator characteristic (ROC) curve plots. RESULTS: We successfully identified 82% of possible study patients; the real eligibility rate in our population was 30%. In 4 months, 70 patients were accrued, and 26 patients followed through to provide global ratings of change scores. Responsiveness by standardized change scores was numerical rating scale (NRS) = 1.19, ODI = 0.91, BQ = 0.78; by relative efficiency it was BQ/ODI = 0.86, ODI/NRS = 0.76, BQ/NRS = 0.66. Area under the curves ranged from 0.69 for the BQ to 0.86 for the NRS. CONCLUSIONS: Recommendations for modification and use of the infrastructure, research capacity, and future outcome and appropriateness assessment projects are offered."," J Manipulative Physiol Ther 26(2): 77-86.","USA",2003,"Unspecified","Not Specified","Bournemouth,ODI","Unknown","Tool Validation","Observational","USA","Unknown","Unspecified","Not Specified","Tool Validation","Observational","BOURNEMOUTH,ODI","2000:2004"]
[290,"Petcharaporn, M., et al. (2007). \"The relationship between thoracic hyperkyphosis and the Scoliosis Research Society outcomes instrument.\" Spine (Phila Pa 1976) 32(20): 2226-2231.",null,"Petcharaporn, M., et al.","The relationship between thoracic hyperkyphosis and the Scoliosis Research Society outcomes instrument","STUDY DESIGN: A retrospective chart review and radiographic analysis. OBJECTIVE: To evaluate the association between thoracic hyperkyphosis and patient quality of life measures as determined by the Scoliosis Research Society (SRS) outcomes instrument. SUMMARY OF BACKGROUND DATA: Although validated outcomes questionnaires (e.g., Pediatric Outcomes Data Collection Instrument and SRS) have been used to evaluate patients with scoliosis, there has been little written about the effects of sagittal plane alignment on these functional outcome measurements. METHODS: Data from the SRS outcomes instrument were collected from patients with thoracic hyperkyphosis as well as those with normal spinal alignment. A total of 50 patients with thoracic kyphosis >or=45 degrees were compared with 50 normal patients with thoracic kyphosis <45 degrees . Correlation analysis was performed to identify significant relationships between the magnitude of the major kyphotic curve and the 4 SRS outcome questionnaire domains (Total Pain, General Self-Image, General Function, and Activity). Lower SRS scores indicate an increase in symptoms. RESULTS: The average age of the subjects was 14 +/- 4 years (range, 8-18 years). The thoracic kyphosis varied between 11 degrees and 95 degrees for all subjects. Significant negative correlations were found between kyphosis magnitude and the total pain, general self-image, general function, overall level of activity, and total SRS scores (P < 0.0001). Of the 4 domains, self-image had the highest correlation with kyphosis magnitude while activity had the lowest. CONCLUSION: These findings indicate that higher kyphosis magnitudes were associated with increased pain, lower self-image, and decreased function and activity. Patients with thoracic hyperkyphosis were significantly more symptomatic than normal subjects in all domains. The r values for this analysis of kyphosis (0.40-0.66), in fact were substantially greater than those previously reported for scoliosis magnitude versus SRS Questionnaire scores (0.16-0.26), suggesting this instrument may be even better suited for the evaluation of hyperkyphosis patients."," Spine (Phila Pa 1976) 32(20): 2226-2231.","USA",2007,"Spinal Deformity","Not Specified","SRS-HRQOL","Adults","PRO study","Retrospective review","USA","Adults","Spinal Deformity","Not Specified","PRO study","Retrospective review","SRS-HRQOL","2005:2009"]
[291,"Petraglia, A. L., et al. (2010). \"Cervical laminoplasty as a management option for patients with cervical spondylotic myelopathy: a series of 40 patients.\" Neurosurgery 67(2): 272-277.",null,"Petraglia, A. L., et al.","Cervical laminoplasty as a management option for patients with cervical spondylotic myelopathy: a series of 40 patients","BACKGROUND: Cervical spondylotic myelopathy (CSM) is one of the leading causes of spinal cord dysfunction in the adult population. Laminoplasty is an effective decompressive procedure for the treatment of CSM. OBJECTIVE: We present our experience with 40 patients who underwent cervical laminoplasty using titanium miniplates for CSM. METHODS: We performed a retrospective review of the medical records of a consecutive series of patients with CSM treated with laminoplasty at the University of Rochester Medical Center or Rochester General Hospital. We documented patient demographic data, presenting symptoms, and postoperative outcome. Data are also presented regarding the general cost of constructs for a hypothetical 3-level fusion. RESULTS: Forty patients underwent cervical laminoplasty; all were available for follow-up. The mean number of levels was 4. All patients were myelopathic, and 17 (42.5%) had signs of radiculopathy preoperatively. Preoperatively, 62.5% of patients had a Nurick grade of 2 or worse. The average follow-up was 31.3 months. The median length of stay was 48 hours. On clinical evaluation, 36 of 40 patients demonstrated an improvement in their myelopathic symptoms; 4 were unchanged. Postoperative kyphosis did not develop in any patients. CONCLUSION: The management of CSM for each of its etiologies remains controversial. As demonstrated in our series, laminoplasty is a cost-effective, decompressive procedure for the treatment of CSM, providing a less destabilizing alternative to laminectomy while preserving mobility. Cervical laminoplasty should be considered in the management of multilevel spondylosis because of its ease of exposure, ability to decompress, effective preservation of motion, maintenance of spinal stability, and overall cost."," Neurosurgery 67(2): 272-277.","USA",2010,"Spondylosis","Surgical","Nurick","Unknown","PRO study","Retrospective review","USA","Unknown","Spondylosis","Surgical","PRO study","Retrospective review","Nurick","2010:2014"]
[292,"Phillips, F. M., et al. (2015). \"Long-term Outcomes of the US FDA IDE Prospective, Randomized Controlled Clinical Trial Comparing PCM Cervical Disc Arthroplasty With Anterior Cervical Discectomy and Fusion.\" Spine (Phila Pa 1976) 40(10): 674-683.",null,"Phillips, F. M., et al.","Long-term Outcomes of the US FDA IDE Prospective, Randomized Controlled Clinical Trial Comparing PCM Cervical Disc Arthroplasty With Anterior Cervical Discectomy and Fusion","STUDY DESIGN: Prospective, multicenter, randomized clinical trial. OBJECTIVE: To evaluate the long-term safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in treatment of patients with symptomatic single-level degenerative spondylosis between C3-C4 and C7-T1 with or without prior cervical fusion. SUMMARY OF BACKGROUND DATA: The 2-year results of the PCM Cervical Disc trial have been reported previously. The current study reports the long-term results of the same trial. METHODS: Patients with single-level cervical spondylosis and radiculopathy with or without myelopathy unresponsive to nonoperative treatment were enrolled. The per protocol patient sample at 5 years included 293 patients (163 PCM, 130 ACDF). Adverse events and secondary surgical procedures are reported on the cohorts through current follow-up, which include 110 patients (68 PCM, 42 ACDF) at 7 years. RESULTS: At 5 years postoperative, all patient-reported outcomes-neck and arm pain visual analogue scale score, neck disability index, and general health (36-Item Short Form Health Survey physical and mental component scores: physical component summary, mental component summary)-were significantly improved from baselines in both groups, and mean scores were significantly better in the PCM group for neck disability index (P=0.001), neck pain (P=0.002), general health (Pphysical component summary=0.014; Pmental component summary=0.004), and patient satisfaction (P=0.005). PCM patients trended toward fewer 2- to 7-year device-related serious adverse events (1/214, 0.5% PCM; 2/190, 1.1% ACDF) and secondary surgical procedures (7/211, 3.3% PCM; 14/290, 7.6% ACDF). Adjacent-level degeneration was radiographically more frequent after ACDF (33.1% PCM, 50.9% ACDF; P=0.006) and was the primary indication for the increase in late-term secondary surgical procedures after ACDF. CONCLUSION: The long-term results show good clinical outcomes after ACDF and PCM arthroplasty. PCM patients showed greater improvement in neck disability index and neck pain scores with a lower rate of radiographical adjacent-level degeneration and a trend toward fewer secondary surgical procedures. These data support PCM arthroplasty to be a viable and sustainable alternative to ACDF. LEVEL OF EVIDENCE: 1."," Spine (Phila Pa 1976) 40(10): 674-683.","USA",2015,"Neck Pain,Spondylosis","Surgical","NDI","Unknown","PRO study","RCT","USA","Unknown","Neck Pain,Spondylosis","Surgical","PRO study","RCT","NDI","2015:2018"]
[293,"Pho, C. and J. Godges (2004). \"Management of whiplash-associated disorder addressing thoracic and cervical spine impairments: a case report.\" J Orthop Sports Phys Ther 34(9): 511-519; discussion 520-513.",null,"Pho, C. and J. Godges","Management of whiplash-associated disorder addressing thoracic and cervical spine impairments: a case report","STUDY DESIGN: Clinical case report. OBJECTIVES: To describe a physical therapy program addressing impairments of the upper thoracic and cervical spine region for an individual with a whiplash-associated disorder. BACKGROUND: A 32-year-old female with complaint of diffuse posterior cervical and upper thoracic region pain was evaluated 2 weeks following a motor vehicle accident. The patient reported that she was unable to sit for longer than 10 minutes or perform household duties for longer than 1 hour. In addition, she was unable to perform her tasks as a postal worker or participate in her customary running and aerobic exercise activities because of pain in the cervical and upper thoracic region. METHODS AND MEASURES: An examination for physical impairments was performed, including the measurement of cervical range of motion using the CROM device, and the assessment of soft tissue and segmental mobility of the upper thoracic and cervical spine regions. The Northwick Park Neck Pain Questionnaire was used to assess functional limitations and disability. Manual therapy and therapeutic exercises were applied to address the identified impairments. Manual therapy techniques included soft tissue mobilization, joint mobilization, and joint manipulation. RESULTS: The patient's cervical range of motion was improved and the disability score improved from 25% to 19.5% 3 days after the initial session addressing the thoracic spine. Following a second session also addressing thoracic spine impairments and the use of therapeutic exercises for 7 days, the disability score improved to 11.1%. At the final visit 17 days following the third visit, which focused on addressing the cervical spine impairments, there was complete resolution of signs and symptoms and disability. CONCLUSIONS: Interventions addressing the impairments of the upper thoracic and cervical spine region were associated with reducing pain, increasing cervical range of motion, and facilitating return to work and physical activities in a patient with a whiplash-associated disorder. There is a need for continued research investigating the efficacy of providing interventions to the thoracic spine for patients with whiplash-related injuries."," J Orthop Sports Phys Ther 34(9): 511-519; discussion 520-513.","USA",2004,"Trauma,Neck Pain","Exercise","Northwick","Unknown","PRO study","Observational","USA","Unknown","Trauma,Neck Pain","Exercise","PRO study","Observational","Northwick","2000:2004"]
[294,"Pink, J., et al. (2014). \"Properties of patient-reported outcome measures in individuals following acute whiplash injury.\" Health Qual Life Outcomes 12: 38.",null,"Pink, J., et al.","Properties of patient-reported outcome measures in individuals following acute whiplash injury","BACKGROUND: The aim of this study was to assess the acceptability, reliability, validity and responsiveness of the Short-Form Health Survey (SF-12) and its preference-based derivative (SF-6D), the EQ-5D and the Neck Disability Index (NDI) in patients recovering from acute whiplash injury. METHODS: Data from the Managing Injuries of the Neck Trial of 3,851 patients with acute whiplash injury formed the basis of this empirical investigation. The EQ-5D and SF-12 were collected at baseline, and all three outcome measures were then collected at 4 months, 8 months and 12 months post-randomisation. The measures were assessed for their acceptability (response rates), internal consistency, validity (known groups validity and discriminant validity) and their internal and external responsiveness. RESULTS: Response rates were broadly similar across the measures, with evidence of a floor effect for the NDI and a ceiling effect for the EQ-5D utility measure. All measures had Cronbach's alpha statistics of greater than 0.7, indicating acceptable internal consistency. The NDI and EQ-5D utility score correlated more strongly with the physical component scale of the SF-12 than the mental component scale, whilst this was reversed for the SF-6D utility score. The smaller standard deviations in SF-6D utility scores meant there were larger effect sizes for differences in utility score between patients with different injury severity at baseline than for the EQ-5D utility measure. However, the EQ-5D utility measure and NDI were both more responsive to longitudinal changes in health status than the SF-6D. CONCLUSIONS: There was no evidence of differences between the EQ-5D utility measure and NDI in terms of their construct validity, discriminant validity or responsiveness in patients with acute whiplash injury. However, both demonstrated superior responsiveness to longitudinal health changes than the SF-6D."," Health Qual Life Outcomes 12: 38.","UK",2014,"Trauma","Not Specified","NDI","Unknown","PRO study","Observational","UK","Unknown","Trauma","Not Specified","PRO study","Observational","NDI","2010:2014"]
[295,"Protopsaltis, T., et al. (2014). \"TheT1 pelvic angle, a novel radiographic measure of global sagittal deformity, accounts for both spinal inclination and pelvic tilt and correlates with health-related quality of life.\" J Bone Joint Surg Am 96(19): 1631-1640.",null,"Protopsaltis, T., et al.","TheT1 pelvic angle, a novel radiographic measure of global sagittal deformity, accounts for both spinal inclination and pelvic tilt and correlates with health-related quality of life","BACKGROUND: Adult spinal deformity is a prevalent cause of pain and disability. Established measures of sagittal spinopelvic alignment such as sagittal vertical axis and pelvic tilt can be modified by postural compensation, including pelvic retroversion, knee flexion, and the use of assistive devices for standing. We introduce the T1 pelvic angle, a novel measure of sagittal alignment that simultaneously accounts for both spinal inclination and pelvic retroversion. The purpose of this study was to investigate the relationship of the T1 pelvic angle and other established sagittal alignment measures and to correlate these parameters with health-related quality-of-life measures. METHODS: This is a multicenter, prospective, cross-sectional analysis of consecutive patients with adult spinal deformity. Inclusion criteria were adult spinal deformity, an age of greater than eighteen years, and any of the following: scoliosis, a Cobb angle of >/= 20 degrees , sagittal vertical axis of >/= 5 cm, thoracic kyphosis of >/= 60 degrees , and pelvic tilt of >/= 25 degrees . Clinical measures of disability included the Oswestry Disability Index (ODI), Scoliosis Research Society (SRS)-22, and Short Form-36 (SF-36) questionnaires. RESULTS: Five hundred and fifty-nine consecutive patients with adult spinal deformity (mean age, 52.5 years) were enrolled. The T1 pelvic angle correlated with the sagittal vertical axis (r = 0.837), pelvic incidence minus lumbar lordosis (r = 0.889), and pelvic tilt (0.933). Categorizing the patients by increasing T1 pelvic angle (<10 degrees , 10 degrees to 20 degrees , 21 degrees to 30 degrees , and > 30 degrees ) revealed a significant and progressive worsening in health-related quality of life (p < 0.001 for all). The T1 pelvic angle and sagittal vertical axis correlated with the ODI (0.435 and 0.455), SF-36 Physical Component Summary (-0.445 and -0.458), and SRS (-0.358 and -0.383) (p < 0.001 for all). Utilizing a linear regression analysis, a T1 pelvic angle of 20 degrees corresponded to a severe disability (an ODI of >40), and the meaningful change in T1 pelvic angle corresponding to one minimal clinically important difference was 4.1 degrees on the ODI. CONCLUSIONS: The T1 pelvic angle correlates with health-related quality of life in patients with adult spinal deformity. The T1 pelvic angle is related to both pelvic tilt and sagittal vertical axis; however, unlike sagittal vertical axis, it does not vary on the basis of the extent of pelvic retroversion or patient support in standing. Since the T1 pelvic angle is an angular and not a linear measure, it does not require calibration of the radiograph. Thus, the T1 pelvic angle measures sagittal deformity independent of many postural compensatory mechanisms, and it can be useful as a preoperative planning tool, with a target T1 pelvic angle of < 14 degrees . LEVEL OF EVIDENCE: Diagnostic Level II. See Instructions for Authors for a complete description of levels of evidence."," J Bone Joint Surg Am 96(19): 1631-1640.","USA",2014,"Spinal Deformity","Surgical","ODI,SRS-HRQOL","Adults","PRO study","Observational","USA","Adults","Spinal Deformity","Surgical","PRO study","Observational","ODI,SRS-HRQOL","2010:2014"]
[296,"Qiao, J., et al. (2013). \"Validation of the Simplified Chinese version of the Core Outcome Measures Index (COMI).\" Eur Spine J 22(12): 2821-2826.",null,"Qiao, J., et al.","Validation of the Simplified Chinese version of the Core Outcome Measures Index (COMI)","PURPOSE: To translate the Core Outcome Measures Index (COMI) into Simplified Chinese and then validate it for Mainland Chinese patients with low back pain (LBP). METHODS: A total of 120 consecutive patients with LBP >3 months who visited our outpatient clinic from December 2011 to March 2012 were asked to complete a questionnaire booklet including the following: (1999) the Roland Morris disability questionnaire (RMQ) (Fan et al. in Spine 37(10):875-880, 2012), (2) the Short Form Health Survey (SF-36) (Zhang et al. in Int J Med Sci 9(7):521-526, 2012), (3) the Oswestry Disability Index (ODI) (Liu et al. in Spine 34(11):1211-1216, 2009), (4) visual analogue scale (VAS) measure of pain, and (5) COMI. These patients were also asked to complete a second COMI questionnaire and a transition questionnaire (5-point Likert scale: better, a little better, no change, a little worse, worse) and to return the second COMI questionnaire via mail within 1 month. RESULTS: The floor effects for the COMI items ranged from 5.8 to 12.5 %. High values (28.3, 27.5, and 25.8 %, respectively) were found for symptom-specific quality of life, social disability, and work disability. Regarding the ceiling effects, the social and work disabilities were relatively high at 17.5 and 24.2 %, respectively. For other items, the values ranged from 0 to 14.2 %. Neither floor nor ceiling effects were found for the COMI summary score. Excellent correlations were found between the COMI pain scores and VAS scores (Rho = 0.89) and between the COMI pain and the SF-36 bodily pain domain (Rho = 0.84). Other individual items and summary scores showed a very good correlation (Rho = 0.54-0.72) with the corresponding questionnaires except for \"symptom-specific well-being\" (0.31-0.45). One-way repeated measures ANOVA was used to determine the intraclass correlation coefficient (ICC). The ICC for the entire COMI score was 0.91 (95 % CI 0.85-0.94) and 0.81-0.86 for the two pain scores (back and leg). The \"minimum detectable change'' (MDC 95 %) for the COMI summary score was 1.91 points. No significant difference in the mean values was found for the repeated scores of individual items or the summary score. CONCLUSION: The Simplified Chinese version of COMI showed satisfactory reliability and good psychometric properties. This concise questionnaire is suitable for widespread use in Mainland China."," Eur Spine J 22(12): 2821-2826.","China",2013,"Back Pain","Not Specified","ODI,RMDQ","Unknown","Tool Validation","Observational","China","Unknown","Back Pain","Not Specified","Tool Validation","Observational","ODI,RMDQ","2010:2014"]
[297,"Qin, Z., et al. (2016). \"Efficacy of acupuncture for degenerative lumbar spinal stenosis: protocol for a randomised sham acupuncture-controlled trial.\" BMJ Open 6(11): e012821.",null,"Qin, Z., et al.","Efficacy of acupuncture for degenerative lumbar spinal stenosis: protocol for a randomised sham acupuncture-controlled trial","INTRODUCTION: Degenerative lumbar spinal stenosis (DLSS) is a major public health problem and the primary reason why older adults seek lumbar spine surgery. Acupuncture may be effective for DLSS, but the evidence supporting this possibility is still limited. METHODS AND ANALYSIS: A total of 80 participants with DLSS will be randomly allocated to either an acupuncture group or a sham acupuncture (SA) group at a ratio of 1:1. 24 treatments will be provided over 8 weeks. The primary outcome is the score change of the Modified Roland-Morris Disability Questionnaire (RMDQ) responses from baseline to week 8. The secondary outcomes include the assessment of lower back pain and leg pain using the Numeric Rating Scale (NRS), the change in the number of steps per month, and the assessment of the specific quality of life using the Swiss Spinal Stenosis Questionnaire (SSSQ). We will follow-up with the participants until week 32. All of the participants who received allocation will be included in the statistical analysis. ETHICS/DISSEMINATION: This protocol has been approved by the Research Ethical Committee of Guang'anmen Hospital (Permission number: 2015EC114) and Fengtai Hospital of Integrated Traditional and Western Medicine (Permission number: 16KE0409). The full data set will be made available when this trial is completed and published. Applications for the release of data should be made to ZL (principal investigator). TRIAL REGISTRATION NUMBER: NCT02644746."," BMJ Open 6(11): e012821.","China",2016,"Back Pain","Acupuncture,Surgical","RMDQ,SSSQ","Unknown","PRO study","RCT","China","Unknown","Back Pain","Acupuncture,Surgical","PRO study","RCT","RMDQ,SSSQ","2015:2018"]
[298,"Qiu, G., et al. (2011). \"Re-evaluation of reliability and validity of simplified Chinese version of SRS-22 patient questionnaire: a multicenter study of 333 cases.\" Spine (Phila Pa 1976) 36(8): E545-550.",null,"Qiu, G., et al.","Re-evaluation of reliability and validity of simplified Chinese version of SRS-22 patient questionnaire: a multicenter study of 333 cases","STUDY DESIGN: A multicenter cross-cultural study to re-evaluate the reliability and validity of the simplified Chinese version of Scoliosis Research Society-22 (SRS-22) Patient Questionnaire. OBJECTIVE: To assess the concurrent validity and reliability of this instrument in mainland China. SUMMARY OF BACKGROUND DATA: The SRS-22 Questionnaire was developed to assess the health-related quality of life for patients with scoliosis in the United States. More recently, the reliability and validity analyses of traditional and simplified Chinese versions of this questionnaire were performed, respectively. However, with respect to the diversity of population and large proportion of rural patients in China, a multicenter study might be necessary to re-evaluate its adaptation. METHODS: The original English version of the SRS-22 Questionnaire was translated into simplified Chinese. Considering the different health care systems in mainland China, the question 15 was modified; the respondent might be the parent if the patient was younger than 18 years. This multicenter study was performed by 13 scoliosis surgeons involving seven spine centers. The SRS-22 Questionnaire and a previously validated 36-Item Short-Form Health Survey Questionnaire were given to 391 patients with idiopathic scoliosis or congenital scoliosis without neurologic deficits. Of those, 136 patients were randomly selected for a second identical SRS-22 Questionnaire filled 1 week later and mailed back with a stamped return envelope. RESULTS: A total of 333 patients fully completed both SRS-22 and 36-Item Short-Form Health Survey Questionnaires. Good consistency was observed for all the five domains of the SRS-22. Poorer internal consistency was found in questions 15 and 18. If question 15 was excluded, the alpha coefficient would increase to 0.68. The pain domain of SRS-22 had a high ceiling effect being 67.5%. The test-retest reproducibility was observed \"good\" in the pain domain and \"excellent\" for the remaining domains of SRS-22 Questionnaire. Good (10 domains) and moderate (23 domains) correlations were demonstrated while seven domains had poor correlation. CONCLUSION: The simplified Chinese version of the SRS-22 Questionnaire was re-evaluated by a multicenter study to respect the diversity of population and cultural differences in mainland China, which showed good internal consistency and satisfactory test-retest reproducibility. It might be useful for clinical evaluation of Chinese adolescents and young adults with scoliosis treated with bracing or surgery, although it also encountered previously reported difficulties with some of the items related to different cultures and health care systems."," Spine (Phila Pa 1976) 36(8): E545-550.","China",2011,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","Tool Validation","Observational","China","Adolescents","Spinal Deformity","Surgical","Tool Validation","Observational","SRS-HRQOL","2010:2014"]
[299,"Que, Q., et al. (2013). \"Effectiveness of acupuncture intervention for neck pain caused by cervical spondylosis: study protocol for a randomized controlled trial.\" Trials 14: 186.",null,"Que, Q., et al.","Effectiveness of acupuncture intervention for neck pain caused by cervical spondylosis: study protocol for a randomized controlled trial","BACKGROUND: Neck pain caused by cervical spondylosis has become a common health problem worldwide among >40-year-old adults. Acupuncture intervention is one of the most popular treatment measures for this disorder. However, evidence for its efficacy in relieving neck pain and recovering neck physiological function has not been established in randomized, placebo-controlled trials. The primary aim of this trial is to assess the efficacy and safety of active acupuncture compared with sham acupuncture intervention for neck pain caused by cervical spondylosis. METHODS/DESIGN: We will conduct a randomized, double-blind, parallel-group, placebo-controlled trial comparing active acupuncture with placebo (sham acupuncture). A total of 456 patients with neck pain caused by cervical spondylosis who meet the eligibility criteria from outpatient clinics of the Second People's Hospital of Fujian Province and the Affiliated Rehabilitation Hospital, Fujian University of Traditional Chinese Medicine will be recruited and randomized into an active acupuncture or sham acupuncture group. The participants will undergo treatment sessions with either active or sham acupuncture intervention five times a week for 2 weeks. Evaluation by blinded assessors at baseline and at intervention for 1 and 2 weeks will include demographic characteristics, validated questionnaires (Northwick Park Neck Pain Questionnaire (NPQ) scale, Short-Form 36 (SF-36) scale, and McGill pain scale), examination of neck physiological function, and adverse events. All included patients will be followed up and investigated for relapse of neck pain at 4, 8, and 12 weeks after intervention. DISCUSSION: This paper describes the rationale and design of a randomized double-blind, placebo-controlled trial that aims to determine the efficacy and safety of acupuncture intervention for neck pain caused by cervical spondylosis. The primary outcomes are changes in the NPQ score and neck physiological function. Secondary outcome measures include quality of life, adverse events, and relapse of neck pain. If successful, this project will provide evidence of the efficacy and safety of acupuncture for neck pain caused by cervical spondylosis. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR-TRC-12002206. Registration date: 11 May 2012."," Trials 14: 186.","China",2013,"Neck Pain,Spondylosis","Acupuncture","Northwick","Unknown","PRO study","RCT","China","Unknown","Neck Pain,Spondylosis","Acupuncture","PRO study","RCT","Northwick","2010:2014"]
[300,"Raftery, M. N., et al. (2013). \"Effectiveness of a cognitive behavioural therapy-based rehabilitation programme (Progressive Goal Attainment Program) for patients who are work-disabled due to back pain: study protocol for a multicentre randomised controlled trial.\" Trials 14: 290.",null,"Raftery, M. N., et al.","Effectiveness of a cognitive behavioural therapy-based rehabilitation programme (Progressive Goal Attainment Program) for patients who are work-disabled due to back pain: study protocol for a multicentre randomised controlled trial","BACKGROUND: Psychologically informed rehabilitation programmes such as the Progressive Goal Attainment Program (PGAP) have the potential to address pain-related disability by targeting known psychological factors that inhibit rehabilitation progress. However, no randomised controlled trials of this intervention exist and it has not been evaluated in the Irish health service context. Our objective was to evaluate the clinical efficacy and cost-effectiveness of the PGAP in a multicentre randomised controlled trial with patients who are work-disabled due to back pain. METHODS AND DESIGN: Adult patients (ages 18 years and older) with nonmalignant back pain who are work-disabled because of chronic pain and not involved in litigation in relation to their pain were invited to take part. Patients were those who show at least one elevated psychosocial risk factor (above the 50th percentile) on pain disability, fear-based activity avoidance, fatigue, depression or pain catastrophizing. Following screening, patients are randomised equally to the intervention or control condition within each of the seven trial locations. Patients allocated to the control condition receive usual medical care only. Patients allocated to the PGAP intervention condition attend a maximum of 10 weekly individual sessions of structured active rehabilitation in addition to usual care. Sessions are delivered by a clinical psychologist and focus on graded activity, goal-setting, pacing activity and cognitive-behavioural therapy techniques to address possible barriers to rehabilitation.The primary analysis will be based on the amount of change on the Roland Morris Disability Questionnaire posttreatment. We will also measure changes in work status, pain intensity, catastrophizing, depression, fear avoidance and fatigue. Outcome measures are collected at baseline, posttreatment and 12-month follow-up. Health-related resource use is also collected pre- and posttreatment and at 12-month follow-up to evaluate cost-effectiveness. DISCUSSION: This study will be the first randomized controlled trial of the PGAP in chronic pain patients and will provide important information about the clinical and cost effectiveness of the programme as well as its feasibility in the context of the Irish health service. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN61650533."," Trials 14: 290.","Ireland",2013,"Back Pain","Psychosocial","RMDQ","Adults","Cost-Effectiveness","RCT","Ireland","Adults","Back Pain","Psychosocial","Cost-Effectiveness","RCT","RMDQ","2010:2014"]
[301,"Ranieri, M., et al. (2009). \"The use of alpha-lipoic acid (ALA), gamma linolenic acid (GLA) and rehabilitation in the treatment of back pain: effect on health-related quality of life.\" Int J Immunopathol Pharmacol 22(3 Suppl): 45-50.",null,"Ranieri, M., et al.","The use of alpha-lipoic acid (ALA), gamma linolenic acid (GLA) and rehabilitation in the treatment of back pain: effect on health-related quality of life","The aim of this trial was to evaluate the effects of alpha-lipoic acid (ALA) and gamma-linolenic acid (GLA) and the beneficial effect of physical exercise on positive sensory symptoms and neuropathic pain in patients with compressive radiculopathy syndrome from disc-nerve root conflict. Often these painful syndromes after the acute event, tend to recurr becoming subacute or chronic syndromes that become for the period of interest disabiling is an event very important in these cases proper prevention, based on a maintenance drug therapy and the strengthening exercises of paravertebral muscles, flexibility exercises on the spine and when needed on the reduction of body weight. In this Observational Cohort, two-arm trial, 203 patients were enrolled and divided into two groups, the first, ALA and GLA group, (n = 101) received oral dose of 600 mg of alpha-lipoic acid (ALA) and 360 mg of gamma-linolenic acid (GLA) and a rehabilitation program for six weeks, the second (n = 102) treated with only rehabilitation program. Patients were recruited at the centre of Physical Medicine and Rehabilitation, they underwent a physiatric examination at the primary outcome (t0) and secondary outcomes were recorded at monitoring visits scheduled at two weeks = t1, four weeks = t2, six weeks = t3, and at the same has been administered the following scale: VAS scale, SF-36, Oswestry Low Back Pain Disability Questionnaire, Aberdeen Back Pain Scale (ABPS), Revised Leeds Disability Questionnaire (LDQ), Roland and Morris Disability Questionnaire. Significant improvements was noted in the ALA and GLA group for paresthesia, stabbing and burning pain, as showed by VAS (Visual Analogue Scale), Oswestry Low Back Pain Disability Questionnaire, Aberdeen Low Back Pain Scale; also, improvements of quality of life has been noted, in the same group, as showed by SF-36, LDQ (Revised Leeds Disability Questionnaire), Roland and Morris disability questionnaire. All these outcome measure showed statistically significant decreases. Oral treatment with alpha-lipoic acid (ALA) and gamma-linolenic acid (GLA) for six weeks in synergy with rehabilitation therapy improved neuropathic symptoms and deficits in patients with radicular neuropathy."," Int J Immunopathol Pharmacol 22(3 Suppl): 45-50.","Italy",2009,"Neuropathic Pain,Radiculopathy","Exercise","Aberdeen LBP","Unknown","PRO study","Prospective Observation","Italy","Unknown","Neuropathic Pain,Radiculopathy","Exercise","PRO study","Prospective Observation","Aberdeen LBP","2005:2009"]
[302,"Rantonen, J., et al. (2014). \"Face-to-face information combined with a booklet versus a booklet alone for treatment of mild low-back pain: a randomized controlled trial.\" Scand J Work Environ Health 40(2): 156-166.",null,"Rantonen, J., et al.","Face-to-face information combined with a booklet versus a booklet alone for treatment of mild low-back pain: a randomized controlled trial","OBJECTIVE: The aim of this study was to determine the effectiveness of face-to-face information for the treatment of mild low-back pain (LBP) in an occupational health (OH) setting. METHODS: We conducted a 48-month randomized controlled trial (RCT) with two 1:1 allocated parallel groups of forestry company employees. Eligibility criteria included permanent employment, age <57 years, and mild LBP [visual analogue scale (VAS) 10-34 mm] in a survey. The intervention group received the Back Book, an information booklet on how to manage LBP, with an additional face-to-face review of the booklet by an OH nurse. The control group received the booklet only. Primary outcomes were physical impairment (Roland-Morris 18-item (RM-18) Disability Questionnaire), LBP (VAS 100 mm), health-related quality of life [15-dimensional quality of life (15-D)] during two years and sickness absence (SA) up to four years. Participants were assigned using block randomization with a computer-generated scheme. RESULTS: The RCT comprised 181 participants (72% male, mean age 44 years). There were no differences between the treatment arms in any of the primary outcomes at any time point. At 24 months, the mean group differences (intervention versus control) were: RM-18: 0 [95% confidence interval (95% CI) -1-1], VAS: 3 mm (95% CI -3-8), and 15-D 0.00 (95% CI -0.02-0.02). The difference in cumulative sickness absence days at 48 months were -3 (95% CI -28-21) for total and 1 (95% CI -3-5) for LBP specific sick leaves. Exploratory analysis revealed no differences at subgroup-levels either. CONCLUSIONS: Face-to-face patient information by an OH nurse in addition to a booklet was not more effective than the booklet alone in treating employees with mild LBP in an OH setting."," Scand J Work Environ Health 40(2): 156-166.","Finland",2014,"Back Pain","Education","RMDQ","Adults","PRO study","RCT","Finland","Adults","Back Pain","Education","PRO study","RCT","RMDQ","2010:2014"]
[303,"Rasotto, C., et al. (2015). \"Tailored exercise program reduces symptoms of upper limb work-related musculoskeletal disorders in a group of metalworkers: A randomized controlled trial.\" Man Ther 20(1999): 56-62.",null,"Rasotto, C., et al.","Tailored exercise program reduces symptoms of upper limb work-related musculoskeletal disorders in a group of metalworkers: A randomized controlled trial","Work-related musculoskeletal disorders (WRMDs) are a leading cause of work-related disability and loss of productivity in the developed countries; these disorders may concur with the indirect costs of an illness or injury included losses of potential output. Literature on workplace physical activity program provided a mixed but positive impact on health and important worksite outcomes. Therefore, programs of physical activity organized and performed in the workplace could reveal as essential tool to reduce musculoskeletal symptoms. This investigation aimed to assess the effectiveness of a tailored physical activity program, performed in a work-environment, to reduce the symptoms in upper extremities and neck with the novelty in personalizing the approach applied to the exercise protocol, basing on pain and disability levels, to reduce the onset and symptoms in upper extremity and neck WRMDs increasing upper-limb strength and flexibility. 68 metalworkers were recruited, 34 were randomly allocated to an intervention group (IG), while the other 34 to a control group. Primary outcomes concerned pain symptoms measured with visual analog scales while disability was measured by DASH (Disability of the Arm, Shoulder and Hand), and NPDS-I (Neck Pain and Disability Scale) questionnaires. Grip strength, upper-limb mobility, neck and shoulder range of motion were also assessed. After the 9-month intervention, IG reduced pain symptoms on neck, shoulders, elbows and on wrists. Grip strength and upper-limb mobility improved as well as scores on questionnaires. This protocol suggests that performing a tailored physical activity program is beneficial to reduce pain and disability on upper-limb WRMDs."," Man Ther 20(1999): 56-62.","Italy",2015,"Neck Pain","Exercise","NPDS","Unknown","Cost-Effectiveness","RCT","Italy","Unknown","Neck Pain","Exercise","Cost-Effectiveness","RCT","NPDS","2015:2018"]
[304,"Rayegani, S., et al. (2011). \"Comparison of the effects of low energy laser and ultrasound in treatment of shoulder myofascial pain syndrome: a randomized single-blinded clinical trial.\" Eur J Phys Rehabil Med 47(3): 381-389.",null,"Rayegani, S., et al.","Comparison of the effects of low energy laser and ultrasound in treatment of shoulder myofascial pain syndrome: a randomized single-blinded clinical trial","BACKGROUND: Myofascial pain syndrome (MPS) is one of the most prevalent musculoskeletal diseases. MPS impaired quality of life in the patients. There is a lot of controversy about different treatment options which include medical treatments, physical therapy, injections, ultrasound and laser. The effects of laser in MPS are challenging. AIM: To assess the effects of laser and ultrasound in treatment of MPS. DESIGN: Randomized single blinded clinical trial SETTING: Outpatient physical therapy clinic at university hospital POPULATION: Sixty three subjects (females: 46, males: 17), (age range: 17-55 year old) who had a diagnosis of definite MPS were entered in the study. METHODS: We measured the pain intensity at rest, during activity and at night using Visual Analogue Scale (VAS) questionnaire. The patients also filled the Neck Disability Index (NDI) form and the pain threshold provoked by pressure was determined using algometric assessment. Then, the patients were categorized randomly in groups A, B and C (receiving laser therapy, ultrasound and sham laser therapy, respectively). Six weeks after the initial visit, they were visited again and filled the forms again. RESULTS: Ultrasound was effective in VAS improvement during activity (46%), at rest (39%) and at night (35%). It also improved NDI scores (34%) and algometric assessment (37%). Laser was effective in VAS improving during activity (54%), at night (51%) and at rest (51%) and also improved NDI scores (73%). It was also found effective in algometric assessment improvement (105%). Laser resulted in more NDI score and algometric assessment improvements comparing to ultrasound (p<0.05). CONCLUSION: This study introduces laser as one of the preferred treatments of myofascial pain syndrome in shoulder."," Eur J Phys Rehabil Med 47(3): 381-389.","Iran",2011,"Myofascial pain syndrome","Physical Therapy","NDI","Unknown","PRO study","RCT","Iran","Unknown","Myofascial pain syndrome","Physical Therapy","PRO study","RCT","NDI","2010:2014"]
[305,"Rhyne, A. L., et al. (2012). \"Oxiplex reduces leg pain, back pain, and associated symptoms after lumbar discectomy.\" Spine (Phila Pa 1976) 37(8): 631-641.",null,"Rhyne, A. L., et al.","Oxiplex reduces leg pain, back pain, and associated symptoms after lumbar discectomy","STUDY DESIGN: Prospective, randomized, blinded clinical trial. OBJECTIVE: To evaluate effectiveness of Oxiplex gel for reduction of pain and associated symptoms after lumbar discectomy. SUMMARY OF BACKGROUND DATA: Oxiplex gel (carboxymethylcellulose, polyethylene oxide, and calcium) is used during discectomy to coat the surgical site for reduction of pain and symptoms after lumbar discectomy. METHODS: Patients undergoing single-level lumbar discectomy performed by laminectomy or laminotomy and randomized to receive either surgery plus Oxiplex gel (treatment group) or surgery alone (control group) were assessed 6 months after surgery using (1999) a quality of life questionnaire (Lumbar Spine Outcomes Questionnaire [LSOQ]) and (2) clinical evaluations. RESULTS: There were no statistically significant differences in baseline demographics, surgical procedures, LSOQ scores, and clinical evaluations between treatment (N = 177) and control (N = 175) groups. More gel-treated patients were satisfied with outcome of their surgical treatment than control patients (P = 0.05). The gel-treated group showed greater reductions in pain and symptoms from baseline compared with surgery-only controls. Additional benefits of gel were consistently shown in reduction of leg and back pain at 6 months in the patient population having substantial back pain at baseline (greater than or equal to the median LSOQ pain score of 63). In that population, there was a statistically significant reduction of leg pain and back pain (P < 0.01) in the treatment group compared with controls. Fewer patients in the treatment group had abnormal musculoskeletal physical examinations at 6 months compared with controls. There were no cases of cerebrospinal fluid leaks and no differences in laboratory values or vital signs. Patients in the treatment group had less hypoesthesia, paraesthesia, sensory loss, and fewer reoperations during the 6-month follow-up than controls (1 vs. 6). CONCLUSION: These data demonstrate improvements in clinical outcomes resulting from the use of Oxiplex gel in discectomy procedures for treatment of lumbar disc herniation."," Spine (Phila Pa 1976) 37(8): 631-641.","USA",2012,"Degenerative Disk Disease","Surgical,Oxiplex gel","LSOQ","Unknown","PRO study","RCT","USA","Unknown","Degenerative Disk Disease","Surgical,Oxiplex gel","PRO study","RCT","LSOQ","2010:2014"]
[306,"Ribeiro, L. H., et al. (2008). \"Effectiveness of a back school program in low back pain.\" Clin Exp Rheumatol 26(1999): 81-88.",null,"Ribeiro, L. H., et al.","Effectiveness of a back school program in low back pain","OBJECTIVES: To evaluate the effectiveness of a back school program in pain, functional status, quality of life, and in anxiety and depression in patients with non-specific low back pain. METHODS: Sixty patients with low back pain were randomized to an intervention and control group. The intervention group underwent a five-weekly back school program. The control group was seen in weekly medical visits, without educative approaches. Both groups took acetaminophen as analgesic medication. All subjects were evaluated by a blind physiotherapist after randomization, 30, 60 and 120 days. Rolland-Morris, SF-36, STAI and Beck questionnaires, pain visual analogical scale and Schober's test were applied. Non-steroidal anti-inflammatory drugs (NSAID) consumption was considered co-intervention. The statistical analyses were performed using Pearson's Chi-Square analysis and Student's t-test to compare the baseline characteristics of the groups and the analysis of variance (ANOVA) with repeated measures to assess changes inter/intra groups. RESULTS: There were no significant differences in the baseline characteristics between the two groups. Fifty-five patients completed the study. The intervention group showed a significant improvement in the general health domain, assessed by SF-36, and also in the reduction of acetaminophen and NSAID intake. There was no significant difference between the groups in pain, functional status, anxiety or depression. CONCLUSION: The back school program was more effective than any educational intervention in general health status and in decreasing acetaminophen and NSAID intake. It was ineffective in the other quality of life domains, in pain, functional status, anxiety and depression."," Clin Exp Rheumatol 26(1999): 81-88.","Brazil",2008,"Back Pain","NSAID","RMDQ,Schober","Unknown","PRO study","Clinical trial","Brazil","Unknown","Back Pain","NSAID","PRO study","Clinical trial","RMDQ,Schober","2005:2009"]
[307,"Richardson, S. S. and S. Berven (2012). \"The development of a model for translation of the Neck Disability Index to utility scores for cost-utility analysis in cervical disorders.\" Spine J 12(1999): 55-62.",null,"Richardson, S. S. and S. Berven","The development of a model for translation of the Neck Disability Index to utility scores for cost-utility analysis in cervical disorders","BACKGROUND CONTEXT: The Neck Disability Index (NDI) is a commonly used disease-specific instrument for cervical spine disorders with good responsiveness and psychometric properties compared with general health status measures. However, NDI scores are unitless and do not have an intrinsic value that is comparable to other health status measures, and these scores have limited value in cost-utility analysis. The translation of disease-specific measures to Short Form-6 Dimensions (SF-6D) utility scores may be useful in cost-utility analysis. PURPOSE: The purpose of this study is to present a model for translating the NDI to SF-6D utility scores, permitting the use of NDI scores in the cost-utility analysis of cervical disorders. STUDY DESIGN/SETTING: A secondary analysis of a multicenter prospective clinical trial of the Synthes ProDisc-C (Synthes, West Chester, PA, USA) was performed. PATIENT SAMPLE: Patients included were randomized to receive either a total disc arthroplasty or anterior cervical discectomy and fusion for treatment of symptomatic cervical disc disease involving one vertebral level between C3 and C7. All subjects completed NDI and 36-Item Short Form Health Survey (SF-36) self-assessments at preoperative and postoperative follow-ups of 6 weeks, 3, 6, 12, 18, and 24 months. OUTCOME MEASURES: The NDI is a validated and widely used self-reported questionnaire designed to assess patient-determined disability resulting from neck pain, including pain level and effects on activities of daily living. The SF-6D is a preference-based health state classification system derived from six health dimensions of the SF-36 self-reported questionnaire, including the domains of physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality. METHODS: The collected data points were divided into two cohorts: one for model formation and one for the assessment of model validity. SF-36 scores were converted to SF-6D utilities via three previously published methods. Correlation analyses and linear regression modeling between SF-6D and NDI created the models for translating scores. For validation, Spearman and Pearson correlations were calculated between the observed and predicted SF-6D utilities, and prediction errors were calculated. RESULTS: Four hundred thirty patients with 2,137 time points were used for creation and validation of the model. Pearson and Spearman correlation coefficients between the NDI and the SF-6D derived from each conversion method were found to be between -0.8255 and -0.8504 (p<.01). R(2) values ranged from 0.68 to 0.71 and root mean squared error (RMSE) from 0.092 to 0.084. Correlations between estimated and observed SF-6D scores ranged from 0.8325 to 0.8372 (p<.01). The mean prediction error was less than 0.006, with standard deviation (SD) between 0.082 and 0.093. DISCUSSION: Correlations between NDI and SF-6D utility scores are strong and statistically significant. The model has a large R(2) and small RMSE. The prediction models produce a small mean prediction error, but the SD of the prediction errors is large. High correlations between NDI and SF-6D permit these models to be used to calculate overall utilities, changes in utilities, and quality-adjusted life-years for large data samples. However, the relatively large observed prediction error SDs may limit the accuracy of translation of individual data points or small sample sizes."," Spine J 12(1999): 55-62.","USA",2012,"Neck Pain","Surgical","NDI","Unknown","Tool Validation","Clinical trial","USA","Unknown","Neck Pain","Surgical","Tool Validation","Clinical trial","NDI","2010:2014"]
[308,"Richter, H., et al. (2016). \"Dynamic Cervical Implant versus Anterior Cervical Diskectomy and Fusion: A Prospective Study of Clinical and Radiologic Outcome.\" J Neurol Surg A Cent Eur Neurosurg 77(4): 300-307.",null,"Richter, H., et al.","Dynamic Cervical Implant versus Anterior Cervical Diskectomy and Fusion: A Prospective Study of Clinical and Radiologic Outcome","Objective To evaluate clinical and radiologic outcome in patients treated with a dynamic cervical implant (DCI) or anterior cervical diskectomy and fusion (ACDF). Study Design A prospective comparative cohort study. Methods The study included 60 patients with one- or two-level cervical degenerative disk disease (DDD) undergoing treatment with either DCI (n = 30) or ACDF (n = 30). Clinical and radiologic outcomes were assessed 3 and 12 months after surgery. Clinical scoring systems included the Visual Analog Scale for Neck (VAS-N) and Arm pain (VAS-A), the Neck Pain and Disability Scale (NPAD), and the European Quality of Life Scale (EQ-5D). Results Both the DCI and ACDF group showed significant clinical improvement 12 months after surgery using the VAS-N (p = 0.034 and p < 0.001, respectively), VAS-A (p < 0.001 and p < 0.001, respectively), NPAD (p < 0.001 and p < 0.001, respectively), and EQ-5D (p < 0.001 and p < 0.001, respectively). There were no significant differences in clinical outcome comparing both groups at the 3- and 12-month follow-up. The fusion rate at 12 months after surgery was 39.4% and 80.0% in the DCI and ACDF groups, respectively. Radiolucency was found in 90.9% in the DCI group at 12-month follow-up. Conclusion The clinical results for DCI treatment are equivalent to those for ACDF in the treatment of one- and two-level cervical DDD at 12 months after surgery. Further studies are necessary to investigate the high rates of radiolucency and fusion associated with DCI treatment."," J Neurol Surg A Cent Eur Neurosurg 77(4): 300-307.","Switzerland",2016,"Neck Pain","Surgical","NPDS","Unknown","PRO study","Prospective Observation","Switzerland","Unknown","Neck Pain","Surgical","PRO study","Prospective Observation","NPDS","2015:2018"]
[309,"Ris, I., et al. (2016). \"Does a combination of physical training, specific exercises and pain education improve health-related quality of life in patients with chronic neck pain? A randomised control trial with a 4-month follow up.\" Man Ther 26: 132-140.",null,"Ris, I., et al.","Does a combination of physical training, specific exercises and pain education improve health-related quality of life in patients with chronic neck pain? A randomised control trial with a 4-month follow up","AIM: To investigate the effect of combining pain education, specific exercises and graded physical activity training (exercise) compared with pain education alone (control) on physical health-related quality of life (HR-QoL) in chronic neck pain patients. METHODS: A multicentre randomised controlled trial of 200 neck pain patients receiving pain education. The exercise group received additional exercises for neck/shoulder, balance and oculomotor function, plus graded physical activity training. Patient-reported outcome measures (Short Form-36 Physical and Mental component summary scores, EuroQol-5D, Beck Depression Inventory-II, Neck Disability Index, Pain Bothersomeness, Patient-Specific Functioning Scale, Tampa Scale of Kinesiophobia, Global Perceived Effect) and clinical tests (Aastrand Physical Fitness, cervical Range of Motion, Pressure Pain Threshold at infraspinatus, tibialis anterior and cervical spine, Cranio-cervical Flexion, Cervical Extension muscle function, and oculomotion) were recorded at baseline and after 4 months. RESULTS: The exercise group showed statistically significant improvement in physical HR-QoL, mental HR-QoL, depression, cervical pressure pain threshold, cervical extension movement, muscle function, and oculomotion. Per protocol analyses confirmed these results with additional significant improvements in the exercise group compared with controls. CONCLUSIONS: This multimodal intervention may be an effective intervention for chronic neck pain patients. TRIAL REGISTRATION: The trial was registered on www.ClinicalTrials.govNCT01431261 and at the Regional Scientific Ethics Committee of Southern Denmark S-20100069."," Man Ther 26: 132-140.","Denmark",2016,"Neck Pain","Exercise","Bothersomeness,NDI","Unknown","PRO study","RCT","Denmark","Unknown","Neck Pain","Exercise","PRO study","RCT","Bothersomeness,NDI","2015:2018"]
[310,"Rivett, L., et al. (2009). \"The relationship between quality of life and compliance to a brace protocol in adolescents with idiopathic scoliosis: a comparative study.\" BMC Musculoskelet Disord 10: 5.",null,"Rivett, L., et al.","The relationship between quality of life and compliance to a brace protocol in adolescents with idiopathic scoliosis: a comparative study","BACKGROUND: Corrective bracing for adolescent idiopathic scoliosis (AIS) has favourable outcomes when patients are compliant. However, bracing may be a stressful and traumatic experience and compliance with a bracing protocol is likely to be dependent upon patients' physical, emotional and social wellbeing. The Brace Questionnaire (BrQ), a recently-developed, condition-specific tool to measure quality of life (QOL) has enabled clinicians to study relationships between QOL and compliance. METHODS: The BrQ was administered to 31 AIS patients after a minimum of 1 year of wearing a brace. Subjects were 13-16 year old South African girls with Cobb angles of 25-40 degrees. Participants were divided into two groups according to their level of compliance with the bracing protocol. Brace Questionnaire sub- and total scores were compared between the two groups using the t-test for comparison of means. RESULTS: Twenty participants were classified as compliant and 11 as non-compliant. Mean total BrQ scores (expressed as a percentage) were 83.7 for the compliant group and 64.4 for the non-compliant group (p < 0.001), and on analysis of the 8 domains that make up the BrQ, the compliant group scored significantly higher in the 6 domains that measured vitality and social, emotional and physical functioning. CONCLUSION: Poor compliance with a brace protocol is associated with poorer QOL, with non-compliant patients lacking vitality and functioning poorly physically, emotionally and socially. Quality of life for adolescents with idiopathic scoliosis may relate more to psychosocial coping mechanisms than to physical deformity and its consequences. It is important to establish whether remedial programmes are capable of addressing personal, group and family issues, improving QOL and promoting compliance."," BMC Musculoskelet Disord 10: 5.","South Africa",2009,"Spinal Deformity","Psychosocial","BrQ","Adolescents","PRO study","Prospective Observation","South Africa","Adolescents","Spinal Deformity","Psychosocial","PRO study","Prospective Observation","BrQ","2005:2009"]
[311,"Rodriguez-Blanco, T., et al. (2010). \"Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial.\" BMC Health Serv Res 10: 12.",null,"Rodriguez-Blanco, T., et al.","Study protocol of effectiveness of a biopsychosocial multidisciplinary intervention in the evolution of non-specific sub-acute low back pain in the working population: cluster randomised trial","BACKGROUND: Non-specific low back pain is a common cause for consultation with the general practitioner, generating increased health and social costs. This study will analyse the effectiveness of a multidisciplinary intervention to reduce disability, severity of pain, anxiety and depression, to improve quality of life and to reduce the incidence of chronic low back pain in the working population with non-specific low back pain, compared to usual clinical care. METHODS/DESIGN: A Cluster randomised clinical trial will be conducted in 38 Primary Health Care Centres located in Barcelona, Spain and its surrounding areas. The centres are randomly allocated to the multidisciplinary intervention or to usual clinical care. Patients between 18 and 65 years old (n = 932; 466 per arm) and with a diagnostic of a non-specific sub-acute low back pain are included. Patients in the intervention group are receiving the recommendations of clinical practice guidelines, in addition to a biopsychosocial multidisciplinary intervention consisting of group educational sessions lasting a total of 10 hours. The main outcome is change in the score in the Roland Morris disability questionnaire at three months after onset of pain. Other outcomes are severity of pain, quality of life, duration of current non-specific low back pain episode, work sick leave and duration, Fear Avoidance Beliefs and Goldberg Questionnaires. Outcomes will be assessed at baseline, 3, 6 and 12 months. Analysis will be by intention to treat. The intervention effect will be assessed through the standard error of measurement and the effect-size. Responsiveness of each scale will be evaluated by standardised response mean and receiver-operating characteristic method. Recovery according to the patient will be used as an external criterion. A multilevel regression will be performed on repeated measures. The time until the current episode of low back pain takes to subside will be analysed by Cox regression. DISCUSSION: We hope to provide evidence of the effectiveness of the proposed biopsychosocial multidisciplinary intervention in avoiding the chronification of low back pain, and to reduce the duration of non-specific low back pain episodes. If the intervention is effective, it could be applied to Primary Health Care Centres. TRIAL REGISTRATION: ISRCTN21392091."," BMC Health Serv Res 10: 12.","Spain",2010,"Back Pain","Psychosocial","RMDQ","Unknown","Cost-Effectiveness","RCT","Spain","Unknown","Back Pain","Psychosocial","Cost-Effectiveness","RCT","RMDQ","2010:2014"]
[312,"Rodriguez-Romero, B., et al. (2015). \"Impact of musculoskeletal pain on health-related quality of life among fishing sector workers.\" Clin Rheumatol 34(6): 1131-1139.",null,"Rodriguez-Romero, B., et al.","Impact of musculoskeletal pain on health-related quality of life among fishing sector workers","This study aims to determine the impact of musculoskeletal pain (in terms of intensity of the pain, location and functional disability due to back pain) and other factors (socio-demographic, lifestyle and co-morbidity) on the health-related quality of life on a group of shellfish gatherers. This observational transversal study included 929 shellfish gatherers (18-69 years, 98.7 % women) who completed a self-administered questionnaire, including socio-demographic and lifestyle questions, co-morbidity, intensity and location of musculoskeletal pain, and Roland-Morris Disability Questionnaire (RMDQ). Health-related quality of life was assessed using the 36-item Short Form Survey (SF-36). Physical component summary (PCS) and mental component summary (MCS) of the SF-36 were considered as outcome variables. The impact of the different factors on the PCS and MCS scores was evaluated using a stepwise linear regression analysis. Physical health was found to be independently associated to intensity of musculoskeletal pain (regression coefficient, B = -0.96), number of locations with musculoskeletal pain (MSP) (B = -0.77), presence of pain in the hip-knee (B = -2.26), self-reported rheumatic disorders (B = -2.79), lower back pain (B = -1.62) and age (B = -0.06). Mental health was associated with the presence of self-reported depressive syndrome (B = -1043.1) and RMDQ score (B = -42.2). The sample had significantly lower values than the reference population in all of the dimensions of the SF-36. Intensity of the pain, pain in the hip-knee, lower back pain, functional disability due to back pain and number of locations with musculoskeletal pain were found to have a detrimental impact on the physical health of the workers. Depressive syndrome and greater functional disability due to back pain, in turn, predict worse mental health."," Clin Rheumatol 34(6): 1131-1139.","Spain",2015,"Back Pain","Not Specified","RMDQ","Adults","PRO study","Observational","Spain","Adults","Back Pain","Not Specified","PRO study","Observational","RMDQ","2015:2018"]
[313,"Roitberg, B. Z., et al. (2013). \"Comparison between patient and surgeon perception of degenerative spine disease outcomes--a prospective blinded database study.\" Acta Neurochir (Wien) 155(5): 757-764.",null,"Roitberg, B. Z., et al.","Comparison between patient and surgeon perception of degenerative spine disease outcomes--a prospective blinded database study","BACKGROUND: Few have studied the correlation between patients' and spine surgeons' perception on outcomes, or compared these with patient-reported outcome scores. Outcomes studies are increasingly important in evaluating costs and benefits to patients and surgeons, and in developing metrics for payer evaluation and health care policy-making. OBJECTIVE: To compare patients' and surgeons' assessment of spine treatment outcome in a prospective blinded patient-driven spine surgery outcomes registry, and to correlate perceived outcomes ratings to validated outcomes scores. METHODS: Patients filled out surveys at baseline, 3 months and 6 months postoperatively, including Visual Analog Scale (VAS), and Neck Disability Index (NDI) or Oswestry Disability Index (ODI). Outcome was rated independently by patients and surgeons on a 7-point Likert-type scale. RESULTS: Two-hundred and sixty-five consecutive adult patients were surgical candidates. Of these, 154 (58.1 %) opted for surgery, with 69 (44.8 %) cervical and 85 (55.2 %) lumbar patients. One hundred and thirty-five (87.7 %) had both patient and surgeon postoperative ratings. Surgeons' and patients' ratings correlated strongly (Spearman rho = 0.53, p < 0.0001, 45.9 % identical, 88.2 % +/- 1 grade). The surgeon rated outcomes were better than patients in 29.8 % and worse in 21.15 %. Patient rating correlated better with the most recent NDI/ODI and pain scores than with incremental change from baseline. In multivariate analysis, age, location (cervical vs lumbar), pain ratings, and functional scores (NDI, ODI) did not have significant impact on the discrepancy between patient and surgeon ratings. CONCLUSIONS: Patients' and surgeons' global outcome ratings for spinal disease correlate highly. Patients' ratings correlate better with most recent functional scores, rather than incremental change from baseline."," Acta Neurochir (Wien) 155(5): 757-764.","USA",2013,"Spine Disease","Surgical","NDI","Unknown","Cost and Resource Use","Prospective Observation","USA","Unknown","Spine Disease","Surgical","Cost and Resource Use","Prospective Observation","NDI","2010:2014"]
[314,"Roy, C., et al. (2012). \"Efficacy of combined treatment with medial branch radiofrequency neurotomy and steroid block in lumbar facet joint arthropathy.\" J Vasc Interv Radiol 23(12): 1659-1664.",null,"Roy, C., et al.","Efficacy of combined treatment with medial branch radiofrequency neurotomy and steroid block in lumbar facet joint arthropathy","PURPOSE: To evaluate the long-term efficacy of combined radiofrequency (RF) neurotomy and steroid nerve block in patients with lumbar facet joint arthropathy. MATERIALS AND METHODS: Combined RF neurotomy and steroid nerve block was performed in 34 patients with chronic paravertebral low back pain. The diagnosis was confirmed by comparative double diagnostic block of the medial branch with bupivacaine and lidocaine. Under fluoroscopy, RF thermal ablation of the medial branch was performed (at RF needle tip temperature 85 degrees C for 90 seconds), three times for each target nerve. At the end of the procedure, 20 mg of methylprednisolone acetate (sustained-release preparation) was infiltrated on each ablated nerve. Outcome variable was the degree of improvement in pain using visual analog scale (VAS) and numerical rating scale (NRS). Improvement in the quality of life was assessed using the Roland-Morris (RM) questionnaire. The procedure was repeated in cases of unbearable pain (>5 VAS score). RESULTS: Patients had a mean VAS score of 8.6 before the procedure. Thereafter, VAS score was 0.91 immediately after the procedure and 3.0, 2.8, 3.7, and 3.6 at 1 month, 2 months, 6 months, and 1 year. NRS showed pain relief after the procedure of 85%, 65%, 78%, 62%, and 59.5% at the same time points. RM score was 18 before the procedure, 7.6 at 6 months after the procedure, and 8.5 at 1 year after the procedure. No major complication was noted except local pain in all patients and numbness of the back in six patients after the procedure. CONCLUSIONS: Combined RF neurotomy and steroid nerve block produced substantial improvement in terms of long-term pain relief and quality of life."," J Vasc Interv Radiol 23(12): 1659-1664.","India",2012,"Back Pain","Surgical","RMDQ","Unknown","PRO study","Prospective Observation","India","Unknown","Back Pain","Surgical","PRO study","Prospective Observation","RMDQ","2010:2014"]
[315,"Rundell, S. D., et al. (2014). \"Mapping a patient-reported functional outcome measure to a utility measure for comparative effectiveness and economic evaluations in older adults with low back pain.\" Med Decis Making 34(7): 873-883.",null,"Rundell, S. D., et al.","Mapping a patient-reported functional outcome measure to a utility measure for comparative effectiveness and economic evaluations in older adults with low back pain","BACKGROUND: Linking patient-reported back pain outcomes with health utility measures is valuable for informing economic evaluations. METHODS: We used the Back pain Outcomes using Longitudinal Data (BOLD) registry to assess back pain and quality-of-life measures. The BOLD registry includes participants >/=65 years from 3 health systems. We used multiple baseline outcome measures: Roland-Morris Disability Questionnaire (RMDQ), Euroqol-5D (EQ-5D), and back and leg pain numerical rating scales (NRS). To develop and validate a model, we used a standard split-sample method and a novel multisite validation approach. We applied linear regression to map RMDQ to EQ-5D, adjusting for age, sex, pain numerical rating scores, and nonlinear transformations of outcome measures. We computed R (2), root mean squared error, and mean absolute error (MAE) for purposes of model selection. The final model included EQ-5D as the dependent variable with independent variables of age, RMDQ, and back NRS. We used this model to predict EQ-5D scores in validation samples. RESULTS: In total, 5224 participants had both baseline RMDQ and EQ-5D. Mean age was 74 years (65% female). Negative correlations (-0.72) were observed at baseline for RMDQ and EQ-5D. The selected model from all developmental samples had R (2) >0.41 and MAE < 0.119. Validation analyses indicated no differences in estimated v. observed mean EQ-5D scores in the split sample. Validation using the multisite validation approach identified prediction error variability, MAE of 0.081 to 0.119, when predicting EQ-5D. LIMITATIONS: The statistical relationship may not generalize well to all study populations as we demonstrated in our multisite analysis. CONCLUSIONS: An empirical algorithm predicting EQ-5D weights from RMDQ scores provides a currently unavailable link for conducting economic evaluations in low back pain studies."," Med Decis Making 34(7): 873-883.","USA",2014,"Back Pain","Not Specified","RMDQ","Adults","PRO study","Retrospective review","USA","Adults","Back Pain","Not Specified","PRO study","Retrospective review","RMDQ","2010:2014"]
[316,"Rundell, S. D., et al. (2015). \"Patient-reported outcomes associated with use of physical therapist services by older adults with a new visit for back pain.\" Phys Ther 95(2): 190-201.",null,"Rundell, S. D., et al.","Patient-reported outcomes associated with use of physical therapist services by older adults with a new visit for back pain","BACKGROUND: Among older adults, it is not clear how different types or amounts of physical therapy may be associated with improvements in back pain and function. OBJECTIVE: The study objective was to investigate the association between types or amounts of physical therapist services and 1-year outcomes among older adults with back pain. DESIGN: This was a prospective cohort study. METHODS: A total of 3,771 older adults who were enrolled in a cohort study and who had a new primary care visit for back pain participated. Physical therapy use was ascertained from electronic health records. The following patient-reported outcomes were collected over 12 months: back-related disability (Roland-Morris Disability Questionnaire) and back and leg pain intensity (11-point numerical rating scale). Marginal structural models were used to estimate average effects of different amounts of physical therapy use on disability and pain for all types of physical therapy and for active, passive, and manual physical therapy. RESULTS: A total of 1,285 participants (34.1%) received some physical therapy. There was no statistically significant gradient in relationships between physical therapy use and back-related disability score. The use of passive or manual therapy was not consistently associated with pain outcomes. Higher amounts of active physical therapy were associated with decreased back and leg pain and increased odds of clinically meaningful improvements in back and leg pain relative to results obtained with no active physical therapy. LIMITATIONS: The fact that few participants had high amounts of physical therapy use limited precision and the ability to test for nonlinear relationships for the amount of use. CONCLUSIONS: Higher amounts of active physical therapy were most consistently related to the greatest improvements in pain intensity; however, as with all observational studies, the results must be interpreted with caution."," Phys Ther 95(2): 190-201.","USA",2015,"Back Pain","Physical Therapy","RMDQ","Adults","PRO study","Prospective Observation","USA","Adults","Back Pain","Physical Therapy","PRO study","Prospective Observation","RMDQ","2015:2018"]
[317,"Rushton, A., et al. (2015). \"Physiotherapy Post Lumbar Discectomy: Prospective Feasibility and Pilot Randomised Controlled Trial.\" PLoS One 10(11): e0142013.",null,"Rushton, A., et al.","Physiotherapy Post Lumbar Discectomy: Prospective Feasibility and Pilot Randomised Controlled Trial","OBJECTIVES: To evaluate: acceptability and feasibility of trial procedures; distribution of scores on the Roland Morris Disability Questionnaire (RMDQ, planned primary outcome); and efficient working of trial components. DESIGN AND SETTING: A feasibility and external pilot randomised controlled trial (ISRCTN33808269, assigned 10/12/2012) was conducted across 2 UK secondary care outpatient physiotherapy departments associated with regional spinal surgery centres. PARTICIPANTS: Consecutive consenting patients aged >18 years; post primary, single level, lumbar discectomy. INTERVENTIONS: Participants were randomised to either 1:1 physiotherapy outpatient management including patient leaflet, or patient leaflet alone. MAIN OUTCOME MEASURES: Blinded assessments were made at 4 weeks post surgery (baseline) and 12 weeks post baseline (proposed primary end point). Secondary outcomes included: Global Perceived Effect, back/leg pain, straight leg raise, return to work/function, quality of life, fear avoidance, range of movement, medication, re-operation. RESULTS: At discharge, 110 (44%) eligible patients gave consent to be contacted. 59 (54%) patients were recruited. Loss to follow up was 39% at 12 weeks, with one site contributing 83% losses. Mean (SD) RMDQ was 10.07 (5.58) leaflet and 10.52 (5.94) physiotherapy/leaflet at baseline; and 5.37 (4.91) leaflet and 5.53 (4.49) physiotherapy/leaflet at 12 weeks. 5.1% zero scores at 12 weeks illustrated no floor effect. Sensitivity to change was assessed at 12 weeks with mean (SD) change -4.53 (6.41), 95%CI -7.61 to -1.44 for leaflet; and -6.18 (5.59), 95%CI -9.01 to -3.30 for physiotherapy/leaflet. RMDQ mean difference (95%CI) between change from baseline to twelve weeks was 1.65(-2.46 to 5.75). Mean difference (95%CI) between groups at 12 weeks was -0.16 (-3.36 to 3.04). Participant adherence with treatment was good. No adverse events were reported. CONCLUSIONS: Both interventions were acceptable, and it is promising that they both demonstrated a trend in reducing disability in this population. A randomised controlled trial, using a different trial design, is needed to ascertain the effectiveness of combining the interventions into a stepped care intervention and comparing to a no intervention arm. Findings will guide design changes for an adequately powered randomised controlled trial, using RMDQ as the primary outcome. TRIAL REGISTRATION: ISRCTN registry 33808269."," PLoS One 10(11): e0142013.","UK",2015,"Spine Disease","Surgical,Education","RMDQ","Adults","PRO study","RCT","UK","Adults","Spine Disease","Surgical,Education","PRO study","RCT","RMDQ","2015:2018"]
[318,"Sakai, Y., et al. (2015). \"Pharmacological management of chronic low back pain in older patients: a randomized controlled trial of the effect of pregabalin and opioid administration.\" Eur Spine J 24(6): 1309-1317.",null,"Sakai, Y., et al.","Pharmacological management of chronic low back pain in older patients: a randomized controlled trial of the effect of pregabalin and opioid administration","PURPOSE: Pregabalin and opioids are used to treat chronic low back pain (LBP). No previous investigations have compared the efficacy of pregabalin and that of opioids for chronic LBP. METHODS: We performed a randomized controlled trial of pregabalin and opioids in 65 consecutive patients aged 65 years or older who had chronic LBP. Each agent was administered randomly in different phases. Pain and activities of daily living (ADL) were evaluated after 4 weeks of treatment using the visual analog scale, Japanese Orthopaedic Association score, Roland Morris Disability Questionnaire, short-form McGill Pain Questionnaire, EuroQol quality-of-life scale, and geriatric depression scale. Neuropathic pain was evaluated using a neuropathic pain screening questionnaire. RESULTS: The effectiveness rate was 73.3% for pregabalin and 83.3% for opioid, showing no significant difference. The mean durations until the onset of effect were 10.2 and 6.1 days, respectively, albeit without significant difference. Pregabalin was effective for LBP with neuropathic pain, whereas opioids were effective for non-neuropathic pain. The improvement of ADL was greater with opioids than with pregabalin. Pregabalin was effective for LBP in patients with lower limb symptoms, whereas opioids were effective for those without lower limb symptoms. CONCLUSIONS: Aside from screening tests, consideration of neuropathic pain and lower extremity symptoms may be an integral component in the selection of the appropriate medication for chronic LBP. Moreover, the therapeutic objectives, including pain relief and/or improvement of ADL, should be specified."," Eur Spine J 24(6): 1309-1317.","Japan",2015,"Neuropathic Pain","Pregabalin","JOACMEQ,RMDQ","Adults","PRO study","RCT","Japan","Adults","Neuropathic Pain","Pregabalin","PRO study","RCT","JOACMEQ,RMDQ","2015:2018"]
[319,"Salaffi, F., et al. (2007). \"Validity and reliability of the Italian version of the ECOS-16 questionnaire in postmenopausal women with prevalent vertebral fractures due to osteoporosis.\" Clin Exp Rheumatol 25(3): 390-403.",null,"Salaffi, F., et al.","Validity and reliability of the Italian version of the ECOS-16 questionnaire in postmenopausal women with prevalent vertebral fractures due to osteoporosis","OBJECTIVE: To investigate the reliability and validity of the Italian version of ECOS-16 (Assessment of health related quality of life in osteoporosis) in comparison to other questionnaires in postmenopausal women with osteoporosis. METHODS: A cross-sectional multicentre study was carried out among postmenopausal women with osteoporosis who were attending primary care centres and hospital outpatient clinics. The patient group included 234 females (mean age 69 years, range 48-89) who presented vertebral fractures due to osteoporosis. The control group consisted of 244 asymptomatic osteoporotic subjects matched for age with the patient group. The psychometric properties of the questionnaires were evaluated in terms of feasibility, validity (construct validity and discriminant validity) and internal consistency. Test-retest reliability was analysed for 196 outpatients who reported that their general health status due to osteoporosis had not changed after one week. In all patients the ECOS-16, the SF-36 (Medical Outcomes Study Short Form-36), EUROQoL (EQ-5D), mini-OQLQ (mini-Osteoporosis Quality of Life Questionnaire), and RMDQ (Roland-Morris Disability Questionnaire) were administered, and all clinical variables and sociodemographic variables were taken into account. Construct and discriminant validity were assessed by Spearman's correlations, the Wilcoxon rank sum test, the Kruskal Wallis test and by receiver operating characteristic (ROC) curves. Internal consistency was evaluated using Cronbach's alpha and the test-retest reliability was evaluated by intra-class correlation coefficients (ICCs). RESULTS: 96.9% of the patients answered all items of the ECOS-16 questionnaires. The mean administration time was 10 minutes. Factor analysis yielded two factors that accounted for 88.4% of the explained variance in the ECOS-16 questionnaire. The first factor was the ECOS-16 Physical Component Score (PCS) (45.9% of the explained variance) and the second factor was the ECOS-16 Mental Component Score (MCS) (42.4% of the explained variance). The inter-item correlation between the two factors was 0.48. Significant correlations were found between the scores of similar domains or subscales of the ECOS-16 and SF-36, EQ-5D and mini-OQLQ, supporting the concept of convergent construct validity. The total ECOS-16 score progressively increased with the number of prevelant vertebral fractures (p<0.001) and the effect of the first fracture was already statistically significant (p<0.01). On ROC curve analysis the total ECOS-16 score showed the highest performance among the different questionnaires in discriminating between patients with vertebral fractures and controls with no fractures. In the reliability study, internal consistency within the domain of ECOS-16 was generally good, with Chronbach's alpha values ranging from 0.81 to 0.89. Test-retest reliability was 0.87 for the total ECOS-16 score. CONCLUSION: The Italian version of the ECOS-16 questionnaire was demonstrated to have good psychometric properties and could offer a useful tool in research and routine clinical practice to evaluate HRQoL in post-menopausal women with osteoporosis. A full validation of the psychometric properties will require data on its sensitivity to change."," Clin Exp Rheumatol 25(3): 390-403.","Italy",2007,"Spinal Fracture","Not Specified","RMDQ","Adults","PRO study","Observational","Italy","Adults","Spinal Fracture","Not Specified","PRO study","Observational","RMDQ","2005:2009"]
[320,"Salfinger, H., et al. (2015). \"Nuclear magnetic resonance therapy in lumbar disc herniation with lumbar radicular syndrome: effects of the intervention on pain intensity, health-related quality of life, disease-related disability, consumption of pain medication, duration of sick leave and MRI analysis.\" Eur Spine J 24(6): 1296-1308.",null,"Salfinger, H., et al.","Nuclear magnetic resonance therapy in lumbar disc herniation with lumbar radicular syndrome: effects of the intervention on pain intensity, health-related quality of life, disease-related disability, consumption of pain medication, duration of sick leave and MRI analysis","PURPOSE: The objective was to assess the effects of therapeutic nuclear magnetic resonance (tNMR) as a conservative treatment for lumbar radicular syndrome (LRS) in patients with lumbar disc herniation. METHODS: The prospective, randomised, double-blind, placebo-controlled trial included 94 patients, aged 20-60 years (44.79 +/- 8.83), with LRS caused by lumbar disc herniation confirmed by MRI scans and with clinical signs of a radicular lesion without indication for surgical intervention. Treatment group (TG) and control group (CG) received standard non-surgical therapy. Additionally, the TG had seven sessions with the tNMR device with a magnetic flux density of 2.3 mT and a frequency of 85 kHz; the CG received 7 sham treatments. Outcome parameters were the treatment effect on pain intensity (Visual Analogue Scale-VAS), health-related quality of life (36-item Short Form Health Survey-SF-36), disease-related disability (Roland Morris Disability Questionnaire-RMDQ), pain medication intake, duration of sick leave and morphological changes assessed by MRI scan analysis. RESULTS: VAS scores improved significantly in both groups (p < 0.000). Only in week 4, improvement in the TG significantly surpassed that of the CG (morning pain p = 0.011, evening pain = 0.001). In both groups, SF-36 scores reflected a significant amendment in the physical component score (p < 0.000) and a significant deterioration in the mental component score (p < 0.000). SF-36 scores did not differ significantly between groups. RMDQ showed a significant amelioration in both groups (TG and CG p < 0.000), with a tendency to a superior benefit in the TG (p = 0.083). Patients in the TG recorded significantly fewer days of sick leave in month 3 after treatment (p = 0.026). MRI scan summary scores improved significantly in both groups (L4/5 p < 0.000, L5/S1 p < 0.001) and did not differ significantly between the groups. CONCLUSIONS: This trial was the first to investigate the effects of tNMR as an additional treatment of lumbar disc herniation with LRS. The application of tNMR did not meet MCID criteria. It rendered few statistically significant differences between patient groups. The overall results of this trial make a clinical implementation of tNMR in the treatment of lumbar disc herniation with LRS appear premature. Further research is needed to better understand the mode of action of tNMR on compressed neural tissue and to elucidate the issue of the cost/benefit ratio."," Eur Spine J 24(6): 1296-1308.","Austria",2015,"Degenerative Disk Disease","Surgical","RMDQ","Adults","Cost and Resource Use","Prospective Observation","Austria","Adults","Degenerative Disk Disease","Surgical","Cost and Resource Use","Prospective Observation","RMDQ","2015:2018"]
[321,"Saper, R. B., et al. (2014). \"Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial.\" Trials 15: 67.",null,"Saper, R. B., et al.","Yoga vs. physical therapy vs. education for chronic low back pain in predominantly minority populations: study protocol for a randomized controlled trial","BACKGROUND: Chronic low back pain causes substantial morbidity and cost to society while disproportionately impacting low-income and minority adults. Several randomized controlled trials show yoga is an effective treatment. However, the comparative effectiveness of yoga and physical therapy, a common mainstream treatment for chronic low back pain, is unknown. METHODS/DESIGN: This is a randomized controlled trial for 320 predominantly low-income minority adults with chronic low back pain, comparing yoga, physical therapy, and education. Inclusion criteria are adults 18-64 years old with non-specific low back pain lasting >/= 12 weeks and a self-reported average pain intensity of >/= 4 on a 0-10 scale. Recruitment takes place at Boston Medical Center, an urban academic safety-net hospital and seven federally qualified community health centers located in diverse neighborhoods. The 52-week study has an initial 12-week Treatment Phase where participants are randomized in a 2:2:1 ratio into i) a standardized weekly hatha yoga class supplemented by home practice; ii) a standardized evidence-based exercise therapy protocol adapted from the Treatment Based Classification method, individually delivered by a physical therapist and supplemented by home practice; and iii) education delivered through a self-care book. Co-primary outcome measures are 12-week pain intensity measured on an 11-point numerical rating scale and back-specific function measured using the modified Roland Morris Disability Questionnaire. In the subsequent 40-week Maintenance Phase, yoga participants are re-randomized in a 1:1 ratio to either structured maintenance yoga classes or home practice only. Physical therapy participants are similarly re-randomized to either five booster sessions or home practice only. Education participants continue to follow recommendations of educational materials. We will also assess cost effectiveness from the perspectives of the individual, insurers, and society using claims databases, electronic medical records, self-report cost data, and study records. Qualitative data from interviews will add subjective detail to complement quantitative data. TRIAL REGISTRATION: This trial is registered in ClinicalTrials.gov, with the ID number: NCT01343927."," Trials 15: 67.","USA",2014,"Back Pain","Exercise","RMDQ","Adults","PRO study","RCT","USA","Adults","Back Pain","Exercise","PRO study","RCT","RMDQ","2010:2014"]
[322,"Saper, R. B., et al. (2017). \"Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial.\" Ann Intern Med 167(2): 85-94.",null,"Saper, R. B., et al.","Yoga, Physical Therapy, or Education for Chronic Low Back Pain: A Randomized Noninferiority Trial","Background: Yoga is effective for mild to moderate chronic low back pain (cLBP), but its comparative effectiveness with physical therapy (PT) is unknown. Moreover, little is known about yoga's effectiveness in underserved patients with more severe functional disability and pain. Objective: To determine whether yoga is noninferior to PT for cLBP. Design: 12-week, single-blind, 3-group randomized noninferiority trial and subsequent 40-week maintenance phase. (ClinicalTrials.gov: NCT01343927). Setting: Academic safety-net hospital and 7 affiliated community health centers. Participants: 320 predominantly low-income, racially diverse adults with nonspecific cLBP. Intervention: Participants received 12 weekly yoga classes, 15 PT visits, or an educational book and newsletters. The maintenance phase compared yoga drop-in classes versus home practice and PT booster sessions versus home practice. Measurements: Primary outcomes were back-related function, measured by the Roland Morris Disability Questionnaire (RMDQ), and pain, measured by an 11-point scale, at 12 weeks. Prespecified noninferiority margins were 1.5 (RMDQ) and 1.0 (pain). Secondary outcomes included pain medication use, global improvement, satisfaction with intervention, and health-related quality of life. Results: One-sided 95% lower confidence limits were 0.83 (RMDQ) and 0.97 (pain), demonstrating noninferiority of yoga to PT. However, yoga was not superior to education for either outcome. Yoga and PT were similar for most secondary outcomes. Yoga and PT participants were 21 and 22 percentage points less likely, respectively, than education participants to use pain medication at 12 weeks. Improvements in yoga and PT groups were maintained at 1 year with no differences between maintenance strategies. Frequency of adverse events, mostly mild self-limited joint and back pain, did not differ between the yoga and PT groups. Limitations: Participants were not blinded to treatment assignment. The PT group had disproportionate loss to follow-up. Conclusion: A manualized yoga program for nonspecific cLBP was noninferior to PT for function and pain. Primary Funding Source: National Center for Complementary and Integrative Health of the National Institutes of Health."," Ann Intern Med 167(2): 85-94.","USA",2017,"Back Pain","Physical Therapy","RMDQ","Adults","PRO study","RCT","USA","Adults","Back Pain","Physical Therapy","PRO study","RCT","RMDQ","2015:2018"]
[323,"Sathira-Angkura, V., et al. (2012). \"Validity and reliability of an adapted Thai version of Scoliosis Research Society-22 questionnaire for adolescent idiopathic scoliosis.\" Spine (Phila Pa 1976) 37(9): 783-787.",null,"Sathira-Angkura, V., et al.","Validity and reliability of an adapted Thai version of Scoliosis Research Society-22 questionnaire for adolescent idiopathic scoliosis","STUDY DESIGN: Cross-sectional observational study to investigate psychometric properties of an adapted Thai version of the refined Scoliosis Research Society-22 (SRS-22) questionnaire. OBJECTIVE: To evaluate the reliability and validity of the adapted Thai version of the refined SRS-22 questionnaire. SUMMARY OF BACKGROUND DATA: The SRS-22 questionnaire is a valid instrument for assessing the health-related quality of life for patients with adolescent idiopathic scoliosis. Recently, the questionnaire has been translated and validated in many languages for non-English-speaking countries. METHODS: Translation/retranslation of the English version of the SRS-22 was conducted, and the cross-cultural adaptation process was performed. The Thai version SRS-22 and previously validated Thai version Short-Form survey version 2.0 (SF-36V2) questionnaires were administered to 77 patients with adolescent idiopathic scoliosis who had surgical treatment. Fifty-eight patients (52 adolescent girls) had filled out the first set of questionnaires. Thirty patients of the first-time responders completed the second set of questionnaires. The mean age at the time of operation was 14.6 years and the mean age at the time of the final follow-up was 18.7 years. The mean preoperative scoliosis curve magnitude was 55.4 degrees (range, 30 degrees -95 degrees ) and postoperative curve magnitude was 20.1 degrees (range, 0 degrees -60 degrees ). Internal consistency was determined with Cronbach alpha coefficient. Intraclass correlation coefficient was used for test-retest reliability. Concurrent validity was evaluated by comparing SRS-22 domains with relevant domains in the SF-36V2 questionnaire, using the Pearson correlation coefficient. RESULTS: The mean overall Cronbach alpha coefficient of the adapted Thai version SRS-22 was 0.76. The 2 of corresponding domains (mental health = 0.80 and self-image = 0.83) had satisfactory internal consistency and the remaining domains (pain = 0.78; function/activity = 0.74; and satisfaction = 0.76) were good. The intraclass correlation coefficient for 5 domains was ranged from 0.79 to 0.90, which demonstrated the satisfactory test/retest reproducibility. The concurrent validity, determined by the Pearson correlation coefficient between SRS-22 and SF-36V2 domains, had a good correlation for 15 relevant comparisons (r = 0.50-0.75). CONCLUSION: The adapted Thai version of the SRS-22 questionnaire had validity and reliability, which can be used to assess the outcome of treatment among Thai-speaking patients with adolescent idiopathic scoliosis."," Spine (Phila Pa 1976) 37(9): 783-787.","Thailand",2012,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","Tool Validation","Observational","Thailand","Adolescents","Spinal Deformity","Surgical","Tool Validation","Observational","SRS-HRQOL","2010:2014"]
[324,"Sattelmayer, M., et al. (2012). \"Predictive value of the Acute Low Back Pain Screening Questionnaire and the Orebro Musculoskeletal Pain Screening Questionnaire for persisting problems.\" Eur Spine J 21 Suppl 6: S773-784.",null,"Sattelmayer, M., et al.","Predictive value of the Acute Low Back Pain Screening Questionnaire and the Orebro Musculoskeletal Pain Screening Questionnaire for persisting problems","INTRODUCTION: A small proportion of individuals with non-specific low back pain (NSLBP) develop persistent problems. Up to 80% of the total costs for NSLBP are owing to chronic NSLBP. Psychosocial factors have been described to be important in the transition from acute to chronic NSLBP. Guidelines recommend the use of the Acute Low Back Pain Screening Questionnaire (ALBPSQ) and the Orebro Musculoskeletal Pain Screening Questionnaire (OMPSQ) to identify individuals at risk of developing persistent problems, such as long-term absence of work, persistent restriction in function or persistent pain. These instruments can be used with a cutoff value, where patients with values above the threshold are further assessed with a more comprehensive examination. METHODS: We systematically reviewed studies evaluating the accuracy of the ALBPSQ and OMPSQ to predict persistent problems. RESULTS: The 13 included studies used different cutoff values for the screening questionnaires ranging from 68 to 147. The pooled sensitivity was 0.59 (0.43-0.74), while the pooled specificity was 0.77 (0.66-0.86). Heterogeneity (I (2)) was 90.02% for sensitivity and 95.41% for specificity. CONCLUSION: Thus, we do not recommend the use of one cutoff value, but the use of a prediction model with all the individual items."," Eur Spine J 21 Suppl 6: S773-784.","Switzerland",2012,"Back Pain","Psychosocial","ALBPSQ","Unknown","Tool Validation","Observational","Switzerland","Unknown","Back Pain","Psychosocial","Tool Validation","Observational","ALBPSQ","2010:2014"]
[325,"Scheer, J. K., et al. (2015). \"Comprehensive study of back and leg pain improvements after adult spinal deformity surgery: analysis of 421 patients with 2-year follow-up and of the impact of the surgery on treatment satisfaction.\" J Neurosurg Spine 22(5): 540-553.",null,"Scheer, J. K., et al.","Comprehensive study of back and leg pain improvements after adult spinal deformity surgery: analysis of 421 patients with 2-year follow-up and of the impact of the surgery on treatment satisfaction","OBJECT Back and leg pain are the primary outcomes of adult spinal deformity (ASD) and predict patients' seeking of surgical management. The authors sought to characterize changes in back and leg pain after operative or nonoperative management of ASD. Outcomes were assessed according to pain severity, type of surgical procedure, Scoliosis Research Society (SRS)-Schwab spine deformity class, and patient satisfaction. METHODS This study retrospectively reviewed data in a prospective multicenter database of ASD patients. Inclusion criteria were the following: age > 18 years and presence of spinal deformity as defined by a scoliosis Cobb angle >/= 20 degrees , sagittal vertical axis length >/= 5 cm, pelvic tilt angle >/= 25 degrees , or thoracic kyphosis angle >/= 60 degrees . Patients were grouped into nonoperated and operated subcohorts and by the type of surgical procedure, spine SRS-Schwab deformity class, preoperative pain severity, and patient satisfaction. Numerical rating scale (NRS) scores of back and leg pain, Oswestry Disability Index (ODI) scores, physical component summary (PCS) scores of the 36-Item Short Form Health Survey, minimum clinically important differences (MCIDs), and substantial clinical benefits (SCBs) were assessed. RESULTS Patients in whom ASD had been operatively managed were 6 times more likely to have an improvement in back pain and 3 times more likely to have an improvement in leg pain than patients in whom ASD had been nonoperatively managed. Patients whose ASD had been managed nonoperatively were more likely to have their back or leg pain remain the same or worsen. The incidence of postoperative leg pain was 37.0% at 6 weeks postoperatively and 33.3% at the 2-year follow-up (FU). At the 2-year FU, among patients with any preoperative back or leg pain, 24.3% and 37.8% were free of back and leg pain, respectively, and among patients with severe (NRS scores of 7-10) preoperative back or leg pain, 21.0% and 32.8% were free of back and leg pain, respectively. Decompression resulted in more patients having an improvement in leg pain and their pain scores reaching MCID. Although osteotomies improved back pain, they were associated with a higher incidence of leg pain. Patients whose spine had an SRS-Schwab coronal curve Type N deformity (sagittal malalignment only) were least likely to report improvements in back pain. Patients with a Type L deformity were most likely to report improved back or leg pain and to have reductions in pain severity scores reaching MCID and SCB. Patients with a Type D deformity were least likely to report improved leg pain and were more likely to experience a worsening of leg pain. Preoperative pain severity affected pain improvement over 2 years because patients who had higher preoperative pain severity experienced larger improvements, and their changes in pain severity were more likely to reach MCID/SCB than for those reporting lower preoperative pain. Reductions in back pain contributed to improvements in ODI and PCS scores and to patient satisfaction more than reductions in leg pain did. CONCLUSIONS The authors' results provide a valuable reference for counseling patients preoperatively about what improvements or worsening in back or leg pain they may experience after surgical intervention for ASD."," J Neurosurg Spine 22(5): 540-553.","USA",2015,"Spinal Deformity","Surgical","ODI","Adults","PRO study","Retrospective review","USA","Adults","Spinal Deformity","Surgical","PRO study","Retrospective review","ODI","2015:2018"]
[326,"Scheer, J. K., et al. (2015). \"Postoperative Recovery After Adult Spinal Deformity Surgery: Comparative Analysis of Age in 149 Patients During 2-year Follow-up.\" Spine (Phila Pa 1976) 40(19): 1505-1515.",null,"Scheer, J. K., et al.","Postoperative Recovery After Adult Spinal Deformity Surgery: Comparative Analysis of Age in 149 Patients During 2-year Follow-up","STUDY DESIGN: Retrospective review of a multicenter, prospective adult spinal deformity (ASD) database. OBJECTIVE: We hypothesized that increased age and increased preoperative disability would negatively impact both the length of time needed to achieve maximal recovery and the amount of functional improvement achieved. In order to gauge the recovery process, a normalization process was used to calculate an integrated health state (IHS) during the 2-year postoperative period. SUMMARY OF BACKGROUND DATA: Elderly patients with ASD generally have worse baseline health-related quality of life (HRQOL) measures than younger patients. Current methods of reporting outcomes are limited, perhaps diminishing the health impact of the entire postoperative recovery experience. METHODS: Inclusion criteria included 18 or more years and ASD. Patient groups: young (</=45 yr), middle (46-64), elderly (>/=65) as well as by baseline Oswestry Disability Index (ODI) scores: MILD (0-30), MEDIUM (31-49), and HIGH (>/=50). Collected HRQOL measures included ODI, Short Form-36(PCS/MCS), and Scoliosis Research Society-22 (SRS22) at baseline, 6 weeks, 1, and 2-year postoperative. All HRQOL measures were normalized to each patient's baseline scores. A 2-year IHS was calculated for each individual patient and the means were compared between groups. RESULTS: 149 patients were included (</=45:32, 46-64:67, >/=65:50). All groups significantly improved in all HRQOL at 2-year compared with baseline (P < 0.05) except for MCS, ODI, and SRS activity for the 45 or less group (P > 0.05). Normalized IHS HRQOL for young patients was worse than elderly for ODI, PCS, MCS, SRS activity, pain and total during the 2-year recovery period from index surgery. The MILD ODI group had significantly worse 2-year IHS values than the HIGH group for all HRQOL measured (P < 0.05) except SRS appearance and satisfaction (P > 0.05). CONCLUSION: Contrary to our hypothesis, an IHS analysis suggested that the recovery process was significantly better for elderly patients than young patients and better for patients with high baseline disability. LEVEL OF EVIDENCE: 3."," Spine (Phila Pa 1976) 40(19): 1505-1515.","USA",2015,"Spinal Deformity","Surgical","SRS-HRQOL,ODI","Elderly","PRO study","Prospective Observation","USA","Elderly","Spinal Deformity","Surgical","PRO study","Prospective Observation","SRS-HRQOL,ODI","2015:2018"]
[327,"Scheer, J. K., et al. (2017). \"Development of a preoperative predictive model for major complications following adult spinal deformity surgery.\" J Neurosurg Spine 26(6): 736-743.",null,"Scheer, J. K., et al.","Development of a preoperative predictive model for major complications following adult spinal deformity surgery","OBJECTIVE The operative management of patients with adult spinal deformity (ASD) has a high complication rate and it remains unknown whether baseline patient characteristics and surgical variables can predict early complications (intraoperative and perioperative [within 6 weeks]). The development of an accurate preoperative predictive model can aid in patient counseling, shared decision making, and improved surgical planning. The purpose of this study was to develop a model based on baseline demographic, radiographic, and surgical factors that can predict if patients will sustain an intraoperative or perioperative major complication. METHODS This study was a retrospective analysis of a prospective, multicenter ASD database. The inclusion criteria were age >/= 18 years and the presence of ASD. In total, 45 variables were used in the initial training of the model including demographic data, comorbidities, modifiable surgical variables, baseline health-related quality of life, and coronal and sagittal radiographic parameters. Patients were grouped as either having at least 1 major intraoperative or perioperative complication (COMP group) or not (NOCOMP group). An ensemble of decision trees was constructed utilizing the C5.0 algorithm with 5 different bootstrapped models. Internal validation was accomplished via a 70/30 data split for training and testing each model, respectively. Overall accuracy, the area under the receiver operating characteristic (AUROC) curve, and predictor importance were calculated. RESULTS Five hundred fifty-seven patients were included: 409 (73.4%) in the NOCOMP group, and 148 (26.6%) in the COMP group. The overall model accuracy was 87.6% correct with an AUROC curve of 0.89 indicating a very good model fit. Twenty variables were determined to be the top predictors (importance >/= 0.90 as determined by the model) and included (in decreasing importance): age, leg pain, Oswestry Disability Index, number of decompression levels, number of interbody fusion levels, Physical Component Summary of the SF-36, Scoliosis Research Society (SRS)-Schwab coronal curve type, Charlson Comorbidity Index, SRS activity, T-1 pelvic angle, American Society of Anesthesiologists grade, presence of osteoporosis, pelvic tilt, sagittal vertical axis, primary versus revision surgery, SRS pain, SRS total, use of bone morphogenetic protein, use of iliac crest graft, and pelvic incidence-lumbar lordosis mismatch. CONCLUSIONS A successful model (87% accuracy, 0.89 AUROC curve) was built predicting major intraoperative or perioperative complications following ASD surgery. This model can provide the foundation toward improved education and point-of-care decision making for patients undergoing ASD surgery."," J Neurosurg Spine 26(6): 736-743.","USA",2017,"Spinal Deformity","Surgical","ODI,SRS-HRQOL","Adults","Tool Validation","Prospective Observation","USA","Adults","Spinal Deformity","Surgical","Tool Validation","Prospective Observation","ODI,SRS-HRQOL","2015:2018"]
[328,"Schillberg, B. and B. Nystrom (2000). \"Quality of life before and after microsurgical decompression in lumbar spinal stenosis.\" J Spinal Disord 13(3): 237-241.",null,"Schillberg, B. and B. Nystrom","Quality of life before and after microsurgical decompression in lumbar spinal stenosis","Twenty consecutive patients (10 men and 10 women; median age, 68 years) with lumbar spinal stenosis were studied before and after microsurgical decompression without laminectomy. Fourteen of the patients had pure stenosis symptoms, whereas six had intercurrent diseases that could exacerbate the symptoms of stenosis. The mean duration of symptoms was 4.5 years (range, 1 to 15 years). All patients were interviewed before operation, and an assessment form based on and modified from the Oswestry Low Back Pain Disability Questionnaire was completed. The ability to perform physical activities including house work, gardening, going to the post office, and so forth was markedly reduced before operation for nearly all patients, and social life such as traveling, meeting friends, and participating in hobbies was similarly restricted. Sleeping was also greatly affected before operation, as were psychological parameters including irritability, depression, infirmity, energy, patience, and concentration. At follow-up 2.8 years after surgery, 13 of the 14 patients with pure stenosis evaluated their quality of life as much improved and principally normal. Among the patients with intercurrent diseases, only two of six judged the quality of their lives as much improved."," J Spinal Disord 13(3): 237-241.","Sweden",2000,"Back Pain","Surgical","ODI","Adults","PRO study","Prospective Observation","Sweden","Adults","Back Pain","Surgical","PRO study","Prospective Observation","ODI","2000:2004"]
[329,"Schouten, R., et al. (2015). \"Expectations of recovery and functional outcomes following thoracolumbar trauma: an evidence-based medicine process to determine what surgeons should be telling their patients.\" J Neurosurg Spine 22(1999): 101-111.",null,"Schouten, R., et al.","Expectations of recovery and functional outcomes following thoracolumbar trauma: an evidence-based medicine process to determine what surgeons should be telling their patients","OBJECT: The aim of this study was to define the expected functional and health-related quality of life outcomes following common thoracolumbar injuries on the basis of consensus expert opinion and the best available literature. Patient expectations are primarily determined by the information provided by health care professionals, and these expectations have been shown to influence outcome in various medical and surgical conditions. This paper presents Part 2 of a multiphase study designed to investigate the impact of patient expectations on outcomes following spinal injury. Part 1 demonstrated substantial variability in the information surgeons are communicating to patients. Defining the expected outcomes following thoracolumbar injury would allow further analysis of this relationship and enable surgeons to more accurately and consistently inform patients. METHODS: Expert opinion was assembled by distributing questionnaires comprising 4 cases representative of common thoracolumbar injuries to members of the Spine Trauma Study Group (STSG). The 4 cases included a thoracolumbar junction burst fracture treated nonoperatively or with posterior transpedicular instrumentation, a low lumbar (L-4) burst fracture treated nonoperatively, and a thoracolumbar junction flexion-distraction injury managed with posterior fusion. For each case, 5 questions about expected outcomes were posed. The questions related to the proportion of patients who are pain free, the proportion who have regained full range of motion, and the patients' recreational activity restrictions and personal care and social life limitations, all at 1 year following injury, as well as the timing of return to work and length of hospital stay. Responses were analyzed and combined with the results of a systematic literature review on the same injuries to define the expected outcomes. RESULTS: The literature review identified 38 appropriate studies that met the preset inclusion criteria. Published data were available for all injuries, but not all outcomes were available for each type of injury. The survey was completed by 31 (57%) of 53 surgeons representing 24 trauma centers across North America (15), Europe (5), India (1999), Mexico (1999), Japan (1999) and Israel (1999). Consensus expert opinion supplemented the available literature and was used exclusively when published data were lacking. For example, 1 year following cast or brace treatment of a thoracolumbar burst fracture, the expected outcomes include a 40% chance of being pain free, a 70% chance of regaining pre-injury range of motion, and an expected ability to participate in high-impact exercise and contact sport with no or minimal limitation. Consensus expert opinion predicts reemployment within 4-6 months. The length of inpatient stay averages 4-5 days. CONCLUSIONS: This synthesis of the best available literature and consensus opinion of surgeons with extensive clinical experience in spine trauma reflects the optimal methodology for determining functional prognosis after thoracolumbar trauma. By providing consistent, accurate information surgeons will help patients develop realistic expectations and potentially optimize outcomes."," J Neurosurg Spine 22(1999): 101-111.","New Zealand",2015,"Trauma","Surgical,Exercise","STSG","Unknown","PRO study","Narrative review","New Zealand","Unknown","Trauma","Surgical,Exercise","PRO study","Narrative review","STSG","2015:2018"]
[330,"Schwerla, F., et al. (2008). \"Osteopathic treatment of patients with chronic non-specific neck pain: a randomised controlled trial of efficacy.\" Forsch Komplementmed 15(3): 138-145.",null,"Schwerla, F., et al.","Osteopathic treatment of patients with chronic non-specific neck pain: a randomised controlled trial of efficacy","OBJECTIVE: Chronic non-specific neck pain (CNP) is a common, often disabling condition which still lacks a reliable therapeutic standard. Empiric evidence suggests that osteopathic interventions might be effective in alleviating CNP symptoms. A randomized controlled clinical trial of efficacy was performed to test this hypothesis. MATERIALS AND METHODS: 135 CNP sufferers were identified through advertisements, and 41 patients who met all relevant predefined criteria were recruited. All participants received a 12-min session of sham ultrasound once a week for an average of 10 weeks. In addition, a test-dependent osteopathic intervention of 45 min was given to 24 participants every other week. 40 participants could be followed up for 12 weeks after the end of therapy. The main outcome parameter was pain intensity measured on a numeric rating scale (NRS, range: 0-10). RESULTS: There were 2 dropouts in the intervention group and 2 in the control group. Average pain intensity decreased from 4.7 to 2.2 in the osteopathic group (p < 0.0005), and from 4.8 to 4.0 in the control group (p = 0.09). The intergroup difference of longitudinal changes was clearly significant, too (p = 0.02). Further slight but comparable reductions were observed at follow-up (0.3 and 0.4 NRS points, respectively). These changes seem to have a positive impact on quality of life, as assessed by generic and specific instruments such as the MOS SF-36 and the Northwick Park Pain Questionnaire. CONCLUSIONS: A series of test-dependent osteopathic interventions may be a promising therapeutic regimen for CNP sufferers. Further studies will have to demonstrate a) whether these findings are reproducible, and b) whether positive long-term outcomes can be achieved."," Forsch Komplementmed 15(3): 138-145.","Germany",2008,"Neck Pain","Osteopathy","Northwick","Unknown","PRO study","RCT","Germany","Unknown","Neck Pain","Osteopathy","PRO study","RCT","Northwick","2005:2009"]
[331,"Schwieger, T., et al. (2016). \"Body Image and Quality-of-Life in Untreated Versus Brace-Treated Females With Adolescent Idiopathic Scoliosis.\" Spine (Phila Pa 1976) 41(4): 311-319.",null,"Schwieger, T., et al.","Body Image and Quality-of-Life in Untreated Versus Brace-Treated Females With Adolescent Idiopathic Scoliosis","STUDY DESIGN: The Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) included skeletally immature high-risk patients with adolescent idiopathic scoliosis (AIS) with moderate curve sizes (20 degrees - 40 degrees ). BrAIST was a multicenter, controlled trial using both randomized and preference treatment arms into either an observation group or a brace treatment group. OBJECTIVE: The aim of this study was to analyze and compare body image and quality-of-life (QOL) in female AIS patients who were observed or treated with a brace. SUMMARY OF BACKGROUND DATA: Brace treatment is an effective means for controlling progressive scoliosis and preventing the need for surgery, but there is no consensus regarding the effect of brace treatment on body image or on QOL in adolescents with AIS. METHODS: Data from female BrAIST patients in the randomized (n = 132) or preference (n = 187) arms and were observed (n = 120) or brace treated (n = 199) were analyzed. Patients completed the Spinal Appearance Questionnaire (SAQ) and the Pediatric Quality of Life Inventory (PedsQOL) 4.0 Generic Scales at baseline and 6 month follow-up visits up to 2 years. Items on the SAQ measured three body image constructs (self, ideal, and overall). The PedsQOL measured health, activities, feelings, social factors, and school. RESULTS: . In general, there were no significant differences within or between study arms or treatments regarding body image or QOL through 2 years of follow-up. Poorer body image was significantly correlated with poorer QOL during the first 2 years of follow-up regardless of study arm or treatment. Patients who crossed-over to a different treatment and patients with largest Cobb angles >/= 40 degrees had significantly poorer body image, in particular self-body image, compared with those that did not. CONCLUSION: This study does not support findings from previous research indicating that wearing a brace has a negative impact on or is negatively impacted by body image or QOL. LEVEL OF EVIDENCE: 2."," Spine (Phila Pa 1976) 41(4): 311-319.","USA",2016,"Spinal Deformity","Surgical","SAQ","Adolescents","PRO study","Retrospective review","USA","Adolescents","Spinal Deformity","Surgical","PRO study","Retrospective review","SAQ","2015:2018"]
[332,"Seferiadis, A., et al. (2016). \"Basic body awareness therapy or exercise therapy for the treatment of chronic whiplash associated disorders: a randomized comparative clinical trial.\" Disabil Rehabil 38(5): 442-451.",null,"Seferiadis, A., et al.","Basic body awareness therapy or exercise therapy for the treatment of chronic whiplash associated disorders: a randomized comparative clinical trial","PURPOSE: Chronic whiplash-associated disorders (WAD) incur both costs and suffering. Treatments that can relieve chronic WAD are therefore needed. Exercise therapy (ET) has been shown to provide pain relief. Another often used treatment for chronic pain in Scandinavia is basic body awareness therapy (BAT). We compared the effectiveness of 10 weeks of twice-weekly, 90-min sessions of either ET or BAT in a randomized comparative trial. METHOD: We recruited 113 patients suffering from chronic WAD grades I-III and several years' duration of symptoms in a primary health care setting. 57 were allocated to ET and 56 to BAT. Primary outcome measures were Neck Disability Index and SF-36 v.2. RESULTS: From baseline to post-treatment, the BAT group increased their physical functioning (median 5, IQR = 15) more than the ET group (median = 0, IQR = 15), p = 0.032, effect size -0.54. Three months after the end of treatment, the BAT group had less bodily pain (m = 17.5, 95% CI 6.9-17.6) than the ET group (m = 4.9, 95% CI -0.1 to 9.8), p = 0.044, effect size -0.4. The BAT group had also increased their social functioning (m = 13.3, 95% CI 6.6-19.9) more than the ET group (m = 3.5, 95% CI -3 to 9.9), p = 0.037, effect size -0.41. No statistically significant differences between groups were found for the change of other outcomes. No serious adverse effects were found in either groups. CONCLUSIONS: The present trial indicates that BAT led to greater improvements than ET for the patients with chronic WAD. IMPLICATIONS FOR REHABILATION: Chronic whiplash-associated disorders are disabling and incur great costs to society often through inability to work. Exercise therapy (ET) may alleviate symptoms of chronic WAD. Basic body awareness therapy (BAT) is often a component of multimodal pain rehabilitation programs. In this randomized comparative trial, BAT increased physical functioning and led to greater pain reduction and social functioning 3 months after the end of treatment."," Disabil Rehabil 38(5): 442-451.","Sweden",2016,"Trauma,Back Pain","Exercise","NDI","Unknown","PRO study","RCT","Sweden","Unknown","Trauma,Back Pain","Exercise","PRO study","RCT","NDI","2015:2018"]
[333,"Seng, C., et al. (2013). \"Surgically treated cervical myelopathy: a functional outcome comparison study between multilevel anterior cervical decompression fusion with instrumentation and posterior laminoplasty.\" Spine J 13(7): 723-731.",null,"Seng, C., et al.","Surgically treated cervical myelopathy: a functional outcome comparison study between multilevel anterior cervical decompression fusion with instrumentation and posterior laminoplasty","BACKGROUND CONTEXT: Multilevel cervical myelopathy can be treated with anterior cervical discectomy and fusion (ACDF) or corpectomy via the anterior approach and laminoplasty via the posterior approach. Till date, there is no proven superior approach. PURPOSE: To elucidate any potential advantage of one approach over the other with regard to clinical midterm outcomes in this study. STUDY DESIGN: A prospective, 2-year follow-up of patients with cervical myelopathy treated with multilevel anterior cervical decompression fusion and plating and posterior laminoplasty. PATIENT SAMPLE: In total, 116 patients were studied. Sixty-four patients underwent ACDF two levels and above or anterior cervical corpectomy and fusion one level and above. Fifty-two patients underwent posterior cervical surgery (laminoplasty C3-C6 and C3-C7). OUTCOME MEASURES: Self-report measures: Japan Orthopedic Association (JOA) score, JOA recovery rate, visual analog scale for neck pain (VASNP), neck disability index (NDI), and American Academy of Orthopaedic Surgeons (AAOS) neurogenic symptom score (AAOS-NSS). Physiologic measures: range of motion (ROM) flexion and extension of neck. Functional measures: short-form 36 (SF-36) score comprising physical functioning, physical role function, bodily pain, general health, vitality, social role function, emotional role function, and mental health scales. METHODS: Comparison of the JOA scores, JOA recovery rates, NDI scores, SF-36 scores, VASNP, and ROM preoperatively to 2 years. Chi-square and two-sided Student t tests were used to analyze the variables. RESULTS: Posterior surgery took an hour shorter (p<.05) and had better improvement in JOA scores at early follow-up of 6 months (p=.025). Anterior surgery group had better improvement of NDI scores at early follow-up of 6 months (p=.024) and was associated with less blood loss intraoperatively compared with posterior surgery. There was no statistical difference between the two groups for JOA scores, JOA recovery rates, SF-36 quality-of-life scores, NDI, AAOS-NSS, VAS neck pain, and ROM at 2 years. Complications were higher for anterior surgery group: two hematoma postoperation, one vocal cord paresis, and one new onset C6/C7 dermatome numbness versus one dura leak in posterior surgery group. CONCLUSIONS: Our study showed that patients with multilevel disease treated with laminoplasty do well and compare favorably with patients treated with an anterior approach. Notably, posterior surgery was associated with shorter operating time, better improvement in JOA scores at 6 months, and a tendency toward lesser complications. Posterior surgery was not associated with increased neck disability and neck pain at 2 years. Anterior surgery had better NDI improvement at early follow-up. There is a need for a larger study that is prospectively randomized with long-term follow-up before we can confidently advocate one approach over the other in the management of cervical myelopathy."," Spine J 13(7): 723-731.","Singapore",2013,"Cervical Myelopathy,Neck Pain","Surgical","NDI,AAOS-NSS","Adults","PRO study","Prospective Observation","Singapore","Adults","Cervical Myelopathy,Neck Pain","Surgical","PRO study","Prospective Observation","NDI,AAOS-NSS","2010:2014"]
[334,"Sepucha, K. R., et al. (2012). \"Psychometric evaluation of a decision quality instrument for treatment of lumbar herniated disc.\" Spine (Phila Pa 1976) 37(18): 1609-1616.",null,"Sepucha, K. R., et al.","Psychometric evaluation of a decision quality instrument for treatment of lumbar herniated disc","STUDY DESIGN: Retrospective and prospective patient surveys and a physician survey using a sample from American Medical Association master file. OBJECTIVE: To evaluate the performance of a new instrument designed to measure the quality of decisions about treatment of herniated disc. SUMMARY OF BACKGROUND DATA: There is growing consensus on the importance of engaging and informing patients to improve the quality of significant medical decisions, yet there are no instruments currently available to measure decision quality. METHODS: The herniated disc-decision quality instrument (HD-DQI) was developed with input from clinical experts, survey research experts, and patients. The HD-DQI produces 2 scores each scaled to 0% to 100%, with higher scores indicating better quality: (1999) a total knowledge score and (2) a concordance score (indicating the percentage of patients who received treatments that matched their goals). We examined hypotheses relating to the acceptability, feasibility, validity, and reliability of the instrument, using data from 3 samples. RESULTS: The HD-DQI survey was feasible to implement and acceptable to patients, with good response rates and low missing data. The knowledge score discriminated between patients who had seen a decision aid or no decision aid (55% vs. 38%, P < 0.001) and between providers and patients (73% vs. 46%, P < 0.001). The knowledge score also had good retest reliability (intraclass correlation coefficient = 0.85). Most patients (78%) received treatments that matched their goals. Patients who received treatments that matched their goals were less likely to regret the decision than those who did not (13% vs. 39%, P = 0.004). CONCLUSION: The HD-DQI met several criteria for high-quality patient-reported survey instruments. It can be used to determine the quality of decisions for treatment of herniated disc. More work is needed to examine acceptability for use as part of routine patient care."," Spine (Phila Pa 1976) 37(18): 1609-1616.","USA",2012,"Degenerative Disk Disease","Not Specified","HD-DQI","Unknown","PRO study","Prospective Observation","USA","Unknown","Degenerative Disk Disease","Not Specified","PRO study","Prospective Observation","HD-DQI","2010:2014"]
[335,"Shahgholi, L., et al. (2012). \"Correlation of the National Institutes of Health patient reported outcomes measurement information system scales and standard pain and functional outcomes in spine augmentation.\" AJNR Am J Neuroradiol 33(11): 2186-2190.",null,"Shahgholi, L., et al.","Correlation of the National Institutes of Health patient reported outcomes measurement information system scales and standard pain and functional outcomes in spine augmentation","BACKGROUND AND PURPOSE: The recently developed National Institutes of Health PROMIS initiative provides reliable and valid measures across many health domains. We correlated changes in pain-related PROMIS measures and changes in both an NRS and the RMDI in patients undergoing spine augmentation. MATERIALS AND METHODS: Fifty patients, composed of 26 women (40-91 years of age; mean, 72.6 years) and 24 men (42-78 years of age, mean, 67.5 years) were enrolled in the study. They were asked at initial presentation and at 30 days to rate the intensity of their pain in the past 24 hours by using a 0-10 pain NRS as well at the 23-item RMDI. Study subjects also completed 3 different PROMIS short forms, including physical function, pain behavior, and pain interference. The Spearman correlation was used to assess the correlation between the scales. The RCI x 1.96 was calculated for each measurement tool as an indicator of change. RESULTS: All instruments were responsive to detection of change during 1 month (all, P < .0001). Correlations between changes in physical function, pain interference, and pain behavior PROMIS scores and changes in RMDI scores were 0.37, 0.44, and 0.42, respectively. Direction of changes (declines versus improvements) in RMDI and other scales were the same in approximately 60% of patients. CONCLUSIONS: All measures evaluated had adequate and comparable psychometric properties. The choice of which measure to use depends on the clinical intent of the intervention."," AJNR Am J Neuroradiol 33(11): 2186-2190.","USA",2012,"Spinal Deformity","Not Specified","RMDQ","Adults","PRO study","Prospective Observation","USA","Adults","Spinal Deformity","Not Specified","PRO study","Prospective Observation","RMDQ","2010:2014"]
[336,"Shahgholi, L., et al. (2015). \"Correlation of the Patient Reported Outcomes Measurement Information System with legacy outcomes measures in assessment of response to lumbar transforaminal epidural steroid injections.\" AJNR Am J Neuroradiol 36(3): 594-599.",null,"Shahgholi, L., et al.","Correlation of the Patient Reported Outcomes Measurement Information System with legacy outcomes measures in assessment of response to lumbar transforaminal epidural steroid injections","BACKGROUND AND PURPOSE: The Patient Reported Outcomes Measurement Information System is a newly developed outcomes measure promulgated by the National Institutes of Health. This study compares changes in pain and physical function-related measures of this system with changes on the Numeric Rating Pain Scale, Roland Morris Disability Index, and the European Quality of Life scale 5D questionnaire in patients undergoing transformational epidural steroid injections for radicular pain. MATERIALS AND METHODS: One hundred ninety-nine patients undergoing transforaminal epidural steroid injections for radicular pain were enrolled in the study. Before the procedure, they rated the intensity of their pain by using the 0-10 Numeric Rating Pain Scale, Roland Morris Disability Index, and European Quality of Life scale 5D questionnaire. Patients completed the Patient Reported Outcomes Measurement Information System Physical Function, Pain Behavior, and Pain Interference short forms before transforaminal epidural steroid injections and at 3 and 6 months. Seventy and 43 subjects replied at 3- and 6-month follow-up. Spearman rank correlations were used to assess the correlation between the instruments. The minimally important differences were calculated for each measurement tool as an indicator of meaningful change. RESULTS: All instruments were responsive in detecting changes at 3- and 6-month follow-up (P < .0001). There was significant correlation between changes in Patient Reported Outcomes Measurement Information System scores and legacy questionnaires from baseline to 3 months (P < .05). There were, however, no significant correlations in changes from 3 to 6 months with any of the instruments. CONCLUSIONS: The studied Patient Reported Outcomes Measurement Information System domains offered responsive and correlative psychometric properties compared with legacy instruments in a population of patients undergoing transforaminal epidural steroid injections for radicular pain."," AJNR Am J Neuroradiol 36(3): 594-599.","USA",2015,"Radiculopathy","Not Specified","RMDQ","Unknown","PRO study","Prospective Observation","USA","Unknown","Radiculopathy","Not Specified","PRO study","Prospective Observation","RMDQ","2015:2018"]
[337,"Shamji, M. F., et al. (2013). \"Comparison of anterior surgical options for the treatment of multilevel cervical spondylotic myelopathy: a systematic review.\" Spine (Phila Pa 1976) 38(22 Suppl 1): S195-209.",null,"Shamji, M. F., et al.","Comparison of anterior surgical options for the treatment of multilevel cervical spondylotic myelopathy: a systematic review","STUDY DESIGN: Systematic review. OBJECTIVE: The primary objectives of this review were to compare the effectiveness and safety of various anterior cervical decompressive and reconstructive procedures for diffuse or multifocal cervical spondylotic myelopathy (CSM). An additional objective was to describe the most common ancillary stabilization techniques used with the different anterior decompressive procedures. SUMMARY OF BACKGROUND DATA: Surgical management of CSM provides for neurological recovery and disease stabilization in a cost-effective way. Although both retrospective and prospective data support management of CSM by anterior cervical decompression and fusion, the choice decision between various anterior surgical options remains unclear. METHODS: We conducted a systematic search in MEDLINE and the Cochrane Collaboration Library for human studies in the English-language literature published through September 2012. We included studies comparing multiple discectomies with single or multiple corpectomy, multiple discectomies with discectomy-corpectomy hybrid, and multiple corpectomies with discectomy-corpectomy hybrid, comparing effectiveness and safety outcomes of each procedure, and defining the ancillary stabilization techniques used. Exclusion criteria included patients with degenerative disc disease or degenerative joint disease without CSM, single-level CSM, ossified posterior longitudinal ligament (OPLL), spinal tumor, concomitant infection, and ankylozing spondylitis. Case series, case reports, data not reported separately for each comparison group, or studies that consisted of an N less than 10 for either comparison group were excluded. The evidence strength was rated using the GRADE (Grades of Recommendation Assessment, Development, and Evaluation) criteria. RESULTS: Of the 49 citations identified from our search, 10 studies were initially found suitable for inclusion. Patients undergoing any of the 3 procedures generally experienced improvements in clinical outcomes (neck disability index, Japanese Orthopaedic Association score, and Visual Analogue Scale score for pain) as well as overall sagittal alignment, with minimal perioperative morbidity. There is moderate evidence supporting selection of multiple discectomies compared with corpectomy or discectomy-corpectomy hybrid procedures with regard to superior clinical outcomes and postoperative sagittal alignment. Furthermore, if more extensive operation is needed, there is evidence to support the selection of discectomy-corpectomy hybrid procedures compared with multiple corpectomies if it is technically feasible to accomplish the requisite decompression. The multiple discectomies approach also may have a lower incidence of C5 palsy than corpectomy or discectomy-corpectomy hybrid approaches. CONCLUSION: All 3 operative approaches are effective strategies for the anterior surgical management of CSM. When the patient pathoanatomy permits, selection of multiple discectomies is favored compared with corpectomy or discectomy-corpectomy hybrid approaches. EVIDENCE-BASED CLINICAL RECOMMENDATIONS: RECOMMENDATION 1: When pathoanatomically appropriate with minimal retrovertebral disease, we recommend the selection of multiple discectomy over corpectomy or discectomy-corpectomy hybrid procedures. OVERALL STRENGTH OF EVIDENCE: Low. STRENGTH OF RECOMMENDATION: Strong. RECOMMENDATION 2: When retrovertebral disease is significant, we recommend, when possible, that discectomy-corpectomy hybrid procedures be performed instead of multiple corpectomies. OVERALL STRENGTH OF EVIDENCE: Moderate. STRENGTH OF RECOMMENDATION: Strong. SUMMARY STATEMENTS: There is no evidence to guide choice of ancillary external immobilization techniques following multilevel anterior decompression and fusion procedures for CSM."," Spine (Phila Pa 1976) 38(22 Suppl 1): S195-209.","Canada",2013,"Cervical Myelopathy,Spondylosis","Surgical","JOACMEQ,NDI","Unknown","Cost-Effectiveness","Systematic review","Canada","Unknown","Cervical Myelopathy,Spondylosis","Surgical","Cost-Effectiveness","Systematic review","JOACMEQ,NDI","2010:2014"]
[338,"Shaughnessy, M. and B. Caulfield (2004). \"A pilot study to investigate the effect of lumbar stabilisation exercise training on functional ability and quality of life in patients with chronic low back pain.\" Int J Rehabil Res 27(4): 297-301.",null,"Shaughnessy, M. and B. Caulfield","A pilot study to investigate the effect of lumbar stabilisation exercise training on functional ability and quality of life in patients with chronic low back pain","In recent times lumbar stabilisation programmes, targeting the local stabilisers in the lumbar region, have increased in popularity in the treatment of chronic low back pain (CLBP) yet their effectiveness in enhancing quality of life remains unclear. The objective of this pilot study was to examine the effectiveness of a programme of lumbar stabilisation exercises in improving quality of life and functional outcomes in patients with CLBP. Forty-one patients with CLBP who volunteered to take part in the study were randomly assigned to a treatment group (n=20) or a control group (n=21). The treatment group underwent a 10-week lumbar stabilisation programme whilst the control group received no intervention. The Roland Disability Questionnaire, Oswestry Disability Questionnaire and the SF-36 survey were administered to subjects in both groups at baseline and follow-up. Significant improvements were seen in all measures in the treatment group whereas control subjects demonstrated either no change or a significant worsening (P<0.05). These results suggest that a programme of lumbar stabilisation is effective in improving quality of life and functional outcome in patients with CLBP."," Int J Rehabil Res 27(4): 297-301.","Ireland",2004,"Back Pain","Exercise","ODI,RMDQ","Unknown","PRO study","Clinical trial","Ireland","Unknown","Back Pain","Exercise","PRO study","Clinical trial","ODI,RMDQ","2000:2004"]
[339,"Shirado, O., et al. (2010). \"Multicenter randomized controlled trial to evaluate the effect of home-based exercise on patients with chronic low back pain: the Japan low back pain exercise therapy study.\" Spine (Phila Pa 1976) 35(17): E811-819.",null,"Shirado, O., et al.","Multicenter randomized controlled trial to evaluate the effect of home-based exercise on patients with chronic low back pain: the Japan low back pain exercise therapy study","STUDY DESIGN: Prospective, randomized, controlled trial. OBJECTIVE: To investigate the effectiveness of home-based exercise on pain, dysfunction, and quality of life (QOL) in Japanese individuals with chronic low back pain (CLBP). SUMMARY OF BACKGROUND DATA: Exercise therapy is a widely used treatment for CLBP in many countries. The studies on its effectiveness have been performed only in Western industrialized countries. The existence of cross-cultural differences and heterogeneity of patients in each country may influence the outcome of interventions for CLBP. Data that would enable researchers to compare the effectiveness of interventions between widely different societies is lacking. METHODS: A total of 201 patients with nonspecific CLBP were randomly assigned to either the control or exercise therapy group: 89 men and 112 women with a mean age of 42.2 years. The control group was treated with nonsteroidal anti-inflammatory drugs (NSAIDs), and the exercise group performed trunk muscle strengthening and stretching exercises. The primary outcome measures were pain intensity (visual analogue scale) and dysfunction level (Japan Low back pain Evaluation Questionnaire [JLEQ] and Roland-Morris Disability Questionnaire [RDQ]) over 12 months. The secondary outcome measure was FFD (Finger-floor distance). Statistical analysis was performed using Wilcoxon signed-ranks and Mann-Whitney U tests, and estimation of the median with 95% CI was calculated. RESULTS: In both groups, significant improvement was found at all points of follow-up assessment. However, JLEQ and RDQ were significantly more improved in the exercise group compared to the control group (P = 0.021 in JLEQ, P = 0.023 in RDQ). The 95% CI for the difference of medians of the change ratio between exercise and NSAID groups, [Exercise] - [NSAID], was -0.25 to -0.02 in JLEQ, -0.33 to 0.00 in RDQ, and -0.20 to 0.06 in visual analogue scale. CONCLUSION: The home-based exercise prescribed and monitored by board-certified orthopedic surgeons was more effective than NSAIDs for Japanese patients with CLBP."," Spine (Phila Pa 1976) 35(17): E811-819.","Japan",2010,"Back Pain","Exercise","RMDQ,JOACMEQ","Adults","PRO study","RCT","Japan","Adults","Back Pain","Exercise","PRO study","RCT","RMDQ,JOACMEQ","2010:2014"]
[340,"Silte Karamanlioglu, D., et al. (2016). \"Effectiveness of ultrasound treatment applied with exercise therapy on patients with ankylosing spondylitis: a double-blind, randomized, placebo-controlled trial.\" Rheumatol Int 36(5): 653-661.",null,"Silte Karamanlioglu, D., et al.","Effectiveness of ultrasound treatment applied with exercise therapy on patients with ankylosing spondylitis: a double-blind, randomized, placebo-controlled trial","The aim of our study was to evaluate effectiveness of ultrasound treatment applied with exercise therapy in patients with ankylosing spondylitis. Fifty-two patients, who were diagnosed according to modified New York criteria, were aged 25-60, and have spine pain, were randomly assigned to two groups. Ultrasound (US) and exercise therapy were applied to treatment group (27); placebo US treatment and exercise therapy were applied to control group (25). Patients were evaluated before treatment, at the end of treatment, and 4 weeks after the treatment. Daily and night pain, morning stiffness, patient global assessment (PGA), doctor global assessment (DGA), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), Ankylosing Spondylitis Quality of Life (ASQoL) questionnaire, Ankylosing Spondylitis Disease Activity Score (ASDAS) erythrocyte sedimentation rate (ESR), and ASDAS C-reactive protein (CRP) were used as clinical parameters. In US group, all parameters showed significant improvements at 2 and 6 weeks, in comparison with the baseline. In placebo US group, significant improvement was obtained for all parameters (except tragus-to-wall distance and modified Schober test at 2 weeks and lumbar side flexion and modified Schober test at 6 weeks). Comparison of the groups showed significantly superior results of US group for parameters of BASMI (p < 0.05), tragus-wall distance (p < 0.05), PGA (p < 0.01), and DGA (p < 0.05) at 2 weeks as well as for the parameters of daily pain (p < 0.01), PGA (p < 0.05), DGA (p < 0.01), BASDAI (p < 0.05), ASDAS-CRP (p < 0.05), ASDAS-ESR (p < 0.01), lumbar side flexion (p < 0.01), the modified Schober test (p < 0.01), and ASQoL (p < 0.05) at 6 weeks. Our study showed that ultrasound treatment increases the effect of exercise in patients with ankylosing spondylitis."," Rheumatol Int 36(5): 653-661.","Turkey",2016,"Back Pain,Spondylosis","Exercise","Schober","Unknown","PRO study","RCT","Turkey","Unknown","Back Pain,Spondylosis","Exercise","PRO study","RCT","Schober","2015:2018"]
[341,"Skare, T. L., et al. (2012). \"Ethnic influence in clinical and functional measures of Brazilian patients with spondyloarthritis.\" J Rheumatol 39(1999): 141-147.",null,"Skare, T. L., et al.","Ethnic influence in clinical and functional measures of Brazilian patients with spondyloarthritis","OBJECTIVE: Spondyloarthritides (SpA) can present different disease spectra according to ethnic background. The Brazilian Registry of Spondyloarthritis (RBE) is a nationwide registry that comprises a large databank on clinical, functional, and treatment data on Brazilian patients with SpA. The aim of our study was to analyze the influence of ethnic background in SpA disease patterns in a large series of Brazilian patients. METHODS: A common protocol of investigation was prospectively applied to 1318 SpA patients in 29 centers distributed through the main geographical regions in Brazil. The group comprised whites (65%), African Brazilians (31.3%), and people of mixed origins (3.7%). Clinical and demographic variables and various disease index scores were compiled. Ankylosing spondylitis (AS) was the most frequent disease in the group (65.1%); others were psoriatic arthritis (18.3%), undifferentiated SpA (6.8%), enteropathic arthritis (3.7%), and reactive arthritis (3.4%). RESULTS: White patients were significantly associated with psoriasis (p = 0.002), positive HLA-B27 (p = 0.014), and use of corticosteroids (p < 0.0001). Hip involvement (p = 0.02), axial inflammatory pain (p = 0.04), and radiographic sacroiliitis (p = 0.025) were associated with African Brazilian descent. Sex distribution, family history, and presence of peripheral arthritis, uveitis, dactylitis, urethritis, and inflammatory bowel disease were similar in the 3 groups, as well as age at disease onset, time from first symptom until diagnosis, and use of anti-tumor necrosis factor-alpha agents (p > 0.05). Schober test and thoracic expansion were similar in the 3 groups, whereas African Brazilians had higher Maastricht Ankylosing Spondylitis Enthesitis Scores (p = 0.005) and decreased lateral lumbar flexion (p = 0.003), while whites had a higher occiput-to-wall distance (p = 0.02). African Brazilians reported a worse patient global assessment of disease (p = 0.011). Other index scores and prevalence of work incapacity were similar in the 3 groups, although African Brazilians had worse performance in the Ankylosing Spondylitis Quality of Life questionnaire (p < 0.001). CONCLUSION: Ethnic background is associated with distinct clinical aspects of SpA in Brazilian patients. African Brazilian patients with SpA have a poorer quality of life and report worse disease compared to whites."," J Rheumatol 39(1999): 141-147.","Brazil",2012,"Spondylosis","Not Specified","Schober","Unknown","PRO study","Prospective Observation","Brazil","Unknown","Spondylosis","Not Specified","PRO study","Prospective Observation","Schober","2010:2014"]
[342,"Skljarevski, V., et al. (2010). \"Duloxetine versus placebo in patients with chronic low back pain: a 12-week, fixed-dose, randomized, double-blind trial.\" J Pain 11(12): 1282-1290.",null,"Skljarevski, V., et al.","Duloxetine versus placebo in patients with chronic low back pain: a 12-week, fixed-dose, randomized, double-blind trial","This randomized, double-blind, placebo-controlled study assessed efficacy and safety of duloxetine in patients with chronic low back pain (CLBP). Adults (n = 401) with a nonneuropathic CLBP and average pain intensity of >/= 4 on an 11-point numerical scale (Brief Pain Inventory [BPI]) were treated with either duloxetine 60 mg once daily or placebo for 12 weeks. The primary measure was BPI average pain. Secondary endpoints included Patient's Global Impressions of Improvement (PGI-I), Roland Morris Disability Questionnaire (RMDQ-24), BPI-Severity (BPI-S), BPI-Interference (BPI-I), and response rates (either >/= 30% or >/= 50% BPI average pain reduction at endpoint). Health outcomes included Short Form-36, European Quality of Life-5 Dimensions, and the Work Productivity and Activity Impairment questionnaire. Safety and tolerability were assessed. Compared with placebo-treated patients, duloxetine-treated patients reported a significantly greater reduction in BPI average pain (P </= .001). Similarly, duloxetine-treated patients reported significantly greater improvements in PGI-I, BPI-S, BPI-I, 50% response rates, and some health outcomes. The RMDQ and 30% response rate showed numerical improvements with duloxetine treatment. Significantly more patients in the duloxetine group (15.2%) than patients in the placebo group (5.4%) discontinued because of adverse events (P = .002). Nausea and dry mouth were the most common treatment-emergent adverse events with rates significantly higher in duloxetine-treated patients. PERSPECTIVE: This study provides clinical evidence of the efficacy and safety of duloxetine at a fixed dose of 60 mg once daily in the treatment of chronic low back pain (CLBP). As of December 2009, duloxetine has not received regulatory approval for the treatment of CLBP."," J Pain 11(12): 1282-1290.","USA",2010,"Back Pain","Duloxetine","RMDQ","Adults","PRO study","RCT","USA","Adults","Back Pain","Duloxetine","PRO study","RCT","RMDQ","2010:2014"]
[343,"Skljarevski, V., et al. (2010). \"Efficacy and safety of duloxetine in patients with chronic low back pain.\" Spine (Phila Pa 1976) 35(13): E578-585.",null,"Skljarevski, V., et al.","Efficacy and safety of duloxetine in patients with chronic low back pain","STUDY DESIGN: This was a randomized, double-blind, placebo-controlled clinical trial. OBJECTIVE: To assess the efficacy and safety of duloxetine in the treatment of chronic low back pain (CLBP). SUMMARY OF BACKGROUND DATA: Imbalance of serotonin and norepinephrine within modulatory pain pathways has been implicated in the development and maintenance of chronic pain. Duloxetine, a selective reuptake inhibitor of serotonin and norepinephrine, has demonstrated clinical efficacy in 3 distinct chronic pain conditions: diabetic peripheral neuropathic pain, fibromyalgia, and chronic pain because of osteoarthritis. METHODS: In this randomized double-blind trial, adult nondepressed patients with a non-neuropathic CLBP and a weekly mean of the 24-hour average pain score>or=4 at baseline (0-10 scale) were treated with either duloxetine or placebo for 13 weeks. The dose of duloxetine during first 7 weeks was 60 mg once daily. At week 7, patients reporting<30% pain reduction had their dose increased to 120 mg. The primary outcome measure was the Brief Pain Inventory (BPI) 24-hour average pain rating. Secondary measures included Roland-Morris Disability Questionnaire-24; Patient's Global Impressions of Improvement; Clinical Global Impressions-Severity (CGI-S); BPI-Severity and -Interference (BPI-I); and weekly means of the 24-hour average pain, night pain, and worst pain scores from patient diaries. Quality-of-life, safety, and tolerability outcomes were also assessed. RESULTS: Compared with placebo-treated patients (least-squares mean change of -1.50), patients on duloxetine (least-squares mean change of -2.32) had a significantly greater reduction in the BPI 24-hour average pain from baseline to endpoint (P=0.004 at week 13). Additionally, the duloxetine group significantly improved on Patient's Global Impressions of Improvement; Roland-Morris Disability Questionnaire-24; BPI-Severity and average BPI-Interference; weekly mean of the 24-hour average pain, night pain, and worst pain. Significantly more patients in the duloxetine group (13.9%) compared with placebo (5.8%) discontinued because of adverse events (P=0.047). The most common treatment-emergent adverse events in the duloxetine group included nausea, dry mouth, fatigue, diarrhea, hyperhidrosis, dizziness, and constipation. CONCLUSION: Duloxetine significantly reduced pain and improved functioning in patients with CLBP. The safety and tolerability were similar to those reported in earlier studies."," Spine (Phila Pa 1976) 35(13): E578-585.","USA",2010,"Neuropathic Pain","Duloxetine","RMDQ","Unknown","PRO study","RCT","USA","Unknown","Neuropathic Pain","Duloxetine","PRO study","RCT","RMDQ","2010:2014"]
[344,"Skolasky, R. L., et al. (2011). \"Minimum clinically important differences in the Cervical Spine Outcomes Questionnaire: results from a national multicenter study of patients treated with anterior cervical decompression and arthrodesis.\" J Bone Joint Surg Am 93(14): 1294-1300.",null,"Skolasky, R. L., et al.","Minimum clinically important differences in the Cervical Spine Outcomes Questionnaire: results from a national multicenter study of patients treated with anterior cervical decompression and arthrodesis","BACKGROUND: The minimum clinically important difference is a clinically relevant threshold of improvement. A substantial clinical benefit is a threshold of change that correlates with clinically important improvement. The Cervical Spine Outcomes Questionnaire is a disease-specific, patient-reported outcomes instrument that was developed to be sensitive to changes associated with surgical treatment for degenerative cervical disc disease. To determine thresholds for change in these domain scores that are important from the patient's perspective, we estimated the minimum clinically important difference and substantial clinical benefit values for this questionnaire's domain scores. METHODS: We evaluated 252 patients from the Cervical Spine Research Society Outcomes Study at their six-month follow-up visits after anterior cervical spine decompression and arthrodesis. Using a receiver operating characteristics curve, with the health transition item of the Short Form-36 as an anchor, we determined that the minimum clinically important difference (the value that maximized sensitivity and specificity to differentiate the \"somewhat better\" and \"much better\" responses from others) and the substantial clinical benefit (the value that maximized sensitivity and specificity to differentiate the \"much better\" response from others) for our questionnaire's domain scores. Responses were scaled between 0 and 1 point; higher scores denoted more severe impairment. Patient and clinical characteristics were tested to determine their influence on score changes. RESULTS: The minimum clinically important difference ranged from 0.13 point (for functional disability) to 0.24 point (for arm/shoulder pain). The substantial clinical benefit score ranged from 0.20 point (for functional disability or physical symptoms other than pain) to 0.30 point (for neck or arm/shoulder pain). Age, sex, and duration of current symptoms were not associated with change in our questionnaire's domain scores. CONCLUSIONS: A 0.13-point change in the functional disability domain score indicated a clinically important difference in a self-reported outcome after anterior cervical spine surgery. A 0.30-point change in neck pain after surgery indicated a clinically important clinical benefit. This information, coupled with previous reports of the psychometric stability of the Cervical Spine Outcomes Questionnaire, should increase the clinical utility of this patient-reported outcomes instrument."," J Bone Joint Surg Am 93(14): 1294-1300.","USA",2011,"Neck Pain","Surgical","CSOQ","Unknown","PRO study","Observational","USA","Unknown","Neck Pain","Surgical","PRO study","Observational","CSOQ","2010:2014"]
[345,"Skolasky, R. L., et al. (2011). \"Predicting health-utility scores from the Cervical Spine Outcomes Questionnaire in a multicenter nationwide study of anterior cervical spine surgery.\" Spine (Phila Pa 1976) 36(25): 2211-2216.",null,"Skolasky, R. L., et al.","Predicting health-utility scores from the Cervical Spine Outcomes Questionnaire in a multicenter nationwide study of anterior cervical spine surgery","STUDY DESIGN: Cross-sectional analysis of the Cervical Spine Research Society Outcomes Study, a longitudinal multicenter cohort study. OBJECTIVE: To provide a statistical model for estimating health utility from the Cervical Spine Outcomes Questionnaire (CSOQ) domain scores. SUMMARY OF BACKGROUND DATA: There is consensus among health-policy researchers that the results of economic evaluations of health can be reported in quality-adjusted life-years (QALY). The CSOQ is a condition-specific instrument that assesses individuals across several domains, including neck and arm/shoulder pain and psychological distress. METHODS: The CSOQ and 36-Item Short Form Health Survey (SF-36) were prospectively administered before surgery (within 4 weeks) and after surgery (at 3, 6, and 24 months) to individuals undergoing anterior cervical decompression and fusion for degenerative disc disease of the cervical spine. Using methods reported by Brazier et al, health utility (SF-6D) was estimated using the SF-36. Regression analyses were used on a training dataset (n = 164) to compute the SF-6D from the domain scores of the CSOQ. A validation dataset (n = 328) was used to estimate the SF-6D for comparison to the calculated health utility from the SF-36. RESULTS.: Domain scores were moderately correlated with health utility (SF-6D) (P < 0.001) with correlation coefficients ranging from 0.48 to 0.70. The regression equation to predict SF-6D on the basis of CSOQ domain scores and patient age using the training dataset accounted for 65% of the variation in health utility. In the validation dataset, predicted SF-6D was positively correlated with observed SF-6D (r = 0.680, P < 0.001). CONCLUSION: Our findings show that the CSOQ's domain scores can be used to estimate health-utility scores among those undergoing elective anterior cervical decompression and fusion for cervical degenerative disc disease. The ability to assess health utility, coupled with the psychometric properties of the CSOQ, should increase the clinical utility of this patient-reported outcomes instrument."," Spine (Phila Pa 1976) 36(25): 2211-2216.","USA",2011,"Spinal Deformity","Surgical","CSOQ","Adults","Tool Validation","Observational","USA","Adults","Spinal Deformity","Surgical","Tool Validation","Observational","CSOQ","2010:2014"]
[346,"Slater, H., et al. (2013). \"Translating evidence for low back pain management into a consumer-focussed resource for use in community pharmacies: a cluster-randomised controlled trial.\" PLoS One 8(8): e71918.",null,"Slater, H., et al.","Translating evidence for low back pain management into a consumer-focussed resource for use in community pharmacies: a cluster-randomised controlled trial","BACKGROUND: This cluster-randomised controlled trial determined the effectiveness of an evidence-based, pamphlet intervention in improving low back pain (LBP)-related beliefs among pharmacy consumers. METHODS: THIRTY FIVE COMMUNITY PHARMACIES WERE RANDOMISED TO THREE GROUPS: pamphlet+education intervention [n = 11]; pamphlet only intervention [n = 11]; control: usual care [n = 13]. Eligibility requirements for clusters included: community-based pharmacies and proprietor participation consent. Pharmacy consumers (N = 317) aged 18-65 years currently experiencing LBP participated. Intervention group allocation depended on the pharmacy attended. Individual-level outcomes were measured at pre-intervention (T0), at two (T1) and eight (T2) weeks post-intervention and included beliefs about LBP [Back Pain Beliefs Questionnaire (BBQ); Fear Avoidance Beliefs Questionnaire (FABQ)]. Secondary outcomes included pain severity, activity impairment and pamphlet perceived usefulness. Blinding to group allocation included primary investigators, outcome assessors and the statistician. Pharmacy staff and consumers were un-blinded. RESULTS: Of 35 pharmacies recruited (317 consumers), no clusters were lost to follow-up. Follow-up was available for n = 24 at 2 weeks only; n = 38 at 8 weeks only; n = 148 at both time points, with n = 148+24+38 = 210 analysed (107 excluded: no follow up). Adjusting for baseline scores demonstrated no significant differences in beliefs (2 or at 8 weeks) between pamphlet (with or without education) versus control, or between 'pamphlet with' versus 'without' education. Work-related fear (FABQ) was significantly lower in consumers receiving pamphlet (with or without education) versus control (difference -2.3, 95%CI: -4.4 to -0.2). There was no significant difference between \"pamphlet with\" versus \"pamphlet without\" groups. Consumers receiving the \"pamphlet with\" reported greater perceived usefulness than consumers receiving the \"pamphlet without\" (difference 0.9 (95%CI: 0.0 to 1.8)). CONCLUSION: Community pharmacies provided a feasible primary care portal for implementing evidence-based information. The associated improvement in work-related LBP-beliefs for consumers receiving the pamphlet suggests this simple intervention may be a useful component of care. TRIAL REGISTRATION: ACTR.org.au ACTRN12611000053921."," PLoS One 8(8): e71918.","Australia",2013,"Back Pain","Education","BBQ","Adults","PRO study","RCT","Australia","Adults","Back Pain","Education","PRO study","RCT","BBQ","2010:2014"]
[347,"Smeets, R. J., et al. (2009). \"More is not always better: cost-effectiveness analysis of combined, single behavioral and single physical rehabilitation programs for chronic low back pain.\" Eur J Pain 13(1999): 71-81.",null,"Smeets, R. J., et al.","More is not always better: cost-effectiveness analysis of combined, single behavioral and single physical rehabilitation programs for chronic low back pain","Several treatment principles for the reduction of chronic low back pain associated disability have been postulated. To examine whether a combination of a physical training and operant-behavioral graded activity with problem solving training is cost-effective compared to either alone one year post-treatment, a full economic analysis alongside a randomized controlled trial was conducted. In total 172 patients with chronic disabling non-specific low back pain referred for rehabilitation treatment, were randomized to 10 weeks of aerobic training and muscle strengthening of back extensors (active physical treatment; APT), 10 weeks of gradual assumption of patient relevant activities based on operant-behavioral principles and problem solving training (graded activity plus problem solving training; GAP), or APT combined with GAP (combination treatment; CT). Total costs, existing of direct health and non-health costs and indirect costs due to absence of paid work were calculated by using cost diaries and treatment attendance lists. The Roland Disability Questionnaire was used to calculate the cost-effectiveness to reduce disability and the gain in quality adjusted life year (QALY) by using the EuroQol-5D. APT, followed by CT showed, although not significant, higher total costs than GAP. Reduction of disability and gain in QALY did not differ significantly between CT and the single treatment modalities. Based on the incremental cost effectiveness ratios (ICERs) and cost-effectiveness acceptability curves CT is not cost-effective at all. However, GAP is cost-effective regarding the reduction of disability and gain in QALY, and to a lesser degree APT is more cost-effective than CT in reducing disability."," Eur J Pain 13(1999): 71-81.","Netherlands",2009,"Back Pain","Physical Therapy","RMDQ","Unknown","Cost-Effectiveness","Clinical trial","Netherlands","Unknown","Back Pain","Physical Therapy","Cost-Effectiveness","Clinical trial","RMDQ","2005:2009"]
[348,"Smith, J. S., et al. (2013). \"Change in classification grade by the SRS-Schwab Adult Spinal Deformity Classification predicts impact on health-related quality of life measures: prospective analysis of operative and nonoperative treatment.\" Spine (Phila Pa 1976) 38(19): 1663-1671.",null,"Smith, J. S., et al.","Change in classification grade by the SRS-Schwab Adult Spinal Deformity Classification predicts impact on health-related quality of life measures: prospective analysis of operative and nonoperative treatment","STUDY DESIGN: Multicenter, prospective, consecutive series. OBJECTIVE: To evaluate responsiveness of the Scoliosis Research Society (SRS)-Schwab adult spinal deformity (ASD) classification to changes in health-related quality of life (HRQOL) after treatment for ASD. SUMMARY OF BACKGROUND DATA: Ideally, a classification system should describe and be responsive to changes in a disease state. We hypothesized that the SRS-Schwab classification is responsive to changes in HRQOL measures after treatment for ASD. METHODS: A multicenter, prospective, consecutive series from the International Spine Study Group. INCLUSION CRITERIA: ASD, age more than 18, operative or nonoperative treatment, baseline and 1-year radiographs, and HRQOL measures (Oswestry Disability Index [ODI], SRS-22, Short Form [SF]-36). The SRS-Schwab classification includes a curve descriptor and 3 sagittal spinopelvic modifiers (sagittal vertical axis [SVA], pelvic tilt, pelvic incidence/lumbar lordosis [PI-LL] mismatch). Changes in modifiers at 1 year were assessed for impact on HRQOL from pretreatment values based on minimal clinically important differences. RESULTS: Three hundred forty-one patients met criteria (mean age = 54; 85% females; 177 operative and 164 nonoperative). Change in pelvic tilt modifier at 1-year follow-up was associated with changes in ODI and SRS-22 (total and appearance scores) (P </= 0.034). Change in SVA modifier at 1 year was associated with changes in ODI, SF-36 physical component score, and SRS-22 (total, activity, and appearance scores) (P </= 0.037). Change in PI-LL modifier at 1 year was associated with changes in SF-36 physical component score and SRS-22 (total, activity, and appearance scores) (P </= 0.03). Patients with improvement of pelvic tilt, SVA, or PI-LL modifiers were significantly more likely to achieve minimal clinically important difference for ODI, SF-36 physical component score (SVA and PI-LL only), SRS activity, and SRS pain (PI-LL only). CONCLUSION: The SRS-Schwab classification provides a validated system to evaluate ASD, and the classification components correlate with HRQOL measures. This study demonstrates that the classification modifiers are responsive to changes in disease state and reflect significant changes in patient-reported outcomes. LEVEL OF EVIDENCE: 3."," Spine (Phila Pa 1976) 38(19): 1663-1671.","USA",2013,"Spinal Deformity","Surgical","SRS-HRQOL,ODI","Unknown","PRO study","Prospective Observation","USA","Unknown","Spinal Deformity","Surgical","PRO study","Prospective Observation","SRS-HRQOL,ODI","2010:2014"]
[349,"Smith, J. S., et al. (2014). \"Surgical treatment of pathological loss of lumbar lordosis (flatback) in patients with normal sagittal vertical axis achieves similar clinical improvement as surgical treatment of elevated sagittal vertical axis: clinical article.\" J Neurosurg Spine 21(2): 160-170.",null,"Smith, J. S., et al.","Surgical treatment of pathological loss of lumbar lordosis (flatback) in patients with normal sagittal vertical axis achieves similar clinical improvement as surgical treatment of elevated sagittal vertical axis: clinical article","OBJECT: Increased sagittal vertical axis (SVA) correlates strongly with pain and disability for adults with spinal deformity. A subset of patients with sagittal spinopelvic malalignment (SSM) have flatback deformity (pelvic incidence-lumbar lordosis [PI-LL] mismatch > 10 degrees ) but remain sagittally compensated with normal SVA. Few data exist for SSM patients with flatback deformity and normal SVA. The authors' objective was to compare baseline disability and treatment outcomes for patients with compensated (SVA < 5 cm and PI-LL mismatch > 10 degrees ) and decompensated (SVA > 5 cm) SSM. METHODS: The study was a multicenter, prospective analysis of adults with spinal deformity who consecutively underwent surgical treatment for SSM. Inclusion criteria included age older than 18 years, presence of adult spinal deformity with SSM, plan for surgical treatment, and minimum 1-year follow-up data. Patients with SSM were divided into 2 groups: those with compensated SSM (SVA < 5 cm and PI-LL mismatch > 10 degrees ) and those with decompensated SSM (SVA >/= 5 cm). Baseline and 1-year follow-up radiographic and health-related quality of life (HRQOL) outcomes included Oswestry Disability Index, Short Form-36 scores, and Scoliosis Research Society-22 scores. Percentages of patients achieving minimal clinically important difference (MCID) were also assessed. RESULTS: A total of 125 patients (27 compensated and 98 decompensated) met inclusion criteria. Compared with patients in the compensated group, patients in the decompensated group were older (62.9 vs. 55.1 years; p = 0.004) and had less scoliosis (43 degrees vs 54 degrees ; p = 0.002), greater SVA (12.0 cm vs. 1.7 cm; p < 0.001), greater PI-LL mismatch (26 degrees vs. 20 degrees ; p = 0.013), and poorer HRQOL scores (Oswestry Disability Index, Short Form-36 physical component score, Scoliosis Research Society-22 total; p </= 0.016). Although these baseline HRQOL differences between the groups reached statistical significance, only the mean difference in Short Form-36 physical component score reached threshold for MCID. Compared with baseline assessment, at 1 year after surgery improvement was noted for patients in both groups for mean SVA (compensated -1.1 cm, decompensated +4.8 cm; p </= 0.009), mean PI-LL mismatch (compensated 6 degrees , decompensated 5 degrees ; p < 0.001), and all HRQOL measures assessed (p </= 0.005). No significant differences were found between the compensated and decompensated groups in the magnitude of HRQOL score improvement or in the percentages of patients achieving MCID for each of the outcome measures assessed. CONCLUSIONS: Decompensated SSM patients with elevated SVA experience significant disability; however, the amount of disability in compensated SSM patients with flatback deformity caused by PI-LL mismatch but normal SVA is underappreciated. Surgical correction of SSM demonstrated similar radiographic and HRQOL score improvements for patients in both groups. Evaluation of SSM should extend beyond measuring SVA. Among patients with concordant pain and disability, PI-LL mismatch must be evaluated for SSM patients and can be considered a primary indication for surgery."," J Neurosurg Spine 21(2): 160-170.","USA",2014,"Spinal Deformity","Surgical","ODI,SRS-HRQOL","Adults","PRO study","Prospective Observation","USA","Adults","Spinal Deformity","Surgical","PRO study","Prospective Observation","ODI,SRS-HRQOL","2010:2014"]
[350,"Smith, J. S., et al. (2015). \"Comparison of best versus worst clinical outcomes for adult spinal deformity surgery: a retrospective review of a prospectively collected, multicenter database with 2-year follow-up.\" J Neurosurg Spine 23(3): 349-359.",null,"Smith, J. S., et al.","Comparison of best versus worst clinical outcomes for adult spinal deformity surgery: a retrospective review of a prospectively collected, multicenter database with 2-year follow-up","OBJECT: Although recent studies suggest that average clinical outcomes are improved following surgery for selected adult spinal deformity (ASD) patients, these outcomes span a broad range. Few studies have specifically addressed factors that may predict favorable clinical outcomes. The objective of this study was to compare patients with ASD with best versus worst clinical outcomes following surgical treatment to identify distinguishing factors that may prove useful for patient counseling and optimization of clinical outcomes. METHODS: This is a retrospective review of a prospectively collected, multicenter, database of consecutively enrolled patients with ASD who were treated operatively. Inclusion criteria were age > 18 years and ASD. For patients with a minimum of 2-year follow-up, those with best versus worst outcomes were compared separately based on Scoliosis Research Society-22 (SRS-22) and Oswestry Disability Index (ODI) scores. Only patients with a baseline SRS-22 </= 3.5 or ODI >/= 30 were included to minimize ceiling/floor effects. Best and worst outcomes were defined for SRS-22 (>/= 4.5 and </= 2.5, respectively) and ODI (</= 15 and >/= 50, respectively). RESULTS: Of 257 patients who met the inclusion criteria, 227 (88%) had complete baseline and 2-year follow-up SRS-22 and ODI outcomes scores and radiographic imaging and were analyzed in the present study. Of these 227 patients, 187 had baseline SRS-22 scores </= 3.5, and 162 had baseline ODI scores >/= 30. Forthe SRS-22, best and worst outcomes criteria were met at follow-up for 25 and 27 patients, respectively. For the ODI, best and worst outcomes criteria were met at follow-up for 43 and 51 patients, respectively. With respect to the SRS-22, compared with best outcome patients, those with worst outcomes had higher baseline SRS-22 scores (p < 0.0001), higher prevalence of baseline depression (p < 0.001), more comorbidities (p = 0.012), greater prevalence of prior surgery (p = 0.007), a higher complication rate (p = 0.012), and worse baseline deformity (sagittal vertical axis [SVA], p = 0.045; pelvic incidence [PI] and lumbar lordosis [LL] mismatch, p = 0.034). The best-fit multivariate model for SRS-22 included baseline SRS-22 (p = 0.033), baseline depression (p = 0.012), and complications (p = 0.030). With respect to the ODI, compared with best outcome patients, those with worst outcomes had greater baseline ODI scores (p < 0.001), greater baseline body mass index (BMI; p = 0.002), higher prevalence of baseline depression (p < 0.028), greater baseline SVA (p = 0.016), a higher complication rate (p = 0.02), and greater 2-year SVA (p < 0.001) and PI-LL mismatch (p = 0.042). The best-fit multivariate model for ODI included baseline ODI score (p < 0.001), 2-year SVA (p = 0.014) and baseline BMI (p = 0.037). Age did not distinguish best versus worst outcomes for SRS-22 or ODI (p > 0.1). CONCLUSIONS: Few studies have specifically addressed factors that distinguish between the best versus worst clinical outcomes for ASD surgery. In this study, baseline and perioperative factors distinguishing between the best and worst outcomes for ASD surgery included several patient factors (baseline depression, BMI, comorbidities, and disability), as well as residual deformity (SVA), and occurrence of complications. These findings suggest factors that may warrant greater awareness among clinicians to achieve optimal surgical outcomes for patients with ASD."," J Neurosurg Spine 23(3): 349-359.","USA",2015,"Spinal Deformity","Surgical","SRS-HRQOL","Adults","PRO study","Retrospective review","USA","Adults","Spinal Deformity","Surgical","PRO study","Retrospective review","SRS-HRQOL","2015:2018"]
[351,"Smucny, M., et al. (2011). \"Patient self-assessment of appearance is improved more by all pedicle screw than by hybrid constructs in surgical treatment of adolescent idiopathic scoliosis.\" Spine (Phila Pa 1976) 36(3): 248-254.",null,"Smucny, M., et al.","Patient self-assessment of appearance is improved more by all pedicle screw than by hybrid constructs in surgical treatment of adolescent idiopathic scoliosis","STUDY DESIGN: A multicenter prospective cohort study. OBJECTIVE: To compare the effect of all pedicle screw versus hybrid constructs on patient self-assessment of appearance after posterior spinal fusion with instrumentation for adolescent idiopathic scoliosis (AIS). This will contribute to future cost-effective analyses on surgical management of AIS. SUMMARY OF BACKGROUND DATA: For surgical management of AIS, the Spinal Appearance Questionnaire (SAQ) and the Scoliosis Research Society outcomes instrument (SRS-30) are reliable surveys of patient satisfaction, but neither tool has been used to assess outcome by implant type. METHODS: Patients received either all pedicle screws or hybrid instrumentation. Self-assessment of appearance pre- and after surgery was measured by SAQ and SRS-30. Statistical significance was evaluated through P values (P < 0.01 in the SAQ, P < 0.05 in the SRS-30) and effect sizes. RESULTS: There were 93 patients in the all pedicle screw cohort and 61 in the hybrid cohort. There were no significant preoperative differences between the cohorts in the SAQ or SRS-30. All pedicle screw patients tended to see more improvement in shoulder level than hybrid patients in 2 separate SAQ questions (P = 0.025, Cohen's D = 0.20; P = 0.013, D = 0.24). The screw patients also tended to have better scores than hybrid patients in the category, \"looking better in clothes\" (P = 0.017, V = 0.24) at 2 years postoperative. All pedicle screw patients self-reported significant greater improvement than hybrid patients in the SRS-30 Appearance and Mental domains (P = 0.016, ES = 0.038; P = 0.005, ES = 0.051). There were no significant differences between cohorts in age, gender, baseline curve, or major curve magnitude. CONCLUSION: All pedicle screw constructs lead to better self-assessment of appearance in operative treatment of AIS, as determined by SAQ and SRS-30."," Spine (Phila Pa 1976) 36(3): 248-254.","USA",2011,"Spinal Deformity,Spinal Fusion","Surgical","SRS-HRQOL,SAQ","Adolescents","Cost and Resource Use","Prospective Observation","USA","Adolescents","Spinal Deformity,Spinal Fusion","Surgical","Cost and Resource Use","Prospective Observation","SRS-HRQOL,SAQ","2010:2014"]
[352,"Soegaard, R., et al. (2007). \"Costs and effects in lumbar spinal fusion. A follow-up study in 136 consecutive patients with chronic low back pain.\" Eur Spine J 16(5): 657-668.",null,"Soegaard, R., et al.","Costs and effects in lumbar spinal fusion. A follow-up study in 136 consecutive patients with chronic low back pain","Although cost-effectiveness is becoming the foremost evaluative criterion within health service management of spine surgery, scientific knowledge about cost-patterns and cost-effectiveness is limited. The aims of this study were (1999) to establish an activity-based method for costing at the patient-level, (2) to investigate the correlation between costs and effects, (3) to investigate the influence of selected patient characteristics on cost-effectiveness and, (4) to investigate the incremental cost-effectiveness ratio of (a) posterior instrumentation and (b) intervertebral anterior support in lumbar spinal fusion. We hypothesized a positive correlation between costs and effects, that determinants of effects would also determine cost-effectiveness, and that posterolateral instrumentation and anterior intervertebral support are cost-effective adjuncts in posterolateral lumbar fusion. A cohort of 136 consecutive patients with chronic low back pain, who were surgically treated from January 2001 through January 2003, was followed until 2 years postoperatively. Operations took place at University Hospital of Aarhus and all patients had either (1999) non-instrumented posterolateral lumbar spinal fusion, (2) instrumented posterolateral lumbar spinal fusion, or (3) instrumented posterolateral lumbar spinal fusion + anterior intervertebral support. Analysis of costs was performed at the patient-level, from an administrator's perspective, by means of Activity-Based-Costing. Clinical effects were measured by means of the Dallas Pain Questionnaire and the Low Back Pain Rating Scale at baseline and 2 years postoperatively. Regression models were used to reveal determinants for costs and effects. Costs and effects were analyzed as a net-benefit measure to reveal determinants for cost-effectiveness, and finally, adjusted analysis (for non-random allocation of patients) was performed in order to reveal the incremental cost-effectiveness ratios of (a) posterior instrumentation and (b) anterior support. The costs of non-instrumented posterolateral spinal fusion were estimated at DKK 88,285(95% CI 81,369;95,546), instrumented posterolateral spinal fusion at DKK 94,396(95% CI 89,865;99,574) and instrumented posterolateral lumbar spinal fusion + anterior intervertebral support at DKK 120,759(95% CI 111,981;133,738). The net-benefit of the regimens was significantly affected by smoking and functional disability in psychosocial life areas. Multi-level fusion and surgical technique significantly affected the net-benefit as well. Surprisingly, no correlation was found between treatment costs and treatment effects. Incremental analysis suggested that the probability of posterior instrumentation being cost-effective was limited, whereas the probability of anterior intervertebral support being cost-effective escalates as willingness-to-pay per effect unit increases. This study reveals useful and hitherto unknown information both about cost-patterns at the patient-level and determinants of cost-effectiveness. The overall conclusion of the present investigation is a recommendation to focus further on determinants of cost-effectiveness. For example, patient characteristics that are modifiable at a relatively low expense may have greater influence on cost-effectiveness than the surgical technique itself--at least from an administrator's perspective."," Eur Spine J 16(5): 657-668.","Denmark",2007,"Back Pain,Spinal Fusion","Surgical","ICF","Adults","Cost-Effectiveness","Prospective Observation","Denmark","Adults","Back Pain,Spinal Fusion","Surgical","Cost-Effectiveness","Prospective Observation","ICF","2005:2009"]
[353,"Steinmetz, M. P., et al. (2008). \"Cervical disc arthroplasty compared with fusion in a workers' compensation population.\" Neurosurgery 63(4): 741-747; discussion 747.",null,"Steinmetz, M. P., et al.","Cervical disc arthroplasty compared with fusion in a workers' compensation population","OBJECTIVE: Patients with cervical radiculopathy and/or myelopathy are often treated with anterior cervical discectomy and fusion. Cervical arthroplasty has recently been advocated as an alternative treatment. Theoretically, arthroplasty should permit early return to activity and protect against adjacent segment disease. Early mobilization and return to activity may, theoretically, reduce cost to the workers' compensation program. METHODS: A subgroup analysis of workers' compensation patients from the randomized controlled trials comparing Prestige ST and Bryan (Medtronic Sofamor Danek, Memphis, TN) cervical arthroplasty to fusion was performed. Primary outcome measures were work status, time to return to work, and neck disability. Secondary outcome measures were neck and arm pain and Medical Outcomes Study Short-Form 36-Item Health Survey score. RESULTS: One thousand four patients were enrolled in the studies, 93 of whom were workers' compensation patients. At 6 weeks and 3 months, significantly more patients in the arthroplasty group were working compared with the fusion group. At 6 months and later, there was no significant difference in return-to-work rates. Overall, patients returned to work at a median of 101 days after arthroplasty, compared with 222 days after anterior cervical discectomy and fusion. This difference was not significant when controlling for sex, study, and preoperative work status. At all time points, the Neck Disability Index was consistently lower in the arthroplasty group compared with the fusion group; however, the difference was not significant at 24 months. There was no statistically significant difference in secondary outcomes, neurological events, or pain-related events. CONCLUSION: In this workers' compensation cohort, it was observed that a greater number of patients in the arthroplasty group returned to work at 6 weeks and 3 months after surgery. A trend toward an earlier return to work was also seen, although this was not statistically significant when controlling for differences in the studies."," Neurosurgery 63(4): 741-747; discussion 747.","USA",2008,"Cervical Myelopathy","Surgical","NDI","Unknown","Cost and Resource Use","RCT","USA","Unknown","Cervical Myelopathy","Surgical","Cost and Resource Use","RCT","NDI","2005:2009"]
[354,"Sterling, M., et al. (2009). \"Dry needling and exercise for chronic whiplash - a randomised controlled trial.\" BMC Musculoskelet Disord 10: 160.",null,"Sterling, M., et al.","Dry needling and exercise for chronic whiplash - a randomised controlled trial","BACKGROUND: Chronic whiplash is a common and costly problem. Sensory hypersensitivity is a feature of chronic whiplash that is associated with poor responsiveness to physical treatments such as exercise. Modalities such as dry-needling have shown some capacity to modulate sensory hypersensitivity, suggesting that when combined with advice and exercise, such an approach may be more effective in the management of chronic whiplash. The primary aim of this project is to investigate the effectiveness of dry-needling, advice and exercise for chronic whiplash. METHOD/DESIGN: A double-blind randomised controlled trial will be conducted. 120 participants with chronic whiplash, grade II will be randomised to receive either 1) dry-needling, advice and exercise or 2) sham dry-needling, advice and exercise. All participants will receive an educational booklet on whiplash. Participants who are randomised to Group 1 will receive 6 treatments of combined dry-needling and exercise delivered in the first 3 weeks of the 6 week program, and 4 treatments of exercise only in the last 3 weeks of the program. Participants randomised to Group 2 will receive an identical protocol, except that a sham dry-needling technique will be used instead of dry-needling. The primary outcome measures are the Neck Disability Index (NDI) and participants' perceived recovery. Outcomes will be measured at 6, 12, 24 and 52 weeks after randomization by an assessor who is blind to the group allocation of the participants. In parallel, an economic analysis will be conducted. DISCUSSION: This trial will utilise high quality trial methodologies in accordance with CONSORT guidelines. The successful completion of this trial will provide evidence of the effectiveness and cost-effectiveness of a combined treatment approach for the management of chronic whiplash. TRIAL REGISTRATION: ACTRN12609000470291."," BMC Musculoskelet Disord 10: 160.","Australia",2009,"Trauma","Exercise","NDI","Unknown","PRO study","RCT","Australia","Unknown","Trauma","Exercise","PRO study","RCT","NDI","2005:2009"]
[355,"Sterling, M., et al. (2012). \"Assessment and validation of prognostic models for poor functional recovery 12 months after whiplash injury: a multicentre inception cohort study.\" Pain 153(8): 1727-1734.",null,"Sterling, M., et al.","Assessment and validation of prognostic models for poor functional recovery 12 months after whiplash injury: a multicentre inception cohort study","Uncertainty surrounds prognostic factors after whiplash injury. Previously we identified a prognostic model for 6-month pain-related disability in a cohort of 80 participants with acute whiplash. Predictors included initial disability, older age, decreased cold pain thresholds, decreased neck rotation movement, posttraumatic stress symptoms and decreased sympathetic vasoconstriction. The objective of this study was to externally validate this model. In a multicentre inception cohort study, 286 participants with acute whiplash (I, II or III) were assessed at <3 weeks and 12 months after injury. The Neck Disability Index (NDI) was the outcome. Observed and predicted NDI scores were generated using the published equation of the original model. Model discrimination between participants with no or mild disability from those with moderate to severe disability was examined by receiver operating characteristic curves. Initial NDI and cold pain threshold predicted current observed 12-month NDI scores (r(2) = 0.50, 95% confidence interval 0.42 to 0.58). There was a significant site effect, and the estimated marginal mean +/- SE of 12-month NDI for Iceland (27.6 +/- 1.79%) was higher than the other 3 sites (Melbourne 11.2 +/- 5.03%, Canada 16.4 +/- 2.36%, Brisbane 16.8 +/- 1.17%). After adjusting for site, age and Impact of Events Scale scores regained significance (r(2) = 0.56, 95% confidence interval 0.48 to 0.64). The tested model was not precise in predicting NDI as a continuous variable. However, it found good accuracy to discriminate participants with moderate to severe disability at 12 months (area under the receiver operating characteristic curve 0.89 [95% confidence interval 0.84-0.94], P<.001) which is clinically useful."," Pain 153(8): 1727-1734.","Australia",2012,"Trauma","Not Specified","NDI","Unknown","PRO study","Observational","Australia","Unknown","Trauma","Not Specified","PRO study","Observational","NDI","2010:2014"]
[356,"Sterling, M., et al. (2015). \"Dry-needling and exercise for chronic whiplash-associated disorders: a randomized single-blind placebo-controlled trial.\" Pain 156(4): 635-643.",null,"Sterling, M., et al.","Dry-needling and exercise for chronic whiplash-associated disorders: a randomized single-blind placebo-controlled trial","This randomized controlled trial investigated the effectiveness and cost-effectiveness of dry-needling and exercise compared with sham dry-needling and exercise for chronic whiplash-associated disorders (WAD). The setting was a single university centre and 4 physiotherapy practices in Queensland, Australia. Eighty patients with chronic WAD (>3 months) were enrolled between June 2009 and August 2012 with 1-year follow-up completed in August 2013. The interventions were 6 weeks of dry-needling to posterior neck muscles (n = 40) and exercise or sham dry-needling and exercise (n = 40). The primary outcomes of the Neck Disability Index (NDI) and self-rated recovery were measured at baseline, 6 and 12 weeks, 6 and 12 months by a blinded assessor. Analysis was intention to treat. An economic evaluation was planned but missing data deemed further analysis unwarranted. Seventy-nine patients (99%) were followed up at 6 weeks, 78 (98%) at 12 weeks, 74 (93%) at 6 months, and 73 (91%) at 12 months. The dry-needling and exercise intervention was more effective than sham dry-needling and exercise in reducing disability at 6 and 12 months but not at 6 and 12 weeks. The treatment effects were small and not clinically worthwhile. At 6 weeks, the treatment effect on the 0-100 NDI was -0.3 (95% confidence interval -5.4 to 4.7), 12 weeks -0.3 (-5.2 to 4.9), 6 months -4.4 (-9.6 to -0.74), and 12 months -3.8 (-9.1 to -0.5). There was no effect for self-rated recovery. In patients with chronic WAD, dry-needling and exercise has no clinically worthwhile effects over sham dry-needling and exercise."," Pain 156(4): 635-643.","Australia",2015,"Trauma","Other,Exercise","NDI","Unknown","Cost-Effectiveness","RCT","Australia","Unknown","Trauma","Other,Exercise","Cost-Effectiveness","RCT","NDI","2015:2018"]
[357,"Stienen, M. N., et al. (2015). \"Surgical Resident Education in Noninstrumented Lumbar Spine Surgery: A Prospective Observational Study with a 4.5-Year Follow-Up.\" World Neurosurg 84(6): 1589-1597.",null,"Stienen, M. N., et al.","Surgical Resident Education in Noninstrumented Lumbar Spine Surgery: A Prospective Observational Study with a 4.5-Year Follow-Up","OBJECTIVE: To review the outcomes of noninstrumented lumbar spine surgery performed by trainees as primary operators versus the outcomes of surgery performed by board-certified faculty neurosurgeons. METHODS: This prospective observational study involved patients undergoing noninstrumented surgery for lumbar disc herniation or lumbar spinal stenosis with a 4.5-year follow-up. Teaching cases (patients were operated on by neurosurgical residents in training) and nonteaching cases (patients were operated on by board-certified faculty neurosurgeons) were reviewed. Back and leg pain on a visual analog scale, functional disability using the Roland Morris Disability Questionnaire and Oswestry Disability Index, and health-related quality of life (HRQOL) using the 12-Item Short Form Survey and EuroQol 5D were assessed, and reoperations since the index surgery were recorded. RESULTS: Questionnaires were returned by 30 patients operated on by residents and 74 patients operated on by board-certified faculty neurosurgeons. On the 12-Item Short Form Survey physical component scale metric, teaching cases were 70% as likely as nonteaching cases (odds ratio = 0.70, 95% confidence interval = 0.25-1.98, P = 0.585) to achieve a favorable HRQOL response to surgery. Visual analog scale measures of back and leg pain were similar for teaching and nonteaching cases. The same was true for functional disability as measured by the Roland Morris Disability Questionnaire and Oswestry Disability Index and for HRQOL measured by the EuroQol 5D. The reoperation rate 4.5 years after the index surgery was also similar for both groups ( approximately 10% for both groups). CONCLUSIONS: The global outcome, as measured by HRQOL response after a mean follow-up of 4.5 years, was similar for teaching and nonteaching cases. Patients from both groups scored virtually equal results on various pain, functional, and HRQOL metrics, and the reoperation rate was similar."," World Neurosurg 84(6): 1589-1597.","Switzerland",2015,"Degenerative Disk Disease","Surgical","RMDQ,ODI","Unknown","PRO study","Prospective Observation","Switzerland","Unknown","Degenerative Disk Disease","Surgical","PRO study","Prospective Observation","RMDQ,ODI","2015:2018"]
[358,"Stienen, M. N., et al. (2016). \"Influence of Body Mass Index on Subjective and Objective Measures of Pain, Functional Impairment, and Health-Related Quality of Life in Lumbar Degenerative Disc Disease.\" World Neurosurg 96: 570-577.e571.",null,"Stienen, M. N., et al.","Influence of Body Mass Index on Subjective and Objective Measures of Pain, Functional Impairment, and Health-Related Quality of Life in Lumbar Degenerative Disc Disease","OBJECTIVE: To analyze the influence of body mass index (BMI) on subjective and objective measures of pain, functional impairment, and health-related quality of life in patients with lumbar degenerative disc disease undergoing surgery. METHODS: Prospective institutional review board-approved 2-center study, measuring visual analog scale (VAS) back and leg pain, Roland-Morris Disability Index (RMDI), Oswestry Disability Index (ODI), EuroQol 5D questionnaire, and Short Form-12 at baseline, 6 weeks, 6 months, and 1 year postoperatively. T-scores of objective functional impairment (OFI) were determined using the Timed Up and Go (TUG) test. RESULTS: A total of 375 patients with a median BMI of 26.6 kg/m(2) (94 obese patients [BMI >/=30 kg/m(2)]) were included. Obese patients presented more VAS back pain (mean, 4.7 vs. 3.6; P = 0.001) and greater disability on the RMDI (mean, 12.6 vs. 11.3; P = 0.045). The prevalence and severity of OFI were similar in obese and nonobese patients. There was a weak positive correlation between BMI and VAS back pain (r = 0.1552; P = 0.0026), on both RMDI (r = 0.1138; P = 0.0276) and ODI (r = 0.1075; P = 0.0374). There was no correlation between BMI and TUG T-scores (r = 0.0475; P = 0.3585). Obese patients were as likely as nonobese patients to show a positive 6-week treatment response, and the outcome up to 1 year was similar. CONCLUSIONS: BMI positively correlates with VAS back pain, RMDI, and ODI. Standardized TUG T scores reflect the patient's degree of OFI well, irrespective of BMI. The TUG test appears to be a good means to estimate functional impairment in populations with a high prevalence of obesity."," World Neurosurg 96: 570-577.e571.","Switzerland,Australia",2016,"Back Pain","Surgical","RMDQ,ODI","Unknown","PRO study","Prospective Observation","Switzerland,Australia","Unknown","Back Pain","Surgical","PRO study","Prospective Observation","RMDQ,ODI","2015:2018"]
[359,"Stienen, M. N., et al. (2017). \"Validation of the baseline severity stratification of objective functional impairment in lumbar degenerative disc disease.\" J Neurosurg Spine 26(5): 598-604.",null,"Stienen, M. N., et al.","Validation of the baseline severity stratification of objective functional impairment in lumbar degenerative disc disease","OBJECTIVE The Timed Up and Go (TUG) test is a simple, objective, and standardized method to measure objective functional impairment (OFI) in patients with lumbar degenerative disc disease (DDD). The objective of the current work was to validate the OFI baseline severity stratification (BSS; with levels of \"none,\" \"mild,\" \"moderate,\" and \"severe\"). METHODS Data were collected in a prospective IRB-approved 2-center study. Patients were assessed with a comprehensive panel of scales for measuring pain (visual analog scale [VAS] for back and leg pain), functional impairment (Roland-Morris Disability Index [RMDI] and Oswestry Disability Index [ODI]), and health-related quality of life (HRQOL; EQ-5D and SF-12). OFI BSS was determined using age- and sex-adjusted cutoff values. RESULTS A total of 375 consecutive patients scheduled for lumbar spine surgery were included. Each 1-step increase on the OFI BSS corresponded to an increase of 0.53 in the back pain VAS score, 0.69 in the leg pain VAS score, 1.81 points in the RMDI, and 5.93 points in the ODI, as well as to a decrease in HRQOL of -0.073 in the EQ-5D, -1.99 in the SF-12 physical component summary (PCS), and -1.62 in the SF-12 mental component summary (MCS; all p < 0.001). Patients with mild, moderate, and severe OFI had increased leg pain by 0.90 (p = 0.044), 1.54 (p < 0.001), and 1.94 (p < 0.001); increased ODI by 7.99 (p = 0.004), 12.64 (p < 0.001), and 17.13 (p < 0.001); and decreased SF-12 PCS by -2.57 (p = 0.049), -3.63 (p = 0.003), and -6.23 (p < 0.001), respectively. CONCLUSIONS The OFI BSS is a valid measure of functional impairment for use in daily clinical practice. The presence of OFI indicates the presence of significant functional impairment on subjective outcome measures."," J Neurosurg Spine 26(5): 598-604.","Switzerland,Australia",2017,"Spine Disease","Surgical","RMDQ,ODI","Unknown","Tool Validation","Prospective Observation","Switzerland,Australia","Unknown","Spine Disease","Surgical","Tool Validation","Prospective Observation","RMDQ,ODI","2015:2018"]
[360,"Stone, J. G., et al. (2015). \"Evaluation of Occipitocervical Arthrodesis Rates with Screw-based Fixation and Osteoinductive Fusion Adjuncts.\" J Neurol Surg A Cent Eur Neurosurg 76(5): 361-368.",null,"Stone, J. G., et al.","Evaluation of Occipitocervical Arthrodesis Rates with Screw-based Fixation and Osteoinductive Fusion Adjuncts","Occipitocervical (OC) instability may be associated with neurologic impairment and even death. There is a paucity of research on the rate of arthrodesis utilizing modern screw-based constructs coupled with adjuvant osteoinductive agents. We reviewed our experience with OC constructs and compared the fusion rate, functional outcome, and rate of adverse events between recombinant human bone morphogenetic protein (BMP)-2, autologous iliac crest bone graft (ICBG), a combination of BMP and ICBG, and local bone autograft alone. We performed a retrospective cohort analysis of all adult admissions for operative treatment of OC instability utilizing segmental screw-based constructs for OC arthrodesis between January 2003 and September 2012. Data concerning demographic characteristics, diagnostic and procedural details, radiographic pathology, and clinical course were abstracted from medical records. The primary end point was evidence of stable fixation and osseous union on either dynamic lateral radiographs or computed tomography (CT) imaging at most recent follow-up. Secondary end points included functional outcome as determined by Nurick scale and Neck disability index (NDI) at >/= 1year postoperation, as well as perioperative morbidity and mortality at 30 days and 3 months. During the study period, 94 patients (mean age: 62 +/- 18 years) underwent OC fixation with segmental screw-based constructs. The four fusion adjunct cohorts analyzed included local autograft alone (32%), ICBG (41%), BMP (14%), or a combination of ICBG and BMP (14%). Notably, demineralized bone matrix was also used in 61% of cases overall, but its use did not differ significantly among the four cohorts (p = 0.28). Median radiographic follow-up was 6 months postoperatively (range: 1.5-54 months). Clinical outcomes were assessed at a median postoperative follow-up of 45 months (range: 12-87 months). Overall, radiographic evidence of arthrodesis was present in 83% of patients assessed and was not significantly different between adjunct cohorts (local autograft 92%, ICBG 77%, BMP 88%, and combination of ICBG and BMP 83%; p = 0.79). This finding persisted despite adjustment for age, pathology, number of levels instrumented, and attendant procedures. Importantly, neither the presence of arthrodesis nor fusion adjunct was significantly associated with functional outcome in both univariate and adjusted regression models. Additionally, perioperative adverse events occurred in 23% of cases and did not vary significantly in incidence or severity between fusion adjunct cohorts. We present a large series of patients treated for OC instability with rigid fixation utilizing modern segmental screw-based constructs. The use of adjuvant osteoinductive agents (BMP, ICBG, or a combination) produced equivalent rates of arthrodesis, functional outcome, and adverse events compared with use of local autograft alone."," J Neurol Surg A Cent Eur Neurosurg 76(5): 361-368.","USA",2015,"Unspecified","Surgical","NDI,Nurick","Adults","PRO study","Retrospective review","USA","Adults","Unspecified","Surgical","PRO study","Retrospective review","NDI,Nurick","2015:2018"]
[361,"Stupar, M., et al. (2015). \"Structural and construct validity of the Whiplash Disability Questionnaire in adults with acute whiplash-associated disorders.\" Spine J 15(11): 2369-2377.",null,"Stupar, M., et al.","Structural and construct validity of the Whiplash Disability Questionnaire in adults with acute whiplash-associated disorders","BACKGROUND CONTEXT: Few instruments are available to measure disability associated with whiplash-associated disorders (WAD). The Whiplash Disability Questionnaire (WDQ) was developed to measure disability resulting from WAD, but its validity is unknown for acute WAD. PURPOSE: The aim was to determine the structural and construct validity of the WDQ in individuals with acute WAD. STUDY DESIGN/SETTING: This was a cohort study. PATIENT SAMPLE: Ontario adults with WAD were enrolled within 3 weeks of their motor vehicle collision. OUTCOME MEASURES: The outcome measure was the WDQ. METHODS: We included insurance claimants who were aged 18 years or older and diagnosed with acute WAD Grades I to III. All participants completed the WDQ, a 13-item questionnaire scored from 0 (no disability) to 130 (complete disability). We assessed the factor structure of the WDQ and tested its construct validity against self-perceived recovery, neck pain (Numerical Rating Scale [NRS]), neck disability (Neck Disability Index [NDI] and Neck Bournemouth Questionnaire), health-related quality of life (36-Item Short Form Health Survey [SF-36]), and depressive symptoms (Center for Epidemiologic Studies Depression Scale [CES-D]). RESULTS: The mean age of the 130 participants was 42.1 years (standard deviation [SD]=13.2), and 70% were women. Twenty-six percent had WAD I, 73.1% had WAD II, and 0.8% had WAD III. Mean time since injury was 6.5 days (SD=4.9). The mean WDQ score was 49.8 (SD=29.1). Our analysis suggested that the WDQ includes two factors: daily activities and emotional status. This factor structure remained stable in sensitivity analyses (eg, zeros imputed for missing values, and the item with the most missing values or resulting in complex loading excluded). Strong correlations were found between the total WDQ score and the NDI, the Bournemouth questionnaire, the SF-36 physical function, and the NRS (for the neck, shoulder, mid and low back pain) satisfying a priori hypotheses. We found a priori hypothesized moderate correlations between the WDQ, and the CES-D and SF-36 mental function. CONCLUSIONS: The WDQ includes two factors and has strong construct validity in individuals with acute WAD. Our results demonstrate that the WDQ is valid for use as an overall summative scale or as the daily activities and emotional subscales in clinical and research settings to determine disability status."," Spine J 15(11): 2369-2377.","Canada",2015,"Trauma,Back Pain,Neck Pain","Not Specified","NDI,Bournemouth","Adults","Tool Validation","Observational","Canada","Adults","Trauma,Back Pain,Neck Pain","Not Specified","Tool Validation","Observational","NDI,BOURNEMOUTH","2015:2018"]
[362,"Sufka, A., et al. (1998). \"Centralization of low back pain and perceived functional outcome.\" J Orthop Sports Phys Ther 27(3): 205-212.",null,"Sufka, A., et al.","Centralization of low back pain and perceived functional outcome","McKenzie's methods for evaluating and treating low back pain are used often but studied little. When using the McKenzie system, it is important to observe signs of symptom movement to a central location (centralization). This study investigated the relationships between centralization of low back pain and/or radiculopathy and the subjects' rating of functional outcome. Thirty-six subjects with low back pain volunteered to participate and were evaluated and treated by six researchers. Subjects were tested initially and again 14 days after initiation of treatment using the Oswestry Low Back Pain Disability Questionnaire and the Performance Assessment and Capacity Testing Spinal Function Sort (SFS). Symptoms were monitored for the occurrence of \"complete centralization.\" Of the 36 subjects, 25 showed complete centralization within 14 days. The SFS score changes were significantly higher for subjects who completely centralized (p = 0.015). The results supported the hypothesis that subjects who centralize will have improved functional outcome and, thus, quality of life. However, shorter time to occurrence of complete centralization does not necessarily correlate with improved outcome."," J Orthop Sports Phys Ther 27(3): 205-212.","USA",1998,"Back Pain","Not Specified","ODI,SFS","Unknown","Tool Validation","Observational","USA","Unknown","Back Pain","Not Specified","Tool Validation","Observational","ODI,SFS","1995:1999"]
[363,"Sundseth, J., et al. (2017). \"The Norwegian Cervical Arthroplasty Trial (NORCAT): 2-year clinical outcome after single-level cervical arthroplasty versus fusion-a prospective, single-blinded, randomized, controlled multicenter study.\" Eur Spine J 26(4): 1225-1235.",null,"Sundseth, J., et al.","The Norwegian Cervical Arthroplasty Trial (NORCAT): 2-year clinical outcome after single-level cervical arthroplasty versus fusion-a prospective, single-blinded, randomized, controlled multicenter study","PURPOSE: Standard surgical treatment for symptomatic cervical disc disease has been discectomy and fusion, but the use of arthroplasty, designed to preserve motion, has increased, and most studies report clinical outcome in its favor. Few of these trials, however, blinded the patients. We, therefore, conducted the Norwegian Cervical Arthroplasty Trial, and present 2-year clinical outcome after arthroplasty or fusion. METHODS: This multicenter trial included 136 patients with single-level cervical disc disease. The patients were randomized to arthroplasty or fusion, and blinded to the treatment modality. The surgical team was blinded to randomization until nerve root decompression was completed. Primary outcome was the self-rated Neck Disability Index. Secondary outcomes were the numeric rating scale for pain and quality of life questionnaires Short Form-36 and EuroQol-5Dimension-3 Level. RESULTS: There was a significant improvement in the primary and all secondary outcomes from baseline to 2-year follow-up for both arthroplasty and fusion (P < 0.001), and no observed significant between-group differences at any follow-up times. However, linear mixed model analyses, correcting for baseline values, dropouts and missing data, revealed a difference in Neck Disability Index (P = 0.049), and arm pain (P = 0.027) in favor of fusion at 2 years. The duration of surgery was longer (P < 0.001), and the frequency of reoperations higher (P = 0.029) with arthroplasty. CONCLUSION: The present study showed excellent clinical results and no significant difference between treatments at any scheduled follow-up. However, the rate of index level reoperations was higher and the duration of surgery longer with arthroplasty. TRIAL REGISTRATION: http://www.clinicaltrials.gov NCT 00735176.19."," Eur Spine J 26(4): 1225-1235.","Norway",2017,"Degenerative Disk Disease","Surgical","NDI","Unknown","PRO study","RCT","Norway","Unknown","Degenerative Disk Disease","Surgical","PRO study","RCT","NDI","2015:2018"]
[364,"Svensson, E., et al. (2009). \"The Balanced Inventory for Spinal Disorders: the validity of a disease specific questionnaire for evaluation of outcomes in patients with various spinal disorders.\" Spine (Phila Pa 1976) 34(18): 1976-1983.",null,"Svensson, E., et al.","The Balanced Inventory for Spinal Disorders: the validity of a disease specific questionnaire for evaluation of outcomes in patients with various spinal disorders","STUDY DESIGN: A prospective validation study. OBJECTIVE: To validate the Balanced Inventory for Spinal Disorders (BIS), a questionnaire concerning the extent to which pain affects perceived physical health, social life, mental health, and quality of life. The operational definitions of the items and the verbal descriptive scales were compared with corresponding items in the Short-Form 36 (SF-36), European Quality of Life Scale (EQ), and Oswestry Disability Index (ODI). SUMMARY OF BACKGROUND DATA: In validation studies, scales that intend to measure the same variable are compared. METHODS: The SF-36, EQ, ODI, and the BIS were filled in by 101 patients before surgical treatment. The comparisons were analyzed by statistical methods that take account of the nonmetric properties of ordered categorical data to obtain reliable results. The level of order-consistency between BIS and comparing items, when present, was calculated. The Spearman rank-order correlation coefficient was also calculated. RESULTS: In the paired comparisons between the BIS pain scales and the other pain scales about 80% units more pairs were ordered than disordered, and the disorder was explained by the discriminating ability of the BIS back and leg pain items. The BIS and ODI items of limitation in walking were comparable, and the assessments of social limitations on the questionnaires were consistent; the disordered pairs being explained by different coverage of activities in the items. The assessments of physical and mental health on BIS were disordered, with the responses in SF-36 in favor of the BIS type of scale categories. The few items and response categories in the EQ did not discriminate the assessments. CONCLUSION: The BIS assessments can be regarded as being a valid disease-specific questionnaire that provides interpretable information regarding the impact of back end leg pain on well-defined physical, social and mental aspects, and on the quality of life."," Spine (Phila Pa 1976) 34(18): 1976-1983.","Sweden",2009,"Spinal Deformity","Surgical","BIS,ODI","Unknown","PRO study","Prospective Observation","Sweden","Unknown","Spinal Deformity","Surgical","PRO study","Prospective Observation","BIS,ODI","2005:2009"]
[365,"Takeshita, K., et al. (2013). \"Validity, reliability and responsiveness of the Japanese version of the Neck Disability Index.\" J Orthop Sci 18(1999): 14-21.",null,"Takeshita, K., et al.","Validity, reliability and responsiveness of the Japanese version of the Neck Disability Index","BACKGROUND: The Neck Disability Index (NDI) is one of the most widely used questionnaires for neck pain. The purpose of this study was to validate the Japanese NDI. METHODS: We performed two surveys with an 8-week interval in 130 patients with neck pain, radiculopathy and myelopathy. We asked patients to answer two versions of the Japanese NDI: the original NDI, which had been completed by a forward-backward translation procedure, and the modified NDI, which has the phrase \"because of neck pain\" to the phase \"because of neck pain or numbness in the arm.\" The other parameters examined were the strength of pain and numbness, the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire, the Hospital Anxiety and Depression Scale, and Short Form 36. Attending surgeons judged the symptom severity. Patients were asked to report the patient global impression of change (PGIC) at the second survey. The internal consistency, criterion-related and discriminative validity, and reliability were evaluated. RESULTS: The original NDI and the modified NDI were 26.9 +/- 17.1 and 29.9 +/- 15.5, respectively. The Cronbach alpha values of the original NDI and the modified NDI were 0.92 and 0.89, respectively. Both versions of the NDI had good to excellent correlative coefficients with the related domains. The modified NDI had a higher validity for numbness and mental health-related QOL. The symptom severity was significantly correlated with the modified NDI. The intraclass correlation coefficients of the two surveys of the modified and original NDI were comparable. The effect sizes of the modified and the original NDI were 0.64 and 0.55, respectively. Spearman's rho between the change of the NDI and the PGIC was 0.47 in the original NDI and 0.59 in the modified NDI. CONCLUSIONS: We demonstrated the validity, reliability and responsiveness of the Japanese NDI. The modified NDI was more strongly correlated with numbness and mental health-related QOL."," J Orthop Sci 18(1999): 14-21.","Japan",2013,"Cervical Myelopathy,Neck Pain","Not Specified","JOACMEQ,NDI","Unknown","Tool Validation","Observational","Japan","Unknown","Cervical Myelopathy,Neck Pain","Not Specified","Tool Validation","Observational","JOACMEQ,NDI","2010:2014"]
[366,"Tan, H. Y., et al. (2015). \"A prospective study of percutaneous vertebroplasty for chronic painful osteoporotic vertebral compression fracture.\" Pain Res Manag 20(1999): e8-e11.",null,"Tan, H. Y., et al.","A prospective study of percutaneous vertebroplasty for chronic painful osteoporotic vertebral compression fracture","BACKGROUND: Percutaneous vertebroplasty (PVP) for patients with chronic painful osteoporotic compression fractures has not been extensively studied. OBJECTIVE: To prospectively evaluate the efficacy of PVP for patients with chronic painful osteoporotic vertebral compression fractures (VCFs). METHODS: Sixty-two consecutive patients with chronic painful osteoporotic VCFs for >/=3 months underwent PVP. All procedures were performed under local anesthesia. The outcomes were pain relief at one week, one month, three months, six months and one year, as measured by visual analogue scale, Oswestry Disability Index, Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) and Roland Morris Disability Questionnaire scores. RESULTS: The PVP procedures were technically successful and well tolerated in all patients. Sixty-two patients underwent PVP on 92 vertebrae in 73 procedures three to five days after referral, and no 30-day mortality was observed. Compared with baseline scores, improvement in visual analogue scale, Oswestry Disability Index, QUALEFFO and Roland Morris Disability Questionnaire scores was significantly greater after PVP at one week (P<0.001), one month (P<0.001), three months (P<0.001), six months (P<0.001) and one year (P<0.001), and the number of patients using drugs for pain treatment was significantly reduced. Five new fractures were reported in five of 62 patients treated with PVP during follow-up. CONCLUSION: PVP is effective in patients with chronic painful osteoporotic VCFs. Pain relief after PVP was immediate, was sustained for one year and may be an important factor for reducing persistent pain."," Pain Res Manag 20(1999): e8-e11.","Unknown",2015,"Back Pain","Surgical","RMDQ,ODI","Unknown","PRO study","Prospective Observation","Unknown","Unknown","Back Pain","Surgical","PRO study","Prospective Observation","RMDQ,ODI","2015:2018"]
[367,"Tanaka, N., et al. (2014). \"An outcome measure for patients with cervical myelopathy: the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ): an average score of healthy volunteers.\" J Orthop Sci 19(1999): 33-48.",null,"Tanaka, N., et al.","An outcome measure for patients with cervical myelopathy: the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ): an average score of healthy volunteers","BACKGROUND: An outcome measure to evaluate the neurological function of patients with cervical myelopathy was proposed by the Japanese Orthopaedic Association (JOA score) and has been widely used in Japan. However, the JOA score does not include patients' satisfaction, disability, handicaps, or general health, which can be affected by cervical myelopathy. In 2007, a new outcome measure, the Japanese Orthopaedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ), which is a self-administered questionnaire, was developed. However, the influence of age and gender on the scores has not been fully examined. The purpose of this study was to establish the standard value of the JOACMEQ by age using healthy volunteers. METHODS: This study was conducted in 23 university hospitals and their affiliated hospitals from September to December 2011. The questionnaire included 24 questions for evaluation of physical function of the cervical spine and spinal cord. A total of 1,629 healthy volunteers were recruited for the study. The ages ranged from 20 to 89 years old. RESULTS: The volunteers comprised 798 men and 831 women. In the elderly healthy volunteers, the JOACMEQ scores decreased with age. In general, the scores for cervical spine function and upper/lower extremity function were retained up to the 60s, then decreased in the 70s and 80s. The scores for quality of life were retained up to the 70s; however, the score for bladder function was retained up to the 40s, then declined with age from the 50s to 80s. CONCLUSION: The standard values of the JOACMEQ by age were established. Differences in the scores were found among different generations. Patients with cervical myelopathy should be evaluated with this new self-administered questionnaire taking into account the standard values according to different ages."," J Orthop Sci 19(1999): 33-48.","Japan",2014,"Cervical Myelopathy","Not Specified","JOACMEQ","Elderly","PRO study","Observational","Japan","Elderly","Cervical Myelopathy","Not Specified","PRO study","Observational","JOACMEQ","2010:2014"]
[368,"Tavafian, S. S., et al. (2011). \"Treatment of chronic low back pain: a randomized clinical trial comparing multidisciplinary group-based rehabilitation program and oral drug treatment with oral drug treatment alone.\" Clin J Pain 27(9): 811-818.",null,"Tavafian, S. S., et al.","Treatment of chronic low back pain: a randomized clinical trial comparing multidisciplinary group-based rehabilitation program and oral drug treatment with oral drug treatment alone","OBJECTIVE: This randomized clinical trial examined the efficacies of a group-based multidisciplinary rehabilitation program and oral drug treatment versus oral drug treatment alone in Iran. METHODS: A total of 197 patients with chronic low back pain were randomized to either intervention group (n=97) receiving a group-based, 5-session multidisciplinary rehabilitation program plus oral medication or to control group (n=100) receiving just oral medication. At baseline and at 3 and 6-month follow-ups, patients filled out questionnaires on health-related quality of life (36-item Short-form General Health Survey) and disability Questionnaires (Quebec Disability Scale and Ronald-Morris Disability). Repeated measure analysis of variance was used to compare 2 groups during time. RESULTS: The 2 groups were comparable regarding all baseline characteristics (P>0.05). There were significant differences within each group by time in terms of all subscales of 36-item Short-form (P<0.01) except for mental health (P=0.7). Furthermore, there were significant differences between groups in terms of all domains of SF-36 scale except for general health (P=0.06), social function (P=0.08) and role emotional (P=0.7). Furthermore, according to the scores of Ronald-Morris Disability Questionnaire and Quebec Disability Scale, the disability of patients in the intervention group was improved over time significantly (P=0.01 and P<0.0001, respectively). DISCUSSION: The findings revealed that the group-based multidisciplinary program could improve most domains of quality of life in chronic low back pain patients in the 6-month period. However, there were no significant differences between two groups in sub scales such as general health, social function and role emotional."," Clin J Pain 27(9): 811-818.","Iran",2011,"Back Pain","Rehabilitation","RMDQ,QBPD","Unknown","PRO study","RCT","Iran","Unknown","Back Pain","Rehabilitation","PRO study","RCT","RMDQ,QBPD","2010:2014"]
[369,"Tavafian, S. S., et al. (2014). \"Treatment of low back pain: randomized clinical trial comparing a multidisciplinary group-based rehabilitation program with oral drug treatment up to 12 months.\" Int J Rheum Dis 17(2): 159-164.",null,"Tavafian, S. S., et al.","Treatment of low back pain: randomized clinical trial comparing a multidisciplinary group-based rehabilitation program with oral drug treatment up to 12 months","BACKGROUND: This study aimed to examine the effects of a multidisciplinary treatment program on health-related quality of life of Iranian patients living with chronic low back, at 12 months follow-up. METHODS: This study is an extended follow-up of an original randomized, controlled trial with registration number NCT00600197. In the present study 87 patients in an intervention group and 91 patients in a control group were assessed at 12 months follow-up. The intervention was a group-based multidisciplinary rehabilitation program which continued by monthly motivational consultation by telephone from 6 to 12 months after intervention. Data from three standard measures, Short Form 36 (SF-36), QDS and RDQ were collected at 3, 6 and 12 months follow-up and analyzed through repeated measures analysis of variance. RESULTS: Despite the similarity between the two groups who completed the 6 month follow-up in terms of all baseline variables, there were significant differences between the two groups in all domains of the SF-36 scale, as well as QDS and RDQ scales (P < 0.05). Also, there were differences within each group over time in the SF-36 domains and disability measurements (P < 0.05). The physical function mean score differed significantly when the interaction between groups and time points was examined (P = 0.02). CONCLUSION: This study indicates that the multidisciplinary program could improve the domains of health related quality of life and disability in chronic low back pain patients up to 12 months."," Int J Rheum Dis 17(2): 159-164.","Iran",2014,"Back Pain","Rehabilitation","QBPD,RMDQ","Unknown","PRO study","RCT","Iran","Unknown","Back Pain","Rehabilitation","PRO study","RCT","QBPD,RMDQ","2010:2014"]
[370,"Terran, J., et al. (2013). \"The SRS-Schwab adult spinal deformity classification: assessment and clinical correlations based on a prospective operative and nonoperative cohort.\" Neurosurgery 73(4): 559-568.",null,"Terran, J., et al.","The SRS-Schwab adult spinal deformity classification: assessment and clinical correlations based on a prospective operative and nonoperative cohort","BACKGROUND: The SRS-Schwab classification of adult spinal deformity (ASD) is a validated system that provides a common language for the complex pathology of ASD. Classification reliability has been reported; however, correlation with treatment has not been assessed. OBJECTIVE: To assess the clinical relevance of the SRS-Schwab classification based on correlations with health-related quality of life (HRQOL) measures and the decision to pursue operative vs nonoperative treatment. METHODS: Prospective analysis of consecutive ASD patients (18 years of age and older) collected through a multicenter group. The SRS-Schwab classification includes a curve type descriptor and 3 sagittal spinopelvic modifiers (sagittal vertical axis, pelvic tilt, pelvic incidence/lumbar lordosis mismatch). Differences in demographics, HRQOL (Oswestry Disability Index, SRS-22, Short Form-36), and classification between operative and nonoperative patients were evaluated. RESULTS: A total of 527 patients (mean age, 52.9 years; range, 18.4-85.1 years) met inclusion criteria. Significant differences in HRQOL were identified based on SRS-Schwab curve type, with thoracolumbar and primary sagittal deformities associated with greater disability and poorer health status than thoracic or double curve deformities. Operative patients had significantly poorer grades for each of the sagittal spinopelvic modifiers, and progressively higher grades were associated with significantly poorer HRQOL (P < .05). Patients with worse sagittal spinopelvic modifier grades were significantly more likely to require major osteotomies, iliac fixation, and decompression (P </= .009). CONCLUSION: The SRS-Schwab classification provides a validated language to describe and categorize ASD. This study demonstrates that the SRS-Schwab classification reflects severity of disease state based on multiple measures of HRQOL and significantly correlates with the important decision of whether to pursue operative or nonoperative treatment."," Neurosurgery 73(4): 559-568.","USA",2013,"Spinal Deformity","Surgical","SRS-HRQOL","Adults","PRO study","Prospective Observation","USA","Adults","Spinal Deformity","Surgical","PRO study","Prospective Observation","SRS-HRQOL","2010:2014"]
[371,"Terrell, J. E., et al. (1997). \"Head and neck cancer-specific quality of life: instrument validation.\" Arch Otolaryngol Head Neck Surg 123(10): 1125-1132.",null,"Terrell, J. E., et al.","Head and neck cancer-specific quality of life: instrument validation","BACKGROUND: The disfigurement and dysfunction associated with head and neck cancer affect emotional well-being and some of the most basic functions of life. Most cancer-specific quality-of-life assessments give a single composite score for head and neck cancer-related quality of life. OBJECTIVE: To develop and evaluate an improved multidimensional instrument to assess head and neck cancer-related functional status and well-being. METHODS: The item selection process included literature review, interviews with health care workers, and patient surveys. A survey with 37 disease-specific questions and the SF-12 survey were administered to 253 patients in 3 large medical centers. Factor analysis was performed to identify disease-specific domains. Domain scores were calculated as the standardized score of the component items. These domains were assessed for construct validity based on clinical hypotheses and test-retest reliability. RESULTS: Four relevant domains were identified: Eating (6 items), Communication (4 items), Pain (4 items), and Emotion (6 items). Each had an internal consistency (Cronbach alpha value) of greater than 0.80. Construct validity was demonstrated by moderate correlations with the SF-12 Physical and Mental component scores (r=0.43-0.60). Test-retest reliability for each domain demonstrated strong reliability between the 2 time points. Correlations were strong for each individual question, ranging from 0.53 to 0.93. Construct validity testing demonstrated that the direction of differences for each domain were as hypothesized. CONCLUSION: The Head and Neck Quality of Life questionnaire is a promising multidimensional tool with which to assess head and neck cancer-specific quality of life."," Arch Otolaryngol Head Neck Surg 123(10): 1125-1132.","USA",1997,"Cancer","Not Specified","HNQOL","Unknown","Tool Validation","Observational","USA","Unknown","Cancer","Not Specified","Tool Validation","Observational","HNQOL","1995:1999"]
[372,"Terrell, J. E., et al. (1998). \"Long-term quality of life after treatment of laryngeal cancer. The Veterans Affairs Laryngeal Cancer Study Group.\" Arch Otolaryngol Head Neck Surg 124(9): 964-971.",null,"Terrell, J. E., et al.","Long-term quality of life after treatment of laryngeal cancer. The Veterans Affairs Laryngeal Cancer Study Group","OBJECTIVE: To assess long-term quality of life in surviving patients with advanced laryngeal cancer. DESIGN: A follow-up long-term quality-of-life survey of patients randomized to the Veterans Affairs Laryngeal Cancer Study No. 268 on induction chemotherapy and radiation (CT + RT) vs surgery and RT. SETTING AND PATIENTS: Forty-six (71%) of the 65 surviving patients with prior stage III or IV laryngeal cancer who could be contacted completed the survey: 25 from the surgery and RT group and 21 from the CT + RT group. Baseline demographic and clinical characteristics among survey respondents were similar, except that those in the CT + RT group were significantly older (mean, 61.2 years) than those in the surgery and RT group (mean, 55.7 years; P<.05). INTERVENTIONS AND MAIN OUTCOME MEASURES: Patients completed the University of Michigan Head and Neck Quality of Life (HNQOL) instrument, the Medical Outcomes Studies Short-Form 36 (SF-36) general health survey, the Beck Depression Inventory as well as smoking and alcohol consumption surveys. RESULTS: Patients randomized to the CT + RT group had significantly better (P<.05) quality-of-life scores on the SF-36 mental health domain (76.0) than the surgery and RT group (63.0), and also had better HNQOL pain scores (81.3 vs 64.3). Compared with patients who underwent laryngectomy, patients with intact larynges (CT + RT with larynx) had significantly less bodily pain (88.5 vs 56.5), better scores on the SF-36 mental health (79.8 vs 64.7), and better HNQOL emotion (89.7 vs 79.4) scores. More patients in the surgery and RT group (28%) were depressed than in the CT + RT group (15%). CONCLUSION: Better quality-of-life scores in the CT + RT groups appear to be related to more freedom from pain, better emotional well-being, and lower levels of depression than to preservation of speech function."," Arch Otolaryngol Head Neck Surg 124(9): 964-971.","USA",1998,"Cancer","Surgical","HNQOL","Adults","PRO study","Observational","USA","Adults","Cancer","Surgical","PRO study","Observational","HNQOL","1995:1999"]
[373,"Terrell, J. E., et al. (1999). \"Health impact of head and neck cancer.\" Otolaryngol Head Neck Surg 120(6): 852-859.",null,"Terrell, J. E., et al.","Health impact of head and neck cancer","A multidimensional Head and Neck Quality of Life (HNQOL) instrument and a general health status measure were administered to 397 patients with head and neck cancer. Scores for the 4 domains of the HNQOL (communication, eating, pain, and emotional well-being) were calculated. Patient demographics, comorbidities, clinical characteristics, treatment data, disability status, and a global \"overall bother\" score were assessed. When compared with the US population aged 55 to 64 years, the group had significantly worse scores in the 8 health domains of the SF-36. Patients' overall bother scores from the head and neck cancer treatment correlated best with the HNQOL emotion domain (r = 0.71) and the HNQOL pain domain (r = 0.63), and least with the patients' perception of their response to treatment (r = 0.39). Pain, eating, emotion, physical component summary score, age, and an interaction term between eating and emotion were significant predictors for overall bother. Of the 217 patients who were working before the diagnosis of cancer, 74 (34. 1%) reported that they had become disabled. Patients who had more than 1 type of treatment were 5.9 times more likely to report themselves as disabled (odds ratio [OR] = 5.94, P < 0.01), even after adjusting for age, emotion score, and physical component summary score, which were other factors that predicted disability."," Otolaryngol Head Neck Surg 120(6): 852-859.","USA",1999,"Cancer","Not Specified","HNQOL","Adults","PRO study","Retrospective review","USA","Adults","Cancer","Not Specified","PRO study","Retrospective review","HNQOL","1995:1999"]
[374,"Terrell, J. E., et al. (2000). \"Pain, quality of life, and spinal accessory nerve status after neck dissection.\" Laryngoscope 110(4): 620-626.",null,"Terrell, J. E., et al.","Pain, quality of life, and spinal accessory nerve status after neck dissection","OBJECTIVE: To assess quality of life (QOL) in patients with head and neck cancer who underwent neck dissection and to compare QOL scores for patients in whom the spinal accessory nerve (CN XI) was resected or preserved. SETTING AND DESIGN AND OUTCOMES MEASURES: Three hundred ninety-seven patients who had undergone treatment for head and neck cancer completed the University of Michigan Head and Neck Quality of Life (HNQOL) instrument, the Medical Outcomes Study SF-12 General Health Survey, and questions on \"pain despite pain medications\" and headaches. RESULTS: Of the 397 patients, 222 had no neck dissection, 46 had neck dissections resecting CN XI, and 129 had dissection sparing CN XI. Of the latter group, 68 patients had dissections sparing level V and 61 dissections included level V. Age, sex, primary site distribution, and T stage were not different between the groups. Patients who had neck dissections sparing CN XI had better scores on the HNQOL pain domain (P = .002), had less shoulder or neck pain (P = .003), and took pain medications less frequently (P = .0004) compared with patients who had neck dissections sacrificing CN XI. When CN XI was preserved, patients who had no level V dissection had better pain domain scores (P = .03) and eating domain scores (P = .007) on the HNQOL, had less shoulder or neck pain (P = .006), and had less physical problems (P = .03) than patients who had level V dissected. On multivariate analysis, pain-related QOL scores after neck dissection were significantly better (P < .01) if patients had dissections with preservation of CN XI and if level V was not dissected. CONCLUSION: Neck dissections sparing CN XI are associated with better pain scores on the HNQOL, less shoulder and neck pain, and less need for medications. When CN XI is spared, not dissecting level V of the neck is associated with better HNQOL pain scores, less shoulder or neck pain, and fewer physical problems."," Laryngoscope 110(4): 620-626.","USA",2000,"Neck Pain,Cancer","Surgical","HNQOL","Unknown","PRO study","Retrospective review","USA","Unknown","Neck Pain,Cancer","Surgical","PRO study","Retrospective review","HNQOL","2000:2004"]
[375,"Terrell, J. E., et al. (2004). \"Clinical predictors of quality of life in patients with head and neck cancer.\" Arch Otolaryngol Head Neck Surg 130(4): 401-408.",null,"Terrell, J. E., et al.","Clinical predictors of quality of life in patients with head and neck cancer","OBJECTIVE: To identify clinical predictors of quality of life (QoL) in a head and neck cancer patient population. DESIGN, PATIENTS, AND SETTING: A convenience sample of 570 patients with upper aerodigestive tract cancers were surveyed at a tertiary care oncology clinic and Veterans Affairs otolaryngology clinic. INTERVENTIONS: A self-administered health survey was constructed to collect demographic, health, smoking, alcohol, depression symptom, and QoL information. Tumor site and tumor stage, clinical, and treatment data were abstracted from the patient medical records. MAIN OUTCOME MEASURES: Quality of life was assessed using the Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36) and the Head and Neck QoL (HNQoL) instrument. RESULTS: Of the 570 eligible respondents, the presence of a feeding tube had the most negative impact on QoL, with significant decrements in 6 of the 8 SF-36 scales and all 4 HNQoL scales (P<.01). In descending order of severity, medical comorbid conditions, presence of a tracheotomy tube, chemotherapy, and neck dissection were also associated with significant (P<.05) decrements in QoL domains. Patients who took the survey more than 1 year after diagnosis had improved QoL in 7 of 12 domains. Hospital site, age, education level, sex, race, and marital status were also significant predictors of QoL. CONCLUSION: There are at least 13 demographic and clinical characteristics that are significant predictors of QoL in patients with head and neck cancer, which should be considered when treating patients and conducting QoL studies in the future."," Arch Otolaryngol Head Neck Surg 130(4): 401-408.","USA",2004,"Cancer","Not Specified","HNQOL","Unknown","PRO study","Observational","USA","Unknown","Cancer","Not Specified","PRO study","Observational","HNQOL","2000:2004"]
[376,"Theologis, A. A., et al. (2016). \"Impact of preoperative depression on 2-year clinical outcomes following adult spinal deformity surgery: the importance of risk stratification based on type of psychological distress.\" J Neurosurg Spine 25(4): 477-485.",null,"Theologis, A. A., et al.","Impact of preoperative depression on 2-year clinical outcomes following adult spinal deformity surgery: the importance of risk stratification based on type of psychological distress","OBJECTIVE The objective of this study was to isolate whether the effect of a baseline clinical history of depression on outcome is independent of associated physical disability and to evaluate which mental health screening tool has the most utility in determining 2-year clinical outcomes after adult spinal deformity (ASD) surgery. METHODS Consecutively enrolled patients with ASD in a prospective, multicenter ASD database who underwent surgical intervention with a minimum 2-year follow-up were retrospectively reviewed. A subset of patients who completed the Distress and Risk Assessment Method (DRAM) was also analyzed. The effects of categorical baseline depression and DRAM classification on the Oswestry Disability Index (ODI), SF-36, and Scoliosis Research Society questionnaire (SRS-22r) were assessed using univariate and multivariate linear regression analyses. The probability of achieving >/= 1 minimal clinically important difference (MCID) on the ODI based on the DRAM's Modified Somatic Perceptions Questionnaire (MSPQ) score was estimated. RESULTS Of 267 patients, 66 (24.7%) had self-reported preoperative depression. Patients with baseline depression had significantly more preoperative back pain, greater BMI and Charlson Comorbidity Indices, higher ODIs, and lower SRS-22r and SF-36 Physical/Mental Component Summary (PCS/MCS) scores compared with those without self-reported baseline depression. They also had more severe regional and global sagittal malalignment. After adjusting for these differences, preoperative depression did not impact 2-year ODI, PCS/MCS, or SRS-22r totals (p > 0.05). Compared with those in the \"normal\" DRAM category, \"distressed somatics\" (n = 11) had higher ODI (+23.5 points), lower PCS (-10.9), SRS-22r activity (-0.9), and SRS-22r total (-0.8) scores (p </= 0.01), while \"distressed depressives\" (n = 25) had lower PCS (-8.4) and SRS-22r total (-0.5) scores (p < 0.05). After adjusting for important covariates, each additional point on the baseline MSPQ was associated with a 0.8-point increase in 2-year ODI (p = 0.03). The probability of improving by at least 1 MCID in 2-year ODI ranged from 77% to 21% for MSPQ scores 0-20, respectively. CONCLUSIONS A baseline clinical history of depression does not correlate with worse 2-year outcomes after ASD surgery after adjusting for baseline differences in comorbidities, health-related quality of life, and spinal deformity severity. Conversely, DRAM improved risk stratification of patient subgroups predisposed to achieving suboptimal surgical outcomes. The DRAM's MSPQ was more predictive than MCS and SRS mental domain for 2-year outcomes and may be a valuable tool for surgical screening."," J Neurosurg Spine 25(4): 477-485.","USA",2016,"Spinal Deformity","Surgical","SRS-HRQOL","Unknown","PRO study","Prospective Observation","USA","Unknown","Spinal Deformity","Surgical","PRO study","Prospective Observation","SRS-HRQOL","2015:2018"]
[377,"Thomas, K. C., et al. (2007). \"Outcome evaluation of surgical and nonsurgical management of lumbar disc protrusion causing radiculopathy.\" Spine (Phila Pa 1976) 32(13): 1414-1422.",null,"Thomas, K. C., et al.","Outcome evaluation of surgical and nonsurgical management of lumbar disc protrusion causing radiculopathy","STUDY DESIGN: Prospective cohort study. OBJECTIVE: To assess health-related quality of life (HRQOL) following either lumbar discectomy or nonoperative care for lumbar disc protrusion causing radiculopathy (LDPR). SUMMARY OF BACKGROUND DATA: Although LDPR is a prevalent disorder, little progress has been made in defining the optimal treatment strategy. METHODS: A total of 497 patients (333 in the lumbar discectomy group and 164 in the nonoperative group) were analyzed. Patients completed baseline as well as 6- and 12-month generic (SF-36) and disease-specific (NASS Lumbar Spine Instrument) HRQOL measures. Demographic comparisons between groups, using standard descriptive statistics, were made. Multivariate analysis was used to obtain a regression coefficient for the primary outcome: the neurogenic symptoms score (NSS) from the NASS instrument. Outcome measures were compared between groups and to published normative data. RESULTS: The mean baseline score was lower in the surgical group (30.9 nonoperative, 25.3 surgical), indicative of greater baseline disability. The scores at follow-up were approximately equivalent (44.6 nonoperative, 43.8 surgical). However, neither group returned to an age-matched normative NSS (51.6) within the timeframe of the study. Using regression analysis, the outcome \"change in NSS\" was not associated with variable \"treatment group.\" CONCLUSIONS: HRQOL after LDPR, as measured in this study by NASS NSS, demonstrated similar improvement in both groups and was not meaningfully associated with the treatment received, within the timeframe of this study. At follow-up, all outcome measures remained lower than population normative scores, suggesting that, irrespective of treatment, an element of disability remained."," Spine (Phila Pa 1976) 32(13): 1414-1422.","Canada",2007,"Radiculopathy","Surgical","NASS-L","Unknown","PRO study","Prospective Observation","Canada","Unknown","Radiculopathy","Surgical","PRO study","Prospective Observation","NASS-L","2005:2009"]
[378,"Tome-Bermejo, F., et al. (2011). \"Identifying patients with chronic low back pain likely to benefit from lumbar facet radiofrequency denervation: a prospective study.\" J Spinal Disord Tech 24(2): 69-75.",null,"Tome-Bermejo, F., et al.","Identifying patients with chronic low back pain likely to benefit from lumbar facet radiofrequency denervation: a prospective study","STUDY DESIGN: Case series. Prospective study. OBJECTIVE: This is a prospective study of a group of patients with chronic low back facet joint pain, meticulously selected using a combination of clinical history, examination, imaging tests, and lumbar facet joint block with a local anesthetic, aimed at assessing the efficacy of treatment with percutaneous rhizolysis in reducing pain and improving related disability. SUMMARY OF BACKGROUND DATA: Percutaneous radiofrequency facet joint denervation (rhizolysis) provides significant alleviation of pain and functional disability in patients with chronic low back pain of facet joint origin. However, accurate patient selection represents a clinical challenge. Patient selection based only on the result of diagnostic blocks may lead to disappointing results as the false-positive rate of the anesthetic diagnostic blocks is reported to be more than 30%. METHODS: A total of 86 patients (mean age, 49.87; mean duration of pain, 7.12 y) finally selected for treatment with rhizolysis were those who presented with chronic lumbar pain and a clinical history and examination with characteristics specific to facet joint pain; whose imaging tests ruled out a possible origin of pain other than the facet joints; and who finally responded favorably to facet joint block with a local lumbar anesthetic. All patients were clinically evaluated according to the indications of the Spanish Society for the Study of Diseases of the Spine (GEER). A follow-up of a minimum of 1 year was conducted. RESULTS: After rhizolysis, lumbar pain, measured by the visual analog scale and the Oswestry Low Back Pain Disability Questionnaire, improved significantly (P<0.05), with the reduction in disability due to lumbar pain being reflected in a notable improvement in the patients' quality of life. A total of 89% of patients experienced significant relief from pain after rhizolysis, with this relief lasting 6 months or more in 66%, and a minimum of 1 year in 50% of cases. At 1 year, 75.67% of patients stated that they would willingly undergo the same treatment again. CONCLUSIONS: Rhizolysis is a valuable tool for the symptomatic treatment of chronic lumbar facet joint pain. A meticulous selection of patients using a combination of clinical history, examination, imaging tests, and lumbar facet joint block with a local anesthetic, achieves long-lasting results by helping reduce the impact on these patients' daily activities."," J Spinal Disord Tech 24(2): 69-75.","Spain",2011,"Back Pain","Not Specified","ODI","Unknown","PRO study","Prospective Observation","Spain","Unknown","Back Pain","Not Specified","PRO study","Prospective Observation","ODI","2010:2014"]
[379,"Tomkins-Lane, C. C., et al. (2012). \"Changes in objectively measured physical activity (performance) after epidural steroid injection for lumbar spinal stenosis.\" Arch Phys Med Rehabil 93(11): 2008-2014.",null,"Tomkins-Lane, C. C., et al.","Changes in objectively measured physical activity (performance) after epidural steroid injection for lumbar spinal stenosis","OBJECTIVE: To examine changes in objectively measured physical activity (performance) at 1 week following epidural steroid injection for lumbar spinal stenosis. DESIGN: Prospective cohort. SETTING: University spine program. PARTICIPANTS: Individuals (N=17) who were undergoing fluoroscopically guided epidural steroid injection for symptomatic lumbar spinal stenosis (mean age +/- SD, 70.1+/-6.7; 47% women). INTERVENTION: Fluoroscopically guided epidural injection. MAIN OUTCOME MEASURE(S): The 2 primary outcomes, measured with accelerometers, were total activity (performance) measured over 7 days and maximum continuous activity (capacity). Walking capacity was also assessed with the Self-Paced Walking Test, and subjects completed the Oswestry Disability Index, Swiss Spinal Stenosis Questionnaire, Medical Outcomes Study 36-Item Short-Form Health Survey, visual analog pain scales, and body diagrams. RESULTS: At 1 week postinjection, 58.8% of the subjects demonstrated increased total activity and 53% had increased maximum continuous activity, although neither change was statistically significant. Significant improvements were observed in a number of the self-report instruments, including the Physical Function Scale of the Swiss Spinal Stenosis Questionnaire, general health (Medical Outcomes Study 36-Item Short-Form Health Survey), role-limitation emotional (Medical Outcomes Study 36-Item Short-Form Health Survey), leg pain intensity (visual analog pain scales), and presence of leg weakness. CONCLUSIONS: While patients perceived improvements in pain and function following injection, these improvements were not reflected in significant changes in performance or capacity. Future studies will continue to find value in subjective measures of pain and quality of life. However, with modern technology, performance is no longer a subjective variable. Use of activity monitors to objectively measure performance can result in more rigorous validation of treatment effects, while simultaneously highlighting the potential need for additional postinjection rehabilitation aimed at improving performance."," Arch Phys Med Rehabil 93(11): 2008-2014.","Canada",2012,"Spinal Deformity","Rehabilitation","SSSQ,ODI","Unknown","PRO study","Prospective Observation","Canada","Unknown","Spinal Deformity","Rehabilitation","PRO study","Prospective Observation","SSSQ,ODI","2010:2014"]
[380,"Tonga, E., et al. (2015). \"Cross-cultural adaptation, reliability and validity of the Turkish version of the spine functional index.\" Health Qual Life Outcomes 13: 30.",null,"Tonga, E., et al.","Cross-cultural adaptation, reliability and validity of the Turkish version of the spine functional index","BACKGROUND: The Spine Functional Index (SFI) is a patient reported outcome measure with sound clinimetric properties and clinical viability for the determination of whole-spine impairment. To date, no validated Turkish version is available. The purpose of this study is to cross-culturally adapted the SFI for Turkish-speaking patients (SFI-Tk) and determine the psychometric properties of reliability, validity and factor structure in a Turkish population with spine musculoskeletal disorders. METHODS: The SFI English version was culturally adapted and translated into Turkish using a double forward and backward method according to established guidelines. Patients (n = 285, cervical = l29, lumbar = 151, cervical and lumbar region = 5, 73% female, age 45 +/- 1) with spine musculoskeletal disorders completed the SFI-Tk at baseline and after a seven day period for test-retest reliability. For criterion validity the Turkish version of the Functional Rating Index (FRI) was used plus the Neck Disability Index (NDI) for cervical patients and the Oswestry Disability Index (ODI) for back patients. Additional psychometric properties were determined for internal consistency (Chronbach's alpha), criterion validity and factor structure. RESULTS: There was a high degree of internal consistency (alpha = 0.85, item range 0.80-0.88) and test-retest reliability (r = 0.93, item range = 0.75-0.95). The factor analysis demonstrated a one-factor solution explaining 24.2% of total variance. Criterion validity with the ODI was high (r = 0.71, p < 0.001) while the FRI and NDI were fair (r = 0.52 and r = 0.58, respectively). The SFI-Tk showed no missing responses with the 'half-mark' option used in 11.75% of total responses by 77.9% of participants. Measurement error from SEM and MDC90 were respectively 2.96% and 7.12%. CONCLUSIONS: The SFI-Tk demonstrated a one-factor solution and is a reliable and valid instrument. The SFI-Tk consists of simple and easily understood wording and may be used to assess spine region musculoskeletal disorders in Turkish speaking patients."," Health Qual Life Outcomes 13: 30.","Turkey,Australia,Spain",2015,"Spinal Deformity","Not Specified","NDI,ODI,SFI","Unknown","Tool Validation","Observational","Turkey,Australia,Spain","Unknown","Spinal Deformity","Not Specified","Tool Validation","Observational","NDI,ODI,SFI","2015:2018"]
[381,"Torenbeek, M., et al. (2001). \"Current use of outcome measures for stroke and low back pain rehabilitation in five European countries: first results of the ACROSS project.\" Int J Rehabil Res 24(2): 95-101.",null,"Torenbeek, M., et al.","Current use of outcome measures for stroke and low back pain rehabilitation in five European countries: first results of the ACROSS project","Objectives were to obtain a view on the current use of outcome measures for stroke and low back pain rehabilitation in five European countries. A postal questionnaire, comparable for different cultural situations, was distributed in August 1998 to 581 rehabilitation facilities in Ireland, Germany, Italy, Austria and the Netherlands. Of these, 102 settings responded. In stroke rehabilitation the Barthel Index is the dominant outcome measure, followed by the Functional Independence Measure and the Frenchay Activities Index. Besides the Visual Analogue Scale, the most used outcome measures in low back pain rehabilitation were the Oswestry Pain Disability Questionnaire and the Roland Disability Questionnaire. Outcome measures are more frequently used in stroke than in low back pain rehabilitation. The purpose of use is mainly for the measurement of effectiveness, while a relation with quality management is seldom made. There appears to be little agreement on which outcome measures to use. Little attention was found to have been given to the assessment of handicap, quality of life and patient satisfaction."," Int J Rehabil Res 24(2): 95-101.","Netherlands",2001,"Back Pain,Stroke","Rehabilitation","ODI,RMDQ","Unknown","PRO study","Observational","Netherlands","Unknown","Back Pain,Stroke","Rehabilitation","PRO study","Observational","ODI,RMDQ","2000:2004"]
[382,"Tschiesner, U., et al. (2008). \"Content comparison of quality of life questionnaires used in head and neck cancer based on the international classification of functioning, disability and health: a systematic review.\" Eur Arch Otorhinolaryngol 265(6): 627-637.",null,"Tschiesner, U., et al.","Content comparison of quality of life questionnaires used in head and neck cancer based on the international classification of functioning, disability and health: a systematic review","The objective of this study is to provide a content comparison of frequently used questionnaires that assess health-related quality of life (hrQOL) in head and neck cancer (HNC) survivors. This systematic content comparison describes which specific areas of hr-QOL research are covered by each questionnaire. Thereby, it shall assist the clinician in the decision process of instrument selection depending on the content of the study question. As a reference, we chose the international classification of functioning, disability and health (ICF), which was adopted by the WHO in 2001. A systematic literature review identified current hrQOL questionnaires relevant for HNC. The concepts of functioning contained in each questionnaire were translated (linked\") to the ICF according to standardized guidelines. Nine questionnaires were selected for further analyses: EORTC-QLQ (C30 + HN35), FACT (G + HN), UW_QOL, QOL-RTI, HN-QOL, PSS-HN, VHI, LORQ, XQ. Within the selected questionnaires, there are 474 concepts, matching 74 second-level ICF categories. The results are presented in tables, showing for each of the validated questionnaires, which of these 74 categories of functioning are addressed. In terms of diversification of content among the questionnaires, there are just eight categories that are used rather frequently and apply to at least five (out of nine) of the questionnaires: e110 Products for personal consumption (i.e., food, drugs), b510 ingestion function, b152 emotional function, b280 sensation of pain, b310 voice, d550 eating, b130 energy and drive function and d850 employment. This ICF-based content comparison provides detailed information on the content that is covered in each questionnaire and thereby assists questionnaire selection. The results question the assumption that HNC-specific questionnaires generally cover the same content. Depending on the study question, the population to be studied and the intervention, there is no unique ideal questionnaire. Compared with other types of qualitative review, the most important advantage of content comparison based on the ICF is the use of an external and independent reference."," Eur Arch Otorhinolaryngol 265(6): 627-637.","Germany",2008,"Cancer","Not Specified","ICF","Unknown","Tool Validation","Systematic review","Germany","Unknown","Cancer","Not Specified","Tool Validation","Systematic review","ICF","2005:2009"]
[383,"Tschiesner, U., et al. (2009). \"Assessment of functioning in patients with head and neck cancer according to the International Classification of Functioning, Disability, and Health (ICF): a multicenter study.\" Laryngoscope 119(5): 915-923.",null,"Tschiesner, U., et al.","Assessment of functioning in patients with head and neck cancer according to the International Classification of Functioning, Disability, and Health (ICF): a multicenter study","OBJECTIVES: To assess the level of functioning in patients with head and neck cancer (HNC) using the the International Classification of Functioning, Disability, and Health (ICF). METHODS: Multicenter study at nine different study centers in four European countries. Data collection included structured interviews according to the extended ICF checklist with 145 HNC patients and completion of the European Organization for Research and Treatment of Cancer-Quality of Life Questionnaires (EORTC-QLQ). The generic ICF checklist was extended by additional HNC-specific categories identified in six HNC-specific questionnaires: EORTC, University of Washington Quality of Life (UW-QOL), Functional Assessment of Cancer Therapy scale (FACT), Performance Status Scale for Head and Neck cancer patients (PSS-HN), Head and Neck Quality of Life instrument (HN-QOL), and Voice Handicap Index (VHI). The ICF qualifier system was applied on a scale from 0 (not impaired) to 4 (completely impaired), as well as \"ns, na\" (not specified, not applicable) and \"c\" (impaired due to comorbidity). ICF categories impaired due to HNC (1-4) in > or = 10% of patients were reported. RESULTS: One hundred fifteen (80%) of 144 categories of the extended ICF checklist were identified to be at least mildly impaired or restricted in > or = 10% of patients. The four areas that were relevant to most of the patients were \"immediate family\" (91%), \"friends\" (86%), \"health services and policies\" (85%) and \"health professionals\" (85%), all belonging to the ICF component of environmental factors. The most often identified categories were \"ingestion\" (75%) for body functions and \"speaking\" (76%) for activities and participation. The summary score of all answers correlated well with the overall level of health and quality of life as assessed in the EORTC questionnaires (0.59, 0.61, respectively). CONCLUSIONS: The ICF identifies problems in functioning in patients with HNC comprehensively. The results emphasize the importance of contextual environmental factors. In particular, environmental factors referring to interpersonal support should be more strongly included in rehabilitation plans for HNC."," Laryngoscope 119(5): 915-923.","Germany",2009,"Cancer","Not Specified","ICF","Unknown","PRO study","Clinical trial","Germany","Unknown","Cancer","Not Specified","PRO study","Clinical trial","ICF","2005:2009"]
[384,"Tunwattanapong, P., et al. (2016). \"The effectiveness of a neck and shoulder stretching exercise program among office workers with neck pain: a randomized controlled trial.\" Clin Rehabil 30(1999): 64-72.",null,"Tunwattanapong, P., et al.","The effectiveness of a neck and shoulder stretching exercise program among office workers with neck pain: a randomized controlled trial","OBJECTIVE: To determine the effectiveness of neck and shoulder stretching exercises for relief neck pain among office workers. DESIGN: Randomized controlled trial. SETTING: An outpatient setting. PARTICIPANTS: A total of 96 subjects with moderate-to-severe neck pain (visual analogue score 5/10) for 3 months. INTERVENTIONS: All participants received an informative brochure indicating the proper position and ergonomics to be applied during daily work. The treatment group received the additional instruction to perform neck and around shoulder stretching exercises two times/day, five days/week during four weeks. MAIN OUTCOMES: Pain, neck functions, and quality of life were evaluated at baseline and week 4 using pain visual analogue scale, Northwick Park Neck Pain Questionnaire, and Short Form-36, respectively. RESULTS: Both groups had comparable baseline data. All outcomes were improved significantly from baseline. When compared between groups, the magnitude of improvement was significantly greater in the treatment group than in the control group (-1.4; 95% CI: -2.2, -0.7 for visual analogue scale; -4.8; 95% CI: -9.3, -0.4 for Northwick Park Neck Pain Questionnaire; and 14.0; 95% CI: 7.1, 20.9 for physical dimension of the Short Form-36). Compared with the patients who performed exercises <3 times/week, those who exercised 3 times/week yielded significantly greater improvement in neck function and physical dimension of quality of life scores (p = 0.005 and p = 0.018, respectively). CONCLUSION: A regular stretching exercise program performed for four weeks can decrease neck and shoulder pain and improve neck function and quality of life for office workers who have chronic moderate-to-severe neck or shoulder pain."," Clin Rehabil 30(1999): 64-72.","Thailand",2016,"Neck Pain","Exercise,Education","Northwick","Unknown","PRO study","RCT","Thailand","Unknown","Neck Pain","Exercise,Education","PRO study","RCT","Northwick","2015:2018"]
[385,"Ulrich, N. H., et al. (2015). \"Clinical outcome in lumbar decompression surgery for spinal canal stenosis in the aged population: a prospective Swiss multicenter cohort study.\" Spine (Phila Pa 1976) 40(6): 415-422.",null,"Ulrich, N. H., et al.","Clinical outcome in lumbar decompression surgery for spinal canal stenosis in the aged population: a prospective Swiss multicenter cohort study","STUDY DESIGN: This is a prospective, multicenter cohort study including 8 medical centers in the metropolitan area of the Canton Zurich, Switzerland. OBJECTIVES: To examine whether outcome and quality of life might improve after decompression surgery for degenerative lumbar spinal stenosis (DLSS) even in patients older than 80 years and to compare data with a younger patient population from our own patient collective. SUMMARY AND BACKGROUND DATA: Lumbar decompression surgery without fusion has been shown to improve quality of life in lumbar spinal canal stenosis. In the population older than 80 years, treatment recommendations for DLSS show conflicting results. METHODS: Eight centers in the metropolitan area of Zurich, Switzerland agreed on the classification of DLSS, surgical principles, and follow-up protocols. Patients were followed from baseline, at 6 months, and 12 months. Baseline characteristics were analyzed with 5 different questionnaires \"Spinal Stenosis Measure, Feeling Thermometer, Numeric Rating Scale, 5D-3L, and Roland and Morris Disability Questionnaire.\" In addition, our study population was compared with a younger control group. Furthermore, we calculated the minimal clinically important differences. RESULTS: Thirty-seven patients with an average age of 82.5 +/- 2.5 years reached the 12-month follow-up. Spinal Stenosis Measure scores, the Feeling Thermometer, the Numeric Rating Scale, and the Roland and Morris Disability Questionnaire showed significant improvements at the 6-month and 12-month follow-ups (P < 0.001). One EQ-5D-3Lsubgroup \"anxiety/depression\" showed no significant improvement (P = 0.109) at 12-month follow-up. The minimal clinically important difference for the \"Symptom Severity scale\" in the Spinal Stenosis Measure was achieved with improvement of 70% in the older patient population. CONCLUSION: Patients 80 years or older can expect a clinically meaningful improvement after lumbar decompression for symptomatic DLSS. Our patient population showed significant positive development in quality of life in the short- and long-term follow-ups. LEVEL OF EVIDENCE: 3."," Spine (Phila Pa 1976) 40(6): 415-422.","Switzerland",2015,"Spinal Deformity","Surgical","RMDQ","Adults","PRO study","Prospective Observation","Switzerland","Adults","Spinal Deformity","Surgical","PRO study","Prospective Observation","RMDQ","2015:2018"]
[386,"Ulrich, N. H., et al. (2016). \"The impact of incidental durotomy on the outcome of decompression surgery in degenerative lumbar spinal canal stenosis: analysis of the Lumbar Spinal Outcome Study (LSOS) data--a Swiss prospective multi-center cohort study.\" BMC Musculoskelet Disord 17: 170.",null,"Ulrich, N. H., et al.","The impact of incidental durotomy on the outcome of decompression surgery in degenerative lumbar spinal canal stenosis: analysis of the Lumbar Spinal Outcome Study (LSOS) data--a Swiss prospective multi-center cohort study","BACKGROUND: Incidental durotomy is a well-known complication during surgery for degenerative lumbar spinal stenosis (DLSS). In this prospective multicenter cohort study including eight medical centers our aim was to assess whether incidental durotomy during first-time lumbar spinal stenosis decompression surgery without fusion has an impact on long-term outcome. METHODS: Patients of the multi-center Lumbar Stenosis Outcome Study (LSOS) with confirmed DLSS undergoing first-time decompression without fusion were enrolled in this study. Baseline patient characteristics and outcomes were analyzed at 6, 12, and 24 months follow-up respectively with the Spinal Stenosis Measure (SSM), the Numeric Rating Scale (NRS), Feeling Thermometer (FT), the EQ-5D-EL, and the Roland and Morris Disability Questionnaire (RMDQ). RESULTS: A total of 167 patients met the inclusion criteria. Fifteen (9%) of those patients had an incidental durotomy. Baseline characteristics were similar between the durotomy and no-durotomy group. All patients improved over time. In the group of durotomy patients, the median improvement in SSM symptoms scale was 1.1 points at 6 months, 1.1 points at 12 months, and 1.6 points at 24 months after baseline. For the no-durotomy group, these improvements were 0.8, 0.9, and 0.9. For SSM function the improvements were 1.0, 0.8, and 0.9 in the durotomy group, and 0.6, 0.8, and 0.8 in the no-durotomy group. None of the between-group differences were statistically significant. CONCLUSIONS: Incidental durotomy in patients with DLSS undergoing first-time decompression surgery without fusion did not have negative effect on long-term outcome and quality of life. However, only 15 patients were included in the durotomy group but these findings remained even after adjusting for observed differences in baseline characteristics."," BMC Musculoskelet Disord 17: 170.","Switzerland",2016,"Spinal Deformity","Surgical","RMDQ","Unknown","PRO study","Prospective Observation","Switzerland","Unknown","Spinal Deformity","Surgical","PRO study","Prospective Observation","RMDQ","2015:2018"]
[387,"Upasani, V. V., et al. (2008). \"Does obesity affect surgical outcomes in adolescent idiopathic scoliosis?\" Spine (Phila Pa 1976) 33(3): 295-300.",null,"Upasani, V. V., et al.","Does obesity affect surgical outcomes in adolescent idiopathic scoliosis?","STUDY DESIGN: A retrospective review of surgical outcomes in adolescents with idiopathic scoliosis. OBJECTIVE: To determine if an association exists between body mass and surgical outcomes in adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: Obesity has reached epidemic proportions globally. In adults, obesity increases the likelihood of developing multiple medical comorbidities and has been associated with an increased incidence of perioperative complications. The effect of obesity on surgical outcomes in the treatment of AIS patients has not been studied previously. METHODS: Radiographic measures, perioperative data, and Scoliosis Research Society Outcomes scores were collected on surgically treated AIS patients. The body mass index (BMI) was calculated for each patient and normalized to sex and age (BMI %). Analysis of variance was used to identify differences between healthy weight (BMI % <85) and overweight patients (BMI % >or=85). The data were checked for normality and equal variances, and the level of significance was set at 0.01. RESULTS: Two hundred forty-one patients (204 women, 37 men; 14.3 +/- 2.0 years) with a minimum of 2-year follow-up met the inclusion criteria for this study. The average BMI (kg/m2) was 20.7 +/- 3.7 (BMI % average: 54.5, range: 1-99). No significant differences were found between the overweight (n = 48) and healthy weight (n = 193) patients with regards to surgical time, estimated blood loss, major Cobb percent correction, maintenance of correction, rate of implant failure, pseudarthrosis, and surgical revision. However, the preoperative thoracic kyphosis was significantly greater in the overweight group (27.0 degrees +/- 12.6 degrees) compared with the healthy weight patients (21.8 degrees +/- 12.5 degrees) (P = 0.004). CONCLUSION: Overweight adolescents (BMI % >or=85) had a greater thoracic kyphosis before surgery compared with their healthy weight peers. Body mass, however, did not affect the ability to achieve coronal or sagittal scoliotic deformity correction, and did not increase perioperative morbidity or mortality. These findings were either influenced by the small sample size of this cohort, or because the comorbidities responsible for increased perioperative complications in adults, had not yet developed in this adolescent population."," Spine (Phila Pa 1976) 33(3): 295-300.","USA",2008,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Retrospective review","USA","Adolescents","Spinal Deformity","Surgical","PRO study","Retrospective review","SRS-HRQOL","2005:2009"]
[388,"Vaccaro, A. R., et al. (2013). \"Functional and quality-of-life outcomes in geriatric patients with type-II dens fracture.\" J Bone Joint Surg Am 95(8): 729-735.",null,"Vaccaro, A. R., et al.","Functional and quality-of-life outcomes in geriatric patients with type-II dens fracture","BACKGROUND: Dens fractures are relatively common in the elderly. The treatment of Type-II dens fractures remains controversial. The aim of this multicenter prospective cohort study was to compare outcomes (assessed with use of validated clinical measures) and complications of nonsurgical and surgical treatment of Type-II dens fractures in patients sixty-five years of age or older. METHODS: One hundred and fifty-nine patients with a Type-II dens fracture were enrolled in a multicenter prospective study. Subjects were treated either surgically (n = 101) or nonsurgically (n = 58) as determined by the treatment preferences of the treating physicians and the patients. The subjects were followed at six and twelve months with validated outcome measures, including the Neck Disability Index (NDI) and Short Form-36v2 (SF-36v2). Treatment complications were prospectively recorded. Statistical analysis was performed to compare outcome measures before and after adjustment for confounding variables. RESULTS: The two groups were similar with regard to baseline characteristics. The most common surgical treatment was posterior C1-C2 arthrodesis (eighty of 101, or 79%) while the most common nonsurgical treatment was immobilization with use of a hard collar (forty-seven of fifty-eight, or 81%). The overall mortality rate was 18% over the twelve-month follow-up period. At twelve months, the NDI had increased (worsened) by 14.7 points in the nonsurgical cohort (p < 0.0001) compared with a nonsignificant increase (worsening) of 5.7 points in the surgical group (p = 0.0555). The surgical group had significantly better outcomes as measured by the NDI and SF-36v2 Bodily Pain dimension compared with the nonsurgical group, and these differences persisted after adjustment. There was no difference in the overall rate of complications, but the surgical group had a significantly lower rate of nonunion (5% versus 21% in the nonsurgical group; p = 0.0033). Mortality was higher in the nonsurgical group compared with the surgical group (annual mortality rates of 26% and 14%, respectively; p = 0.059). CONCLUSIONS: We demonstrated a significant benefit with surgical treatment of dens fractures as measured by the NDI, a disease-specific functional outcome measure. As a result of the nonrandomized nature of the study, the results are vulnerable to the effects of possible residual confounding. We recommend that elderly patients with a Type-II dens fracture who are healthy enough for general anesthesia be considered for surgical stabilization to improve functional outcome as well as the union and fusion rates."," J Bone Joint Surg Am 95(8): 729-735.","USA",2013,"Spinal Fracture","Surgical","NDI","Elderly","PRO study","Prospective Observation","USA","Elderly","Spinal Fracture","Surgical","PRO study","Prospective Observation","NDI","2010:2014"]
[389,"Vaidya, R., et al. (2007). \"Complications of anterior cervical discectomy and fusion using recombinant human bone morphogenetic protein-2.\" Eur Spine J 16(8): 1257-1265.",null,"Vaidya, R., et al.","Complications of anterior cervical discectomy and fusion using recombinant human bone morphogenetic protein-2","The use of bone morphogenetic protein-2 (rhBMP-2) in spinal fusion has increased dramatically since an FDA approval for its use in anterior lumbar fusion with the LT cage. There are several reports of its use in transforaminal lumbar interbody fusion, posterolateral fusion, and anterior cervical fusion. Reports on adverse effects of rhBMP-2 when used in spinal fusion are scarce in literature. An Institutional Review Board approved retrospective study was conducted in patients undergoing anterior spinal fusion and instrumentation following diskectomy at a single center. Forty-six consecutive patients were included. Twenty-two patients treated with rhBMP-2 and PEEK cages were compared to 24 in whom allograft spacers and demineralized bone matrix was used. Patients filled out Cervical Oswestry Scores, VAS for arm pain, neck pain, and had radiographs preoperatively as well at every follow up visit. Radiographic examination following surgery revealed end plate resorption in all patients in whom rhBMP-2 was used. This was followed by a period of new bone formation commencing at 6 weeks. In contrast, allograft patients showed a progressive blurring of end plate-allograft junction. Dysphagia was a common complication and it was significantly more frequent and more severe in patients in whom rhBMP-2 was used. Post operative swelling anterior to the vertebral body on lateral cervical spine X-ray was significantly larger in the rhBMP-2 group when measured from 1 to 6 weeks after which it was similar. These effects are possibly due to an early inflammatory response to rhBMP-2 and were observed to be dose related. With the parameters we used, there was no significant difference in the clinical outcome of patients in the two groups at 2 years. The cost of implants in patients treated with rhBMP-2 and PEEK spacers was more than three times the cost of allograft spacers and demineralized bone matrix in 1, 2, and 3-level cases. Despite providing consistently good fusion rates, we have abandoned using rhBMP-2 and PEEK cages for anterior cervical fusion, due to the side effects, high cost, and the availability of a suitable alternative."," Eur Spine J 16(8): 1257-1265.","USA",2007,"Neck Pain,Spinal Fusion","Surgical","Oswestry","Adults","PRO study","Retrospective review","USA","Adults","Neck Pain,Spinal Fusion","Surgical","PRO study","Retrospective review","Oswestry","2005:2009"]
[390,"Vakharia, K. T., et al. (2007). \"Quality-of-life impact of participation in a head and neck cancer support group.\" Otolaryngol Head Neck Surg 136(3): 405-410.",null,"Vakharia, K. T., et al.","Quality-of-life impact of participation in a head and neck cancer support group","OBJECTIVE: To assess if participation by patients in a head and neck cancer support group improves perceived quality of life (QOL). STUDY DESIGN AND SETTING: Subjects for this study included 47 patients at a tertiary Veterans Affairs Medical Center who were previously treated for head and neck cancer. This was a quasi-experimental, post-test study comparing the QOL of 24 patients who participated in a head and neck cancer support group with 23 patients who did not participate. The validated University of Michigan Head and Neck Quality of Life (HNQOL) instrument was used to evaluate head and neck cancer-related QOL. RESULTS: Patients who participated in the head and neck cancer support group exhibited significantly better scores in the domains of eating, emotion, and pain as well as in the global bother and response to treatment questions of the HNQOL instrument compared with those patients who did not participate. Additional subgroup analysis comparing age, type of treatment, and length of time since cancer diagnosis suggests that these variables were less important predictors of QOL than was support group participation. CONCLUSIONS: Our findings suggest that patient participation in a head and neck cancer support group is associated with improved QOL. SIGNIFICANCE: Support groups may be beneficial in improving QOL after head and neck cancer treatment."," Otolaryngol Head Neck Surg 136(3): 405-410.","USA",2007,"Cancer","Not Specified","HNQOL","Unknown","PRO study","Prospective Observation","USA","Unknown","Cancer","Not Specified","PRO study","Prospective Observation","HNQOL","2005:2009"]
[391,"Valasek, T., et al. (2013). \"Reliability and validity study on the Hungarian versions of the oswestry disability index and the Quebec back pain disability scale.\" Eur Spine J 22(5): 1010-1018.",null,"Valasek, T., et al.","Reliability and validity study on the Hungarian versions of the oswestry disability index and the Quebec back pain disability scale","PURPOSE: Patient-reported outcome measurements (PROMs) are widely used in spine care. The development of reliable and valid National versions of spine-related disability questionnaires is strongly recommended from both the clinical and scientific points-of-view. The aims of this study were to adapt and validate the Oswestry Disability Index (ODI) and the Quebec back pain disability scale (QDS) for use with the Hungarian language. METHODS: After translating and culturally adapting the ODI and QDS, 133 patients with lumbar degenerative spinal disorder filled in the questionnaire booklet twice within 2 weeks. Subjects completed the Hungarian versions of the two PROMs as well as the WHOQoL-BREF validated as a general life quality questionnaire and Visual Analogue Scale of pain. Internal consistency, reliability and construct validity of the questionnaires were determined, as were the standard error of measurement (SEM) and minimal detectable change (MDC) scores. RESULTS: The Hungarian ODI consisted of one factor that showed good internal consistency (Cronbach-alpha 0.890). The QDS showed a four-factor structure with Cronbach-alpha values between 0.788 and 0.917. No significant floor or ceiling effects were observed. The test-retest analysis showed excellent reliability of the Hungarian ODI and QDS. The intraclass correlation coefficients (ICC) were 0.927 and 0.923, respectively. SEM values of 4.8 and 5.2 resulted in a MDC of 13 and 14 points in the Hungarian ODI and QDS, respectively. The correlation coefficient (r) between pain and ODI was 0.680 (p < 0.001) and the correlation between the ODI and the physical subscale of WHOQoL was also very good (r = -0.705, p < 0.001). The QDS total score and its four subscales correlated significantly with pain and with the physical subscale of WHOQoL (r > 0.4, p < 0.001). The level of disability measured by the Hungarian ODI and QDS was significantly higher in the surgical subgroup than in non-surgically treated patients (p < 0.001). CONCLUSIONS: Translation and cultural adaptation of the ODI and QDS were successful. Hungarian versions of the ODI and QDS proved to be reliable, valid PROMs confirming that they can be used in future clinical and scientific work with Hungarian-speaking spine patients."," Eur Spine J 22(5): 1010-1018.","Hungary",2013,"Back Pain","Surgical","ODI,QBPD","Unknown","Tool Validation","Observational","Hungary","Unknown","Back Pain","Surgical","Tool Validation","Observational","ODI,QBPD","2010:2014"]
[392,"van der Roer, N., et al. (2008). \"Economic evaluation of an intensive group training protocol compared with usual care physiotherapy in patients with chronic low back pain.\" Spine (Phila Pa 1976) 33(4): 445-451.",null,"van der Roer, N., et al.","Economic evaluation of an intensive group training protocol compared with usual care physiotherapy in patients with chronic low back pain","STUDY DESIGN: Economic evaluation from a societal perspective conducted alongside a randomized controlled trial with a follow-up of 52 weeks. OBJECTIVE: To evaluate the cost effectiveness and cost utility of an intensive group training protocol compared with usual care physiotherapy in patients with nonspecific chronic low back pain. The intensive group training protocol combines exercise therapy, back school, and behavioral principles. SUMMARY OF BACKGROUND DATA: Two studies found a significant reduction in absenteeism for a graded activity program in occupational health care. This program has not yet been evaluated in a primary care physiotherapy setting. METHODS: Participating physical therapists in primary care recruited 114 patients with chronic nonspecific low back pain. Eligible patients were randomized to either the protocol group or the guideline group. Outcome measures included functional status (Roland Morris Disability Questionnaire), pain intensity (11-point numerical rating scale), general perceived effect and quality of life (EuroQol-5D). Cost data were measured with cost diaries and included direct and indirect costs related to low back pain. RESULTS: After 52 weeks, the direct health care costs were significantly higher for patients in the protocol group, largely due to the costs of the intervention. The mean difference in total costs amounted to [Euro sign] 233 (95% confidence interval: [Euro sign] -2.185; [Euro sign] 2.764). The cost-effectiveness planes indicated no significant differences in cost effectiveness between the 2 groups. CONCLUSION: The results of this economic evaluation showed no difference in total costs between the protocol group and the guideline group. The differences in effects were small and not statistically significant. At present, national implementation of the protocol is not recommended."," Spine (Phila Pa 1976) 33(4): 445-451.","Netherlands",2008,"Back Pain","Exercise","RMDQ","Unknown","Cost-Effectiveness","Clinical trial","Netherlands","Unknown","Back Pain","Exercise","Cost-Effectiveness","Clinical trial","RMDQ","2005:2009"]
[393,"van Dulmen, S. A., et al. (2017). \"Patient reported outcome measures (PROMs) for goalsetting and outcome measurement in primary care physiotherapy, an explorative field study.\" Physiotherapy 103(1999): 66-72.",null,"van Dulmen, S. A., et al.","Patient reported outcome measures (PROMs) for goalsetting and outcome measurement in primary care physiotherapy, an explorative field study","OBJECTIVES: Routine use of patient reported outcome measures (PROMs) may provide an effective way of monitoring patient valued outcomes. In this study we explored (1999) the current use of PROMs; (2) to what extent the goals correspond with the selected PROMs; (3) the health outcomes based on PROMs. DESIGN: Observational clinical cohort study. SETTING: Dutch primary care physiotherapy practices (n=43). PARTICIPANTS: Patients (n=299) with neck pain or low back pain. MAIN OUTCOME MEASURES: The number of PROMs used per patient were calculated. The International Classification of Functioning, Disability and Health was used to map the patients' goals and the percentages of PROMS selected that match the domains of the goals were calculated. Health outcomes were assessed using two approaches for estimating the minimal clinically important difference (MCID). RESULTS: Repeated measurements with the Visual Analogue Scale, the Patient Specific Complaints questionnaire, the Quebec Back Pain Disability Scale, or the Neck Disability Index were completed by more than 60% of the patients. The PROMs used matched in 46% of the cases with goals for pain improvement, and in 43% with goals set at activity/participation level. The mean differences between baseline and follow up scores for all PROMs were statistically significant. Improvements of patients based on MCID varied from 57% to 90%. CONCLUSIONS: PROMs were used in the majority of the patients, showed improved health outcomes and fitted moderately with goals. The results of this study can be used for future research assessing the routine use of outcome measurements with PROMs."," Physiotherapy 103(1999): 66-72.","Netherlands",2017,"Back Pain,Neck Pain","Physical Therapy","NDI,QBPD","Unknown","PRO study","Prospective Observation","Netherlands","Unknown","Back Pain,Neck Pain","Physical Therapy","PRO study","Prospective Observation","NDI,QBPD","2015:2018"]
[394,"van Erp, R. M., et al. (2015). \"A biopsychosocial primary care intervention (Back on Track) versus primary care as usual in a subgroup of people with chronic low back pain: protocol for a randomised, controlled trial.\" J Physiother 61(3): 155.",null,"van Erp, R. M., et al.","A biopsychosocial primary care intervention (Back on Track) versus primary care as usual in a subgroup of people with chronic low back pain: protocol for a randomised, controlled trial","INTRODUCTION: Multidisciplinary biopsychosocial interventions are effective at improving functional disability in people with chronic low back pain. However, these interventions are often expensive and have long waiting times before treatment starts. Therefore, implementing biopsychosocial interventions in primary care settings may be of interest. Because people with chronic low back pain show different biopsychosocial profiles, they might respond differently to specific interventions. RESEARCH QUESTIONS: This study will investigate the difference in (cost) effectiveness between a biopsychosocial primary care intervention, Back on Track, and primary care physiotherapy as usual in a subgroup of adults with chronic low back pain. DESIGN: Double-blind, multicentre (n = 8), randomised, controlled trial. PARTICIPANTS: Eighty-six adults with chronic low back pain, aged 18 to 65 years, experiencing low to moderate levels of disability and in whom the contributing role of psychosocial factors to this disability is restricted. INTERVENTION: The Back on Track intervention: four individual and eight group sessions, based on biopsychosocial approaches from multidisciplinary pain rehabilitation programs and provided by trained physiotherapists. CONTROL: Primary care physiotherapy as usual. MEASUREMENTS: The primary outcome is functional disability (Quebec Back Pain Disability Scale) at post treatment, and 3-month and 12-month follow-up. Secondary measures are: credibility and expectancy, anxiety and depression, catastrophising, pain intensity, kinesiophobia, self-efficacy, participant's global perceived effect, cost-effectiveness, and cost-utility estimated with cost diaries and quality-adjusted life years. ANALYSIS: Linear mixed models using an intention-to-treat principle. Incremental cost-effectiveness and cost-utility ratios will be calculated and plotted on a cost-effectiveness plane. DISCUSSION: This study will provide useful information on a biopsychosocial intervention for chronic low back pain in primary care settings."," J Physiother 61(3): 155.","Netherlands",2015,"Back Pain","Psychosocial","QBPD","Adults","Cost-Effectiveness","RCT","Netherlands","Adults","Back Pain","Psychosocial","Cost-Effectiveness","RCT","QBPD","2015:2018"]
[395,"van Hoeven, L., et al. (2016). \"Study protocol for a cluster randomized controlled trial to evaluate a referral strategy for axial spondyloarthritis in young primary care patients with chronic low back pain; an impact study.\" BMC Musculoskelet Disord 17: 278.",null,"van Hoeven, L., et al.","Study protocol for a cluster randomized controlled trial to evaluate a referral strategy for axial spondyloarthritis in young primary care patients with chronic low back pain; an impact study","BACKGROUND: Axial spondyloarthritis (axSpA) is a disabling inflammatory joint disease with chronic low back pain (CLBP) as leading symptom. Recognizing axSpA in the large amount of CLBP patients is difficult for general practioners (GP). This evaluation aims to assess the effect of a referral strategy for axSpA in young primary care patients with CLBP by comparing the use of the strategy with usual care. The effect is measured at three different levels; by patient reported outcomes (the clinical effect), process and costs evaluation. METHODS/DESIGN: This study design is a cluster randomized controlled trial with GP as clusters. GPs throughout the Netherlands are invited to participate and randomized to either the intervention or the control group. Patients from participating GPs are invited to participate if they have ever been registered with low back pain, without radiation (ICPC L03) and aged 18-45 years. To be included in the study, patients need to have current low back pain and chronic low back pain (>12 weeks). In the intervention arm a referral strategy for axSpA will be applied in CLBP patients, in the control arm care as usual will be provided for CLBP patients. The referral strategy consists of four easy to use variables. All are questions about the back pain complaints of the patients. Data is prospectively collected in an online database at baseline (T0), 4 months (T1), 12 months (T2) and 24 months (T3). After time point T1 (4 months) patients from the control group will also receive the intervention i.e. the application of a referral strategy for axSpA. The effect of the referral strategy is measured at three different levels, by patient outcomes (e.g. pain scores, quality of life), process measures (e.g. number of axSpA diagnoses by rheumatologists) and by costs (work productivity and health care resources use). Our primary outcome is the Roland Morris Disability Questionnaire after 4 months, secondary outcomes are pain and quality of life. Costs will be assessed before and after the use of the referral strategy, to estimate if the use of the strategy will lead to a reduction in health care costs and improvement in work participation. DISCUSSION: It is anticipated that using the axSpA referral strategy for primary care CLBP patients will increase the quality of life of CLBP patients, will result in more (correct) diagnoses of axSpA by the rheumatologists, and will be cost-effective. Ultimately, the results of this study may contribute to the startup of a national implementation of the axSpA referral strategy to identify timely CLBP patients with axSpA. TRIAL REGISTRATION: NCT01944163 , date of registration; September 6, 2013 (Clinicaltrials.gov)."," BMC Musculoskelet Disord 17: 278.","Netherlands",2016,"Back Pain,Spondylosis","Radiotherapy","RMDQ","Adults","Cost and Resource Use","RCT","Netherlands","Adults","Back Pain,Spondylosis","Radiotherapy","Cost and Resource Use","RCT","RMDQ","2015:2018"]
[396,"van Hooff, M. L., et al. (2010). \"Daily functioning and self-management in patients with chronic low back pain after an intensive cognitive behavioral programme for pain management.\" Eur Spine J 19(9): 1517-1526.",null,"van Hooff, M. L., et al.","Daily functioning and self-management in patients with chronic low back pain after an intensive cognitive behavioral programme for pain management","Chronic low back pain (CLBP) is associated with persistent or recurrent disability which results in high costs for society. Cognitive behavioral treatments produce clinically relevant benefits for patients with CLBP. Nevertheless, no clear evidence for the most appropriate intervention is yet available. The purpose of this study is to evaluate the mid-term effects of treatment in a cohort of patients with CLBP participating in an intensive pain management programme. The programme provided by RealHealth-Netherlands is based on cognitive behavioral principles and executed in collaboration with orthopedic surgeons. Main outcome parameters were daily functioning (Roland and Morris Disability Questionnaire and Oswestry Disability Questionnaire), self-efficacy (Pain Self-Efficacy Questionnaire) and quality of life (Short Form 36 Physical Component Score). All parameters were measured at baseline, last day of residential programme and at 1 and 12 months follow-up. Repeated measures analysis was applied to examine changes over time. Clinical relevance was examined using minimal clinical important differences (MCID) estimates for main outcomes. To compare results with literature effect sizes (Cohen's d) and Standardized Morbidity Ratios (SMR) were determined. 107 patients with CLBP participated in this programme. Mean scores on outcome measures showed a similar pattern: improvement after residential programme and maintenance of results over time. Effect sizes were 0.9 for functioning, 0.8 for self-efficacy and 1.3 for physical functioning related quality of life. Clinical relevancy: 79% reached MCID on functioning, 53% on self-efficacy and 80% on quality of life. Study results on functioning were found to be 36% better and 2% worse when related to previous research on, respectively, rehabilitation programmes and spinal surgery for similar conditions (SMR 136 and 98%, respectively). The participants of this evidence-based programme learned to manage CLBP, improved in daily functioning and quality of life. The study results are meaningful and comparable with results of spinal surgery and even better than results from less intensive rehabilitation programmes."," Eur Spine J 19(9): 1517-1526.","Netherlands",2010,"Back Pain","CBT,Surgical","ODI,RMDQ","Unknown","PRO study","Clinical trial","Netherlands","Unknown","Back Pain","CBT,Surgical","PRO study","Clinical trial","ODI,RMDQ","2010:2014"]
[397,"Vas, J., et al. (2006). \"Efficacy and safety of acupuncture for the treatment of non-specific acute low back pain: a randomised controlled multicentre trial protocol [ISRCTN65814467].\" BMC Complement Altern Med 6: 14.",null,"Vas, J., et al.","Efficacy and safety of acupuncture for the treatment of non-specific acute low back pain: a randomised controlled multicentre trial protocol [ISRCTN65814467]","BACKGROUND: Low back pain and its associated incapacitating effects constitute an important healthcare and socioeconomic problem, as well as being one of the main causes of disability among adults of working age. The prevalence of non-specific low back pain is very high among the general population, and 60-70% of adults are believed to have suffered this problem at some time. Nevertheless, few randomised clinical trials have been made of the efficacy and efficiency of acupuncture with respect to acute low back pain. The present study is intended to assess the efficacy of acupuncture for acute low back pain in terms of the improvement reported on the Roland Morris Questionnaire (RMQ) on low back pain incapacity, to estimate the specific and non-specific effects produced by the technique, and to carry out a cost-effectiveness analysis. METHODS/DESIGN: Randomised four-branch controlled multicentre prospective study made to compare semi-standardised real acupuncture, sham acupuncture (acupuncture at non-specific points), placebo acupuncture and conventional treatment. The patients are blinded to the real, sham and placebo acupuncture treatments. Patients in the sample present symptoms of non specific acute low back pain, with a case history of 2 weeks or less, and will be selected from working-age patients, whether in paid employment or not, referred by General Practitioners from Primary Healthcare Clinics to the four clinics participating in this study. In order to assess the primary and secondary result measures, the patients will be requested to fill in a questionnaire before the randomisation and again at 3, 12 and 48 weeks after starting the treatment. The primary result measure will be the clinical relevant improvement (CRI) at 3 weeks after randomisation. We define CRI as a reduction of 35% or more in the RMQ results. DISCUSSION: This study is intended to obtain further evidence on the effectiveness of acupuncture on acute low back pain and to isolate the specific and non-specific effects of the treatment."," BMC Complement Altern Med 6: 14.","Spain",2006,"Back Pain","Acupuncture","RMDQ","Adults","PRO study","Prospective Observation","Spain","Adults","Back Pain","Acupuncture","PRO study","Prospective Observation","RMDQ","2005:2009"]
[398,"Verma, K., et al. (2014). \"International utilization of the SRS-22 instrument to assess outcomes in adolescent idiopathic scoliosis: what can we learn from a medical outreach group in Ghana?\" J Pediatr Orthop 34(5): 503-508.",null,"Verma, K., et al.","International utilization of the SRS-22 instrument to assess outcomes in adolescent idiopathic scoliosis: what can we learn from a medical outreach group in Ghana?","BACKGROUND: Cross-cultural studies on adolescent idiopathic scoliosis (AIS) populations are limited. This study evaluated the discriminate validity of the Scoliosis Research Society Questionnaire (SRS-22) in Ghana between adolescents with and without AIS. SRS-22 outcomes from AIS and normal adolescents in Ghana were also compared with scores from AIS and normal adolescents in America. METHODS: A retrospective review of preoperative SRS-22 questionnaires from Ghana and New York City was completed. In Ghana, 84 adolescents without scoliosis (healthy-G) (32 female adolescents; mean age, 13.3 y) and 61 patients with AIS (AIS-G) (76 female adolescents; mean age, 15.4 y) were administered with the SRS-22 questionnaire. From the New York City, 450 healthy adolescents (healthy-US) (279 female adolescents; mean age, 16 y) and 302 patients with AIS (AIS-US) (227 female adolescents; mean age, 14.9 y) also completed the SRS-22 questionnaire. Patients with curve magnitudes <40 (nonoperative) were then excluded. All 4 groups were matched based on age and sex, resulting in 4 groups of 40 subjects (25 female adolescents; mean age, 14.5 y for all groups). Differences in SRS-22 scores across the groups were analyzed using analysis of variance and analysis of covariance, with the Bonferroni post hoc tests, to control for differences in curve magnitude. RESULTS: Mean curve magnitude for the matched groups was larger for the AIS-G group [67.2 degrees (range, 42 to 130 degrees)] as compared with the AIS-US group [52 degrees (range, 40 to 76 degrees)] (P<0.01). When controlling for the curve magnitude, a significant difference between all 4 study groups was found within all domains and total score (P<0.01). AIS-G displayed significantly lower scores in the activity, image, pain, and mental health domains (P<0.01); this reached the minimal clinically importance difference for these domains. Healthy-US and healthy-G had better overall and domain-specific scores than AIS-US and AIS-G, respectively (P<0.05). CONCLUSIONS: These findings illustrate the affect of AIS within a culture as well as across cultures. Healthy adolescents had significantly better scores than scoliotic adolescents. Ghanaian adolescents had significantly worse Health-Related Quality-of-Life scores than American adolescents, especially those suffering from AIS. These differences should be kept in mind by those treating this already emotionally vulnerable adolescent population. LEVEL OF EVIDENCE: Level II Prognostic."," J Pediatr Orthop 34(5): 503-508.","USA",2014,"Spinal Deformity","Not Specified","SRS-HRQOL","Adolescents","PRO study","Retrospective review","USA","Adolescents","Spinal Deformity","Not Specified","PRO study","Retrospective review","SRS-HRQOL","2010:2014"]
[399,"Vitale, M. G., et al. (2010). \"Development and initial validation of a disease specific outcome measure for early onset scoliosis.\" Stud Health Technol Inform 158: 172-176.",null,"Vitale, M. G., et al.","Development and initial validation of a disease specific outcome measure for early onset scoliosis","INTRODUCTION: Treatment of children with early onset scoliosis (EOS) seeks to improve natural history and health related quality of life (QOL). QOL measurement presents a significant challenge given the young age, comorbidities, and heterogeneity of this population. OBJECTIVE: To develop a disease specific measure reflecting issues of importance to EOS patients and caretakers. MATERIALS AND METHODS: Review of the literature and relevant measures informed development of semi-structured qualitative interviews. Interviews of caregivers of EOS patients were interpreted through the framework technique. A master-list of 75-items was created and responses were scaled on a 5-point Likert-scale. Psychometric analysis was performed to group items into domains, to maintain score distribution, to create a responsive instrument, and to identify question redundancy. RESULTS: Content validation revealed 8-items with low content validity indices. Item distribution analysis demonstrated 19-items with skewed distribution. Item reliability demonstrated redundant items within domains (r> or =0.5). Construct validity demonstrated unique domains measuring intended issues of interest. The resulting Early Onset Scoliosis Questionnaire (EOSQ) includes 33-items in 13-domains: General Health, Pain, Physical Function, Pulmonary Function, Daily Living, Fatigue, Emotion, Surgical Concerns, Satisfaction, Transfer, Financial Burden, Parental Burden, and Treatment Outcomes. CONCLUSION: The EOSQ reflects QOL and caregiver burden in the EOS population. The EOSQ will expand options for outcome assessment in this unique population."," Stud Health Technol Inform 158: 172-176.","USA",2010,"Spinal Deformity","Surgical","EOSQ","Infants","Tool Validation","Observational","USA","Infants","Spinal Deformity","Surgical","Tool Validation","Observational","EOSQ","2010:2014"]
[400,"Vollenbroek-Hutten, M. M., et al. (2004). \"Differences in outcome of a multidisciplinary treatment between subgroups of chronic low back pain patients defined using two multiaxial assessment instruments: the multidimensional pain inventory and lumbar dynamometry.\" Clin Rehabil 18(5): 566-579.",null,"Vollenbroek-Hutten, M. M., et al.","Differences in outcome of a multidisciplinary treatment between subgroups of chronic low back pain patients defined using two multiaxial assessment instruments: the multidimensional pain inventory and lumbar dynamometry","OBJECTIVE: To investigate the effects of a multidisciplinary back school programme (Roessingh Back Rehabilitation Programme, RRP) compared with usual care, as well as differences in treatment outcome between subgroups defined using two multiaxial assessment instruments: the Multidimensional Pain Inventory (MPI-DLV) and lumbar dynamometry. DESIGN: Randomized controlled trial. SETTING: Rehabilitation. SUBJECTS: One hundred and sixty-three patients with chronic, aspecific low back pain. INTERVENTION: All subjects were randomly assigned either to a multidisciplinary, physically oriented group treatment or to their usual care. MAIN OUTCOME MEASURES: The Roland Disability Questionnaire and health-related quality of life (EuroQol, EQ5-D) were measured as primary outcomes before randomization and after eight weeks and six months follow-up. RESULT: Only 30-50% of the patients in the RRP group showed improvement and this number is not significantly different from the control group. Subgroup analyses give some first indications that multiaxial measurement instruments can be used to identify subgroups with differences in treatment effects. CONCLUSION: The overall effect of a multidisciplinary treatment is disappointing, however multiaxial assessment before admission might be valuable in clinical practice, resulting in more effective treatments for patients with chronic low back pain."," Clin Rehabil 18(5): 566-579.","Netherlands",2004,"Back Pain","Physical Therapy","RMDQ","Unknown","PRO study","Clinical trial","Netherlands","Unknown","Back Pain","Physical Therapy","PRO study","Clinical trial","RMDQ","2000:2004"]
[401,"Wand, B. M., et al. (2004). \"Early intervention for the management of acute low back pain: a single-blind randomized controlled trial of biopsychosocial education, manual therapy, and exercise.\" Spine (Phila Pa 1976) 29(21): 2350-2356.",null,"Wand, B. M., et al.","Early intervention for the management of acute low back pain: a single-blind randomized controlled trial of biopsychosocial education, manual therapy, and exercise","STUDY DESIGN: A single blind randomized controlled trial comparing two models of care for patients with acute simple low back pain. OBJECTIVES: To compare two research-based models of care for acute low back pain and investigate the effect of the timing of physical intervention. SUMMARY OF BACKGROUND DATA: National guidelines offer conflicting information on the delivery of physical treatment in the management of acute low back pain. The guidelines suggest two different models of care. Direct comparisons between these models are lacking in the literature. The present study aims to compare these approaches to the management of acute low back pain. METHODS: Among 804 referred patients, 102 subjects met the specific admission criteria and were randomly assigned to an \"assess/advise/treat\" group or an \"assess/advise/wait\" group. The intervention consisted of biopsychosocial education, manual therapy, and exercise. Assessment of short-term outcome enables comparison to be made between intervention and advice to stay active. Assessment of long-term outcome enables comparison to be made between early and late intervention. Study outcomes of reported pain (Visual Analogue Scale), functional disability (the Roland and Morris Disability Questionnaire), mood (Modified Zung Self Rated Depression Score, Modified Somatic Perception Questionnaire, State-Trait Anxiety Inventory), general health (Euroqol), and quality of life (Short Form 36) were assessed at baseline, 6 weeks, 3 months, and 6 months. RESULTS: At 6 weeks, the assess/advise/treat group demonstrated greater improvements in disability, mood, general health, and quality of life than patients in the assess/advise/wait group (P < 0.05). Disability and pain were not significantly different between the groups at long-term follow up (P > 0.05). However, mood, general health, and quality of life remained significantly better in the assess/advise/treat group (P < 0.05). CONCLUSIONS: At short-term, intervention is more effective than advice on staying active, leading to more rapid improvement in function, mood, quality of life, and general health. The timing of intervention affects the development of psychosocial features. If treatment is provided later, the same psychosocial benefits are not achieved. Therefore, an assess/advise/treat model of care seems to offer better outcomes than an assess/advise/wait model of care."," Spine (Phila Pa 1976) 29(21): 2350-2356.","Australia",2004,"Back Pain","Exercise","RMDQ","Unknown","PRO study","RCT","Australia","Unknown","Back Pain","Exercise","PRO study","RCT","RMDQ","2000:2004"]
[402,"Wang, C., et al. (2009). \"Effect of preoperative brace treatment on quality of life in adolescents with idiopathic scoliosis following corrective surgery.\" Orthopedics 32(8).",null,"Wang, C., et al.","Effect of preoperative brace treatment on quality of life in adolescents with idiopathic scoliosis following corrective surgery","Bracing is frequently used for the treatment of adolescent idiopathic scoliosis. Such treatment is not always effective, and corrective surgery may be warranted. Brace treatment has been suggested to negatively affect quality of life. This study assessed postoperative quality of life and surgical outcome in Chinese patients with adolescent idiopathic scoliosis and failed brace treatment. Ninety-four patients with adolescent idiopathic scoliosis who underwent simple posterior corrective surgery and pedicle screw fixation were studied. The patients were divided into 2 groups: brace and surgery treatment (BS group) and surgery with no brace treatment (S group). Radiological parameters were assessed preoperatively, immediately postoperatively, and >2 years postoperatively. Postoperative quality of life was determined using the Scoliosis Research Society-22 (SRS-22) questionnaire. The preoperative minor curve Cobb angle was significantly greater in the BS group (34.9 degrees vs 29.4 degrees ; P=.037). Postoperative radiological parameters in the coronal and sagittal planes were similar. There were a significantly higher number of fused vertebrae in BS compared to S group patients (10.3 vs 9.6; P=.044). There were no significant postoperative differences between groups in function/activity, pain, mental health, or satisfaction of management as determined by the SRS-22. Self-image/appearance scores were significantly higher in BS compared to S group patients (4.0 vs 3.8; P=.010). Preoperative brace treatment may be a risk factor for minor curve progression but does not appear to significantly influence surgical outcome. Postoperative self-perceived quality of life is not negatively affected by preoperative brace treatment."," Orthopedics 32(8).","China",2009,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Prospective Observation","China","Adolescents","Spinal Deformity","Surgical","PRO study","Prospective Observation","SRS-HRQOL","2005:2009"]
[403,"Warke, K., et al. (2006). \"Efficacy of transcutaneous electrical nerve stimulation (tens) for chronic low-back pain in a multiple sclerosis population: a randomized, placebo-controlled clinical trial.\" Clin J Pain 22(9): 812-819.",null,"Warke, K., et al.","Efficacy of transcutaneous electrical nerve stimulation (tens) for chronic low-back pain in a multiple sclerosis population: a randomized, placebo-controlled clinical trial","OBJECTIVE: This study was designed to investigate the hypoalgesic effects of self-applied transcutaneous electrical nerve stimulation (TENS) on chronic low-back pain (LBP) in a multiple sclerosis (MS) population. METHODS: Ninety participants with probable or definite MS (aged 21 to 78 y) presenting with chronic LBP were recruited and randomized into 3 groups (n=30 per group): (1999) low-frequency TENS group (4 Hz, 200 micros); (2) high-frequency TENS group (110 Hz, 200 micros); and (3) placebo TENS. Participants self-applied TENS for 45 minutes, a minimum of twice daily, for 6 weeks. Outcome measures were recorded at weeks 1, 6, 10, and 32. Primary outcome measures included: Visual Analog Scale for average LBP and the McGill Pain Questionnaire. Secondary outcome measures included: Visual Analog Scale for worst and weekly LBP, back and leg spasm; Roland Morris Disability Questionnaire; Barthel Index; Rivermead Mobility Index; Multiple Sclerosis Quality of Life-54 Instrument, and a daily logbook. Data were analyzed blind using parametric and nonparametric tests, as appropriate. RESULTS: Results indicated a statistically significant interactive effect between groups for average LBP (P=0.008); 1-way analysis of covariance did not show any significant effects at any time point once a Bonferonni correction was applied (P>0.05). However, clinically important differences were observed in some of the outcome measures in both active treatment groups during the treatment and follow-up periods. DISCUSSION: Although not statistically significant, the observed effects may have implications for the clinical prescription and the use of TENS within this population."," Clin J Pain 22(9): 812-819.","UK",2006,"Back Pain","Physical Therapy","RMDQ","Unknown","PRO study","RCT","UK","Unknown","Back Pain","Physical Therapy","PRO study","RCT","RMDQ","2005:2009"]
[404,"Werner, E. L., et al. (2016). \"Cognitive Patient Education for Low Back Pain in Primary Care: A Cluster Randomized Controlled Trial and Cost-Effectiveness Analysis.\" Spine (Phila Pa 1976) 41(6): 455-462.",null,"Werner, E. L., et al.","Cognitive Patient Education for Low Back Pain in Primary Care: A Cluster Randomized Controlled Trial and Cost-Effectiveness Analysis","STUDY DESIGN: A pragmatic cluster randomized controlled trial in primary care. OBJECTIVE: The aim of this study was to estimate the clinical effectiveness and cost-effectiveness of a cognitive-based education program on patients with subacute or chronic low back pain (LBP) in primary care, compared to usual treatment, provided by general practitioners (GP) and physiotherapists (PT). SUMMARY OF BACKGROUND DATA: Patient education has been reported to have a favorable effect on patients with chronic musculoskeletal disorders. In this study, an \"Explain Pain\" model was adapted to fit into an ordinary clinical setting in Norwegian primary care. METHODS: Sixteen GPs and 20 PTs participated in the study and a total of 216 patients were recruited. The GPs and PTs were randomly assigned to provide either a cognitive patient education or usual treatment. All patients in both groups were provided with four consultations of 30 min with their provider during the study. In the intervention group the patients were educated according to a specific manual written for the purpose of this study. RESULTS: Eighty-one percent responded at 4-week, and 68% at the 12-month follow-up. There was a substantial improvement in function, pain, and sick leave in both groups. After 4 weeks the intervention group scored 0.51 RMDQ points lower than the control group (Beta -0.506 [95% CI -1.76-0.75]). After 12 months the intervention group scored 0.66 RMDQ points higher than the control group (Beta 0.66 [95% CI -0.56-1.88]). There was no significant difference in QALYs in the two treatment groups; the estimated difference was 0.005 (-0.016-0.027) in favor of the intervention. CONCLUSION: This study showed no clinical or health economic benefits as a result of adding a cognitive education program to usual treatment for patients with subacute and chronic LBP. Potential weaknesses such as a long recruiting period and potentially low compliance with the cognitive intervention warrant a careful interpretation of the results."," Spine (Phila Pa 1976) 41(6): 455-462.","Norway",2016,"Back Pain","CBT","RMDQ","Unknown","Cost-Effectiveness","RCT","Norway","Unknown","Back Pain","CBT","Cost-Effectiveness","RCT","RMDQ","2015:2018"]
[405,"Whitehurst, D. G., et al. (2007). \"A brief pain management program compared with physical therapy for low back pain: results from an economic analysis alongside a randomized clinical trial.\" Arthritis Rheum 57(3): 466-473.",null,"Whitehurst, D. G., et al.","A brief pain management program compared with physical therapy for low back pain: results from an economic analysis alongside a randomized clinical trial","OBJECTIVE: Guidelines for the management of acute low back pain in primary care recommend early intervention to address psychosocial risk factors associated with long-term disability. We assessed the cost utility and cost effectiveness of a brief pain management program (BPM) targeting psychosocial factors compared with physical therapy (PT) for primary care patients with low back pain of <12 weeks' duration. METHODS: A total of 402 patients were randomly assigned to BPM or PT. We adopted a health care perspective, examining the direct health care costs of low back pain. Outcome measures were quality-adjusted life years (QALYs) and 12-month change scores on the Roland and Morris disability questionnaire. Resource use data related to back pain were collected at 12-month followup. Cost effectiveness was expressed as incremental ratios, with uncertainty assessed using cost-effectiveness planes and acceptability curves. RESULTS: There were no statistically significant differences in mean health care costs or outcomes between treatments. PT had marginally greater effectiveness at 12 months, albeit with greater health care costs (BPM 142 pounds, PT 195 pounds). The incremental cost-per-QALY ratio was 2,362 pounds. If the UK National Health Service were willing to pay 10,000 pound per additional QALY, there is only a 17% chance that BPM provides the best value for money. CONCLUSION: PT is a cost-effective primary care management strategy for low back pain. However, the absence of a clinically superior treatment program raises the possibility that BPM could provide an additional primary care approach, administered in fewer sessions, allowing patient and doctor preferences to be considered."," Arthritis Rheum 57(3): 466-473.","UK",2007,"Back Pain","Physical Therapy","RMDQ","Adults","Cost-Effectiveness","RCT","UK","Adults","Back Pain","Physical Therapy","Cost-Effectiveness","RCT","RMDQ","2005:2009"]
[406,"Whitfill, T., et al. (2010). \"Early intervention options for acute low back pain patients: a randomized clinical trial with one-year follow-up outcomes.\" J Occup Rehabil 20(2): 256-263.",null,"Whitfill, T., et al.","Early intervention options for acute low back pain patients: a randomized clinical trial with one-year follow-up outcomes","INTRODUCTION: In an earlier study, Gatchel et al. (J Occup Rehabil 13:1-9, 2003) demonstrated that participants at high risk for developing chronic low back pain disability (CLBPD), who received a biopsychosocial early intervention treatment program, displayed significantly more symptom improvement, as well as cost savings, relative to participants receiving standard care. The purpose of the present study was to expand on these results by examining whether the addition of a work-transition component would further strengthen the effectiveness of this early intervention treatment. METHODS: Using an existing algorithm, participants were identified as being high-risk (HR) or low-risk (LR) for developing CLBPD. HR participants were then randomly assigned to one of three groups: early intervention (EI); early intervention with work transition (EI/WT); or standard care (SC). Participants provided information regarding pain, disability, work status, and psychosocial functioning at baseline, periodically during treatment, and again 1 year following completion of treatment. RESULTS: At 1-year follow-up, no significant differences were found between the EI and EI/WT groups in terms of occupational status, self-reports of pain and disability, coping ability or psychosocial functioning. However, significant differences in all these outcomes were found comparing these groups to standard care. CONCLUSION: The addition of a work transition component to an early intervention program for the treatment of ALBP did not significantly contribute to improved work outcomes. However, results further support the effectiveness of early intervention for high-risk ALBP patients."," J Occup Rehabil 20(2): 256-263.","USA",2010,"Back Pain","Psychosocial","Aberdeen LBP","Unknown","PRO study","RCT","USA","Unknown","Back Pain","Psychosocial","PRO study","RCT","Aberdeen LBP","2010:2014"]
[407,"Wieland, L. S., et al. (2017). \"Yoga treatment for chronic non-specific low back pain.\" Cochrane Database Syst Rev 1: Cd010671.",null,"Wieland, L. S., et al.","Yoga treatment for chronic non-specific low back pain","BACKGROUND: Non-specific low back pain is a common, potentially disabling condition usually treated with self-care and non-prescription medication. For chronic low back pain, current guidelines state that exercise therapy may be beneficial. Yoga is a mind-body exercise sometimes used for non-specific low back pain. OBJECTIVES: To assess the effects of yoga for treating chronic non-specific low back pain, compared to no specific treatment, a minimal intervention (e.g. education), or another active treatment, with a focus on pain, function, and adverse events. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, five other databases and four trials registers to 11 March 2016 without restriction of language or publication status. We screened reference lists and contacted experts in the field to identify additional studies. SELECTION CRITERIA: We included randomized controlled trials of yoga treatment in people with chronic non-specific low back pain. We included studies comparing yoga to any other intervention or to no intervention. We also included studies comparing yoga as an adjunct to other therapies, versus those other therapies alone. DATA COLLECTION AND ANALYSIS: Two authors independently screened and selected studies, extracted outcome data, and assessed risk of bias. We contacted study authors to obtain missing or unclear information. We evaluated the overall certainty of evidence using the GRADE approach. MAIN RESULTS: We included 12 trials (1080 participants) carried out in the USA (seven trials), India (three trials), and the UK (two trials). Studies were unfunded (one trial), funded by a yoga institution (one trial), funded by non-profit or government sources (seven trials), or did not report on funding (three trials). Most trials used Iyengar, Hatha, or Viniyoga forms of yoga. The trials compared yoga to no intervention or a non-exercise intervention such as education (seven trials), an exercise intervention (three trials), or both exercise and non-exercise interventions (two trials). All trials were at high risk of performance and detection bias because participants and providers were not blinded to treatment assignment, and outcomes were self-assessed. Therefore, we downgraded all outcomes to 'moderate' certainty evidence because of risk of bias, and when there was additional serious risk of bias, unexplained heterogeneity between studies, or the analyses were imprecise, we downgraded the certainty of the evidence further.For yoga compared to non-exercise controls (9 trials; 810 participants), there was low-certainty evidence that yoga produced small to moderate improvements in back-related function at three to four months (standardized mean difference (SMD) -0.40, 95% confidence interval (CI) -0.66 to -0.14; corresponding to a change in the Roland-Morris Disability Questionnaire of mean difference (MD) -2.18, 95% -3.60 to -0.76), moderate-certainty evidence for small to moderate improvements at six months (SMD -0.44, 95% CI -0.66 to -0.22; corresponding to a change in the Roland-Morris Disability Questionnaire of MD -2.15, 95% -3.23 to -1.08), and low-certainty evidence for small improvements at 12 months (SMD -0.26, 95% CI -0.46 to -0.05; corresponding to a change in the Roland-Morris Disability Questionnaire of MD -1.36, 95% -2.41 to -0.26). On a 0-100 scale there was very low- to moderate-certainty evidence that yoga was slightly better for pain at three to four months (MD -4.55, 95% CI -7.04 to -2.06), six months (MD -7.81, 95% CI -13.37 to -2.25), and 12 months (MD -5.40, 95% CI -14.50 to -3.70), however we pre-defined clinically significant changes in pain as 15 points or greater and this threshold was not met. Based on information from six trials, there was moderate-certainty evidence that the risk of adverse events, primarily increased back pain, was higher in yoga than in non-exercise controls (risk difference (RD) 5%, 95% CI 2% to 8%).For yoga compared to non-yoga exercise controls (4 trials; 394 participants), there was very-low-certainty evidence for little or no difference in back-related function at three months (SMD -0.22, 95% CI -0.65 to 0.20; corresponding to a change in the Roland-Morris Disability Questionnaire of MD -0.99, 95% -2.87 to 0.90) and six months (SMD -0.20, 95% CI -0.59 to 0.19; corresponding to a change in the Roland-Morris Disability Questionnaire of MD -0.90, 95% -2.61 to 0.81), and no information on back-related function after six months. There was very low-certainty evidence for lower pain on a 0-100 scale at seven months (MD -20.40, 95% CI -25.48 to -15.32), and no information on pain at three months or after seven months. Based on information from three trials, there was low-certainty evidence for no difference in the risk of adverse events between yoga and non-yoga exercise controls (RD 1%, 95% CI -4% to 6%).For yoga added to exercise compared to exercise alone (1 trial; 24 participants), there was very-low-certainty evidence for little or no difference at 10 weeks in back-related function (SMD -0.60, 95% CI -1.42 to 0.22; corresponding to a change in the Oswestry Disability Index of MD -17.05, 95% -22.96 to 11.14) or pain on a 0-100 scale (MD -3.20, 95% CI -13.76 to 7.36). There was no information on outcomes at other time points. There was no information on adverse events.Studies provided limited evidence on risk of clinical improvement, measures of quality of life, and depression. There was no evidence on work-related disability. AUTHORS' CONCLUSIONS: There is low- to moderate-certainty evidence that yoga compared to non-exercise controls results in small to moderate improvements in back-related function at three and six months. Yoga may also be slightly more effective for pain at three and six months, however the effect size did not meet predefined levels of minimum clinical importance. It is uncertain whether there is any difference between yoga and other exercise for back-related function or pain, or whether yoga added to exercise is more effective than exercise alone. Yoga is associated with more adverse events than non-exercise controls, but may have the same risk of adverse events as other back-focused exercise. Yoga is not associated with serious adverse events. There is a need for additional high-quality research to improve confidence in estimates of effect, to evaluate long-term outcomes, and to provide additional information on comparisons between yoga and other exercise for chronic non-specific low back pain."," Cochrane Database Syst Rev 1: Cd010671.","USA,Germany,UK",2017,"Back Pain","Yoga","RMDQ,ODI","Unknown","PRO study","Systematic review","USA,Germany,UK","Unknown","Back Pain","Yoga","PRO study","Systematic review","RMDQ,ODI","2015:2018"]
[408,"Wilkens, P., et al. (2010). \"Effect of glucosamine on pain-related disability in patients with chronic low back pain and degenerative lumbar osteoarthritis: a randomized controlled trial.\" Jama 304(1999): 45-52.",null,"Wilkens, P., et al.","Effect of glucosamine on pain-related disability in patients with chronic low back pain and degenerative lumbar osteoarthritis: a randomized controlled trial","CONTEXT: Chronic low back pain (LBP) with degenerative lumbar osteoarthritis (OA) is widespread in the adult population. Although glucosamine is increasingly used by patients with chronic LBP, little is known about its effect in this setting. OBJECTIVE: To investigate the effect of glucosamine in patients with chronic LBP and degenerative lumbar OA. DESIGN, SETTING, AND PARTICIPANTS: A double-blind, randomized, placebo-controlled trial conducted at Oslo University Hospital Outpatient Clinic, Oslo, Norway, with 250 patients older than 25 years of age with chronic LBP (>6 months) and degenerative lumbar OA. INTERVENTIONS: Daily intake of 1500 mg of oral glucosamine (n = 125) or placebo (n = 125) for 6 months, with assessment of effect after the 6-month intervention period and at 1 year (6 months postintervention). MAIN OUTCOME MEASURES: The primary outcome was pain-related disability measured with the Roland Morris Disability Questionnaire (RMDQ). Secondary outcomes were numerical scores from pain-rating scales of patients at rest and during activity, and the quality-of-life EuroQol-5 Dimensions (EQ-5D) instrument. Data collection occurred during the intervention period at baseline, 6 weeks, 3 and 6 months, and again 6 months following the intervention at 1 year. Group differences were analyzed using linear mixed models analysis. RESULTS: At baseline, mean RMDQ scores were 9.2 (95% confidence interval [CI], 8.4-10.0) for glucosamine and 9.7 (95% CI, 8.9-10.5) for the placebo group (P = .37). At 6 months, the mean RMDQ score was the same for the glucosamine and placebo groups (5.0; 95% CI, 4.2-5.8). At 1 year, the mean RMDQ scores were 4.8 (95% CI, 3.9-5.6) for glucosamine and 5.5 (95% CI, 4.7-6.4) for the placebo group. No statistically significant difference in change between groups was found when assessed after the 6-month intervention period and at 1 year: RMDQ (P = .72), LBP at rest (P = .91), LBP during activity (P = .97), and quality-of-life EQ-5D (P = .20). Mild adverse events were reported in 40 patients in the glucosamine group and 46 in the placebo group (P = .48). CONCLUSIONS: Among patients with chronic LBP and degenerative lumbar OA, 6-month treatment with oral glucosamine compared with placebo did not result in reduced pain-related disability after the 6-month intervention and after 1-year follow-up. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00404079."," Jama 304(1999): 45-52.","Norway",2010,"Back Pain","Glucosamine","RMDQ","Adults","PRO study","RCT","Norway","Adults","Back Pain","Glucosamine","PRO study","RCT","RMDQ","2010:2014"]
[409,"Wilkens, P., et al. (2013). \"Prognostic factors of prolonged disability in patients with chronic low back pain and lumbar degeneration in primary care: a cohort study.\" Spine (Phila Pa 1976) 38(1999): 65-74.",null,"Wilkens, P., et al.","Prognostic factors of prolonged disability in patients with chronic low back pain and lumbar degeneration in primary care: a cohort study","STUDY DESIGN: A cohort study with 1-year follow-up. OBJECTIVE: To identify prognostic factors in patients with chronic nonspecific low back pain (LBP). SUMMARY OF BACKGROUND DATA: The factors (e.g., sociodemographical, low back-related, radiological, and biological) associated with persistent pain and disability for patients with chronic nonspecific LBP are uncertain. Furthermore, sparse information exists about the relationship between biological factors like impaired fasting glucose tolerance and chronic nonspecific LBP. METHODS: The participants consisted of 250 patients with nonspecific LBP of more than 6 months duration and degenerative lumbar osteoarthritis. The patients were originally recruited for a randomized controlled trial from the clinics of general practitioners, physiotherapists, and chiropractors. Potential predictors were evaluated at baseline. The outcome was absolute level of pain-related disability (Roland-Morris Disability Questionnaire [RMDQ]) at 1 year. The association between potential prognostic factors and the outcome was analyzed with multivariate linear backward regression. RESULTS: At baseline and 1 year, the RMDQ scores were 9.5 and 5.1 points, respectively. Mean (SD) baseline values for body mass index (BMI), EuroQol (EQ)-index, EQ-visual analogue scale were 25.4 (4.3), 0.60 (0.3), and 61.2 (20.8), respectively. Higher pain-related disability levels (1-year RMDQ score) were associated with 6.1 mmol/L or more fasting glucose level at baseline (beta, 3.7; 95% confidence interval [CI], 1.2-6.1; P = 0.00), baseline pain-related disability (beta 0.2; 95% CI, 0.1-0.4; P = 0.00), BMI (beta, 0.2; 95% CI, 0.1-0.3; P < 0.03), EQ-index (beta, -4.5; 95% CI, 6.9 to 2.1; P = 0.00), and EQ-visual analogue scale (beta, 0.3; 95% CI, -0.6 to -0.0; P = 0.03). However, a limited number of patients had 6.1 mmol/L or more of fasting glucose level at baseline (13/250 patients). The imaging findings, modic changes, and high intensity zones had no predictive ability. CONCLUSION: Increased pain-related disability at 1 year was seen in patients with impaired fasting glucose tolerance, greater pain-related disability, higher BMI, and lower quality of life at baseline."," Spine (Phila Pa 1976) 38(1999): 65-74.","Norway",2013,"Back Pain","Not Specified","RMDQ","Unknown","PRO study","Observational","Norway","Unknown","Back Pain","Not Specified","PRO study","Observational","RMDQ","2010:2014"]
[410,"Williams, N. H., et al. (2003). \"Randomized osteopathic manipulation study (ROMANS): pragmatic trial for spinal pain in primary care.\" Fam Pract 20(6): 662-669.",null,"Williams, N. H., et al.","Randomized osteopathic manipulation study (ROMANS): pragmatic trial for spinal pain in primary care","BACKGROUND: Spinal pain is common and frequently disabling. Management guidelines have encouraged referral from primary care for spinal manipulation. However, the evidence base for these recommendations is weak. More pragmatic trials and economic evaluations have been recommended. OBJECTIVES: Our aim was to assess the effectiveness and health care costs of a practice-based osteopathy clinic for subacute spinal pain. METHODS: A pragmatic randomized controlled trial was carried out in a primary care osteopathy clinic accepting referrals from 14 neighbouring practices in North West Wales. A total of 201 patients with neck or back pain of 2-12 weeks duration were allocated at random between usual GP care and an additional three sessions of osteopathic spinal manipulation. The primary outcome measure was the Extended Aberdeen Spine Pain Scale (EASPS). Secondary measures included SF-12, EuroQol and Short-form McGill Pain Questionnaire. Health care costs were estimated from the records of referring GPs. RESULTS: Outcomes improved more in the osteopathy group than the usual care group. At 2 months, this improvement was significantly greater in EASPS [95% confidence interval (CI) 0.7-9.8] and SF-12 mental score (95% CI 2.7-10.7). At 6 months, this difference was no longer significant for EASPS (95% CI -1.5 to 10.4), but remained significant for SF-12 mental score (95% CI 1.0-9.9). Mean health care costs attributed to spinal pain were significantly greater by 65 UK pounds in the osteopathy group (95% CI 32-155 UK pounds). Though osteopathy also cost 22 UK pounds more in mean total health care cost, this was not significant (95% CI - 159 to 142 UK pounds). CONCLUSION: A primary care osteopathy clinic improved short-term physical and longer term psychological outcomes, at little extra cost. Rigorous multicentre studies are now needed to assess the generalizability of this approach."," Fam Pract 20(6): 662-669.","UK",2003,"Back Pain","Psychosocial","Aberdeen LBP","Unknown","Cost-Effectiveness","RCT","UK","Unknown","Back Pain","Psychosocial","Cost-Effectiveness","RCT","Aberdeen LBP","2000:2004"]
[411,"Wilson, P. L., et al. (2002). \"A multicenter study analyzing the relationship of a standardized radiographic scoring system of adolescent idiopathic scoliosis and the Scoliosis Research Society outcomes instrument.\" Spine (Phila Pa 1976) 27(18): 2036-2040.",null,"Wilson, P. L., et al.","A multicenter study analyzing the relationship of a standardized radiographic scoring system of adolescent idiopathic scoliosis and the Scoliosis Research Society outcomes instrument","STUDY DESIGN: A multicenter study examining the association between radiographic and outcomes measures in adolescent idiopathic scoliosis. OBJECTIVES: To evaluate the association between an objective radiographic scoring system and patient quality of life measures as determined by the Scoliosis Research Society outcomes instrument. SUMMARY OF BACKGROUND DATA: Although surgical correction of scoliosis has been reported to be positively correlated with patient outcomes, studies to date have been unable to demonstrate an association between radiographic measures of deformity and outcomes measures in patients with adolescent idiopathic scoliosis. METHODS: A standardized radiographic deformity scoring system and the Scoliosis Research Society outcome tool were used prospectively in seven scoliosis centers to collect data on patients with adolescent idiopathic scoliosis. A total of 354 data points for 265 patients consisting of those with nonoperative or preoperative curves >or=10 degrees, as well as those with surgically treated curves, were analyzed. Correlation analysis was performed to identify significant relationships between any of the radiographic measures, the Harms Study Group radiographic deformity scores (total, sagittal, coronal), and the seven Scoliosis Research Society outcome domains (Total Pain, General Self-Image, General Function, Activity, Postoperative Self-Image, Postoperative Function, and Satisfaction) as well as Scoliosis Research Society outcomes instrument total scores. Radiographic measures that were identified as significantly correlated with Scoliosis Research Society outcome scores were then entered into a stepwise regression analysis. RESULTS: The coronal measures of thoracic curve and lumbar curve magnitude were found to be significantly correlated with the Total Pain, General Self-Image, and total Scoliosis Research Society scores (P < 0.0001). The thoracic and upper thoracic curve magnitudes were also correlated with General Function (P < 0.002). The \"coronal\" subscore as well as the \"total\" score of the Harms Study Group radiographic scoring system were also significantly correlated with these Scoliosis Research Society domain and total scores. No radiographic measures taken after surgery were significantly correlated with the postoperative domains of the Scoliosis Research Society outcomes instrument. Stepwise regression analysis of these radiographic measures as predictors of Scoliosis Research Society scores resulted in adjusted R2 values of 0.03-0.07 (P < 0.0001). Although these results show that a significant association exists between the radiographic Cobb angle measure of the scoliosis and the Scoliosis Research Society outcomes scores, the low R2 values indicate that variables other than the radiographic appearance of the deformity (e.g., psychosocial, functional) must also be affecting these scores. CONCLUSION: The Cobb angle measure of the major deformity has a small, but statistically significant, correlation with the reported Total Pain, General Self-Image, and General Function as measured by the Scoliosis Research Society outcomes instrument. None of the radiographic measures in this population correlated with postoperative domain scores of the Scoliosis Research Society outcomes tool."," Spine (Phila Pa 1976) 27(18): 2036-2040.","USA",2002,"Spinal Deformity","Surgical","SRS-HRQOL","Adolescents","PRO study","Prospective Observation","USA","Adolescents","Spinal Deformity","Surgical","PRO study","Prospective Observation","SRS-HRQOL","2000:2004"]
[412,"Wong, C. K. H., et al. (2017). \"Mapping the SRS-22r questionnaire onto the EQ-5D-5L utility score in patients with adolescent idiopathic scoliosis.\" PLoS One 12(4): e0175847.",null,"Wong, C. K. H., et al.","Mapping the SRS-22r questionnaire onto the EQ-5D-5L utility score in patients with adolescent idiopathic scoliosis","This is a prospective study to establish prediction models that map the refined Scoliosis Research Society 22-item (SRS-22r) onto EuroQoL-5 dimension 5-level (EQ-5D-5L) utility scores in adolescent idiopathic scoliosis (AIS) patients. Comparison of treatment outcomes in AIS can be determined by cost-utility analysis. However, the mainstay spine-specific health-related quality of life outcome measure, the SRS-22r questionnaire does not provide utility assessment. In this study, AIS patients were prospectively recruited to complete both the EQ-5D-5L and SRS-22r questionnaires by trained interviewers. Ordinary least squares regression was undertaken to develop mapping models, which the validity and robustness were assessed by using the 10-fold cross-validation procedure. EQ-5D-5L utility scores were regressed on demographics, Cobb angle, curve types, treatment modalities, and five domains of the SRS-22r questionnaire. Three models were developed using stepwise selection method. EQ-5D-5L scores were regressed on 1) main effects of SRS-22r subscale scores, 2) as per 1 plus squared and interaction terms, and 3) as per 2 plus demographic and clinical characteristics. Model goodness-of-fit was assessed using R-square, adjusted R-square, and information criteria; whereas the predictive performance was evaluated using root mean square error (RMSE), mean absolute error (MAE), and the proportion of absolute error within the threshold of 0.05 and 0.10. A total of 227 AIS patients with mean age of 15.6 years were recruited. The EQ-5D-5L scores were predicted by four domains of SRS-22r (main effects of 'Function', 'Pain', 'Appearance' and 'Mental Health', and squared term of 'Function' and 'Pain'), and Cobb angle in Model 3 with the best goodness-of-fit (R-square/adjusted R-square: 62.1%/60.9%). Three models demonstrated an acceptance predictive performance in error analysis applying 10-fold cross-validation to three models where RMSE and MAE were between 0.063-0.065 and between 0.039-0.044, respectively. Model 3 was therefore recommended out of three mapping models established in this paper. To our knowledge, this is the first study to map a spine-specific health-related quality of life measure onto EQ-5D-5L for AIS patients. With the consideration and incorporation of demographic and clinical characteristics, over 60% variance explained by mapping model 3 enabled the satisfactory prediction of EQ-5D-5L utility scores from existing SRS-22r data for health economic appraisal of different treatment options."," PLoS One 12(4): e0175847.","China",2017,"Spinal Deformity","Not Specified","SRS-HRQOL","Adolescents","PRO study","Prospective Observation","China","Adolescents","Spinal Deformity","Not Specified","PRO study","Prospective Observation","SRS-HRQOL","2015:2018"]
[413,"Xia, T., et al. (2014). \"Study protocol for patient response to spinal manipulation - a prospective observational clinical trial on physiological and patient-centered outcomes in patients with chronic low back pain.\" BMC Complement Altern Med 14: 292.",null,"Xia, T., et al.","Study protocol for patient response to spinal manipulation - a prospective observational clinical trial on physiological and patient-centered outcomes in patients with chronic low back pain","BACKGROUND: Low back pain (LBP) is a major health issue due to its high prevalence rate and socioeconomic cost. While spinal manipulation (SM) is recommended for LBP treatment by recently published clinical guidelines, the underlying therapeutic mechanisms remain unclear. Spinal stiffness is routinely examined and used in clinical decisions for SM delivery. It has also been explored as a predictor for clinical improvement. Flexion-relaxation phenomenon has been demonstrated to distinguish between LBP and healthy populations. The primary objective of the current study is to collect preliminary estimates of variability and effect size for the associations of these two physiological measures with patient-centered outcomes in chronic LBP patients. Additionally biomechanical characteristics of SM delivery are collected with the intention to explore the potential dose-response relationship between SM and LBP improvement. METHODS/DESIGN: This is a prospective, observational study applying side-lying, high velocity, low amplitude SM as treatment for patients with LBP over a course of 6 weeks. Approximately 80 participants will be enrolled if they present with chronic LBP of 1, 2 or 3 in Quebec Task Force Classification for spinal disorders, a Roland-Morris Disability Questionnaire (RMDQ) score >/= 6, and persistent LBP >/= 2 with a maximum >/= 4 using numerical rating scale. Patient-centered outcomes include LBP using visual analog scale, RMDQ, and PROMIS-29. Lumbar spine stiffness is assessed using palpation, a hand-held instrumented device, and an automated device. Flexion-relaxation is assessed using surface electromyography at the third level of the lumbar spine. Biomechanical characteristics of SM are assessed using a self-reported, itemized description system, as well as advanced kinetic measures that will be applied to estimate forces and moments at the lumbar segment level targeted by SM. DISCUSSION: Beside alterations in material properties of the passive components of the spine, increased neuromuscular activity may also contribute to a stiffened spine. Examining changes in both spinal stiffness and flexion-relaxation along the course of the treatment provides an opportunity to understand if the therapeutic effect of SM is associated with its action on active and/or passive components of the spine. TRIAL REGISTRATION: NCT01670292 on clinicaltrials.gov."," BMC Complement Altern Med 14: 292.","USA",2014,"Back Pain","Not Specified","RMDQ,QBPD","Unknown","PRO study","Prospective Observation","USA","Unknown","Back Pain","Not Specified","PRO study","Prospective Observation","RMDQ,QBPD","2010:2014"]
[414,"Xia, T., et al. (2017). \"Association of lumbar spine stiffness and flexion-relaxation phenomenon with patient-reported outcomes in adults with chronic low back pain - a single-arm clinical trial investigating the effects of thrust spinal manipulation.\" BMC Complement Altern Med 17(1999): 303.",null,"Xia, T., et al.","Association of lumbar spine stiffness and flexion-relaxation phenomenon with patient-reported outcomes in adults with chronic low back pain - a single-arm clinical trial investigating the effects of thrust spinal manipulation","BACKGROUND: Spinal manipulation (SM) is used commonly for treating low back pain (LBP). Spinal stiffness is routinely assessed by clinicians performing SM. Flexion-relaxation ratio (FRR) was shown to distinguish between LBP and healthy populations. The primary objective of this study was to examine the association of these two physiological variables with patient-reported pain intensity and disability in adults with chronic LBP (>12 weeks) receiving SM. METHODS: A single-arm trial provided 12 sessions of side-lying thrust SM in the lumbosacral region over 6 weeks. Inclusion criteria included 21-65 years old, Roland-Morris Disability Questionnaire (RMDQ) score >/= 6 and numerical pain rating score >/= 2. Spinal stiffness and FRR were assessed pre-treatment at baseline, after 2 weeks and after 6 weeks of treatment. Lumbar spine global stiffness (GS) were calculated from the force-displacement curves obtained using i) hand palpation, ii) a hand-held device, and iii) an automated indenter device. Lumbar FRR was assessed during trunk flexion-extension using surface electromyography. The primary outcomes were RMDQ and pain intensity measured by visual analog scale (VAS). Mixed-effects regression models were used to analyze the data. RESULTS: The mean age of the 82 participants was 45 years; 48% were female; and 84% reported LBP >1 year. The mean (standard deviation) baseline pain intensity and RMDQ were 46.1 (18.1) and 9.5 (4.3), respectively. The mean reduction (95% confidence interval) after 6 weeks in pain intensity and RMDQ were 20.1 mm (14.1 to 26.1) and 4.8 (3.7 to 5.8). There was a small change over time in the palpatory GS but not in the hand-held or automated GS, nor in FRR. The addition of each physiologic variable did not affect the model-estimated changes in VAS or RMDQ over time. There was no association seen between physiological variables and LBP intensity. Higher levels of hand-held GS at L3 and automated GS were significantly associated with higher levels of RMDQ (p = 0.02 and 0.03, respectively) and lower levels of flexion and extension FRR were significantly associated with higher levels of RMDQ (p = 0.02 and 0.008, respectively) across the 3 assessment time points. CONCLUSIONS: Improvement in pain and disability observed in study participants with chronic LBP was not associated with the measured GS or FRR. TRIAL REGISTRATION: NCT01670292 on clinicaltrials.gov, August 2, 2012."," BMC Complement Altern Med 17(1999): 303.","USA,Canada",2017,"Back Pain","Not Specified","RMDQ","Adults","PRO study","Clinical trial","USA,Canada","Adults","Back Pain","Not Specified","PRO study","Clinical trial","RMDQ","2015:2018"]
[415,"Xiao, C., et al. (2017). \"Quality of Life and Performance Status From a Substudy Conducted Within a Prospective Phase 3 Randomized Trial of Concurrent Standard Radiation Versus Accelerated Radiation Plus Cisplatin for Locally Advanced Head and Neck Carcinoma: NRG Oncology RTOG 0129.\" Int J Radiat Oncol Biol Phys 97(4): 667-677.",null,"Xiao, C., et al.","Quality of Life and Performance Status From a Substudy Conducted Within a Prospective Phase 3 Randomized Trial of Concurrent Standard Radiation Versus Accelerated Radiation Plus Cisplatin for Locally Advanced Head and Neck Carcinoma: NRG Oncology RTOG 0129","PURPOSE/OBJECTIVE(S): To analyze quality of life (QOL) and performance status (PS) for head and neck cancer (HNC) patients treated on NRG Oncology RTOG 0129 by treatment (secondary outcome) and p16 status, and to examine the association between QOL/PS and survival. METHODS AND MATERIALS: Eligible patients were randomized into either an accelerated-fractionation arm or a standard-fractionation arm, and completed the Performance Status Scale for the Head and Neck (PSS-HN), the Head and Neck Radiotherapy Questionnaire (HNRQ), and the Spitzer Quality of Life Index (SQLI) at 8 time points from before treatment to 5 years after treatment. RESULTS: The results from the analysis of area under the curve showed that QOL/PS was not significantly different between the 2 arms from baseline to year after treatment (P ranged from .39 to .98). The results from general linear mixed models further supported the nonsignificant treatment effects until 5 years after treatment (P=.95, .90, and .84 for PSS-HN Diet, Eating, and Speech, respectively). Before treatment and after 1 year after treatment, p16-positive oropharyngeal cancer (OPC) patients had better QOL than did p16-negative patients (P ranged from .0283 to <.0001 for all questionnaires). However, QOL/PS decreased more significantly from pretreatment to the last 2 weeks of treatment in the p16-positive group than in the p16-negative group (P ranged from .0002 to <.0001). Pretreatment QOL/PS was a significant independent predictor of overall survival, progression-free survival, and local-regional failure but not of distant metastasis (P ranged from .0063 to <.0001). CONCLUSIONS: The results indicated that patients in both arms may have experienced similar QOL/PS. p16-positive patients had better QOL/PS at baseline and after 1 year of follow-up. Patients presenting with better baseline QOL/PS scores had better survival."," Int J Radiat Oncol Biol Phys 97(4): 667-677.","USA,Canada",2017,"Cancer","Radiotherapy","PSSHN","Unknown","PRO study","RCT","USA,Canada","Unknown","Cancer","Radiotherapy","PRO study","RCT","PSSHN","2015:2018"]
[416,"Xue, X., et al. (2016). \"Surgical Versus Nonsurgical Treatment for High-Grade Spondylolisthesis in Children and Adolescents: A Systematic Review and Meta-Analysis.\" Medicine (Baltimore) 95(11): e3070.",null,"Xue, X., et al.","Surgical Versus Nonsurgical Treatment for High-Grade Spondylolisthesis in Children and Adolescents: A Systematic Review and Meta-Analysis","The optimal management of high-grade spondylolisthesis in children and adolescent is controversial. There is a paucity of literature regarding operatively or nonoperative management in this setting. To assessment of the current state of evidence regarding high-grade spondylolisthesis treatment with the goal of obtaining outcome comparisons in these patients managed either operatively or nonoperatively. We performed a systematic literature search up to November 2014, using Medline, Embase, and The Cochrane Library. The analysis and eligibility criteria were documented according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA-guidelines) and Cochrane Back Review Group editorial board. We used the Newcastle-Ottawa quality assessment scale (NOS-scale) to assess the quality. Five observational studies were considered eligible for analysis based on the evaluation of 1596 identified papers. The mean overall difference in the Scoliosis Research Society questionnaire 22 between the surgical and nonsurgical groups was not statistically significant (95% CI: -0.17 to 0.21, P = 0.84). The pooled mean difference in progression of slip between the surgical and nonsurgical groups was no significant difference (OR: 0.47, 95% CI: 0.12-1.81, P = 0.27, I = 0%). Because of the preponderance of uncontrolled case series, low-quality evidence indicates that the quality of life and progression of slips was no significant difference between surgery and nonoperation group. Nonoperative patients had no radiologic progression of their slip during the follow-up period."," Medicine (Baltimore) 95(11): e3070.","China",2016,"Spinal Deformity,Spondylosis","Surgical","SRS-HRQOL","Adolescents","PRO study","Systematic review","China","Adolescents","Spinal Deformity,Spondylosis","Surgical","PRO study","Systematic review","SRS-HRQOL","2015:2018"]
[417,"Yi, H., et al. (2014). \"Reliability and validity of simplified Chinese version of Swiss Spinal Stenosis Questionnaire for patients with degenerative lumbar spinal stenosis.\" Spine (Phila Pa 1976) 39(10): 820-825.",null,"Yi, H., et al.","Reliability and validity of simplified Chinese version of Swiss Spinal Stenosis Questionnaire for patients with degenerative lumbar spinal stenosis","STUDY DESIGN: This was a prospective clinical validation study. OBJECTIVE: To evaluate the reliability and validity of the adapted simplified Chinese version of Swiss Spinal Stenosis (SC-SSS) Questionnaire. SUMMARY OF BACKGROUND DATA: The SSS Questionnaire is a reliable and valid instrument to assess the perception of function and pain for patients with degenerative lumbar spinal stenosis. However, there is no culturally adapted SSS Questionnaire for use in mainland China. METHODS: This was a prospective clinical validation study. The adaption was conducted according to International Quality of Life Assessment Project guidelines. To examine the psychometric properties of the adapted SC-SSS Questionnaire, a sample of 105 patients with lumbar spinal stenosis were included. Thirty-two patients were randomly selected to evaluate the test-retest reliability. Reliability assessment of the SC-SSS Questionnaire was determined by calculating Cronbach alpha and intraclass coefficient values. Concurrent validity was assessed by correlating SC-SSS Questionnaire scores with relevant domains of the 36-Item Short Form Health Survey. RESULTS: Cronbach alpha of the symptom severity scale, physical function scale, patients, and satisfaction scale of SC-SSS Questionnaire are 0.89, 0.86, 0.91, respectively, which revealed very good internal consistency. The test-retest reproducibility was found to be excellent with the intraclass correlation coefficient of 0.93, 0.91, and 0.95. In terms of concurrent validity, SC-SSS Questionnaire had good correlation with physical functioning and bodily pain of 36-Item Short Form Health Survey (r = 0.663, 0.653) and low correlation with mental health (r = 0.289). The physical function scale had good correlation with physical functioning of 36-Item Short Form Health Survey (r = 0.637), whereas the rest had moderate correlation. The satisfaction scale score was highly correlated with the change in the symptom severity (r = 0.71) and physical function (r = 0.68) scale score. CONCLUSION: The SC-SSS Questionnaire showed satisfactory reliability and validity in the evaluation of functionality in patients with lumbar spinal stenosis who are experiencing neurogenic claudication. It is simple and easy to use and can be recommended in clinical and research practice in mainland China. LEVEL OF EVIDENCE: 3."," Spine (Phila Pa 1976) 39(10): 820-825.","China",2014,"Spine Disease","Not Specified","SSSQ","Unknown","PRO study","Prospective Observation","China","Unknown","Spine Disease","Not Specified","PRO study","Prospective Observation","SSSQ","2010:2014"]
[418,"Yildirim, K., et al. (2009). \"Gabapentin monotherapy in patients with chronic radiculopathy: the efficacy and impact on life quality.\" J Back Musculoskelet Rehabil 22(1999): 17-20.",null,"Yildirim, K., et al.","Gabapentin monotherapy in patients with chronic radiculopathy: the efficacy and impact on life quality","OBJECTIVE: The purpose of this, open-label, non-comparative study, was to evaluate the efficacy on quality of life and the efficacy of gabapentin monotherapy in patients with chronic radiculopathy. METHODS: Thirty-five patients with radicular pain and diagnosed as L4, L5 or S1 radiculopathy were treated with oral gabapentin from a total of 300 mg per day once up to a total of 1800 mg per day divided in 3 doses for eight-week trial period. Quality of life, functional disability and psychological mood of the patients were assessed using the Nottingham Healthy Profile (NHP), Oswestry Low Back Pain Disability Questionnaire (ODQ) and Beck Depression Inventory (BDI). RESULTS: Of the patients (n = 35), 25 were females and 10 were males (mean age: 41.8 +/- 10.4, range: 24-60 years); mean radiculopathy duration was 16.4 +/- 14.2 months (range: 3-48 months). The pain intensity at rest, quality of life, functional disability and depression scores were determined significantly improved after treatment and 4 months compared to baseline scores (p < 0.001). 1.5 points compared to baseline for at pain rest and 15 points improvement on the ODQ were obtained. CONCLUSION: Gabapentin may provide benefits in terms of alleviation of pain and overall quality of life in patients with chronic radiculopathy."," J Back Musculoskelet Rehabil 22(1999): 17-20.","Turkey",2009,"Back Pain,Radiculopathy","Gabapentin","Oswestry","Adults","PRO study","Observational","Turkey","Adults","Back Pain,Radiculopathy","Gabapentin","PRO study","Observational","Oswestry","2005:2009"]
[419,"Yoon, S. H., et al. (2009). \"Comparison of 3 needle sizes for trigger point injection in myofascial pain syndrome of upper- and middle-trapezius muscle: a randomized controlled trial.\" Arch Phys Med Rehabil 90(8): 1332-1339.",null,"Yoon, S. H., et al.","Comparison of 3 needle sizes for trigger point injection in myofascial pain syndrome of upper- and middle-trapezius muscle: a randomized controlled trial","OBJECTIVES: To investigate (1999) the relation between needle diameter and treatment efficacy of myofascial pain syndrome and (2) the relation between needle diameter and pain intensity during injection. DESIGN: Randomized controlled trial. SETTING: University-affiliated tertiary-care hospital. PARTICIPANTS: Volunteers (N=77) with myofascial pain syndrome affecting upper- and middle-trapezius muscles with at least 3 months' duration of pain. INTERVENTION: Participants were randomly assigned to receive trigger point injections on 1 side of the trapezius with a 21-, 23-, or 25-gauge needle. After a 1-time injection, participants were followed up for 14 days. Participants and the assessor were blinded for group assignment. MAIN OUTCOME MEASURES: Treatment efficacy was measured with the visual analog scale (VAS; at pretreatment, and posttreatment on days 1, 4, 7, 14) for neck and upper-back pain, the Neck Disability Index (NDI; at pretreatment, and posttreatment on days 7, 14), and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36, at pretreatment and posttreatment on days 7, 14) for health-related quality of life. Pain intensity during injection was evaluated immediately after injection with VAS. RESULTS: VAS scores for posttreatment on days 4, 7, and 14 decreased significantly compared with pretreatment scores in all groups; NDI scores on days 7 and 14 decreased significantly compared with pretreatment scores in all groups; SF-36 scores on days 7 and 14 decreased significantly compared with pretreatment scores in the 21- and 23-gauge needle groups; and SF-36 score on day 14 showed significant difference between the 21- and 25-gauge needle groups. For pain intensity during injection, VAS scores indicated no significant difference between the 3 groups. CONCLUSIONS: No difference between the needle types was observed in terms of VAS or NDI, or in terms of pain intensity felt by patients during injection. In terms of SF-36 scores, injections with 21- or 23-gauge needles were found to be more effective. However, a well-controlled investigation is needed to explore the effect of needle thickness on health-related quality of life."," Arch Phys Med Rehabil 90(8): 1332-1339.","Republic of Korea",2009,"Back Pain","Not Specified","NDI","Unknown","PRO study","RCT","Republic of Korea","Unknown","Back Pain","Not Specified","PRO study","RCT","NDI","2005:2009"]
[420,"Yuan, J., et al. (2009). \"Different frequencies of acupuncture treatment for chronic low back pain: an assessor-blinded pilot randomised controlled trial.\" Complement Ther Med 17(3): 131-140.",null,"Yuan, J., et al.","Different frequencies of acupuncture treatment for chronic low back pain: an assessor-blinded pilot randomised controlled trial","OBJECTIVES: To examine the feasibility of a main RCT to compare the effectiveness of two frequencies (2 versus 5 times/week) of acupuncture treatment for chronic low back pain (LBP). METHODS: Participants (n=30) with chronic LBP were randomised into two groups to receive 10 acupuncture treatments: Low Frequency Group, 2 times/week for five weeks (n=15); High Frequency Group, 5 times/week for two weeks (n=15). The following outcomes were measured blindly at baseline, 2 weeks, 5 weeks, 3 months and 1 year: pain on a VAS, functional disability using the RMDQ, quality of life using the Measure Yourself Medical Outcome Profile (MYMOP-2), psychological impact with the Coping Strategies Questionnaire (CSQ) and Pain Locus of Control (PLC) questionnaire. Two objective outcomes, the Shuttle Walk Test (SWT) and Lateral Trunk Flexibility (LTF), were also measured. RESULTS: The compliance rate was 100% for each group. Some of the measurements were shown to be sensitive (VAS, RMDQ, MYMOP-2 Wellbeing). 66-330 participants would be required for a fully powered non-inferiority trial. The groups were balanced at baseline for LBP and demographic characteristics. There were no significant differences between the groups in terms of any of the outcomes, at each follow-up time point. It was notable however that the clinically important improvement in terms of pain, functional disability, quality of life, and SWT in both groups was achieved within the first two weeks, which was maintained at one year follow-up. CONCLUSIONS: It is feasible to conduct a main RCT, to compare different frequencies of acupuncture for LBP, using sensitive measurements. Also the trend for early clinically important improvement within a minimum of four measurements is worthy of further study."," Complement Ther Med 17(3): 131-140.","UK",2009,"Back Pain","Acupuncture","RMDQ","Unknown","PRO study","RCT","UK","Unknown","Back Pain","Acupuncture","PRO study","RCT","RMDQ","2005:2009"]
[421,"Zheng, Y., et al. (2015). \"Tolerability of Biphasic-Release Hydrocodone Bitartrate/Acetaminophen Tablets (MNK-155): A Phase III, Multicenter, Open-Label Study in Patients With Osteoarthritis or Chronic Low Back Pain.\" Clin Ther 37(6): 1235-1247.",null,"Zheng, Y., et al.","Tolerability of Biphasic-Release Hydrocodone Bitartrate/Acetaminophen Tablets (MNK-155): A Phase III, Multicenter, Open-Label Study in Patients With Osteoarthritis or Chronic Low Back Pain","PURPOSE: This study aimed to assess the tolerability of the extended use (</=35 days) of MNK-155, a biphasic (immediate-release/extended-release) hydrocodone bitartrate/N-acetyl-p-aminophenol (acetaminophen) (IR/ER HB/APAP) 7.5/325-mg fixed-dose combination analgesic agent, in patients with chronic noncancer pain (CNCP) caused by osteoarthritis or chronic low back pain. IR/ER HB/APAP tablets deliver 25% of the HB dose and 50% of the APAP dose by IR and the remainder by ER over a 12-hour dosing interval. Although IR/ER HB/APAP is being developed for the management of moderate to severe acute pain, this model of CNCP was used for assessing tolerability over a term longer than would be possible in a model of acute pain. METHODS: This Phase III, multicenter, open-label study enrolled patients with moderate to severe OA (knee or hip) pain despite the use of nonopioid or opioid analgesic agents, or with moderate to severe CLBP present for several hours per day for >/=3 months. Patients received a 3-tablet initial dose of IR/ER HB/APAP (total dose, 22.5/975 mg) on day 1, followed by 2 tablets of IR/ER HB/APAP (total dose, 15/650 mg) q12h for up to 35 days. Tolerability, the primary end point, was assessed using time to treatment discontinuation, the prevalence of treatment-emergent adverse events (TEAEs), vital sign measurements, pulse oximetry, clinical laboratory tests, and compliance. Secondary outcomes included the modified Brief Pain Inventory-Short Form, the Western Ontario and McMaster Universities Arthritis Index, and The Roland-Morris Low Back Pain and Disability Questionnaire. FINDINGS: Of the 153 patients enrolled (95 women [62.1%]; mean age, 53.9 [14.5] years; OA, n = 73; CLBP, n = 80), 37 (24.2%) discontinued the study early (mean time to discontinuation, 21.3 days). Thirteen patients (8.5%) discontinued because of TEAEs. A total of 88 patients (57.5%) reported >/=1 TEAE, 65 (42.5%) of whom experienced AEs considered by the investigator as treatment related. The most frequent TEAEs were nausea (16.3%), somnolence (14.4%), and constipation (11.1%). Eight severe TEAEs were experienced by 6 (3.9%) patients and included single occurrences of nausea, fatigue, nasopharyngitis, elevated liver enzymes, headache, nightmare, and ejaculation delay. No serious treatment-related AEs were reported. Clinically significant changes in laboratory values were reported in 13 patients, 6 of whom had abnormal liver function test results that did not meet Hy's law criteria for acute liver failure. Most laboratory abnormalities were mild and transient. Measures of pain intensity, function, and quality of life improved from baseline but in an open-label study these changes cannot be attributed to treatment. IMPLICATIONS: The safety profile of IR/ER HB/APAP during extended use was consistent with those of other low-dose opioid/APAP combination products. IR/ER HB/APAP is intended for acute pain; its efficacy for relief of CNCP would require further evaluation in an active- or placebo-controlled study. ClinicalTrials.gov Identifier: NCT01722864."," Clin Ther 37(6): 1235-1247.","USA",2015,"Back Pain,Cancer","MNK-155","RMDQ","Adults","PRO study","Clinical trial","USA","Adults","Back Pain,Cancer","MNK-155","PRO study","Clinical trial","RMDQ","2015:2018"]

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[null,null,"Locations",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null," "]
[null,null,"Interventions",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null," "]
[null,null,"Diseases",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null," ",null," ",null,null," "]
[null,null,"PRO tools"]
[null,null,"Sub-populations"]
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[null,null,"Study methodologies"]
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[null,{"$f":"IF(CF3=\"\",\"\",CF3)","v":1960},null,null,{"$f":"IF(CG3=\"\",\"\",CG3)","v":1989},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"C2","C2","Interventions",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1962,false,"Segment count",1995,1999,"1995:1999","Diseases","Brazil","Bone Grafting","Cardiovascular Disease","Aberdeen LBP","Children","PRO study","Observational",null,null,null,null,"Narrative review"]
[null,{"$f":"IF(CF4=\"\",\"\",CF4)","v":1990},null,null,{"$f":"IF(CG4=\"\",\"\",CG4)","v":1994},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"C3","C3","Diseases",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"locationCategories",null,null,null,1963,false,null,2000,2004,"2000:2004","PRO tools","Canada","Brace","Cervical Myelopathy","BBQ","Elderly","Protocol","Prospective Observation",null,null,null,null,"Observational"]
[null,1995,null,null,1999,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"C4","C4","Sub-populations",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"interventionCategories",null,null,null,1964,false,null,2005,2009,"2005:2009","subPopulations","China","CBT","Degenerative Disk Disease","BIS","General","Tool Validation","RCT",null,null,null,null,"Prospective Observation"]
[null,2000,null,null,2004,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"C5","C5","PRO tools",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"diseaseCategories",null,null,null,1965,false,null,2010,2014,"2010:2014","Study types","Denmark","Chiropractic","Diabetes","BOURNEMOUTH","Infants",null,"Retrospective review",null,null,null,null,"RCT"]
[null,2005,null,null,2009,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Study types",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"protoolCategories",null,null,null,1966,false,null,2015,2018,"2015:2018","Study methodologies","Egypt","Duloxetine","Functional Dyspepsia","Bothersomeness","Therapists",null,"Systematic review",null,null,null,null,"Retrospective review"]
[null,2010,null,null,2014,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Study methodologies",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"subpopulationCategories",null,null,null,1967,false,null,null,null,"",null,"Finland","Education","Low Birth Weight","BrQ","Unknown",null,null,null,null,null,null,"Systematic review"]
[null,2015,null,null,2018,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Location categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"studytypeCategories",null,null,null,1968,false,null,null,null,"",null,"France","Electrotherapy","Myofascial pain syndrome","CNFDS",null,null,null,null,null,null,null,""]
[null,{"$f":"IF(CF10=\"\",\"\",CF10)","v":""},null,null,{"$f":"IF(CG10=\"\",\"\",CG10)","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Intervention categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"studymethodCategories",null,null,null,1969,false,null,null,null,"",null,"Germany","Exercise","Neck Pain","CSOQ",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Disease categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1970,false,null,null,null,"",null,"Greece","Gabapentin","Neuropathic Pain","CSSS",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Sub-populations categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1971,false,null,null,null,"",null,"Hungary","Glucocorticoids","Osteoporosis","EOSQ",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"PRO tool categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1972,false,null,null,null,"",null,"India","Glucosamine","Pectus Excavatum","HD-DQI",null,null,null,null,null,null,null,""]
[null,"",null,null,{"$f":"IF(CG14=\"\",\"\",CG14)","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Study type categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1973,false,null,null,null,"",null,"Iran","Ketamine","Radiculopathy","HNQOL",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Study methodology categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1974,false,null,null,null,"",{"$f":"COLUMN()","v":87},"Ireland","Laser Therapy","Schizophrenia","ICF",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1975,false,null,null,null,"",null,"Israel","MNK-155","Spinal Deformity","JOACMEQ",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1976,false,null,null,null,"",null,"Italy","Manipulations","Spinal Fracture","LBOS",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1977,false,null,null,null,"",null,"Japan","Massage","Spinal Fusion","LSDI",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1978,false,null,null,null,"",null,"Lebanon","NSAID","Spine Disease","LSOQ",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1979,false,null,null,null,"",null,"Netherlands","Not Specified","Spondylosis","Maine",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1980,false,null,null,null,"",null,"New Zealand","Opioid","Stroke","NASS-L",null,null,null,null,null,null,null,""]
[null,"",22,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1981,false,null,null,null,"",null,"Norway","Osteopathy","Trauma","NDI",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1982,false,null,null,null,"",null,"Philippines","Other","Unspecified","NPDIQ",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1983,false,null,null,null,"",null,"Poland","Oxiplex gel",null,"NPDS",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1984,false,null,null,null,"",null,"Republic of Korea","Physical Therapy",null,"NRS",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1985,false,null,null,null,"",null,"Serbia","Pregabalin",null,"Northwick",null,null,null,null,null,null,null,""]
[null,null,null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1986,false,null,null,null,"",null,"Singapore","Psychosocial",null,"Nurick",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1987,false,null,null,null,"",null,"South Africa","Radiotherapy",null,"ODI",null,null,null,null,null,null,null,""]
[null,null,null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1988,false,null,null,null,{"$f":"IF(CF31<>\"\",_xlfn.CONCAT(CF31,\":\",CG31),\"\")","v":""},null,"Spain","Rehabilitation",null,"Odom",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1989,false,null,null,null,"",null,"Sweden","Surgical",null,"Oswestry",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1990,true,null,null,null,"",null,"Switzerland","Topiramate",null,"PSSHN",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1991,false,null,null,null,"",null,"Taiwan","Tramadol",null,"Pectus",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1992,false,null,null,null,"",null,"Thailand","Ultrasound",null,"QBPD",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1993,false,null,null,null,"",null,"Turkey","Yoga",null,"QLPSD",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1994,false,null,null,null,"",null,"UK",null,null,"QLSDP",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1995,true,null,null,null,"",null,"USA",null,null,"RMDQ",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1996,false,null,null,null,"",null,"Unknown",null,null,"SAQ",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1997,false,null,null,null,{"$f":"IF(CF40<>\"\",_xlfn.CONCAT(CF40,\":\",CG40),\"\")","v":""},null,null,null,null,"SCI",null,null,null,null,null,null,null,""]
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