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Objective: To investigate the cost-effectiveness of exercise therapy in the treatment of patients with non-specific neck pain and low back pain., Design: Systematic review of economic evaluations., Data Sources: The search was performed in 5 clinical and 3 economic electronic databases., Eligibility Criteria for Selecting Studies: We included economic evaluations performed alongside randomised controlled trials. Differences in costs and effects were pooled in a meta-analysis, if possible, and incremental cost-utility ratios (ICUR) were descriptively analysed., Results: Twenty-two studies were included. On average, exercise therapy was associated with lower costs and larger effects for quality-adjusted life-year (QALY) in comparison with usual care for subacute and chronic low back pain from a healthcare perspective (based on ICUR). Exercise therapy had similar costs and effect for QALY in comparison with other interventions for neck pain from a societal perspective, and subacute and chronic low back pain from a healthcare perspective. There was limited or inconsistent evidence on the cost-effectiveness of exercise therapy compared with usual care for neck pain and acute low back pain, other interventions for acute low back pain and different types of exercise therapy for neck pain and low back pain., Conclusions: Exercise therapy seems to be cost-effective compared with usual care for subacute and chronic low back pain. Exercise therapy was not (more) cost-effective compared with other interventions for neck pain and low back pain. The cost-utility estimates are rather uncertain, indicating that more economic evaluations are needed., Registration: PROSPERO, CRD42017059025., Competing Interests: Competing interests: None declared., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2019. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objective: To review the diagnostic accuracy of the Ottawa Ankle and Midfoot Rules and explore if clinical features and/or methodological quality of the study influence diagnostic accuracy estimates., Design: Systematic review with meta-analysis., Data Sources: MEDLINE, EMBASE, CINAHL, SPORTDiscus and Cochrane Library., Eligibility Criteria for Selecting Studies: Primary diagnostic studies reporting the accuracy of the Rules in people with ankle and/or midfoot injury were retrieved. Diagnostic accuracy estimates, overall and for subgroups (patient's age, profession of the assessor and setting of application), were made. Sensitivity analyses included studies with a low risk of bias and studies where all patients received radiographs., Results: 66 studies were included. Ankle and Midfoot Rules presented similar accuracies, which were homogeneous and high for sensitivity and negative likelihood ratios and poor and heterogeneous for specificity and positive likelihood ratios (mean, 95% CI pooled sensitivity of Ankle Rules: 99.4%, 97.9% to 99.8%; specificity: 35.3%, 28.8% to 42.3%). Sensitivity of the Ankle Rules was higher in adults than in children, but the profession of the assessor did not appear to influence accuracy. Specificity was higher for Midfoot than for Ankle Rules. There were not enough studies to allow comparison according to setting of application. Studies with a low risk of bias and where all patients received radiographs provided lower accuracy estimates. Specificity heterogeneity was not explained by assessor training, use of imaging in all patients and low risk of bias., Conclusions: Study features and the methodological quality influence estimates of the diagnostic accuracy of the Ottawa Ankle and Midfoot Rules., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Study Design: Longitudinal observational cohort., Background: The impact of ankle fracture on physical activity and sitting time and the course of recovery of physical activity are unclear., Objectives: To assess the course of recovery of physical activity after ankle fracture and the extent to which this population may be less physically active and more sedentary than the general population., Methods: A cohort of individuals with ankle fracture was derived from a randomized trial and assessed with the International Physical Activity Questionnaire-Short Form (IPAQ-SF) at immobilization removal and 1, 3, and 6 months later. Total metabolic equivalent (MET) minutes per week were calculated to evaluate the course of recovery of physical activity. Sitting time (minutes per day) and the percentage of those who met the World Health Organization physical activity guidelines were calculated. Normative data were derived from a population-based cohort study that assessed physical activity using the IPAQ-SF., Results: In people with ankle fracture (n = 214), physical activity increased in the first month (from a median of 99 at immobilization removal to 979 MET min/wk) and leveled off by 6 months (1386 MET min/wk). Only 22% of the ankle fracture cohort met World Health Organization guidelines at immobilization removal, compared to 80% of the cohort from the general population (P<.001). This difference diminished over time. Sitting time in the ankle fracture cohort was higher than population norms at all time points (P<.001)., Conclusion: People with ankle fracture are less physically active and more sedentary than the general population. Strategies to increase physical activity must be considered. LEVEL OF EVIDENCE Prognosis, level 4.

Objectives: The Douleur Neuropathique 4 (DN4), ID Pain, Leeds Assessment of Neuropathic Symptoms and Signs (LANSS), PainDETECT, and Neuropathic Pain Questionnaire have been recommended as screening questionnaires for neuropathic pain. This systematic review aimed to evaluate the measurement properties (eg, criterion validity and reliability) of these questionnaires., Study Design and Setting: Online database searches were conducted and two independent reviewers screened studies and extracted data. Methodological quality of included studies and the measurement properties were assessed against established criteria. A modified Grading of Recommendations Assessment, Development and Evaluation approach was used to summarize the level of evidence., Results: Thirty-seven studies were included. Most studies recruited participants from pain clinics. The original version of the DN4 (French) and Neuropathic Pain Questionnaire (English) had the most number of satisfactory measurement properties. The ID Pain (English) demonstrated satisfactory hypothesis testing and reliability, but all other properties tested were unsatisfactory. The LANSS (English) was unsatisfactory for all properties, except specificity. The PainDETECT (English) demonstrated satisfactory hypothesis testing and criterion validity. In general, the cross-cultural adaptations had less evidence than the original versions., Conclusion: Overall, the DN4 and Neuropathic Pain Questionnaire were most suitable for clinical use. These screening questionnaires should not replace a thorough clinical assessment., (Crown Copyright © 2015. Published by Elsevier Inc. All rights reserved.)

Purpose: Inconsistent reporting of outcomes in clinical trials of patients with non-specific low back pain (NSLBP) hinders comparison of findings and the reliability of systematic reviews. A core outcome set (COS) can address this issue as it defines a minimum set of outcomes that should be reported in all clinical trials. In 1998, Deyo et al. recommended a standardized set of outcomes for LBP clinical research. The aim of this study was to update these recommendations by determining which outcome domains should be included in a COS for clinical trials in NSLBP., Methods: An International Steering Committee established the methodology to develop this COS. The OMERACT Filter 2.0 framework was used to draw a list of potential core domains that were presented in a Delphi study. Researchers, care providers and patients were invited to participate in three Delphi rounds and were asked to judge which domains were core. A priori criteria for consensus were established before each round and were analysed together with arguments provided by panellists on importance, overlap, aggregation and/or addition of potential core domains. The Steering Committee discussed the final results and made final decisions., Results: A set of 280 experts was invited to participate in the Delphi; response rates in the three rounds were 52, 50 and 45%. Of 41 potential core domains presented in the first round, 13 had sufficient support to be presented for rating in the third round. Overall consensus was reached for the inclusion of three domains in this COS: 'physical functioning', 'pain intensity' and 'health-related quality of life'. Consensus on 'physical functioning' and 'pain intensity' was consistent across all stakeholders, 'health-related quality of life' was not supported by the patients, and all the other domains were not supported by two or more groups of stakeholders. Weighting all possible argumentations, the Steering Committee decided to include in the COS the three domains that reached overall consensus and the domain 'number of deaths'., Conclusions: The following outcome domains were included in this updated COS: 'physical functioning', 'pain intensity', 'health-related quality of life' and 'number of deaths'. The next step for the development of this COS will be to determine which measurement instruments best measure these domains.

Objective: To investigate the efficacy and safety of paracetamol (acetaminophen) in the management of spinal pain and osteoarthritis of the hip or knee., Design: Systematic review and meta-analysis., Data Sources: Medline, Embase, AMED, CINAHL, Web of Science, LILACS, International Pharmaceutical Abstracts, and Cochrane Central Register of Controlled Trials from inception to December 2014., Eligibility Criteria for Selecting Studies: Randomised controlled trials comparing the efficacy and safety of paracetamol with placebo for spinal pain (neck or low back pain) and osteoarthritis of the hip or knee., Data Extraction: Two independent reviewers extracted data on pain, disability, and quality of life. Secondary outcomes were adverse effects, patient adherence, and use of rescue medication. Pain and disability scores were converted to a scale of 0 (no pain or disability) to 100 (worst possible pain or disability). We calculated weighted mean differences or risk ratios and 95% confidence intervals using a random effects model. The Cochrane Collaboration's tool was used for assessing risk of bias, and the GRADE approach was used to evaluate the quality of evidence and summarise conclusions., Results: 12 reports (13 randomised trials) were included. There was "high quality" evidence that paracetamol is ineffective for reducing pain intensity (weighted mean difference -0.5, 95% confidence interval -2.9 to 1.9) and disability (0.4, -1.7 to 2.5) or improving quality of life (0.4, -0.9 to 1.7) in the short term in people with low back pain. For hip or knee osteoarthritis there was "high quality" evidence that paracetamol provides a significant, although not clinically important, effect on pain (-3.7, -5.5 to -1.9) and disability (-2.9, -4.9 to -0.9) in the short term. The number of patients reporting any adverse event (risk ratio 1.0, 95% confidence interval 0.9 to 1.1), any serious adverse event (1.2, 0.7 to 2.1), or withdrawn from the study because of adverse events (1.2, 0.9 to 1.5) was similar in the paracetamol and placebo groups. Patient adherence to treatment (1.0, 0.9 to 1.1) and use of rescue medication (0.7, 0.4 to 1.3) was also similar between groups. "High quality" evidence showed that patients taking paracetamol are nearly four times more likely to have abnormal results on liver function tests (3.8, 1.9 to 7.4), but the clinical importance of this effect is uncertain., Conclusions: Paracetamol is ineffective in the treatment of low back pain and provides minimal short term benefit for people with osteoarthritis. These results support the reconsideration of recommendations to use paracetamol for patients with low back pain and osteoarthritis of the hip or knee in clinical practice guidelines., Systematic Review Registration: PROSPERO registration number CRD42013006367., (© Machado et al 2015.)

Background: Regular paracetamol is the recommended first-line analgesic for acute low-back pain; however, no high-quality evidence supports this recommendation. We aimed to assess the efficacy of paracetamol taken regularly or as-needed to improve time to recovery from pain, compared with placebo, in patients with low-back pain., Methods: We did a multicentre, double-dummy, randomised, placebo controlled trial across 235 primary care centres in Sydney, Australia, from Nov 11, 2009, to March 5, 2013. We randomly allocated patients with acute low-back pain in a 1:1:1 ratio to receive up to 4 weeks of regular doses of paracetamol (three times per day; equivalent to 3990 mg paracetamol per day), as-needed doses of paracetamol (taken when needed for pain relief; maximum 4000 mg paracetamol per day), or placebo. Randomisation was done according to a centralised randomisation schedule prepared by a researcher who was not involved in patient recruitment or data collection. Patients and staff at all sites were masked to treatment allocation. All participants received best-evidence advice and were followed up for 3 months. The primary outcome was time until recovery from low-back pain, with recovery defined as a pain score of 0 or 1 (on a 0-10 pain scale) sustained for 7 consecutive days. All data were analysed by intention to treat. This study is registered with the Australian and New Zealand Clinical Trial Registry, number ACTN 12609000966291., Findings: 550 participants were assigned to the regular group (550 analysed), 549 were assigned to the as-needed group (546 analysed), and 553 were assigned to the placebo group (547 analysed). Median time to recovery was 17 days (95% CI 14-19) in the regular group, 17 days (15-20) in the as-needed group, and 16 days (14-20) in the placebo group (regular vs placebo hazard ratio 0·99, 95% CI 0·87-1·14; as-needed vs placebo 1·05, 0·92-1·19; regular vs as-needed 1·05, 0·92-1·20). We recorded no difference between treatment groups for time to recovery (adjusted p=0·79). Adherence to regular tablets (median tablets consumed per participant per day of maximum 6; 4·0 [IQR 1·6-5·7] in the regular group, 3·9 [1·5-5·6] in the as-needed group, and 4·0 [1·5-5·7] in the placebo group), and number of participants reporting adverse events (99 [18·5%] in the regular group, 99 [18·7%] in the as-needed group, and 98 [18·5%] in the placebo group) were similar between groups., Interpretation: Our findings suggest that regular or as-needed dosing with paracetamol does not affect recovery time compared with placebo in low-back pain, and question the universal endorsement of paracetamol in this patient group., Funding: National Health and Medical Research Council of Australia and GlaxoSmithKline Australia., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Background: Evidence suggests that brief physiotherapy programmes are as effective for acute whiplash-associated disorders as more comprehensive programmes; however, whether this also holds true for chronic whiplash-associated disorders is unknown. We aimed to estimate the effectiveness of a comprehensive exercise programme delivered by physiotherapists compared with advice in people with a chronic whiplash-associated disorder., Methods: PROMISE is a two group, pragmatic randomised controlled trial in patients with chronic (>3 months and <5 years) grade 1 or 2 whiplash-associated disorder. Participants were randomly assigned by a computer-generated randomisation schedule to receive either the comprehensive exercise programme (20 sessions) or advice (one session and telephone support). Sealed opaque envelopes were used to conceal allocation. The primary outcome was pain intensity measured on a 0-10 scale. Outcomes were measured at baseline, 14 weeks, 6 months, and 12 months by a masked assessor. Analysis was by intention to treat, and treatment effects were calculated with linear mixed models. The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12609000825257., Findings: 172 participants were allocated to either the comprehensive exercise programme (n=86) or advice group (n=86); 157 (91%) were followed up at 14 weeks, 145 (84%) at 6 months, and 150 (87%) at 12 months. A comprehensive exercise programme was not more effective than advice alone for pain reduction in the participants. At 14 weeks the treatment effect on a 0-10 pain scale was 0·0 (95% CI -0·7 to 0·7), at 6 months 0·2 (-0·5 to 1·0), and at 12 months -0·1 (-0·8 to 0·6). CNS hyperexcitability and symptoms of post-traumatic stress did not modify the effect of treatment. We recorded no serious adverse events., Interpretation: We have shown that simple advice is equally as effective as a more intense and comprehensive physiotherapy exercise programme. The need to identify effective and affordable strategies to prevent and treat acute through to chronic whiplash associated disorders is an important health priority. Future avenues of research might include improving understanding of the mechanisms responsible for persistent pain and disability, investigating the effectiveness and timing of drugs, and study of content and delivery of education and advice., Funding: The National Health and Medical Research Council of Australia, Motor Accidents Authority of New South Wales, and Motor Accident Insurance Commission of Queensland., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Objectives: Expenditure on research has grown substantially; however, a major challenge for conducting successful clinical research is the efficient recruitment of participants. We investigated factors influencing the rate at which general practitioners (GPs) recruit participants to a randomized controlled trial., Study Design and Setting: We used data on 363 GPs recruiting participants for a randomized controlled trial of low back pain. Multivariate negative binomial regression was used to determine associations of characteristics of the GP and study operational aspects with the recruitment rate., Results: GPs recruited 1,195 participants at a rate of 0.013 participants/day. GPs located in a high socioeconomic area recruited at half the rate as those located in a low socioeconomic area [incident rate ratio (IRR), 0.52; 95% confidence interval (CI): 0.37, 0.74]. A follow-up within 2 weeks of training the GP and a higher number of face-to-face visits were operational procedures associated with a higher rate of recruitment (IRR, 2.15; 95% CI: 1.58, 2.94 and IRR, 1.17; 95% CI: 1.11, 1.24, respectively). Other contacts made with a GP were not associated with recruitment., Conclusion: The results suggested that the type of operational procedures used in clinical trial recruitment strategies are important aspects to consider. The ability to predict which GPs will recruit based on GP characteristics seems limited., (Copyright © 2014 Elsevier Inc. All rights reserved.)

It is often assumed that patients with pain-related disability due to low back pain (LBP) will have reduced physical activity levels, but recent studies have provided results that challenge this assumption. The aim of our systematic review was to examine the relationship between physical activity and disability in LBP. The literature search included 6 electronic databases and the reference list of relevant systematic reviews and studies to May 2010. To be included, studies had to measure both disability (eg, with the Roland Morris Disability Questionnaire) and physical activity (eg, by accelerometry) in patients with non-specific LBP. Two independent reviewers screened search results and extracted data, and authors were contacted for additional data. Correlation coefficients were pooled using the random-effects model. The search identified 3213 records and 18 studies were eligible for inclusion. The pooled results showed a weak relationship between physical activity and disability in acute or subacute (<3months) LBP (r=-0.08, 95% confidence interval=-0.17 to 0.002), and a moderate and negative relationship in chronic (>3months) LBP (r=-0.33, 95% confidence interval=-0.51 to -0.15). That is, persons with acute or subacute LBP appear to vary in the levels of physical activity independent of their pain-related disability. Persons with chronic LBP with high levels of disability are also likely to have low levels of physical activity. Persons with acute or subacute back pain appear to vary in the levels of physical activity independent of disability. Persons with chronic back pain with high levels of disability will likely have low levels of physical activity., (Copyright © 2010 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.)

Objective: The primary aim of this study was to determine the effectiveness and cost-effectiveness of adding manual therapy to a physiotherapy programme for ankle fracture., Design: Assessor-blinded randomized controlled trial., Participants: Ninety-four adults were recruited within one week of cast removal for isolated ankle fracture. Inclusion criteria were: they were able to weight-bear as tolerated or partial weight-bear, were referred for physiotherapy, and experienced pain. Ninety-one participants completed the study., Methods: Participants were randomly allocated to receive manual therapy (anterior-posterior joint mobilization over the talus) plus a standard physiotherapy programme (experimental), or the standard physiotherapy programme only (control). They were assessed by a blinded assessor at baseline, and at 4, 12 and 24 weeks. The main outcomes were activity limitation and quality of life. Information on costs and healthcare utilization was collected every 4 weeks up to 24 weeks., Results: There were no clinically worthwhile differences in activity limitation or quality of life between groups at any time-point. There was also no between-group difference in quality-adjusted life-years, but the experimental group incurred higher out-of-pocket costs (mean between-group difference = AU$200, 95% confidence interval 26-432)., Conclusion: When provided in addition to a physiotherapy programme, manual therapy did not enhance outcome in adults after ankle fracture.