The smallest worthwhile effect on pain intensity of exercise therapy for people with chronic low back pain: a discrete choice experiment study.

OBJECTIVE: To identify the smallest worthwhile effect (SWE) of exercise therapy for people with non-specific chronic low back pain (CLBP). DESIGN: Discrete choice experiment. METHODS: The SWE was estimated as the lowest reduction in pain that participants would consider exercising worthwhile, compared to not exercising i.e., effects due to natural history and other components (e.g., regression to the mean). We recruited English-speaking adults in Australia with non-specific CLBP to our online survey via email obtained from a registry of previous participants and advertisements on social media. We used discrete choice experiment to estimate the SWE of exercise compared to no exercise for pain intensity. We analysed the discrete choice experiment using a mixed logit model, and mitigated hypothetical bias through certainty calibration, with sensitivity analyses performed with different certainty calibration thresholds. RESULTS: Two-hundred and thirteen participants completed the survey. The mean age (±SD) was 50.7±16.5, median (IQR) pain duration 10 years (5-20), and mean pain intensity (±SD) was 5.8±2.3 on a 0-10 numerical rating scale. For people with CLBP the SWE of exercise was a between-group reduction in pain of 20%, compared to no exercise. In the sensitivity analyses, the SWE varied with different levels of certainty calibration; from 0% without certainty calibration to 60% with more extreme certainty calibration. CONCLUSION: This patient-informed threshold of clinical importance could guide the interpretation of findings from randomised trials and meta-analyses of exercise therapy compared to no exercise.

Reporting of Observational Studies Explicitly Aiming to Emulate Randomized Trials: A Systematic Review.

Importance: Observational (nonexperimental) studies that aim to emulate a randomized trial (ie, the target trial) are increasingly informing medical and policy decision-making, but it is unclear how these studies are reported in the literature. Consistent reporting is essential for quality appraisal, evidence synthesis, and translation of evidence to policy and practice. Objective: To assess the reporting of observational studies that explicitly aimed to emulate a target trial. Evidence Review: We searched Medline, Embase, PsycINFO, and Web of Science for observational studies published between March 2012 and October 2022 that explicitly aimed to emulate a target trial of a health or medical intervention. Two reviewers double-screened and -extracted data on study characteristics, key predefined components of the target trial protocol and its emulation (eligibility criteria, treatment strategies, treatment assignment, outcome[s], follow-up, causal contrast[s], and analysis plan), and other items related to the target trial emulation. Findings: A total of 200 studies that explicitly aimed to emulate a target trial were included. These studies included 26 subfields of medicine, and 168 (84%) were published from January 2020 to October 2022. The aim to emulate a target trial was explicit in 70 study titles (35%). Forty-three studies (22%) reported use of a published reporting guideline (eg, Strengthening the Reporting of Observational Studies in Epidemiology). Eighty-five studies (43%) did not describe all key items of how the target trial was emulated and 113 (57%) did not describe the protocol of the target trial and its emulation. Conclusion and Relevance: In this systematic review of 200 studies that explicitly aimed to emulate a target trial, reporting of how the target trial was emulated was inconsistent. A reporting guideline for studies explicitly aiming to emulate a target trial may improve the reporting of the target trial protocols and other aspects of these emulation attempts.

The smallest worthwhile effect on pain intensity of nonsteroidal anti-inflammatory drugs and exercise therapy for acute and chronic low back pain: a benefit-harm trade-off study.

QUESTION: What are the smallest worthwhile effects of nonsteroidal anti-inflammatory drugs (NSAIDs) for people with acute and chronic low back pain (LBP)? What is the smallest worthwhile effect of individualised exercise for people with chronic LBP compared with no intervention? DESIGN: Benefit-harm trade-off study. PARTICIPANTS: Participants were recruited by advertisement on social media and included if they were English-speaking adults in Australia who had non-specific LBP. OUTCOME MEASURE: Pain intensity. RESULTS: A total of 116 people with acute LBP and 230 people with chronic LBP were recruited. For acute LBP, the smallest worthwhile effect of NSAIDs additional to no intervention was a 30% (IQR 10 to 40%) reduction in pain intensity. For chronic LBP, the smallest worthwhile effect of NSAIDs additional to no intervention was a 27.5% (IQR 10 to 50%) reduction in pain intensity. For chronic LBP, the smallest worthwhile effect of exercise additional to no intervention was a 20% (IQR 10 to 40%) reduction in pain intensity. There were small associations between baseline pain, duration of pain and level of exercise and the smallest worthwhile effect of NSAIDs for acute LBP. There were no other clear associations. CONCLUSIONS: For people with LBP, the smallest worthwhile effect of exercise and NSAIDs additional to no intervention is approximately a 20 to 30% reduction in pain. These results can inform the interpretation of the effects of NSAIDs and exercise in randomised trials and meta-analyses, incorporating consumers' perspectives. Further research on comparisons between different interventions and on other core LBP outcomes may inform decision-making. REGISTRATION: OSF osf.io/3erjx/.

Effectiveness of Cognitive Functional Therapy for Reducing Pain and Disability in Chronic Low Back Pain: A Systematic Review and Meta-analysis.

OBJECTIVE: We aimed to evaluate whether cognitive functional therapy (CFT) is an effective treatment for adults with chronic low back pain (LBP). DESIGN: Intervention systematic review with meta-analysis. LITERATURE SEARCH: We searched 4 electronic databases (CENTRAL, CINAHL, MEDLINE, and Embase) and 2 clinical trial registers (ClinicalTrials. gov and the EU Clinical Trials Register) from inception up to March 2022. STUDY SELECTION CRITERIA: We included randomized controlled trials evaluating CFT for adults with LBP. DATA SYNTHESIS: The primary outcomes were pain intensity and disability. Secondary outcomes were psychological status, patient satisfaction, global improvement, and adverse events. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach. Random-effects meta-analysis with the Hartung-Knapp-Sidik-Jonkman adjustment was used to estimate pooled effects. RESULTS: Fifteen trials were included (9 ongoing and 1 terminated), of which 5 provided data (n = 507; n = 262 CFT, and n = 245 control). There was very low certainty for the effectiveness of CFT compared to manual therapy plus core exercises (2 studies, n = 265) for reducing pain intensity (mean difference: -1.02/10, 95% confidence interval: -14.75, 12.70) and disability (mean difference: -6.95/100, 95% confidence interval: -58.58, 44.68). Narrative synthesis showed mixed results for pain intensity, disability, and secondary outcomes. No adverse events were reported. All studies were judged to be at high risk of bias. CONCLUSION: Cognitive functional therapy may not be more effective than other common interventions for reducing pain and disability in adults with chronic LBP. The effectiveness of CFT is very uncertain and will remain so until higher-quality studies are available. J Orthop Sports Phys Ther 2023;53(5):1-42. Epub: 23 February 2023. doi:10.2519/jospt.2023.11447.

Effects of a single exercise session on pain intensity in adults with chronic pain: a systematic review and meta-analysis.

BACKGROUND: Chronic pain is prevalent amongst society, making it necessary to find strategies to manage chronic pain. Regular exercise is efficacious; however, pain is a barrier to initiating exercise. A single exercise session is also believed to acutely reduce pain, however, the evidence for this is less robust. OBJECTIVES: This systematic review and meta-analysis aimed to identify the effect of a single exercise session on pain intensity in adults with chronic pain. METHODS: We searched eight databases and trial registries to identify randomised controlled trials evaluating the effect of a single exercise session on pain intensity in adults with chronic pain compared to a non-exercise control. Literature screening, data extraction, risk of bias (Cochrane 2.0) and quality assessment (GRADE) were conducted independently and in duplicate. Random-effects meta-analyses were performed using the metafor package in R. RESULTS: We included 17 trials (46 study arms with 664 adults [44% female]). There were no significant differences in pain intensity (mean difference on a 0-10 scale) immediately post-exercise -0.02 (95% CI = -0.06, 0.62; I2 = 77.1%) or up to 45-min post-exercise -0.17 (95% CI = -0.49, 0.16; I2 = 34.2%). All trials were at high risk of bias and the overall confidence in these findings was very low. CONCLUSION: A single exercise session did not reduce pain intensity up to 1-h post-exercise. Notably, increases in pain were not observed either, suggesting that while pain can be a barrier to initiating exercise, clinicians can educate patients on the unlikelihood of exercise acutely increasing pain intensity.