Exercise treatment effect modifiers in persistent low back pain: an individual participant data meta-analysis of 3514 participants from 27 randomised controlled trials (original) (raw)
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Background: Low back pain (LBP) is one of the leading causes of disability and has a major socioeconomic impact. Despite a large amount of research in the field, there remains uncertainty about the best treatment approach for chronic LBP, and identification of relevant patient subgroups is an important goal. Exercise therapy is a commonly used strategy to treat chronic low back pain and is one of several interventions that evidence suggests is moderately effective. In parallel with an update of the 2005 Cochrane review, we will undertake an individual participant data (IPD) metaanalysis, which will allow us to standardize analyses across studies and directly derive results, and to examine differential treatment effects across individuals to estimate how patients' characteristics modify treatment benefit. Methods/design: We will use standard systematic review methods advocated by the Cochrane Collaboration to identify relevant trials. We will include trials evaluating exercise therapy compared to any or no other interventions in adult non-specific chronic LBP. Our primary outcomes of interest include pain, functional status, and return-towork/absenteeism. We will assess potential risk of bias for each study meeting selection criteria, using criteria and methods recommended by the Cochrane BRG. The original individual participant data will be requested from the authors of selected trials having moderate to low risk of bias. We will test original data and compile a master dataset with information about each trial mapped on a pre-specified framework, including reported characteristics of the study sample, exercise therapy characteristics, individual patient characteristics at baseline and all follow-up periods, subgroup and treatment effect modifiers investigated. Our analyses will include descriptive, study-level meta-analysis and meta-regression analyses of the overall treatment effect, and individual-level IPD meta-analyses of treatment effect modification. IPD meta-analyses will be conducted using a one-step approach where the IPD from all studies are modeled simultaneously while accounting for the clustering of participants with studies. Discussion: We will analyze IPD across a large number of LBP trials. The resulting larger sample size and consistent presentation of data will allow additional analyses to explore patient-level heterogeneity in treatment outcomes and prognosis of chronic LBP.
Meta-Analysis: Exercise Therapy for Nonspecific Low Back Pain
Annals of Internal Medicine, 2005
Background: Exercise therapy is widely used as an intervention in low back pain. Objective: To evaluate the effectiveness of exercise therapy in adult nonspecific acute, subacute, and chronic low back pain versus no treatment and other conservative treatments. Data Sources: MEDLINE, EMBASE, PsychInfo, CINAHL, and Cochrane Library databases to October 2004; citation searches and bibliographic reviews of previous systematic reviews. Study Selection: Randomized, controlled trials evaluating exercise therapy for adult nonspecific low back pain and measuring pain, function, return to work or absenteeism, and global improvement outcomes. Data Extraction: Two reviewers independently selected studies and extracted data on study characteristics, quality, and outcomes at short-, intermediate-, and long-term follow-up. Data Synthesis: 61 randomized, controlled trials (6390 participants) met inclusion criteria: acute (11 trials), subacute (6 trials), and chronic (43 trials) low back pain (1 trial was unclear). Evidence suggests that exercise therapy is effective in chronic back pain relative to comparisons at all follow-up periods. Pooled mean improvement (of 100 points) was 7.3 points (95% CI, 3.7 to 10.9 points) for pain and 2.5 points (CI, 1.0 to 3.9 points) for function at earliest follow-up. In studies investigating patients (people seeking care for back pain), mean improvement was 13.3 points (CI, 5.5 to 21.1 points) for pain and 6.9 points (CI, 2.2 to 11.7 points) for function, compared with studies where some participants had been recruited from a general population (for example, with advertisements). Some evidence suggests effectiveness of a graded-activity exercise program in subacute low back pain in occupational settings, although the evidence for other types of exercise therapy in other populations is inconsistent. In acute low back pain, exercise therapy and other programs were equally effective (pain, 0.03 point [CI, ؊1.3 to 1.4 points]). Limitations: Limitations of the literature, including low-quality studies with heterogeneous outcome measures inconsistent and poor reporting, and possibility of publication bias. Conclusions: Exercise therapy seems to be slightly effective at decreasing pain and improving function in adults with chronic low back pain, particularly in health care populations. In subacute low back pain populations, some evidence suggests that a gradedactivity program improves absenteeism outcomes, although evidence for other types of exercise is unclear. In acute low back pain populations, exercise therapy is as effective as either no treatment or other conservative treatments.
2021
Persistent non-specific low back pain (NSLBP) is the leading cause of years lived with disability globally, and exercise is the most widely recommended treatment for persistent NSLBP. Previous randomised controlled trials (RCTs) tend to conclude that, on average, exercise has small to medium effects when benefits, versus comparison arms, are judged using the primary outcomes of pain and function. RCTs should select their primary outcome domain(s) and measure(s) based on the rationale of the treatment(s) they are comparing. This programme of research aimed to i) identify whether existing RCTs match their primary outcome domains to their specified exercise treatment targets, ii) explore whether better matching of primary outcome domains with exercise treatment targets might change the results and conclusions of existing RCT datasets, iii) compare whether composite outcomes composed of multiple matched outcome domains might change the estimates of the between-arm differences through se...
Clinical rehabilitation, 2015
To determine, for adults with chronic low back pain, which exercise interventions are the most effective at reducing pain compared to other treatments. A search of MEDLINE, CINAHL, EMBASE, SPORTDiscus, PsycINFO and The Cochrane Library was conducted up to October 2014. Databases were searched for published reports of randomised trials that investigated the treatment of chronic low back pain of non-specific origin with an exercise intervention. Two authors independently reviewed and selected relevant trials. Methodological quality was evaluated using the Downs and Black tool. Forty-five trials met the inclusion criteria and thirty-nine were included in the meta-analysis. Combined meta-analysis revealed significantly lower chronic low back pain with intervention groups using exercise compared to a control group or other treatment group (Standard Mean Deviation (SMD) =-0.32, CI 95% -0.44 to -0.19, P<0.01). Separate exploratory subgroup analysis showed a significant effect for streng...
BackgroundExercise therapy is a common intervention recommended for chronic low back pain (cLBP). Although adequate reporting of intervention is crucial to understand and replicate exercise therapy, it does not help clinicians to determine the therapeutic quality. So The international Consensus on Therapeutic Exercise aNd Training (i-CONTENT) tool was developed to assess therapeutic quality of exercise. Therefore, we will assess the therapeutic quality of different exercise interventions by i-CONTENT tool in cLBP RCTs and its inter-rater reliability.MethodsWe will perform a meta-research study, starting from Cochrane review publication “Exercise therapy for chronic low back pain”. We will select a random sample of 100 arms with different type of exercises included (i.e. Core Strengthening, General Strengthening, Stretching, Aerobic exercises, Motor Control, Pilates, McKenzie, Qigong, Yoga, Tai Chi). For each included study’s arm, two pairs of independent reviewers will assess the th...
Systematic Reviews, 2020
BackgroundAcute low back pain is associated with pain and disability, but symptoms are often self-healing. The effectiveness of exercise therapy for acute low back pain remains uncertain with conflicting evidence from systematic reviews. The aim of this systematic review of systematic reviews was to assess the overall certainty of evidence for the effects of exercise therapy, compared with other interventions, on pain, disability, recurrence, and adverse effects in adult patients with acute low back pain.MethodsPubMed, the Cochrane library, CINAHL, PEDro, Open Grey, Web of Science, and PROSPERO were searched for systematic reviews of randomized controlled trials. Methodological quality was assessed independently by two authors using AMSTAR. Meta-analyses were performed if possible, using data from the original studies. Data for pain, disability, recurrence, and adverse effects were analyzed. Certainty of evidence was assessed using GRADE.ResultsThe searches retrieved 2602 records, o...
Spine, 2000
A systematic review of randomized controlled trials was performed. Exercise therapy is a widely used treatment for low back pain. To evaluate the effectiveness of exercise therapy for low back pain with regard to pain intensity, functional status, overall improvement, and return to work. The Cochrane Controlled Trials Register, Medline, Embase, PsycLIT, and reference lists of articles were searched. Randomized trials testing all types of exercise therapy for subjects with nonspecific low back pain with or without radiation into the legs were included. Two reviewers independently extracted data and assessed trial quality. Because trials were considered heterogeneous with regard to study populations, interventions, and outcomes, it was decided not to perform a meta-analysis, but to summarize the results using a rating system of four levels of evidence: strong, moderate, limited, or none. In this review, 39 trials were identified. There is strong evidence that exercise therapy is not m...
Spine, 2007
Critical appraisal of the literature. The objective of this study was to assess if results of back pain trials are statistically significant and clinically important. There seems to be a discrepancy between conclusions reported by authors and actual results of randomized controlled trials. Little attention has been paid to the problem of over-reporting of conclusions. All 43 trials of the Cochrane review on exercise therapy for low back pain were included. Descriptive analyses were conducted. Eighteen trials reported positive conclusions in favor of exercise. Only six of the 43 studies showed both clinically important and statistically significant differences in favor of the exercise groups on function, and 4 on pain. It seems that many conclusions of studies of exercise therapy for chronic low back pain have been based on statistical significance of results rather than on clinical importance and, consequently, may have been too positive. Authors of trials should report not only sta...