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Rehabilitation interventions in randomized controlled trials for low back pain: proof of statistical significance often is not relevant.

ABSTRACT: BACKGROUND:An observed statistically significant difference between two interventions does not necessarily imply that this difference is clinically important for patients and clinicians. We aimed to assess if treatment effects of randomized controlled trials (RCTs) for low back pain (LBP) are statistically significant and clinically relevant, and if RCTs were powered to achieve clinically relevant differences on continuous outcomes. METHODS:We searched for all RCTs included in Cochrane Systematic Reviews focusing on the efficacy of rehabilitation interventions for LBP and published until April 2017. RCTs having sample size calculation and a planned minimal important difference were considered. In the primary analysis, we calculated the proportion of RCTs classified as "statistically significant and clinically relevant", "statistically significant but not clinically relevant", "not statistically significant but clinically relevant", and "not statistically significant and not clinically relevant". Then, we investigated how many times the mismatch between statistical significance and clinical relevance was due to inadequate power. RESULTS:From 20 eligible SRs including 101 RCTs, we identified 42 RCTs encompassing 81 intervention comparisons. Overall, 60% (25 RCTs) were statistically significant while only 36% (15 RCTs) were both statistically and clinically significant. Most trials (38%) did not discuss the clinical relevance of treatment effects when results did not reached statistical significance. Among trials with non-statistically significant findings, 60% did not reach the planned sample size, therefore being at risk to not detect an effect that is actually there (type II error). CONCLUSION:Only a minority of positive RCT findings was both statistically significant and clinically relevant. Scarce diligence or frank omissions of important tactic elements of RCTs, such as clinical relevance, and power, decrease the reliability of study findings to current practice.

SUBMITTER: Gianola S

PROVIDER: S-EPMC6647152 | biostudies-other | 2019 Jul

REPOSITORIES: biostudies-other

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Rehabilitation interventions in randomized controlled trials for low back pain: proof of statistical significance often is not relevant.

Gianola Silvia S Castellini Greta G Corbetta Davide D Moja Lorenzo L

Health and quality of life outcomes 20190722 1

<h4>Background</h4>An observed statistically significant difference between two interventions does not necessarily imply that this difference is clinically important for patients and clinicians. We aimed to assess if treatment effects of randomized controlled trials (RCTs) for low back pain (LBP) are statistically significant and clinically relevant, and if RCTs were powered to achieve clinically relevant differences on continuous outcomes.<h4>Methods</h4>We searched for all RCTs included in Coc ...[more]

PMID: 31331343

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Project description:BackgroundPreventing transition to chronic back pain (CBP) is a long-sought strategy that could rescue patients from prolonged suffering. Recent rodent and human brain imaging studies suggest involvement of sexually dimorphic, dopaminergic-motivational, mesolimbic circuits in the transition to chronic pain (tCBP), and hint that the combination of carbidopa/levodopa and naproxen (LDP + NPX) may block tCBP. Here we evaluated, in people with recent-onset back pain, whether a 3-month treatment with LDP + NPX is safe, blocks tCBP, and whether its efficacy is sex-dependent.MethodsA total of 72 participants were enrolled and stratified by risk for tCBP using brain-imaging biomarkers. Low-risk participants entered a no-treatment arm. Others were randomized to placebo + naproxen or LDP + NPX for 3 months.ResultsBoth treatments resulted in more than 50% pain relief for approximately 75% of participants. A strong sex by treatment interaction was observed for daily pain intensity (phone NRS, P = 0.007), replicated on 4-week average pain (Pain/4w, P = 0.00001), and in intent-to-treat analysis (Pain/4w, P = 0.000004). Nucleus accumbens functional connectivity with medial prefrontal cortex, a predefined objective biomarker, showed sex dependence at baseline (P = 0.03) and sex-by-treatment interaction effect 3 months after treatment cessation (P = 0.031). Treatment modified the psychological profile of participants, and disrupted brain modeling-based predicted back pain intensity trajectories. Forty participants were queried 3.3 years from trial start; back pain ratings were similar between end of treatment and at 3.3 years (P = 0.62), indicating persistence of relief for this duration.ConclusionsThese results provide the first evidence for preventing transition to chronic back pain using sex-specific pharmacotherapy. These provocative observations require confirmation in a larger study. ClinicalTrials.gov identifier: NCT01951105.

Project description:BackgroundMillions of people in Germany suffer from chronic pain, in which course and intensity are multifactorial. Besides physical injuries, certain psychosocial risk factors are involved in the disease process. The national health care guidelines for the diagnosis and treatment of non-specific low back pain recommend the screening of psychosocial risk factors as early as possible, to be able to adapt the therapy to patient needs (e.g., unimodal or multimodal). However, such a procedure has been difficult to implement in practice and has not yet been integrated into the rehabilitation care structures across the country.MethodsThe aim of this study is to implement an individualized therapy and aftercare program within the rehabilitation offer of the German Pension Insurance in the area of orthopedics and to examine its success and sustainability in comparison to the previous standard aftercare program. The study is a multicenter randomized controlled trial including 1204 patients from six orthopedic rehabilitation clinics. A 2:1 allocation ratio to intervention (individualized and home-based rehabilitation aftercare) versus the control group (regular outpatient rehabilitation aftercare) is set. Upon admission to the rehabilitation clinic, participants in the intervention group will be screened according to their psychosocial risk profile. They could then receive either unimodal or multimodal, together with an individualized training program. The program is instructed in the clinic (approximately 3 weeks) and will continue independently at home afterwards for 3 months. The success of the program is examined by means of a total of four surveys. The co-primary outcomes are the Characteristic Pain Intensity and Disability Score assessed by the German version of the Chronic Pain Grade questionnaire (CPG).DiscussionAn improvement in terms of pain, work ability, patient compliance, and acceptance in our intervention program compared to the standard aftercare is expected. The study contributes to provide individualized care also to patients living far away from clinical centers.Trial registrationDRKS, DRKS00020373 . Registered on 15 April 2020.

Project description:Low back pain (LBP) is a common and disabling disorder in western society. The management of LBP comprises a range of different intervention strategies including surgery, drug therapy, and non-medical interventions. The objective of the present study is to determine the effectiveness of physical and rehabilitation interventions (i.e. exercise therapy, back school, transcutaneous electrical nerve stimulation (TENS), low level laser therapy, education, massage, behavioural treatment, traction, multidisciplinary treatment, lumbar supports, and heat/cold therapy) for chronic LBP. The primary search was conducted in MEDLINE, EMBASE, CINAHL, CENTRAL, and PEDro up to 22 December 2008. Existing Cochrane reviews for the individual interventions were screened for studies fulfilling the inclusion criteria. The search strategy outlined by the Cochrane Back Review Groups (CBRG) was followed. The following were included for selection criteria: (1) randomized controlled trials, (2) adult (? 18 years) population with chronic (? 12 weeks) non-specific LBP, and (3) evaluation of at least one of the main clinically relevant outcome measures (pain, functional status, perceived recovery, or return to work). Two reviewers independently selected studies and extracted data on study characteristics, risk of bias, and outcomes at short, intermediate, and long-term follow-up. The GRADE approach was used to determine the quality of evidence. In total 83 randomized controlled trials met the inclusion criteria: exercise therapy (n = 37), back school (n = 5), TENS (n = 6), low level laser therapy (n = 3), behavioural treatment (n = 21), patient education (n = 1), traction (n = 1), and multidisciplinary treatment (n = 6). Compared to usual care, exercise therapy improved post-treatment pain intensity and disability, and long-term function. Behavioural treatment was found to be effective in reducing pain intensity at short-term follow-up compared to no treatment/waiting list controls. Finally, multidisciplinary treatment was found to reduce pain intensity and disability at short-term follow-up compared to no treatment/waiting list controls. Overall, the level of evidence was low. Evidence from randomized controlled trials demonstrates that there is low quality evidence for the effectiveness of exercise therapy compared to usual care, there is low evidence for the effectiveness of behavioural therapy compared to no treatment and there is moderate evidence for the effectiveness of a multidisciplinary treatment compared to no treatment and other active treatments at reducing pain at short-term in the treatment of chronic low back pain. Based on the heterogeneity of the populations, interventions, and comparison groups, we conclude that there are insufficient data to draw firm conclusion on the clinical effect of back schools, low-level laser therapy, patient education, massage, traction, superficial heat/cold, and lumbar supports for chronic LBP.

Project description:While journals and reporting guidelines recommend the presentation of confidence intervals, many authors adhere strictly to statistically significant testing. Our objective was to determine what proportions of not statistically significant (NSS) cardiovascular trials include potentially clinically meaningful effects in primary outcomes and if these are associated with authors' conclusions.Cardiovascular studies published in six high-impact journals between 1 January 2010 and 31 December 2014 were identified via PubMed. Two independent reviewers selected trials with major adverse cardiovascular events (stroke, myocardial infarction, or cardiovascular death) as primary outcomes and extracted data on trial characteristics, quality, and primary outcome. Potentially clinically meaningful effects were defined broadly as a relative risk point estimate ?0.94 (based on the effects of ezetimibe) and/or a lower confidence interval ?0.75 (based on the effects of statins).We identified 127 randomized trial comparisons from 3200 articles. The primary outcomes were statistically significant (SS) favoring treatment in 21% (27/127), NSS in 72% (92/127), and SS favoring control in 6% (8/127). In 61% of NSS trials (56/92), the point estimate and/or lower confidence interval included potentially meaningful effects. Both point estimate and confidence interval included potentially meaningful effects in 67% of trials (12/18) in which authors' concluded that treatment was superior, in 28% (16/58) with a neutral conclusion, and in 6% (1/16) in which authors' concluded that control was superior. In a sensitivity analysis, 26% of NSS trials would include potential meaningful effects with relative risk thresholds of point estimate ?0.85 and/or a lower confidence interval ?0.65.Point estimates and/or confidence intervals included potentially clinically meaningful effects in up to 61% of NSS cardiovascular trials. Authors' conclusions often reflect potentially meaningful results of NSS cardiovascular trials. Given the frequency of potentially clinical meaningful effects in NSS trials, authors should be encouraged to continue to look beyond significance testing to a broader interpretation of trial results.

Project description:BackgroundLow back pain (LBP) is the leading cause of disability worldwide. Physical exercise, as a treatment, is beneficial for the improvement of quality of life in patients with LBP, and it is widely accepted.ObjectiveWe aimed to develop a protocol for a feasibility study that is designed to compare the effectiveness of different interventions in reducing pain, functional, and psychosocial factors among patients with chronic LBP after 8 weeks of randomization.MethodsThis is a study protocol for a randomized controlled trial that will consist of individuals with chronic LBP who are aged between 18 and 65 years. Participants will be allocated, through block randomization, to one of the following groups: the motor control exercises (MCEs), pain education, MCEs+pain education, and usual care groups. The primary outcome will be pain intensity, and the secondary outcomes will be the pressure pain threshold, which will be measured with a digital algometer; LBP-related disability; fears and beliefs; the fear of movement; quality of life; mood states; and levels of depression and anxiety. The trial was approved by the ethics committee for research involving human beings of the Federal University of Pelotas (reference number: 5.717.390) in September 2022, and it will be conducted until August 2023.ResultsThe researchers are being trained to apply the questionnaires and carry out the interventions. Patient recruitment will begin at the end of 2022 and results are expected to be achieved by August 2023.ConclusionsOur trial will provide preliminary data regarding the feasibility and safety of MCEs and pain education for patients with LBP. It will also provide preliminary outcome data that can be used to identify the most efficient intervention and the level of health care that should be implemented in public health services.Trial registrationBrazilian Registry of Clinical Trials U1111-1221-4106; https://ensaiosclinicos.gov.br/rg/RBR-2xx2r2/.International registered report identifier (irrid)PRR1-10.2196/31345.

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Rehabilitation interventions in randomized controlled trials for low back pain: proof of statistical significance often is not relevant.

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Rehabilitation interventions in randomized controlled trials for low back pain: proof of statistical significance often is not relevant.

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