The RESOLVE Trial for people with chronic low back pain: statistical analysis plan.
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ABSTRACT: Background
Statistical analysis plans describe the planned data management and analysis for clinical trials. This supports transparent reporting and interpretation of clinical trial results. This paper reports the statistical analysis plan for the RESOLVE clinical trial. The RESOLVE trial assigned participants with chronic low back pain to graded sensory-motor precision training or sham-control.Results
We report the planned data management and analysis for the primary and secondary outcomes. The primary outcome is pain intensity at 18-weeks post randomization. We will use mixed-effects models to analyze the primary and secondary outcomes by intention-to-treat. We will report adverse effects in full. We also describe analyses if there is non-adherence to the interventions, data management procedures, and our planned reporting of results.Conclusion
This statistical analysis plan will minimize the potential for bias in the analysis and reporting of results from the RESOLVE trial.Trial registration
ACTRN12615000610538 (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368619).
SUBMITTER: Bagg MK
PROVIDER: S-EPMC7817870 | biostudies-literature | 2021 Jan-Feb
REPOSITORIES: biostudies-literature
Publications
The RESOLVE Trial for people with chronic low back pain: statistical analysis plan.
Bagg Matthew K MK Lo Serigne S Cashin Aidan G AG Herbert Rob D RD O'Connell Neil E NE Lee Hopin H Hübscher Markus M Wand Benedict M BM O'Hagan Edel E Rizzo Rodrigo R N RRN Moseley G Lorimer GL Stanton Tasha R TR Maher Christopher G CG Goodall Stephen S Saing Sopany S McAuley James H JH
Brazilian journal of physical therapy 20200618 1
<h4>Background</h4>Statistical analysis plans describe the planned data management and analysis for clinical trials. This supports transparent reporting and interpretation of clinical trial results. This paper reports the statistical analysis plan for the RESOLVE clinical trial. The RESOLVE trial assigned participants with chronic low back pain to graded sensory-motor precision training or sham-control.<h4>Results</h4>We report the planned data management and analysis for the primary and seconda ...[more]
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Project description:BackgroundChronic low back pain (CLBP) is a global health problem associated with an increasing burden on individuals, health care systems, and society. Common treatments for people with CLBP produce, on average, small short-term improvements in pain and function compared with minimal care. The RESOLVE trial randomly allocated 276 people with CLBP to a new complex treatment strategy, pain education integrated with graded sensorimotor precision training (RESOLVE), or a sham control. The RESOLVE treatment was developed within a theoretical framework to target possible treatment mechanisms associated with CLBP development and persistence.ObjectiveThis protocol describes the planned evaluation of these proposed treatment mechanisms. Improved understanding of the mechanisms underpinning the RESOLVE treatment may guide its refinement and implementation.MethodsWe will use causal mediation analysis to evaluate the proposed treatment mechanisms, including pain self-efficacy, back beliefs, pain catastrophizing, kinesiophobia, back perception, tactile acuity, and movement coordination. The primary outcomes are pain intensity and function at 18 weeks following allocation. Data were collected blind to allocation and hypotheses at baseline (mediators, outcomes, confounders), end of treatment (mediators), and at 18 weeks following allocation (outcomes). We will test the robustness of our findings by conducting planned sensitivity analyses.ResultsEthical approval was granted by the University of New South Wales Human Research Ethics Committee (HC15357). A total of 276 participants have been recruited from primary care practices and the community in Sydney, Australia.ConclusionsThe RESOLVE treatment constitutes a new paradigm for CLBP management with potentially wide-reaching implications. This mechanistic evaluation will provide evidence for the hypothesized treatment mechanisms and help explain why the treatment strategy did or did not have an effect on patient-reported outcomes. These results will help guide the treatment refinement and implementation.Trial registrationAustralian and New Zealand Clinical Trials Registry ACTRN12615000610538; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368619&isReview=true.International registered report identifier (irrid)DERR1-10.2196/26053.
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Project description:ObjectiveMindfulness is a nonpharmacologic mind-body therapy that has been shown to be effective in older adults with chronic low back pain (cLBP). There are few first-person accounts in the literature that describe the older adult experience and perspective while learning mindfulness and meditation to treat pain. The objective of this study was to investigate dominant themes present in the experiences of older adults applying mindfulness and meditation to cope with cLBP.DesignQualitative analysis of four focus groups.SubjectTwenty-five adults age 65?years or older who had completed an eight-week mindfulness program.MethodsThe focus groups met for a comprehensive discussion session about their experience with mindfulness and meditation. The audio for each session was recorded, and the discussions were transcribed. Codebook development, qualitative coding, and thematic analysis were performed. The coders each coded all four transcripts, following which they met to adjudicate all coding differences until they were in complete agreement on coding.ResultsSeveral key themes were brought up by older adults utilizing mindfulness as a means of coping with pain, which included overcoming fear of pain ("Before [learning mindfulness], I used to dread pain"), pain awareness ("You're focusing more on being aware than the pain; now that's what helps me"), and pain significance ("It becomes insignificant").ConclusionsThe themes identify several ways mindfulness impacts older adults with cLBP, including decreased negative emotions related to chronic pain such as fear of pain, a different perspective or change in awareness about pain, and reducing the significance of pain.
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