The RESOLVE Trial for people with chronic low back pain: statistical analysis plan.
Bagg MK., Lo S., Cashin AG., Herbert RD., O'Connell NE., Lee H., Hübscher M., Wand BM., O'Hagan E., Rizzo RRN., Moseley GL., Stanton TR., Maher CG., Goodall S., Saing S., McAuley JH.
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).