The RESOLVE Trial for people with chronic low back pain: statistical analysis plan.
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).
['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|']
D059350:Chronic Pain D006801:Humans D017116:Low Back Pain D026741:Physical Therapy Modalities D016032:Randomized Controlled Trials as Topic D012107:Research Design
Back pain Clinical trial Chronic pain Statistical data analysis