Effectiveness of a Healthy Lifestyle Program (HeLP) for low back pain: statistical analysis plan for a randomised controlled trial.

BACKGROUND: This paper describes the statistical analysis plan for a randomised controlled trial of a Healthy Lifestyle Program (HeLP) for low back pain targeting multiple health risks and behaviours, weight, physical activity, diet and smoking, to improve disability. We describe the methods for the main analyses and economic analysis of the trial. METHODS AND DESIGN: The trial is a two-arm pragmatic randomised controlled trial comparing the effect of the HeLP intervention to usual care on low back pain disability at 26 weeks. A total of 346 adults with low back pain were recruited from the Newcastle and Hunter region between September 2017 and November 2019 and randomised to either HeLP or usual care. HeLP is a 6-month intervention with participant outcomes measured at weeks 6, 12, 26 and 52 post randomisation. This statistical analysis plan describes data integrity, handling and preparation of data for analyses and methods for analyses. The primary endpoint for the trial is disability at 26 weeks using the 24-item self-report Roland Morris Disability Questionnaire. The primary analysis will follow the intention-to-treat principle using linear mixed regression models. DISCUSSION: The statistical analysis plan for this trial was produced to reduce outcome reporting bias arising from knowledge of the study findings. Any deviations will be described and justified in the final report. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12617001288314 . Registered on 6 September 2017.