TOPS – a randomized controlled trial of exercise and education to prevent recurrence of low back pain: statistical analysis plan

Abstract

BackgroundThis a priori statistical analysis plan describes the methods of analysis for the Trial Of Prevention Strategies for low back pain (TOPS). ObjectivesTOPS aimed to investigate the effectiveness and cost-effectiveness of exercise and education classes compared with a minimal intervention control in preventing recurrence of low back pain (LBP) in people who have recently recovered from an episode of LBP. MethodsTOPS is a superiority, pragmatic, parallel-group randomized controlled trial with allocation concealment, blinded outcome assessors, and intention-to-treat analysis. Participants were randomized to a physical therapist-led exercise and education program for 12 weeks or minimal intervention. The primary outcome was days to recurrence of an episode of LBP. The three key secondary outcomes were days to recurrence of an episode of LBP resulting in (1) activity limitation, (2) care seeking for LBP; and (3) work absence of at least 1 day. Differences in survival curves for the primary (days to recurrence) and secondary outcome (days to LBP with activity limitation, days to care seeking due to LBP, and days to work absence due to LBP) will be compared using Cox regression. Hazard ratios (HRs) and median survival times with 95% confidence intervals (CI) will be calculated. The number of adverse events, including serious adverse events will be reported and the proportion of adverse events between groups will be compared using a Chi-squared test. DiscussionThis paper will provide a detailed description of the planned analyses for the TOPS trial. Trial registrationAustralian New Zealand Clinical Trials Registry (ACTRN12615000939594).