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

Giovanni E. Ferreira*, Chung Wei Christine Lin, Matthew Leigh Stevens, Mark J. Hancock, Jane Latimer, Trish Wisbey-Roth, Chris G. Maher, Trial Of Prevention Strategies (TOPS) trial investigators

*Corresponding author for this work

    Research output: Contribution to journalArticlepeer-review

    1 Citation (Scopus)


    Background: This a priori statistical analysis plan describes the methods of analysis for the Trial Of Prevention Strategies for low back pain (TOPS). Objectives: TOPS 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. Methods: TOPS 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. Discussion: This paper will provide a detailed description of the planned analyses for the TOPS trial. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12615000939594).

    Original languageEnglish
    Pages (from-to)373-380
    Number of pages8
    JournalBrazilian Journal of Physical Therapy
    Issue number4
    Early online date27 May 2020
    Publication statusPublished - Jul 2020


    • Exercise
    • Low back pain
    • Randomized controlled trial
    • Rehabilitation
    • Secondary prevention


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