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 journalArticle

Abstract

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
Volume24
Issue number4
Early online date27 May 2020
DOIs
Publication statusPublished - Jul 2020

Keywords

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

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