Abstract
BACKGROUND: Exercise for the prevention of low back pain recurrences is recommended, but under-researched. The effectiveness and cost-effectiveness of a walking program for preventing low back pain recurrence remains unknown. This a priori statistical analysis plan describes the methods of analysis for the WalkBack trial.
METHODS: WalkBack is a prospectively registered, pragmatic, randomised controlled trial. The aim is to investigate the effectiveness and cost-effectiveness of a 6-month progressive and individualised walking and education program (intervention) for the prevention of low back pain recurrences, compared to a no-treatment control group. The primary outcome is days to the first recurrence of an episode of activity-limiting low back pain. Key secondary outcomes include days to any recurrence of low back pain, days to a care-seeking recurrence of low back pain, disability level, health-related quality of life, costs associated with low back pain and adverse events. All participants will be followed for a minimum of 12 months. Analysis will follow the intention-to-treat principle. Cox regression is planned to assess the effects for the outcomes of time to activity-limiting, minimal and care-seeking recurrence. Hazard ratios and median survival times with 95% confidence intervals will be calculated. The effect of the intervention on continuous outcomes will be estimated with repeated-measure linear mixed models. An economic evaluation will be performed from the societal perspective for recurrence prevented (yes/no) and quality-adjusted life years. The proportion of adverse events between groups will be compared using Fisher's exact test.
DISCUSSION: The WalkBack trial will provide evidence on the effectiveness and cost-effectiveness of a walking intervention to prevent low back pain recurrences. This statistical analysis plan provides transparency on the analysis of the trial.
TRIAL REGISTRATION: WalkBack - Effectiveness and cost-effectiveness of a progressive individualised walking and education program for the prevention of a recurrence of low back pain. ACTRN12619001134112 . Date Registered: 14/08/2019.
Original language | English |
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Article number | 197 |
Pages (from-to) | 1-11 |
Number of pages | 11 |
Journal | Trials |
Volume | 24 |
Issue number | 1 |
DOIs | |
Publication status | Published - 16 Mar 2023 |
Bibliographical note
Publisher Copyright:© 2023. The Author(s).
Funding
The WalkBack trial is endorsed by the Australia & New Zealand Musculoskeletal (ANZMUSC) Clinical Trials Network. The investigators would also like to extend our thanks to the 701 participants enrolled in the trial, the 25 physiotherapists who have provided the intervention arm of the trial, and the broader research team who have so far aided in the project conception and implementation. This work is supported by the National Health and Medical Research Council in Australia (grant number APP1161889). NCP is a PhD candidate and received a three-year scholarship from Macquarie University (Macquarie University Research Excellence Scholarship) and a one-year NHMRC Low Back Pain Centre of Research Excellence – ANZBACK PhD scholarship. CWCL is funded by an Emerging Leadership Fellowship from the NHMRC (APP1193939). CGM is funded by a Leadership 3 Fellowship from the NHMRC (APP1194283). These funding sources had no role in the trial design and will have no role in the trial conduct, analysis interpretation or formulation of the final manuscript.
Funders | Funder number |
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Australia & New Zealand Musculoskeletal | |
National Health and Medical Research Council in Australia | APP1161889 |
National Health and Medical Research Council | APP1194283, APP1193939 |
Macquarie University |
Keywords
- Low back pain
- Prevention
- Randomised-controlled trial
- Statistical analysis plan
- Walking