Effectiveness and cost-effectiveness of a progressive, individualised walking and education program for prevention of low back pain recurrence in adults: statistical analysis plan for the WalkBack randomised controlled trial.
Study Goal
The researchers aimed to determine the effectiveness and cost-effectiveness of a 6-month progressive walking and education program for preventing low back pain recurrences compared to a no-treatment control group.
Results Summary
The study will assess time to recurrence of activity-limiting low back pain, disability levels, quality of life, and cost-effectiveness, but final results are not yet reported in the abstract. The planned analysis includes Cox regression and linear mixed models to evaluate outcomes.
Population
Individuals at risk of low back pain recurrences.
Effective Dosage
Progressive and individualized walking program (specific dosage not detailed).
Duration
6 months.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
a 6-month progressive and individualised walking and education program | decrease | prevention of low back pain recurrences | participants with low back pain | - | investigate the effectiveness and cost-effectiveness | #1 |
a 6-month progressive and individualised walking and education program | increase | days to the first recurrence of an episode of activity-limiting low back pain | participants with low back pain | - | investigate the effectiveness and cost-effectiveness | #2 |
a 6-month progressive and individualised walking and education program | increase | days to any recurrence of low back pain | participants with low back pain | - | investigate the effectiveness and cost-effectiveness | #3 |
a 6-month progressive and individualised walking and education program | increase | days to a care-seeking recurrence of low back pain | participants with low back pain | - | investigate the effectiveness and cost-effectiveness | #4 |
a 6-month progressive and individualised walking and education program | decrease | disability level | participants with low back pain | - | investigate the effectiveness and cost-effectiveness | #5 |
a 6-month progressive and individualised walking and education program | increase | health-related quality of life | participants with low back pain | - | investigate the effectiveness and cost-effectiveness | #6 |
a 6-month progressive and individualised walking and education program | decrease | costs associated with low back pain | participants with low back pain | - | investigate the effectiveness and cost-effectiveness | #7 |
a 6-month progressive and individualised walking and education program | no change | adverse events | participants with low back pain | - | investigate the effectiveness and cost-effectiveness | #8 |
a 6-month progressive and individualised walking and education program | increase | recurrence prevented (yes/no) | participants with low back pain | - | investigate the effectiveness and cost-effectiveness | #9 |
a 6-month progressive and individualised walking and education program | increase | quality-adjusted life years | participants with low back pain | - | investigate the effectiveness and cost-effectiveness | #10 |
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.