Journal Article

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

Maher, Christopher G., Latimer, Jane, Merom, Dafna, Graham, Petra L., Pocovi, Natasha C., Lin, Chung-Wei Christine, Hancock, Mark J., van Dongen, Johanna M., Tiedemann, Anne, Clavisi, Ornella, French, Simon D.

2023

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Absenteeism / Accounting records / Adult / Back pain / Biomedicine / Care and treatment / Causes of / Clinical trials / Cost analysis / Cost benefit analysis / Diseases / Education / Exercise / Exercise therapy / Health Sciences / Humans / Hypotheses / Intervention / Low back pain / Low Back Pain - diagnosis / Low Back Pain - prevention & control / Medicine / Medicine & Public Health / Methods / Pain / Patient outcomes / Physical fitness / Physical therapy / Prevention / Quality of Life / Questionnaires / Randomised-controlled trial / Relapse / Self report / Statistical analysis / Statistical analysis plan / Statistics for Life Sciences / Telemedicine / Update / Walking