Effectiveness of McKenzie Method-Based Self-Management Approach for the Secondary Prevention of a Recurrence of Low Back Pain (SAFE Trial): Protocol for a Pragmatic Randomized Controlled Trial.

Abstract

Background Although many people recover quickly from an episode of low back pain (LBP), recurrence is very common. There is limited evidence on effective prevention strategies for recurrences of LBP. Objective The purpose of this study was to determine the effectiveness of a McKenzie method-based self-management approach in the secondary prevention of LBP. Design This will be a pragmatic randomized controlled trial. Setting Participants will be recruited from the community and primary care, with the intervention delivered in a number of physical therapist practices in Sydney, Australia. Participants The study will have 396 participants, all of whom are at least 18 years old. Intervention Participants will be randomly assigned to either the McKenzie method-based self-management approach group or a minimal intervention control group. Measurements The primary outcome will be days to first self-reported recurrence of an episode of activity-limiting LBP. The secondary outcomes will include: days to first self-reported recurrence of an episode of LBP, days to first self-reported recurrence of an episode of LBP leading to care seeking, and the impact of LBP over a 12-month period. All participants will be followed up monthly for a minimum of 12 months or until they have a recurrence of activity-limiting LBP. All participants will also be followed-up at 3, 6, 9, and 12 months to assess the impact of back pain, physical activity levels, study program adherence, credibility, and adverse events. Limitations Participants and therapists will not be masked to the interventions. Conclusions To our knowledge, this will be the first large, high-quality randomized controlled trial investigating the effectiveness of a McKenzie method-based self-management approach for preventing recurrences of LBP. If this approach is found to be effective, it will offer a low-cost, simple method for reducing the personal and societal burdens of LBP.

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