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.

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.