TEXT4myBACK - A Text Message Intervention to Improve Function in People With Low Back Pain: Protocol of a Randomized Controlled Trial.

OBJECTIVE To describe the protocol of a randomized controlled trial that will investigate the effects of the TEXT4myBACK self-management text message intervention compared with control, in people with low back pain. METHODS A single-blind (assessor and statistician) randomized controlled trial with economic analysis and process evaluation will be conducted. 304 people with non-specific low back pain of less than 12 weeks will be enrolled and randomly allocated either to TEXT4myBACK intervention or control groups. The TEXT4myBACK intervention group will receive four semi-personalized text messages per week providing advice, motivation and information about low back pain, physical activity, sleep, mood, use of care, medication during 12 weeks. The control group will receive one text message with a link to a low back pain and diet online information package. Outcomes will be assessed at baseline, 3, 6 and 12 months. The primary outcome will be function assessed with the Patient-Specific Functional Scale. Secondary outcomes will include pain intensity, physical activity participation, sedentary behavior, global impression of change, health-related quality of life and eHealth literacy. Data on demographic characteristics, smallest worthwhile change (ie, smallest function scored needed to be achieved at the end of the intervention to consider it to be worthwhile), health care utilization and adverse events (ie, any new health issue that occurs during participation in the study) will be collected. An economic and process evaluation will also be conducted. IMPACT This study will assess if a self-management text message intervention is effective and cost-effective in improving function of people with low back pain. This study can inform clinical practice of a simple, scalable and affordable intervention for managing low back pain.