Effectiveness and Cost-Effectiveness of Different Weekly Frequencies of Pilates for Chronic Low Back Pain: Randomized Controlled Trial

Background The Pilates method has been recommended to patients with low back pain, but the evidence on effectiveness is inconclusive. In addition, there is still no evidence for the cost-effectiveness of this method or for the ideal number of sessions to achieve the highest effectiveness. Objective The aim of this study will be to investigate the effectiveness and cost-effectiveness of the Pilates method with different weekly frequencies in the treatment of patients with nonspecific low back pain. Design This is a randomized controlled trial with blinded assessor. Setting This study will be conducted at a physical therapy clinic in São Paulo, Brazil. Participants Two hundred ninety-six patients with nonspecific low back pain between the ages of 18 and 80 years will be assessed and randomly allocated to 4 groups (n=74 patients per group). Intervention All groups will receive an educational booklet. The booklet group will not receive additional exercises. Pilates group 1 will follow a Pilates-based program once a week, Pilates group 2 will follow the same program twice a week, and Pilates group 3 will follow the same program 3 times a week. The intervention will last 6 weeks. Measurements A blinded assessor will evaluate pain, quality-adjusted life-years, general and specific disability, kinesiophobia, pain catastrophizing, and global perceived effect 6 weeks, 6 months, and 12 months after randomization. Limitations Therapists and patients will not be blinded. Conclusions This will be the first study to investigate different weekly frequencies of treatment sessions for nonspecific low back pain. The results of this study will contribute to a better definition of treatment programs for this population.