Abstract
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.
Footnotes
Dr Cabral and Ms Miyamoto developed the study. Dr Cabral and Ms Miyamoto initiated the study design. Ms Oliveira, Mr Franco, Mr Amaral, Ms Branco, Ms Moura, and Ms Silva helped with the implementation and data collection. Ms Oliveira and Ms Moura are the technical fellows, and Mr Amaral, Ms Branco, and Ms Silva are the undergraduate researchers. Dr Cabral provided statistical support in the clinical trial design and will perform the primary statistical analysis. Dr Cabral and Ms Miyamoto contributed to the improvement of the study protocol, and all authors approved the final manuscript.
This study was approved by the Human Research Ethics Approval Committee of Comitê de Ética em Pesquisa da Universidade Cidade de São Paulo (approval number: CAAE 29303014.7.0000.0064).
The authors thank the São Paulo Research Foundation (FAPESP) (process number 2013/26321-8) for financial support and Universidade Cidade de São Paulo for providing the facilities for the recruitment and treatment of the participants.
ClinicalTrials.gov registration number: NCT02241538.
- Received July 21, 2015.
- Accepted August 9, 2015.
- © 2016 American Physical Therapy Association
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