Abstract
Background: The aim of this study was to assess the effectiveness and cost-effectiveness of Pilates versus aerobic exercises in the treatment of patients with fibromyalgia syndrome from a societal perspective. Methods: This two-arm randomized controlled trial with blinded assessor and economic evaluation included 98 patients diagnosed with fibromyalgia syndrome using the American College of Rheumatology 2010 criteria, aged between 20 and 75 years, and pain intensity ≥3 points in the Pain Numerical Rating Scale. Patients were randomly allocated into the aerobic or Pilates group. Treatment was performed twice a week for 8 weeks. The primary outcome was the impact of fibromyalgia measured 8 weeks after randomization. Cost-effectiveness and cost-utility analyses were conducted for the impact of fibromyalgia and quality-adjusted life-years (QALYs), respectively, with a 12-month time horizon. Results: There was no difference between the groups for the impact of fibromyalgia (MD: 6.5 points; 95% CI: −1.8 to 14.9). The incremental cost-effectiveness ratio showed that 1-point increase in the impact of fibromyalgia was on average associated with a societal cost of £56 for the Pilates group compared to the aerobic group. The cost-utility analysis showed that the Pilates group had a 0.71 probability of being cost-effective at a willingness-to-pay of £30,000 per QALY gained. Conclusion: There was no significant difference between groups for the impact of fibromyalgia. Pilates was not cost-effective compared to aerobic exercises for the impact of fibromyalgia. However, Pilates seemed to be the preferred option of treatment considering QALYs, although it depends on the willingness-to-pay threshold. Significance: Pilates showed to be a safe and effective alternative for the treatment of patients with fibromyalgia syndrome. Pilates presented similar results for the impact of fibromyalgia and superior results for pain relief compared to aerobic exercises, a highly recommended intervention for the treatment of fibromyalgia syndrome. Pilates was not cost-effective compared to aerobic exercises for the impact of fibromyalgia. However, Pilates seemed to be a cost-effective intervention for QALYs, depending on the decision-maker's willingness-to-pay threshold.
| Original language | English |
|---|---|
| Pages (from-to) | 54-71 |
| Number of pages | 18 |
| Journal | European Journal of Pain (United Kingdom) |
| Volume | 27 |
| Issue number | 1 |
| Early online date | 13 Sept 2022 |
| DOIs | |
| Publication status | Published - Jan 2023 |
Bibliographical note
Funding Information:The authors thank the São Paulo Research Foundation (FAPESP) (grants 2015/21590‐6, 2016/12962‐0, 2018/07599‐9 and 2019/09593‐0) for financial support, and Universidade Cidade de São Paulo for providing the facilities for the recruitment and treatment of the patients. The authors also thank the journal BMC Rheumatology for the permission to reproduce some of the exercise figures, previously published in the study protocol, in this study.
Funding Information:
This study was funded by the São Paulo Research Foundation (FAPESP—grant numbers 2015/21590–6, 2016/12962–0, 2018/07599–9 and 2019/09593–0). FAPESP was not involved with data collection or analysis.
Funding Information:
This study was prospectively approved by the Research Ethics Committee of Universidade Cidade de São Paulo (CAAE: 51328215.1.0000.0064), registered on Clinical Trials Registry (NCT03050606) and funded by the Sao Paulo Research Foundation ‐ FAPESP (grants 2015/21590–6, 2016/12962–0, 2018/07599–9 and 2019/09593–0). All patients were assessed and treated between February 2017 and December 2018 at the Center for Excellence in Clinical Research in Physical Therapy at Universidade Cidade de São Paulo, Sao Paulo—SP, Brazil. Details of the study design and interventions were previously published in the protocol (Franco et al., 2019 ).
Publisher Copyright:
© 2022 European Pain Federation - EFIC ®.
Funding
The authors thank the São Paulo Research Foundation (FAPESP) (grants 2015/21590‐6, 2016/12962‐0, 2018/07599‐9 and 2019/09593‐0) for financial support, and Universidade Cidade de São Paulo for providing the facilities for the recruitment and treatment of the patients. The authors also thank the journal BMC Rheumatology for the permission to reproduce some of the exercise figures, previously published in the study protocol, in this study. This study was funded by the São Paulo Research Foundation (FAPESP—grant numbers 2015/21590–6, 2016/12962–0, 2018/07599–9 and 2019/09593–0). FAPESP was not involved with data collection or analysis. This study was prospectively approved by the Research Ethics Committee of Universidade Cidade de São Paulo (CAAE: 51328215.1.0000.0064), registered on Clinical Trials Registry (NCT03050606) and funded by the Sao Paulo Research Foundation ‐ FAPESP (grants 2015/21590–6, 2016/12962–0, 2018/07599–9 and 2019/09593–0). All patients were assessed and treated between February 2017 and December 2018 at the Center for Excellence in Clinical Research in Physical Therapy at Universidade Cidade de São Paulo, Sao Paulo—SP, Brazil. Details of the study design and interventions were previously published in the protocol (Franco et al., 2019 ).
