Effectiveness and cost-effectiveness of the modified Pilates method versus aerobic exercise in the treatment of patients with fibromyalgia: protocol for a randomized controlled trial

Author(s)

Moura Franco, Katherinne Ferro ; dos Santos Franco, Yuri Rafael ; Espirito Santo Salvador, Evany Maira ; Brajon do Nascimento, Bruna Cristina ; Miyamoto, Gisela Cristiane ; Nunes Cabral, Cristina Maria

• Document type: Journal article
• Source: BMC RHEUMATOLOGY; v. 3, n. 1, p. 9-pg., 2019-01-01.

Abstract

BackgroundFibromyalgia is characterized by chronic generalized pain, fatigue, sleep disorders and other symptoms. Physical exercise is recommended as the first choice of non-pharmacological therapy. Thus, the aim of this study is to evaluate the effectiveness and cost-effectiveness of modified Pilates exercises compared to aerobic exercises in the treatment of patients with fibromyalgia.MethodsIn this randomized controlled trial with blinded assessor, 98 patients who meet the fibromyalgia classification criteria of the American College of Rheumatology 2010, aged between 20 and 75years, and with pain intensity greater than or equal to 3 points in the Pain Numerical Rating Scale, will be randomly divided into Aerobic Group (aerobic exercises on treadmills or stationary bikes) and Pilates Group (modified Pilates exercises), and treated twice a week for eight weeks on the Center for Excellence in Clinical Research in Physical Therapy at Universidade Cidade de SAo Paulo, Brazil. The following outcomes will be evaluated by a blinded assessor at baseline, eight weeks, six months, and 12months after randomization: impact of fibromyalgia assessed by the Fibromyalgia Impact Questionnaire, pain intensity by the Pain Numerical Rating Scale, kinesiophobia by the Tampa Scale of Kinesiophobia, specific disability by the Patient-Specific Functional Scale, functional capacity by the 6-min Walk Test, quality of sleep by the Pittsburgh Sleep Quality Index, and health-related quality of life by EQ-5D-3L and SF-6D questionnaires.DiscussionIt is expected that the Pilates exercises will be more effective than aerobic exercises in improving clinical outcomes and that this improvement will be maintained over the medium to long term. This study aims to clarify whether the Pilates method can be incorporated into the clinical practice of physical therapists treating patients with fibromyalgia. The study will also provide information on which exercise will be most cost-effective, information that can be used by insurers and public health systems.Trial registrationThis study was prospectively registered at the Clinical Trials Registry (NCT03050606) in February 2017. (AU)

• FAPESP's process: 16/12962-0 - Effectiveness of the modified Pilates method versus aerobic exercise in the treatment of patients with chronic pain: randomized controlled trial
• Grantee: Cristina Maria Nunes Cabral
• Support Opportunities: Regular Research Grants
• FAPESP's process: 15/21590-6 - Effectiveness and cost-effectiveness of modified Pilates Method versus aerobic exercise in the treatment of fibromyalgia: a randomized controlled trial
• Grantee: Katherinne Ferro Moura Franco
• Support Opportunities: Scholarships in Brazil - Doctorate