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 75 years, 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 São Paulo, Brazil. The following outcomes will be evaluated by a blinded assessor at baseline, eight weeks, six months, and 12 months 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.
Highlights
Fibromyalgia is characterized by chronic generalized pain, fatigue, sleep disorders and other symptoms
The Aerobic Group will perform aerobic exercises, and the training heart rate (HR) will be 57 to 76% of maximum heart rate (HRmax), which corresponds to the mild to moderate exercise intensity indicated for these patients [16, 25, 44]
Current evidence shows that aerobic exercise does not generate very good adherence in the treatment of patients with fibromyalgia [60], it has a low to moderate effect on the improvement of their symptoms [16]
Summary
Fibromyalgia is characterized by chronic generalized pain, fatigue, sleep disorders and other symptoms. Fibromyalgia is a rheumatologic disease characterized by chronic generalized pain, hyperalgesia, and allodynia [1] It is characterized by the presence of symptoms such as fatigue, sleep disorders, morning stiffness, headache, and paresthesia [1]. One of the main pathophysiological mechanisms of fibromyalgia is central sensitization, defined as increased responsiveness of nociceptive neurons in the central nervous system to their normal or subthreshold afferent input [3]. In this case, pain can arise spontaneously or be elicited by a normally innocuous stimuli (allodynia), is exaggerated and prolonged in response to a noxious stimuli (hyperalgesia), and spreads beyond the site of injury (secondary hyperalgesia) [4]
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