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

Abstract

Background Fibromyalgia 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. Methods In 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. Discussion It 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 registration This study was prospectively registered at the Clinical Trials Registry ( NCT03050606 ) in February 2017. Electronic supplementary material The online version of this article (10.1186/s41927-018-0051-6) contains supplementary material, which is available to authorized users.

Comparison between different health state utility instruments in patients with fibromyalgia

“…This longitudinal study is a secondary analysis of data from a randomized controlled trial (RCT) on patients with fibromyalgia. 29 In that trial, data were collected at baseline and in three post-treatment periods: eight-week and sixand 12-month follow-ups (Fig. 1).…”

“…Details of the RCT protocol were previously published. 29 The aim of the RCT was to evaluate the clinical and costeffectiveness of Pilates compared to aerobic exercises in the treatment of patients with fibromyalgia. In this study, which included 97 randomly assigned patients with fibromyalgia, the main results showed that, except for the EQ-5D at 12month follow-up, there was no difference between Pilates and aerobic exercises for the impact of fibromyalgia and health-related quality of life (HRQoL) at eight-week and six-and 12-month follow-ups.…”

“…Both groups received an educational intervention in the first session. 29 Additionally, patients randomized to the Pilates group received Pilates-based exercises including exercises on a mat with accessories, and on apparatus, with activation of the core muscles while exhaling. Patients randomized to the aerobic exercise group received aerobic exercises on a stationary bike or treadmill, with training heart rate of 57 to 76% of the maximum heart rate, corresponding to mild to moderate intensity of exercise.…”

“…Patients randomized to the aerobic exercise group received aerobic exercises on a stationary bike or treadmill, with training heart rate of 57 to 76% of the maximum heart rate, corresponding to mild to moderate intensity of exercise. 29 Both groups received 16 one-hour individualized exercise sessions over eight weeks. 29 Due to the nature of the intervention, patients and therapists were not blinded to group allocation.…”

“…29 Both groups received 16 one-hour individualized exercise sessions over eight weeks. 29 Due to the nature of the intervention, patients and therapists were not blinded to group allocation.…”