Is Pilates more effective and cost-effective than aerobic exercise in the treatment of patients with fibromyalgia syndrome? A randomized controlled trial with economic evaluation.

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.

Comparison between different health state utility instruments in patients with fibromyalgia.

BACKGROUND: Cost-utility analysis uses utility indexes to assess treatment effects. Some discrepancies between different utility indexes instruments are suggested and need to be identified in health conditions not yet investigated. OBJECTIVE: To compare different utility indexes instruments in Brazilian patients with fibromyalgia and identify variables associated with these instruments. METHODS: Impact of fibromyalgia (Fibromyalgia Impact Questionnaire [FIQ]) and utility indexes (Short-Form 6 Dimensions [SF-6D], EuroQol 5 Dimensions [EQ-5D], and EuroQol - Visual Analogue Scale [EQ-VAS]) were assessed in 97 patients with fibromyalgia at baseline, 8-week (after an exercise-based intervention), and 6- and 12-month follow-up. Construct validity and responsiveness of the utility indexes instruments were compared. Multiple regression models were used to verify the variables associated with the utility indexes instruments. RESULTS: Construct validity analysis showed that FIQ presented moderate correlation with the SF-6D, the EQ-5D, and the EQ-VAS (r=-0.43, -0.41, -0.30, respectively, all p < .01). There was a moderate correlation between the SF-6D and the EQ-5D (r = 0.51, p < .001), moderate correlation between the SF-6D and the EQ-VAS (r = 0.41, p < .001), and no correlation between the EQ-VAS and the EQ-5D. The EQ-5D was responsive at the 8-week and 6-month follow-up, the SF-6D was responsive only at 6-month follow-up and the EQ-VAS was not responsive. The FIQ was associated with the EQ-5D and the SF-6D indexes, and symptom duration and depression with the EQ-VAS index. CONCLUSION: The EQ-5D better assessed the clinical change in patients with fibromyalgia. Furthermore, impact of fibromyalgia, symptom duration, and depression seem to be associated with the utility indexes.

Analysis of the measurement properties of the Brazilian-Portuguese version of the Tampa Scale for Kinesiophobia-11 in patients with fibromyalgia.

OBJECTIVE: To analyze the measurement properties of the Brazilian-Portuguese version of the Tampa Scale for Kinesiophobia-11 in patients with fibromyalgia. METHODS: Assessment was made at three time points: baseline (n=130) and 15 days (n=54) and eight weeks after baseline (n=51). Data collected at baseline were used to assess internal consistency, criterion and construct validity, and ceiling and floor effects. Data collected at baseline and 15 days after baseline were used to assess reliability and measurement error, and data collected before and after an eight-week exercise-based physical therapy intervention were used to assess interpretability of change scores. RESULTS: The Tampa Scale for Kinesiophobia-11 showed adequate internal consistency (Cronbach's alpha=0.77; alpha if item deleted: 0.74-0.77), substantial reliability (intraclass correlation coefficient2,1=0.85; 95% confidence interval: 0.75, 0.90), good measurement error (standard error of measurement: 2.65 points), and a minimal detectable change (90% confidence) of 6.16 points. For validity, the Tampa Scale for Kinesiophobia-11 showed a positive and good correlation with the original Tampa Scale for Kinesiophobia (r=0.84, p<0.01), positive and moderate correlation with the Pain Catastrophizing Scale (r=0.55, p<0.01), positive and weak correlation with the Numerical Pain Rating Scale (r=0.25, p<0.01), positive and moderate correlation with the Beck Depression Inventory (r=0.39, p<0.01), and no correlation with the Patient-Specific Functional Scale (r=0.11, p=0.23). Kinesiophobia, pain, function, catastrophizing, and depression statistically improved after the eight-week intervention (p<0.01). CONCLUSION: The Tampa Scale for Kinesiophobia-11 is consistent, reliable, and appropriate to assess fear of movement in patients with fibromyalgia in the clinical context. Responsiveness of the Tampa Scale for Kinesiophobia-11 should be tested in future studies.

Effectiveness of the Pilates method versus aerobic exercises in the treatment of older adults with chronic low back pain: a randomized controlled trial protocol.

BACKGROUND: Chronic low back pain is potentially disabling for older adults, and exercise is considered the best treatment. The Pilates method and aerobic exercises have been proven to be effective in pain and function improvement in patients with low back pain, but evidence in the treatment of older adults with low back pain is scarce. Therefore, the objective of this study is to investigate the effectiveness of the Pilates method compared to aerobic exercises in the treatment of older adults with chronic nonspecific low back pain. METHODS: This is a randomized controlled trial with blinded assessor, to be held in a physical therapy clinic in Sao Paulo, Brazil. Seventy four patients aged 65 to 85 years with chronic nonspecific pain will be randomized into Pilates Group (n = 37) with exercises based on the Pilates method and Aerobic Group (n = 37) with treadmill aerobic exercise. The primary outcomes will be pain intensity and general disability, assessed eight weeks after randomization. The secondary outcomes will be: pain intensity and general disability, assessed six months after randomization; and global perceived improvement, specific disability, dynamic balance, muscle strength (gluteus maximus, gluteus medius, and lateral hip rotators), and pressure pain threshold, assessed eight weeks and six months after randomization. Therapists and patients will not be blinded. DISCUSSION: This study has the potential to reduce pain and, consequently, improve balance and function of older adults with chronic low back pain with both therapies. However, Pilates may be more effective because the exercises are more targeted to the trunk stabilization muscles. The results of this study may provide valuable information on the effects of Pilates and aerobic exercise in older adults with chronic low back pain and contribute to a better selection of the treatment program according to the patient preference. TRIAL REGISTRATION: ClinicalTrials.gov NCT02729779 , April 6, 2016.

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.

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.