ObjectiveTo determine the efficacy of two physiotherapeutic interventions – aquatic therapy (AT) and land-based therapy (LBT) – for reducing pain in women with fibromyalgia. DesignSingle-blind, randomised controlled, equivalence trial. SettingFibromyalgia, Chronic Fatigue Syndrome and Multiple Chemical Sensitivity Association in A Coruña, Spain. ParticipantsForty women with fibromyalgia were assigned at random in a 1:1 manner to two groups: AT (n = 20) and LBT (n = 20). InterventionsTwo therapeutic exercise programmes, with 60-min sessions, were undertaken three times per week for 12 weeks. Sessions were carried out in groups by a trained physiotherapist. OutcomeThe primary outcome was pain intensity (visual analogue scale). The secondary outcomes were pressure pain threshold (algometer), quality of life (Revised Fibromyalgia Impact Questionnaire), sleep quality (Pittsburgh Sleep Quality Index), fatigue (Multidimensional Fatigue Inventory) and physical ability (6-Minute Walk Test). Patients were evaluated at baseline, 12 weeks (post-treatment) and 18 weeks (follow-up). The statistical analysis was per-protocol. P < 0.05 was considered to indicate significance. Effect size was calculated. ResultsThe mean age was 50 [standard deviation (SD) 9] years, with median body mass index of 27 [interquartile range (IQR) 25–30] kg/m2 and median symptom duration of 11 (IQR 6–15) years. No differences were observed between the groups post-treatment, but differences in favour of AT were found in pain intensity [2.7 (IQR 1.5-4.9) vs 5.5 (IQR 3.3-7.6); p= 0.023; large effect, Cohen's d= 0.8; 95% confidence interval (CI) 0.1-1.5] and sleep quality [12.0 (IQR 7.3-15.3) vs 15.0 (IQR 13.0-17.0); p= 0.030; large effect, Cohen's d= 0.8; 95% CI 0.1-1.5] at follow-up. ConclusionsThe results suggest that AT is better than LBT for reducing pain intensity and improving sleep quality after 6 weeks of follow-up. AT may be a good treatment option for women with fibromyalgia. Clinical Trials Registration NumberClinicalTrials.gov NCT02695875 Contribution of the paper•This paper provides evidence that aquatic therapy is an effective intervention for reducing pain and improving sleep quality of women with fibromyalgia.•The matched protocols designed for this study highlighted the influence of the environment on symptom management in women with fibromyalgia.
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