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Different doses of Pilates-based exercise therapy for chronic low back pain: a randomised controlled trial with economic evaluation [with consumer summary] |
Miyamoto GC, Franco KFM, van Dongen JM, dos Santos Franco YR, de Oliveira NTB, Amaral DDV, Branco ANC, da Silva ML, van Tulder MW, Cabral CMN |
British Journal of Sports Medicine 2018 Jul;52(13):859-868 |
clinical trial |
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
OBJECTIVES: To evaluate the effectiveness and cost-utility of the addition of different doses of Pilates to an advice for non-specific chronic low back pain (NSCLBP) from a societal perspective. DESIGN: Randomised controlled trial with economic evaluation. SETTING: Physiotherapy clinic in Sao Paulo, Brazil. PARTICIPANTS: 296 patients with NSCLBP. INTERVENTIONS: All patients received advice and were randomly allocated to four groups (n = 74 per group): booklet group (BG), Pilates once a week (Pilates group 1, PG1), Pilates twice a week (Pilates group 2, PG2) and Pilates three times a week (Pilates group 3, PG3). MAIN OUTCOME MEASURES: Primary outcomes were pain and disability at 6-week follow-up. RESULTS: Compared with the BG, all Pilates groups showed significant improvements in pain (PG1 mean difference (MD) -1.2, 95% CI -2.2 to -0.3; PG2 MD -2.3, 95% CI -3.2 to -1.4; PG3 MD -2.1, 95% CI -3.0 to -1.1) and disability (PG1 MD -1.9, 95% CI -3.6 to -0.1; PG2 MD -4.7, 95% CI -6.4 to -3.0; PG3 MD -3.3, 95% CI -5.0 to -1.6). Among the different doses, PG2 showed significant improvements in comparison with PG1 for pain (MD -1.1, 95% CI -2.0 to -0.1) and disability (MD -2.8, 95% CI -4.5 to -1.1). The cost-utility analysis showed that PG3 had a 0.78 probability of being cost-effective at a willingness-to-pay of Great British Pounds 20,000 per quality-adjusted life-year gained. CONCLUSIONS: Adding two sessions of Pilates exercises to advice provided better outcomes in pain and disability than advice alone for patients with NSCLBP; non-specific elements such as greater attention or expectation might be part of this effect. The cost-utility analysis showed that Pilates three times a week was the preferred option. TRIAL REGISTRATION NUMBER: NCT02241538, completed.
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