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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.
Reproduced with permission from the BMJ Publishing Group.

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