Methods | RCT, DB, parallel groups New patches applied to the affected painful area for 12 consecutive hours twice daily, for up to 14 days Assessed at baseline, 14 days in clinic and daily patient diary |
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Participants | Minor sports injuries (sprains, sprains, contusions, <72 hours) N = 372 M 253, F 119 Mean age 33 years Baseline pain at rest ≥5/10 |
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Interventions | Diclofenac epolamine patch (Flector Tissuegel) 2 × daily (equivalent to 140 mg diclofenac sodium/patch), n = 191 Placebo patch, n = 181 |
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Outcomes | PGE: 5 point scale (responder = “good” and “excellent”) Pain resolved: <moderate for 2 days Spontaneous pain: 10 cm VAS (mean data) Adverse events Withdrawals |
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Notes | Oxford Quality Score: R1, DB2, W1. Total = 4/5 Oxford Validity Score: 16/16 |
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Risk of bias | ||
Bias | Authors’ judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes |
Unclear risk | “Systeme identique” without diclofenac |