Joussellin 2003.
Methods | R, DB, PC, parallel groups Plaster applied to skin over affected area once daily Assessed at baseline, 1, 2, 3, 7 days |
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Participants | Ankle sprain (< 48 hours) N = 134 M 72, F 62 Age range 18 to 65 years Baseline spontaneous pain ≥ 50 mm |
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Interventions | DHEP plaster (Flector Tissugel 1%), x 1 daily, n = 68 Placebo plaster, x 1 daily, n = 66 Rescue medication: paracetamol |
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Outcomes | PGE: 4‐point scale (responder = "excellent") Pain on movement: VAS (mean) Adverse events Withdrawals |
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Notes | Oxford Quality Score: R1, DB2, W1. Total = 4/5 | |
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 | Low risk | "Identical in size, appearance and used same formula as active patch, without active ingredient" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants included in responder analysis |
Size | Unclear risk | 50 to 200 participants per treatment arm |