Methods | RCT, DB, parallel groups Participants given specific instructions on how to apply gel (not reported) to affected area two to six times daily as required Assessment at baseline, 3, 7 days in clinic |
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Participants | Soft tissue injuries (<48 hours) N = 120 M 85, F 35 Mean age 27 years Basline pain moderate to severe |
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Interventions | Naproxen gel 10%, 2-6 × daily, n = 60 Placebo gel, n = 60 Rescue medication: paracetamol 500 mg |
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Outcomes | PGE: 5 point (responder = “good” and “very good”) Pain on passive movement: 4 point scale (mean data) Adverse events Withdrawals |
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Notes | Oxford Quality Score: R1, DB1, W1. Total = 3/5 Oxford Validity Score: 13/16 |
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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 |
Low risk | “supplied in unmarked tubes” |