Machen 2002.
Methods | R, DB, PC, parallel groups Gel gently ("minimal rub", not vigorously) massaged into skin over affected site until absorbed 3 times daily until symptoms disappeared or for maximum of 7 days Assessment at baseline and once daily using diary cards to 7 days |
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Participants | Soft tissue injury (< 2 weeks and untreated) N = 85 (81 analysed) M 42, F 39 Mean age 41 years Baseline pain > 50 mm 4 placebo participants lost to follow‐up |
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Interventions | Ibuprofen gel 5%, x 3 daily, n = 40 Placebo gel, x 3 daily, n = 41 Initiation of other medication or physiotherapy not allowed during study |
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Outcomes | PGE: 5‐point scale (responder = "marked improvement" or "complete clearance") 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 | Gels had similar physical characteristics and were supplied in identical tubes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | < 5% missing participants. Remaining participants included in responder analysis |
Size | High risk | < 50 participants per treatment arm |