Dreiser 1989.
Methods | R, DB, PC, parallel groups Gel applied twice daily to affected area with light massage, then covered with standard compress Assessed at baseline, 3, 7 days |
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Participants | Uncomplicated, recent ankle sprain N = 60 M 36, F 24 Mean age 33 years Mean baseline pain 54 mm |
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Interventions | Ketoprofen gel 2.5%, 2 x 5 cm daily, n = 30 Placebo gel, n = 30 No concomitant therapy other than simple oral analgesia allowed |
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Outcomes | PGE: 3‐point scale (responder = "better") Improvement in pain: VAS (mean data) Adverse events Withdrawals |
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Notes | Oxford Quality Score: R2, DB2, W1. Total = 5/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "drawing lots" |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Low risk | Treatments "identical in every way except that placebo did not contain active principle" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants included in analysis |
Size | High risk | < 50 participant per treatment arm |