Predel 2013a.
Methods | R, DB, PC, parallel groups Treatment for 14 days Assessed at baseline, 3, 7, 10 and 14 days (± 1 day) | |
Participants | Uncomplicated, one‐sided ankle sprain with swelling ≥ 12 mm (2 to 18 hours)
PI on movement, tenderness, joint mobility (scale 0 to 3) summed as ≥ 5 and ≤ 7
N = 232 M 126, F 106 Mean age 29 years |
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Interventions | Diclofenac 4% spray gel, 3 x 4 to 5 sprays daily (96 to 120 mg diclofenac sodium), n = 118
Placebo spray gel, 3 x 4 to 5 sprays daily, n = 114 Rescue medication: paracetamol 500 mg (maximum 10 tablets per week) No ice or bandaging allowed |
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Outcomes | None or slight PI on movement at 3 and 7 days PGE: 4‐point scale (responder = "very good" at 14 days) > 50% reduction in swelling at 10 days 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 | Unclear risk | "placebo (vehicle only, no active ingredient)" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | LOCF for full or early cure. Withdrawals < 2% |
Size | Unclear risk | 50 to 200 participants per treatment arm |