NCT01272934.
Methods | R, DB, PC, parallel group study Gel applied 4 x daily |
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Participants | Acute lateral ankle sprain, Grade I to II, ≤ 12 hours
N = 205 M 101, F 104 Mean (± SD) age 32 years (± 11) Baseline PI not reported |
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Interventions | Diclofenac sodium gel 1%, x 4 daily, n = 102 Placebo gel, x 4 daily, n = 103 | |
Outcomes | Mean PI on movement Adverse events |
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Notes | Oxford Quality Score: R1, DB1, W1. Total = 3/5 | |
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 | Method of blinding not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants accounted for |
Size | Unclear risk | 50 to 200 participants per treatment arm |