Predel 2012.
Methods | R, DB, PC, parallel groups Treatment for 7 days Assessed at baseline, 1, 3, 5 and 8 days | |
Participants | Grade I or II ankle sprain with lateral external ligament involvement, < 12 hours
PI on movement ≥ 50/100
N = 242 M 152, F 90 Mean age 32 years Mean baseline pain on movement = 75/100 |
|
Interventions | Diclofenac gel (Voltaren Emulgel 2.32%), 2 x 5 cm + 1 x 5 cm placebo gel daily, n = 80
Diclofenac gel (Voltaren Emulgel 2.32%), 3 x 5 cm daily, n = 80
Placebo gel, 3 x 5 cm daily, n = 82 Rescue medication: paracetamol (to maximum 2 g daily) No ice or bandages after randomisation |
|
Outcomes | ≥ 50% reduction in PI on movement at 5 days PGE: 5‐point scale (responder = "good" or 'very good") Patient satisfaction: 5‐point scale (responder = "good" or 'very good" or "excellent") Rescue medication Adverse events Withdrawals |
|
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 | "identical in composition, appearance, texture and smell" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | LOCF, but withdrawals < 3% in all treatment arms |
Size | Unclear risk | 50 to 200 participants per treatment arm |