Skip to main content
. 2015 Jun 15;2015(6):CD007402. doi: 10.1002/14651858.CD007402.pub3

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
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
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
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