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

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