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. Author manuscript; available in PMC: 2014 Sep 15.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Jun 16;(6):CD007402. doi: 10.1002/14651858.CD007402.pub2
Methods RCT, DB, parallel groups
New patches applied to the affected painful area for 12 consecutive hours twice daily, for up to 14 days
Assessed at baseline, 14 days in clinic and daily patient diary
Participants Minor sports injuries (sprains, sprains, contusions, <72 hours)
N = 372
M 253, F 119
Mean age 33 years
Baseline pain at rest ≥5/10
Interventions Diclofenac epolamine patch (Flector Tissuegel) 2 × daily (equivalent to 140 mg diclofenac sodium/patch), n = 191
Placebo patch, n = 181
Outcomes PGE: 5 point scale (responder = “good” and “excellent”)
Pain resolved: <moderate for 2 days
Spontaneous pain: 10 cm VAS (mean data)
Adverse events
Withdrawals
Notes Oxford Quality Score: R1, DB2, W1. Total = 4/5
Oxford Validity Score: 16/16
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 “Systeme identique” without diclofenac