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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
Participants given specific instructions on how to apply gel (not reported) to affected area two to six times daily as required
Assessment at baseline, 3, 7 days in clinic
Participants Soft tissue injuries (<48 hours)
N = 120
M 85, F 35
Mean age 27 years
Basline pain moderate to severe
Interventions Naproxen gel 10%, 2-6 × daily, n = 60
Placebo gel, n = 60
Rescue medication: paracetamol 500 mg
Outcomes PGE: 5 point (responder = “good” and “very good”)
Pain on passive movement: 4 point scale (mean data)
Adverse events
Withdrawals
Notes Oxford Quality Score: R1, DB1, W1. Total = 3/5
Oxford Validity Score: 13/16
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
Low risk “supplied in unmarked tubes”