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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
Gel applied to affected area 3 or 4 times daily with no occlusion for up to 14 days
Assessed at baseline, 7, 14 days
Participants Muscle pain and/or inflammation in neck, shoulder, back, chest and upper and lower extremities
N = 271 (247 analysed)
M 97, F 149
Age <20 to 89 yrs
Baseline pain mostly mild to mod
Exclusions: 24 due to protocol violations, loss to follow up
Interventions Piroxicam gel 0.5%, 3-4 × 1 g daily, n = 92
Indomethacin gel 1%, 3-4 × 1 g daily, n = 90
Placebo gel, n = 89
No concomitant oral or topical analgesic or anti-inflammatory medication allowed. No physical therapy initiated after start of study
Outcomes PGE: 5 point scale (responder = “better” or “much better”)
Physician rated Improvement: 5 point scale (responder = “marked Improvement”)
Adverse events
Withdrawals
Notes Oxford Quality Score: R1, DB2, W1. Total=4/5
Oxford Validity Score: 15/16
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not described
Allocation concealment (selection bias) Low risk Cartons numbered randomly and numbers held in a key code until study completion
Blinding (performance bias and detection bias)
All outcomes
Low risk “identical tubes” packed in numbered carton. Gel bases slightly different in appearance, so dispensing physician did not have access to them