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 |
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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 |
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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 |
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Outcomes | PGE: 5 point scale (responder = “better” or “much better”) Physician rated Improvement: 5 point scale (responder = “marked Improvement”) Adverse events Withdrawals |
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Notes | Oxford Quality Score: R1, DB2, W1. Total=4/5 Oxford Validity Score: 15/16 |
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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 |