Russell 1991.
Methods | R, DB, PC, parallel groups Affected area washed with soap and water and dried, then gel applied and carefully rubbed into skin, 4 times daily for at least 7 days Assessed at baseline, 4, 8, 15 (if necessary) days at clinic, and daily patient diary |
|
Participants | Acute soft tissue injuries (recent, not recurrent) N = 214 (200 analysed) M 95, F 105 Mean age 40 years Baseline pain > 65 mm |
|
Interventions | Piroxicam gel 0.5%, 4 x 5 mg daily, n = 100 Placebo gel, n = 100 No other NSAIDs or analgesic drugs, including liniments containing salicylates, allowed. Ancillary therapy at the discretion of the investigator |
|
Outcomes | PGE: 4‐point scale (responder = "good" and "excellent") Spontaneous pain: mean reduction Adverse events Withdrawals |
|
Notes | Oxford Quality Score: R2, DB2, W1. Total = 5/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "computer generated randomization code" |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Low risk | "identical base formulation" |
Incomplete outcome data (attrition bias) All outcomes | High risk | High withdrawal rate (8% with piroxicam, 50% with placebo). No information about imputation |
Size | Unclear risk | 50 to 100 participants per treatment group |