Dreiser 1990.
Methods | R, DB, PC, parallel groups Gel lightly massaged into skin over affected area 3 times daily, then covered with standard compress Assessed at baseline, 3, 7 days |
|
Participants | Uncomplicated, ankle sprain (< 4 days) N = 60 (59 analysed) M 29, F 29 (not stated for 1 participant) Mean age 33 years Baseline pain ≥ moderately severe Exclusions: 1 participant had only moderate pain at baseline |
|
Interventions | Niflumic acid gel 2.5%, 3 x 5 g daily, n = 30 Placebo gel, n = 30 Concomitant treatment with systemic NSAIDs, local therapies, or physiotherapy were not allowed |
|
Outcomes | PGE: 4‐point scale (responder = "cured" or "improved") Improvement in pain: VAS (mean data) Adverse events Withdrawals and exclusions |
|
Notes | Oxford Quality Score: R1, DB1, W1. Total = 3/5 | |
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 | Not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants included in analysis |
Size | High risk | < 50 participants per treatment arm |