Whitefield 2002.
Methods | R, DB (double dummy), AC, parallel groups Gel applied to affected site, with gentle massage, and 1 tablet taken 3 times daily for at least 7 days Assessed at baseline, 7, 14 (if necessary) days in clinic, and daily patient diary |
|
Participants | Soft tissue injuries (< 24 hours) N = 100 M 95, F 5 Mean age 26 years (range 18 to 50) Mean baseline pain on movement 2.2 cm |
|
Interventions | Ibuprofen gel 5% + placebo tablet 3 x daily, n = 50 Ibuprofen 400 mg tablet + placebo gel 3 x daily, n = 50 No other medication or physical therapy was prescribed and no other analgesics were allowed |
|
Outcomes | PGE: 3‐point scale (responder = "excellent") Change in condition of injury site: 5‐point scale (responder = "completely better") Adverse events Withdrawals |
|
Notes | Oxford Quality Score: R1, DB2, W1. Total = 4/5 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not reported |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding (performance bias and detection bias) All outcomes | Low risk | Placebo tablets Identical in appearance to active tablets. Active and placebo gels had similar physical characteristics and were supplied in identical tubes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants included in analysis |
Size | Unclear risk | 50 participants per treatment arm |