Saillant 1998.
Methods | R, DB, PC, parallel groups Treatment for 7 days Assessed at baseline, 1, 2, 3, and 7 days | |
Participants | Ankle sprain (< 48 hours) N = 140 M 72, F 62 Age 18 to 65 years Baseline spontaneous pain ≥ 50 mm | |
Interventions | (1) DHEP plaster (Flector Tissugel 1%), 1 x daily, n = 70
(2) Placebo plaster, 1 x daily, n = 70 Rescue medication: paracetamol (to maximum 3 g daily) Ice allowed |
|
Outcomes | ≥ 30% decrease in PI at 7 days PGE: 4‐point scale (responder = "excellent") No or low pain on passive stretch Single foot leaning OK without pain 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 described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Low risk | Identical in size, appearance, and used same formula as active patch, without active ingredient |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Used LOCF for primary outcome. Withdrawals < 7% and equal between groups. All participants included in analysis |
Size | Unclear risk | 50 to 200 participants per treatment arm |