Rothhaar 1982.
Methods | RCT, DB, parallel groups Duration 9 days Assessment on days 3, 7, 9 |
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Participants | Sports injuries Baseline pain mild to severe N = 100 M = 49, F = 32 Average age 30 years (range 14 to 58) |
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Interventions | Escin 1%, diethylamine salicylate 5% (Reparil‐Gel), n = 50 Placebo gel, n = 50 Gel applied at least x 4 daily to affected area |
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Outcomes | PI (spontaneous): 4‐point scale PI with load: 4‐point scale PI on movement: 4‐point scale PI with pressure: 4‐point scale Tightness: 4‐point scale Temperature: 4‐point scale Haematoma: 4‐point scale Swelling: 4‐point scale Ratio of range of movement to unaffected limb Ratio of size to unaffected limb Patient global assessment: 5‐point scale Improvement in spontaneous pain: 3‐point scale Improvement in movement pain: 3‐point scale Remission in spontaneous pain: 3‐point scale Remission in movement pain: 3‐point scale Withdrawals Adverse events |
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Notes | Oxford Quality Score: R1, DB2, W1. Total = 4/5 19 patients had no data and were not included |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method used to generate random sequence not described |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | "Geprüft wurde gegen ein vom Verum‐Präparat hinsichtlich Verpakkung, Aussehen und Geruch nicht unterscheidbares Plazebo‐Gel" [tested against a placebo gel which was indistinguishable in packaging, appearance and odour] |
Incomplete outcome data (attrition bias) All outcomes | High risk | > 10% randomised participants provided no data |
Size | High risk | < 50 participants per treatment arm provided data |