Frahm 1993.
Methods | RCT, DB, parallel groups Duration 11 days Assessment at on days 2, 4, 9, 11 |
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Participants | Acute ankle or knee sprain within 24 h Patients had moderate or slight pain N = 156 (163 randomised, 7 protocol infringements) M = 98, F = 58 Mean age 32 years (range 18 ‐ 65) |
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Interventions | Salicylic acid (2%), mucopolysaccharide polysulphate (0.2%) cream (Movelat), n = 78 Placebo cream, n = 78 10 cm x 2 daily |
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Outcomes | PI on movement: 100 mm VAS PI at rest: 100 mm VAS Swelling Withdrawals Adverse events |
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Notes | Oxford Quality Score: R1, DB2, W0. Total = 3/5 No concomitant treatment allowed except max 1 g paracetamol x3 daily |
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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. Block randomisation used |
Allocation concealment (selection bias) | Unclear risk | Method not described |
Blinding (performance bias and detection bias) All outcomes | Low risk | "There were no differences in the appearance, smell, or physical properties of the preparations" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Exclusions (protocol infringements) < 10% (7/163) |
Size | Unclear risk | 50 ‐ 200 participants per treatment arm |