Diebschlag 1987.
Methods | RCT, DB, parallel groups Duration 15 days Assessment on days 2, 3, 4, 8, 15, 29 |
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Participants | Acute ankle sprain presenting within 48 h Injury severity rated moderate or severe N = 80 M = 63, F = 17 Mean age 27 years (range 18 ‐ 50) |
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Interventions | Salicylic acid (2%), adrenal extract (1%), mucopolysaccharide polysulphate (0.2%) ointment (Mobilat), n = 40 Placebo ointment, n = 40 10 ‐ 15 cm x 2 daily |
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Outcomes | Pressure distribution on walking Swelling Ankle joint movement PI at rest: 100 mm VAS PI on movement: 100 mm VAS Adverse events |
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Notes | Oxford Quality Score: R2, DB2, W1. Total = 5/5 Suprarenal extract results in 0.02% corticosteroids |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "wurden mittels einer Zufallszahlentabelle mit fortlaufenden Behandlungnummern versehen" [sequence generated by means of a random numbers table] |
Allocation concealment (selection bias) | Low risk | "Die Reihenfolge des Eintritts der Patienten in den Versuch bestimmte die Zuordnung zu der jeweils folgenden Behandlungnummern und damit die Zuordnung zu einem der Vergleichspräparte" [participants were allocated consecutive treatment numbers in order of enrolment into the study] |
Blinding (performance bias and detection bias) All outcomes | Low risk | "Das Placebo enthielt die wirkstofffreie Salbengrundlage. Beide Zubereitungen unterscheiden sich nicht nach Aussehen, Geruch und physikalischen Eigenschaften" [The placebo contained the drug‐free ointment base. The preparations were identical in appearance, odour and physical properties] |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants completed study |
Size | High risk | < 50 participants per treatment arm |