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Controlled trial of an ankle support (Malleotrain) in acute ankle injuries
O'Hara J, Valle-Jones JC, Walsh H, O'Hara H, Davey NB, Hopkin-Richards H, Butcher RM
British Journal of Sports Medicine 1992 Sep;26(3):139-142
clinical trial
4/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

A randomized, controlled parallel-group trial has assessed 14 days' use of a new ankle support (Malleotrain, Bauerfeind, Aldershot, UK) in 220 patients (118 Malleotrain, 102 control group) with acute ankle injuries. Self-assessed pain levels were significantly lower in the group using Malleotrain at the end of the trial (p < 0.05), as were median times taken for reduction of symptom scores to 10% (p < 0.05) and total analgesic consumption during the trial (p < 0.05). Overall clinical assessment scores were significantly superior in the Malleotrain group (p < 0.02). Of those patients who received Malleotrain, 112 of 116 patients who commented (95% of all Malleotrain-treated patients) did so positively and only one patient stopped wearing the support during the trial. Malleotrain is acceptable to patients with acute ankle injuries and its use increases the rate of alleviation of symptoms. Its use should therefore be considered in the management of all such patients.
Reproduced with permission from the BMJ Publishing Group.

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