Use of noninvasive interactive neurostimulation to improve short-term recovery in patients with surgically repaired bimalleolar ankle fractures: a prospective, randomized clinical trial.

We undertook a trial with 60 patients who had undergone operative reduction and internal fixation of bimalleolar, AO type B2 ankle fractures with comminution. Patients were randomized into 2 groups, one of which received postoperative treatment using a noninvasive interactive neurostimulation device (InterX) and the other with a sham device. The trial was designed to test the hypothesis that incorporation of noninvasive interactive neurostimulation into the rehabilitation protocol would result in reduced pain, increased range of motion, reduced edema, and reduced consumption of pain medication, in comparison with the sham therapy group. Outcome measurements included the patient's subjective assessment of level of pain, range of motion, and the extent of edema in the involved ankle, and the use of ketorolac for postoperative control of pain. The results showed significantly better results in the patients receiving treatment with active neurostimulation (repeated measures analysis of variance, P < .001). Copyright 2010 American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.

RCT Entities:   Population Interventions Outcomes