51 adult patients with tibial fractures were included in a randomized pilot study to evaluate the feasibility of a definitive trial assessing the use of ultrasound in the treatment of tibial fractures. Patients were randomized to receive low-intensity pulsed ultrasound (LIPUS) or a sham device. At 6 months, the LIPUS group demonstrated significantly greater Short Form-36 physical function scores and Health Utilities Index-III scores than the sham group. There was no difference between the two groups with respect to any other outcomes. In addition, good results were found for the recruitment and follow up rate, investigator adherence to the study protocol, and patient compliance. A definitive trial investigating the effectiveness of LIPUS was therefore considered to be feasible.
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