Randomized controlled trial.
To assess whether monitoring increases brace-wearing compliance in patients with adolescent idiopathic scoliosis (AIS).
Noncompliance is a barrier to brace treatment of AIS. Studies have demonstrated that monitoring improves medication compliance; however, this has not been investigated in spinal braces.
Twenty-one patients (mean age = 12.4 ± 2.0 years) with AIS were prescribed treatment with a custom-made Thoraco-Lumbo-Sacral-Orthosis for 18 hours a day using a standardized script. Before beginning treatment, 10 patients were randomized to be informed that their compliance was monitored, whereas 11 patients were unaware. Compliance was measured via a temperature probe embedded within the Thoraco-Lumbo-Sacral-Orthosis hidden from view.
Patients who were notified that they had a monitor in their brace demonstrated significantly increased compliance during the first 14 weeks of treatment compared with those who were uninformed (85.7% vs. 56.5%, P = 0.029), corresponding to a mean difference of 5.24 hours of daily brace wear.
Electronic monitoring can improve compliance with orthoses in patients with spinal deformity during a short observation period.
Braces of patients with adolescent idiopathic scoliosis were affixed with a temperature monitor to record patient brace-wearing activity. Patients were randomized with respect to knowledge of the presence of this monitor. Patients who were aware of compliance monitoring demonstrated significantly increased compliance during the initial 14 weeks of treatment.
*Division of Pediatric Orthopaedic Surgery, Department of Orthopaedic Surgery, Columbia University Medical Center, New York, NY
†Pediatric Orthopaedic Surgery, New York-Presbyterian, Morgan Stanley Children's Hospital, Columbia University Medical Center, New York, NY.
Address correspondence and reprint requests to Michael G. Vitale, MD, MPH, New York-Presbyterian, Morgan Stanley Children's Hospital, Columbia University Medical Center, 3959 Broadway, Ste 800 North, New York, NY 10032; E-mail: firstname.lastname@example.org
Acknowledgment date: August 25, 2010. Revision date: July 20, 2011. Acceptance date: July 20, 2011.
The device(s)/drug(s) that is/are the subject of this manuscript is/are not FDA approved for this indication and is/are not commercially available in the United States.
This work was supported by a grant from the Doris Duke Charitable Foundation to Columbia University, College of Physicians and Surgeons to fund Clinical Research Fellows Jeanne Franzone and Daniel Miller, as well as project support from the East Coast Orthotics and Prosthetics Corporation.
No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.