STUDY DESIGN: Randomized controlled trial. OBJECTIVE: To assess whether monitoring increases brace-wearing compliance in patients with adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: 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. METHODS: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. RESULTS: 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. CONCLUSION:Electronic monitoring can improve compliance with orthoses in patients with spinal deformity during a short observation period.
RCT Entities:
STUDY DESIGN: Randomized controlled trial. OBJECTIVE: To assess whether monitoring increases brace-wearing compliance in patients with adolescent idiopathic scoliosis (AIS). SUMMARY OF BACKGROUND DATA: 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. METHODS: 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. RESULTS: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. CONCLUSION: Electronic monitoring can improve compliance with orthoses in patients with spinal deformity during a short observation period.
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