Randomized controlled trial of orthosis after kyphoplasty: activity, pain and posture
Abstract
The successful conservative treatment of spinal osteoporotic fractures with orthoses has been extensively studied in the past, but data on the benefit of additional orthotic treatment after kyphoplasty are lacking. The aim of this study was to examine the influence of a thoracolumbar orthosis (TLO) on movement activity, pain perception, and functional parameters after kyphoplasty of osteoporotic spinal fractures. This randomized-controlled-trial included patients with osteoporotic spine fractures of the thoracal and lumbar spine with indication for primary kyphoplastic treatment. The intervention group postoperatively wore a TLO for eight weeks (controlled by a thermal sensor and diary) while the control group did not receive an orthosis. Both groups were equipped with an activity tracker to determine step activity during this time. An examination of activity, pain perception, and functional parameters was performed pre- and immediately postoperatively as well as 2/8/12/24 weeks after surgery. Fifty five patients (mean age: 69 ± 7 years) were included in this study. Over the 8-week postoperative period, both groups showed significant changes in step activity (p = 0.003) but no group difference (p = 0.891). Furthermore, no group differences were seen in weekly activity, pain perception, and functional parameters (p = 0.580; 0.298; 0.529). According to the temperature measurement, participants in the intervention group wore the orthosis for an average of 2.8 h per day but…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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