Randomized controlled trial of orthosis after kyphoplasty: activity, pain and posture.

BACKGROUND

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.

METHODS

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.

RESULTS

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 stated to wear it 4-6 h per day in their diaries.

CONCLUSIONS

The TLO showed no influence on postoperative physical conditions after kyphoplasty. However, tendencies of lower pain perception in the intervention group could be shown. The contrast between objective and subjective wearing time highlights the significance of sensitizing patients in wearing orthoses to achieve a clinically relevant outcome. The reduced wearing time could have influenced the results, which probably means that the effects cannot be fully utilized. For this reason, additional training in way of wearing and duration including control mechanisms as well as motivational systems are needed to improve the patient's compliance and the effect of the orthosis.

LEVEL OF EVIDENCE: Therapeutic Level I.