Comparative Effectiveness of Sacroiliac Belt versus Lumbar Orthosis Utilization on Nonspecific Low Back Pain: a Crossover Randomized Clinical Trial.

Abstract

Back braces are commonly utilized in the management of low back pain (LBP). The aim of this study is to evaluate (1) user satisfaction with a sacroiliac belt versus a lumbar orthosis and (2) the effect of a sacroiliac belt versus a lumbar orthosis on pain, functional disability status, and analgesic use for subjects with subacute or chronic non-specific LBP. This is a prospective randomized crossover study. For the two-week study period, control group subjects wore the Horizon 627 Lumbar Brace ("lumbar orthosis") during the first week and the Serola Sacroiliac Belt ("sacroiliac belt") during the second week; experimental group subjects wore the sacroiliac belt during the first week and the lumbar orthosis during the second week. User satisfaction (Quebec User Evaluation of Satisfaction with Assistive Technology 2.0 [QUEST 2.0] score), functional disability status (Oswestry Disability Index [ODI]), pain, and analgesic use were recorded. Overall, the sacroiliac belt demonstrated significantly higher user satisfaction than the Horizon brace (QUEST Score = 20.31 vs.16.17, p = 0.0375) for the entire study period. Significant negative correlations were identified between user satisfaction and functional disability (t = -4.71, p < 0.0001), pain magnitude (t = -6.81, p < 0.0001) as well as pain frequency (t = -6.66, p < 0.0001). In this prospective randomized crossover study, subject satisfaction was associated with improvements in functional disability, pain magnitude and pain frequency. The sacroiliac belt demonstrated significantly higher user satisfaction and similar effectiveness compared to the lumbar orthosis.