CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 54 enrolled
Drug / intervention
Lumbar corset (Quickdraw, Aspen Medical Products)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02251106
NCT02251106N/ACompleted

Effect of Lumbar Bracing on Spinal Function

University of Alberta·interventional·Posted Sep 29, 2014·Updated Mar 8, 2023

In Brief

A clinical study evaluating Lumbar corset (Quickdraw, Aspen Medical Products) for Low Back Pain. Completed, enrolled 54 participants.

Detailed Summary

A recent province-wide survey (Alberta, Canada) suggests that clinicians' beliefs about soft lumbar bracing for low back pain (LBP) vary substantially. Approximately 50% of clinicians (MDs, DCs, PTs) find back braces "useful" for acute back pain while the remaining half report that bracing causes muscle atrophy. While previous studies suggest bracing for acute low back conditions can reduce pain and does not cause atrophy, no prior study has assessed back function after bracing using self-reported and objective measures within the same cohort. PURPOSE: To assess both self-reported and objective measures of spine function before, and after, use of an inelastic lumbar brace over a two week period. STUDY DESIGN: Before-After Design OUTCOME MEASURES: Self-reported spine function, spinal stiffness and muscle endurance. METHODS: Three groups were studied: asymptomatics who did not wear a brace (-LBP/-Brace), asymptomatics who were braced (-LBP/+Brace) and acute LBP subjects who were braced (+LBP/+Brace). Both groups of braced subjects (-LBP/+Brace; +LBP/+Brace) were instructed to wear the brace continually for 2 weeks with the exception of bedroom \& bathroom activities. Before and after the 2 week period, 3 measures of spine function were performed: spinal stiffness via motorized indentation of the L3 spinous process, a modified Sorensen test (timed lumbar extension against gravity), and the Oswestry Disability Index (ODI). Unbraced (-LBP/-Brace) subjects were studied over the same time with the same measures. Repeated measures analyses of variance were conducted for all three outcomes with a significance level of 0.05.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
Countries--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 29, 2014
Enrollment StartMay 1, 2012
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 11.8 years ago

Interventions

Lumbar corset (Quickdraw, Aspen Medical Products)device

The corset (a.k.a. brace) is made of webbing and elastic. It is wrapped around the trunk and tightened with Velcro and a series of cords (like tying shoes).