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Effect of Lumbar Bracing on Spinal Function

NCT02251106 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-03-08

Study results available
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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.

Conditions

  • Low Back Pain

Interventions

DEVICE

Lumbar corset (Quickdraw, Aspen Medical Products)

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).

Sponsors & Collaborators

  • Aspen Medical Products

    collaborator OTHER

  • University of Alberta

    lead OTHER

Principal Investigators

  • Greg N Kawchuk, PhD · University of Alberta

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-01-31
Completion
2014-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02251106 on ClinicalTrials.gov