N/A N=54 Basic Science

Effect of Lumbar Bracing on Spinal Function

Low Back Pain

Bottom Line

View on ClinicalTrials.gov: NCT02251106 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2023

Primary outcome: Primary: Oswestry Disability Index — .42; .83; 10.41; .42 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Lumbar corset (Quickdraw, Aspen Medical Products) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Alberta
Primary completion: Jan 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Oswestry Disability Index	.42; .83; 10.41; .42; .52; 6.1	—
SECONDARY Modified Sorensen Test	96.47; 119.83; 49.76; 119.21; 129.00; 54.35	—
SECONDARY Bulk Spinal Stiffness	—	—
SECONDARY Rehabilitation Ultrasound Imaging	—	—

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.

Eligibility Criteria

Inclusion Criteria

Subjects enrolled in the study will be between the ages of 18 and 65 and include both genders.

Asymptomatic subjects will be asymptomatic for low back pain for a period of 3 months or more.

Symptomatic subjects will have non-specific low back pain that is of an acute or chronic nature. Recruiting those with non-specific low back pain ensures that we are not enrolling subjects with a specific cause for back pain (eg, spinal fracture) for which spinal function testing is contraindicated.

Exclusion Criteria

Specific to the spinal function tests used here, excluded subjects will include those with suspected or confirmed malignancy as the cause for back pain, spinal fracture (current or within the last 5 years), previous non-day surgery to the abdomen, spine pelvis or hips, presence of nerve root involvement (presence of at least 2 of the 3: myotomal weakness, altered sensation in dermatomal patterns, and/or altered knee/ankle reflexes), ankylosing spondylitis and current skin conditions that may be aggravated by bracing, These exclusion criteria relate to back conditions for which spinal function testing is contraindicated (eg, malignancy) or in which there is a greater chance of causing discomfort (eg, nerve root involvement).

General exclusion criteria include: osteoporosis, rheumatoid arthritis (or taking any disease modifying anti-rheumatic drugs), pregnancy or suspected pregnancy, known severe spondylolisthesis, severe scoliosis, Type I diabetes mellitus, hyperparathyroidism, hyperthyroidism, inability to lie prone for at least 40 minutes, inability to tolerate back extension or spinal indentation (eg, indentations cause discomfort), inability to speak or read English (to ensure that participants understand what is happening and can reliably relay any discomfort). People currently taking muscle relaxants will also be excluded. In addition, subjects who are hypertensive, or are prone to hypertension (smokers), will be excluded from this study as will subjects who have a history of aortic aneurysm. Although hypertension and aortic aneurysm are not contraindications to lumbar bracing, we will exclude them from this trial. Finally, some persons with low or high body mass indexes may not be eligible to participate if they are unable to be fitted properly with a brace. Subjects will also be excluded if they feel they would be unable to lie prone (i.e. face-down) for up to 1 hour during spinal stiffness and RUSI testing.

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Data sourced from ClinicalTrials.gov (NCT02251106). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.