Effect of Lumbar Bracing on Spinal Function

NCT02251106 | Completed Results

• 1 other identifier: Pro00030976
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index

  The Oswestry Disability Index (ODI) questionnaire is a self-reported measure of function that examines the perceived level of disability. The ODI is made up of 10 questions. Each question is scored from 0-5 (minimum to maximum) The point total from each section is summed and then divided by the total number of questions answered and multiplied by 100 to create a percentage disability. The scores range from 0-100% with lower scores meaning less disability. If one section is missed (or not applicable) the score is calculated: (Total scored) / (total possible score with section removed) x 100 = \_\_%

  2 weeks

Secondary Outcomes (3)

• Modified Sorensen Test

  2 weeks

• Bulk Spinal Stiffness

  2 weeks

• Rehabilitation Ultrasound Imaging

  2 weeks

Study Arms (3)

-LBP/-Brace

NO INTERVENTION

Subjects in this arm did not have back pain nor did they wear brace (asymptomatic controls). Subjects had their spine function measured before and after a two week period.

-LBP/+Brace

ACTIVE COMPARATOR

Intervention = Lumbar corset (Quickdraw, Aspen Medical Products) Subjects in this arm did not have back pain but wore a brace for a two week period (asymptomatic intervention). Subjects had their spine function measured before and after a two week period.

Device: Lumbar corset (Quickdraw, Aspen Medical Products)

+LBP/+Brace

EXPERIMENTAL

Intervention = Lumbar corset (Quickdraw, Aspen Medical Products) Subjects in this arm had back pain and wore a brace for a two week period (symptomatic intervention). Subjects had their spine function measured before and after a two week period.

Device: Lumbar corset (Quickdraw, Aspen Medical Products)

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).

Also known as: Soft lumbar brace

+LBP/+Brace; -LBP/+Brace

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Aspen Medical Products: collaborator

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Greg Kawchuk
• Organization: University of Alberta

greg.kawchuk@ualberta.ca

780-492-6891

Study Officials

• Greg N Kawchuk, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: September 29, 2014
• Study Start: May 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: March 8, 2023
• Results First Posted: March 8, 2023

Record last verified: 2022-03