We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Lumbar Bracing on Spinal Function

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02251106
First Posted: September 29, 2014
Last Update Posted: October 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aspen Medical Products
Information provided by (Responsible Party):
University of Alberta
  Purpose

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.


Condition Intervention
Low Back Pain Device: Lumbar corset (Quickdraw, Aspen Medical Products)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of Lumbar Bracing on Spinal Function

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: 2 weeks ]
    The Oswestry Disability Index is a self-reported measure of function. The ODI has established reliability and validity and has been used extensively in low back pain research. Outcome obtained before, and after, a two week period (no brace worn)


Secondary Outcome Measures:
  • Modified Sorensen Test [ Time Frame: 2 weeks ]
    This is a timed test of spine endurance where subjects are asked to straigthen their backs from a semi-prone position.

  • Bulk Spinal Stiffness [ Time Frame: 2 weeks ]
    This test uses a blunt probe to non-invasively push into the back of a prone, resting subject.

  • Rehabilitation Ultrasound Imaging [ Time Frame: 2 weeks ]
    This test uses ultrasonic imaging to visualize spine muscles during simple tasks such as arm extension


Enrollment: 54
Study Start Date: May 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: -LBP/-Brace
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.
Active Comparator: -LBP/+Brace
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)
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).
Other Name: Soft lumbar brace
Experimental: +LBP/+Brace
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)
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).
Other Name: Soft lumbar brace

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02251106


Sponsors and Collaborators
University of Alberta
Aspen Medical Products
Investigators
Principal Investigator: Greg N Kawchuk, PhD University of Alberta
  More Information

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02251106     History of Changes
Other Study ID Numbers: Pro00030976
First Submitted: September 24, 2014
First Posted: September 29, 2014
Last Update Posted: October 15, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms