Status:
COMPLETED
Effect of Lumbar Bracing on Spinal Function
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Aspen Medical Products
Conditions:
Low Back Pain
Eligibility:
All Genders
18-65 years
Phase:
NA
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) ...
Detailed Description
Background: While various treatments for low back pain (LBP) are prescribed, one in particular appears to be frequently self-prescribed: external lumbar bracing (i.e. elastic corsets and other similar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT02251106
Start Date
May 1 2012
End Date
January 1 2014
Last Update
March 8 2023
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