Status:
TERMINATED
Lumbar Bracing for People With Type I Modic Changes
Lead Sponsor:
University of Alberta
Conditions:
Low Back Pain
Bone Marrow Edema
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Despite the high prevalence of low back pain, little is still known about its underlying pathology. Only a small proportion of people (\~1%) have a diagnosable pathoanatomical entity causing low back ...
Detailed Description
Purpose Modic changes are now known to have a high specificity for low back pain. Modic changes represent bone oedema and are dynamic lesions that may progress to a higher grade, stop, or even revers...
Eligibility Criteria
Inclusion
- Pain between the 12th rib and buttocks with or without symptoms into one or both legs, which, in the opinion of the examiner, originate from the lumbar region
- Have MRI evidence of type I Modic changes
- Have a baseline Oswestry Disability Index \>25%
- Aged between 18 and 65 years
- Are ambulatory
- Can read and understand English
- Living in Edmonton, Alberta, Canada
Exclusion
- Back pain due to a systemic or specific disease such as known cancer, spinal infection, fracture, or ankylosing spondylitis
- Severe pain in the hip and knee joints
- Claustrophobia
- Any contraindications for MRI, such as pacemakers, orthopaedic prosthesis, device or implants at the spine or pelvic girdle
- Pregnancy
- Implanted with an intrauterine contraceptive device
- Significant compression of the spinal cord/nerves
- Previous back surgery
- Waist circumference greater than 70 inches
- Have received back injections within the last 4 weeks
- On-going workers' compensation or litigation cases
Key Trial Info
Start Date :
July 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2024
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT03829644
Start Date
July 20 2019
End Date
February 20 2024
Last Update
May 29 2024
Active Locations (1)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7