Lumbar Bracing for People With Type I Modic Changes

NCT03829644 | Terminated

• 1 other identifier: Pro00086518
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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 pain. The other types of back pain are classified as non-specific low back pain. Thus, current back pain management typically focuses on relieving symptoms. This is largely ineffective without understanding the cause. Yet, there are some pathologies which are thought to be associated with low back pain. Vertebral bone marrow oedemas are now known to be a hallmark feature for low back pain. There are three types of vertebral bone marrow oedemas. Type I oedemas are dynamic lesions that may progress to a higher grade, stop, or even return to normal. Although the precise cause of type I oedemas is not well understood, loading on the spine plays a key role in its development. Lumbar braces are known to reduce loads on the spine. Thus, they may reduce the size of oedema by modifying loads on the spine. The investigators already know that wearing a lumbar brace reduces pain in people with back pain and type I vertebral bone marrow oedemas. Unfortunately, there is no study showing that pain reduction with bracing is associated with a reduction of oedema. The goal of this study is to determine if wearing a lumbar brace for six weeks will reduce the dimensions of type I vertebral bone marrow oedema.

Conditions

Low Back Pain; Bone Marrow Edema; Brace; Modic Changes; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (6)

• Change in the pain level

  Change in the pain level between the baseline and 6-week follow-up will be evaluated using the Numeric Pain Rating Scale \[0-10\].

  Week 6

• Change in the pain level

  Change in the pain level between the baseline and 4-month follow-up will be evaluated using the Numeric Pain Rating Scale \[0-10\].

  Month 4

• Change in the pain level

  Change in the pain level between the baseline and 8-month follow-up will be evaluated using the Numeric Pain Rating Scale \[0-10\].

  Month 8

• Change in the pain level

  Change in the pain level between the baseline and 12-month follow-up will be evaluated using the Numeric Pain Rating Scale \[0-10\].

  Month 12

• Change in the size of the bone marrow lesions

  Change in the size of the bone marrow lesion (Modic Changes) between the baseline and six-week follow-up will be evaluated by measuring the area of the lesion.

  Week 6

• Change in the size of the texture of marrow lesions

  Change in the texture of the bone marrow lesion (Modic Changes) between the baseline and six weeks will be evaluated using grey level co-occurrence matrix (Contrast, correlation, homogeneity, and the entropy).

  Weeks 0 and 6

Secondary Outcomes (8)

• Change in the self-reported Disability Level - Questionnaire A

  6 Weeks

• Change in the self-reported Disability Level - Questionnaire A

  4 Months

• Change in the self-reported Disability Level - Questionnaire A

  8 Months

• Change in the self-reported Disability Level - Questionnaire A

  12 Months

• Change in the self-reported Disability Level - Questionnaire B

  6 weeks

Other Outcomes (10)

• Change in healthcare resource utilization- regulated prescriptions filled (after enrollment)

  12 months

• Change in healthcare resource utilization- primary care visits (after enrollment)

  12 months

• Change in healthcare resource utilization- specialist visits (after enrollment)

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in the intervention arm will be fitted with a semi-rigid prefabricated lumbar brace (Horizon 627 Lumbar Brace, Aspen Medical Company, Oak Canyon, Irvine, CA 92618) in addition to their current back pain management program.

Device: Horizon 627 Lumbar Brace, Aspen Medical Company, Oak Canyon, Irvine, CA 92618

Control

NO INTERVENTION

Participants in this arm will be instructed to follow their current back pain management program.

Interventions

Horizon 627 Lumbar Brace, Aspen Medical Company, Oak Canyon, Irvine, CA 92618 DEVICE

The brace is an FDA Class I device, one-size adjustable design to fit waists ranging from 24-70 inches. Participants will be instructed to wear the brace for six weeks. As this brace is semi-rigid, it does not prevent motion - only reduces motion in the lumbar areas. Our prior work and that of others have shown that this type of bracing does not reduce spinal function and is not associated with atrophy.

Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Greg Kawchuk, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of each intervention, blinding will not be feasible for participants. However, the MR technician, outcomes assessor, outcome adjudicators, and the statistician will be blinded to the actual allocation. The actual allocation will not be disclosed to the research assistant responsible for image processing, data entry, and the statistician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, superiority, 1:1 parallel randomised control trial with concealed allocation. Superiority will be based on a minimally clinically significant difference of the Modic changes (our primary outcome measure).

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: February 4, 2019
• Study Start: July 20, 2019
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)