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Lumbar Bracing for People With Type I Modic Changes

NCT03829644 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2024-05-29

No results posted yet for this study

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

Interventions

DEVICE

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

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.

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Greg Kawchuk, PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-20
Primary Completion
2024-02-20
Completion
2024-02-20

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03829644 on ClinicalTrials.gov