Advanced MR Imaging in Patients With Painful, Degenerative Disc Disease: A Pilot Study

Terminated

• Conditions: Degenerative Disc Disease
• Interventions: Device: Magnetic Resonance Imaging

• Registration Number: NCT00706459
• Lead Sponsor: University of California, San Francisco

Brief Summary

In this study, we will use advanced and newly available MR imaging techniques at 3 Tesla (including in situ axial loading and quantitative T1rho, T2, and diffusion measurements) to assess the intervertebral discs and adjacent vertebrae in patients with lumbar back pain scheduled for back surgery (n=20), patients with degenerative disease without classic discogenic back pain (n=10), patients who had discectomies for herniated discs (n=5), and age-matched volunteers without back pain (n=10). In all patients standard imaging procedures will also be performed, including radiographs, standard MRI at 1.5 Tesla and discography. All patients will have specimen of the intervertebral disc harvested at surgery and pathologic analysis and spectroscopy of these specimen will be performed. Post-surgical findings/outcome combined with discography will serve as a standard of reference for the identification of the painful disc(s). The diagnostic performance of the new techniques in assessing the painful disc will be evaluated. We will collect disc specimens from 50 patients undergoing back surgery but did not have pre-surgical MR imaging. These disc specimens will be analyzed in the same manner as the specimens collected from surgical patients who had pre-surgical MRI. This study will serve as a pilot study for a larger project focusing on advanced imaging of the painful intervertebral disc.

We hypothesis that advanced, dedicated MR examinations at 3T can identify painful degenerated discs in patients with chronic lumbar back pain.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2008-06-24
• Study First Submitted QC: 2008-06-26
• Study First Posted: 2008-06-27
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-13
• Last Update Posted: 2012-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

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Exclusion Criteria

• prior back surgery (except as mentioned above)
• spine fractures
• Radiographic confirmation of facet joint disease or degeneration
• Radiographic confirmation of sacroiliac joint pathology
• Lytic spondylolisthesis of spinal stenosis
• Degenerative spondylolisthesis of > grade 1
• Metabolic bone disease
• Spine infection , osteomyelitis
• Rheumatoid arthritis or any other systemic or autoimmune disease
• Active malignancy
• MRI Contraindications (fragment in eye, aneurysms clips, ear implants, spinal nerve stimulators, pacemaker, claustrophobia, or pregnant women, etc.,)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Magnetic Resonance Imaging	Patients with lumbar back pain scheduled for back surgery.
3	Magnetic Resonance Imaging	Normal control without back pain.
4	Magnetic Resonance Imaging	Post Surgical discectomy patients
2	Magnetic Resonance Imaging	Patients with degenerative disease without classic discogenic back pain
5	Magnetic Resonance Imaging	disc specimens

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States