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

NCT ID: NCT00706459

Last Updated: 2012-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2009-12-31

Brief Summary

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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

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Conditions

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Degenerative Disc Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients with lumbar back pain scheduled for back surgery.

Magnetic Resonance Imaging

Intervention Type DEVICE

All study subjects will have a 3T MRI examination. The MRI exam will take approximately 90 minutes to complete and will involve the scanning o the spine.

2

Patients with degenerative disease without classic discogenic back pain

Magnetic Resonance Imaging

Intervention Type DEVICE

All study subjects will have a 3T MRI examination. The MRI exam will take approximately 90 minutes to complete and will involve the scanning o the spine.

3

Normal control without back pain.

Magnetic Resonance Imaging

Intervention Type DEVICE

All study subjects will have a 3T MRI examination. The MRI exam will take approximately 90 minutes to complete and will involve the scanning o the spine.

4

Post Surgical discectomy patients

Magnetic Resonance Imaging

Intervention Type DEVICE

All study subjects will have a 3T MRI examination. The MRI exam will take approximately 90 minutes to complete and will involve the scanning o the spine.

5

disc specimens

Magnetic Resonance Imaging

Intervention Type DEVICE

All study subjects will have a 3T MRI examination. The MRI exam will take approximately 90 minutes to complete and will involve the scanning o the spine.

Interventions

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Magnetic Resonance Imaging

All study subjects will have a 3T MRI examination. The MRI exam will take approximately 90 minutes to complete and will involve the scanning o the spine.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* age range 25-60 years old
* Back and/or leg (back\>leg) pain
* Degenerative disc disease in one or more adjacent vertebral levels between L3-S1
* Radiologic confirmation of degenerative disc disease:
* Segmental instability (3 mm translation or 5 degree angulation)
* Decreased disc height \>2 mm
* Scarring, thickening of annulus fibrosis
* Vacuum phenomenon
* No significant foraminal stenosis and nerve root compression
* Failed observative treatment for at least 6 months
* Oswestry LB disability questionnaire score of at least 20/50 (40%) (interpreted as moderate to severe disability)
* Psychosocially and mentally normal
* Patients who are scheduled for back surgery


* Age range 25-60 years old
* Patients with diagnosis of idiopathic scoliosis, spondylolysis, or spondylolisthesis


* No symptoms
* Age range 25-60 years old


* Patients who had successful disc surgery for lumbar herniated disc and no further back pain
* Patients who had unsuccessful disc surgery for lumbar herniated disc and still with residual back pain

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.,)
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sharmila Majumdar, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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SpineMRI

Identifier Type: -

Identifier Source: org_study_id