Advanced MR Imaging in Patients With Painful, Degenerative Disc Disease: A Pilot Study - Full Text View

Sponsor:	University of California, San Francisco
Collaborator:	National Institutes of Health (NIH)
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00706459

Purpose

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.

Condition	Intervention
Degenerative Disc Disease	Device: Magnetic Resonance Imaging

Study Type:	Interventional
Study Design:	Open Label, Factorial Assignment
Official Title:	Advanced MR Imaging in Patients With Painful, Degenerative Disc Disease: A Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Back Pain MRI Scans Surgery

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Estimated Enrollment:	105
Study Start Date:	March 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Patients with lumbar back pain scheduled for back surgery.	Device: 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.
2: Active Comparator Patients with degenerative disease without classic discogenic back pain	Device: 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.
3: No Intervention Normal control without back pain.	Device: 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.
4: Active Comparator Post Surgical discectomy patients	Device: 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.
5: No Intervention disc specimens	Device: 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.

Eligibility

Ages Eligible for Study:	25 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria for Patient with classic discogenic back pain:

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

Inclusion criteria for patients with degenerative disc disease without the classic discogenic back pain:

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

Inclusion criteria for normal controls:

No symptoms
Age range 25-60 years old

Inclusion Criteria for post-surgical discectomy patients:

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.,)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706459

Contacts

Contact: Thelma Munoz

415-353-9446

thelma.munoz@radiology.ucsf.edu

Locations

United States, California
University of California, San Francisco	Recruiting
San Francisco, California, United States, 94133
Contact: Thelma Munoz 415-353-9446 thelma.munoz@radiology.ucsf.edu
Contact: Melissa Guan 415-353-4216 melissa.guan@radiology.ucsf.edu
Sub-Investigator: Thomas M Link, MD
Sub-Investigator: Xiaojuan Li, PhD
Sub-Investigator: Sigurd Berven, MD
Sub-Investigator: Serena Hu, MD
Sub-Investigator: Shane Burch, MD
Sub-Investigator: Mauricio Campos, MD
Sub-Investigator: David Bradford, MD
Sub-Investigator: Jeffrey Lotz, PhD

Sponsors and Collaborators

University of California, San Francisco

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Sharmila Majumdar, PhD

University of California, San Francisco

More Information

No publications provided

Responsible Party:	University of California, San Francisco ( Sharmila Majumdar, Ph.D. )
Study ID Numbers:	SpineMRI
Study First Received:	June 24, 2008
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00706459 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Spinal Diseases
Musculoskeletal Diseases
Bone Diseases

ClinicalTrials.gov processed this record on November 30, 2009