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

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00706459
• Other study ID #: SpineMRI
• Status: Terminated
• Phase: N/A
• First received: June 24, 2008
• Last updated: November 13, 2012
• Start date: March 2005
• Est. completion date: December 2009

Study information

• Verified date: November 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 60 Years

Eligibility

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.,)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spinal Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States,