Clinical Trials Directory

Trials / Terminated

TerminatedNCT00706459

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

Status
Terminated
Phase
Study type
Observational
Enrollment
53 (actual)
Sponsor
University of California, San Francisco · Academic / Other
Sex
All
Age
25 Years – 60 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEMagnetic Resonance ImagingAll 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.

Timeline

Start date
2005-03-01
Primary completion
2009-12-01
Completion
2009-12-01
First posted
2008-06-27
Last updated
2012-11-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00706459. Inclusion in this directory is not an endorsement.