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Advanced MR Imaging in Patients With Painful, Degenerative Disc Disease: A Pilot Study
This study is currently recruiting participants.
Study NCT00706459   Information provided by University of California, San Francisco
First Received: June 24, 2008   Last Updated: April 20, 2009   History of Changes

June 24, 2008
April 20, 2009
March 2005
December 2009   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00706459 on ClinicalTrials.gov Archive Site
 
 
 
Advanced MR Imaging in Patients With Painful, Degenerative Disc Disease: A Pilot Study
Advanced MR Imaging in Patients With Painful, Degenerative Disc Disease: A Pilot Study

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.

 
 
Interventional
Other, Open Label, Factorial Assignment
Degenerative Disc Disease
Device: Magnetic Resonance Imaging
  • Active Comparator: Patients with lumbar back pain scheduled for back surgery.
  • Active Comparator: Patients with degenerative disease without classic discogenic back pain
  • No Intervention: Normal control without back pain.
  • Active Comparator: Post Surgical discectomy patients
  • No Intervention: disc specimens
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
105
December 2009
December 2009   (final data collection date for primary outcome measure)

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.,)
Both
25 Years to 60 Years
Yes
Contact: Thelma Munoz 415-353-9446 thelma.munoz@radiology.ucsf.edu
United States
 
NCT00706459
Sharmila Majumdar, Ph.D., University of California, San Francisco
SpineMRI
University of California, San Francisco
National Institutes of Health (NIH)
Principal Investigator: Sharmila Majumdar, PhD University of California, San Francisco
University of California, San Francisco
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP