Status:
TERMINATED
Advanced MR Imaging in Patients With Painful, Degenerative Disc Disease: A Pilot Study
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
25-60 years
Brief 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 interver...
Eligibility Criteria
Inclusion
- 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.,)
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00706459
Start Date
March 1 2005
End Date
December 1 2009
Last Update
November 14 2012
Active Locations (1)
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1
University of California, San Francisco
San Francisco, California, United States, 94133