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

Study Overview
=================
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 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.

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

Conditions
-----------------
Degenerative Disc Disease

Intervention / Treatment
-----------------
* Device: Magnetic Resonance Imaging


Participation Criteria
=================
Eligibility 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.,)

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with lumbar back pain scheduled for back surgery. | Device: Magnetic Resonance Imaging<br>* 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.<br>|
| 2<br>Patients with degenerative disease without classic discogenic back pain | Device: Magnetic Resonance Imaging<br>* 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.<br>|
| 3<br>Normal control without back pain. | Device: Magnetic Resonance Imaging<br>* 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.<br>|
| 4<br>Post Surgical discectomy patients | Device: Magnetic Resonance Imaging<br>* 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.<br>|
| 5<br>disc specimens | Device: Magnetic Resonance Imaging<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |