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.

Study Overview

• Status: Terminated
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Device: Magnetic Resonance Imaging

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94133
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Potential subjects are patients seen by surgeons in the UCSF ACC Orthopedic Clinic. If a patient meets all inclusion and exclusion criteria, the orthopedic surgeon will talk to the patient about the new dedicated examinations using 3 Tesla MRI that can identify painful degenerated discs. When patient is comfortable with participating and has made a decision to go ahead with the MRI, patient can let the orthopedic surgeon's assistant know about his/her decision, the assistant will make sure that patient still meets the inclusion and exclusion criteria and will call the coordinator at the Imaging Center to set up an MRI appointment.

Flyers will be posted at different UCSF campuses to recruit for normal age-matched and young normal volunteers.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Patients with lumbar back pain scheduled for back surgery.	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.
2; Patients with degenerative disease without classic discogenic back pain	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.
3; Normal control without back pain.	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.
4; Post Surgical discectomy patients	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.
5; disc specimens	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.

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Sharmila Majumdar, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: June 24, 2008
• First Submitted That Met QC Criteria: June 26, 2008
• First Posted (Estimate): June 27, 2008

Study Record Updates

• Last Update Posted (Estimate): November 14, 2012
• Last Update Submitted That Met QC Criteria: November 13, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Intervertebral Disc Degeneration; Spinal Diseases
• Other Study ID Numbers: SpineMRI