Advanced MR Imaging in Patients With Painful, Degenerative Disc Disease: A Pilot Study
| Tracking Information | |||||
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| First Received Date ICMJE | June 24, 2008 | ||||
| Last Updated Date | November 13, 2012 | ||||
| Start Date ICMJE | March 2005 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00706459 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Advanced MR Imaging in Patients With Painful, Degenerative Disc Disease: A Pilot Study | ||||
| Official Title ICMJE | Advanced MR Imaging in Patients With Painful, Degenerative Disc Disease: A Pilot Study | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Disc specimens are taken out during back surgery and will be studied using techniques for tissue analysis to explain the properties and characteristics of disc tissue from patients with back pain. |
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| 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. |
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| Condition ICMJE | Degenerative Disc Disease | ||||
| Intervention ICMJE | 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. |
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| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 53 | ||||
| Completion Date | December 2009 | ||||
| Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria for Patient with classic discogenic back pain:
Inclusion criteria for patients with degenerative disc disease without the classic discogenic back pain:
Inclusion criteria for normal controls:
Inclusion Criteria for post-surgical discectomy patients:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 25 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00706459 | ||||
| Other Study ID Numbers ICMJE | SpineMRI | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University of California, San Francisco | ||||
| Study Sponsor ICMJE | University of California, San Francisco | ||||
| Collaborators ICMJE | National Institutes of Health (NIH) | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, San Francisco | ||||
| Verification Date | November 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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