Degenerative Disc DiseaseNCT00706459
Advanced MR Imaging in Patients With Painful, Degenerative Disc Disease: A Pilot Study
An observational study of Degenerative Disc Disease, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Magnetic Resonance Imaging
- Type of treatment
- Medical device
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- No symptoms
- Age range 25-60 years old
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.,)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94133
About this 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.
- Conditions
- Degenerative Disc Disease
- Being tested
- Magnetic Resonance Imaging
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with lumbar back pain scheduled for back surgery. Receives: Device: Magnetic Resonance Imaging | |
| 2 | Patients with degenerative disease without classic discogenic back pain Receives: Device: Magnetic Resonance Imaging | |
| 3 | Normal control without back pain. Receives: Device: Magnetic Resonance Imaging | |
| 4 | Post Surgical discectomy patients Receives: Device: Magnetic Resonance Imaging | |
| 5 | disc specimens Receives: Device: Magnetic Resonance Imaging |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2008 (estimated)
- Study startMar 2005
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Due to funding issue, study has been terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Sharmila Majumdar, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00706459
- Sponsor's protocol ID
- SpineMRI
- Status last verified
- Nov 2012
- First submitted
- 24 Jun 2008
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced MR Imaging in Patients With Painful, Degenerative Disc Disease: A Pilot Study
- ClinicalTrials.gov ID
- NCT00706459
- Acronym / sponsor ID
- SpineMRI
- Conditions
- Degenerative Disc Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to funding issue, study has been terminated.
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Mar 2005
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 27 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Magnetic Resonance ImagingPatients with lumbar back pain scheduled for back surgery. |
| 2 | – | Device: Magnetic Resonance ImagingPatients with degenerative disease without classic discogenic back pain |
| 3 | – | Device: Magnetic Resonance ImagingNormal control without back pain. |
| 4 | – | Device: Magnetic Resonance ImagingPost Surgical discectomy patients |
| 5 | – | Device: Magnetic Resonance Imagingdisc specimens |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- No symptoms
- Age range 25-60 years old
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingAll 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. | Device | 1, 2, 3, 4, 5 |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Due to funding issue, study has been terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharmila Majumdar, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to funding issue, study has been terminated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2012.