Tissue Collection for Understanding Intervertebral Disc Degeneration and Back Pain
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Purpose
The purpose of the research is to collect and examine spinal disc and ligament tissues to see if there are any biological markers that can be correlated with MRI images to help us learn more about causes of back pain. Spinal discs are the pillow-like cushions between the bones of the spine. They act as shock-absorbers for the spine. Spinal ligaments support the disc structure during movement.
| Condition |
|---|
|
Intervertebral Disc Degeneration Back Pain |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Tissue Collection for Understanding Intervertebral Disc Degeneration and Back Pain |
Intervertebral disc tissue Spinal Ligament Tissue Blood serum
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2011 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Degenerative disc disease is the most prevalent indication for spine surgery and the major source of back pain in afflicted patients. Age related degeneration of the intervertebral discs is not the exception, but the rule. Degenerative changes are associated with weakening of the disc and hypertrophy of the ligamentum flavum in the spine. The aim of this study is to determine if there are any local or systemic biomarkers that correlate with the severity of degeneration as indicated by radiological examination. To date, Imaging (XRay, MRI, CT scans) are the most widely used diagnostic tools for identifying degenerated discs. Physical changes in the disc are also associated with increased secretion and expression of inflammatory mediators in the tissue. The investigators are interested in measuring both gene and protein level changes of inflammatory mediators in degenerated discs in order to correlate these levels with imaging based indicators of degeneration. Protein level changes in the disc and ligamentum flavum have yet to be correlated with MRI-derived disc modic changes classification system. The investigators hypothesize that as the image characteristics of advancing degenerative disease increase, a corresponding change will be present in the secretion (or expression) of specific markers related to inflammatory processes in the disc. Cytokines found to be upregulated in disc tissue or ligamentum flavum will also be measured in patient's serum levels to begin developing a systemic diagnostic method for detecting disc degeneration.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Subjects who meet inclusion criteria will be recruited from the patients undergoing surgery at The North Shore University Hospital
Inclusion Criteria:
- 18 years of age or older
- Patients requiring surgery in lumbar spine region (L1-L2 to L5-S1)
- Potential procedures: Spinal stenosis, discectomy, laminectomy, lumbar fusion, disc herniation.
Exclusion Criteria:
- Patients requiring revision surgery in lumbar spine
- Patients who have had a discography procedure performed at the same disc level as the one being operated on.
- Known inflammatory conditions- Rheumatoid arthritis, Osteomyelitis, Discitis, Gout, Ankylosing spondylitis, and other infections.
- Oncologic conditions- any history of cancer of any type.
Contacts and Locations| Contact: Nadeen Chahine, PhD | 516-562-2574 | nchahine@nshs.edu |
| Contact: Mitchell Levine, MD | (516) 773-7737 | mlevine@nshs.edu |
| United States, New York | |
| North Shore University Hospital | Recruiting |
| Manhasset, New York, United States, 11030 | |
| Contact: Mitchell Levine, MD 516-773-7737 mlevine@nshs.edu | |
| Principal Investigator: Mitchell Levine, MD | |
More Information
Additional Information:
No publications provided
| Responsible Party: | North Shore Long Island Jewish Health System |
| ClinicalTrials.gov Identifier: | NCT01633034 History of Changes |
| Other Study ID Numbers: | 10-329A |
| Study First Received: | June 29, 2012 |
| Last Updated: | July 3, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by North Shore Long Island Jewish Health System:
|
intervertebral disc degeneration back pain spine surgery |
Additional relevant MeSH terms:
|
Back Pain Intervertebral Disk Degeneration Pain Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Spinal Diseases Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013