Tissue Collection for Understanding Intervertebral Disc Degeneration and Back Pain



Status:Recruiting
Conditions:Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:January 2011
End Date:December 2020
Contact:Mitchell Levine, MD
Email:mlevine@northwell.edu
Phone:212-434-3900

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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.

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.

Inclusion Criteria:

1. 18 years of age or older

2. Patients requiring surgery in lumbar spine region (L1-L2 to L5-S1)

3. Potential procedures: Spinal stenosis, discectomy, laminectomy, lumbar fusion, disc
herniation.

Exclusion Criteria:

1. Patients requiring revision surgery in lumbar spine

2. Patients who have had a discography procedure performed at the same disc level as the
one being operated on.

3. Known inflammatory conditions- Rheumatoid arthritis, Osteomyelitis, Discitis, Gout,
Ankylosing spondylitis, and other infections.

4. Oncologic conditions- any history of cancer of any type.
We found this trial at
2
sites
300 Community Drive
Manhasset, New York 11030
(516) 562-0100
Principal Investigator: Mitchell Levine, MD
Phone: 516-773-7737
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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Phone: 212-434-3900
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