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Tissue Collection for Understanding Intervertebral Disc Degeneration and Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01633034
Recruitment Status : Recruiting
First Posted : July 4, 2012
Last Update Posted : May 17, 2019
Information provided by (Responsible Party):
Mitchell Levine, Northwell Health

Brief Summary:
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 or disease
Intervertebral Disc Degeneration Back Pain

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Tissue Collection for Understanding Intervertebral Disc Degeneration and Back Pain
Study Start Date : January 2011
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Primary Outcome Measures :
  1. Inflammatory profile [ Time Frame: At surgery ]

Biospecimen Retention:   Samples Without DNA
Intervertebral disc tissue Spinal Ligament Tissue Blood serum

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects who meet inclusion criteria will be recruited from the patients undergoing surgery at The North Shore University Hospital and at Lenox Hill Hospital.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01633034

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Contact: Mitchell Levine, MD 212-434-3900

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United States, New York
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Mitchell Levine, MD    516-773-7737   
Principal Investigator: Mitchell Levine, MD         
Lenox Hill Hospital Recruiting
Manhattan, New York, United States, 10021
Contact: Mitchell Levine    212-434-3900   
Sponsors and Collaborators
Northwell Health
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Principal Investigator: Mitchell Levine, MD Northwell Health
Additional Information:
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Responsible Party: Mitchell Levine, Director, Spine Surgery, Department of Neurosurgery, Northwell Health Identifier: NCT01633034    
Other Study ID Numbers: 10-329A
First Posted: July 4, 2012    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mitchell Levine, Northwell Health:
intervertebral disc degeneration
back pain
spine surgery
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Back Pain
Neurologic Manifestations
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases