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Tissue Collection for Understanding Intervertebral Disc Degeneration and Back Pain

This study is currently recruiting participants.
Verified December 2016 by Nadeen Chahine, Northwell Health
Sponsor:
ClinicalTrials.gov Identifier:
NCT01633034
First Posted: July 4, 2012
Last Update Posted: December 28, 2016
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.
Information provided by (Responsible Party):
Nadeen Chahine, Northwell Health
  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

Resource links provided by NLM:


Further study details as provided by Nadeen Chahine, Northwell Health:

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

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

Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01633034


Contacts
Contact: Nadeen Chahine, PhD 516-562-2574 nchahine@northwell.edu
Contact: Mitchell Levine, MD (516) 773-7737 mlevine@northwell.edu

Locations
United States, New York
North Shore University Hospital Recruiting
Manhasset, New York, United States, 11030
Contact: Mitchell Levine, MD    516-773-7737    mlevine@northwell.edu   
Principal Investigator: Mitchell Levine, MD         
Lenox Hill Hospital Recruiting
Manhattan, New York, United States, 10021
Contact: Mitchell Levine    212-434-3900    mlevine@northwell.edu   
Sponsors and Collaborators
Northwell Health
Investigators
Principal Investigator: Nadeen Chahine, PhD Northwell Health
  More Information

Additional Information:
Responsible Party: Nadeen Chahine, Associate Investigator, Feinstein Institute for Medical Research, Northwell Health
ClinicalTrials.gov Identifier: NCT01633034     History of Changes
Other Study ID Numbers: 10-329A
First Submitted: June 29, 2012
First Posted: July 4, 2012
Last Update Posted: December 28, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nadeen Chahine, Northwell Health:
intervertebral disc degeneration
back pain
spine surgery

Additional relevant MeSH terms:
Back Pain
Intervertebral Disc Degeneration
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases