Tissue Collection for Understanding Intervertebral Disc Degeneration and Back Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by North Shore Long Island Jewish Health System
Sponsor:
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01633034
First received: June 29, 2012
Last updated: May 8, 2014
Last verified: May 2014
  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 North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Inflammatory profile [ Time Frame: At surgery ] [ Designated as safety issue: No ]

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 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633034

Contacts
Contact: Nadeen Chahine, PhD 516-562-2574 nchahine@nshs.edu
Contact: Mitchell Levine, MD (516) 773-7737 mlevine@nshs.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@nshs.edu   
Principal Investigator: Mitchell Levine, MD         
Sponsors and Collaborators
North Shore Long Island Jewish Health System
  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: May 8, 2014
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 Disc Degeneration
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 26, 2014