Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

June 29, 2012
May 8, 2014
January 2011
December 2015   (final data collection date for primary outcome measure)
Inflammatory profile [ Time Frame: At surgery ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01633034 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Tissue Collection for Understanding Intervertebral Disc Degeneration and Back Pain
Tissue Collection for Understanding Intervertebral Disc Degeneration and Back Pain

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA
Description:

Intervertebral disc tissue Spinal Ligament Tissue Blood serum

Non-Probability Sample

Subjects who meet inclusion criteria will be recruited from the patients undergoing surgery at The North Shore University Hospital

  • Intervertebral Disc Degeneration
  • Back Pain
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
December 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact: Nadeen Chahine, PhD 516-562-2574 nchahine@nshs.edu
Contact: Mitchell Levine, MD (516) 773-7737 mlevine@nshs.edu
United States
 
NCT01633034
10-329A
No
North Shore Long Island Jewish Health System
North Shore Long Island Jewish Health System
Not Provided
Not Provided
North Shore Long Island Jewish Health System
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP