Tissue Collection for Understanding Intervertebral Disc Degeneration and Back Pain

Back Pain Clinical Trial

Official title:

Tissue Collection for Understanding Intervertebral Disc Degeneration and Back Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01633034
• Other study ID #: 10-329A
• Status: Active, not recruiting
• Start date: January 2011
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Intervertebral Disc Degeneration

Locations

Country	Name	City	State
United States	North Shore University Hospital	Manhasset	New York
United States	Lenox Hill Hospital	Manhattan	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory profile		At surgery