Intervertebral Disc DegenerationNCT01633034
Tissue Collection for Understanding Intervertebral Disc Degeneration and Back Pain
An observational study of Intervertebral Disc Degeneration and Back Pain, run by Northwell Health at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intervertebral Disc Degeneration, Back Pain
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2011to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 18 years of age or older
- Patients requiring surgery in lumbar spine region (L1-L2 to L5-S1)
- Potential procedures: Spinal stenosis, discectomy, laminectomy, lumbar fusion, disc herniation.
Who cannot join
- Patients requiring revision surgery in lumbar spine
- Patients who have had a discography procedure performed at the same disc level as the one being operated on.
- Known inflammatory conditions- Rheumatoid arthritis, Osteomyelitis, Discitis, Gout, Ankylosing spondylitis, and other infections.
- Oncologic conditions- any history of cancer of any type.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
North Shore University Hospital
Manhasset, New York, 11030
Lenox Hill Hospital
Manhattan, New York, 10021
About this study
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.
Read the 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.
- Conditions
- Intervertebral Disc Degeneration, Back Pain
- Keywords
- intervertebral disc degeneration, back pain, spine surgery
- Medical subject headings
- Intervertebral Disc Degeneration, Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory profile
Measured: At surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2012 (estimated)
- Study startJan 2011
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc DegenerationStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitchell Levine, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633034
- Sponsor's protocol ID
- 10-329A
- Status last verified
- Mar 2024
- First submitted
- 29 Jun 2012
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Collection for Understanding Intervertebral Disc Degeneration and Back Pain
- ClinicalTrials.gov ID
- NCT01633034
- Acronym / sponsor ID
- 10-329A
- Conditions
- Intervertebral Disc Degeneration, Back Pain
- Keywords
- intervertebral disc degeneration, back pain, spine surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 4 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 18 years of age or older
- Patients requiring surgery in lumbar spine region (L1-L2 to L5-S1)
- Potential procedures: Spinal stenosis, discectomy, laminectomy, lumbar fusion, disc herniation.
Key exclusion criteria (4 listed)
- Patients requiring revision surgery in lumbar spine
- Patients who have had a discography procedure performed at the same disc level as the one being operated on.
- Known inflammatory conditions- Rheumatoid arthritis, Osteomyelitis, Discitis, Gout, Ankylosing spondylitis, and other infections.
- Oncologic conditions- any history of cancer of any type.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inflammatory profile
Time frame: At surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Levine, MD principal investigator
Northwell Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intervertebral Disc Degeneration and Back Pain, run by Northwell Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory profile (time frame: At surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.