Disc DiseaseNCT01079026
Outcome After Lumbar Epidural Steroid Injection
An observational study of Disc Disease, run by Scuderi, Gaetano J., M.D..
Trial summary
prospectively validate a fibronectin-aggrecan complex as a biomarker for response to ESI for radiculopathy with HNP Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Disc Disease
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Mar 2010
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients considered candidates for ESI were 18 years of age or greater with a history of leg sensory complaints primarily dictated by pain with associated sensory symptoms and/or low back pain for two weeks or more who had failed expectant management with NSAIDS, activity modification, and/or physical therapy.
Who may be able to join
- Acute onset of sensory symptoms with the primary complaint as pain as well as varying sensory symptoms (e.g. tingling, numbness) in one or more lumbar nerve root distributions
- Positive physical exam findings including sensory findings consistent with a spinal nerve root, a positive straight leg raise test, and/or a diminished patellar or Achilles DTR consistent with sensory symptoms; AND
- MRI of lumbar spine positive for HNP in a distribution correlating with physical examination
Who cannot join
- Plain radiography demonstrating severe loss of disc height, high grade DDD, spondylolisthesis greater than grade I
- A history of prior lumbar surgery or trauma, weakness in a consistent distribution (non-progressive with strength at least 4/5)
- Red flags including progressive weakness, bowel/bladder complaints, radiographic unknown mass, unexpected weight loss; AND
- Diagnosis of inflammatory arthritides, crystalline arthropathies, or other rheumatologic diseases
About this study
Official title: Functional Outcome After Lumbar Epidural Steroid Injection
prospectively validate a fibronectin-aggrecan complex as a biomarker for response to ESI for radiculopathy with HNP
Read the detailed description
We will measure levels of the protein complex in the epidural space of patients undergoing lumbar ESI for radiculopathy with HNP. We assess functional outcomes at baseline and after treatment with the Medical Outcomes Study Short Form-36 instrument (SF-36). Our hypothesis was that the complex is present in patients with clinically significant functional improvement after ESI.
- Conditions
- Disc Disease
- Keywords
- biomarker, epidural steroid, radiculopathy, hnp
- Medical subject headings
- Radiculopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
functional outcome on SF-36 following ESI
Measured: 2-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startMar 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disc DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scuderi, Gaetano J., M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Cytonics Corporation
- Investigators
- Gaetano J Scuderi, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01079026
- Sponsor's protocol ID
- CYt.003
- Status last verified
- Mar 2010
- First submitted
- 1 Mar 2010
- Last updated
- 2 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcome After Lumbar Epidural Steroid Injection
- ClinicalTrials.gov ID
- NCT01079026
- Acronym / sponsor ID
- CYt.003
- Conditions
- Disc Disease
- Keywords
- biomarker, epidural steroid, radiculopathy, hnp
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Scuderi, Gaetano J., M.D.University, hospital or other
- Collaborators
- Cytonics Corporation
- Study start
- Mar 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 2 Mar 2010 (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.
prospectively validate a fibronectin-aggrecan complex as a biomarker for response to ESI for radiculopathy with HNP
Detailed description
We will measure levels of the protein complex in the epidural space of patients undergoing lumbar ESI for radiculopathy with HNP. We assess functional outcomes at baseline and after treatment with the Medical Outcomes Study Short Form-36 instrument (SF-36). Our hypothesis was that the complex is present in patients with clinically significant functional improvement after ESI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients considered candidates for ESI were 18 years of age or greater with a history of leg sensory complaints primarily dictated by pain with associated sensory symptoms and/or low back pain for two weeks or more who had failed expectant management with NSAIDS, activity modification, and/or physical therapy.
Key inclusion criteria (3 listed)
- Acute onset of sensory symptoms with the primary complaint as pain as well as varying sensory symptoms (e.g. tingling, numbness) in one or more lumbar nerve root distributions
- Positive physical exam findings including sensory findings consistent with a spinal nerve root, a positive straight leg raise test, and/or a diminished patellar or Achilles DTR consistent with sensory symptoms; AND
- MRI of lumbar spine positive for HNP in a distribution correlating with physical examination
Key exclusion criteria (4 listed)
- Plain radiography demonstrating severe loss of disc height, high grade DDD, spondylolisthesis greater than grade I
- A history of prior lumbar surgery or trauma, weakness in a consistent distribution (non-progressive with strength at least 4/5)
- Red flags including progressive weakness, bowel/bladder complaints, radiographic unknown mass, unexpected weight loss; AND
- Diagnosis of inflammatory arthritides, crystalline arthropathies, or other rheumatologic diseases
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
functional outcome on SF-36 following ESI
Time frame: 2-6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
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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.
Gaetano J Scuderi, MD principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
An observational study of Disc Disease, run by Scuderi, Gaetano J., M.D..
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: finished, as of the sponsor's last update on 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
functional outcome on SF-36 following ESI (time frame: 2-6 weeks). 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 2 Mar 2010.