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Outcome After Lumbar Epidural Steroid Injection

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ClinicalTrials.gov Identifier: NCT01079026
Recruitment Status : Completed
First Posted : March 2, 2010
Last Update Posted : March 2, 2010
Sponsor:
Collaborator:
Cytonics Corporation
Information provided by:
Scuderi, Gaetano J., M.D.

Brief Summary:
prospectively validate a fibronectin-aggrecan complex as a biomarker for response to ESI for radiculopathy with HNP

Condition or disease
Disc Disease

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 Type : Observational
Actual Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Outcome After Lumbar Epidural Steroid Injection
Study Start Date : March 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010



Primary Outcome Measures :
  1. functional outcome on SF-36 following ESI [ Time Frame: 2-6 weeks ]

Biospecimen Retention:   Samples With DNA
lavage fluid from epidural space


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01079026


Sponsors and Collaborators
Scuderi, Gaetano J., M.D.
Cytonics Corporation
Investigators
Principal Investigator: Gaetano J Scuderi, MD Stanford University

Responsible Party: Gaetano J Scuderi, MD, Stanford University
ClinicalTrials.gov Identifier: NCT01079026     History of Changes
Other Study ID Numbers: CYt.003
First Posted: March 2, 2010    Key Record Dates
Last Update Posted: March 2, 2010
Last Verified: March 2010

Keywords provided by Scuderi, Gaetano J., M.D.:
biomarker
epidural steroid
radiculopathy
hnp