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Outcome After Lumbar Epidural Steroid Injection

This study has been completed.
Sponsor:
Collaborator:
Cytonics
Information provided by:
Scuderi, Gaetano J., M.D.
ClinicalTrials.gov Identifier:
NCT01079026
First received: March 1, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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


Condition
Disc Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Outcome After Lumbar Epidural Steroid Injection

Further study details as provided by Scuderi, Gaetano J., M.D.:

Primary Outcome Measures:
  • functional outcome on SF-36 following ESI [ Time Frame: 2-6 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

lavage fluid from epidural space


Enrollment: 26
Study Start Date: March 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079026

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

No publications provided

Responsible Party: Gaetano J Scuderi, MD, Stanford University
ClinicalTrials.gov Identifier: NCT01079026     History of Changes
Other Study ID Numbers: CYt.003
Study First Received: March 1, 2010
Last Updated: March 1, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013