Status:
COMPLETED
Efficacy of Epidural Etanercept in the Treatment of Sciatica
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Walter Reed Army Medical Center
Conditions:
Sciatica
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Tumor necrosis factor (TNF)-alpha has been strongly implicated as a major contributing factor for the development of radiculopathy. In animal studies, the application of TNF-alpha to nerve roots resul...
Detailed Description
As per the wishes of the Dept. of the Army and Walter Reed Army Medical Center Dept. of Clinical Investigation, patients will be randomized in a 3:1 ratio to receive 2 transforaminal epidural etanerce...
Eligibility Criteria
Inclusion
- Chronic low back pain of radicular origin of \> 2 months but \< 1 year duration.
- Failure of conservative therapy to include physical and pharmacotherapy.
- MRI evidence of a herniated disc corresponding to the patient's radicular symptoms.
- Normal white blood cell count (drawn in 1 blood vial).
Exclusion
- Uncontrolled coagulopathy.
- Pregnancy, which will be ruled out by a urine pregnancy test if any question as to the patient's status exists.
- Allergy to contrast dye.
- Unstable medical condition (e.g., unstable angina or congestive heart failure).
- Rheumatoid arthritis, Crohn's disease or spondylarthropathy.
- Unstable neurological condition (e.g., multiple sclerosis)
- Systemic infection
- Age \< 18 or \> 70 years.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00364572
Start Date
May 1 2006
End Date
December 1 2007
Last Update
January 22 2009
Active Locations (1)
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1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307