Efficacy of Epidural Etanercept in the Treatment of Sciatica
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Sciatica
In brief
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 results in pain behavior indicative of radiculopathy. The use of TNF-alpha inhibitors (etanercept and infliximab) have been shown to prevent this pain behavior. Open-label studies in humans have shown both etanercept and infliximab provide excellent, long-term relief in patients with acute radiculopathy from herniated disc. However, a recent placebo-controlled study failed to demonstrate any significant difference from placebo. The investigators have already established the safety of neuraxial etanercept in a trial that has just been completed (not yet published). The objective of this study is to determine whether small doses of epidural etanercept, an anti-TNF-a medication, is an effective treatment for LBP caused by nerve root irritation (i.e., radiculopathy).
Key facts
- Study ID
- NCT00364572
- Run by
- Johns Hopkins University
- People needed
- 24
- Starts
- 2006-05-01
- Expected to finish
- 2007-12-01
- Last updated by the study team
- 2009-01-22
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Walter Reed Army Medical Center — Washington D.C., District of Columbia, United States
Full record on ClinicalTrials.gov
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