Efficacy of Epidural Etanercept in the Treatment of Sciatica

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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 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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Walter Reed Army Medical Center
• Treatments: Etanercept

Criteria

Inclusion Criteria:

1. Chronic low back pain of radicular origin of > 2 months but < 1 year duration.

2. Failure of conservative therapy to include physical and pharmacotherapy.

3. MRI evidence of a herniated disc corresponding to the patient's radicular symptoms.

4. Normal white blood cell count (drawn in 1 blood vial).

Exclusion Criteria:

1. Uncontrolled coagulopathy.

2. Pregnancy, which will be ruled out by a urine pregnancy test if any question as to the patient's status exists.

3. Allergy to contrast dye.

4. Unstable medical condition (e.g., unstable angina or congestive heart failure).

5. Rheumatoid arthritis, Crohn's disease or spondylarthropathy.

6. Unstable neurological condition (e.g., multiple sclerosis)

7. Systemic infection

8. Age < 18 or > 70 years.