Efficacy of Epidural Etanercept in the Treatment of Sciatica

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2007-12-31

Brief Summary

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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).

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Detailed Description

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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 etanercept or saline injections at 2-week intervals. Both patients and physicians will be blinded as to the injectate and treatment group. There will be 3 study groups. Group I will receive either 2 mg of etanercept or saline per injection. Group II will receive either 4 mg of etanercept or saline per injection. Group III will receive either 6 mg of etanercept or saline per injection. In each group there will be 8 patients: 6 who receive etanercept and 2 who receive saline. As per a previous study we just completed, etanercept doses will not be escalated until all 6 patients have completed their 1-month follow-up visits without any evidence of toxicity or complications.

Conditions

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Sciatica

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Two injections of epidural saline 2 weeks apart

Group Type PLACEBO_COMPARATOR

placebo (control procedure)

Intervention Type DRUG

Two injections of epidural saline 2 weeks apart

Epidural injection of etanercept

Two injections of epidural etanercept 2 weeks apart

Group Type EXPERIMENTAL

epidural injection of etanercept

Intervention Type DRUG

2 injections of etanercept 2 weeks apart with doses ranging from 2 mg to 6 mg

Interventions

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epidural injection of etanercept

2 injections of etanercept 2 weeks apart with doses ranging from 2 mg to 6 mg

Intervention Type DRUG

placebo (control procedure)

Two injections of epidural saline 2 weeks apart

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No