Efficacy of Epidural Etanercept in the Treatment of Sciatica

January 21, 2009 updated by: Johns Hopkins University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20307
        • Walter Reed Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 1
Two injections of epidural saline 2 weeks apart
Drug: placebo (control procedure)
Two injections of epidural saline 2 weeks apart
EXPERIMENTAL: Epidural injection of etanercept
Two injections of epidural etanercept 2 weeks apart
Drug: epidural injection of etanercept
2 injections of etanercept 2 weeks apart with doses ranging from 2 mg to 6 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual analogue scale pain score, Oswestry disability index, medication intake
Time Frame: 7 months
7 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Global perceived effect, white blood cell count
Time Frame: 7 months
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Walter Reed Army Medical Center

Investigators

  • Principal Investigator: Steven P Cohen, MD, Johns Hopkins School of Medicine and Walter Reed Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

August 14, 2006

First Submitted That Met QC Criteria

August 14, 2006

First Posted (ESTIMATE)

August 15, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

January 22, 2009

Last Update Submitted That Met QC Criteria

January 21, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WU#06-20009A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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