Efficacy of Epidural Etanercept in the Treatment of Sciatica

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00364572
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : January 22, 2009
Walter Reed Army Medical Center
Information provided by:
Johns Hopkins University

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 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).

Condition or disease Intervention/treatment Phase
Sciatica Drug: epidural injection of etanercept Drug: placebo (control procedure) Phase 1 Phase 2

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  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Epidural Etanercept in the Treatment of Sciatica
Study Start Date : May 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sciatica
Drug Information available for: Etanercept

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

Primary Outcome Measures :
  1. Visual analogue scale pain score, Oswestry disability index, medication intake [ Time Frame: 7 months ]

Secondary Outcome Measures :
  1. Global perceived effect, white blood cell count [ Time Frame: 7 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00364572

United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
Sponsors and Collaborators
Johns Hopkins University
Walter Reed Army Medical Center
Principal Investigator: Steven P Cohen, MD Johns Hopkins School of Medicine and Walter Reed Army Medical Center

Publications of Results:

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Steve P. Cohen, Walter Reed Army Medical Center Identifier: NCT00364572     History of Changes
Other Study ID Numbers: WU#06-20009A
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: January 22, 2009
Last Verified: January 2009

Keywords provided by Johns Hopkins University:
low back pain
tumor necrosis factor

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Sciatic Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors