Efficacy of Epidural Etanercept in the Treatment of Sciatica

This study has been completed.
Sponsor:
Collaborator:
Walter Reed Army Medical Center
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00364572
First received: August 14, 2006
Last updated: January 21, 2009
Last verified: January 2009
  Purpose

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 Intervention Phase
Sciatica
Drug: epidural injection of etanercept
Drug: placebo (control procedure)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Epidural Etanercept in the Treatment of Sciatica

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

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

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

Enrollment: 24
Study Start Date: May 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00364572

Locations
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
Investigators
Principal Investigator: Steven P Cohen, MD Johns Hopkins School of Medicine and Walter Reed Army Medical Center
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steve P. Cohen, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier: NCT00364572     History of Changes
Other Study ID Numbers: WU#06-20009A
Study First Received: August 14, 2006
Last Updated: January 21, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Sciatica
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Sciatic Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 21, 2014