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

August 14, 2006
January 21, 2009
May 2006
December 2007   (final data collection date for primary outcome measure)
Visual analogue scale pain score, Oswestry disability index, medication intake [ Time Frame: 7 months ]
Visual analogue scale pain score Oswestry disability index, medication intake
Complete list of historical versions of study NCT00364572 on ClinicalTrials.gov Archive Site
Global perceived effect, white blood cell count [ Time Frame: 7 months ]
Global perceived effect, white blood cell count
Not Provided
Not Provided
 
Efficacy of Epidural Etanercept in the Treatment of Sciatica
Efficacy of Epidural Etanercept in the Treatment of Sciatica

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).

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Sciatica
  • Drug: epidural injection of etanercept
    2 injections of etanercept 2 weeks apart with doses ranging from 2 mg to 6 mg
  • Drug: placebo (control procedure)
    Two injections of epidural saline 2 weeks apart
  • Placebo Comparator: 1
    Two injections of epidural saline 2 weeks apart
    Intervention: Drug: placebo (control procedure)
  • Experimental: Epidural injection of etanercept
    Two injections of epidural etanercept 2 weeks apart
    Intervention: Drug: epidural injection of etanercept

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2007
December 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00364572
WU#06-20009A
Yes
Steve P. Cohen, Walter Reed Army Medical Center
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
Johns Hopkins University
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP