Efficacy of Epidural Etanercept in the Treatment of Sciatica


Phase 1/Phase 2
18 Years
70 Years
Not Enrolling
Both
Sciatica

Thank you

Trial Information

Efficacy of Epidural Etanercept in the Treatment of Sciatica


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.


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.

Type of Study:

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

Outcome Measure:

Visual analogue scale pain score, Oswestry disability index, medication intake

Outcome Time Frame:

7 months

Principal Investigator

Steven P Cohen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins School of Medicine and Walter Reed Army Medical Center

Authority:

United States: Institutional Review Board

Study ID:

WU#06-20009A

NCT ID:

NCT00364572

Start Date:

May 2006

Completion Date:

December 2007

Related Keywords:

  • Sciatica
  • sciatica
  • low back pain
  • epidural
  • tumor necrosis factor
  • Sciatica

Name

Location
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000