Efficacy of Epidural Etanercept in the Treatment of Sciatica
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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 |
- Visual analogue scale pain score, Oswestry disability index, medication intake [ Time Frame: 7 months ]
- 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 |
Inclusion Criteria:
- Chronic low back pain of radicular origin of > 2 months but < 1 year duration.
- Failure of conservative therapy to include physical and pharmacotherapy.
- MRI evidence of a herniated disc corresponding to the patient's radicular symptoms.
- Normal white blood cell count (drawn in 1 blood vial).
Exclusion Criteria:
- Uncontrolled coagulopathy.
- Pregnancy, which will be ruled out by a urine pregnancy test if any question as to the patient's status exists.
- Allergy to contrast dye.
- Unstable medical condition (e.g., unstable angina or congestive heart failure).
- Rheumatoid arthritis, Crohn's disease or spondylarthropathy.
- Unstable neurological condition (e.g., multiple sclerosis)
- Systemic infection
- Age < 18 or > 70 years.
Contacts and Locations| United States, District of Columbia | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307 | |
| 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 June 18, 2013