Sciatica
Conditions
Keywords
sciatica, low back pain, epidural, tumor necrosis factor
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).
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.
Interventions
DRUGepidural injection of etanercept
2 injections of etanercept 2 weeks apart with doses ranging from 2 mg to 6 mg
DRUGplacebo (control procedure)
Two injections of epidural saline 2 weeks apart
Sponsors
Walter Reed Army Medical Center
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analogue scale pain score, Oswestry disability index, medication intake | 7 months |
Secondary
| Measure | Time frame |
|---|---|
| Global perceived effect, white blood cell count | 7 months |
Countries
United States
Outcome results
None listed