Status:
COMPLETED
A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Walter Reed Army Medical Center
National Naval Medical Center
Conditions:
Lumbosacral Radiculopathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
Lumbosacral radiculopathy is one of the leading of cause of disability in the U.S. and worldwide. Among recent reviews evaluating epidural steroid injections, some 1 but not all 2 concluded them to be...
Detailed Description
This is a 3-arm multi-center, randomized, double-blind, placebo-controlled study comparing two treatments with transforaminal epidural saline. Each group will receive a 2nd procedure identical to the ...
Eligibility Criteria
Inclusion
- Chronic low back pain of radicular origin of \> 4 weeks but \< 6 months duration.
- Leg pain \> back pain.
- Failure of conservative therapy to include physical and pharmacotherapy.
- MRI evidence of a lateral or paracentral herniated disc corresponding to the patient's radicular symptoms.
Exclusion
- Uncontrolled coagulopathy.
- Pregnancy, which will be ruled out by a urine pregnancy test in women of childbearing age.
- Allergy to contrast dye or amide local anesthetics.
- Previous epidural steroid injection within last year.
- Unstable medical or psychiatric condition (e.g. unstable angina, congestive heart failure or severe depression) that could preclude an optimal treatment response.
- Rheumatoid arthritis or spondylarthropathy.
- Unstable neurological condition (e.g. multiple sclerosis)
- Systemic infection
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00733096
Start Date
August 1 2008
End Date
March 1 2011
Last Update
October 8 2012
Active Locations (2)
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1
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States, 20307
2
Womack Army Medical Center
Fort Bragg, North Carolina, United States