Lumbosacral Radiculopathy Clinical Trial
Verified date | September 2010 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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 effective in the long-term. In our own double-blind, placebo-controlled
study evaluating epidural etanercept, the results showed significant benefit in favor of the
etanercept group, but no subject was included with a duration of pain > 9 months, and the
results of this study have yet to be replicated.
Currently, epidural steroid injections are the most frequently performed procedures in pain
clinics across the U.S. However, epidural steroids may benefit only a select group of
patients. The literature on treating sciatica is notable for a lack of randomized
comparative studies involving various treatments. The objective of this project is to
conduct a 3-arm study to determine the efficacy of 1) transforaminal epidural
corticosteroids; and 2) transforaminal epidural etanercept, in patients with lumbosacral
radiculopathy.
Status | Completed |
Enrollment | 84 |
Est. completion date | March 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Chronic low back pain of radicular origin of > 4 weeks but < 6 months duration. 2. Leg pain > back pain. 3. Failure of conservative therapy to include physical and pharmacotherapy. 4. MRI evidence of a lateral or paracentral herniated disc corresponding to the patient's radicular symptoms. Exclusion Criteria: 1. Uncontrolled coagulopathy. 2. Pregnancy, which will be ruled out by a urine pregnancy test in women of childbearing age. 3. Allergy to contrast dye or amide local anesthetics. 4. Previous epidural steroid injection within last year. 5. Unstable medical or psychiatric condition (e.g. unstable angina, congestive heart failure or severe depression) that could preclude an optimal treatment response. 6. Rheumatoid arthritis or spondylarthropathy. 7. Unstable neurological condition (e.g. multiple sclerosis) 8. Systemic infection |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Womack Army Medical Center | Fort Bragg | North Carolina |
United States | Walter Reed Army Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Landstuhl Regional Medical Center, Massachusetts General Hospital, National Naval Medical Center, Walter Reed Army Medical Center, Womack Army Medical Center |
United States,
Mulleman D, Mammou S, Griffoul I, Watier H, Goupille P. Pathophysiology of disk-related sciatica. I.--Evidence supporting a chemical component. Joint Bone Spine. 2006 Mar;73(2):151-8. Epub 2005 Jun 22. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numerical Rating Leg Pain Score | 0-10 pain score. 0= no pain, 10= worst imaginable pain. | 1 month | No |
Secondary | Oswestry Disability Score | 0-100%. 0= no disability, 100% is complete disability | 1 month | No |
Secondary | Global Perceived Effect | Satisfaction. Number of participants with positive perceived global satisfaction. | 1 month | No |
Secondary | Medication Reduction | Number of people who reduced medications | 1 month | No |
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