A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy
NCT ID: NCT00733096
Last Updated: 2012-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
84 participants
INTERVENTIONAL
2008-08-31
2011-03-31
Brief Summary
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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.
Detailed Description
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Seventy-eight study participants will be randomized via a computerized randomization system using SPSS software in groups of 6 at each institution by a research nurse not involved in patient care. There will be 26 patients in each of the 3 groups. A physician unaware of the patient's treatment group will place 22-gauge needles in the relevant foramen under fluoroscopic guidance as determined by patient's symptoms and MRI findings. Once correct placement is confirmed by contrast injection, the blinded physician will leave the room and another physician will inject the medication. In group I, this will be 60 mg of depo-methylprednisolone. In group II, this will be 4 mg of etanercept reconstituted in 2 ml of sterile water. In group III, this will be normal saline.
Two weeks after the initial procedure, an identical procedure to the first one will be done by the same physician or his designate. In addition to the study medication, each patient in each group will receive 0.5 ml of 0.5% bupivacaine local anesthetic for immediate pain relief during both injections before the study drug is delivered. The efficacy of blinding will be assessed by a disinterested observer unaware of the randomization results after the second procedure before discharge. Follow-up visits will be conducted one, three and six months after the second injection, for those subjects who continue to experience \> 50% pain relief.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Epidural etanercept 4 mg, two doses 2 weeks apart
etanercept
Two transforaminal epidural injections of 4 mg, two weeks apart
2
Epidural methylprednisolone 60 mg, two doses 2 weeks apart
methylprednisolone
Two transforaminal epidural steroid injections with 60 mg, two weeks apart
3
Epidural saline, two doses 2 weeks apart
normal saline
Two transforaminal epidural saline injections, two weeks apart
Interventions
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etanercept
Two transforaminal epidural injections of 4 mg, two weeks apart
methylprednisolone
Two transforaminal epidural steroid injections with 60 mg, two weeks apart
normal saline
Two transforaminal epidural saline injections, two weeks apart
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
70 Years
ALL
No
Sponsors
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Walter Reed Army Medical Center
FED
National Naval Medical Center
FED
Womack Army Medical Center
FED
Landstuhl Regional Medical Center
FED
Massachusetts General Hospital
OTHER
Johns Hopkins University
OTHER
Responsible Party
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Walter Reed Army Medical Center
Locations
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Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
Womack Army Medical Center
Fort Bragg, North Carolina, United States
Countries
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References
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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. doi: 10.1016/j.jbspin.2005.03.003. Epub 2005 Jun 22.
Cohen SP, White RL, Kurihara C, Larkin TM, Chang A, Griffith SR, Gilligan C, Larkin R, Morlando B, Pasquina PF, Yaksh TL, Nguyen C. Epidural steroids, etanercept, or saline in subacute sciatica: a multicenter, randomized trial. Ann Intern Med. 2012 Apr 17;156(8):551-9. doi: 10.7326/0003-4819-156-8-201204170-00397.
Other Identifiers
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08-6891
Identifier Type: -
Identifier Source: org_study_id