A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy
1 other identifier
interventional
84
1 country
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2008
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 11, 2008
CompletedFirst Posted
Study publicly available on registry
August 12, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
October 8, 2012
CompletedOctober 8, 2012
September 1, 2010
2.6 years
August 11, 2008
August 24, 2012
October 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Numerical Rating Leg Pain Score
0-10 pain score. 0= no pain, 10= worst imaginable pain.
1 month
Secondary Outcomes (3)
Oswestry Disability Score
1 month
Global Perceived Effect
1 month
Medication Reduction
1 month
Study Arms (3)
1
EXPERIMENTALEpidural etanercept 4 mg, two doses 2 weeks apart
2
ACTIVE COMPARATOREpidural methylprednisolone 60 mg, two doses 2 weeks apart
3
PLACEBO COMPARATOREpidural saline, two doses 2 weeks apart
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Universitylead
- Walter Reed Army Medical Centercollaborator
- National Naval Medical Centercollaborator
- Womack Army Medical Centercollaborator
- Landstuhl Regional Medical Centercollaborator
- Massachusetts General Hospitalcollaborator
Study Sites (2)
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307, United States
Womack Army Medical Center
Fort Bragg, North Carolina, United States
Related Publications (2)
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.
PMID: 16046173BACKGROUNDCohen 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.
PMID: 22508732DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Subjects who failed to obtain benefit were unblinded after 1-month, which limits conclusions regarding long-term efficacy.
Results Point of Contact
- Title
- Steven P. Cohen
- Organization
- Johns Hopkins School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 11, 2008
First Posted
August 12, 2008
Study Start
August 1, 2008
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
October 8, 2012
Results First Posted
October 8, 2012
Record last verified: 2010-09