A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00733096
Recruitment Status : Completed
First Posted : August 12, 2008
Results First Posted : October 8, 2012
Last Update Posted : October 8, 2012
Walter Reed Army Medical Center
National Naval Medical Center
Womack Army Medical Center
Landstuhl Regional Medical Center
Massachusetts General Hospital
Information provided by:
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Lumbosacral Radiculopathy Drug: etanercept Drug: methylprednisolone Drug: normal saline Phase 2 Phase 3

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 first 2 weeks after the initial procedure.

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2008
Primary Completion Date : March 2011
Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Epidural etanercept 4 mg, two doses 2 weeks apart
Drug: etanercept
Two transforaminal epidural injections of 4 mg, two weeks apart
Active Comparator: 2
Epidural methylprednisolone 60 mg, two doses 2 weeks apart
Drug: methylprednisolone
Two transforaminal epidural steroid injections with 60 mg, two weeks apart
Placebo Comparator: 3
Epidural saline, two doses 2 weeks apart
Drug: normal saline
Two transforaminal epidural saline injections, two weeks apart

Primary Outcome Measures :
  1. Numerical Rating Leg Pain Score [ Time Frame: 1 month ]
    0-10 pain score. 0= no pain, 10= worst imaginable pain.

Secondary Outcome Measures :
  1. Oswestry Disability Score [ Time Frame: 1 month ]
    0-100%. 0= no disability, 100% is complete disability

  2. Global Perceived Effect [ Time Frame: 1 month ]
    Satisfaction. Number of participants with positive perceived global satisfaction.

  3. Medication Reduction [ Time Frame: 1 month ]
    Number of people who reduced medications

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00733096

United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
United States, North Carolina
Womack Army Medical Center
Fort Bragg, North Carolina, United States
Sponsors and Collaborators
Johns Hopkins University
Walter Reed Army Medical Center
National Naval Medical Center
Womack Army Medical Center
Landstuhl Regional Medical Center
Massachusetts General Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Steven P. cohen, Walter Reed Army Medical Center Identifier: NCT00733096     History of Changes
Other Study ID Numbers: 08-6891
First Posted: August 12, 2008    Key Record Dates
Results First Posted: October 8, 2012
Last Update Posted: October 8, 2012
Last Verified: September 2010

Keywords provided by Johns Hopkins University:
low back pain

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Antirheumatic Agents