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

This study has been completed.
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT00733096
First received: August 11, 2008
Last updated: October 5, 2012
Last verified: September 2010
  Purpose

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 Intervention Phase
Lumbosacral Radiculopathy
Drug: etanercept
Drug: methylprednisolone
Drug: normal saline
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

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


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

  • Global Perceived Effect [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Satisfaction. Number of participants with positive perceived global satisfaction.

  • Medication Reduction [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Number of people who reduced medications


Enrollment: 84
Study Start Date: August 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733096

Locations
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven P. cohen, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier: NCT00733096     History of Changes
Other Study ID Numbers: 08-6891
Study First Received: August 11, 2008
Results First Received: August 24, 2012
Last Updated: October 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
radiculopathy
sciatica
low back pain

Additional relevant MeSH terms:
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Methylprednisolone acetate
Prednisolone acetate
TNFR-Fc fusion protein
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on July 20, 2014