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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

August 11, 2008
October 5, 2012
August 2008
March 2011   (final data collection date for primary outcome measure)
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.
numerical rating pain score [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00733096 on ClinicalTrials.gov Archive Site
  • 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
  • Oswestry disability score [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: No ]
  • global perceived effect [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: No ]
  • medication reduction [ Time Frame: 1, 3 and 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A 3-arm Multi-center, Randomized Controlled Study Comparing Transforaminal Corticosteroid, Transforaminal Etanercept and Transforaminal Saline for Lumbosacral Radiculopathy
Not Provided

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Lumbosacral Radiculopathy
  • Drug: etanercept
    Two transforaminal epidural injections of 4 mg, two weeks apart
  • Drug: methylprednisolone
    Two transforaminal epidural steroid injections with 60 mg, two weeks apart
  • Drug: normal saline
    Two transforaminal epidural saline injections, two weeks apart
  • Experimental: 1
    Epidural etanercept 4 mg, two doses 2 weeks apart
    Intervention: Drug: etanercept
  • Active Comparator: 2
    Epidural methylprednisolone 60 mg, two doses 2 weeks apart
    Intervention: Drug: methylprednisolone
  • Placebo Comparator: 3
    Epidural saline, two doses 2 weeks apart
    Intervention: Drug: normal saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00733096
08-6891
No
Steven P. cohen, Walter Reed Army Medical Center
Johns Hopkins University
  • Walter Reed Army Medical Center
  • National Naval Medical Center
  • Womack Army Medical Center
  • Landstuhl Regional Medical Center
  • Massachusetts General Hospital
Not Provided
Johns Hopkins University
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP