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

Lumbosacral Radiculopathy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733096
• Other study ID #: 08-6891
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 11, 2008
• Last updated: October 5, 2012
• Start date: August 2008
• Est. completion date: March 2011

Study information

• Verified date: September 2010
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lumbosacral Radiculopathy
• Radiculopathy

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Womack Army Medical Center	Fort Bragg	North Carolina
United States	Walter Reed Army Medical Center	Washington	District of Columbia

Sponsors (6)

Lead Sponsor	Collaborator
Johns Hopkins University	Landstuhl Regional Medical Center, Massachusetts General Hospital, National Naval Medical Center, Walter Reed Army Medical Center, Womack Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epub 2005 Jun 22. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Rating Leg Pain Score	0-10 pain score. 0= no pain, 10= worst imaginable pain.	1 month	No
Secondary	Oswestry Disability Score	0-100%. 0= no disability, 100% is complete disability	1 month	No
Secondary	Global Perceived Effect	Satisfaction. Number of participants with positive perceived global satisfaction.	1 month	No
Secondary	Medication Reduction	Number of people who reduced medications	1 month	No