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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Lumbosacral Radiculopathy

Intervention / Treatment
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* Drug: etanercept
* Drug: methylprednisolone
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Epidural etanercept 4 mg, two doses 2 weeks apart | Drug: etanercept<br>* Two transforaminal epidural injections of 4 mg, two weeks apart<br>|
| Active Comparator: 2<br>Epidural methylprednisolone 60 mg, two doses 2 weeks apart | Drug: methylprednisolone<br>* Two transforaminal epidural steroid injections with 60 mg, two weeks apart<br>|
| Placebo Comparator: 3<br>Epidural saline, two doses 2 weeks apart | Drug: normal saline<br>* Two transforaminal epidural saline injections, two weeks apart<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Leg Pain Score | 0-10 pain score. 0= no pain, 10= worst imaginable pain. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oswestry Disability Score | 0-100%. 0= no disability, 100% is complete disability | 1 month | 
| Global Perceived Effect | Satisfaction. Number of participants with positive perceived global satisfaction. | 1 month | 
| Medication Reduction | Number of people who reduced medications | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiculopathy, sciatica, low back pain