Evaluation of the Effectiveness of Transforaminal Epidural Injections in Lumbar Disc Herniation or Radiculitis

Study Overview
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Brief Summary
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To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids. To evaluate and compare the adverse event profile in all patients.

Detailed Description
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Recruitment is indicated in patients with chronic low back and lower extremity pain secondary to lumbar disc herniation and/or lumbar radiculitis of at least 6-months duration, non-responsive to conservative management with NSAIDs, physical therapy, chiropractic treatment, and exercises. This is a single center study performed in an interventional pain management referral center in the United States. The study involves 120 patients studied in 2 groups with 60 patients in each group. Randomization includes sequence generation, allocation concealment, implementation, and blinding. Data management analysis includes sample size justification of 40 patients in each group with a power of 80% and a 0.05% 2-sided significance level. Statistical methodology includes chi-squared statistics, Fisher's exact test, t-test, and paired t-test with significance evaluated at P value < 0.05.

Official Title
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A Randomized, Prospective, Double-Blind, Equivalence, Controlled Evaluation of the Effectiveness of Transforaminal Epidural Injections in Lumbar Disc Herniation or Radiculitis With or Without Steroids

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: lumbar transforaminal epidural injections


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients with disc herniation or radiculitis Patients who are 18 years of age Patients with a history of chronic function-limiting low back and lower extremity pain of at least 6 months duration Patients who are competent to understand the study protocol and provide voluntary, written informed consent and participate in outcome measurements Exclusion criteria: Previous lumbar surgery, radiculitis secondary to spinal stenosis without disc herniation Uncontrollable or unstable opioid use Uncontrolled psychiatric disorders Uncontrolled medical illness either acute or chronic Any conditions that could interfere with the interpretation of the outcome assessments Pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Without Steroids<br>Group I patients receiving lumbar transforaminal epidural injections with an injection of local anesthetic (lidocaine 1% or bupivacaine 0.25% | Procedure: lumbar transforaminal epidural injections<br>* with an injection of local anesthetic or with 1% lidocaine or 0.25% bupivacaine with 3 mg of steroid per level<br>* Other names: Transforaminal Epidural;|
| Active Comparator: steroids<br>Group II patients will receive lumbar transforaminal epidural injections with 1% lidocaine or 0.25% bupivacaine with 3 mg of steroid per level | Procedure: lumbar transforaminal epidural injections<br>* with an injection of local anesthetic or with 1% lidocaine or 0.25% bupivacaine with 3 mg of steroid per level<br>* Other names: Transforaminal Epidural;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric rating scale (NRS), Oswestry Disability Index (ODI), duration of significant pain relief, opioid intake, and return to work |  | Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event profile of side effects and complications. |  | Adverse events are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment, and at any time during the procedure or after the procedure the adverse events are suspected or expected. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic low back pain, Lumbar disc herniation, Lower extremity pain, Lumbar radiculitis, Local anesthetic, Steroid, Lumbar transforaminal epidural injection