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

Pain Management Center of Paducah120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

120

Conditions

Low Back Pain

Interventions

lumbar transforaminal epidural injectionsPROCEDURE

with an injection of local anesthetic or with 1% lidocaine or 0.25% bupivacaine with 3 mg of steroid per level

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ambulatory Surgery Center

Paducah, Kentucky, United States

Outcomes

Primary Outcomes

Numeric rating scale (NRS), Oswestry Disability Index (ODI), duration of significant pain relief, opioid intake, and return to work

Time frame: Outcomes are measured at baseline and at 3, 6, 12, 18, and 24 months post-treatment.

Secondary Outcomes

Adverse event profile of side effects and complications.

Time frame: 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.

Data from ClinicalTrials.gov

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