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

Pain Management Center of Paducah

Status: Completed

Conditions: Low Back Pain

Treatments: Procedure: lumbar transforaminal epidural injections

Study type: Interventional

Funder types: Other

Identifiers

NCT01052571

Protocol 24

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Without Steroids

Active Comparator group

Description:

Group I patients receiving lumbar transforaminal epidural injections with an injection of local anesthetic (lidocaine 1% or bupivacaine 0.25%

Treatment:

Procedure: lumbar transforaminal epidural injections

steroids

Active Comparator group

Description:

Group II patients will receive lumbar transforaminal epidural injections with 1% lidocaine or 0.25% bupivacaine with 3 mg of steroid per level

Treatment:

Procedure: lumbar transforaminal epidural injections