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

NCT ID: NCT01052571

Last Updated: 2015-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2014-08-31

Brief Summary

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

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Without Steroids

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

Group Type: ACTIVE_COMPARATOR

lumbar transforaminal epidural injections

Intervention Type: PROCEDURE

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

steroids

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

Group Type: ACTIVE_COMPARATOR

lumbar transforaminal epidural injections

Intervention Type: PROCEDURE

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

Interventions

lumbar transforaminal epidural injections

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

Intervention Type: PROCEDURE

Other Intervention Names

Transforaminal Epidural

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pain Management Center of Paducah

OTHER

Sponsor Role: lead

Responsible Party

Laxmaiah Manchikanti, MD

Medical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laxmaiah Manchikanti, MD

Role: PRINCIPAL_INVESTIGATOR

Ambulatory Surgery Center, Paducah

Locations

Ambulatory Surgery Center

Paducah, Kentucky, United States

Countries

United States

Other Identifiers

Protocol 24

Identifier Type: -

Identifier Source: org_study_id