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

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Procedure: lumbar transforaminal epidural injections

• Registration Number: NCT01052571
• Lead Sponsor: Pain Management Center of Paducah

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.

Study Timeline

• Study First Submitted: 2010-01-18
• Study First Submitted QC: 2010-01-18
• Study First Posted: 2010-01-20
• Study Start: 2010-02
• Primary Completion: 2012-01
• Study Completion: 2014-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-20
• Last Update Posted: 2015-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Without Steroids	lumbar transforaminal epidural injections	Group I patients receiving lumbar transforaminal epidural injections with an injection of local anesthetic (lidocaine 1% or bupivacaine 0.25%
steroids	lumbar transforaminal epidural injections	Group II patients will receive lumbar transforaminal epidural injections with 1% lidocaine or 0.25% bupivacaine with 3 mg of steroid per level

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Ambulatory Surgery Center; 🇺🇸 Paducah, Kentucky, United States