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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01052571
• Other study ID #: Protocol 24
• Status: Completed
• Phase: N/A
• First received: January 18, 2010
• Last updated: October 20, 2015
• Start date: February 2010
• Est. completion date: August 2014

Study information

• Verified date: October 2015
• Source: Pain Management Center of Paducah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2014
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Low Back Pain

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United States	Ambulatory Surgery Center	Paducah	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Pain Management Center of Paducah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	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.	Yes