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

Primary Purpose

Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

lumbar transforaminal epidural injections

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Chronic low back pain, Lumbar disc herniation, Lower extremity pain, Lumbar radiculitis, Local anesthetic, Steroid, Lumbar transforaminal epidural injection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Ambulatory Surgery Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Without Steroids

steroids

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse event profile of side effects and complications.

Full Information

NCT ID

NCT01052571

First Posted

January 18, 2010

Last Updated

October 20, 2015

Sponsor

Pain Management Center of Paducah

1. Study Identification

Unique Protocol Identification Number

NCT01052571

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Pain Management Center of Paducah

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

Chronic low back pain, Lumbar disc herniation, Lower extremity pain, Lumbar radiculitis, Local anesthetic, Steroid, Lumbar transforaminal epidural injection

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Without Steroids

Arm Type

Active Comparator

Arm Description

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

Arm Title

steroids

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

lumbar transforaminal epidural injections

Other Intervention Name(s)

Transforaminal Epidural

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laxmaiah Manchikanti, MD

Organizational Affiliation

Ambulatory Surgery Center, Paducah

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ambulatory Surgery Center

City

Paducah

State/Province

Kentucky

ZIP/Postal Code

42001

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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