Treatment of Chronic Low Back and Lower Extremity Pain

October 20, 2015 updated by: Laxmaiah Manchikanti, MD, Pain Management Center of Paducah

A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Lumbar Interlaminar Epidural Injections in Lumbar Disc Herniation, and Discogenic Pain

  1. To demonstrate clinically significant improvements in patients undergoing lumbar interlaminar epidurals. Improvement will be assessed in relation to the clinical outcome measures of pain and function.
  2. To evaluate and compare the adverse event profile in all patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Paducah, Kentucky, United States, 42001
        • Ambulatory Surgery Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects of at least 18 years of age
  • Subjects with a history of chronic, function-limiting chronic low back pain of at least 6 months in duration
  • Subjects who are able to give voluntary, written informed consent to participate in this investigation
  • Subjects who, in the opinion of the PI, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the center for all the required post-operative follow-ups
  • Subjects have not had recent surgical procedures within the last 3 months.

Exclusion Criteria:

  • Cauda Equina symptoms and/or compressive radiculopathy
  • Narcotic use of no greater than hydrocodone 100 mg/day, methadone of 60 mg, or morphine 180 mg, or dose equivalent
  • Uncontrolled major depression or uncontrolled psychiatric disorders
  • Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intracranial pressure, pseudotumor cerebri, intracranial tumors, unstable angina, and severe chronic obstructive pulmonary disease.
  • Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function
  • Women who are pregnant or lactating
  • Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment
  • Patients with multiple complaints involving concomitant hip osteoarthritis, due to the overlap of pain complaints
  • Inability to achieve appropriate positioning and inability to understand informed consent and protocol
  • History of adverse reaction to local anesthetic or anti-inflammatory drugs and history of gastrointestinal bleeding or ulcers
  • Previous surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group I
Lumbar interlaminar epidural injection with local anesthetic only
Procedure: Lumbar Interlaminar Epidural
  1. Lumbar interlaminar epidural injections under fluoroscopy
  2. Epidural tray and needle
  3. Drugs:

0.5% Xylocaine and non-particulate Celestone

Procedure: Lumbar Interlaminar Epidural injection
  1. Lumbar interlaminar epidural injections under fluoroscopy
  2. Epidural tray and needle
  3. Drugs:

0.5% Xylocaine and non-particulate Celestone
Other: Group II
Lumbar Interlaminar Epidural Injection with local anesthetic wiht 6 mg of non-particulate Celestone
Procedure: Lumbar Interlaminar Epidural
  1. Lumbar interlaminar epidural injections under fluoroscopy
  2. Epidural tray and needle
  3. Drugs:

0.5% Xylocaine and non-particulate Celestone

Procedure: Lumbar Interlaminar Epidural injection
  1. Lumbar interlaminar epidural injections under fluoroscopy
  2. Epidural tray and needle
  3. Drugs:

0.5% Xylocaine and non-particulate Celestone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To demonstrate clinically significant improvement or lack thereof with the lumbar interlaminar epidural patients with or without steroids.
Time Frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.
Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids.
Time Frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.
Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.
To evaluate and compare the adverse event profile in all patients.
Time Frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.
Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pain Management Center of Paducah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 14, 2008

First Submitted That Met QC Criteria

May 19, 2008

First Posted (Estimate)

May 21, 2008

Study Record Updates

Last Update Posted (Estimate)

October 21, 2015

Last Update Submitted That Met QC Criteria

October 20, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • protocol 15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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