Effectiveness of Caudal Epidural Injections in Treatment of Chronic Low Back and Lower Extremity Pain

August 14, 2013 updated by: Laxmaiah Manchikanti, MD, Pain Management Center of Paducah

A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Caudal Epidural Injections in Lumbar Disc Herniations, Spinal Stenosis, Discogenic Pain, and Post-Lumbar Laminectomy Syndrome

To demonstrate clinically significant improvements or lack thereof in the caudal epidural patients with our without steroids.

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 assess improvements among patients and compare steroid groups with each other and local anesthetic group.

To evaluate and compare the adverse event profile in all patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with chronic low back pain of at least 6 months duration, non-responsive to conservative management with NSAIDS, physical therapy or chiropractic treatment exercises.

A single-center, prospective, controlled, double blinded, randomized study of patients in 4 groups.

  • Group 1. local anesthetics only
  • Group 2. local anesthetic with 6mg of non-particulate Celestone
  • Group 3. local anesthetic with 6 mg of brand name Celestone
  • Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol

All patients will be unblinded in 12 months.

Non-responsive patients will be unblinded after 3 months and will be crossed over to a different group

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Early Phase 1

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 18 years of age
  • History of chronic, function-limiting low back pain of at least 6 months duration
  • Able to give voluntary, written informed consent to participate,
  • Able to understand the investigation, cooperate with the procedures, and willing to return for follow-up
  • No recent surgical procedures within last three months

Exclusion Criteria:

  • Cauda Equina symptoms and/or compressive radiculopathy
  • Narcotic use of no greater than 100mg/day hydrocodone, 60mg Methadone. or 100mg morphine
  • Uncontrolled major Depression or uncontrolled psychiatric disorder
  • Uncontrolled or acute medical illnesses
  • Chronic severe conditions that could interfere with outcome assessments
  • 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
  • Inability to achieve proper 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

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: local anesthetic
Group 1. local anesthetics only
Drug: Caudal epidural injection
group 1: Caudal epidural injection local anesthetics only
Other Names:
  • Group 1
Active Comparator: Local anesthetic with generic Celestone
Group 2. local anesthetic with 6mg of non-particulate Celestone
Drug: Caudal Epidural Injection with generic Celestone
Group 2. Caudal Epidural Injection local anesthetic with 6mg of non-particulate Celestone
Other Names:
  • Group 2
Active Comparator: Local anesthetic with Celestone
Group 3. local anesthetic with 6 mg of brand nameCelestone
Drug: Caudal Epidural Injection with Celestone
Group 3. Caudal Epidural Injection with local anesthetic with 6 mg of brand name Celestone
Other Names:
  • Group 3
Active Comparator: Local anesthetic with DepoMedrol
Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol
Drug: Caudal Epidural Injection with DepoMedrol
Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol
Other Names:
  • Group 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate for differences between the patients in various groups in the physical function and pain at 1, 3, 6, and 12 months post treatment
Time Frame: 1,3,6,12 months
1,3,6,12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess adverse events in all four groups.
Time Frame: 1,3,6,12 months
1,3,6,12 months

Collaborators and Investigators

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

Sponsor

Pain Management Center of Paducah

Investigators

  • Principal Investigator: Laxmaiah Manchikanti, MD, Ambulatory Surgery Center

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

January 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

August 30, 2006

First Submitted That Met QC Criteria

August 30, 2006

First Posted (Estimate)

September 1, 2006

Study Record Updates

Last Update Posted (Estimate)

August 16, 2013

Last Update Submitted That Met QC Criteria

August 14, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • protocol 10

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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