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

Tracking Information

First Received Date ^ICMJE

August 30, 2006

Last Updated Date

May 19, 2008

Start Date ^ICMJE

January 2006

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00370799 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To assess adverse events in all four groups.
Adverse events will be recorded and reported appropriately throughout the study.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Treatment of Chronic Low Back and Lower Extremity Pain: 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

Brief Summary

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

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Low Back Pain

Intervention ^ICMJE

Procedure: Caudal epidural injections under fluoroscopy
Drug: 0.5% Xylocaine, Non-particulate Celestone, or DepoMedrol
Device: Epidural tray and needle

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

240

Completion Date

September 2007

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00370799

Responsible Party

Study ID Numbers ^ICMJE

protocol 10

Study Sponsor ^ICMJE

Pain Management Center of Paducah

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Laxmaiah Manchikanti, MD

Ambulatory Surgery Center

Information Provided By

Pain Management Center of Paducah

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP