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

Sponsor:	Pain Management Center of Paducah
Information provided by:	Pain Management Center of Paducah
ClinicalTrials.gov Identifier:	NCT00370799

Purpose

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

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Hernia Spinal Stenosis

Drug Information available for: Methylprednisolone

U.S. FDA Resources

Further study details as provided by Pain Management Center of Paducah:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	240
Study Start Date:	January 2006
Study Completion Date:	September 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370799

Locations

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

Sponsors and Collaborators

Pain Management Center of Paducah

Investigators

Principal Investigator:

Laxmaiah Manchikanti, MD

Ambulatory Surgery Center

More Information

No publications provided

Study ID Numbers:	protocol 10
Study First Received:	August 30, 2006
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00370799 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Pain Management Center of Paducah:

Caudal Epidural injections
lumbar disc herniation
spinal stenosis
discogenic pain
post-lumbar laminectomy syndrome

Additional relevant MeSH terms:

Spinal Diseases
Anti-Inflammatory Agents
Nervous System Diseases
Low Back Pain
Methylprednisolone acetate
Pain
Back Pain

Bone Diseases
Pharmacologic Actions
Spinal Stenosis
Signs and Symptoms
Musculoskeletal Diseases
Therapeutic Uses
Neurologic Manifestations

ClinicalTrials.gov processed this record on February 08, 2010