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”

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 Type: Interventional

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

Study Primary Completion Date: January 2007

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

Intervention(s) in this Clinical Trial

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

Primary 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 Measures

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

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pain Management Center of Paducah

Overall Clinical Trial Officials and Contacts

Laxmaiah Manchikanti, MD Principal Investigator Ambulatory Surgery Center  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00370799

Study ID Number: protocol 10

ClinicalTrials.gov Identifier: NCT00370799

Health Authority: United States: Institutional Review Board