NCT00370799

Effectiveness of Caudal Epidural Injections in 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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Pain Management Center of Paducah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DRUG	Caudal epidural injection	group 1: Caudal epidural injection local anesthetics only
DRUG	Caudal Epidural Injection with generic Celestone	Group 2. Caudal Epidural Injection local anesthetic with 6mg of non-particulate Celestone
DRUG	Caudal Epidural Injection with Celestone	Group 3. Caudal Epidural Injection with local anesthetic with 6 mg of brand name Celestone
DRUG	Caudal Epidural Injection with DepoMedrol	Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-12-01
• Completion: 2010-03-01
• First posted: 2006-09-01
• Last updated: 2013-08-16

Locations

1 site across 1 country: United States