CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 240 enrolled
Drug / intervention
Caudal epidural injection +3 moredrug
Likely dose
Caudal Epidural Injection with generic Celestone 6mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00370799
NCT00370799Early Ph 1Completed
CompareCT.gov

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

Pain Management Center of Paducah·interventional·Posted Sep 1, 2006·Updated Aug 16, 2013

In Brief

A Early Phase 1 clinical trial evaluating Caudal epidural injection, Caudal Epidural Injection with generic Celestone, and 2 other interventions for Low Back Pain. Completed, enrolled 240 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 1, 2006
Enrollment StartJan 1, 2007
Primary CompletionDec 1, 2009
Study CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 19.8 years ago

Interventions

Caudal epidural injectiondrug

group 1: Caudal epidural injection local anesthetics only

Caudal Epidural Injection with generic Celestonedrug

Group 2. Caudal Epidural Injection local anesthetic with 6mg of non-particulate Celestone

Caudal Epidural Injection with Celestonedrug

Group 3. Caudal Epidural Injection with local anesthetic with 6 mg of brand name Celestone

Caudal Epidural Injection with DepoMedroldrug

Group 4. local anesthetic with 40 mg of alcohol-free DepoMedrol