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

NCT00370799 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2013-08-16

No results posted yet for this study

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

Conditions

  • Low Back Pain

Interventions

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

Sponsors & Collaborators

  • Pain Management Center of Paducah

    lead OTHER

Principal Investigators

  • Laxmaiah Manchikanti, MD · Ambulatory Surgery Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-12-31
Completion
2010-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00370799 on ClinicalTrials.gov