Caudal Epidural Steroid Injections for Low Back Pain/Sciatic Lumbar Pain (FIA1)

This study is currently recruiting participants.

Verified June 2012 by University of Ioannina

Sponsor:

Information provided by (Responsible Party):

Avraam Ploumis, University of Ioannina

ClinicalTrials.gov Identifier:

NCT01407913

First received: July 29, 2011

Last updated: June 12, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 29, 2011

Last Updated Date

June 12, 2012

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

change from preinjection of oswestry disability index at 15 days and at 3-6 months postinjection [ Time Frame: pre injection to 3-6 months postinjection ] [ Designated as safety issue: No ]
change from preinjection of Visual Analogue Scale at 15 days and at 3-6 months postinjection [ Time Frame: preinjection to 3-6 months postinjection ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01407913 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Caudal Epidural Steroid Injections for Low Back Pain/Sciatic Lumbar Pain

Official Title ^ICMJE

Efficacy Study of Caudal Epidural Steroid Injections in Patients With Low Back Pain/Radiculopathy

Brief Summary

The study hypothesis is that caudal epidural steroid injections provides short term relief to patients with persistent low back pain and sciatica due degenerative disc disease or lumbar spinal stenosis. Patients will be evaluated wiht clinical examination and radiological examinations before injections. They will be followed up with questionnaires on pain and disability up to 6 months postinjection.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pain
Disability

Intervention ^ICMJE

Procedure: caudal epidural steroid injection

injecting steroids in the epidural space via caudal route

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2013

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

low back pain and sciatica due to lumbar disc herniation or lumbar spinals stenosis

Exclusion Criteria:

infection, cancer, allergy to steroids or anesthetic, non controlled diabetes or hypertension, clotting disorder

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Avraam Ploumis, Assist Professor

APLOUMIS@CC.UOI.GR

Location Countries ^ICMJE

Greece

Administrative Information

NCT Number ^ICMJE

NCT01407913

Other Study ID Numbers ^ICMJE

191/2010

Has Data Monitoring Committee

Responsible Party

Avraam Ploumis, University of Ioannina

Study Sponsor ^ICMJE

University of Ioannina

Collaborators ^ICMJE

Investigators ^ICMJE

Information Provided By

University of Ioannina

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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