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

This study is currently recruiting participants.
Verified May 2013 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: May 1, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Pain
Disability
 Procedure: caudal epidural steroid injection
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy Study of Caudal Epidural Steroid Injections in Patients With Low Back Pain/Radiculopathy

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by University of Ioannina:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: caudal epidural steroid injection
    injecting steroids in the epidural space via caudal route
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01407913

Contacts
Contact: Avraam Ploumis, Assist Professor APLOUMIS@CC.UOI.GR

Locations
Greece
University Hospital of Ioannina Recruiting
Ioannina, Greece
Contact: Stavrou Vasiliki, RN         vstavroy2000@gmail.com    
Principal Investigator: Avraam Ploumis, Ass Professor            
Sub-Investigator: Dimitrios Varvarousis, MD            
Sub-Investigator: Vasiliki Stavrou, RN            
Sponsors and Collaborators
University of Ioannina
  More Information

No publications provided

Responsible Party: Avraam Ploumis, Assistant Professor of PMR, Orthopaedic Spine Surgeon, University of Ioannina
ClinicalTrials.gov Identifier: NCT01407913     History of Changes
Other Study ID Numbers: 191/2010
Study First Received: July 29, 2011
Last Updated: May 1, 2013
Health Authority: Greece: National Drug Organisation (*EOF)

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013