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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01407913
Recruitment Status : Completed
First Posted : August 2, 2011
Last Update Posted : May 27, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Pain Disability Procedure: caudal epidural steroid injection Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy Study of Caudal Epidural Steroid Injections in Patients With Low Back Pain/Radiculopathy
Study Start Date : October 2010
Primary Completion Date : June 2014
Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Intervention Details:
    Procedure: caudal epidural steroid injection
    injecting steroids in the epidural space via caudal route

Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. change from preinjection of Visual Analogue Scale at 15 days and at 3-6 months postinjection [ Time Frame: preinjection to 3-6 months postinjection ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407913

University Hospital of Ioannina
Ioannina, Greece
Sponsors and Collaborators
University of Ioannina
More Information

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
First Posted: August 2, 2011    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

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