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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01407913
First Posted: August 2, 2011
Last Update Posted: May 27, 2015
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.
Information provided by (Responsible Party):
Avraam Ploumis, University of Ioannina
  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: 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

Resource links provided by NLM:


Further study details as provided by Avraam Ploumis, 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 ]
  • change from preinjection of Visual Analogue Scale at 15 days and at 3-6 months postinjection [ Time Frame: preinjection to 3-6 months postinjection ]

Enrollment: 42
Study Start Date: October 2010
Study Completion Date: June 2014
Primary Completion Date: June 2014 (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

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
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
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


Locations
Greece
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 Submitted: July 29, 2011
First Posted: August 2, 2011
Last Update Posted: May 27, 2015
Last Verified: May 2015

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