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

This study has been completed.
Information provided by (Responsible Party):
Avraam Ploumis, University of Ioannina Identifier:
First received: July 29, 2011
Last updated: May 26, 2015
Last verified: May 2015

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
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:

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 ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT01407913

University Hospital of Ioannina
Ioannina, Greece
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 Identifier: NCT01407913     History of Changes
Other Study ID Numbers: 191/2010
Study First Received: July 29, 2011
Last Updated: May 26, 2015
Health Authority: Greece: National Drug Organisation (*EOF)

Additional relevant MeSH terms:
Low Back Pain
Back Pain
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on October 02, 2015