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

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ClinicalTrials.gov Identifier: NCT01407913
Recruitment Status : Completed
First Posted : August 2, 2011
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Avraam Ploumis, University of Ioannina

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: N/A
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
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Intervention Details:
  • Procedure: caudal epidural steroid injection
    injecting steroids in the epidural space via caudal route

Outcome Measures
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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
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
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
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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
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Greece
University Hospital of Ioannina
Ioannina, Greece
Sponsors and Collaborators
University of Ioannina
More Information
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Responsible Party: Avraam Ploumis, Assistant Professor of PMR, Orthopaedic Spine Surgeon, University of Ioannina
ClinicalTrials.gov Identifier: NCT01407913    
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:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations