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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
Sponsor:
Information provided by (Responsible Party):
Avraam Ploumis, University of Ioannina

Tracking Information
First Submitted Date  ICMJE July 29, 2011
First Posted Date  ICMJE August 2, 2011
Last Update Posted Date May 27, 2015
Study Start Date  ICMJE October 2010
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2011)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Caudal Epidural Steroid Injections for Low Back Pain/Sciatic Lumbar Pain
Official Title  ICMJE Efficacy Study of Caudal Epidural Steroid Injections in Patients With Low Back Pain/Radiculopathy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Disability
Intervention  ICMJE Procedure: caudal epidural steroid injection
injecting steroids in the epidural space via caudal route
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2015)
42
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2011)
20
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01407913
Other Study ID Numbers  ICMJE 191/2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avraam Ploumis, University of Ioannina
Study Sponsor  ICMJE University of Ioannina
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Ioannina
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP