Back to resultsCaudal Epidural Steroid Injections for Low Back Pain/Sciatic Lumbar Pain (FIA1)
Primary Purpose
Pain, Disability
Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
caudal epidural steroid injection
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility 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
Sites / Locations
- University Hospital of Ioannina
Outcomes
Primary Outcome Measures
change from preinjection of oswestry disability index at 15 days and at 3-6 months postinjection
change from preinjection of Visual Analogue Scale at 15 days and at 3-6 months postinjection
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01407913
Brief Title
Caudal Epidural Steroid Injections for Low Back Pain/Sciatic Lumbar Pain
Acronym
FIA1
Official Title
Efficacy Study of Caudal Epidural Steroid Injections in Patients With Low Back Pain/Radiculopathy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ioannina
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Disability
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
caudal epidural steroid injection
Intervention Description
injecting steroids in the epidural space via caudal route
Primary Outcome Measure Information:
Title
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
Title
change from preinjection of Visual Analogue Scale at 15 days and at 3-6 months postinjection
Time Frame
preinjection to 3-6 months postinjection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Hospital of Ioannina
City
Ioannina
Country
Greece
12. IPD Sharing Statement
Learn more about this trial
Caudal Epidural Steroid Injections for Low Back Pain/Sciatic Lumbar Pain
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