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

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

Tracking Information

• First Submitted Date: July 29, 2011
• First Posted Date: August 2, 2011
• Last Update Posted Date: May 27, 2015
• Study Start Date: October 2010
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Caudal Epidural Steroid Injections for Low Back Pain/Sciatic Lumbar Pain
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Pain
• Disability

Intervention

Procedure: caudal epidural steroid injection

injecting steroids in the epidural space via caudal route

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 26, 2015): 42
• Original Estimated Enrollment (submitted: August 1, 2011): 20
• Actual Study Completion Date: June 2014
• Actual Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Greece

Administrative Information

• NCT Number: NCT01407913
• Other Study ID Numbers: 191/2010
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Avraam Ploumis, University of Ioannina
• Study Sponsor: University of Ioannina
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Ioannina
• Verification Date: May 2015