Caudal Epidural Steroid Injections for Low Back Pain/Sciatic Lumbar Pain

Pain Clinical Trial

— FIA1  

Official title:

Efficacy Study of Caudal Epidural Steroid Injections in Patients With Low Back Pain/Radiculopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01407913
• Other study ID #: 191/2010
• Status: Completed
• Phase: Phase 4
• First received: July 29, 2011
• Last updated: May 26, 2015
• Start date: October 2010
• Est. completion date: June 2014

Study information

• Verified date: May 2015
• Source: University of Ioannina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Drug Organisation (*EOF)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disability
• Low Back Pain
• Pain

Intervention

Procedure:
• caudal epidural steroid injection
injecting steroids in the epidural space via caudal route

Locations

Country	Name	City	State
Greece	University Hospital of Ioannina	Ioannina

Sponsors (1)

Lead Sponsor	Collaborator
University of Ioannina

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from preinjection of oswestry disability index at 15 days and at 3-6 months postinjection		pre injection to 3-6 months postinjection	No
Primary	change from preinjection of Visual Analogue Scale at 15 days and at 3-6 months postinjection		preinjection to 3-6 months postinjection	No