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Clinical Trials/NCT01407913
NCT01407913
Completed
Phase 4

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

University of Ioannina1 site in 1 country42 target enrollmentOctober 2010
ConditionsPainDisability

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Pain
Sponsor
University of Ioannina
Enrollment
42
Locations
1
Primary Endpoint
change from preinjection of oswestry disability index at 15 days and at 3-6 months postinjection
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
June 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Avraam Ploumis

Assistant Professor of PMR, Orthopaedic Spine Surgeon

University of Ioannina

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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