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

NCT ID: NCT01407913

Last Updated: 2015-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2014-06-30

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.

Conditions

Pain; Disability

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

caudal epidural steroid injection

injecting steroids in the epidural space via caudal route

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ioannina

OTHER

Sponsor Role: lead

Responsible Party

Avraam Ploumis

Assistant Professor of PMR, Orthopaedic Spine Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital of Ioannina

Ioannina, , Greece

Countries

Greece

Other Identifiers

191/2010

Identifier Type: -

Identifier Source: org_study_id