Steroid Injections Given at the "Level of MRI Pathology" Versus at the "Level of Clinical Symptoms" to See if One is More Effective Than the Other.

NCT ID: NCT02196883

Last Updated: 2016-06-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31

Brief Summary

Patients are being asked to participate in a research study because the patients are being treated for low back pain and the patients have decided to have an epidural steroid injection.

Low back pain has a tremendous impact on the individual and society. It not only affects the individuals quality of life, it also contributes to lost productivity and increased health care costs.

Epidural steroid injections (ESIs) are a common treatment option for many forms of low back pain. They have been used for low back problems since 1952 and are still being used as a non-surgical form of treatment for low back pain. The goal of the injections is reduction of pain, increased quality of life and improved function.

This study is being conducted to determine the outcomes of injections given at the "level of MRI Pathology" versus at the "level of clinical symptoms" to see if one is more effective than the other and to learn more about the characteristics of the two different injections.

Conditions

Radiculopathy; Spinal Stenosis; Intervertebral Disc Displacement

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

MRI Pathology

Group Type: ACTIVE_COMPARATOR

Transforaminal Epidural Steroid Injection

Intervention Type: PROCEDURE

Physical Exam Pathology

Group Type: ACTIVE_COMPARATOR

Transforaminal Epidural Steroid Injection

Intervention Type: PROCEDURE

Interventions

Transforaminal Epidural Steroid Injection

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of Single level spinal stenosis.
• Single level radiculopathy with MRI findings at a different level than clinical pattern.
• Chronic low back pain with radicular symptoms of > 4 weeks, but < 6 months.
• Failure of conservative therapy to include physical and pharmacotherapy.
• Patient is at least 21 years of age.
• Patient is willing to be blinded to treatment until after the 3-month follow up visit.
• Patient is willing and able to review and sign the study's informed consent form.

Exclusion Criteria

• Patient has a mental or physical condition that would invalidate evaluation results.
• Patient has had prior lumbar surgery at any level.
• Patient is pregnant.
• Patient has systemic infection or infection at the proposed injection site.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York - Upstate Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SUNY Upstate Medical Center

Syracuse, New York, United States

Countries

United States

Other Identifiers

593154-1

Identifier Type: -

Identifier Source: org_study_id