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.

Not Applicable

Withdrawn

• Conditions: Radiculopathy; Spinal Stenosis; Intervertebral Disc Displacement
• Interventions: Procedure: Transforaminal Epidural Steroid Injection

• Registration Number: NCT02196883
• Lead Sponsor: State University of New York - Upstate Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Status Verified: 2014-07
• Study First Submitted: 2014-07-18
• Study First Submitted QC: 2014-07-21
• Study First Posted: 2014-07-22
• Primary Completion: 2015-05
• Last Update Submitted: 2016-06-10
• Last Update Posted: 2016-06-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI Pathology	Transforaminal Epidural Steroid Injection	-
Physical Exam Pathology	Transforaminal Epidural Steroid Injection	-

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale	2 weeks to 6months

Secondary Outcome Measures

Name	Time	Method
Oswestry Disability Index	2 weeks to 6months
Short Form 36 Health Survey	2 weeks to 6months

Trial Locations

Locations (1)

SUNY Upstate Medical Center; 🇺🇸 Syracuse, New York, United States