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.

Spinal Stenosis Clinical Trial

Official title:

A Prospective, Randomized, Single Blind Study Comparing Transforaminal Epidural Steroid Injections at the Level of MRI Pathology vs Clinical Symptoms

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02196883
• Other study ID #: 593154-1
• Status: Withdrawn
• Phase: N/A
• First received: July 18, 2014
• Last updated: June 10, 2016
• Start date: May 2014

Study information

• Verified date: July 2014
• Source: State University of New York - Upstate Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: May 2015
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Intervertebral Disc Displacement
• Radiculopathy
• Spinal Stenosis

Intervention

Procedure:
• Transforaminal Epidural Steroid Injection

Locations

Country	Name	City	State
United States	SUNY Upstate Medical Center	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale		2 weeks to 6months
Secondary	Short Form 36 Health Survey		2 weeks to 6months
Secondary	Oswestry Disability Index		2 weeks to 6months