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.

June 10, 2016 updated by: State University of New York - Upstate Medical University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MRI Pathology
Procedure: Transforaminal Epidural Steroid Injection
Active Comparator: Physical Exam Pathology
Procedure: Transforaminal Epidural Steroid Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Analog Scale
Time Frame: 2 weeks to 6months
2 weeks to 6months

Secondary Outcome Measures

Outcome Measure
Time Frame
Short Form 36 Health Survey
Time Frame: 2 weeks to 6months
2 weeks to 6months
Oswestry Disability Index
Time Frame: 2 weeks to 6months
2 weeks to 6months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York - Upstate Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

May 1, 2015

Study Registration Dates

First Submitted

July 18, 2014

First Submitted That Met QC Criteria

July 21, 2014

First Posted (Estimate)

July 22, 2014

Study Record Updates

Last Update Posted (Estimate)

June 14, 2016

Last Update Submitted That Met QC Criteria

June 10, 2016

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 593154-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intervertebral Disc Displacement

Clinical Trials on Transforaminal Epidural Steroid Injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe