Dispersal Pattern for Spine Injections (Gadolinium Contrast)

May 26, 2017 updated by: Christina Goldstein, University of Missouri-Columbia

Dispersal Pattern of Injectate After Cervical Epidural Steroid Evaluated With Magnetic Resonance Imaging

This study will analyze injectate dispersal patterns after standard-of-care cervical epidural steroid injections using gadolinium as a marker and magnetic resonance imaging (MRI) to characterize the pattern. Although these procedures are performed with high frequency under the assumption that injectate remains localized to injection site, no peer-reviewed studies have validated this assumption. Comprehensive characterization of injectate dispersal patterns will provide important data regarding safety, as well as diagnostic and therapeutic potential of cervical epidural steroid injections.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Epidural steroid injections have long had an impact in the treatment of various spine-related conditions, particularly radiculopathy. The efficacy of epidural spinal injections has been attributed to the anatomic location reached by the injectate. Cervical epidural steroid injections are also used as an injury location indicator. This application is based on documenting pain relief after injection into a specific location in the cervical spine. Both the diagnostic and therapeutic applications for epidurals assume that the injectate remains local to the injection site in order to have its effects. However, in a recently completed study, the investigators group documented substantial diffusion of injectate after lumbar epidurals used computerized tomography (CT) assessments.1 Based on the exposure to ionizing radiation associated with CT along with the superior imaging specificity and sensitivity of MRI, the investigators are shifting their imaging modality to MRI for future studies. The proposed study is designed to evaluate the use of gadolinium and MRI to assess nature and amount of diffusion of injectate in the cervical region after standard-of-care epidural injections. To the investigators knowledge, this will be the first study to critically assess this common procedure in order to evaluate safety and efficacy in a clinical setting.

Study Type

Interventional

Enrollment (Actual)

20

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

    • Missouri
      • Columbia, Missouri, United States, 65212
        • Missouri Orthopaedic Institute

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-85
  • Cervical radiculopathy patient as identified by principle investigator

Exclusion Criteria:

  • Patients unable to give consent or comply with rehabilitation process
  • Pregnant
  • Co-morbidities such as infection, malignancy, myelopathy or an uncontrolled medical condition
  • Allergy to injectate
  • Anticoagulative state
  • Severe claustrophobia
  • Non-MRI compatible pacemaker, neurostimulator, bladder stimulator or other mechanical device
  • Renal disease that would cause the patient to be at an increased risk of complication of receiving the contrast agent

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: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Injection with Gadolinium
This group of patients identified by the PI as having cervical radiculopathy will receive gadolinium (the intervention) in their epidural cervical injection along with steroid (DepoMedrol). There is no control group in this study.
Gadavist (gadobutrol) injection is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system
Other Names:
  • Gadavist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Injection Dispersal Patterns Measured (in cm) in the Superoinferior Directions on Post-injection MRI With a Calibrated Internal Measurement Software.
Time Frame: 1 hour
Determine the relative efficacy (diagnostic and therapeutic) of cervical epidural injections based on injectate diffusion. We will measure (with post-injection MRI) how far the injection travels in the superoinferior directions (in cm) within in the epidural space.
1 hour
Circumferential Contrast Spread
Time Frame: 1 hour

Number of study subjects who achieved circumferential contrast spread in the epidural space. Circumferential contrast spread is achieved when the contrast reaches all directions in the epidural space in the horizontal/axial plane.

This includes contrast spread in the anterior, posterior, medial and lateral directions (in relation to the spinal cord).

1 hour

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Christina L Goldstein, MD, University of Missouri Department of Orthopaedics

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

April 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

March 21, 2014

First Submitted That Met QC Criteria

August 14, 2014

First Posted (Estimate)

August 15, 2014

Study Record Updates

Last Update Posted (Actual)

June 28, 2017

Last Update Submitted That Met QC Criteria

May 26, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 1210810

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.

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