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Dispersal Pattern for Spine Injections (Gadolinium Contrast)

Primary Purpose

Cervical Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Injection with Gadolinium
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cervical Radiculopathy focused on measuring Cervical Radiculopathy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Missouri Orthopaedic Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Injection with Gadolinium

Arm Description

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.

Outcomes

Primary Outcome Measures

Injection Dispersal Patterns Measured (in cm) in the Superoinferior Directions on Post-injection MRI With a Calibrated Internal Measurement Software.
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.
Circumferential Contrast Spread
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).

Secondary Outcome Measures

Full Information

First Posted
March 21, 2014
Last Updated
May 26, 2017
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02217280
Brief Title
Dispersal Pattern for Spine Injections (Gadolinium Contrast)
Official Title
Dispersal Pattern of Injectate After Cervical Epidural Steroid Evaluated With Magnetic Resonance Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy
Keywords
Cervical Radiculopathy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Injection with Gadolinium
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Injection with Gadolinium
Other Intervention Name(s)
Gadavist
Intervention Description
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
Primary Outcome Measure Information:
Title
Injection Dispersal Patterns Measured (in cm) in the Superoinferior Directions on Post-injection MRI With a Calibrated Internal Measurement Software.
Description
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.
Time Frame
1 hour
Title
Circumferential Contrast Spread
Description
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).
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina L Goldstein, MD
Organizational Affiliation
University of Missouri Department of Orthopaedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Missouri Orthopaedic Institute
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

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Dispersal Pattern for Spine Injections (Gadolinium Contrast)

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