- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02217280
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
Conditions
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
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Missouri
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Columbia, Missouri, United States, 65212
- Missouri Orthopaedic Institute
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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.
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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:
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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
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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.
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1 hour
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
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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