Dispersal Pattern for Spine Injections (Gadolinium Contrast)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Radiculopathy

Intervention / Treatment
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* Drug: Injection with Gadolinium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injection with Gadolinium<br>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. | Drug: Injection with Gadolinium<br>* 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<br>* Other names: Gadavist;|

What is the study measuring?
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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. | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Radiculopathy