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Dispersal Pattern for Spine Injections (Gadolinium Contrast)

Not Applicable
Completed
Conditions
Cervical Radiculopathy
Interventions
Registration Number
NCT02217280
Lead Sponsor
University of Missouri-Columbia
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Injection with GadoliniumInjection with GadoliniumThis 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.
Primary Outcome Measures
NameTimeMethod
Injection Dispersal Patterns Measured (in cm) in the Superoinferior Directions on Post-injection MRI With a Calibrated Internal Measurement Software.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.

Circumferential Contrast Spread1 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).

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Missouri Orthopaedic Institute

🇺🇸

Columbia, Missouri, United States

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