Dispersal Pattern for Spine Injections (Gadolinium Contrast)

University of Missouri (MU)

Status: Completed

Conditions: Cervical Radiculopathy

Treatments: Drug: Injection with Gadolinium

Study type: Interventional

Funder types: Other

Identifiers

NCT02217280

1210810

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Injection with Gadolinium

Experimental group

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.

Treatment:

Drug: Injection with Gadolinium