Clinical trial NCT02217280: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Radiculopathy
Keywords: Cervical Radiculopathy
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Injection Dispersal Patterns Measured (in cm) in the Superoinferior Directions on Post-injection MRI With a Calibrated Internal Measurement Software.
timeFrame: 1 hour
measure: Circumferential Contrast Spread
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Missouri Orthopaedic Institute
state: Missouri
Study officials:
affiliation: University of Missouri Department of Orthopaedics
name: Christina L Goldstein, MD
role: PRINCIPAL_INVESTIGATOR
References: