Dispersal Pattern for Spine Injections (Gadolinium Contrast)

Cervical Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02217280
• Other study ID #: 1210810
• Status: Completed
• Phase: N/A
• First received: March 21, 2014
• Last updated: May 6, 2016
• Start date: April 2015
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cervical Radiculopathy
• Radiculopathy

Intervention

Drug:
• Injection with Gadolinium
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

Locations

Country	Name	City	State
United States	Missouri Orthopaedic Institute	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dispersal patterns measured (in mm) of injection 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 believe that the epidural injections will remain localized within the epidural space. We will measure (with post-injection MRI) how far cranial and caudal as well as anterior and posterior the injection is travelling in the epidural space.	1 hour	No
Secondary	Pain Scores on the Visual Analog Scale		1 hour	No