Cervical Radiculopathy
Conditions
Keywords
Cervical Radiculopathy
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.
Interventions
DRUGInjection 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
Sponsors
University of Missouri-Columbia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Spread | 1 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cervical ESI With Gadolinium Male and female subjects between the ages of 18-85 with cervical radiculopathy as identified by the study PI. This was a single arm study with a one-time cervical interlaminar injection at the C7-T1 level. A total injection dose of 10.1 ml included 0.1 mL of gadolinium, 2 ml of 10 mg/ml dexamethasone and 8 ml normal saline, which was administered under fluoroscopic guidance. | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Post-consent sceen fail | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Cervical ESI With Gadolinium | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 16 Participants | — |
| Age, Continuous | 51.18 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 16 Participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
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).
Time frame: 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Injection With Gadolinium | Circumferential Contrast Spread | 16 Participants |
Primary
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.
Time frame: 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Injection With Gadolinium | Injection Dispersal Patterns Measured (in cm) in the Superoinferior Directions on Post-injection MRI With a Calibrated Internal Measurement Software. | 14.73 cm | Standard Deviation 3.15 |