N/A
N=20
Dispersal Pattern for Spine Injections (Gadolinium Contrast)
Cervical Radiculopathy
Bottom Line
View on ClinicalTrials.gov: NCT02217280 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Injection Dispersal Patterns Measured (in cm) in the Superoinferior Directions on Post-injection MRI With a Calibrated Internal Measurement Software. — 14.73 cm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Injection with Gadolinium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Missouri-Columbia
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Injection Dispersal Patterns Measured (in cm) in the Superoinferior Directions on Post-injection MRI With a Calibrated Internal Measurement Software. |
14.73 | — |
| PRIMARY Circumferential Contrast Spread |
16 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02217280). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.