Cervical RadiculopathyNCT02217280
Dispersal Pattern for Spine Injections (Gadolinium Contrast)
A study testing Injection with Gadolinium in people with Cervical Radiculopathy, run by University of Missouri-Columbia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Injection with Gadolinium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-85
- Cervical radiculopathy patient as identified by principle investigator
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Missouri Orthopaedic Institute
Columbia, Missouri, 65212
About this study
Official title: Dispersal Pattern of Injectate After Cervical Epidural Steroid Evaluated With Magnetic Resonance Imaging
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.
Read the 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.
- Conditions
- Cervical Radiculopathy
- Being tested
- Injection with Gadolinium
- Keywords
- Cervical Radiculopathy
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection with GadoliniumDrug
Also called Gadavist
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
| Study group | Role | What they receive |
|---|---|---|
| Injection with Gadolinium | Experimental | 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. Receives: Drug: Injection with Gadolinium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
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).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startApr 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Goldstein, University of Missouri-Columbia
- Investigators
- Christina L Goldstein, MD, Principal investigator, University of Missouri Department of Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217280
- Sponsor's protocol ID
- 1210810
- Status last verified
- May 2017
- First submitted
- 21 Mar 2014
- Last updated
- 28 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dispersal Pattern of Injectate After Cervical Epidural Steroid Evaluated With Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT02217280
- Acronym / sponsor ID
- 1210810
- Conditions
- Cervical Radiculopathy
- Keywords
- Cervical Radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Posted 28 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injection with Gadolinium | Experimental | Drug: Injection with GadoliniumThis 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-85
- Cervical radiculopathy patient as identified by principle investigator
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection with GadoliniumAlso: GadavistGadavist (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 | Drug | Injection with Gadolinium |
Primary outcome
Injection Dispersal Patterns Measured (in cm) in the Superoinferior Directions on Post-injection MRI With a Calibrated Internal Measurement Software.
Time frame: 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
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina L Goldstein, MD principal investigator
University of Missouri Department of Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection with Gadolinium in people with Cervical Radiculopathy, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Injection Dispersal Patterns Measured (in cm) in the Superoinferior Directions on Post-injection MRI With a Calibrated Internal Measurement Software. (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2017.