CervicalgiaNCT06731920
USG CMBB DSA Study
An observational study of Cervicalgia, run by Montreal General Hospital at 1 site in Canada.
Trial summary
Injections that freeze neck joints can be done using x-rays or ultrasound imaging, which as a newer way of guiding the needle to the right spot. This study will look at how often freezing liquid goes into a blood vessel during neck injections that freeze neck joints when ultrasound guidance is used to place the… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cervicalgia
- What is being tested?
- cervical medial branch block
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jan 2025to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cervical medial branch blocks as part of their usual care.
Who may be able to join
- Consenting patients over 19 years of age undergoing an ultrasound-guided cervical medial branch blocks as part of their usual care.
Who cannot join
- Subjects with one or more of the following characteristics will be excluded from the study:
- Known bleeding disorder or coagulopathy Patients on antiplatelet medication other than aspirin and those on anticoagulants (coumadin, AT III agents) Inability to visualize targeted structures on ultrasound Known allergy to contrast agents
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Bill Nelems Pain and Research Centre
Kelowna, British Columbia, V1Y 0G1
Roderick J Finlayson, MD, 250-860-9754, roderick.finlayson@mac.com
Roderick J Finlayson, MD
About this study
Official title: The Incidence of Inadvertent Intravascular Injection During Ultrasound-guided Cervical Medial Branch Blocks: a Fluoroscopically Controlled Study
Injections that freeze neck joints can be done using x-rays or ultrasound imaging, which as a newer way of guiding the needle to the right spot. This study will look at how often freezing liquid goes into a blood vessel during neck injections that freeze neck joints when ultrasound guidance is used to place the needle. When this happens, it can go undetected because it does not make the patient feel any different, however it could cause a test block to be falsely negative, leading to the wrong diagnosis. Based on previous studies, we think that this happens rarely, and the purpose of this study is to prove that conclusively
Read the detailed description
Cervical medial branch blocks (CMBB) are commonly employed for the diagnosis and management of facet-related pain. The latter constitutes the most important cause of axial neck pain and has been implicated in 40% of all cases. In addition, the upper cervical joints can also cause cervicogenic headaches, an often-debilitating condition representing up to 20% of chronic headaches3. Well-defined pain referral patterns for each joint can help operators select the appropriate injection level. While fluoroscopy has long been the imaging standard for spinal procedures, ultrasound guidance (USG) is being increasingly adopted as an alternative and presents several advantages such as the ability to identify and avoid soft tissue structures such as blood vessels during needle insertion. From a clinical perspective, avoiding blood vessels and reducing the incidence of vascular breach can lessen the occurrence of intravascular injections that are associated with false negative diagnostic blocks. Indeed, a recent study examining the safety of USG CMBB reported a lower incidence of vascular breach than previous studies that had used fluoroscopic guidance. While these findings suggested a potential benefit associated with USG, further confirmatory studies employing digital subtraction angiography (DSA), the current imaging standard to detect intravascular spread, are required. We hypothesize that USG will be associated will a lower incidence of intravascular spread during primary needle placement than has been reported with fluoroscopic guidance.
- Conditions
- Cervicalgia
- Being tested
- cervical medial branch block
- Keywords
- Ultrasound, cervical medial branch block, safety, digital subtraction angiography
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical medial branch blockDiagnostic test
ultrasound-guided cervical medial branch block with fluoroscopic control and digital subtraction angiography
| Study group | Role | What they receive |
|---|---|---|
| Main study group | Patients undergoing cervical medial branch blocks as part of their usual care. Receives: Diagnostic Test: cervical medial branch block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of vascular uptake
Incidence of intravascular spread of contrast as determined after a review of the DSA sequences by a physician not involved in the patient's care.
Measured: During the course of needle placement
Secondary outcomes (4)
Observed blood vessels
Number and distribution of vessels observed near the target.
Measured: During needle placement
Incidence of vascular breach
Incidence of vascular breach during needle placement.
Measured: During needle placement
Number of needle repositionings
Number of needle repositionings required (before and after DSA)
Measured: During needle placement
Complications
Occurrence of any block-related complications.
Measured: From beginning to completion of block procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start10 Jan 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CervicalgiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Principal investigator, Roderick Finlayson, University of British Columbia
- Investigators
- Roderick J Finlayson, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731920
- Sponsor's protocol ID
- 2024-25-007-H
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Inadvertent Intravascular Injection During Ultrasound-guided Cervical Medial Branch Blocks: a Fluoroscopically Controlled Study
- ClinicalTrials.gov ID
- NCT06731920
- Acronym / sponsor ID
- 2024-25-007-H
- Conditions
- Cervicalgia
- Keywords
- Ultrasound, cervical medial branch block, safety, digital subtraction angiography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Montreal General HospitalUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- 10 Jan 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Injections that freeze neck joints can be done using x-rays or ultrasound imaging, which as a newer way of guiding the needle to the right spot. This study will look at how often freezing liquid goes into a blood vessel during neck injections that freeze neck joints when ultrasound guidance is used to place the needle. When this happens, it can go undetected because it does not make the patient feel any different, however it could cause a test block to be falsely negative, leading to the wrong diagnosis. Based on previous studies, we think that this happens rarely, and the purpose of this study is to prove that conclusively
Detailed description
Cervical medial branch blocks (CMBB) are commonly employed for the diagnosis and management of facet-related pain. The latter constitutes the most important cause of axial neck pain and has been implicated in 40% of all cases. In addition, the upper cervical joints can also cause cervicogenic headaches, an often-debilitating condition representing up to 20% of chronic headaches3. Well-defined pain referral patterns for each joint can help operators select the appropriate injection level. While fluoroscopy has long been the imaging standard for spinal procedures, ultrasound guidance (USG) is being increasingly adopted as an alternative and presents several advantages such as the ability to identify and avoid soft tissue structures such as blood vessels during needle insertion. From a clinical perspective, avoiding blood vessels and reducing the incidence of vascular breach can lessen the occurrence of intravascular injections that are associated with false negative diagnostic blocks. Indeed, a recent study examining the safety of USG CMBB reported a lower incidence of vascular breach than previous studies that had used fluoroscopic guidance. While these findings suggested a potential benefit associated with USG, further confirmatory studies employing digital subtraction angiography (DSA), the current imaging standard to detect intravascular spread, are required. We hypothesize that USG will be associated will a lower incidence of intravascular spread during primary needle placement than has been reported with fluoroscopic guidance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main study group | – | Diagnostic Test: cervical medial branch blockPatients undergoing cervical medial branch blocks as part of their usual care. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cervical medial branch blocks as part of their usual care.
Key inclusion criteria (1 listed)
- Consenting patients over 19 years of age undergoing an ultrasound-guided cervical medial branch blocks as part of their usual care.
Key exclusion criteria (2 listed)
- Subjects with one or more of the following characteristics will be excluded from the study:
- Known bleeding disorder or coagulopathy Patients on antiplatelet medication other than aspirin and those on anticoagulants (coumadin, AT III agents) Inability to visualize targeted structures on ultrasound Known allergy to contrast agents
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 |
|---|---|---|
| cervical medial branch blockultrasound-guided cervical medial branch block with fluoroscopic control and digital subtraction angiography | Diagnostic test | Main study group |
Primary outcome
Incidence of vascular uptake
Time frame: During the course of needle placement
Incidence of intravascular spread of contrast as determined after a review of the DSA sequences by a physician not involved in the patient's care.
4 secondary outcomes
Observed blood vessels
Time frame: During needle placement
Incidence of vascular breach
Time frame: During needle placement
Number of needle repositionings
Time frame: During needle placement
Complications
Time frame: From beginning to completion of block procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Roderick J Finlayson, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervicalgia, run by Montreal General Hospital at 1 site in Canada.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 Dec 2024. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roderick J Finlayson, MD (250-860-9754, roderick.finlayson@mac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of vascular uptake (time frame: During the course of needle placement). 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 13 Dec 2024.