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USG CMBB DSA Study

NCT ID: NCT06731920

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-10

Study Completion Date

2026-08-31

Brief Summary

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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

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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

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Cervicalgia

Keywords

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Ultrasound cervical medial branch block safety digital subtraction angiography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Main study group

Patients undergoing cervical medial branch blocks as part of their usual care.

cervical medial branch block

Intervention Type DIAGNOSTIC_TEST

ultrasound-guided cervical medial branch block with fluoroscopic control and digital subtraction angiography

Interventions

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cervical medial branch block

ultrasound-guided cervical medial branch block with fluoroscopic control and digital subtraction angiography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Consenting patients over 19 years of age undergoing an ultrasound-guided cervical medial branch blocks as part of their usual care.

Exclusion Criteria

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role collaborator

Montreal General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Roderick Finlayson

RODERICK FINLAYSON MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roderick J Finlayson, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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Bill Nelems Pain and Research Centre

Kelowna, British Columbia, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Roderick J Finlayson, MD

Role: CONTACT

Phone: 250-860-9754

Email: [email protected]

Facility Contacts

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Roderick J Finlayson, MD

Role: primary

Roderick J Finlayson, MD

Role: backup

Other Identifiers

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2024-25-007-H

Identifier Type: -

Identifier Source: org_study_id