USG CMBB DSA Study

NCT06731920 | Recruiting

• 1 other identifier: 2024-25-007-H
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Cervicalgia

Keywords

Ultrasound; cervical medial branch block; safety; digital subtraction angiography

Outcome Measures

Primary Outcomes (1)

• 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.

  During the course of needle placement

Secondary Outcomes (4)

• Observed blood vessels

  During needle placement

• Incidence of vascular breach

  During needle placement

• Number of needle repositionings

  During needle placement

• Complications

  From beginning to completion of block procedure

Study Arms (1)

Main study group

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

Diagnostic Test: cervical medial branch block

Interventions

cervical medial branch block DIAGNOSTIC_TEST

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

Main study group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montreal General Hospital: lead
• University of British Columbia: collaborator

Study Sites (1)

Bill Nelems Pain and Research Centre

Kelowna, British Columbia, V1Y 0G1, Canada

RECRUITING

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Roderick J Finlayson, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roderick J Finlayson, MD

CONTACT

250-860-9754; roderick.finlayson@mac.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RODERICK FINLAYSON MD

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 13, 2024
• Study Start: January 10, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)