Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06731920
Status:
RECRUITING
Last Update Posted:
2024-12-13
First Post:
2024-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
USG CMBB DSA Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2024-12-11', 'studyFirstSubmitQcDate': '2024-12-11', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of vascular uptake', 'timeFrame': 'During the course of needle placement', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Observed blood vessels', 'timeFrame': 'During needle placement', 'description': 'Number and distribution of vessels observed near the target.'}, {'measure': 'Incidence of vascular breach', 'timeFrame': 'During needle placement', 'description': 'Incidence of vascular breach during needle placement.'}, {'measure': 'Number of needle repositionings', 'timeFrame': 'During needle placement', 'description': 'Number of needle repositionings required (before and after DSA)'}, {'measure': 'Complications', 'timeFrame': 'From beginning to completion of block procedure', 'description': 'Occurrence of any block-related complications.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasound', 'cervical medial branch block', 'safety', 'digital subtraction angiography'], 'conditions': ['Cervicalgia']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing cervical medial branch blocks as part of their usual care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nConsenting patients over 19 years of age undergoing an ultrasound-guided cervical medial branch blocks as part of their usual care.\n\nExclusion Criteria:\n\nSubjects with one or more of the following characteristics will be excluded from the study:\n\nKnown 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'}, 'identificationModule': {'nctId': 'NCT06731920', 'briefTitle': 'USG CMBB DSA Study', 'organization': {'class': 'OTHER', 'fullName': 'Montreal General Hospital'}, 'officialTitle': 'The Incidence of Inadvertent Intravascular Injection During Ultrasound-guided Cervical Medial Branch Blocks: a Fluoroscopically Controlled Study', 'orgStudyIdInfo': {'id': '2024-25-007-H'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Main study group', 'description': 'Patients undergoing cervical medial branch blocks as part of their usual care.', 'interventionNames': ['Diagnostic Test: cervical medial branch block']}], 'interventions': [{'name': 'cervical medial branch block', 'type': 'DIAGNOSTIC_TEST', 'description': 'ultrasound-guided cervical medial branch block with fluoroscopic control and digital subtraction angiography', 'armGroupLabels': ['Main study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V1Y 0G1', 'city': 'Kelowna', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Roderick J Finlayson, MD', 'role': 'CONTACT', 'email': 'roderick.finlayson@mac.com', 'phone': '250-860-9754'}, {'name': 'Roderick J Finlayson, MD', 'role': 'CONTACT'}], 'facility': 'Bill Nelems Pain and Research Centre', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}], 'centralContacts': [{'name': 'Roderick J Finlayson, MD', 'role': 'CONTACT', 'email': 'roderick.finlayson@mac.com', 'phone': '250-860-9754'}], 'overallOfficials': [{'name': 'Roderick J Finlayson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montreal General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of British Columbia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'RODERICK FINLAYSON MD', 'investigatorFullName': 'Roderick Finlayson', 'investigatorAffiliation': 'University of British Columbia'}}}}