Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT04852393
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2021-04-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound-guided Cervical Medial Branch Blocks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D055009', 'term': 'Spondylosis'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003766', 'term': 'Dental Occlusion'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2021-04-12', 'studyFirstSubmitQcDate': '2021-04-15', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immediate complications', 'timeFrame': 'Immediately after block', 'description': 'Proportion of patients with immediate block-related complications including any of the following: vasovagal, local anesthetic toxicity (dizziness, tinnitus, altered LOC, seizure) and trauma to non-targeted neural structures (paresthesia or other neuro symptoms)'}, {'measure': 'Delayed complications', 'timeFrame': '14 days after block', 'description': 'Proportion of patients with delayed block-related complications including any of the following: redness/irritation/swelling at injection site, hematoma, infection, skin bruising, soreness at injection site or increased pain, any neurological symptoms (new onset radicular pain, numbness/weakness or paresthesia in upper extremities).'}], 'secondaryOutcomes': [{'measure': 'Patient reported pain', 'timeFrame': 'Pre-block, then every 2 weeks for 3 months.', 'description': 'Lowest/highest/average pain score over last 7 days (NRS, 11-point scale)'}, {'measure': 'NDI', 'timeFrame': 'Pre-block, then every 2 weeks for 3 months.', 'description': 'Neck disability index'}, {'measure': 'PHQ-9', 'timeFrame': 'Pre-block then at 1,2 and 3 months post block.', 'description': 'Depression scale'}, {'measure': 'GAD-7', 'timeFrame': 'Pre-block then at 1,2 and 3 months post block.', 'description': 'Anxiety scale'}, {'measure': 'PCS', 'timeFrame': 'Pre-block then at 1,2 and 3 months post block.', 'description': 'Pain catastrophizing scale'}, {'measure': 'PGIC', 'timeFrame': 'Pre-block, then every 2 weeks for 3 months.', 'description': 'Patient global impression of change 7-point scale'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neck Pain', 'Cervical Spondylosis']}, 'referencesModule': {'references': [{'pmid': '40441772', 'type': 'DERIVED', 'citation': 'Finlayson RJ, Etheridge JB, Godard R, Kaseweter K, Etheridge JP, Curatolo M. Do cervical medial branch blocks have a therapeutic role? a prospective cohort study. Reg Anesth Pain Med. 2025 May 28:rapm-2025-106457. doi: 10.1136/rapm-2025-106457. Online ahead of print.'}, {'pmid': '38508589', 'type': 'DERIVED', 'citation': 'Etheridge JB, Finlayson RJ, Venter J, De Villiers F, Etheridge JP, Wakefield R, Watanitanon A. Prospective evaluation of the safety of ultrasound-guided cervical medial branch blocks using the in-plane technique. Reg Anesth Pain Med. 2025 Mar 5;50(3):237-242. doi: 10.1136/rapm-2024-105296.'}]}, 'descriptionModule': {'briefSummary': 'In this study we will prospectively examine the safety and clinical effects of ultrasound-guided cervical medial branch blocks.', 'detailedDescription': 'While several clinical trials have found that ultrasound guidance provides similar accuracy to fluoroscopy and reduces performance times for cervical medial branch blocks, larger studies documenting safety-related outcomes are lacking. In addition, although cervical medial branch blocks are an accepted tool to diagnose neck pain originating from the cervical facets, there are reports of long-lasting analgesic effects in a subset of patients, suggesting that these blocks may have long-term benefits. We therefore propose to prospectively examine the incidence of adverse events, as well as the clinical long-term effects of ultrasound-guided cervical medial branch blocks, in a cohort of pain clinic patients undergoing these procedures as part of their usual care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting to a tertiary outpatient pain clinic for diagnosis and treatment of chronic neck pain', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consenting patients over 18 years of age undergoing cervical medial branch blocks as part of their usual care and who have a pain intensity of at least 5/10 (at rest or on movement) and a pain duration of at least 4 months.\n\nExclusion Criteria:\n\n* Inability to communicate or complete follow up questionnaires\n* Known bleeding disorder or coagulopathy\n* Patients on antiplatelet medication other than aspirin and those on anticoagulants (coumadin, AT III agents)\n* Inability to visualize targeted structures on ultrasound\n* Presence of acute radiculopathy of new onset neurological symptoms in the upper extremities\n* Patients with bilateral neck pain if only one side is treated'}, 'identificationModule': {'nctId': 'NCT04852393', 'briefTitle': 'Ultrasound-guided Cervical Medial Branch Blocks', 'organization': {'class': 'OTHER', 'fullName': 'Montreal General Hospital'}, 'officialTitle': 'A Prospective Evaluation of the Safety and Clinical Effects of Ultrasound-guided Cervical Medial Branch Blocks', 'orgStudyIdInfo': {'id': '2020-21-105-H'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Block', 'description': 'Patients undergoing ultrasound-guided cervical medial branch blocks as part of their usual care', 'interventionNames': ['Procedure: Block']}], 'interventions': [{'name': 'Block', 'type': 'PROCEDURE', 'description': 'cervical medial branch block', 'armGroupLabels': ['Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V1Y 0G1', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Bill Nelems Pain and Research Centre', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}], 'overallOfficials': [{'name': 'Roderick J Finlayson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}, {'name': 'John-Paul B Etheridge, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montreal General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Roderick Finlayson', 'investigatorAffiliation': 'University of British Columbia'}}}}