Ignite Creation Date:
2025-12-24 @ 1:28 PM
Ignite Modification Date:
2025-12-31 @ 8:21 AM
Study NCT ID:
NCT04422795
Status:
WITHDRAWN
Last Update Posted:
2023-04-07
First Post:
2020-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Evaluation of External Thermomechanical Stimulation for Pain Reduction in Patients Undergoing Nail Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009260', 'term': 'Nail Diseases'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Due to reallocation of resources, this study could not be initiated', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-05', 'studyFirstSubmitDate': '2020-06-04', 'studyFirstSubmitQcDate': '2020-06-04', 'lastUpdatePostDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The level of pain and change in pain between each time point will be assessed using the Wong-Baker FACES scale with use of thermomechanical device delivering stimuli, without delivering stimuli, and with use of ethyl chloride skin refrigerant spray.', 'timeFrame': 'prior to treatment, immediately after the needle insertion, during infiltration and 5 seconds after needle extraction', 'description': 'Pain will be self-reported, using the Wong-Baker FACES (0-10, with 0 representing absence of pain and 10 unbearable pain). Participants will be questioned about their level of pain in their nail prior to treatment, immediately after the needle insertion, during infiltration, and 5 seconds after needle extraction'}], 'secondaryOutcomes': [{'measure': 'Number of participants with at least one adverse event', 'timeFrame': 'Patients will be followed for 3 days following their nail injection', 'description': 'Adverse events will only include those that are determined to be related to the study device'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Nails', 'Thermomechanical stimulation', 'Intralesional injection'], 'conditions': ['Nail Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of a thermomechanical device delivering vibration and cold stimuli in lowering pain during intramatricial nail injections'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 18 years or older\n* Must understand and voluntarily sign an informed consent form\n* All patients undergoing intramatricial nail injections at the Weill Cornell Medicine (WCM) Department of Dermatology\n* Willingness to participate in the study\n\nExclusion Criteria:\n\n* Inability of the patient to provide written informed consent for any reason\n* Failure to have nail injection performed\n* Likely inability to comply with the study protocol or cooperate fully with the research team'}, 'identificationModule': {'nctId': 'NCT04422795', 'briefTitle': 'The Evaluation of External Thermomechanical Stimulation for Pain Reduction in Patients Undergoing Nail Injection', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'The Evaluation of External Thermomechanical Stimulation for Pain Reduction in Patients Undergoing Nail Injection', 'orgStudyIdInfo': {'id': '20-03021647'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'External thermomechanical device delivering stimuli', 'description': 'The thermomechanical device is placed on the digit proximally to the injection site with the ice wings frozen and the vibration mechanism switched on.', 'interventionNames': ['Device: External thermomechanical device delivering cold and vibration stimuli']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'External thermomechanical device without delivering stimuli', 'description': 'The thermomechanical device is placed on the digit proximally to the injection site with the ice wings at room temperature (unfrozen) and the vibration mechanism switched off.', 'interventionNames': ['Device: External thermomechanical device without delivering cold and vibration stimuli']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nail injection with ethyl chloride skin refrigerant spray', 'description': 'Ethyl chloride skin refrigerant spray is applied to the area of injection immediately before needle insertion', 'interventionNames': ['Drug: Ethyl chloride skin refrigerant spray']}], 'interventions': [{'name': 'External thermomechanical device delivering cold and vibration stimuli', 'type': 'DEVICE', 'description': 'the thermomechanical device will be placed on the digit 2 cm proximally to the injection site with the ice wings frozen and the vibration mechanism switched on, delivering vibration and cold stimuli to the area for 30 seconds before the intramatricial injection and until needle withdrawal', 'armGroupLabels': ['External thermomechanical device delivering stimuli']}, {'name': 'External thermomechanical device without delivering cold and vibration stimuli', 'type': 'DEVICE', 'description': 'the thermomechanical device will be placed on the digit 2 cm proximally to the injection site with the ice wings at unfrozen and the vibration mechanism switched off, for 30 seconds before the intramatricial injection and until needle withdrawal', 'armGroupLabels': ['External thermomechanical device without delivering stimuli']}, {'name': 'Ethyl chloride skin refrigerant spray', 'type': 'DRUG', 'description': 'Ethyl chloride skin refrigerant spray is applied to the area of injection for 3 seconds immediately before needle insertion', 'armGroupLabels': ['Nail injection with ethyl chloride skin refrigerant spray']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Shari R Lipner, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}