Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 11:30 PM
Study NCT ID:
NCT05969093
Status:
UNKNOWN
Last Update Posted:
2023-08-01
First Post:
2023-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Refining the Interpretation of the Tinel's Sign for Carpal Tunnel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-22', 'studyFirstSubmitDate': '2023-07-22', 'studyFirstSubmitQcDate': '2023-07-22', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "EMG activity of the thenar muscles during the Tinel's Sign performed at different wrist positions.", 'timeFrame': 'Baseline', 'description': "The amplitude of EMG activity of the thenar muscles will be measured during the Tinel's Sign performed at different wrist positions. The amplitude will be quantified in microvolts (µV)."}, {'measure': "EMG activity of the hypothenar muscles during the Tinel's Sign performed at different wrist positions.", 'timeFrame': 'Baseline', 'description': "The amplitude of EMG activity of the hypothenar muscles will be measured during the Tinel's Sign performed at different wrist positions. The amplitude will be quantified in microvolts (µV)."}, {'measure': "Nerve conduction velocity of the median nerve during the Tinel's Sign performed at different wrist positions.", 'timeFrame': 'Baseline', 'description': "The NCV of the median nerve will be measured during the Tinel's Sign performed at different wrist positions. The NCV will be quantified in meters per second (m/s)."}, {'measure': "Nerve conduction velocity of the ulnar nerve during the Tinel's Sign performed at different wrist positions.", 'timeFrame': 'Baseline', 'description': "The NCV of the ulnar nerve will be measured during the Tinel's Sign performed at different wrist positions. The NCV will be quantified in meters per second (m/s)."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': "This is an observational study to investigate the electromyographic (EMG) activity and nerve conduction velocity (NCV) of healthy individuals during the Tinel's Sign performed at different wrist positions. The study aims to identify the wrist position that best isolates median nerve activity during the Tinel's Sign.", 'detailedDescription': "The study will be conducted in a controlled laboratory setting, equipped with an electromyography (EMG) machine and a nerve conduction velocity (NCV) measurement device. We will recruit 30 healthy adults, aged 18-45 years, with no history of hand or wrist pain, neurological or muscular disorders. Participants will be excluded if they have any contraindications to EMG or NCV measurement. The independent variable will be the wrist position during the Tinel's Sign, and the dependent variables will be the EMG activity of the thenar and hypothenar muscles and the NCV of the median and ulnar nerves. EMG activity will be measured using surface electrodes placed on the thenar and hypothenar muscles. NCV will be measured using a standard NCV measurement device. To minimize bias, the same trained examiner will perform all tests and measurements, and the examiner will be blinded to the EMG and NCV data during the tests. Differences in EMG activity and NCV across different wrist positions will be analyzed using repeated measures ANOVA. Post-hoc pairwise comparisons will be performed using Bonferroni correction. The study protocol will be submitted to the local ethics committee for approval, and all participants will provide informed consent."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy individuals aged 18-60 years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy individuals aged 18-45 years\n* No history of hand or wrist pain, neurological or muscular disorders\n\nExclusion Criteria:\n\n* Any contraindications to EMG or NCV measurement'}, 'identificationModule': {'nctId': 'NCT05969093', 'briefTitle': "Refining the Interpretation of the Tinel's Sign for Carpal Tunnel Syndrome", 'organization': {'class': 'OTHER', 'fullName': 'Ahram Canadian University'}, 'officialTitle': "Refining the Interpretation of the Tinel's Sign for Carpal Tunnel Syndrome: An Electromyographic and Nerve Conduction Velocity Study", 'orgStudyIdInfo': {'id': '012/TINEL2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy individuals', 'description': "Participants will undergo the Tinel's Sign at different wrist positions while EMG activity and NCV are recorded.", 'interventionNames': ["Diagnostic Test: Tinel's Sign performed at different wrist positions"]}], 'interventions': [{'name': "Tinel's Sign performed at different wrist positions", 'type': 'DIAGNOSTIC_TEST', 'description': "Participants will undergo the Tinel's Sign at different wrist positions while EMG activity and NCV are recorded to investigate the effect of wrist position on median nerve activity.", 'armGroupLabels': ['Healthy individuals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3221405', 'city': 'Al Ḩayy Ath Thāmin', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed M ElMeligie, Ph.d', 'role': 'CONTACT', 'email': 'mohamed.elmeligie@acu.edu.eg', 'phone': '01064442032'}], 'facility': 'Outpatient clinic of faculty of physical therapy, Ahram Canadian University'}], 'centralContacts': [{'name': 'Mohamed M ElMeligie, Ph.d', 'role': 'CONTACT', 'email': 'mohamed.elmeligie@acu.edu.eg', 'phone': '+201064442032'}], 'overallOfficials': [{'name': 'Amal Fawzy, Ph.d', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Physical Therapy, Ahram Canadian University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahram Canadian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Physical Therapy and Director of Electromyography Lab', 'investigatorFullName': 'Mohamed Magdy ElMeligie', 'investigatorAffiliation': 'Ahram Canadian University'}}}}