Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:55 AM
Study NCT ID:
NCT07433166
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Evaluation in Carpal Tunnel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}, {'id': 'D020423', 'term': 'Median Neuropathy'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018608', 'term': 'Ultrasonography, Doppler'}], 'ancestors': [{'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-19', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraneural Vascularity', 'timeFrame': 'Baseline', 'description': 'Intraneural blood flow will be evaluated using power Doppler ultrasonography at the level of the carpal tunnel inlet. The presence and degree of intraneural vascularity will be graded using a semi-quantitative scoring system:\n\n0 = No detectable intraneural flow\n\n1. = Single vessel signal\n2. = Multiple vessel signals\n3. = Marked hypervascularity\n\nThe total score ranges from 0 to 3. Higher scores indicate increased intraneural vascularity.'}, {'measure': 'Cross sectional Area', 'timeFrame': 'baseline', 'description': 'The cross-sectional area of the median nerve will be measured using ultrasonography at the level of the pisiform bone (carpal tunnel inlet) and proximal to transvers carpal ligament. Measurements will be obtained by tracing the inner border of the hyperechoic epineurium.\n\nValues will be recorded in square millimeters (mm²). Higher values indicate greater nerve swelling.'}], 'secondaryOutcomes': [{'measure': 'Boston Carpal Tunnel Questionnaire', 'timeFrame': 'Baseline, 3th and 6th months', 'description': 'Change in Symptom Severity Score of the Boston Carpal Tunnel Questionnaire The Boston Carpal Tunnel Questionnaire is a patient-reported outcome measure consisting of 11 questions assessing symptom severity. Each item is scored from 1 (no symptoms) to 5 (most severe symptoms). The total score ranges from 11 to 55. Higher scores indicate worse symptom severity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['carpal tunnel', 'ultrasound', 'power doppler'], 'conditions': ['Carpal Tunnel Syndrome (CTS)']}, 'referencesModule': {'references': [{'pmid': '34261588', 'type': 'BACKGROUND', 'citation': 'Erickson M, Lawrence M, Lucado A. The role of diagnostic ultrasound in the examination of carpal tunnel syndrome: an update and systematic review. J Hand Ther. 2022 Apr-Jun;35(2):215-225. doi: 10.1016/j.jht.2021.04.014. Epub 2021 Apr 14.'}]}, 'descriptionModule': {'briefSummary': 'This prospective cohort study aims to evaluate median nerve cross-sectional area and intraneural vascularity using power Doppler ultrasonography in patients with carpal tunnel syndrome. Ultrasonographic findings will be compared between diabetic and non-diabetic patients. Clinical severity and electrophysiological findings will be correlated with ultrasonographic parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Carpal Tunnel Syndrome Patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinically and electrophysiologically confirmed carpal tunnel syndrome\n* symptom duration \\> 3 months\n* written informed consent\n\nExclusion Criteria:\n\n* previous wrist surgery\n* cervical radiculopathy\n* inflammatory arthritis\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT07433166', 'acronym': 'CTS-PD', 'briefTitle': 'Ultrasound Evaluation in Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'SB Istanbul Education and Research Hospital'}, 'officialTitle': 'Prospective Evaluation of Median Nerve Cross-Sectionall Area and Power Doppler Signal Changes in Patients With Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': 'CTS-PD-DM-2026'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Doppler ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'The predictive power of cross-sectional area and intraneural blood flow measured by ultrasound on surgical outcomes will be tested.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data sharing is not planned due to patient confidentially and instutional policy'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SB Istanbul Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Baris Acar', 'investigatorAffiliation': 'SB Istanbul Education and Research Hospital'}}}}