Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-24 @ 12:21 PM
Study NCT ID:
NCT06834061
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2025-02-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Added Value of Ultrasonography in the Diagnosis, Management, and Follow-Up of Carpal Tunnel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}, {'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2025-02-13', 'studyFirstSubmitQcDate': '2025-02-13', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of ultrasound in diagnosis of carpal tunnel syndrome', 'timeFrame': 'Intraoperatively', 'description': 'Sensitivity of ultrasound in diagnosis of carpal tunnel syndrome will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ultrasonography', 'Diagnosis', 'Management', 'Follow-Up', 'Carpal Tunnel Syndrome']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the ultrasound (US) and nerve conduction studies (NCS) as a tool for diagnosis, treatment planning and follow-up of patients with carpal tunnel syndrome (CTS).', 'detailedDescription': 'Carpal tunnel syndrome (CTS) is one of the most common upper extremity compression neuropathies and is caused by compression of the median nerve in the carpal tunnel at the wrist.\n\nThe ultrasound (US) is a follow-up option as a diagnostic tool in CTS. It is a readily available non-invasive tool which has a shorter examination time. It can measure a number of median nerve parameters, including size, vascularity (using power Doppler) and mobility (using dynamic imaging). In addition,the US provides information on anatomical variations of the median nerve and surrounding structures that may be a causative factor in CTS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This retrospective study will be carried out on 60 patients with CTS admitted in KafrElsheikh University Hospitals over a period of 6 months starting from approval of the Medical Sciences Ethics Committee of KafrElsheikh Faculty of Medicine and all the included patients will provide written informed consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years old.\n* Both sexes.\n* Patients with carpal tunnel syndrome.\n\nExclusion Criteria:\n\n* History of wrist surgery (including carpal tunnel injection) or fracture.\n* Clinical or electrophysiological evidence of an accompanying condition that mimics carpal tunnel syndrome or interferes with its evaluation, such as proximal median neuropathy, cervical radiculopathy or polyneuropathy.\n* History of underlying disorders associated with carpal tunnel syndrome such as diabetes mellitus, rheumatoid arthritis, pregnancy, acromegaly or hypothyroidism.\n* Electrodiagnostic findings suggestive of co-existing neurological disorders.\n* Subclinical sensory polyneuropathy.'}, 'identificationModule': {'nctId': 'NCT06834061', 'briefTitle': 'Added Value of Ultrasonography in the Diagnosis, Management, and Follow-Up of Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Added Value of Ultrasonography in the Diagnosis, Management, and Follow-Up of Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': 'KFSIRB200-513'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ultrasound group', 'description': 'All patients underwent high-resolution real-time sonography of the carpal tunnel (both hands) using an Ultrasound (US) machine and a 12 MHz linear array transducer. US examination will be performed before and 3 months after surgery.', 'interventionNames': ['Procedure: Ultrasound']}], 'interventions': [{'name': 'Ultrasound', 'type': 'PROCEDURE', 'description': 'All patients underwent high-resolution real-time sonography of the carpal tunnel (both hands) using an Ultrasound (US) machine and a 12 MHz linear array transducer. US examination will be performed before and 3 months after surgery.', 'armGroupLabels': ['Ultrasound group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33516', 'city': 'Kafr ash Shaykh', 'state': 'Kafrelsheikh', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed A Zahra, MD', 'role': 'CONTACT', 'email': 'a86anas@gmail.com', 'phone': '00201004642184'}], 'facility': 'Kafrelsheikh University', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}], 'centralContacts': [{'name': 'Ahmed A Zahra, MD', 'role': 'CONTACT', 'email': 'a86anas@gmail.com', 'phone': '00201004642184'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After the end of study for one year.', 'ipdSharing': 'YES', 'description': 'The data will be available upon a reasonable request from the corresponding author after the end of study for one year.', 'accessCriteria': 'The data will be available upon a reasonable request from the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Neurosurgery, Faculty of Medicine, KafrElsheikh University, KafrElsheikh, Egypt.', 'investigatorFullName': 'Ahmed Anas Zahra', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}