Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-01-06 @ 7:52 PM
Study NCT ID:
NCT06451094
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2024-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness Transfer Energy Capacitive and Resistive Therapy in Patients With 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-10', 'studyFirstSubmitDate': '2024-06-03', 'studyFirstSubmitQcDate': '2024-06-07', 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'baseline (0 th day), after-treatment (15 th day), 1th month, 3rd month', 'description': '0 min , 10 is maximum pain score'}, {'measure': 'Boston Carpal Tunnel Questionnaire (BCTQ)', 'timeFrame': 'baseline (0 th day), after-treatment (15 th day), 1th month, 3rd month', 'description': 'symptom severity on functional tasks (Symptom Severity Scale), involving 11 items, and the other one on function status properly (Functional Status Scale), involving 8 items. Both subscales of BCTQ are scored between 1 and 5, and higher scores illustrate a greater degree of disability.'}], 'secondaryOutcomes': [{'measure': 'Median nerve cross-sectional area (CSA) measurement', 'timeFrame': 'baseline (0 th day), after-treatment (15 th day), 1th month, 3rd month', 'description': 'Median nerve CSA was measured by ultrasound on axial view at the scaphoid-pisiform level which is a reliable measurement for CTS. Three measurements were taken for analysis and the average value was recorded'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carpal tunnel syndrome', 'TECAR therapy', 'median nerve CSA'], 'conditions': ['Carpal Tunnel Syndrome', 'Energy Transfer Capacitative and Resistive Therapy']}, 'referencesModule': {'references': [{'pmid': '40106005', 'type': 'DERIVED', 'citation': 'Tezen O, Ata AM, Uzun O, Cakir F, Yasar E. Comparison of the effectiveness of ultrasound and transfer energy capacitive and resistive (TECAR) therapy in patients with carpal tunnel syndrome. Lasers Med Sci. 2025 Mar 19;40(1):147. doi: 10.1007/s10103-025-04412-z.'}]}, 'descriptionModule': {'briefSummary': 'Objective: The aim of this study was to evaluate the effect of Transfer Energy Capacitive and Resistive (TECAR) therapy on pain, symptom severity and function in patients diagnosed with carpal tunnel syndrome (CTS) based on clinical and electromyography (EMG) findings and to compare it with ultrasound therapy (US).\n\nMethods: A total of 42 patients aged between 18 and 65 years, were randomly divided into two groups; group 1, US therapy 5 minutes intermittently for 2 weeks, 5 times a week, for a total of 10 sessions, group 2 TECAR therapy 5 min capacitive (CAP) and 10 min resistive (RES), 3 days a week for 2 weeks, for a total of 6 sessions. Both groups received paraffin therapy and wrist orthosis. All Patients were evaluated using the Visual Analog Scale (VAS) for pain and paresthesia levels, the Boston Carpal Tunnel Questionnaire (BCTQ) for symptom severity and functional levels. Additionally, median nerve CSA was measured by ultrasound, at the baseline, post-treatment, first and third months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age and over\n* had pain and numbness in their hands for more than 3 months were evaluated\n* Patients diagnosed with mild and moderate CTS by EMG\n\nExclusion Criteria:\n\n* metabolic, rheumatic, or neurological diseases that could affect the median nerve cross-sectional area (CSA)\n* patients who had previously undergone surgery on the wrist,\n* oncology patients,\n* pregnancy,\n* pacemakers.'}, 'identificationModule': {'nctId': 'NCT06451094', 'briefTitle': 'Effectiveness Transfer Energy Capacitive and Resistive Therapy in Patients With Carpal Tunnel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Comparison of the Effectiveness of Ultrasound and Transfer Energy Capacitive and Resistive (TECAR) Therapy in Patients With Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': 'E2-23-3833'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'US therapy, paraffin therapy', 'description': 'Group 1, US therapy to the palmar region of the wrist, 5 minutes intermittently for 2 weeks, 5 times a week, for a total of 10 sessions and Paraffin therapy to the wrist area by dipping the hand 3 times into a paraffin bath and removing it, covering the entire wrist with paraffin, and waiting for 15 min (2 weeks, 5 times a week, for a total of 10 sessions).', 'interventionNames': ['Device: US therapy']}, {'type': 'EXPERIMENTAL', 'label': 'TECAR therapy, paraffin therapy', 'description': 'Group 2, TECAR therapy to the palmar region of the wrist, 5 min capacitive (CAP) and 10 min resistive (RES), 3 days a week for 2 weeks, for a total of 6 sessions and Paraffin therapy to the wrist area by dipping the hand 3 times into a paraffin bath and removing it, covering the entire wrist with paraffin, and waiting for 15 min (2 weeks, 5 times a week, for a total of 10 sessions).', 'interventionNames': ['Device: TECAR']}], 'interventions': [{'name': 'US therapy', 'type': 'DEVICE', 'description': '3 MHz probe with a BTL brand device at a dose of 1.5 watts/cm2 for 5 minutes intermittently for 2 weeks, 5 times a week, for a total of 10 sessions.', 'armGroupLabels': ['US therapy, paraffin therapy']}, {'name': 'TECAR', 'type': 'DEVICE', 'description': 'Transfer Energy Capacitative and Resistive Therapy', 'armGroupLabels': ['TECAR therapy, paraffin therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Özge TEZEN', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}