Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-01-04 @ 12:09 AM
Study NCT ID:
NCT06418360
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2024-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of TECAR Therapy in Patients With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-13', 'studyFirstSubmitDate': '2024-05-06', 'studyFirstSubmitQcDate': '2024-05-13', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'Before and the after treatment 0th day , 1th month, 3rd month', 'description': '0 min , 10 is maximum pain score'}, {'measure': 'Western Ontario and McMaster Universities Arthritis Index (WOMAC)', 'timeFrame': 'Before and the after treatment 0th day, 1th month, 3rd month', 'description': 'This 24-item index comprises three subscales: pain, stiffness, and physical function, each measured on a five-point Likert scale ranging from "none" to "extreme."'}, {'measure': 'Range of Motion (ROM)', 'timeFrame': 'Before and the after treatment 0th day, 1th month, 3rd month', 'description': 'Flexion and extension of the knee joint were measured using a universal goniometer relative to reference points.'}], 'secondaryOutcomes': [{'measure': 'The Diers Myoline Isometric Muscle Strength Measurement System', 'timeFrame': 'Before and the end of treatment 0th day, 1th month, 3rd month', 'description': 'quadriceps muscle Isometric Strength Measure: Increased isometric muscle strength is an indicator of recovery.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['knee pain, osteoarthritis, capacitative and resistive energy transfer therap'], 'conditions': ['Knee Osteoarthritis', 'Energy Transfer Capacitative and Resistive Therapy']}, 'descriptionModule': {'briefSummary': "Objective: The aim of the present study was to investigate the treatment efficacy of TECAR therapy, a modern application that has been increasingly used in recent years, compared to conventional physical therapy applications in the treatment of knee osteoarthritis, according to the evaluation of the clinical findings of patients.\n\nMethods: A total of 54 patients, aged between 40 and 75 years, were randomly divided into two groups. Both groups received CPT. Group 2 received TECAR therapy in addition to CPT, applied three times a week for two weeks, for a total of 6 sessions. All patient's knee joint range of motion (ROM) was measured goniometrically, isometric quadriceps muscle strength was measured, and pain levels were assessed using the Visual Analog Scale (VAS), and disability levels were assessed using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) before treatment, at the end of treatment, at 1 month, and at 3 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 3 months of conservative treatment for unresponsive knee pain\n* Kellgren-Lawrence grade 2-3 on radiographic evaluation\n* Agreed to participate in the study.\n\nExclusion Criteria:\n\n* History of physical therapy (electrotherapy/exercise) in the past 3 months\n* Intra-articular injection therapy in the past 3 months,\n* History of surgery or trauma to the affected knee\n* Inflammatory or neurological disease affecting the lower extremities\n* Active vasculitis or severe peripheral vascular disease\n* Pregnancy or lactation\n* Diagnosed restless legs syndrome\n* Neoplasia\n* Local sensory impairment,\n* Local or systemic acute infections\n* Severe osteoporosis\n* Pacemaker\n* Psychiatric disorder and cognitive impairment.'}, 'identificationModule': {'nctId': 'NCT06418360', 'briefTitle': 'Efficacy of TECAR Therapy in Patients With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Evaluation of The Efficacy of TECAR Therapy in Patients With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'E2-23-3792'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'conventional physical therapy (CPT)', 'description': 'Group 1 (HP, TENS, knee isometric and theraband exercise) to painful side knee area, two weeks, five times a week, 10 sessions.', 'interventionNames': ['Device: conventional physical therapy; Transcutaneous Electrical Nerve Stimulation, hotpack']}, {'type': 'EXPERIMENTAL', 'label': 'conventional physical therapy (CPT) and TECAR therapy', 'description': 'Group 2 (HP, TENS, knee isometric and theraband exercise) 10 sessions, two weeks, five times a week and in addition TECAR therapy, to painful side knee quadriceps and peripatellar area, three times a week for two weeks, for a total of 6 sessions.', 'interventionNames': ['Device: TECAR']}], 'interventions': [{'name': 'TECAR', 'type': 'DEVICE', 'description': 'Transfer Energy Capacitative and Resistive Therapy', 'armGroupLabels': ['conventional physical therapy (CPT) and TECAR therapy']}, {'name': 'conventional physical therapy; Transcutaneous Electrical Nerve Stimulation, hotpack', 'type': 'DEVICE', 'description': '10 sessions of HP and TENS for two weeks, five times a week. HP was applied to the painful knee area for 20 minutes using a heating pad for superficial heating purposes. TENS was applied to the painful knee area for 20 minutes at 80 Hz frequency', 'armGroupLabels': ['conventional physical therapy (CPT)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Özge TEZEN', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'participant data will not share'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}