Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 2:03 AM
Study NCT ID:
NCT07438392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tecar Therapy in Chronic Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-23', 'studyFirstSubmitQcDate': '2026-02-23', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': 'baseline, 3th week, 12th week', 'description': "VAS is a pain rating scale with numbers 0 and 10. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale. Patients' night, rest and activity pain will be evaluated separately."}], 'secondaryOutcomes': [{'measure': 'WOMAC', 'timeFrame': 'baseline, 3th week, 12th week', 'description': 'WOMAC consists of three main subgroups: pain, stiffness, and difficulty performing daily activities. It is a questionnaire with a total of 24 questions. Each question has five alternative answers: none, mild, moderate, severe, and very severe. Scoring is given as follows: pain (maximum 20), stiffness (8), and difficulty performing daily activities (68). High scores indicate worsening symptoms, significant limitations, and insufficient overall health. The Turkish version of the scale was developed by Tüzün et al. in 2005.'}, {'measure': 'The 6-minute walk test (6MWT)', 'timeFrame': 'baseline, 3th week, 12th week', 'description': 'The 6-minute walk test (6MWT) will be used to assess physical capacity. Patients will be asked to walk at their preferred pace for 6 minutes in a 30-meter corridor marked at 3-meter intervals. Rest periods or adjustments to walking speed will be allowed if necessary. The maximum distance covered in 6 minutes along the 30-meter corridor will be measured.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['osteoarthritis', 'Radiofrequency Therapy', 'Pain', 'Physical Functional Performance'], 'conditions': ['Osteearthritis']}, 'referencesModule': {'references': [{'pmid': '30362981', 'type': 'BACKGROUND', 'citation': 'Coccetta CA, Sale P, Ferrara PE, Specchia A, Maccauro G, Ferriero G, Ronconi G. Effects of capacitive and resistive electric transfer therapy in patients with knee osteoarthritis: a randomized controlled trial. Int J Rehabil Res. 2019 Jun;42(2):106-111. doi: 10.1097/MRR.0000000000000324.'}, {'pmid': '36922781', 'type': 'BACKGROUND', 'citation': 'Elboim-Gabyzon M, Nahhas F. Laser therapy versus pulsed electromagnetic field therapy as treatment modalities for early knee osteoarthritis: a randomized controlled trial. BMC Geriatr. 2023 Mar 16;23(1):144. doi: 10.1186/s12877-022-03568-5.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to investigate the effects of Tecar therapy on pain, physical function, and physical capacity in patients with chronic knee osteoarthritis.', 'detailedDescription': 'Knee osteoarthritis is a degenerative, inflammatory, and chronic joint disease with an increasing incidence and prevalence worldwide. By causing pain, disability, and deterioration in quality of life, it constitutes a significant public health problem globally. Furthermore, the health, social, and economic burdens associated with chronic knee osteoarthritis are expected to increase in the future. For these reasons, and due to the rising incidence of the disease, clinicians are increasingly focusing on novel treatment strategies.\n\nCurrently, both surgical and non-surgical treatment modalities are used in the management of chronic knee osteoarthritis. The cornerstone of treatment consists of patient education, exercise, and weight control. Subsequent steps include pharmacological treatments, intra-articular injections, and physical therapy modalities. These modalities include transcutaneous electrical stimulation, therapeutic ultrasound, thermal modalities, laser therapy, extracorporeal shock wave therapy, electromagnetic field therapy, and capacitive and resistive electric transfer (Tecar therapy).\n\nTecar therapy is an endogenous diathermy modality that operates in the long-wave range using radiofrequency energy of approximately 0.5 MHz to heat the treated tissues. It consists of two electrodes-capacitive and resistive-with a long-wave current generator and multi-frequency sequential emission systems that deliver energy to tissues in two different modes. In the capacitive mode, an insulated electrode with a metal plate is generally used. The electrical charges generated by the radiofrequency generator accumulate near the insulated electrode, which acts as a dielectric surface. This method is used for the treatment of superficial tissues adjacent to the insulated electrode. In the resistive mode, two metal electrodes distribute electrical charges that tend to accumulate near bone, tendon, and connective tissue.\n\nTecar therapy has been shown to have positive effects on pain and quality of life in many patients with degenerative and inflammatory orthopedic conditions. Among diathermy modalities, Tecar therapy is considered one of the most appropriate and safe methods, as-unlike ultrasound-it has no limitation in terms of treatment area and does not cause excessive heat accumulation between the skin and the electrode .\n\nTo the best of our knowledge, there are very few studies investigating the use of Tecar therapy in chronic knee osteoarthritis. Therefore, the aim of this study was to investigate the effects of Tecar therapy on pain, physical function, and physical capacity in patients with chronic knee osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Kellgren-Lawrence stage 2 or 3 knee osteoarthritis\n* Patients with bilateral knee pain for at least 6 weeks\n* Male and female patients aged 40-75\n* Patients who accept and sign the informed consent form\n\nExclusion Criteria:\n\n* Those who have received physical therapy for knee pain in the last 6 months\n* Those who have received intraarticular injection treatments such as hyaluronic acid, PRP, or steroids for knee pain in the last 6 months\n* Those who have undergone knee surgery for any reason\n* Those with inflammatory arthritis\n* Those with existing neurological, cognitive, or psychiatric disorders\n* Those with pacemakers\n* Those with a history of malignancy\n* Those with local vascular or sensory impairment\n* Those with local or systemic infections\n* Those with open wounds on the skin\n* Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT07438392', 'briefTitle': 'Tecar Therapy in Chronic Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Kirsehir Ahi Evran Universitesi'}, 'officialTitle': 'Effects of Tecar Therapy (Targeted Radiofrequency Therapy) on Pain, Physical Function, and Physical Capacity in Patients With Chronic Knee Osteoarthritis: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'AhiEvranU-FTR-NK-Tecar'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tecar theraphy', 'description': 'Conventional physical therapy and Tecar therapy:\n\nConventional physiotherapy will include 15 sessions of TENS (100 Hz frequency, 10-30 mA intensity) and Hotpack therapy for all groups, 5 sessions per week over 3 weeks. A heating pad will be applied to the painful knee area for 20 minutes to provide superficial heat, followed by 20 minutes of TENS at 100 Hz using an HP or Chattanooga device. Simultaneously, all groups will receive knee isometric and Theraband exercise therapy under the supervision of a physiotherapist. This group will also receive TECAR therapy three times a week for three weeks, a total of nine sessions, at 0.5 MHz frequency, in a 5 min CAP + 10 min RES + 5 min CAP mode, administered by an experienced physiotherapist.', 'interventionNames': ['Other: Tecar Therapy', 'Other: conventional physical therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Sham tecar theraphy', 'description': 'Conventional physical therapy and sham Tecar therapy:\n\nConventional physiotherapy will include 15 sessions of TENS (100 Hz frequency, 10-30 mA intensity) and Hotpack therapy for all groups, 5 sessions per week over 3 weeks. A heating pad will be applied to the painful knee area for 20 minutes to provide superficial heat, followed by 20 minutes of TENS at 100 Hz using an HP or Chattanooga device. Simultaneously, all groups will receive knee isometric and Theraband exercise therapy under the supervision of a physiotherapist. This group will also receive TECAR sham therapy three times a week for three weeks, a total of nine sessions, at 0.5 MHz frequency, in a 5 min CAP + 10 min RES + 5 min CAP mode, administered by an experienced physiotherapist. The gel will be applied before the device is activated.', 'interventionNames': ['Other: ShamTecar Therapy', 'Other: conventional physical therapy']}, {'type': 'EXPERIMENTAL', 'label': 'conventional physiotherapy', 'description': 'Conventional FTR:\n\nConventional physical therapy will include 15 sessions of TENS (100 Hz frequency, 10-30 mA intensity) and Hotpack therapy for all groups, 5 sessions per week over 3 weeks. A heating pad will be applied to the painful knee area for 20 minutes to provide superficial heat, followed by 20 minutes of TENS at 100 Hz using an HP or Chattanooga device. Simultaneously, all groups will receive knee isometric and Theraband exercise therapy under the supervision of a physiotherapist.', 'interventionNames': ['Other: conventional physical therapy']}], 'interventions': [{'name': 'Tecar Therapy', 'type': 'OTHER', 'description': 'Tecar Therapy and conventional physical therapy', 'armGroupLabels': ['Tecar theraphy']}, {'name': 'ShamTecar Therapy', 'type': 'OTHER', 'description': 'ShamTecar Therapy and conventional physical therapy', 'armGroupLabels': ['Sham tecar theraphy']}, {'name': 'conventional physical therapy', 'type': 'OTHER', 'description': 'conventional physical therapy', 'armGroupLabels': ['Sham tecar theraphy', 'Tecar theraphy', 'conventional physiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kırşehir', 'state': 'Kırşehir', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Nazife Kapan Tunçer, Asst. Prof.', 'role': 'CONTACT', 'email': 'nazifekapan@gmail.com', 'phone': '03862803924'}], 'facility': 'Kırşehir Ahi Evran Üniversitesi', 'geoPoint': {'lat': 39.14583, 'lon': 34.16389}}], 'centralContacts': [{'name': 'Nazife K Kapan Tunçer, Asst. Prof.', 'role': 'CONTACT', 'email': 'nazifekapan@gmail.com', 'phone': '+90 5555839701'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kirsehir Ahi Evran Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof.', 'investigatorFullName': 'Nazife Kapan', 'investigatorAffiliation': 'Kirsehir Ahi Evran Universitesi'}}}}