Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT06289218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-09
First Post:
2024-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Kinesio Taping Versus Interferential Current Therapy in Treating Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 63}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-09-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-06', 'studyFirstSubmitDate': '2024-02-18', 'studyFirstSubmitQcDate': '2024-02-28', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'knee flexion range of motion', 'timeFrame': 'pre-intervention and after 4 weeks of treatment', 'description': 'to measure Knee joint active range of motion (flexion) by universal goniometer'}, {'measure': 'knee extension range of motion', 'timeFrame': 'pre-intervention and after 4 weeks of treatment', 'description': 'to measure Knee joint active range of motion (extension) by universal goniometer'}, {'measure': 'quadriceps muscle strength', 'timeFrame': 'pre-intervention and after 4 weeks of treatment', 'description': 'to test the isometric quadriceps muscle strength by hand-held dynamometer'}, {'measure': 'The Western Ontario and McMaster Universities Osteoarthritis Index', 'timeFrame': 'pre-intervention and after 4 weeks of treatment', 'description': 'to measure knee function and knee pain degree'}, {'measure': 'Timed up and go test', 'timeFrame': 'pre-intervention and after 4 weeks of treatment', 'description': 'to measure knee function mobility by the Timed up and go test'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '8320274', 'type': 'BACKGROUND', 'citation': 'Aaron RK, Ciombor DM. 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Clin J Sport Med. 2015 Nov;25(6):509-17. doi: 10.1097/JSM.0000000000000170.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study will be to compare the combined effect of using Kinesio taping versus interferential current with an exercise program on knee pain, function, knee range of motion, knee muscle strength, and functional mobility in chronic knee osteoarthritis.', 'detailedDescription': "Knee osteoarthritis (KOA) is the most common form of degenerative joint disease affecting 15%-40% of people over 40 years of age. In 2020, the global incidence of KOA was 86.7 million individuals. KOA is responsible for substantial health and economic costs. KOA is the most common cause of pain and disability among older persons. The key symptoms of KOA are pain, functional disability, and decreased patient quality of life through its negative effects on mobility, mood, and sleep. Other symptoms are swelling, stiffness, joint deformity, and muscular atrophy.\n\nThe Treatment goals for KOA are to decrease pain and improve physical function. Physical therapy decreased pain and functional disability in patients with KOA. The therapeutic techniques include therapeutic exercises, electrotherapy, and manual therapy. Several meta-analysis and systematic reviews have evidence of various types of exercises including aerobic and resistance exercises which is effective in reducing pain and functional disabilities in a patient with KOA especially quadriceps muscle strengthening with open and closed chain training. Specific recommendations including physical activity, reducing body weight, reducing sedentary time, and managing diabetes disease can improve function and symptoms of KOA. To improve the individual's function, and reduce pain and disability, several interventions had been investigated to promote physical activity.\n\nKinesio taping (KT) is a conservative therapeutic technique used for the treatment of several musculoskeletal disorders which has increased attention from physicians and physiotherapists in recent years. KT, first introduced in 1979 in Japan, is used for the treatment and prevention of several sports injuries and several clinical conditions. In 2011, KT is recommended by the American College of Rheumatology (ACR) for the treatment of patients with knee OA, and it is commonly used to treat knee OA.\n\nKinesio taping (KT) is an alternative taping technique which is an elastic woven cotton strip with heat-sensitive acrylic adhesive, a high-stretch elastic adhesive material, it is applied directly to the skin and can be left on the skin for several days due to its strong adherence. The application of KT for four weeks can reduce the pain so the patient can reduce the use pain killers. Kinesio taping (KT) is a low-cost, safe, noninvasive, non-pharmacological method, that has minimal side effects and can be a convenient option for the treatment of musculoskeletal disorders such as knee OA.\n\nInterferential current (IFC) is a simple, non-invasive, non-pharmacological, more comfortable treatment used to relieve pain. IFC known as kilohertz-frequency alternating current, which is a pair of signal generators with one fixed frequency of 4000 Hz and the other varying in frequency between 4000 and 4250 Hz. IFC can reduce skin impedance, reach deeper tissue, and can be utilized as an alternative medication or supplement to drugs in treating pain. IFC is the most effective pain relief treatment for the management of KOA.\n\nExercises play a major role in treating patients with KOA; it can improve both pain and function. Therefore What about comparing the application of kinesio taping combined with exercises versus the IFC therapy combined with exercises in treating patients with KOA?"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* sixty-three Male and female patients aged between 40 and 65 years old were diagnosed clinically and radiologically as knee osteoarthritis grade mild and moderate chronic knee osteoarthritis.\n* BMI ranges between 20 and 32 kg/m2.\n* Knee OA grades 1 and 2 are based on Kellgren and Lawrence's grades. Narrowing of joint space, definite osteophytes.\n* Unilateral knee osteoarthritis.\n* Knee pain for most days of the prior month, in addition to at least 3 of the following:\n\n 1. Crepitus on active joint motion\n 2. Morning stiffness less than 30 minutes duration\n 3. Age older than 50 years\n 4. Bony enlargement of the knee on examination\n 5. Bony tenderness of the knee on examination\n 6. No palpable warmth.\n\nExclusion Criteria:\n\n* Patients having the following conditions will be excluded from the study:\n\n * Comorbidities such as (rheumatoid arthritis, cancer, osteoporosis, and joint infection).\n * Previous surgery for knee OA.\n * BMI more than 33 kg/m2.\n * Suffering from polyarticular disease.\n * Severe mechanical deformity (diaphyseal Varus deformity of 4° and valgus of 16°).\n * Previous arthroscopy within the last year.\n * Systemic autoimmune rheumatoid disease (connective tissue disease and systemic necrotizing vasculitis)."}, 'identificationModule': {'nctId': 'NCT06289218', 'briefTitle': 'Kinesio Taping Versus Interferential Current Therapy in Treating Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Kinesio Taping Versus Interferential Current Therapy in Treating Knee Osteoarthritis: a Comparative Study', 'orgStudyIdInfo': {'id': 'Treating knee osteoarthritis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'interferential current plus exercise', 'description': 'interferential current plus exercise group', 'interventionNames': ['Device: interferential current']}, {'type': 'EXPERIMENTAL', 'label': 'kinesio taping plus exercise', 'description': 'kinesio taping plus exercise group', 'interventionNames': ['Other: kinesio taping']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Control group', 'interventionNames': ['Other: exercise']}], 'interventions': [{'name': 'interferential current', 'type': 'DEVICE', 'otherNames': ['IFC'], 'description': 'IFC plus exercise', 'armGroupLabels': ['interferential current plus exercise']}, {'name': 'kinesio taping', 'type': 'OTHER', 'otherNames': ['KT'], 'description': 'KT plus exercise', 'armGroupLabels': ['kinesio taping plus exercise']}, {'name': 'exercise', 'type': 'OTHER', 'description': 'exercise only', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nourhan Elsaid Ahmed Elsaid', 'role': 'CONTACT', 'email': 'nourhanelsaid1993@gmail.com', 'phone': '966540792567'}, {'name': 'Marihan Zakaria Aziz Makary, Dr', 'role': 'CONTACT', 'email': 'marihan_aziz@cu.edu.eg', 'phone': '01201227971'}], 'overallOfficials': [{'name': 'Salwa Fadl Abd Elmageed, Prof.Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor at Department of Physical Therapy for Musculoskeletal Disorders and Its Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Norhan Elsaid Ahmed Elsaid', 'investigatorAffiliation': 'Cairo University'}}}}