Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-25 @ 2:31 PM
Study NCT ID:
NCT07253766
Status:
COMPLETED
Last Update Posted:
2025-11-28
First Post:
2025-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effectiveness of Kinesiologic Taping in Patients With Knee Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D000092442', 'term': 'Kinesiophobia'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-30', 'size': 123964, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-07T08:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2025-09-18', 'studyFirstSubmitQcDate': '2025-11-19', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale', 'timeFrame': 'Four Weeks', 'description': 'A Visual Analog scale(VAS) was used to assess pain intensity. Participants were asked to rate their perceived pain on a 10-cm horizontal line, where 0 cm indicates "no pain" and 10 cm indicates "worst pain imaginable." The participants marked a point on the line that best represented their pain intensity at rest and during activity. The distance (in centimeters) from the "no pain" end to the participant\'s mark was measured and recorded as the VAS score.'}, {'measure': 'Tampa Kinesiophobia Scale', 'timeFrame': 'Four Weeks', 'description': 'Kinesiophobia was assessed using the Tampa Scale for Kinesiophobia (TSK), a self-report questionnaire designed to measure fear of movement or re-injury. The scale consists of 17 items, each rated on a 4-point Likert scale ranging from 1 ("strongly disagree") to 4 ("strongly agree"). Higher scores indicate a greater degree of kinesiophobia, with a total score range between 17 and 68 points.'}, {'measure': 'Timed up and Go test', 'timeFrame': 'Four weeks', 'description': 'Functional mobility was assessed using the Timed Up and Go (TUG) test, a simple and reliable measure of dynamic balance and mobility. Participants were instructed to rise from a standard chair, walk three meters, turn around, walk back, and sit down at their normal walking speed. The time taken to complete the task was measured in seconds using a stopwatch. Shorter completion times indicate better functional mobility.'}, {'measure': 'Disease Activity', 'timeFrame': 'Four weeks', 'description': "Disease activity was evaluated using the Disease Activity Score-28 (DAS28), which incorporates the number of tender and swollen joints (out of 28), the erythrocyte sedimentation rate (ESR), and the patient's global health assessment (GH) on a 100-mm Visual Analog Scale. The DAS28 score was calculated according to the standard formula, with values below 2.6 indicating remission, 2.6-3.2 low disease activity, 3.2-5.1 moderate activity, and above 5.1 high disease activity. This index is widely used to monitor disease progression and treatment response in patients with rheumatoid arthritis."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rheumatoid arthritis', 'pain', 'kinesiophobia', 'kinesiologic taping'], 'conditions': ['Rheumatoid Arthritis', 'Pain', 'Kinesiophobia']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if kinesiologic taping works to treat individuals with Rheumatoid Arthritis.\n\nThe main questions it aim to answer:\n\n* Is kinesiologic taping applied to the knee joint an effective treatment for pain, mobility, and kinesiophobia in individuals diagnosed with rheumatoid arthritis?\n* Which is more effective? Kinesiologic taping or non-therapeutic sham taping? Which is better for pain, functional capacity, kinesiophobia and disease activity? Researchers will compare kinesiologic taping and non-therapeutic sham taping . Patients will be randomly divided into groups. The first group of patients was treated with sham taping, and the application period was applied consecutively for 4 weeks, with a minimum interval of 3 days and a maximum interval of 5 days. Group 2 patients underwent kinesiological taping, with the application period ranging from 3 to 5 days per week for 4 consecutive weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged 45 to 60\n* Patients diagnosed with acute or chronic rheumatoid arthritis;\n* Patients whose rheumatic medication protocol has not changed in the last 3 months; -Patients who do not smoke, drink alcohol or use drugs;\n* Patients who have no vision, hearing or speech problems;\n* Patients who are not amputees;\n* Patients who can walk independently.\n\nExclusion Criteria:\n\n* individuals over the age of 61;\n* individuals with neurological disorders, severe chronic obstructive pulmonary disease, liver or kidney failure, malignancies, uncontrolled diabetes mellitus, major psychiatric disorders, or pregnancy; and those with concomitant conditions that could cause balance problems.\n* Pregnant and breastfeeding women;\n* individuals who had undergone surgery in the last few months;\n* patients with loss of cooperation (e.g., those diagnosed with dementia or Alzheimer's disease) were also excluded from the study."}, 'identificationModule': {'nctId': 'NCT07253766', 'acronym': 'Taping', 'briefTitle': 'The Effectiveness of Kinesiologic Taping in Patients With Knee Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Rumeli University'}, 'officialTitle': 'The Effectiveness of Kinesiologic Taping in Patients With Knee Rheumatoid Arthritis in Terms of Pain, Function, and Kinesiophobia: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'E53938333-050-45035'}, 'secondaryIdInfos': [{'id': 'Istanbul Rumeli University', 'type': 'OTHER', 'domain': 'Istanbul Rumeli University'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'kinesiologic taping group', 'description': 'Kinesiology tape will be applied to the knee joint.', 'interventionNames': ['Other: kinesiologic taping']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham taping', 'description': 'Non-therapeutic sham taping will be applied to the knee joint', 'interventionNames': ['Other: sham taping']}], 'interventions': [{'name': 'kinesiologic taping', 'type': 'OTHER', 'description': 'The taping will be applied to the knee joint for 4 weeks.', 'armGroupLabels': ['kinesiologic taping group']}, {'name': 'sham taping', 'type': 'OTHER', 'description': 'The non-therapeutic taping will be applied to the knee joint for 4 weeks.', 'armGroupLabels': ['Sham taping']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Rumeli University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Rumeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist.Prof', 'investigatorFullName': 'Ozden Baskan', 'investigatorAffiliation': 'Istanbul Rumeli University'}}}}