Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 12:23 AM
Study NCT ID:
NCT06010394
Status:
COMPLETED
Last Update Posted:
2023-12-07
First Post:
2023-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Control of Edema in the Knee 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': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'classical physical therapy, exercise therapy, classical massage'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-06', 'studyFirstSubmitDate': '2023-08-18', 'studyFirstSubmitQcDate': '2023-08-18', 'lastUpdatePostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Injury and Osteoarthritis Outcome Score', 'timeFrame': '4 weeks', 'description': 'It is used to detect symptoms and restrictions in current work that individuals do in daily life. The test is collected under 2 main headings, consisting of 6 questions about the effect of symptoms and 8 sub-activities that question the status of the activity. The answer to each question in the test is scored between 0-5. The scores that the person gets from each question are added together and these scores are divided by 70 and multiplied by 100. High score means low quality of life.'}, {'measure': 'Western Ontario and McMaster Universities Osteoarthritis Index', 'timeFrame': '4 weeks', 'description': 'Pain, joint stiffness and functional status; Evaluated with the Arthritis Index of Western Ontario and McMaster Universities. The scale is a disease-specific, multidimensional, self-administered health status tool used in hip or knee osteoarthritis27. It consists of 24 questions on pain, stiffness and physical disability and is approximately 10 min. can be completed in Western Ontario and McMaster Universities Osteoarthritis Index consists of 24 questions under three sub-headings. Pain consists of 5 questions, stiffness 2 questions and function 17 questions. Each sub-parameter is scored between 0-4 points. Accordingly, it is classified as pain (0-20), stiffness (0-8) and function (0-68). A high score indicates poor health, a low score indicates good health.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['massage'], 'conditions': ['Knee Osteoarthritis', 'Edema', 'Edema Leg']}, 'referencesModule': {'references': [{'pmid': '26581486', 'type': 'BACKGROUND', 'citation': "Maricar N, Callaghan MJ, Parkes MJ, Felson DT, O'Neill TW. Clinical assessment of effusion in knee osteoarthritis-A systematic review. Semin Arthritis Rheum. 2016 Apr;45(5):556-63. doi: 10.1016/j.semarthrit.2015.10.004. Epub 2015 Oct 22."}, {'pmid': '15271540', 'type': 'BACKGROUND', 'citation': 'Hofmann S, Kramer J, Vakil-Adli A, Aigner N, Breitenseher M. Painful bone marrow edema of the knee: differential diagnosis and therapeutic concepts. Orthop Clin North Am. 2004 Jul;35(3):321-33, ix. doi: 10.1016/j.ocl.2004.04.005.'}, {'pmid': '36155729', 'type': 'BACKGROUND', 'citation': 'Molfetta L, Florian A, Saviola G, Frediani B. Bone Marrow Edema: pathogenetic features. Clin Ter. 2022 Sep-Oct;173(5):434-439. doi: 10.7417/CT.2022.2459.'}, {'pmid': '30919810', 'type': 'BACKGROUND', 'citation': 'Kan HS, Chan PK, Chiu KY, Yan CH, Yeung SS, Ng YL, Shiu KW, Ho T. Non-surgical treatment of knee osteoarthritis. Hong Kong Med J. 2019 Apr;25(2):127-133. doi: 10.12809/hkmj187600. Epub 2019 Mar 28.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to compare the effectiveness of exercise and classical massage in the control of knee edema in patients with knee osteoarthritis.', 'detailedDescription': 'This study will be a prospective randomized controlled study. It is planned to include 75 patients with knee osteoarthritis in this study. It was categorized as osteoarthritis(OA) stages according to Kellgren-Lawrence criteria. Patients were randomly divided into three groups. the investigators first group is the control group (KG) and this group will receive classical physical therapy with ultrasound and subcutaneous electrical nerve stimulation. Exercise therapy will be applied to the second group in addition to the classical physical therapy applied to the KG. The third group will be given classical massage in addition to the classical physical therapy applied to the KG. The treatments to be applied to the patients will be 3 sessions per week and it is planned to continue for 4 weeks. Knee edema, pain severity, functional status and daily life activities will be measured at the beginning and in the 4th week of the patients. The data obtained will be analyzed statistically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between the ages of 30-65\n* Patients with a diagnosis of osteoarthritis in stage 2 and stage 3 according to Kellgren-Lawrence criteria(1) and also with measurable edema\n\nExclusion Criteria:\n\n* Inability to continue treatment regularly\n* situations that prevent you from doing the exercise\n* inflammation that interferes with massage.'}, 'identificationModule': {'nctId': 'NCT06010394', 'briefTitle': 'Control of Edema in the Knee in Patients With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Uskudar University'}, 'officialTitle': 'Comparison of the Effectiveness of Exercise and Classical Massage in the Control of Edema in the Knee in Patients With Knee Osteoarthritis.', 'orgStudyIdInfo': {'id': 'Uskudar50'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'commensal physiotherapy will be applied', 'interventionNames': ['Other: conventional physiotherapy']}, {'type': 'EXPERIMENTAL', 'label': 'exercise group', 'description': 'exercises will be given', 'interventionNames': ['Other: conventional physiotherapy', 'Other: exercises for the knee area']}, {'type': 'EXPERIMENTAL', 'label': 'massage group', 'description': 'massage will be done', 'interventionNames': ['Other: conventional physiotherapy', 'Other: payment oriented massage']}], 'interventions': [{'name': 'conventional physiotherapy', 'type': 'OTHER', 'description': 'ultrasound electrotherapy cold applications', 'armGroupLabels': ['control group', 'exercise group', 'massage group']}, {'name': 'exercises for the knee area', 'type': 'OTHER', 'description': 'range of motion exercises strengthening exercises exercises to reduce edema', 'armGroupLabels': ['exercise group']}, {'name': 'payment oriented massage', 'type': 'OTHER', 'description': '10 / 15-minute massage treatments to reduce payment', 'armGroupLabels': ['massage group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Uskudar university', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Enver Deniz YILDIRIM', 'role': 'STUDY_CHAIR', 'affiliation': 'Uskudar University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uskudar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asst. Prof. Dr.', 'investigatorFullName': 'Dr. Öğr. Üyesi Ömer Şevgin', 'investigatorAffiliation': 'Uskudar University'}}}}