Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT04531969
Status:
COMPLETED
Last Update Posted:
2023-09-25
First Post:
2020-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Outpatient and Inpatient Spa Therapy
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Patients will be aware of group distribution due to the nature of the study. Therefore, the only outcome assessor will be blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-22', 'studyFirstSubmitDate': '2020-08-26', 'studyFirstSubmitQcDate': '2020-08-26', 'lastUpdatePostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Western Ontario and McMaster University (WOMAC) osteoarthritis index', 'timeFrame': 'two weeks', 'description': 'The form consists of three parts (pain, stiffness, and physical function) and 24 questions. High WOMAC values indicate an increase in pain and stiffness and impairment of physical function.'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'two weeks', 'description': 'The patient was asked to mark the severity of his or her pain with active motion on a horizontal line 100 millimeters in length. The intensity of the pain was calculated by measuring the area in which the individual marked between 0 (no pain) and 10 (the most severe pain I felt in my life).'}, {'measure': 'Timed Up and Go (TUG)', 'timeFrame': 'two weeks', 'description': "The patient starts in a seated position and stands up upon therapist's command: walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated. The subject is allowed to use an assistive device."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spa therapy', 'Electrotherapy', 'Ultrasound', 'Hotpack'], 'conditions': ['Osteoarthritis, Knee']}, 'descriptionModule': {'briefSummary': 'In this study, we aimed to compare the effectiveness of inpatient and outpatient physical therapy modalities and spa combination treatments on pain and functional status in patients with knee osteoarthritis.', 'detailedDescription': 'Osteoarthritis (OA) has an important place in musculoskeletal diseases and is the most common rheumatic joint disorder characterized by progressive cartilage degeneration. Osteoarthritis of the knee is the most common symptomatic osteoarthritis characterized by chronic knee pain, joint stiffness, limited daily activities, and decreased quality of life.\n\nIn this study, it was aimed to compare the effects of inpatient and outpatient applications of HP, US, TENS, spa combination treatments on pain and functional status in patients with knee osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with primary knee osteoarthritis\n\nExclusion Criteria:\n\n* Patients who have secondary knee osteoarthritis due to various diseases\n* Patients with pronounced pathology in the waist, hip and ankle joint, patients with active tumors\n* Patients with febrile infectious disease\n* Having had serious surgical operations in the last 6 months\n* Patients who have undergone and/or have been injected with intraarticular steroid and hyaluronic acid into the knee joint\n* Patients who have received balneotherapy and peloidotherapy in the last one year\n* Patients with decompensated organ failure, those with inflammatory disease, those with pregnancy and breastfeeding\n* People with neurological diseases such as epilepsy, inner ear hearing aids, pacemakers and other individuals with a small metallic implant'}, 'identificationModule': {'nctId': 'NCT04531969', 'briefTitle': 'Comparison of Outpatient and Inpatient Spa Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Abant Izzet Baysal University'}, 'officialTitle': 'Comparison of Outpatient and Inpatient Spa Therapy in Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'Physical Med-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Inpatient group', 'description': 'Spa therapy,HP application, deep heater application, and TENS.', 'interventionNames': ['Other: Spa therapy and conventional physical therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Outpatient group', 'description': 'Spa therapy,HP application, deep heater application, and TENS.', 'interventionNames': ['Other: Spa therapy and conventional physical therapy']}], 'interventions': [{'name': 'Spa therapy and conventional physical therapy', 'type': 'OTHER', 'description': 'HP application +deep heater application + TENS. HP application: A hotpack wrapped in a towel for 20 minutes will be placed on the knee and surrounding soft tissues.\n\nDeep heater application: The application will be performed with a therapeutic ultrasound device at a dose of 1.5watt / cm2 for each string for 6 minutes.\n\nTENS application:TENS device with two electrodes surrounding tendon will be performed for 30 minutes at low-frequency current application.\n\nSpa therapy: A conventional water bath water at 38 ° C will be applied in the pool for 20 minutes a day.', 'armGroupLabels': ['Inpatient group', 'Outpatient group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14100', 'city': 'Bolu', 'state': 'Merkez', 'country': 'Turkey (Türkiye)', 'facility': 'Abant Izzet Baysal University', 'geoPoint': {'lat': 40.73583, 'lon': 31.60611}}], 'overallOfficials': [{'name': 'Mustafa Fatih Yaşar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bolu Abant Izzet Baylsa University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abant Izzet Baysal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ramazan KURUL', 'investigatorAffiliation': 'Abant Izzet Baysal University'}}}}