Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-30 @ 5:27 AM
Study NCT ID:
NCT05036551
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2021-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kinesiophobia, Pain, Functional Status and Self-Efficacy 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': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D000092442', 'term': 'Kinesiophobia'}, {'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': 'D010698', 'term': 'Phobic Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-03', 'studyFirstSubmitDate': '2021-08-27', 'studyFirstSubmitQcDate': '2021-09-03', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': 'After the participants were examined, evaluations were made before starting the physical therapy program.', 'description': 'Pain assessment, between 0-10 points. Low score low pain'}, {'measure': 'Tampa Scale for Kinesiophobia', 'timeFrame': 'After the participants were examined, evaluations were made before starting the physical therapy program.', 'description': 'Kinesiophobia assessment, between 17-68 points. Low score low kinesiophobia.'}, {'measure': 'The Western Ontario and McMaster Universities Arthritis Index', 'timeFrame': 'After the participants were examined, evaluations were made before starting the physical therapy program.', 'description': 'Functional state assessment, between 0-96 points. Low score good functional status.'}, {'measure': 'Arthritis Self Efficacy Scale', 'timeFrame': 'After the participants were examined, evaluations were made before starting the physical therapy program.', 'description': 'Self Efficacy assessment, between 20-100 points. Low score low self-efficacy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee', 'Osteoarthritis', 'Kinesiophobia', 'Pain', 'Functional Status', 'Self Efficacy'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Objective: The aim of this study is to examine the relationship between kinesiophobia, pain, functional status and self efficacy in patients with knee osteoarthritis.', 'detailedDescription': 'Material and Methods: The study was performed on 72 individuals diagnosed with Stage 2 and Stage 3 knee osteoarthritis according to the Kellgren Lawrence classification. The Tampa Scale for Kinesiophobia (TSK) was used to evaluate kinesiophobia, and the Visual Analogue Scale (VAS) was used to assess pain. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) was used to asses the functional status. Self efficacy was assessed using the Arthritis Self Efficacy Scale (ASES).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'community sample', 'genderDescription': 'Male and female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being between the ages of 40-85 and diagnosed with stage 2-3 bilateral knee osteoarthritis according to Kellgren Lawrence classification.\n\nExclusion Criteria:\n\n* With a history of lower extremity surgery and a major trauma, orthopedic knee injuries such as tendinopathy, bursitis, ligament and meniscus injuries, a neurological or cardiopulmonary disease that may affect the evaluations, and any other joint in the lower limb that may cause reflected pain in the knee, individuals who had inflammatory rheumatic disease such as gout, rheumatoid arthritis, have participated in physical therapy and rehabilitation program in the last 6 months and who have been given knee injections'}, 'identificationModule': {'nctId': 'NCT05036551', 'briefTitle': 'Kinesiophobia, Pain, Functional Status and Self-Efficacy in Patients With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Relationship Between Kinesiophobia, Pain, Functional Status and Self-Efficacy in Patients With Knee Osteoarthrıtıs', 'orgStudyIdInfo': {'id': 'HU-FTR-NK-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stage 2 Knee osteoarthritis', 'description': 'The Visual Analogue Scale (VAS) was used to determine the severity of the pain. Tampa Scale for Kinesiophobia (TSK) was used to evaluate kinesiophobia. The functional state was evaluated using The Western Ontario and McMaster Universities Arthritis Index (WOMAC). The Arthritis Self Efficacy Scale was used to determine self efficacy perception.', 'interventionNames': ['Diagnostic Test: Kellgren Lawrence classification']}, {'label': 'Stage 3 Knee osteoarthritis', 'description': 'The Visual Analogue Scale (VAS) was used to determine the severity of the pain. Tampa Scale for Kinesiophobia (TSK) was used to evaluate kinesiophobia. The functional state was evaluated using The Western Ontario and McMaster Universities Arthritis Index (WOMAC). The Arthritis Self Efficacy Scale was used to determine self efficacy perception.', 'interventionNames': ['Diagnostic Test: Kellgren Lawrence classification']}], 'interventions': [{'name': 'Kellgren Lawrence classification', 'type': 'DIAGNOSTIC_TEST', 'description': 'The Kellgren Lawrence classification was used in the radiological evaluation. It is a classification method used in the staging of knee osteoarthritis. Five stages were defined according to the anteroposterior X-ray.(Stage 0-5)', 'armGroupLabels': ['Stage 2 Knee osteoarthritis', 'Stage 3 Knee osteoarthritis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University Faculty of Physical Therapy and Rehabilitation', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Hacettepe Üniversity, Intitue', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hacettepe University Health Sciences Institute'}, {'name': 'Nurhayat Korkmaz, PhDstudent', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hacettepe University Health Sciences Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research assistant', 'investigatorFullName': 'Nurhayat KORKMAZ', 'investigatorAffiliation': 'Hacettepe University'}}}}