Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-01-11 @ 9:28 PM
Study NCT ID:
NCT03588195
Status:
COMPLETED
Last Update Posted:
2018-07-26
First Post:
2018-07-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Educational Program for Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010146', 'term': 'Pain'}], '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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-24', 'studyFirstSubmitDate': '2018-07-04', 'studyFirstSubmitQcDate': '2018-07-04', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain', 'timeFrame': 'Baseline and after 4 and 12 weeks', 'description': 'Evaluated using a numeric pain scale'}], 'secondaryOutcomes': [{'measure': 'Change in function', 'timeFrame': 'Baseline and after 4 and 12 weeks', 'description': 'Evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index'}, {'measure': 'Change in Anxiety', 'timeFrame': 'Baseline and after 4 and 12 weeks', 'description': 'Evaluated using the Inventory Anxiety Trait Inventory - State'}, {'measure': 'Change in Generic Quality of life', 'timeFrame': 'Baseline and after 4 and 12 weeks', 'description': 'Evaluated using the SF-36 questionnaire'}, {'measure': 'Change in Functional capacity', 'timeFrame': 'Baseline and after 4 and 12 weeks', 'description': 'Evaluated with the six minute walk test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Education', 'Pain', 'Function', 'Quality of life'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'Sixty patients with a diagnosis of knee osteoarthritis, aged between 40 and 80 years, of both genders were included. The patients were divided into: experimental group that carried out an educational program - 5 consecutive sessions held once a week, with a duration of 60 minutes each class and at the end of the last class, a booklet was delivered for each patient with all the contents of the classes and the Transcutaneous Nerve Electro-Stimulation device - being performed twice weekly, for 5 weeks for 40 minutes each session; and control group who only underwent treatment with the Transcutaneous Nerve Electro-Stimulation in the same parameters as experimental group. The evaluations were performed at the beginning of the treatment, 4 and 12 weeks after the beginning of the treatment using a numerical pain scale; WOMAC; IDATE and SF-36 questionnaires; and 6-minute walk test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of knee Osteoarthritis by American College of Rheumatology criteria;\n* Age between 40 and 80 years;\n* Both genders;\n* Numerical Pain Scale in the knee between 3 and 8 centimeters on a scale of 0 to 10 centimeters.\n\nExclusion Criteria:\n\n* Systemic inflammatory diseases or any condition that prevents the practice of physical activity;\n* Regular physical activity started or changed in the last twelve weeks;\n* No ambulation;\n* Joint injection in the knee in the previous twelve weeks;\n* Previous knee surgery or surgery planned for the next twenty-four weeks;\n* Physiotherapy in the last twelve weeks;\n* Other disease that affects the lower limbs;\n* Open wounds at the electrode application site;\n* Planned trip in the next twelve weeks.'}, 'identificationModule': {'nctId': 'NCT03588195', 'briefTitle': 'Educational Program for Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Evaluation of the Effectiveness of an Educational Program in Patients With Osteoarthritis of the Knee: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CEP UNIFESP 458293'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Education Group', 'interventionNames': ['Other: Educational Program', 'Device: Transcutaneous Nerve Electro-Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'interventionNames': ['Device: Transcutaneous Nerve Electro-Stimulation']}], 'interventions': [{'name': 'Educational Program', 'type': 'OTHER', 'description': 'Educational program consist in 5 consecutive sessions held once a week, with a duration of 60 minutes each class and at the end of the last class, a booklet was delivered for each patient with all the contents of the classes. This group also received Transcutaneous Nerve Electro-Stimulation twice weekly, for 5 weeks for 40 minutes each session', 'armGroupLabels': ['Education Group']}, {'name': 'Transcutaneous Nerve Electro-Stimulation', 'type': 'DEVICE', 'description': 'Transcutaneous Nerve Electro-Stimulation performed twice weekly, for 5 weeks for 40 minutes each session', 'armGroupLabels': ['Control Group', 'Education Group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Anamaria Jones', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}