Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT04736069
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2021-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Which Physical Therapy Program is Cost-effective in Knee Osteoarthritis?
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nihancuzdan@hotmail.com', 'phone': '5052706846', 'title': 'Nihan Cüzdan', 'organization': 'Ufuk University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Skin and Subcutaneous Tissue Disorders', 'eventGroups': [{'id': 'EG000', 'title': 'Inpatient Physical Therapy', 'description': 'Patients who received physical therapy and rehabilitation program at inpatient clinic', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Outpatient Physical Therapy', 'description': 'Patients who received physical therapy and rehabilitation program at outpatient clinic', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain; Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inpatient Physical Therapy', 'description': 'The group received 21 sessions of physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program at inpatient clinic.\n\nPhysical therapy program: In the physical therapy program, 20 minutes of hot pack, 20 minutes of transcutaneous electrical nerve stimulation (TENS; 30 to 40 Hz), 6 minutes of ultrasound (US; 1 MHz, 1 to 1.5 Watt/cm2) therapy were applied to both groups. Both of the programs were supervised by physical therapists. A combined range of motion and strengthening exercises were given to both groups to be performed two times a day.'}, {'id': 'OG001', 'title': 'Outpatient Physical Therapy', 'description': 'The group received the same physical therapy program including electrotherapy, superficial-deep heat applications and basic knee exercise program at outpatient clinic.\n\nPhysical therapy program: In the physical therapy program, 20 minutes of hot pack, 20 minutes of transcutaneous electrical nerve stimulation (TENS; 30 to 40 Hz), 6 minutes of ultrasound (US; 1 MHz, 1 to 1.5 Watt/cm2) therapy were applied to both groups. Both of the programs were supervised by physical therapists. A combined range of motion and strengthening exercises were given to both groups to be performed two times a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '6'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Change from Baseline VAS scores at 6 months', 'description': "Patients were requested to sign their pain level on a 10 cm horizontal line with terminal ends of 'no pain' and 'the worst pain'", 'unitOfMeasure': 'cm', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Physical Function; Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inpatient Physical Therapy', 'description': 'Patients who received physical therapy and rehabilitation program at inpatient clinic'}, {'id': 'OG001', 'title': 'Outpatient Physical Therapy', 'description': 'Patients who received physical therapy and rehabilitation program at outpatient clinic'}], 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '38'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '38'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Change from Baseline WOMAC scores at 6 months', 'description': 'WOMAC questionnaire includes five items for pain, two for stiffness, and 17 for functional limitation (score range 0-68). All the items are scored on a scale of 0-4, with higher scores indicating a higher level of symptoms or physical disability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Fall Risk Assessment; Hendrich II Fall Risk Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inpatient Physical Therapy', 'description': 'The group received 21 sessions of physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program at inpatient clinic.\n\nPhysical therapy program: In the physical therapy program, 20 minutes of hot pack, 20 minutes of transcutaneous electrical nerve stimulation (TENS; 30 to 40 Hz), 6 minutes of ultrasound (US; 1 MHz, 1 to 1.5 Watt/cm2) therapy were applied to both groups. Both of the programs were supervised by physical therapists. A combined range of motion and strengthening exercises were given to both groups to be performed two times a day.'}, {'id': 'OG001', 'title': 'Outpatient Physical Therapy', 'description': 'The group received the same physical therapy program including electrotherapy, superficial-deep heat applications and basic knee exercise program at outpatient clinic.\n\nPhysical therapy program: In the physical therapy program, 20 minutes of hot pack, 20 minutes of transcutaneous electrical nerve stimulation (TENS; 30 to 40 Hz), 6 minutes of ultrasound (US; 1 MHz, 1 to 1.5 Watt/cm2) therapy were applied to both groups. Both of the programs were supervised by physical therapists. A combined range of motion and strengthening exercises were given to both groups to be performed two times a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Change from Baseline Hendrich II Fall Risk Scale at 6 months', 'description': 'The scale includes seven items. These items are confusion \\& disorientation, depression, change in excretion, dizziness, gender, antiepileptic \\& benzodiazepine use, and get up and walk test. The final score is the sum of these scores; (the score range is between 0-16; 16 is the highest possible score) Patients five or more scores on the scale are considered to be at high risk.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Quality of Life; Short-Form 36-General Health', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inpatient Physical Therapy', 'description': 'The group received 21 sessions of physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program at inpatient clinic.\n\nPhysical therapy program: 20 minutes of hot pack, 20 minutes of transcutaneous electrical nerve stimulation (TENS; 30 to 40 Hz), 6 minutes of ultrasound (US; 1 MHz, 1 to 1.5 Watt/cm2); A combined range of motion and strengthening exercises/two times a day'}, {'id': 'OG001', 'title': 'Outpatient Physical Therapy', 'description': 'The group received the same physical therapy program including electrotherapy, superficial-deep heat applications and basic knee exercise program at outpatient clinic.\n\nPhysical therapy program: 20 minutes of hot pack, 20 minutes of transcutaneous electrical nerve stimulation (TENS; 30 to 40 Hz), 6 minutes of ultrasound (US; 1 MHz, 1 to 1.5 Watt/cm2); A combined range of motion and strengthening exercises:two times a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.5', 'groupId': 'OG000', 'lowerLimit': '-20', 'upperLimit': '0'}, {'value': '-7.5', 'groupId': 'OG001', 'lowerLimit': '-20', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Change from Baseline Short-Form 36 scores at 6 months', 'description': 'Short-Form 36 (SF-36) which is composed of eight multi-item scales as bodily pain, physical functioning, social functioning, role-physical, role-emotional, vitality, general health, mental health. Each score of these scales ranging from 0 to 100; higher scores indicating higher QoL.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Median Total Cost Per Participant for Health Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Inpatient Physical Therapy', 'description': 'The group received 21 sessions of physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program at inpatient clinic.\n\nPhysical therapy program:, 20 minutes of hot pack, 20 minutes of transcutaneous electrical nerve stimulation (TENS; 30 to 40 Hz), 6 minutes of ultrasound (US; 1 MHz, 1 to 1.5 Watt/cm2) therapy were applied to both groups. A combined range of motion and strengthening exercises; two times a day.'}, {'id': 'OG001', 'title': 'Outpatient Physical Therapy', 'description': 'The group received the same physical therapy program including electrotherapy, superficial-deep heat applications and basic knee exercise program at outpatient clinic.\n\nPhysical therapy program: 20 minutes of hot pack, 20 minutes of transcutaneous electrical nerve stimulation (TENS; 30 to 40 Hz), 6 minutes of ultrasound (US; 1 MHz, 1 to 1.5 Watt/cm2) therapy were applied to both groups. A combined range of motion and strengthening exercises; two times a day.'}], 'classes': [{'categories': [{'measurements': [{'value': '552.4', 'groupId': 'OG000', 'lowerLimit': '497.2', 'upperLimit': '1372.5'}, {'value': '276.3', 'groupId': 'OG001', 'lowerLimit': '218.0', 'upperLimit': '1023.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'baseline-six months', 'description': 'median total expenses for health care at the end of the study', 'unitOfMeasure': 'euros', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Inpatient Physical Therapy', 'description': 'Patients who received physical therapy and rehabilitation program at inpatient clinic'}, {'id': 'FG001', 'title': 'Outpatient Physical Therapy', 'description': 'Patients who received physical therapy and rehabilitation program at outpatient clinic'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Inpatient Physical Therapy', 'description': 'Group 1 received 21 physical therapy sessions, including electrotherapy, superficial-deep heat applications, and a basic knee exercise program at inpatient clinic.'}, {'id': 'BG001', 'title': 'Outpatient Physical Therapy', 'description': 'Group 2 received 21 physical therapy sessions, including electrotherapy, superficial-deep heat applications, and a basic knee exercise program at outpatient clinic.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '66.8', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '61.0', 'spread': '14.1', 'groupId': 'BG001'}, {'value': '64.4', 'spread': '13.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Turkey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '30.2', 'spread': '4.0', 'groupId': 'BG000'}, {'value': '26.8', 'spread': '4.3', 'groupId': 'BG001'}, {'value': '28.8', 'spread': '4.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Occupation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'title': 'unemployed', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'working', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Occupational intensity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'title': 'light', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'moderate', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'heavy', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Trauma history presence', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'title': 'present', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'absent', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Kellgren Lawrence Grading', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}], 'categories': [{'title': 'grade 1/2', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'grade 3', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'grade 4', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Kellgren-Lawrence classification system is used for osteoarthritis grading; grade: 0: none; grade:1 doubtful, grade 2: minimal, grade 3: moderate, grade 4:severe', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2010-10-03', 'size': 81092, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-02-19T12:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group 1 received 21 sessions of inpatient physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program. Group 2 received the same physical therapy program at outpatient clinic.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2013-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2021-01-27', 'resultsFirstSubmitDate': '2021-02-19', 'studyFirstSubmitQcDate': '2021-01-29', 'lastUpdatePostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-26', 'studyFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain; Visual Analog Scale (VAS)', 'timeFrame': 'Change from Baseline VAS scores at 6 months', 'description': "Patients were requested to sign their pain level on a 10 cm horizontal line with terminal ends of 'no pain' and 'the worst pain'"}, {'measure': 'Physical Function; Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index', 'timeFrame': 'Change from Baseline WOMAC scores at 6 months', 'description': 'WOMAC questionnaire includes five items for pain, two for stiffness, and 17 for functional limitation (score range 0-68). All the items are scored on a scale of 0-4, with higher scores indicating a higher level of symptoms or physical disability.'}, {'measure': 'Fall Risk Assessment; Hendrich II Fall Risk Scale', 'timeFrame': 'Change from Baseline Hendrich II Fall Risk Scale at 6 months', 'description': 'The scale includes seven items. These items are confusion \\& disorientation, depression, change in excretion, dizziness, gender, antiepileptic \\& benzodiazepine use, and get up and walk test. The final score is the sum of these scores; (the score range is between 0-16; 16 is the highest possible score) Patients five or more scores on the scale are considered to be at high risk.'}, {'measure': 'Quality of Life; Short-Form 36-General Health', 'timeFrame': 'Change from Baseline Short-Form 36 scores at 6 months', 'description': 'Short-Form 36 (SF-36) which is composed of eight multi-item scales as bodily pain, physical functioning, social functioning, role-physical, role-emotional, vitality, general health, mental health. Each score of these scales ranging from 0 to 100; higher scores indicating higher QoL.'}, {'measure': 'Median Total Cost Per Participant for Health Care', 'timeFrame': 'baseline-six months', 'description': 'median total expenses for health care at the end of the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cost-effectiveness', 'knee', 'osteoarthritis', 'physical therapy'], 'conditions': ['Osteoarthritis, Knee']}, 'referencesModule': {'references': [{'pmid': '15766999', 'type': 'BACKGROUND', 'citation': 'Dieppe PA, Lohmander LS. Pathogenesis and management of pain in osteoarthritis. Lancet. 2005 Mar 12-18;365(9463):965-73. doi: 10.1016/S0140-6736(05)71086-2.'}, {'pmid': '3068365', 'type': 'BACKGROUND', 'citation': 'Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.'}, {'pmid': '12624858', 'type': 'BACKGROUND', 'citation': 'Hendrich AL, Bender PS, Nyhuis A. Validation of the Hendrich II Fall Risk Model: a large concurrent case/control study of hospitalized patients. Appl Nurs Res. 2003 Feb;16(1):9-21. doi: 10.1053/apnr.2003.YAPNR2.'}]}, 'descriptionModule': {'briefSummary': 'Knee osteoarthritis (OA) is a disease with significant levels of socioeconomic burden to the society. P The non-pharmacologic interventions in knee OA include weight loss, exercise, and physical therapy. In this study, we aimed to to compare the cost-effectiveness of inpatient and outpatient physical therapy programs in patients with knee osteoarthritis.', 'detailedDescription': "Knee osteoarthritis (OA) is a major problem for society with a heavy economic burden. Especially in the elderly population, integrated rehabilitation programs are frequently used to improve patients' symptoms and quality of life. To estimate the costs and utility of the rehabilitation programs may help clinicians decide optimal treatment strategy with proper usage of resources. Therefore, we aimed to to compare the cost-effectiveness of inpatient and outpatient physical therapy programs in patients with knee osteoarthritis.The study included 52 patients with the diagnose of knee osteoarthritis. Patients were divided into two groups. Group 1 (n=30) received 21 sessions of inpatient physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program. Group 2 (n=22) received the same physical therapy program at outpatient clinic."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Knee OA diagnosed patients based on American College of Rheumatology Criteria\n\nExclusion Criteria:\n\n* visual disturbances\n* malignancy\n* inflammatory rheumatic diseases\n* pregnancy\n* advanced cardiovascular, kidney or liver pathologies\n* uncontrolled hypertension\n* patients who had injuries in their lower extremities\n* patients who underwent under total hip or knee prosthetic surgeries.'}, 'identificationModule': {'nctId': 'NCT04736069', 'briefTitle': 'Which Physical Therapy Program is Cost-effective in Knee Osteoarthritis?', 'organization': {'class': 'OTHER', 'fullName': 'Ufuk University'}, 'officialTitle': 'The Cost-effectiveness of Inpatient and Outpatient Physical Therapy Programs in Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'UfukUniv'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Inpatient physical therapy program', 'description': 'The group received 21 sessions of physical therapy program including electrotherapy, superficial- deep heat applications and basic knee exercise program at inpatient clinic.', 'interventionNames': ['Other: Physical therapy program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Outpatient physical therapy program', 'description': 'The group received the same physical therapy program including electrotherapy, superficial-deep heat applications and basic knee exercise program at outpatient clinic.', 'interventionNames': ['Other: Physical therapy program']}], 'interventions': [{'name': 'Physical therapy program', 'type': 'OTHER', 'description': 'In the physical therapy program, 20 minutes of hot pack, 20 minutes of transcutaneous electrical nerve stimulation (TENS; 30 to 40 Hz), 6 minutes of ultrasound (US; 1 MHz, 1 to 1.5 Watt/cm2) therapy were applied to both groups. Both of the programs were supervised by physical therapists. A combined range of motion and strengthening exercises were given to both groups to be performed two times a day.', 'armGroupLabels': ['Inpatient physical therapy program', 'Outpatient physical therapy program']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Nihan CUZDAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ufuk University School of Medicine'}]}, 'ipdSharingStatementModule': {'url': "http://'nihancuzdan@hotmail.com", 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Starting 6 months after publication', 'ipdSharing': 'YES', 'description': 'The authors will consider providing data for all individual requests after the publication. Requests can be done through e-mail. All individual requests will be evaluated and the data will be shared by the principal investigator.', 'accessCriteria': 'The authors will consider providing data for all individual requests after the publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ufuk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Nihan Cuzdan', 'investigatorAffiliation': 'Ufuk University'}}}}