Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-03-05 @ 1:00 PM
Study NCT ID:
NCT04168593
Status:
COMPLETED
Last Update Posted:
2025-03-27
First Post:
2019-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Association of Acupuncture and Cupping in Advanced Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D000079742', 'term': 'Cupping Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tsai.andre@gmail.com', 'phone': '5511981456449', 'title': 'Andre Wan Wen Tsai', 'organization': 'USaoPauloGH'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'after 5 weeks from initial treatment', 'description': 'no serious adverse event, only local hematoma', 'eventGroups': [{'id': 'EG000', 'title': 'Group A', 'description': 'Sham + Sham', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group B', 'description': 'Sham Acp + Real Cupping', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 1, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group C', 'description': 'Real ACP + Sham Cupping', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 2, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Group D', 'description': 'Real + Real', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 2, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 30, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 30, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 30, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'WOMAC - Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Sham Acupuncture + Sham Cupping'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Sham Acupuncture + Real Cupping'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Real Acupuncture + Sham Cupping'}, {'id': 'OG003', 'title': 'Group D', 'description': 'Real Acupuncture + Real Cupping'}], 'classes': [{'categories': [{'measurements': [{'value': '11.60', 'spread': '4.17', 'groupId': 'OG000'}, {'value': '11.30', 'spread': '4.23', 'groupId': 'OG001'}, {'value': '10.80', 'spread': '4.64', 'groupId': 'OG002'}, {'value': '9.83', 'spread': '4.76', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'value collected at 5 week', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Womac-Pain section. Score: 0 (no pain) to 20 (worse condition)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We used the concept of Intent to Treat (ITT) for statistical analysis purposes, that is, all recruited participants, even if they did not complete the proposed 10-session treatment, were included in the final analysis'}, {'type': 'PRIMARY', 'title': 'VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Sham Acupuncture + Sham Cupping'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Sham Acupuncture + Real Cupping'}, {'id': 'OG002', 'title': 'Group C', 'description': 'Real Acupuncture + Sham Cupping'}, {'id': 'OG003', 'title': 'Group D', 'description': 'Real Acupuncture + Real Cupping'}], 'classes': [{'categories': [{'measurements': [{'value': '67.43', 'spread': '23.09', 'groupId': 'OG000'}, {'value': '61.57', 'spread': '25.57', 'groupId': 'OG001'}, {'value': '47.87', 'spread': '27.23', 'groupId': 'OG002'}, {'value': '47.43', 'spread': '28.99', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Value collected at 5 weeks', 'description': 'Intensity of pain 0-100 mm (0 corresponds to a better condition, otherwise, 100 correspond to a worst condition of pain)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'We used the concept of Intent to Treat (ITT) for statistical analysis purposes, that is, all recruited participants, even if they did not complete the proposed 10-session treatment, were included in the final analysis.'}, {'type': 'SECONDARY', 'title': 'Analgesic Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Number of Participants With Reduction in the Use of Pain Medications', 'description': 'During the study, the name of the drug in use was noted, as well as its dosage, before and after the protocol.'}, {'id': 'OG001', 'title': 'Group A', 'description': 'Sham Acupuncture + Sham Cupping'}, {'id': 'OG002', 'title': 'Group B', 'description': 'Sham Acupuncture + Real Cupping'}, {'id': 'OG003', 'title': 'Group C', 'description': 'Real Acupuncture + Sham Cupping'}, {'id': 'OG004', 'title': 'Group D', 'description': 'Real Acupuncture + Real Cupping'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Number of Participants with reduction in the use of pain medications after protocol (at 5 week)', 'description': 'number of pills per day For each group, those who had a reduction in the use of pain medications (analgesics and/or anti-inflammatory drugs) we described as Y (yes), and those who maintained or even increased the amount or simply did not return such information we described as N (no).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'We used the concept of Intent to Treat (ITT) for statistical analysis purposes, that is, all recruited participants, even if they did not complete the proposed 10-session treatment, were included in the final analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'A- Acupuncture Sham + Cupping Sham', 'description': 'Sham acupuncture: Placement of placebo "dagger" needles. The needle tip, when touching the patient\'s skin, retracts into itself without puncturing the skin. Application locations: LI11, SP9, SP10, LR8, GB34, ST34, Ex-LE5. Running time of 20 minutes.\n\nSham cupping: after each acupuncture session (Sham or True), the respective needles were removed, and acrylic suction cups were placed over the region where the needles were, attached to a strip (micropore) without exerting any negative pressure or movement. Application time of 10 minutes.'}, {'id': 'FG001', 'title': 'B -Sham Acupuncture + Real Cupping', 'description': 'Acupuncture 20 min of Acupuncture section follow by 10 min of cupping around the knee'}, {'id': 'FG002', 'title': 'C - Real Acupuncture + Sham Cupping', 'description': '20 min of Acupuncture section follow by 10 min of cupping around the knee'}, {'id': 'FG003', 'title': 'D - Real Acupuncture + Real Cupping', 'description': '20 min of Acupuncture section follow by 10 min of cupping around the knee'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'recruitment by phone from a list of patients with advanced KOA who is waiting for a TKR. the inclusion criteria is applied.', 'preAssignmentDetails': 'by phone we applied the WOMAC-Pain and invite who have 15 points or more'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'A- Placebo', 'description': 'Sham Acupuncture and Sham Cupping\n\n20 min of Acupuncture section using placebo needle follow by 10 min of cupping sham (no negative pressure) around the knee'}, {'id': 'BG001', 'title': 'B -Cupping', 'description': 'Sham Acupuncture and Real Cupping\n\n20 min of Acupuncture section using placebo needle follow by 10 min of real cupping around the knee'}, {'id': 'BG002', 'title': 'C - Acupuncture', 'description': 'Real Acupuncture and Sham Cupping\n\n20 min of Real Acupuncture section follow by 10 min of sham cupping around the knee'}, {'id': 'BG003', 'title': 'D - Acupuncture + Cupping', 'description': 'Real Acupuncture and Real Cupping\n\n20 min of Real Acupuncture section follow by 10 min of real cupping around the knee'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age distribution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '66.1', 'spread': '10.88', 'groupId': 'BG000'}, {'value': '66.1', 'spread': '10.86', 'groupId': 'BG001'}, {'value': '68.1', 'spread': '11.15', 'groupId': 'BG002'}, {'value': '66.8', 'spread': '8.09', 'groupId': 'BG003'}, {'value': '66.8', 'spread': '10.17', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'WOMAC-Pain', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '16.83', 'spread': '1.74', 'groupId': 'BG000'}, {'value': '16.50', 'spread': '1.38', 'groupId': 'BG001'}, {'value': '16.40', 'spread': '1.43', 'groupId': 'BG002'}, {'value': '16.90', 'spread': '1.75', 'groupId': 'BG003'}, {'value': '16.66', 'spread': '1.58', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'range 0-20, 0 correspond to a better condition, otherwise, 20 correspond to a worst condition of pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'VAS', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '84.03', 'spread': '13.75', 'groupId': 'BG000'}, {'value': '89.57', 'spread': '11.81', 'groupId': 'BG001'}, {'value': '82.83', 'spread': '12.97', 'groupId': 'BG002'}, {'value': '91.30', 'spread': '11.43', 'groupId': 'BG003'}, {'value': '89.92', 'spread': '12.88', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'range 0-100, 0 correspond to a better condition, otherwise 100 correspond to a worst condition of pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-18', 'size': 22469, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-01-04T11:02', 'hasProtocol': True}, {'date': '2017-01-18', 'size': 31334, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-01-04T10:59', 'hasProtocol': False}, {'date': '2017-09-06', 'size': 42749, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-01-04T11:00', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2019-11-12', 'resultsFirstSubmitDate': '2022-12-20', 'studyFirstSubmitQcDate': '2019-11-18', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-03-26', 'studyFirstPostDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'WOMAC - Pain', 'timeFrame': 'value collected at 5 week', 'description': 'Western Ontario and McMaster Universities Osteoarthritis Womac-Pain section. Score: 0 (no pain) to 20 (worse condition)'}, {'measure': 'VAS', 'timeFrame': 'Value collected at 5 weeks', 'description': 'Intensity of pain 0-100 mm (0 corresponds to a better condition, otherwise, 100 correspond to a worst condition of pain)'}], 'secondaryOutcomes': [{'measure': 'Analgesic Consumption', 'timeFrame': 'Number of Participants with reduction in the use of pain medications after protocol (at 5 week)', 'description': 'number of pills per day For each group, those who had a reduction in the use of pain medications (analgesics and/or anti-inflammatory drugs) we described as Y (yes), and those who maintained or even increased the amount or simply did not return such information we described as N (no).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acupuncture', 'Cupping', 'Osteoarthritis', 'Pain'], 'conditions': ['Knee Osteoarthritis', 'Pain, Chronic']}, 'referencesModule': {'references': [{'pmid': '25865392', 'type': 'BACKGROUND', 'citation': 'Kraus VB, Blanco FJ, Englund M, Karsdal MA, Lohmander LS. Call for standardized definitions of osteoarthritis and risk stratification for clinical trials and clinical use. Osteoarthritis Cartilage. 2015 Aug;23(8):1233-41. doi: 10.1016/j.joca.2015.03.036. Epub 2015 Apr 9.'}, {'pmid': '23973143', 'type': 'RESULT', 'citation': 'Corbett MS, Rice SJ, Madurasinghe V, Slack R, Fayter DA, Harden M, Sutton AJ, Macpherson H, Woolacott NF. Acupuncture and other physical treatments for the relief of pain due to osteoarthritis of the knee: network meta-analysis. Osteoarthritis Cartilage. 2013 Sep;21(9):1290-8. doi: 10.1016/j.joca.2013.05.007.'}]}, 'descriptionModule': {'briefSummary': 'Given the lack of studies in the literature associating the use of acupuncture and sliding suction cup in patients with advanced knee osteoarthritis, the objective of this study is to evaluate the benefits of this association in patients of the Institute of Orthopedics and Traumatology outpatient clinic of the University of São Paulo while awaiting surgical treatment of knee osteoarthritis as a method of pain relief, limb function improvement and quality of life.', 'detailedDescription': '120 patients with indications for surgical knee treatment from IOT-HCFMUSP will be invited to participate in the project. Inclusion applications and those who agree to sign a free and informed consent form (IC) will be included.\n\nDuring the period of inclusion of patients, will be clarified regarding the application and evaluation methods that will be used through consultation and initial medical evaluation. Then, the included patients are randomized into four existing groups:\n\nGroup A - Acupuncture Sham + Cupping Sham; Group B - Sham Acupuncture + Real Cupping; Group C - Real Acupuncture + Sham Cupping; Group D - Real Acupuncture + Real Cupping.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients with a diagnosis of knee osteoarthritis\n* WOMAC-Pain greater than or equal to 15 points.\n\nExclusion Criteria:\n\n* advanced degenerative central neuropathy (Parkinson's, Alzheimer's)\n* diabetic peripheral neuropathy\n* stroke sequela\n* history of digestive bleeding\n* chronic renal failure\n* renal failure\n* heart failure\n* fibromyalgia\n* rheumatoid arthritis\n* SLE\n* severe depression\n* psychiatric disorders\n* concomitance with hip arthritis"}, 'identificationModule': {'nctId': 'NCT04168593', 'briefTitle': 'Association of Acupuncture and Cupping in Advanced Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Randomized Controlled Trial of the Use of Acupuncture and Cupping in Patients Awaiting Total Knee Arthroplasty (TKA) Due to Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'Acupuncture in KOA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'A- Placebo', 'description': 'Sham Acupuncture and Sham Cupping', 'interventionNames': ['Procedure: Acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B -Cupping', 'description': 'Sham Acupuncture and Real Cupping', 'interventionNames': ['Procedure: Acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C - Acupuncture', 'description': 'Real Acupuncture and Sham Cupping', 'interventionNames': ['Procedure: Acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'D - Acupuncture + Cupping', 'description': 'Real Acupuncture and Real Cupping', 'interventionNames': ['Procedure: Acupuncture']}], 'interventions': [{'name': 'Acupuncture', 'type': 'PROCEDURE', 'otherNames': ['Cupping'], 'description': '20 min of Acupuncture section follow by 10 min of cupping around the knee', 'armGroupLabels': ['A- Placebo', 'B -Cupping', 'C - Acupuncture', 'D - Acupuncture + Cupping']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'USaoPauloGH', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Chin Lin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'these data are totally confidencial and unique to this protocol'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}