Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-31 @ 8:49 PM
Study NCT ID:
NCT00333606
Status:
COMPLETED
Last Update Posted:
2019-10-22
First Post:
2006-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acupuncture and Auditory Evoked Potentials
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'taras@uni-greifswald.de', 'phone': '+493834865828', 'title': 'Taras Usichenko, director of the trial', 'organization': 'Ernst Moritz Arndt University of Greifswald'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '2 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Verum Acupuncture', 'description': 'verum acupuncture means stimulation of specific acupuncture points', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sham Acupuncture', 'description': 'Sham acupuncture means stimulation of non-specific points', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 0, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Latencies of Auditory Evoked Potentials', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Verum Acupuncture', 'description': 'Acupuncture of specific acupuncture points\n\nAcupuncture: Body acupuncture of 1 specific point per trial session'}, {'id': 'OG001', 'title': 'Sham Acupuncture', 'description': 'Acupuncture of non-specific acupuncture points\n\nAcupuncture: Body acupuncture of 1 specific point per trial session'}], 'classes': [{'categories': [{'measurements': [{'value': '255', 'spread': '55', 'groupId': 'OG000'}, {'value': '255', 'spread': '55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'before acupuncture stimulation', 'unitOfMeasure': 'ms', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sham Acupuncture', 'description': 'Sham acupuncture means stimulation of non-specific points'}, {'id': 'OG001', 'title': 'Verum Acupuncture', 'description': 'Acupuncture needles applied to specific acupuncture points'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '60'}, {'value': '20', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30 min', 'description': 'Visual Analogue Scale 0-100 mm, where 0=no pain, and 100=maximal pain', 'unitOfMeasure': 'mm', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sham, Then Verum Acupuncture', 'description': 'Stimulation was applied to sham acupuncture point'}, {'id': 'FG001', 'title': 'Verum, Then Sham Acupuncture', 'description': 'Stimulation was applied to verum acupuncture point'}], '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': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This was the crossover study with 60 participants. Each participant underwent 2 conditions: verum and sham acupuncture within an interval of at least one week.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Verum, Then Sham Acupuncture', 'description': 'verum acupuncture means stimulation of specific acupuncture points'}, {'id': 'BG001', 'title': 'Sham, Then Verum Acupuncture', 'description': 'Sham acupuncture means stimulation of non-specific points'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Healthy volunteers'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-18', 'studyFirstSubmitDate': '2006-06-03', 'resultsFirstSubmitDate': '2011-02-25', 'studyFirstSubmitQcDate': '2006-06-03', 'lastUpdatePostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-18', 'studyFirstPostDateStruct': {'date': '2006-06-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Latencies of Auditory Evoked Potentials', 'timeFrame': 'before acupuncture stimulation'}], 'secondaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': '30 min', 'description': 'Visual Analogue Scale 0-100 mm, where 0=no pain, and 100=maximal pain'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Evoked Potentials', 'Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'To investigate whether body acupuncture of acupuncture points specific for hearing influences the auditory avoked potentials in comparison to puncture of non-specific acupuncture points'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy volunteers aged 20-40 years\n2. Physical status I according to American Society of Anesthesiologists (ASA) classification\n3. No history of nervous or psychiatric disease\n4. Normal audiogram before the study\n5. No chronic consume of analgesics, anticoagulants and/or antiplatelet agents, sedatives or alcohol\n6. No local infection at the site of acupuncture\n7. Volunteers who have given informed consent\n\nExclusion Criteria:\n\n1. Pregnant or nursing females.\n2. History of peripheral neuropathy\n3. Abnormal skin conditions (infection, scars, psoriasis, eczema)\n4. Inflamed site of acupuncture within 1 week'}, 'identificationModule': {'nctId': 'NCT00333606', 'briefTitle': 'Acupuncture and Auditory Evoked Potentials', 'organization': {'class': 'OTHER', 'fullName': 'University Medicine Greifswald'}, 'officialTitle': 'Effects of Acupuncture on the Auditory Evoked Potentials: a Randomized Volunteer Crossover Study', 'orgStudyIdInfo': {'id': 'III UV 12/06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Verum acupuncture', 'description': 'Acupuncture of specific acupuncture points', 'interventionNames': ['Behavioral: Acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham acupuncture', 'description': 'Acupuncture of non-specific acupuncture points', 'interventionNames': ['Behavioral: Acupuncture']}], 'interventions': [{'name': 'Acupuncture', 'type': 'BEHAVIORAL', 'description': 'Body acupuncture of 1 specific point per trial session', 'armGroupLabels': ['Sham acupuncture', 'Verum acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17475', 'city': 'Greifswald', 'country': 'Germany', 'facility': 'Ernst Moritz Arndt University', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}], 'overallOfficials': [{'name': 'Taras I Usichenko, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Ernst Moritz Arndt University'}, {'name': 'Reinhard Schmidt, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ernst Moritz Arndt University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taras Usichenko', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr. Taras Usichenko', 'investigatorFullName': 'Taras Usichenko', 'investigatorAffiliation': 'University Medicine Greifswald'}}}}