Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-28 @ 6:50 PM
Study NCT ID:
NCT01197950
Status:
COMPLETED
Last Update Posted:
2022-09-21
First Post:
2010-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acupuncture With Manual and Electrical Stimulation to Reduce Labour Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'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'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lena.martensson@his.se', 'phone': '+46500448000', 'title': 'Professor Lena Mårtensson', 'organization': 'Universty of Skovde'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Three hours', 'description': 'We did not expected any adverse event except for infections in the injection area or after the acupuncture needles were removed.', 'eventGroups': [{'id': 'EG000', 'title': 'Manual Acupuncture', 'description': 'Manual stimulation\n\nManual Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour.', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 0, 'seriousNumAtRisk': 99, 'deathsNumAffected': 99, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Electro Acupuncture', 'description': 'Electrical and manual stimulation\n\nElectro Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. Eight needles in the painful area (local points) will be connected to an electro-stimulator and stimulated with high frequency (80 Hz) square wave pulses (0.18-ms duration) with alternating polarity. The woman will adjust the intensity of the electrical stimulation to be just under pain threshold.', 'otherNumAtRisk': 103, 'deathsNumAtRisk': 103, 'otherNumAffected': 0, 'seriousNumAtRisk': 103, 'deathsNumAffected': 103, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Standard Care', 'description': 'Standard care - no acupuncture treatment at all', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 0, 'seriousNumAtRisk': 101, 'deathsNumAffected': 101, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Only minor adverse events were expected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 101, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'Other'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Use of Epidural Analgesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Manual Acupuncture', 'description': 'Manual stimulation\n\nManual Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour.'}, {'id': 'OG001', 'title': 'Electro Acupuncture', 'description': 'Electrical and manual stimulation\n\nElectro Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. Eight needles in the painful area (local points) will be connected to an electro-stimulator and stimulated with high frequency (80 Hz) square wave pulses (0.18-ms duration) with alternating polarity. The woman will adjust the intensity of the electrical stimulation to be just under pain threshold.'}, {'id': 'OG002', 'title': 'Standard Care', 'description': 'Standard care'}], 'classes': [{'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of treatment until birth', 'description': 'Frequecy of epidural analgesia', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Manual Acupuncture', 'description': 'Manual stimulation\n\nManual Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour.'}, {'id': 'FG001', 'title': 'Electro Acupuncture', 'description': 'Electrical and manual stimulation\n\nElectro Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. Eight needles in the painful area (local points) will be connected to an electro-stimulator and stimulated with high frequency (80 Hz) square wave pulses (0.18-ms duration) with alternating polarity. The woman will adjust the intensity of the electrical stimulation to be just under pain threshold.'}, {'id': 'FG002', 'title': 'Standard Care', 'description': 'Standard Care No acupucture'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}, {'groupId': 'FG001', 'numSubjects': '103'}, {'groupId': 'FG002', 'numSubjects': '101'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': "women's request (9), high workload (3), returned home (1), partus in one hour (1), other (2)", 'groupId': 'FG000', 'numSubjects': '83'}, {'comment': "women's request (11) high workload (4) returned to home (1)", 'groupId': 'FG001', 'numSubjects': '87'}, {'comment': "woman's request (11) high workload (1) returned to home (2) other (4)", 'groupId': 'FG002', 'numSubjects': '83'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': "Women's request (31), high workload (8), returned home (4), partus in one hour (1), other (6)", 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '18'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}, {'value': '303', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Manual Acupuncture', 'description': 'Manual stimulation\n\nManual Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour.'}, {'id': 'BG001', 'title': 'Electro Acupuncture', 'description': 'Electrical and manual stimulation\n\nElectro Acupuncture: The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. Eight needles in the painful area (local points) will be connected to an electro-stimulator and stimulated with high frequency (80 Hz) square wave pulses (0.18-ms duration) with alternating polarity. The woman will adjust the intensity of the electrical stimulation to be just under pain threshold.'}, {'id': 'BG002', 'title': 'Standard Care', 'description': 'No acupunture'}, {'id': 'BG003', '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}, {'value': '303', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}, {'value': '303', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Sweden', 'categories': [{'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}, {'value': '303', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 303}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-07', 'studyFirstSubmitDate': '2010-08-26', 'resultsFirstSubmitDate': '2020-04-25', 'studyFirstSubmitQcDate': '2010-09-07', 'lastUpdatePostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-03', 'studyFirstPostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Use of Epidural Analgesia', 'timeFrame': 'From start of treatment until birth', 'description': 'Frequecy of epidural analgesia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['acupuncture', 'labour', 'pain', 'pain relief', 'complementary'], 'conditions': ['Labour Pain']}, 'referencesModule': {'references': [{'pmid': '26066641', 'type': 'BACKGROUND', 'citation': 'Vixner L, Martensson LB, Schytt E. Acupuncture with manual and electrical stimulation for labour pain: a two month follow up of recollection of pain and birth experience. BMC Complement Altern Med. 2015 Jun 12;15:180. doi: 10.1186/s12906-015-0708-2.'}, {'pmid': '22577468', 'type': 'BACKGROUND', 'citation': 'Vixner L, Martensson LB, Stener-Victorin E, Schytt E. Manual and electroacupuncture for labour pain: study design of a longitudinal randomized controlled trial. Evid Based Complement Alternat Med. 2012;2012:943198. doi: 10.1155/2012/943198. Epub 2012 Apr 17.'}, {'pmid': '27986648', 'type': 'BACKGROUND', 'citation': "Vixner L, Schytt E, Martensson LB. Associations between maternal characteristics and women's responses to acupuncture during labour: a secondary analysis from a randomised controlled trial. Acupunct Med. 2017 Jun;35(3):180-188. doi: 10.1136/acupmed-2016-011164. Epub 2016 Dec 16."}, {'pmid': '24913704', 'type': 'BACKGROUND', 'citation': 'Vixner L, Schytt E, Stener-Victorin E, Waldenstrom U, Pettersson H, Martensson LB. Acupuncture with manual and electrical stimulation for labour pain: a longitudinal randomised controlled trial. BMC Complement Altern Med. 2014 Jun 9;14:187. doi: 10.1186/1472-6882-14-187.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of manual acupuncture and electro-acupuncture on labour pain.', 'detailedDescription': "Acupuncture is used in obstetric care in spite of insufficient evidence of its potential to reduce labour pain. The findings so far are contradictory, which may reflect methodological limitations. The present study will take issues into account, such as sufficiently large sample to allow detection of possible differences between study groups; optimal timing of the intervention; controlling for intensity of the treatment; qualified training of persons giving the treatment; biological markers of pain and stress; possible effects on mother and infant; women's experiences such as overall birth experience and memory of pain."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admission to the labour ward in spontaneous onset of labour\n* Latent or active phase of labour\n* Nulliparity\n* Singleton pregnancy, cephalic presentation\n* Gestation: 37+0 to 41+6 (weeks + days)\n* Expressed need for labour pain relief\n* Swedish speaking (well enough to understand written and oral instructions)\n\nExclusion Criteria:\n\n* No pharmacological pain relief within 24 hours prior to inclusion into the study\n* Severe preeclampsia\n* Treatment with oxytocin at the time point of allocation\n* Treatment with anticoagulant\n* Pacemaker'}, 'identificationModule': {'nctId': 'NCT01197950', 'briefTitle': 'Acupuncture With Manual and Electrical Stimulation to Reduce Labour Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Skövde'}, 'officialTitle': 'A Randomized Controlled Trial of Acupuncture to Reduce Labour Pain', 'orgStudyIdInfo': {'id': '136-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Manual Acupuncture', 'description': 'Manual stimulation', 'interventionNames': ['Device: Manual Acupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'Electro Acupuncture', 'description': 'Electrical and manual stimulation', 'interventionNames': ['Device: Electro Acupuncture']}, {'type': 'NO_INTERVENTION', 'label': 'Standard care', 'description': 'No acupunture'}], 'interventions': [{'name': 'Manual Acupuncture', 'type': 'DEVICE', 'otherNames': ['Acupuncture'], 'description': 'The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour.', 'armGroupLabels': ['Manual Acupuncture']}, {'name': 'Electro Acupuncture', 'type': 'DEVICE', 'otherNames': ['Acupuncture'], 'description': 'The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. Eight needles in the painful area (local points) will be connected to an electro-stimulator and stimulated with high frequency (80 Hz) square wave pulses (0.18-ms duration) with alternating polarity. The woman will adjust the intensity of the electrical stimulation to be just under pain threshold.', 'armGroupLabels': ['Electro Acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-541 28', 'city': 'Skövde', 'country': 'Sweden', 'facility': 'School of Life Sciences, University of Skövde', 'geoPoint': {'lat': 58.39118, 'lon': 13.84506}}], 'overallOfficials': [{'name': 'Lena B Martensson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Skövde'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Skövde', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD RNM Senior Lecturer', 'investigatorFullName': 'Lena B Martensson', 'investigatorAffiliation': 'University of Skövde'}}}}