Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-01-07 @ 11:53 PM
Study NCT ID:
NCT02914834
Status:
TERMINATED
Last Update Posted:
2021-10-07
First Post:
2016-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acupuncture for Individuals With Stable Angina
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D017566', 'term': 'Microvascular Angina'}, {'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'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': 'jschlaeg@uic.edu', 'phone': '3124134669', 'title': 'Judith Schlaeger, PhD', 'organization': 'University of Illinois Chicago'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Event data were collected over the duration of the 5-week study protocol', 'eventGroups': [{'id': 'EG000', 'title': 'Device Acupuncture', 'description': 'Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions\n\nAcupuncture: Standardized acupuncture treatment administered for 30 minutes each session', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Non-pain Related Video Health Education', 'description': 'The attention control group will receive non-pain related video health education over 5 weeks equal to the approximate 10 hours of treatment for the acupuncture group.\n\nNon-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of Study Protocol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Acupuncture', 'description': 'Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions\n\nAcupuncture: Standardized acupuncture treatment administered for 30 minutes each session'}, {'id': 'OG001', 'title': 'Non-pain Related Video Health Education', 'description': 'The attention control group will receive non-pain related video health education over 5 weeks equal to the approximate 10 hours of treatment for the acupuncture group.\n\nNon-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.'}], 'classes': [{'title': 'Participants recruited', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Participants retained', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Participants completed', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)', 'description': 'Feasibility was measured by recruitment (%), retention (%), completion (%). Feasibility was defined as ≥ 80% recruitment, ≥75% retention following enrollment, and ≥ 80% completion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Protocol Acceptability Scale for Treating Angina With Acupuncture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Acupuncture', 'description': 'Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions\n\nAcupuncture: Standardized acupuncture treatment administered for 30 minutes each session'}, {'id': 'OG001', 'title': 'Non-pain Related Video Health Education', 'description': 'The attention control group will receive non-pain related video health education over 5 weeks equal to the approximate 10 hours of treatment for the acupuncture group.\n\nNon-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.9', 'groupId': 'OG000'}, {'value': '51.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)', 'description': 'Protocol Acceptability Scale for Treating Angina with Acupuncture is a 9-item instrument used to measure acceptability of the study processes and protocols. Items are measured on a 0 to 2 scale, where 0 means "did not like the study and did not like acupuncture", and 2 means "liked the study and liked acupuncture". The protocol was deemed to have high acceptability if 80% of participants scored ≥ 80% of possible points on the acceptability scale. The investigators calculated the mean score for each of the 9 questions in each arm, divided the total score for the 9 questions by the maximum possible points for the measure (18 x number of participants in each arm), and converted the total mean scores to percentage of participants who liked the study/liked acupuncture in each arm.', 'unitOfMeasure': 'percentage of subjects who liked study', 'reportingStatus': 'POSTED', 'populationDescription': 'Those completing the study protocol at 5 weeks'}, {'type': 'SECONDARY', 'title': 'Average Pain Intensity From the McGill Pain Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Acupuncture', 'description': 'Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions\n\nAcupuncture: Standardized acupuncture treatment administered for 30 minutes each session'}, {'id': 'OG001', 'title': 'Non-pain Related Video Health Education', 'description': 'The attention control group will receive non-pain related video health education over 5 weeks equal to the approximate 10 hours of treatment for the acupuncture group.\n\nNon-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.'}], 'classes': [{'title': 'Baseline Average pain intensity', 'categories': [{'measurements': [{'value': '3.81', 'spread': '1.99', 'groupId': 'OG000'}, {'value': '3.42', 'spread': '2.56', 'groupId': 'OG001'}]}]}, {'title': 'Completion Average pain intensity', 'categories': [{'measurements': [{'value': '1.21', 'spread': '1.13', 'groupId': 'OG000'}, {'value': '2.97', 'spread': '1.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks', 'description': 'Average Pain Intensity from the McGill Pain Questionnaire is the average of pain now, least pain in the past 24 hours, and worst pain in the past 24 hours. Average Pain Intensity is scored on a 0 to 10 Likert type scale with 0 = no pain and 10 = excruciating pain. Pain intensity is the pre-specified outcome measure, while pain now and least and worst pain are values used to calculate average pain intensity and were not specified outcome measures.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Seattle Angina Questionnaire-7 (SAQ-7)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Acupuncture', 'description': 'Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions\n\nAcupuncture: Standardized acupuncture treatment administered for 30 minutes each session'}, {'id': 'OG001', 'title': 'Non-pain Related Video Health Education', 'description': 'The attention control group will receive non-pain related video health education over 5 weeks equal to the approximate 10 hours of treatment for the acupuncture group.\n\nNon-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.'}], 'classes': [{'title': 'Baseline Functional status', 'categories': [{'measurements': [{'value': '16.67', 'spread': '15.18', 'groupId': 'OG000'}, {'value': '29.78', 'spread': '26.77', 'groupId': 'OG001'}]}]}, {'title': 'Completion Functional status', 'categories': [{'measurements': [{'value': '46.67', 'spread': '27.49', 'groupId': 'OG000'}, {'value': '16.92', 'spread': '19.36', 'groupId': 'OG001'}]}]}, {'title': 'Baseline symptoms', 'categories': [{'measurements': [{'value': '55.00', 'spread': '20.23', 'groupId': 'OG000'}, {'value': '62.67', 'spread': '13.35', 'groupId': 'OG001'}]}]}, {'title': 'Completion Symptoms', 'categories': [{'measurements': [{'value': '72.73', 'spread': '15.55', 'groupId': 'OG000'}, {'value': '56.15', 'spread': '8.70', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Quality of Life', 'categories': [{'measurements': [{'value': '20.83', 'spread': '26.82', 'groupId': 'OG000'}, {'value': '16.67', 'spread': '13.91', 'groupId': 'OG001'}]}]}, {'title': 'Completion Quality of life', 'categories': [{'measurements': [{'value': '54.55', 'spread': '23.90', 'groupId': 'OG000'}, {'value': '11.54', 'spread': '12.97', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Total score', 'categories': [{'measurements': [{'value': '29.29', 'spread': '13.01', 'groupId': 'OG000'}, {'value': '36.57', 'spread': '16.14', 'groupId': 'OG001'}]}]}, {'title': 'Completion Total score', 'categories': [{'measurements': [{'value': '56.44', 'spread': '19.74', 'groupId': 'OG000'}, {'value': '27.51', 'spread': '9.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks', 'description': 'The instrument consists of 7 items measuring functional status, symptoms, and quality of life on participants. Item responses are coded sequentially from worst to best status and range from 1 to 6, except Quality of Life (range 1-5). Scores are generated for each domain and are scaled 0 to 100, with 0 denoting the worst and 100 the best possible status.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Inflammatory Biomarkers Blood Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Acupuncture', 'description': 'Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions\n\nAcupuncture: Standardized acupuncture treatment administered for 30 minutes each session'}, {'id': 'OG001', 'title': 'Non-pain Related Video Health Education', 'description': 'The attention control group will receive non-pain related video health education over 5 weeks equal to the approximate 10 hours of treatment for the acupuncture group.\n\nNon-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.'}], 'classes': [{'title': 'Mean change IL-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.394', 'spread': '22.523', 'groupId': 'OG000'}, {'value': '11.595', 'spread': '17.414', 'groupId': 'OG001'}]}]}, {'title': 'Mean Change IL-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.444', 'spread': '2.724', 'groupId': 'OG000'}, {'value': '-.818', 'spread': '2.306', 'groupId': 'OG001'}]}]}, {'title': 'Mean Change IL-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-.096', 'spread': '.863', 'groupId': 'OG000'}, {'value': '-.212', 'spread': '1.224', 'groupId': 'OG001'}]}]}, {'title': 'Mean Change IL-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.065', 'spread': '7.671', 'groupId': 'OG000'}, {'value': '1.255', 'spread': '5.373', 'groupId': 'OG001'}]}]}, {'title': 'Mean Change IL-10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.317', 'spread': '14.373', 'groupId': 'OG000'}, {'value': '7.386', 'spread': '38.165', 'groupId': 'OG001'}]}]}, {'title': 'Mean Change IL-18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.695', 'spread': '65.646', 'groupId': 'OG000'}, {'value': '16.540', 'spread': '68.665', 'groupId': 'OG001'}]}]}, {'title': 'Mean change TNF-alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.312', 'spread': '25.370', 'groupId': 'OG000'}, {'value': '8.763', 'spread': '20.667', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks', 'description': 'Inflammatory biomarkers between the acupuncture and control group \\[interleukin (IL)- 2, IL-4, IL-6, IL-8, IL-10, IL-18; tumor necrosis factor alpha (TNF-α)\\]. Changes in these values from before first treatment at baseline to after 10th acupuncture treatment at 5 weeks is reported.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Overall number of participants analyzed differ based on difficulty drawing blood on subjects.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Inflammatory Biomarkers Blood Test- Mean Change C-reactive Protein (CRP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Device Acupuncture', 'description': 'Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions\n\nAcupuncture: Standardized acupuncture treatment administered for 30 minutes each session'}, {'id': 'OG001', 'title': 'Non-pain Related Video Health Education', 'description': 'The attention control group will receive non-pain related video health education over 5 weeks equal to the approximate 10 hours of treatment for the acupuncture group.\n\nNon-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.'}], 'classes': [{'categories': [{'measurements': [{'value': '-302.903', 'spread': '1049.445', 'groupId': 'OG000'}, {'value': '-457.205', 'spread': '1416.052', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks.', 'description': 'Inflammatory biomarker CRP between the acupuncture and control group. Changes in these values from before first treatment at baseline to after 10th acupuncture treatment at 5 weeks is reported.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Device Acupuncture', 'description': 'Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions\n\nAcupuncture: Standardized acupuncture treatment administered for 30 minutes each session'}, {'id': 'FG001', 'title': 'Non-pain Related Video Health Education', 'description': 'The attention control group will receive non-pain related video health education over 5 weeks equal to the approximate 10 hours of treatment for the acupuncture group.\n\nNon-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Study halted due to COVID', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': '1 subject withdrew', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Device Acupuncture', 'description': 'Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions\n\nAcupuncture: Standardized acupuncture treatment administered for 30 minutes each session'}, {'id': 'BG001', 'title': 'Non-pain Related Video Health Education', 'description': 'The attention control group will receive non-pain related video health education over 5 weeks equal to the approximate 10 hours of treatment for the acupuncture group.\n\nNon-pain related video health education: Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.'}, {'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': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '27 subjects recruited and enrolled, 24 subjects completed the trial.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-28', 'size': 292435, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-07-06T14:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'whyStopped': 'Research activity halted due to the Coronavirus Disease 2019 (COVID-19) pandemic. We were obliged to stop the in-person study in March 2020 due to the mandated lockdowns as a result of COVID.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-04', 'studyFirstSubmitDate': '2016-08-13', 'resultsFirstSubmitDate': '2021-03-16', 'studyFirstSubmitQcDate': '2016-09-23', 'lastUpdatePostDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-04', 'studyFirstPostDateStruct': {'date': '2016-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Inflammatory Biomarkers Blood Test', 'timeFrame': 'From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks', 'description': 'Inflammatory biomarkers between the acupuncture and control group \\[interleukin (IL)- 2, IL-4, IL-6, IL-8, IL-10, IL-18; tumor necrosis factor alpha (TNF-α)\\]. Changes in these values from before first treatment at baseline to after 10th acupuncture treatment at 5 weeks is reported.'}, {'measure': 'Inflammatory Biomarkers Blood Test- Mean Change C-reactive Protein (CRP)', 'timeFrame': 'From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks.', 'description': 'Inflammatory biomarker CRP between the acupuncture and control group. Changes in these values from before first treatment at baseline to after 10th acupuncture treatment at 5 weeks is reported.'}], 'primaryOutcomes': [{'measure': 'Feasibility of Study Protocol', 'timeFrame': 'After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)', 'description': 'Feasibility was measured by recruitment (%), retention (%), completion (%). Feasibility was defined as ≥ 80% recruitment, ≥75% retention following enrollment, and ≥ 80% completion.'}, {'measure': 'Protocol Acceptability Scale for Treating Angina With Acupuncture', 'timeFrame': 'After 10th acupuncture treatment, at 5 weeks post-baseline (study completion)', 'description': 'Protocol Acceptability Scale for Treating Angina with Acupuncture is a 9-item instrument used to measure acceptability of the study processes and protocols. Items are measured on a 0 to 2 scale, where 0 means "did not like the study and did not like acupuncture", and 2 means "liked the study and liked acupuncture". The protocol was deemed to have high acceptability if 80% of participants scored ≥ 80% of possible points on the acceptability scale. The investigators calculated the mean score for each of the 9 questions in each arm, divided the total score for the 9 questions by the maximum possible points for the measure (18 x number of participants in each arm), and converted the total mean scores to percentage of participants who liked the study/liked acupuncture in each arm.'}], 'secondaryOutcomes': [{'measure': 'Average Pain Intensity From the McGill Pain Questionnaire', 'timeFrame': 'From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks', 'description': 'Average Pain Intensity from the McGill Pain Questionnaire is the average of pain now, least pain in the past 24 hours, and worst pain in the past 24 hours. Average Pain Intensity is scored on a 0 to 10 Likert type scale with 0 = no pain and 10 = excruciating pain. Pain intensity is the pre-specified outcome measure, while pain now and least and worst pain are values used to calculate average pain intensity and were not specified outcome measures.'}, {'measure': 'Seattle Angina Questionnaire-7 (SAQ-7)', 'timeFrame': 'From before first treatment at baseline to after 10th acupuncture treatment (study completion) at 5 weeks', 'description': 'The instrument consists of 7 items measuring functional status, symptoms, and quality of life on participants. Item responses are coded sequentially from worst to best status and range from 1 to 6, except Quality of Life (range 1-5). Scores are generated for each domain and are scaled 0 to 100, with 0 denoting the worst and 100 the best possible status.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Angina, Stable', 'Chest Pain', 'Microvascular Angina', 'Heart Failure']}, 'referencesModule': {'references': [{'pmid': '34856826', 'type': 'DERIVED', 'citation': 'DeVon HA, Uwizeye G, Cai HY, Shroff AR, Briller JE, Ardati A, Hoppensteadt D, Rountree L, Schlaeger JM. Feasibility and preliminary efficacy of acupuncture for angina in an underserved diverse population. Acupunct Med. 2022 Apr;40(2):152-159. doi: 10.1177/09645284211055754. Epub 2021 Dec 2.'}]}, 'descriptionModule': {'briefSummary': 'This RCT aims to determine if it is possible to perform acupuncture on men and women diagnosed with stable angina who have symptoms, chest pain, and/or chest discomfort. The investigators want to determine if acupuncture reduces the pain and other symptoms of angina, chest pain, and chest discomfort. The investigators also want to examine whether this study is acceptable to the participants, and by carrying out this study the investigators will be able to tell how many participants they will need in a future larger study to further test acupuncture to reduce the symptoms of angina in women.', 'detailedDescription': 'The investigators are conducting a RCT aimed at gathering feasibility, and initial efficacy for a randomized controlled trial (RCT) to test the effect of acupuncture on anginal symptoms, chest pain, and chest discomfort in men and women. The investigators long term goal is pain and symptom management resulting in improved functional status and quality of life for men and women with stable angina, chest pain, and chest discomfort. This study will include 69 community dwelling men and women with a medically confirmed diagnosis of stable angina, chest pain which includes non-ischemic or ischemic cardiomyopathy, microvascular coronary dysfunction (MCD), heart failure with preserved ejection fraction (HFpEF), heart failure with reduced ejection fraction (HFrEF), or chest discomfort whose pain and associated symptoms have not been completely controlled with guideline-directed medical management. The investigators will use a randomized attention control design with 13 men and women assigned to initial acupuncture and 13 to control. Participants in the experimental group will receive a standardized acupuncture point prescription two treatments per week, for 5 weeks. The attention control group will receive non-pain related video health education over 5 weeks equal to the approximate 10 hours of treatment for the acupuncture group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* provision of a verified diagnosis from a care provider\n* male or female sex\n* at least 21 years of age\n* intermittent angina symptoms (pain, pressure, or discomfort in the chest or other areas of the upper body)\n* medical confirmation of a diagnosis of stable angina for at least 6 months\n\nmedical confirmation of a diagnosis of chest pain including non-ischemic or ischemic cardiomyopathy\n\nmedical confirmation of a diagnosis of microvascular coronary dysfunction (MCD)\n\nmedical confirmation of a diagnosis of heart failure with preserved ejection fraction (HFpEF), heart failure with reduced ejection fraction (HFrEF) medical confirmation of chest discomfort.\n\nExclusion criteria:\n\n* pregnancy\n* chronic obstructive pulmonary disease (COPD) causing pain or associated symptoms\n* autoimmune dysfunction\n* use of steroid medications\n* concomitant physical therapy\n* biofeedback\n* massage\n* additional acupuncture'}, 'identificationModule': {'nctId': 'NCT02914834', 'acronym': 'AIMS-A', 'briefTitle': 'Acupuncture for Individuals With Stable Angina', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Feasibility Testing of a Randomized Controlled Trial of Acupuncture to Improve Symptoms for Individuals With Stable Angina (AIMS-A)', 'orgStudyIdInfo': {'id': '2016-0642'}, 'secondaryIdInfos': [{'id': 'R21NR017705-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R21NR017705-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Device Acupuncture', 'description': 'Standardized acupuncture protocol twice per week for 5 weeks for a total of 10 sessions', 'interventionNames': ['Other: Acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-pain related video health education', 'description': 'The attention control group will receive non-pain related video health education over 5 weeks equal to the approximate 10 hours of treatment for the acupuncture group.', 'interventionNames': ['Other: Non-pain related video health education']}], 'interventions': [{'name': 'Acupuncture', 'type': 'OTHER', 'description': 'Standardized acupuncture treatment administered for 30 minutes each session', 'armGroupLabels': ['Device Acupuncture']}, {'name': 'Non-pain related video health education', 'type': 'OTHER', 'description': 'Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.', 'armGroupLabels': ['Non-pain related video health education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago College of Nursing', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Holli A DeVon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Judith Schlaeger', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}