Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-02-28 @ 3:53 AM
Study NCT ID:
NCT02456727
Status:
COMPLETED
Last Update Posted:
2020-09-18
First Post:
2015-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acupuncture Approaches for Chronic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D001416', 'term': 'Back Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Diane.Mckee@einstein.yu.edu', 'phone': '718-430-2952', 'title': 'Diane McKee', 'organization': 'Albert Einstein College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '24 weeks (12 weeks of treatment plus 12 weeks post-treatment)', 'eventGroups': [{'id': 'EG000', 'title': 'Group Acupuncture', 'description': 'Participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.', 'otherNumAtRisk': 389, 'deathsNumAtRisk': 389, 'otherNumAffected': 10, 'seriousNumAtRisk': 389, 'deathsNumAffected': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Individual Acupuncture', 'description': 'Participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.', 'otherNumAtRisk': 390, 'deathsNumAtRisk': 390, 'otherNumAffected': 5, 'seriousNumAtRisk': 390, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Prolonged Musculo-Skeletal Pain', 'notes': 'Procedural complication due to receiving acupuncture. Which may cause an increase in pain for some time.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 390, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncopal Symptoms', 'notes': 'Procedural complication of receiving acupuncture because of the increased risk for fainting and lightheadedness.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'notes': 'Procedural complication of receiving acupuncture. Swelling may occur.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 390, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Prolonged Bruising', 'notes': 'Bruising may be caused by acupuncture. It is also a side effect of Gua Sha.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Loss of vaccaria seed in ear', 'notes': "Ear seed fell into the participant's ear. Seeds from the Vaccaria plant are secured on the ear with tape over acupuncture points. The seeds stimulate the point by exerting mild pressure. The patient can rub or press on them for an added effect.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'notes': 'Participant fainted during treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 389, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 390, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Interference as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.'}, {'id': 'OG001', 'title': 'Individual Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '385', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.0', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '279', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '277', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0691', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3714', 'ciLowerLimit': '-0.7720', 'ciUpperLimit': '0.0291', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2039', 'estimateComment': 'The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)', 'description': "The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much the participants' pain interferes with daily life. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Investigators measured improvement in BPI pain interference from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data.", 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'PRIMARY', 'title': 'Pain Interference as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks and attended \\>=8 sessions.'}, {'id': 'OG001', 'title': 'Individual Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks and attended \\>=8 sessions.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '229', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.8', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '194', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '3.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5077', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1631', 'ciLowerLimit': '-0.6452', 'ciUpperLimit': '0.319', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.246', 'estimateComment': 'The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window))', 'description': 'The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. We measured improvement in BPI pain interference from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'PRIMARY', 'title': 'Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '271', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.'}, {'id': 'OG001', 'title': 'Individual Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.'}], 'classes': [{'categories': [{'title': '>=30% Improvement in Pain Interference', 'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}, {'title': '<30% Improvement in Pain Interference', 'measurements': [{'value': '189', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.24', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0724', 'ciLowerLimit': '-0.0058', 'ciUpperLimit': '0.1506', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0399', 'estimateComment': 'The estimated value is the difference of proportion of respondents (\\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 12 (End of Treatment Window)', 'description': 'The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in their pain interference from baseline to the end of treatment window (week 12). 30% improvement is a decrease of \\>=2 points on the BPI from baseline to the end of treatment window (week 12). A 30% decrease is considered a clinically significant improvement in pain. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were analyzed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'PRIMARY', 'title': 'Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks and attended \\>= 8 sessions.'}, {'id': 'OG001', 'title': 'Individual Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks and attended \\>= 8 sessions.'}], 'classes': [{'categories': [{'title': '>=30% Improvement in Pain Interference', 'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}, {'title': '<30% Improvement in Pain Interference', 'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0531', 'ciLowerLimit': '-0.0422', 'ciUpperLimit': '0.1485', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0487', 'estimateComment': 'The estimated value is the difference of proportion of respondents (\\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 12 (End of Treatment)', 'description': 'The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in pain interference from baseline to the end of treatment window (week 12). 30% improvement is a decrease of \\>=2 points on the BPI from baseline to the end of treatment window (week 12). A 30% decrease is considered a clinically significant improvement in pain. Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Only participants who completed a week 12 questionnaire were analyzed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'PRIMARY', 'title': 'Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.'}, {'id': 'OG001', 'title': 'Individual Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.'}], 'classes': [{'categories': [{'title': '>=30% Improvement in Pain Interference', 'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}, {'title': '<30% Improvement in Pain Interference', 'measurements': [{'value': '191', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0625', 'ciLowerLimit': '-0.0151', 'ciUpperLimit': '0.1401', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0396', 'estimateComment': 'The estimated value is the difference of proportion of respondents (\\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 24 (12 weeks after treatment window)', 'description': 'The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in pain interference from baseline to week 24 (12 weeks after treatment window). 30% improvement is a decrease of \\>=2 points on the BPI from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were included in the analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'PRIMARY', 'title': 'Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '182', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks and attended \\>= 8 sessions.'}, {'id': 'OG001', 'title': 'Individual Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks and attended \\>= 8 sessions.'}], 'classes': [{'categories': [{'title': '>=30% Improvement in Pain Interference', 'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}, {'title': '<30% Improvement in Pain Interference', 'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.40', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0882', 'ciLowerLimit': '-0.0075', 'ciUpperLimit': '0.184', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0488', 'estimateComment': 'The estimated value is the difference of proportion of respondents (\\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 24 (12 weeks after treatment window)', 'description': 'The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in pain interference from baseline to week 24 (12 weeks after treatment). 30% improvement is a decrease of \\>=2 points on the BPI from baseline to week 24 (12 weeks after treatment). The definition of Per Protocol is all participants who have been randomized and who attended \\>=8 sessions of acupuncture. Only patients who completed a week 24 questionnaire were included in the analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, lost to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Pain Severity as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.'}, {'id': 'OG001', 'title': 'Individual Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}, {'value': '386', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.8', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '301', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '276', 'groupId': 'OG000'}, {'value': '279', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.9', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1387', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2643', 'ciLowerLimit': '-0.6136', 'ciUpperLimit': '0.0851', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1782', 'estimateComment': 'The estimated value is the difference of score change from baseline to 12 weeks between the two treatment arms (Individual-Group).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The outcome is the change in score from baseline to 12 weeks, adjusting for the baseline score.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)', 'description': 'The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and then divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. We measured improvement in BPI pain severity from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is anyone who intended to receive treatment; in our case, it is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Pain Severity as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks and attended \\>=8 sessions.'}, {'id': 'OG001', 'title': 'Individual Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks and attended \\>=8 sessions.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.3', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2725', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2334', 'ciLowerLimit': '-0.6497', 'ciUpperLimit': '0.1829', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.2124', 'estimateComment': 'The estimated value is the difference of score change from baseline to 12 weeks between the two treatment arms (Individual-Group).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The outcome is the change in score from baseline to 12 weeks, adjusting for the baseline score.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)', 'description': 'The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. We measured improvement in BPI pain severity from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '299', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.'}, {'id': 'OG001', 'title': 'Individual Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.'}], 'classes': [{'categories': [{'title': '>=30% Improvement in Pain Severity', 'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}, {'title': '<30% Improvement in Pain Severity', 'measurements': [{'value': '198', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0426', 'ciLowerLimit': '-0.0334', 'ciUpperLimit': '0.1185', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0388', 'estimateComment': 'The estimated value is the difference of proportion of respondents (\\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 12 (End of Treatment Window)', 'description': 'The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity from baseline to the end of treatment window (week 12). 30% improvement is a decrease of \\>=2 points on the BPI from baseline to the end of treatment window (week 12). A 30% decrease in pain severity is considered a clinically significant improvement in pain. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were analyzed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '201', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks and attended \\>= 8 sessions.'}, {'id': 'OG001', 'title': 'Individual Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks and attended \\>= 8 sessions.'}], 'classes': [{'categories': [{'title': '>=30% Improvement in Pain Severity', 'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}, {'title': '<30% Improvement in Pain Severity', 'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0283', 'ciLowerLimit': '-0.0651', 'ciUpperLimit': '0.1218', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0477', 'estimateComment': 'The estimated value is the difference of proportion of respondents (\\>=30% improvement) at 12 weeks between two treatment arms (Individual-Group)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 12 (End of Treatment Window)', 'description': 'The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity from baseline to the end of treatment window (week 12). 30% improvement is a decrease of \\>=2 points on the BPI from baseline to the end of treatment window (week 12). A 30% decrease in pain severity is considered a clinically significant improvement in pain. The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Only participants who completed a week 12 questionnaire were analyzed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.'}, {'id': 'OG001', 'title': 'Individual Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.'}], 'classes': [{'categories': [{'title': '>=30% Improvement in Pain Severity', 'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}, {'title': '<30% Improvement in Pain Severity', 'measurements': [{'value': '220', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0262', 'ciLowerLimit': '-0.0436', 'ciUpperLimit': '0.0961', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0356', 'estimateComment': 'The estimated value is the difference of proportion of respondents (\\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 24 (12 Weeks After Treatment Window)', 'description': 'The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity from baseline to week 24 (12 weeks after treatment window). 30% improvement is a decrease of \\>=2 points on the BPI from baseline to week 24 (12 weeks after treatment window). A 30% decrease in pain severity is considered a clinically significant improvement in pain. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were analyzed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, lost to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks and attended \\>= 8 sessions.'}, {'id': 'OG001', 'title': 'Individual Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks and attended \\>= 8 sessions.'}], 'classes': [{'categories': [{'title': '>=30% Improvement in Pain Severity', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}, {'title': '<30% Improvement in Pain Severity', 'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0323', 'ciLowerLimit': '-0.0539', 'ciUpperLimit': '0.1186', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.044', 'estimateComment': 'The estimated value is the difference of proportion of respondents (\\>=30% improvement) at 24 weeks between two treatment arms (Individual-Group)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 24 (12 Weeks After Treatment Window)', 'description': 'The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity from baseline to week 24 (12 weeks after treatment window). 30% improvement is a decrease of \\>=2 points on the BPI from baseline to week 24 (12 weeks after treatment window). A 30% decrease in pain severity is considered a clinically significant improvement in pain. The definition of Per Protocol is all participants who have been randomized and who attended \\>=8 sessions of acupuncture. Only patients who completed a week 24 questionnaire were analyzed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Intent to Treat Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.'}, {'id': 'OG001', 'title': 'Individual Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '289', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1475', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.22', 'ciLowerLimit': '-0.5288', 'ciUpperLimit': '0.0795', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.15', 'estimateComment': 'The estimated value is the difference of PGIC change from baseline to 12 weeks between two treatment arms (Individual-Group).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The outcome is the change of PGIC from baseline to 12 weeks.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)', 'description': 'The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a participant has perceived a change in their condition after having some sort of treatment. In this case, we evaluated whether the participants experienced a positive change after receiving treatment, a decrease in their pain, from baseline (before receiving treatment) to week 24 (12 weeks after treatment window). The PGIC is scored from 0 (much better) to 10 (much worse). A higher score indicates that a participant has felt worse since starting treatment. The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Per Protocol Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks and attended \\>=8 sessions.'}, {'id': 'OG001', 'title': 'Individual Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks and attended \\>=8 sessions.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.546', 'ciUpperLimit': '0.1706', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.18', 'estimateComment': 'The estimated value is the difference of PGIC change from baseline to 12 weeks between two treatment arms (Individual-Group).', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The outcome is the change of PGIC from baseline to 12 weeks.'}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 (end of treatment window), and week 24 (12 weeks after treatment window)', 'description': 'The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a participant has perceived a change in their condition after having some sort of treatment. In this case, we evaluated whether the participants experienced a positive change after receiving treatment, a decrease in their pain, from baseline (before receiving treatment) to week 24 (12 weeks after treatment window). The PGIC is scored from 0 (much better) to 10 (much worse). A higher score indicates that a participant has felt worse since starting treatment. The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Intent to Treat Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '294', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.'}, {'id': 'OG001', 'title': 'Individual Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.'}], 'classes': [{'categories': [{'title': 'Improved (>=6 point score)', 'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}, {'title': 'Not improved (<=5 point score)', 'measurements': [{'value': '191', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0251', 'ciLowerLimit': '-0.0517', 'ciUpperLimit': '0.1018', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0392', 'estimateComment': 'The estimated value is the difference of proportion of respondents (change post treatment\\>=6) at 12 weeks between two treatment arms (Individual-Group)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12 (End of Treatment Window)', 'description': 'The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of \\>=6 points on the PGIC at week 12 (end of treatment window) as reported by the participants. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were included in the analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Per Protocol Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '206', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks and attended \\>=8 sessions.'}, {'id': 'OG001', 'title': 'Individual Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks and attended \\>=8 sessions.'}], 'classes': [{'categories': [{'title': 'Improved (>=6 point score)', 'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}, {'title': 'Not improved (<=5 point score)', 'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0018', 'ciLowerLimit': '-0.0925', 'ciUpperLimit': '0.096', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0481', 'estimateComment': 'The estimated value is the difference of proportion of respondents (change post treatment\\>=6) at 12 weeks between two treatment arms (Individual-Group)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12 (End of Treatment Window)', 'description': 'The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of \\>=6 points on the PGIC at week 12 (end of treatment window) as reported by the participants. The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Only participants who completed a week 12 questionnaire were included in the analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Intent to Treat Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.'}, {'id': 'OG001', 'title': 'Individual Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.'}], 'classes': [{'categories': [{'title': 'Improved (>=6 point score)', 'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}, {'title': 'Not improved (<=5 point score)', 'measurements': [{'value': '214', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.00', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0104', 'ciLowerLimit': '-0.081', 'ciUpperLimit': '0.0602', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.036', 'estimateComment': 'The estimated value is the difference of proportion of respondents (change post treatment\\>=6) at 24 weeks between two treatment arms (Individual-Group)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24 (12 Weeks After Treatment Window', 'description': 'The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of \\>=6 points on the PGIC at week 24 (12 weeks after treatment window) as reported by the participants. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were included in the analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Per Protocol Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '207', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks and attended \\>=8 sessions.'}, {'id': 'OG001', 'title': 'Individual Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks and attended \\>=8 sessions.'}], 'classes': [{'categories': [{'title': 'Improved (>=6 point score)', 'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}, {'title': 'Not improved (<=5 point score)', 'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0154', 'ciLowerLimit': '-0.0755', 'ciUpperLimit': '0.1063', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0464', 'estimateComment': 'The estimated value is the difference of proportion of respondents (change post treatment\\>=6) at 24 weeks between two treatment arms (Individual-Group)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24 (12 Week After Treatment Window)', 'description': 'The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of \\>=6 points on the PGIC at week 24 (12 weeks after treatment window) as reported by the participants. The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Only participants who completed a week 24 questionnaire were included in the analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.'}, {'id': 'OG001', 'title': 'Individual Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '387', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.8', 'spread': '7.2', 'groupId': 'OG000'}, {'value': '34.8', 'spread': '7.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '295', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.5', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '38.7', 'spread': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '287', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.2', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '37.8', 'spread': '8.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8778', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.082', 'ciLowerLimit': '-0.9659', 'ciUpperLimit': '1.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.5336', 'estimateComment': 'The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window))', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for physical health only 4 questions are used, scoring for physical health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 16.2-67.7. For this measure, we collected physical health scores from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks and attended \\>=8 sessions.'}, {'id': 'OG001', 'title': 'Individual Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks and attended \\>=8 sessions.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.3', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '35.2', 'spread': '7.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '207', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.4', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '39.6', 'spread': '8.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.2', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '38.7', 'spread': '8.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5626', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3623', 'ciLowerLimit': '-0.8667', 'ciUpperLimit': '1.5912', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.6252', 'estimateComment': 'The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for physical health only 4 questions are used, scoring for physical health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 16.2-67.7. For this measure, we collected physical health scores from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data..', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.'}, {'id': 'OG001', 'title': 'Individual Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.'}], 'classes': [{'categories': [{'title': '>=2 point Improvement in Physical health', 'measurements': [{'value': '173', 'groupId': 'OG000'}, {'value': '193', 'groupId': 'OG001'}]}, {'title': '<2 point Improvement in Physical health', 'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0362', 'ciLowerLimit': '-0.0419', 'ciUpperLimit': '0.1144', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0399', 'estimateComment': 'The estimated value is the difference of proportion of respondents (score change\\>=2) at 12 weeks between two treatment arms (Individual-Group)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 12 (End of treatment window)', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a \\>=2-point increase is considered a 30% improvement. The definition of intent to treat is all participants who have been randomized into treatment. Only patients who completed a week 12 questionnaire were included in the analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.'}, {'id': 'OG001', 'title': 'Individual Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.'}], 'classes': [{'categories': [{'title': '>=2 point Improvement in Physical health', 'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}, {'title': '<2 point Improvement in Physical health', 'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.22', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0647', 'ciLowerLimit': '-0.0266', 'ciUpperLimit': '0.156', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0466', 'estimateComment': 'The estimated value is the difference of proportion of respondents (score change\\>=2) at 12 weeks between two treatment arms (Individual-Group)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 12 (End of Treatment Window)', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a \\>=2-point increase is considered a 30% improvement. The definition of Per Protocol is all participants who have been randomized and who attended \\>=8 sessions of acupuncture. Only patients who completed a week 12 questionnaire were included in the analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '283', 'groupId': 'OG000'}, {'value': '296', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.'}, {'id': 'OG001', 'title': 'Individual Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.'}], 'classes': [{'categories': [{'title': '>=2 point Improvement in Physical health', 'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}, {'title': '<2 point Improvement in Physical health', 'measurements': [{'value': '141', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0523', 'ciLowerLimit': '-0.029', 'ciUpperLimit': '0.1335', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0415', 'estimateComment': 'The estimated value is the difference of proportion of respondents (score change\\>=2) at 24 weeks between two treatment arms (Individual-Group)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 24 (12 Weeks After Treatment Window)', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window), a \\>=2-point increase is considered a 30% improvement. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were included in the analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks and attended \\>=8 sessions.'}, {'id': 'OG001', 'title': 'Individual Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks and attended \\>=8 sessions.'}], 'classes': [{'categories': [{'title': '>=2 point Improvement in Physical health', 'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}, {'title': '<2 point Improvement in Physical health', 'measurements': [{'value': '97', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0928', 'ciLowerLimit': '-0.0047', 'ciUpperLimit': '0.1903', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0498', 'estimateComment': 'The estimated value is the difference of proportion of respondents (score change\\>=2) at 24 weeks between two treatment arms (Individual-Group)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 24 (12 Weeks After Treatment Window)', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as a \\>= 2-point increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Only participants who completed a week 24 questionnaire were included in the analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.'}, {'id': 'OG001', 'title': 'Individual Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '385', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.8', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '42.4', 'spread': '9.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '291', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.8', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '44.5', 'spread': '9.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '297', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.3', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '44.1', 'spread': '9.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4831', 'ciLowerLimit': '-0.6468', 'ciUpperLimit': '1.6129', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.5753', 'estimateComment': 'The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for mental health only 4 questions are used, scoring for mental health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 21.2-67.6. For this measure, we collected mental health scores from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks and attended \\>=8 sessions.'}, {'id': 'OG001', 'title': 'Individual Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks and attended \\>=8 sessions.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '226', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.6', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '43.5', 'spread': '9.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '218', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.4', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '45.2', 'spread': '9.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '206', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.1', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '45.0', 'spread': '9.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.307', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6617', 'ciLowerLimit': '-0.61', 'ciUpperLimit': '1.9334', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.647', 'estimateComment': 'The estimated value is the difference of score change from baseline to 12 weeks between two treatment arms (Individual-Group).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The outcome is the change of score from baseline to 12 weeks, adjusting for the baseline score.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for mental health only 4 questions are used, scoring for mental health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 21.2-67.6. For this measure, we collected mental health scores from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data.', 'unitOfMeasure': 'T-Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '288', 'groupId': 'OG000'}, {'value': '304', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.'}, {'id': 'OG001', 'title': 'Individual Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.'}], 'classes': [{'categories': [{'title': '>=5 point Improvement in Mental health', 'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}, {'title': '<5 point Improvement in Mental health', 'measurements': [{'value': '213', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0159', 'ciLowerLimit': '-0.0555', 'ciUpperLimit': '0.0873', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0364', 'estimateComment': 'The estimated value is the difference of proportion of respondents (score change\\>=5) at 12 weeks between two treatment arms (Individual-Group)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 12 (End of Treatment Window)', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a \\>=5-point increase is what we used to measure improvement. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were included in the analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks and attended \\>=8 sessions.'}, {'id': 'OG001', 'title': 'Individual Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks and attended \\>=8 sessions.'}], 'classes': [{'categories': [{'title': '>=5 point Improvement in Mental health', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}, {'title': '<5 point Improvement in Mental health', 'measurements': [{'value': '155', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0287', 'ciLowerLimit': '-0.0544', 'ciUpperLimit': '0.1117', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0424', 'estimateComment': 'The estimated value is the difference of proportion of respondents (score change\\>=5) at 12 weeks between two treatment arms (Individual-Group)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 12 (End of Treatment Window)', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a \\>=5-point increase is what we used to measure improvement. The definition of Per Protocol is all participants who have been randomized and who attended \\>=8 sessions of acupuncture. Only patients who completed a week 12 questionnaire were included in the analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.'}, {'id': 'OG001', 'title': 'Individual Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.'}], 'classes': [{'categories': [{'title': '>=5 point Improvement in Mental health', 'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}, {'title': '<5 point Improvement in Mental health', 'measurements': [{'value': '213', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0389', 'ciLowerLimit': '-0.0335', 'ciUpperLimit': '0.1112', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0369', 'estimateComment': 'The estimated value is the difference of proportion of respondents (score change\\>=5) at 24 weeks between two treatment arms (Individual-Group)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 24 (12 Weeks After Treatment Window)', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T-score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window), a \\>=5-point increase is what we used to measure improvement. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were included in the analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks and attended \\>=8 sessions.'}, {'id': 'OG001', 'title': 'Individual Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks and attended \\>=8 sessions.'}], 'classes': [{'categories': [{'title': '>=5 point Improvement in Mental health', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}, {'title': '<5 point Improvement in Mental health', 'measurements': [{'value': '152', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0608', 'ciLowerLimit': '-0.0247', 'ciUpperLimit': '0.1463', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0436', 'estimateComment': 'The estimated value is the difference of proportion of respondents (score change\\>=5) at 24 weeks between two treatment arms (Individual-Group)', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The null hypothesis is that the group treatment is inferior to the individual treatment. 10% is set as the non-inferiority margin. If the upper limit of 90% confidence interval of the estimated value does not exceed 10%, non-inferiority is demonstrated.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 24 (12 Weeks After Treatment Window)', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T-score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window), a \\>=5-point increase is what we used to measure improvement. The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Only participants who completed a week 24 questionnaire were included in the analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for each time point. This may have been due to withdrawal, loss to follow up, or declining to answer a question. If a participant declined to answer a question their score could not be calculated which excludes them.'}, {'type': 'SECONDARY', 'title': 'Participants Who Reported Use of Prescription Opioids in the Last Week (Intent to Treat Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.'}, {'id': 'OG001', 'title': 'Individual Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.'}], 'classes': [{'title': 'Opioid use within a week of Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '381', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'Opioid use within a week of Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Opioid use within a week of Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '285', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1658', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Two treatment arms are combined as one group to compare the outcome of interest pre- and post-randomization.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no change in the proportion of participants with self-reported opioid prescription comparing 12 weeks vs baseline.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)', 'description': 'Participants were asked whether they took any opioid medication within the last week. We compared self-reported prescription opioid use within a week of their baseline and week 12 questionnaires. The definition of intent to treat is all participants who have been randomized into treatment. Only participants who report having an opioid prescription are included in the analysis therefore if the participant did not have an opioid prescription they were excluded from the analysis. Statistical analysis only performed on baseline and week 12 (end of treatment) data.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for this time point. This may have been due to withdrawal, loss to follow up, or declining to answer this question. Only participants who responded to having taken prescription opioids were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Participants Who Reported Use of Prescription Opioids in the Last Week (Per Protocol Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks and attended \\>=8 sessions.'}, {'id': 'OG001', 'title': 'Individual Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks and attended \\>=8 sessions.'}], 'classes': [{'title': 'Opioid use within a week of Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Opioid use within a week of week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '205', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Opioid use within a week of week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1172', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Two treatment arms are combined as one group to compare the outcome of interest pre- and post-randomization.', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no change in the proportion of participants with self-reported opioid prescription comparing 12 weeks vs baseline.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)', 'description': 'Participants were asked whether they took any opioid medication within the last week. We compared self-reported prescription opioid use within a week of their baseline and week 12 questionnaires. The definition of Per Protocol is all participants who have been randomized and who attended \\>=8 sessions of acupuncture. Only participants who report having an opioid prescription are included in the analysis therefore if the participant did not have an opioid prescription they were excluded from the analysis. Statistical analysis only performed on baseline and week 12 (end of treatment) data.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for this time point. This may have been due to withdrawal, loss to follow up, or declining to answer this question. Only participants who responded to having taken prescription opioids were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Intent to Treat Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks and had an active prescription for an opioid medication.'}, {'id': 'OG001', 'title': 'Individual Acupuncture ITT', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks and had an active prescription for an opioid medication.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': '12 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '3.6', 'groupId': 'OG001'}]}]}, {'title': '24 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0326', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Two treatment arms are combined as one group to compare the outcome of interest prior- and post-randomization.', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no change in the days of self-reported opioid medication use comparing 12 weeks vs baseline.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)', 'description': 'Participants were asked whether they took any opioid medication within the last week. If they did take any opioids in the last week we asked how many days they took their opioid medication. We collected data on the mean number of days participants took prescription opioid medication from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data.', 'unitOfMeasure': 'Days of Opioid use', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for this time point. This may have been due to withdrawal, loss to follow up, or declining to answer this question. Only participants who responded to having taken prescription opioids were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Per Protocol Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks, attended \\>=8 sessions and had an active prescription for an opioid medication.'}, {'id': 'OG001', 'title': 'Individual Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks, attended \\>=8 sessions and had an active prescription for an opioid medication.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '3.0', 'groupId': 'OG001'}]}]}, {'title': '12 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '3.2', 'groupId': 'OG001'}]}]}, {'title': '24 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '3.0', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '2.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0026', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Two treatment arms are combined as one group to compare the outcome of interest prior- and post-randomization.', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The null hypothesis is that there is no change in the days of self-reported opioid medication use comparing 12 weeks vs baseline.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)', 'description': 'Participants were asked whether they took any opioid medication within the last week. If they did take any opioids in the last week we asked how many days they took their opioid medication. We collected data on the mean number of days participants took prescription opioid medication from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data.', 'unitOfMeasure': 'Days of Opioid use', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The data differs in participants from the overall data due to a few factors. Some participants did not complete the questionnaires for this time point. This may have been due to withdrawal, loss to follow up, or declining to answer this question. Only participants who responded to having taken prescription opioids were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Participant Opioid Use in Milligrams of Morphine Equivalents (MME) Between 3 Months Pre and 3 Months Post-treatment Using Electronic Medical Record (EMR) Data (Intent to Treat Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture ITT', 'description': 'Participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive week and had an active prescription for an opioid medication in EMR.'}, {'id': 'OG001', 'title': 'Individual Acupuncture ITT', 'description': 'Participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive week and had an active prescription for an opioid medication in EMR.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '8.8'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-12.8', 'upperLimit': '3.0'}]}]}], 'analyses': [{'pValue': '0.129', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The change in MME was not normally distributed, thus we report median and IQR rather than mean/standard deviation. We employed Mann-Whitney to assess whether the change in MME between pre- and post-treatment periods differed across intervention arms.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)', 'description': 'Milligrams of Morphine Equivalence (MME) is a value assigned to represent how strong an opioid is. It is determined by calculating a dose of morphine equivalent to the prescribed opioid. We compared the MME for participants who had Opioid prescriptions in their electronic medical records (EMR) during the 6 month period around treatment (3 months prior and post-treatment). A smaller MME indicates that the participant was using less medication. The definition of intent to treat is all participants who were randomized into treatment. The analysis is limited to participants who have documented opioid prescriptions in EMR. The change in MME was defined as post treatment minus pre treatment (in milligrams).', 'unitOfMeasure': 'Milligrams of Morphine Equivalents', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is limited to participants who have documented opioid prescriptions in EMR. A participant could have a prescription in the pre-treatment period, post-treatment period or both.'}, {'type': 'SECONDARY', 'title': 'Change in Participant Opioid Use in Milligrams of Morphine Equivalents (MME) Between 3 Months Pre and 3 Months Post-treatment Using Electronic Record (EMR) Data (Per Protocol Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks, attended \\>=8 sessions and had an active prescription for an opioid medication in EMR (3 months pre- and 3 months post-treatment).'}, {'id': 'OG001', 'title': 'Individual Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks, attended \\>=8 sessions and had an active prescription for an opioid medication in EMR around treatment (3 months pre- and 3 months post-treatment).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-2.0', 'upperLimit': '8.4'}, {'value': '-0.5', 'groupId': 'OG001', 'lowerLimit': '-13.3', 'upperLimit': '1.2'}]}]}], 'analyses': [{'pValue': '0.031', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The change in MME was not normally distributed, thus we report median and IQR rather than mean/standard deviation. We employed Mann-Whitney to assess whether the change in MME between pre- and post-treatment periods differed across intervention arms.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)', 'description': 'Milligrams of Morphine Equivalence (MME) is a value assigned to represent how strong an opioid is. It is determined by calculating a dose of morphine equivalent to the prescribed opioid. We compared the MME of participants who had Opioid prescriptions in their electronic medical records (EMR) during the 6 month period around treatment (3 months pre- and 3 months post-treatment). A smaller MME indicates that the participant was using less medication. The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. The analysis is limited to participants who have documented opioid prescriptions in EMR. The change in MME was defined as post treatment minus pre treatment (in milligrams).', 'unitOfMeasure': 'Milligrams of Morphine Equivalents', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis is limited to participants who have documented opioid prescriptions in EMR. A participant could have a prescription in the pre-treatment period, post-treatment period or both.'}, {'type': 'SECONDARY', 'title': 'Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data (Intent to Treat Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture ITT', 'description': 'Participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks and had an active prescription for an opioid medication in EMR.'}, {'id': 'OG001', 'title': 'Individual Acupuncture ITT', 'description': 'Participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks and had an active prescription for an opioid medication in EMR.'}], 'classes': [{'title': 'Opioid Prescription 3 Months Pre-Treatment', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Opioid Prescription 3 Months Post-Treatment', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0059', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Difference in change in proportion pre and post-treatment differs by treatment arm.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)', 'description': 'Participants\' electronic medical records (EMR) were reviewed to see if they had a prescription for opioids during the 6-month period around their treatment window (3 months pre- and 3 months post-treatment). The definition of intent to treat is all participants who were randomized into treatment. There were 191 total participants that had "any documented opioid prescriptions in EMR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis includes all participants who were randomized. A participant could have a prescription in the pre-treatment period, post-treatment period or both. Thus the total number of participants analyzed is not equal to the sum of participants in pre- and post-treatment periods.'}, {'type': 'SECONDARY', 'title': 'Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data ) (Per Protocol Model)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '230', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks, attended \\>=8 sessions and had an active prescription for an opioid medication in EMR (3 months pre- and 3 months post-treatment).'}, {'id': 'OG001', 'title': 'Individual Acupuncture PP', 'description': 'All the participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks, attended \\>=8 sessions and had an active prescription for an opioid medication in EMR (3 months pre- and 3 months post-treatment).'}], 'classes': [{'title': 'Opioid Prescription 3 Months Pre-Treatment', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}, {'title': 'Opioid Prescription 3 Months Post-Treatment', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0385', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)', 'description': "Participants' electronic medical records (EMR) were reviewed to see if they had a prescription for opioids during the 6-month period around their treatment window (3 months pre- and 3 month post-treatment). The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis includes all participants who attended \\>= 8 sessions. A participant could have a prescription in the pre-treatment period, post-treatment period or both. Thus the total number of participants analyzed is not equal to the sum of participants in pre- and post-treatment periods.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group Acupuncture', 'description': 'Participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.'}, {'id': 'FG001', 'title': 'Individual Acupuncture', 'description': 'Participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Participants who were baselined and completed an oral consent.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '389'}, {'groupId': 'FG001', 'numSubjects': '390'}]}, {'type': 'Initiated Treatment', 'comment': 'Participants who signed the treatment consent form and attended at least one session of acupuncture.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '346'}, {'groupId': 'FG001', 'numSubjects': '360'}]}, {'type': '6 Week', 'comment': 'Patients who completed the week 6 follow up questionnaires.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '298'}, {'groupId': 'FG001', 'numSubjects': '320'}]}, {'type': '12 Week', 'comment': 'Patients who completed the week 12 follow up questionnaires.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '295'}, {'groupId': 'FG001', 'numSubjects': '310'}]}, {'type': '24 Week', 'comment': 'Patients who completed the week 24 follow up questionnaires.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '280'}, {'groupId': 'FG001', 'numSubjects': '284'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '280'}, {'groupId': 'FG001', 'numSubjects': '284'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}, {'groupId': 'FG001', 'numSubjects': '106'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Never Initiated Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '30'}]}]}], 'recruitmentDetails': 'Participants were referred by their primary care providers (PCPs) from their participating health care center. For patients who met the eligibility criteria, PCPs completed a study-specific referral form and obtained permission to contact the patient by phone. Participants were then contacted by the study staff and screened for eligibility.', 'preAssignmentDetails': 'Participants were screened by phone and completed an oral consent. They were mailed a treatment consent form and told to contact the study team in order to complete the baseline and receive their treatment arm. Several participants were excluded for various reasons including ineligibility and declining participation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group Acupuncture', 'description': 'Participants who were randomized to receive acupuncture weekly in a group acupuncture setting for 12 consecutive weeks.'}, {'id': 'BG001', 'title': 'Individual Acupuncture', 'description': 'Participants who were randomized to receive acupuncture weekly in an individual acupuncture setting for 12 consecutive weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}], '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': '316', 'groupId': 'BG000'}, {'value': '303', 'groupId': 'BG001'}, {'value': '619', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54.19', 'spread': '13.77', 'groupId': 'BG000'}, {'value': '55.44', 'spread': '13.20', 'groupId': 'BG001'}, {'value': '54.80', 'spread': '13.49', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Median', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54.93', 'groupId': 'BG000', 'lowerLimit': '45.87', 'upperLimit': '62.44'}, {'value': '55.42', 'groupId': 'BG001', 'lowerLimit': '47.45', 'upperLimit': '63.96'}, {'value': '55.19', 'groupId': 'BG002', 'lowerLimit': '46.78', 'upperLimit': '63.20'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '315', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '627', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '219', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '443', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '327', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '134', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '255', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '389', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Spoken Language', 'classes': [{'title': 'English', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'BG000'}, {'value': '371', 'groupId': 'BG001'}, {'value': '743', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '292', 'groupId': 'BG000'}, {'value': '290', 'groupId': 'BG001'}, {'value': '582', 'groupId': 'BG002'}]}]}, {'title': 'Spanish', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'BG000'}, {'value': '371', 'groupId': 'BG001'}, {'value': '743', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '372', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '762', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants were told to select their preferred language. Some participants declined to select one language.'}, {'title': 'Working Status', 'classes': [{'title': 'Unable to Work Due to Disability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '290', 'groupId': 'BG002'}]}]}, {'title': 'Unemployed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '387', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Household Income Support', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'BG000'}, {'value': '382', 'groupId': 'BG001'}, {'value': '766', 'groupId': 'BG002'}]}], 'categories': [{'title': 'No support', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}, {'title': 'Any Support', 'measurements': [{'value': '270', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '549', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Row population differs from the overall because some participants declined to answer this question.'}, {'title': 'Participants Receiving Supplemental Security Insurance (SSI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Not Receiving SSI', 'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '385', 'groupId': 'BG002'}]}, {'title': 'Receiving SSI', 'measurements': [{'value': '177', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '394', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Participants with Health Insurance Coverage', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Medicaid', 'measurements': [{'value': '301', 'groupId': 'BG000'}, {'value': '288', 'groupId': 'BG001'}, {'value': '589', 'groupId': 'BG002'}]}, {'title': 'Private', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}, {'title': 'None', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Annual Household Income', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Less than $20,000', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '362', 'groupId': 'BG002'}]}, {'title': '$20-$29,000', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}, {'title': '$30-$39,000', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': '$40-$49,000', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Greater than $50,000', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': "Don't know / Refused", 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Participants Reporting Opioid Use at baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '381', 'groupId': 'BG000'}, {'value': '384', 'groupId': 'BG001'}, {'value': '765', 'groupId': 'BG002'}]}], 'categories': [{'title': 'No', 'measurements': [{'value': '275', 'groupId': 'BG000'}, {'value': '291', 'groupId': 'BG001'}, {'value': '566', 'groupId': 'BG002'}]}, {'title': 'Yes', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Row population differs from the overall because some participants declined to answer this question.'}, {'title': 'Condition Participants were Referred to the Study for', 'classes': [{'title': 'Back pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '261', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '534', 'groupId': 'BG002'}]}]}, {'title': 'Neck pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}]}, {'title': 'Osteoarthritis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}]}, {'title': 'Multiple conditions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Each referring condition is not mutually exclusive. Participants were randomized based on their referring condition. Those who have multiple conditions are counted in the exclusive (back, neck, etc) categories and also in the multiple category.', 'unitOfMeasure': 'Participants'}, {'title': 'Depression Score as Measured by Patient Health Questionnaire 9 question (PHQ-9) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '779', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.75', 'spread': '6.02', 'groupId': 'BG000'}, {'value': '8.74', 'spread': '6.07', 'groupId': 'BG001'}, {'value': '8.74', 'spread': '6.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Patient Health Questionnaire 9 (PHQ9) consisting of 9 questions ranging from not at all (0 points) - nearly every day (3 points) and measures depression severity. The highest score is 27. A score 0-4 is considered minimal to none, 5-9 is mild, 10-14 is moderate, 15-19 is moderately severe, and 20-27 is severe.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Reported Global Health Score as Measured by The PROMIS-10', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '389', 'groupId': 'BG000'}, {'value': '389', 'groupId': 'BG001'}, {'value': '778', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Poor', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '165', 'groupId': 'BG002'}]}, {'title': 'Fair', 'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '297', 'groupId': 'BG002'}]}, {'title': 'Good', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}, {'title': 'Very good', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}]}, {'title': 'Excellent', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, scoring for the test can range from 8-40 (Raw score), the higher the score the worse the outcome. Those scores are changed into T scores that range from 32.4-85.2. The score is divided into categories. Physical health and mental health scores are calculated, which ranges from 4-20 (raw score each) each.', 'unitOfMeasure': 'Participants', 'populationDescription': '1 participant in the individual arm declined to answer this question.'}], 'populationDescription': 'All participants who were randomized to receive acupuncture weekly in either a group or an individual acupuncture setting for 12 consecutive weeks.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-25', 'size': 1637167, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-08-22T15:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 779}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-31', 'studyFirstSubmitDate': '2015-03-31', 'resultsFirstSubmitDate': '2018-07-06', 'studyFirstSubmitQcDate': '2015-05-26', 'lastUpdatePostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-31', 'studyFirstPostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Interference as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model)', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)', 'description': "The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much the participants' pain interferes with daily life. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Investigators measured improvement in BPI pain interference from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data."}, {'measure': 'Pain Interference as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model)', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window))', 'description': 'The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. We measured improvement in BPI pain interference from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data.'}, {'measure': 'Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model)', 'timeFrame': 'Baseline, Week 12 (End of Treatment Window)', 'description': 'The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in their pain interference from baseline to the end of treatment window (week 12). 30% improvement is a decrease of \\>=2 points on the BPI from baseline to the end of treatment window (week 12). A 30% decrease is considered a clinically significant improvement in pain. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were analyzed.'}, {'measure': 'Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model)', 'timeFrame': 'Baseline, Week 12 (End of Treatment)', 'description': 'The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in pain interference from baseline to the end of treatment window (week 12). 30% improvement is a decrease of \\>=2 points on the BPI from baseline to the end of treatment window (week 12). A 30% decrease is considered a clinically significant improvement in pain. Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Only participants who completed a week 12 questionnaire were analyzed.'}, {'measure': 'Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model)', 'timeFrame': 'Baseline, Week 24 (12 weeks after treatment window)', 'description': 'The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in pain interference from baseline to week 24 (12 weeks after treatment window). 30% improvement is a decrease of \\>=2 points on the BPI from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were included in the analysis.'}, {'measure': 'Improvement in Pain Interference as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model)', 'timeFrame': 'Baseline, Week 24 (12 weeks after treatment window)', 'description': 'The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the primary measure of how much your pain interferes with your life. It is a quality of life measure. Pain interference is calculated using 7 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 7, therefore final scores can range from 0 - 10. Having a higher score indicates your pain interference is worse. Respondent data is used for this analysis which shows whether participants experienced improvement in pain interference from baseline to week 24 (12 weeks after treatment). 30% improvement is a decrease of \\>=2 points on the BPI from baseline to week 24 (12 weeks after treatment). The definition of Per Protocol is all participants who have been randomized and who attended \\>=8 sessions of acupuncture. Only patients who completed a week 24 questionnaire were included in the analysis.'}], 'secondaryOutcomes': [{'measure': 'Pain Severity as Measured by the Brief Pain Inventory (BPI) (Intent to Treat Model)', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)', 'description': 'The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and then divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. We measured improvement in BPI pain severity from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is anyone who intended to receive treatment; in our case, it is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data.'}, {'measure': 'Pain Severity as Measured by the Brief Pain Inventory (BPI) (Per Protocol Model)', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)', 'description': 'The Brief Pain Inventory (BPI) short form, is a self-reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. We measured improvement in BPI pain severity from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data.'}, {'measure': 'Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Intent to Treat Model)', 'timeFrame': 'Baseline, Week 12 (End of Treatment Window)', 'description': 'The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity from baseline to the end of treatment window (week 12). 30% improvement is a decrease of \\>=2 points on the BPI from baseline to the end of treatment window (week 12). A 30% decrease in pain severity is considered a clinically significant improvement in pain. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were analyzed.'}, {'measure': 'Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 12 (Per Protocol Model)', 'timeFrame': 'Baseline, Week 12 (End of Treatment Window)', 'description': 'The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity from baseline to the end of treatment window (week 12). 30% improvement is a decrease of \\>=2 points on the BPI from baseline to the end of treatment window (week 12). A 30% decrease in pain severity is considered a clinically significant improvement in pain. The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Only participants who completed a week 12 questionnaire were analyzed.'}, {'measure': 'Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Intent to Treat Model)', 'timeFrame': 'Baseline, Week 24 (12 Weeks After Treatment Window)', 'description': 'The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity from baseline to week 24 (12 weeks after treatment window). 30% improvement is a decrease of \\>=2 points on the BPI from baseline to week 24 (12 weeks after treatment window). A 30% decrease in pain severity is considered a clinically significant improvement in pain. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were analyzed.'}, {'measure': 'Improvement in Pain Severity as Measured by the Brief Pain Inventory (BPI) at Week 24 (Per Protocol Model)', 'timeFrame': 'Baseline, Week 24 (12 Weeks After Treatment Window)', 'description': 'The Brief Pain Inventory (BPI) short form, is a participant reported questionnaire that serves as the measure of how severe your pain is. Pain severity is calculated using 4 questions that range from a score of 0 (no pain) to 10 (worst pain imaginable). The scores are added and divided by 4, therefore final scores can range from 0 - 10. Having a higher mean score indicates your pain severity is worse. Respondent data is used for this analysis which shows whether participants experienced an improvement in their pain severity from baseline to week 24 (12 weeks after treatment window). 30% improvement is a decrease of \\>=2 points on the BPI from baseline to week 24 (12 weeks after treatment window). A 30% decrease in pain severity is considered a clinically significant improvement in pain. The definition of Per Protocol is all participants who have been randomized and who attended \\>=8 sessions of acupuncture. Only patients who completed a week 24 questionnaire were analyzed.'}, {'measure': 'Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Intent to Treat Model)', 'timeFrame': 'Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)', 'description': 'The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a participant has perceived a change in their condition after having some sort of treatment. In this case, we evaluated whether the participants experienced a positive change after receiving treatment, a decrease in their pain, from baseline (before receiving treatment) to week 24 (12 weeks after treatment window). The PGIC is scored from 0 (much better) to 10 (much worse). A higher score indicates that a participant has felt worse since starting treatment. The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data.'}, {'measure': 'Patient Global Impression of Change (PGIC) at Week 12 and Week 24 (Per Protocol Model)', 'timeFrame': 'Week 12 (end of treatment window), and week 24 (12 weeks after treatment window)', 'description': 'The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a participant has perceived a change in their condition after having some sort of treatment. In this case, we evaluated whether the participants experienced a positive change after receiving treatment, a decrease in their pain, from baseline (before receiving treatment) to week 24 (12 weeks after treatment window). The PGIC is scored from 0 (much better) to 10 (much worse). A higher score indicates that a participant has felt worse since starting treatment. The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data.'}, {'measure': 'Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Intent to Treat Model)', 'timeFrame': 'Week 12 (End of Treatment Window)', 'description': 'The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of \\>=6 points on the PGIC at week 12 (end of treatment window) as reported by the participants. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were included in the analysis.'}, {'measure': 'Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 12 (Per Protocol Model)', 'timeFrame': 'Week 12 (End of Treatment Window)', 'description': 'The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of \\>=6 points on the PGIC at week 12 (end of treatment window) as reported by the participants. The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Only participants who completed a week 12 questionnaire were included in the analysis.'}, {'measure': 'Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Intent to Treat Model)', 'timeFrame': 'Week 24 (12 Weeks After Treatment Window', 'description': 'The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of \\>=6 points on the PGIC at week 24 (12 weeks after treatment window) as reported by the participants. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were included in the analysis.'}, {'measure': 'Improvement as Measured by the Patient Global Impression of Change (PGIC) at Week 24 (Per Protocol Model)', 'timeFrame': 'Week 24 (12 Week After Treatment Window)', 'description': 'The Patient Global Impression of Change (PGIC) is a self-reported questionnaire that indicates if a patient has perceived a change in their condition after having some sort of treatment. Respondent data is used for this analysis which shows whether participants experienced improvement. Respondent data for the PGIC is scored using one question that ranges from 0 (no change or the condition got worse) to 7 (a great deal better). Improvement is defined as a score of \\>=6 points on the PGIC at week 24 (12 weeks after treatment window) as reported by the participants. The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Only participants who completed a week 24 questionnaire were included in the analysis.'}, {'measure': 'Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model)', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window))', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for physical health only 4 questions are used, scoring for physical health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 16.2-67.7. For this measure, we collected physical health scores from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data.'}, {'measure': 'Participant Physical Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model)', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for physical health only 4 questions are used, scoring for physical health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 16.2-67.7. For this measure, we collected physical health scores from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data..'}, {'measure': 'Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model)', 'timeFrame': 'Baseline, Week 12 (End of treatment window)', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a \\>=2-point increase is considered a 30% improvement. The definition of intent to treat is all participants who have been randomized into treatment. Only patients who completed a week 12 questionnaire were included in the analysis.'}, {'measure': 'Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model)', 'timeFrame': 'Baseline, Week 12 (End of Treatment Window)', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a \\>=2-point increase is considered a 30% improvement. The definition of Per Protocol is all participants who have been randomized and who attended \\>=8 sessions of acupuncture. Only patients who completed a week 12 questionnaire were included in the analysis.'}, {'measure': 'Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model)', 'timeFrame': 'Baseline, Week 24 (12 Weeks After Treatment Window)', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window), a \\>=2-point increase is considered a 30% improvement. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were included in the analysis.'}, {'measure': 'Improvement in Physical Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model)', 'timeFrame': 'Baseline, Week 24 (12 Weeks After Treatment Window)', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The physical health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 16.2 to 67.7. The higher the score the better your physical health is. Improvement is categorized as a \\>= 2-point increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Only participants who completed a week 24 questionnaire were included in the analysis.'}, {'measure': 'Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Intent to Treat Model)', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for mental health only 4 questions are used, scoring for mental health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 21.2-67.6. For this measure, we collected mental health scores from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data.'}, {'measure': 'Participant Mental Health Score as Measured by the Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) (Per Protocol Model)', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. It consists of 10 questions, for mental health only 4 questions are used, scoring for mental health can range from 4-20 (Raw score), the higher the score the better the outcome. The raw scores are changed into T-scores that range from 21.2-67.6. For this measure, we collected mental health scores from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data.'}, {'measure': 'Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Intent to Treat Model)', 'timeFrame': 'Baseline, Week 12 (End of Treatment Window)', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a \\>=5-point increase is what we used to measure improvement. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 12 questionnaire were included in the analysis.'}, {'measure': 'Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 12 (Per Protocol Model)', 'timeFrame': 'Baseline, Week 12 (End of Treatment Window)', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 12 (end of treatment window), a \\>=5-point increase is what we used to measure improvement. The definition of Per Protocol is all participants who have been randomized and who attended \\>=8 sessions of acupuncture. Only patients who completed a week 12 questionnaire were included in the analysis.'}, {'measure': 'Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Intent to Treat Model)', 'timeFrame': 'Baseline, Week 24 (12 Weeks After Treatment Window)', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T-score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window), a \\>=5-point increase is what we used to measure improvement. The definition of intent to treat is all participants who were randomized into treatment. Only participants who completed a week 24 questionnaire were included in the analysis.'}, {'measure': 'Improvement in Mental Health as Measured by Patient-Reported Outcomes Measure Information System 10 (PROMIS-10) at Week 24 (Per Protocol Model)', 'timeFrame': 'Baseline, Week 24 (12 Weeks After Treatment Window)', 'description': 'The Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) is a publically available questionnaire that allows for the measurement of quality of life for chronic conditions. The mental health score is calculated using 4 questions on the PROMIS-10 that range from 1 to 5. The score is then converted into a T-score which can range from 21.2 to 67.6. The higher the score the better your mental health is. Improvement is categorized as an increase in the PROMIS-10 T-score from baseline to week 24 (12 weeks after treatment window), a \\>=5-point increase is what we used to measure improvement. The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Only participants who completed a week 24 questionnaire were included in the analysis.'}, {'measure': 'Participants Who Reported Use of Prescription Opioids in the Last Week (Intent to Treat Model)', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)', 'description': 'Participants were asked whether they took any opioid medication within the last week. We compared self-reported prescription opioid use within a week of their baseline and week 12 questionnaires. The definition of intent to treat is all participants who have been randomized into treatment. Only participants who report having an opioid prescription are included in the analysis therefore if the participant did not have an opioid prescription they were excluded from the analysis. Statistical analysis only performed on baseline and week 12 (end of treatment) data.'}, {'measure': 'Participants Who Reported Use of Prescription Opioids in the Last Week (Per Protocol Model)', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)', 'description': 'Participants were asked whether they took any opioid medication within the last week. We compared self-reported prescription opioid use within a week of their baseline and week 12 questionnaires. The definition of Per Protocol is all participants who have been randomized and who attended \\>=8 sessions of acupuncture. Only participants who report having an opioid prescription are included in the analysis therefore if the participant did not have an opioid prescription they were excluded from the analysis. Statistical analysis only performed on baseline and week 12 (end of treatment) data.'}, {'measure': 'Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Intent to Treat Model)', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)', 'description': 'Participants were asked whether they took any opioid medication within the last week. If they did take any opioids in the last week we asked how many days they took their opioid medication. We collected data on the mean number of days participants took prescription opioid medication from baseline to week 24 (12 weeks after treatment window). The definition of intent to treat is all participants who were randomized into treatment. Statistical analysis only performed on baseline and week 12 (end of treatment) data.'}, {'measure': 'Number of Days Participants Reported Using Prescription Opioids in the Last 7 Days (Per Protocol Model)', 'timeFrame': 'Baseline, Week 12 (end of treatment window), and Week 24 (12 Weeks After Treatment Window)', 'description': 'Participants were asked whether they took any opioid medication within the last week. If they did take any opioids in the last week we asked how many days they took their opioid medication. We collected data on the mean number of days participants took prescription opioid medication from baseline to week 24 (12 weeks after treatment window). The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. Statistical analysis only performed on baseline and week 12 (end of treatment) data.'}, {'measure': 'Change in Participant Opioid Use in Milligrams of Morphine Equivalents (MME) Between 3 Months Pre and 3 Months Post-treatment Using Electronic Medical Record (EMR) Data (Intent to Treat Model)', 'timeFrame': '6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)', 'description': 'Milligrams of Morphine Equivalence (MME) is a value assigned to represent how strong an opioid is. It is determined by calculating a dose of morphine equivalent to the prescribed opioid. We compared the MME for participants who had Opioid prescriptions in their electronic medical records (EMR) during the 6 month period around treatment (3 months prior and post-treatment). A smaller MME indicates that the participant was using less medication. The definition of intent to treat is all participants who were randomized into treatment. The analysis is limited to participants who have documented opioid prescriptions in EMR. The change in MME was defined as post treatment minus pre treatment (in milligrams).'}, {'measure': 'Change in Participant Opioid Use in Milligrams of Morphine Equivalents (MME) Between 3 Months Pre and 3 Months Post-treatment Using Electronic Record (EMR) Data (Per Protocol Model)', 'timeFrame': '6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)', 'description': 'Milligrams of Morphine Equivalence (MME) is a value assigned to represent how strong an opioid is. It is determined by calculating a dose of morphine equivalent to the prescribed opioid. We compared the MME of participants who had Opioid prescriptions in their electronic medical records (EMR) during the 6 month period around treatment (3 months pre- and 3 months post-treatment). A smaller MME indicates that the participant was using less medication. The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture. The analysis is limited to participants who have documented opioid prescriptions in EMR. The change in MME was defined as post treatment minus pre treatment (in milligrams).'}, {'measure': 'Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data (Intent to Treat Model)', 'timeFrame': '6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)', 'description': 'Participants\' electronic medical records (EMR) were reviewed to see if they had a prescription for opioids during the 6-month period around their treatment window (3 months pre- and 3 months post-treatment). The definition of intent to treat is all participants who were randomized into treatment. There were 191 total participants that had "any documented opioid prescriptions in EMR.'}, {'measure': 'Participants With Opioid Prescription Within a 6 Month Period Around Treatment Window According to Electronic Medical Record (EMR) Data ) (Per Protocol Model)', 'timeFrame': '6-Month Period Around Treatment Window (3 months pre- and 3 months post-treatment)', 'description': "Participants' electronic medical records (EMR) were reviewed to see if they had a prescription for opioids during the 6-month period around their treatment window (3 months pre- and 3 month post-treatment). The definition of Per Protocol is all participants who were randomized and who attended \\>=8 sessions of acupuncture."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acupuncture', 'Group/Community Acupuncture', 'Individual Acupuncture', 'Chronic Pain', 'Underserved', 'Urban Primary Care', 'Osteoarthritis', 'Back Pain', 'Neck Pain'], 'conditions': ['Chronic Pain', 'Osteoarthritis', 'Neck Pain', 'Back Pain']}, 'referencesModule': {'references': [{'pmid': '32076985', 'type': 'DERIVED', 'citation': 'McKee MD, Nielsen A, Anderson B, Chuang E, Connolly M, Gao Q, Gil EN, Lechuga C, Kim M, Naqvi H, Kligler B. Individual vs. Group Delivery of Acupuncture Therapy for Chronic Musculoskeletal Pain in Urban Primary Care-a Randomized Trial. J Gen Intern Med. 2020 Apr;35(4):1227-1237. doi: 10.1007/s11606-019-05583-6. Epub 2020 Feb 19.'}]}, 'descriptionModule': {'briefSummary': "Chronic pain is a major public health problem that places many burdens on individuals, including impairment of physical and psychological functioning, lost productivity, and side effects of medications used to treat pain. There is also substantial evidence that minority populations differ both in prevalence and outcomes of chronic pain; access to care is a key component in these differences. Strong evidence now supports the use of acupuncture in the treatment of chronic pain conditions, including when provided in the primary care setting to participants from ethnically diverse, medically underserved populations. Acupuncture is slowly being integrated into pain management in many conventional health care settings, but cost and reimbursement for this service remain obstacles to offering acupuncture, especially in primary care and safety net settings. Because group acupuncture can be offered at much lower cost, demonstrating that individual and group delivery are equally effective could reduce barriers to use of this effective pain management approach.\n\nThe primary aim of this study will be to evaluate whether acupuncture delivered in the group setting for participants with chronic pain is equal to acupuncture delivered in the individual setting. A secondary objective will be to use qualitative analysis to understand and describe the participants' experience of both acupuncture approaches, and to utilize this data to inform intervention delivery and dissemination, to better incorporate the participants' perspective."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Referred by a primary care provider from one of our participating primary care health centers\n* Provider-documented diagnosis of osteoarthritis (any joint), neck pain, OR back pain\n* Self-reported pain score of ≥4 for at least 3 months prior to program entry\n* Able to provide consent for treatment and data collection in either English or Spanish\n\nExclusion Criteria:\n\n* \\< 21 years of age\n* Chronic pain not documented OR self reported pain of ≥4 for less than 3 months.\n* Currently taking oral or injectable anticoagulants.\n* Lack of contact information OR unavailable for duration of entire treatment period (24 weeks)\n* Inability to consent to treatment and data collection.\n* Active psychosis\n* Active substance abuse'}, 'identificationModule': {'nctId': 'NCT02456727', 'acronym': 'AADDOPT-2', 'briefTitle': 'Acupuncture Approaches for Chronic Pain', 'organization': {'class': 'OTHER', 'fullName': 'Albert Einstein College of Medicine'}, 'officialTitle': 'Acupuncture Approaches to Decrease Disparities in Outcomes of Pain Treatment - A Two Arm Comparative Effectiveness Trial', 'orgStudyIdInfo': {'id': '2014-4192'}, 'secondaryIdInfos': [{'id': 'AD-1402-10857', 'type': 'OTHER', 'domain': 'PCORI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Individual Acupuncture', 'description': 'Participants will be treated weekly with individual acupuncture treatment sessions for 12 consecutive weeks. Quality of life assessments will be taken at intervals during treatment and post-treatment.', 'interventionNames': ['Procedure: Individual Acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group/Community Acupuncture', 'description': 'Participants will be treated weekly with group acupuncture treatments sessions for 12 consecutive weeks. Quality of life assessments will be taken at intervals during treatment and post-treatment.', 'interventionNames': ['Procedure: Group/Community Acupuncture']}], 'interventions': [{'name': 'Group/Community Acupuncture', 'type': 'PROCEDURE', 'description': 'Acupuncture treatment in a group setting.', 'armGroupLabels': ['Group/Community Acupuncture']}, {'name': 'Individual Acupuncture', 'type': 'PROCEDURE', 'description': 'Acupuncture treatment in an individual setting.', 'armGroupLabels': ['Individual Acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Group', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'M. Diane McKee, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine'}, {'name': 'Benjamin Kligler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mount Sinai Beth Israel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Montefiore Medical Center', 'class': 'OTHER'}, {'name': 'Mount Sinai Beth Israel Department of Integrated Medicine', 'class': 'UNKNOWN'}, {'name': 'Pacific College of Oriental Medicine', 'class': 'OTHER'}, {'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Family and Social Medicine', 'investigatorFullName': 'Diane Mckee', 'investigatorAffiliation': 'Albert Einstein College of Medicine'}}}}