Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT05540002
Status:
COMPLETED
Last Update Posted:
2025-03-19
First Post:
2022-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], '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': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rjamison@bwh.harvard.edu', 'phone': '617-732-9046', 'title': 'Robert Jamison', 'organization': "Brigham and Women's Hospital"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'There were several limitations. The study included a limited number of subjects. Subjects were only followed for 3 months. The subjects had other medical comorbidities.'}}, 'adverseEventsModule': {'timeFrame': 'During the 3-month trial', 'eventGroups': [{'id': 'EG000', 'title': 'High Intensity Stimulation', 'description': 'Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks.\n\nHigh Intensity Quell: Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 19, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Intensity Stimulation', 'description': 'Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks.\n\nLow Intensity Quell: Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day.', 'otherNumAtRisk': 57, 'deathsNumAtRisk': 57, 'otherNumAffected': 14, 'seriousNumAtRisk': 57, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Unrelated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 57, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Brief Pain Inventory Interference Scale (BPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Intensity Stimulation', 'description': 'Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks.\n\nHigh Intensity Quell: Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.'}, {'id': 'OG001', 'title': 'Low Intensity Stimulation', 'description': 'Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks.\n\nLow Intensity Quell: Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Between group differences at 3-months', 'description': 'This is a validated measure of combined activity interference on a numerical scale of 0-10, with higher scores representing greater activity interference. We collected ratings on how much pain interfered over the past 24 hours with 1) General activity, 2) Mood, 3) Walking ability, 4) Normal work, 5) Relations with other people, 6) Sleep, and 7) Enjoyment of life on a scale of 0=does not interfere to 10=completely interferes. The table represents combined mean scores between groups. These ratings were collected at 3 months after start of the study.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Catastrophizing Scale (PCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Intensity Stimulation', 'description': 'Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks.\n\nHigh Intensity Quell: Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.'}, {'id': 'OG001', 'title': 'Low Intensity Stimulation', 'description': 'Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks.\n\nLow Intensity Quell: Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '24.8', 'spread': '13.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Changes from Baseline to 3-month Follow-Up', 'description': 'Measures thoughts and feelings when patient is experiencing pain on a 13-item scale ranging from 0-52 with higher scores meaning a worse outcome and higher catastrophizing', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Disability Index (PDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Intensity Stimulation', 'description': 'Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks.\n\nHigh Intensity Quell: Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.'}, {'id': 'OG001', 'title': 'Low Intensity Stimulation', 'description': 'Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks.\n\nLow Intensity Quell: Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.3', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '36.3', 'spread': '16.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Changes from Baseline to 3-month Follow-Up', 'description': 'Rating scales designed to measure levels of pain disability, or the degree to which pain is preventing a patient from doing what they normally would be doing, or doing it as well as they normally would on a 7-item scale of 0-10 ranging from 0-70 with higher scores meaning a worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Anxiety and Depression Scale (HADS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Intensity Stimulation', 'description': 'Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks.\n\nHigh Intensity Quell: Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.'}, {'id': 'OG001', 'title': 'Low Intensity Stimulation', 'description': 'Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks.\n\nLow Intensity Quell: Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.1', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '16.9', 'spread': '7.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Changes from Baseline to 3-month Follow-Up', 'description': 'Measures mood on a 14-item scale ranging from 0 to 42 with higher scores meaning a worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pain Detect Neuropathic Pain Questionnaire (painDETECT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Intensity Stimulation', 'description': 'Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks.\n\nHigh Intensity Quell: Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.'}, {'id': 'OG001', 'title': 'Low Intensity Stimulation', 'description': 'Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks.\n\nLow Intensity Quell: Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.1', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '16.5', 'spread': '7.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Changes from Baseline to 3-month Follow-Up', 'description': "Measures the presence of neuropathic pain on a scale ranging from 1 to 38 on ratings of 'never to very strongly' with higher scores meaning a worse outcome", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Symptom Impact Questionnaire (SIQR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Intensity Stimulation', 'description': 'Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks.\n\nHigh Intensity Quell: Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.'}, {'id': 'OG001', 'title': 'Low Intensity Stimulation', 'description': 'Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks.\n\nLow Intensity Quell: Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '115.8', 'spread': '37.4', 'groupId': 'OG000'}, {'value': '106.1', 'spread': '38.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Changes from Baseline to 3-month Follow-Up', 'description': 'Measures 20 pain symptoms and function on a scale of 0-10 with scores ranging from 0 to 200 with higher scores meaning a worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Patient's Global Impression of Change (PGIC)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Intensity Stimulation', 'description': 'Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks.\n\nHigh Intensity Quell: Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.'}, {'id': 'OG001', 'title': 'Low Intensity Stimulation', 'description': 'Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks.\n\nLow Intensity Quell: Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Changes from Baseline to 3-month Follow-Up', 'description': 'Measures the subject\'s overall belief about the efficacy of treatment on a 7-point categorical verbal rating scale. The scale ranges from (1) "no change or condition has gotten worse" to (7) "a great deal better and a considerable improvement that has made all the difference.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Healthcare Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Intensity Stimulation', 'description': 'Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks.\n\nHigh Intensity Quell: Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.'}, {'id': 'OG001', 'title': 'Low Intensity Stimulation', 'description': 'Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks.\n\nLow Intensity Quell: Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day.'}], 'classes': [{'title': 'Clinic visits', 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Hospital visits', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Changes from Baseline to 3-month Follow-Up', 'description': 'Monthly clinic and ED visits', 'unitOfMeasure': 'Number of visits', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Satisfaction and Qualitative Questions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Intensity Stimulation', 'description': 'Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks.\n\nHigh Intensity Quell: Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.'}, {'id': 'OG001', 'title': 'Low Intensity Stimulation', 'description': 'Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks.\n\nLow Intensity Quell: Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.6', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '2.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3-month Follow-up', 'description': 'A satisfaction questionnaire was developed for this study specifically related to use of the pain management device (Quell) and use of the study app. Ten items related to use of the device and five items were related to use of the smartphone study app all rated on a scale of 0 (worse) to 10 (better). Below are group differences on "How willing would you be to using the Quell in the future?" rated from 0=Not at all willing to 10=Very willing. This questionnaire was only administered at the end of the trial.', 'unitOfMeasure': 'score on a 0-10 scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quantitative Sensory Testing (QST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Intensity Stimulation', 'description': 'Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks.\n\nHigh Intensity Quell: Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.'}, {'id': 'OG001', 'title': 'Low Intensity Stimulation', 'description': 'Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks.\n\nLow Intensity Quell: Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Changes from Baseline to 3-month Follow-Up', 'description': 'Set of psychophysical methods used to quantify somatosensory function. Combined hypersensitivity measure that measures responses to repeated touch, mechanical/pressure pain assessment, and cold pain assessment. Overall sensitivity based on z scores categorized into high and low sensitivity. Higher scores represent less sensitivity. The mean score is 0.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Brief Pain Inventory Pain Intensity Scale (BPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Intensity Stimulation', 'description': 'Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks.\n\nHigh Intensity Quell: Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.'}, {'id': 'OG001', 'title': 'Low Intensity Stimulation', 'description': 'Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks.\n\nLow Intensity Quell: Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Changes from Baseline to 3-month Follow-Up', 'description': 'Average pain on a scale of 0-10 with higher scores meaning a worse outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'MasterMyPain App', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Intensity Stimulation', 'description': 'Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks.\n\nHigh Intensity Quell: Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.'}, {'id': 'OG001', 'title': 'Low Intensity Stimulation', 'description': 'Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks.\n\nLow Intensity Quell: Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '3.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Daily ratings over 3-months', 'description': 'Daily ratings of pain related factors on smartphone pain app on a scale of 0-10 with higher scores meaning a worse outcome. Multiple daily assessments were averaged for mean and standard deviation scores.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Intensity Stimulation', 'description': 'Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks.\n\nHigh Intensity Quell: Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.'}, {'id': 'FG001', 'title': 'Low Intensity Stimulation', 'description': 'Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks.\n\nLow Intensity Quell: Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High Intensity Stimulation', 'description': 'Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks.\n\nHigh Intensity Quell: Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.'}, {'id': 'BG001', 'title': 'Low Intensity Stimulation', 'description': 'Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks.\n\nLow Intensity Quell: Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-09-07', 'size': 144175, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-05T12:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Neither the principal investigator, the co-investigators, the research assistant, or the subjects will know if they are given the high intensity Quell device or the low intensity Quell device.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be equally randomized to one of the two treatment groups: the High Intensity Quell group or the Low Intensity Quell group. All groups will receive the same questionnaires and undergo quantitative sensory testing.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-28', 'studyFirstSubmitDate': '2022-09-12', 'resultsFirstSubmitDate': '2025-01-08', 'studyFirstSubmitQcDate': '2022-09-12', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-28', 'studyFirstPostDateStruct': {'date': '2022-09-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Brief Pain Inventory Interference Scale (BPI)', 'timeFrame': 'Between group differences at 3-months', 'description': 'This is a validated measure of combined activity interference on a numerical scale of 0-10, with higher scores representing greater activity interference. We collected ratings on how much pain interfered over the past 24 hours with 1) General activity, 2) Mood, 3) Walking ability, 4) Normal work, 5) Relations with other people, 6) Sleep, and 7) Enjoyment of life on a scale of 0=does not interfere to 10=completely interferes. The table represents combined mean scores between groups. These ratings were collected at 3 months after start of the study.'}], 'secondaryOutcomes': [{'measure': 'Pain Catastrophizing Scale (PCS)', 'timeFrame': 'Changes from Baseline to 3-month Follow-Up', 'description': 'Measures thoughts and feelings when patient is experiencing pain on a 13-item scale ranging from 0-52 with higher scores meaning a worse outcome and higher catastrophizing'}, {'measure': 'Pain Disability Index (PDI)', 'timeFrame': 'Changes from Baseline to 3-month Follow-Up', 'description': 'Rating scales designed to measure levels of pain disability, or the degree to which pain is preventing a patient from doing what they normally would be doing, or doing it as well as they normally would on a 7-item scale of 0-10 ranging from 0-70 with higher scores meaning a worse outcome'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Changes from Baseline to 3-month Follow-Up', 'description': 'Measures mood on a 14-item scale ranging from 0 to 42 with higher scores meaning a worse outcome'}, {'measure': 'Pain Detect Neuropathic Pain Questionnaire (painDETECT)', 'timeFrame': 'Changes from Baseline to 3-month Follow-Up', 'description': "Measures the presence of neuropathic pain on a scale ranging from 1 to 38 on ratings of 'never to very strongly' with higher scores meaning a worse outcome"}, {'measure': 'Symptom Impact Questionnaire (SIQR)', 'timeFrame': 'Changes from Baseline to 3-month Follow-Up', 'description': 'Measures 20 pain symptoms and function on a scale of 0-10 with scores ranging from 0 to 200 with higher scores meaning a worse outcome'}, {'measure': "Patient's Global Impression of Change (PGIC)", 'timeFrame': 'Changes from Baseline to 3-month Follow-Up', 'description': 'Measures the subject\'s overall belief about the efficacy of treatment on a 7-point categorical verbal rating scale. The scale ranges from (1) "no change or condition has gotten worse" to (7) "a great deal better and a considerable improvement that has made all the difference.'}, {'measure': 'Healthcare Utilization', 'timeFrame': 'Changes from Baseline to 3-month Follow-Up', 'description': 'Monthly clinic and ED visits'}, {'measure': 'Satisfaction and Qualitative Questions', 'timeFrame': '3-month Follow-up', 'description': 'A satisfaction questionnaire was developed for this study specifically related to use of the pain management device (Quell) and use of the study app. Ten items related to use of the device and five items were related to use of the smartphone study app all rated on a scale of 0 (worse) to 10 (better). Below are group differences on "How willing would you be to using the Quell in the future?" rated from 0=Not at all willing to 10=Very willing. This questionnaire was only administered at the end of the trial.'}, {'measure': 'Quantitative Sensory Testing (QST)', 'timeFrame': 'Changes from Baseline to 3-month Follow-Up', 'description': 'Set of psychophysical methods used to quantify somatosensory function. Combined hypersensitivity measure that measures responses to repeated touch, mechanical/pressure pain assessment, and cold pain assessment. Overall sensitivity based on z scores categorized into high and low sensitivity. Higher scores represent less sensitivity. The mean score is 0.'}, {'measure': 'The Brief Pain Inventory Pain Intensity Scale (BPI)', 'timeFrame': 'Changes from Baseline to 3-month Follow-Up', 'description': 'Average pain on a scale of 0-10 with higher scores meaning a worse outcome'}, {'measure': 'MasterMyPain App', 'timeFrame': 'Daily ratings over 3-months', 'description': 'Daily ratings of pain related factors on smartphone pain app on a scale of 0-10 with higher scores meaning a worse outcome. Multiple daily assessments were averaged for mean and standard deviation scores.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Multiple Chronic Overlapping Pain Conditions', 'Adults 21 and older'], 'conditions': ['Chronic Pain', 'Adults 21 and Older', 'Multiple Chronic Overlapping Pain Conditions', 'Hypersensitivity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://rally.massgeneralbrigham.org/study/_quellcopcs', 'label': 'Link to rally website to Quell COPCs'}]}, 'descriptionModule': {'briefSummary': 'This study will examine the pain-relieving effects of a transcutaneous electrical nerve stimulator device called a Quell for persons with multiple chronic overlapping pain conditions.', 'detailedDescription': 'This study will examine the pain-relieving effects of a transcutaneous electrical nerve stimulator device called a Quell for persons with multiple chronic overlapping pain conditions. Participants will attend two quantitative sensory testing visits in order to determine their level of pain sensitivity, one at the beginning of the study and the second at the 3-month Follow-up session. Participants will be asked to test out the Quell device to check for sensation tolerance, and will then be randomized into one of the two treatment groups: the High Intensity Quell group or the Low Intensity Quell group. Participants will be asked to wear the device for at least 3 hours every day and to complete daily assessments, along with a total of three sets of questionnaires: one at the start of the study, the second 6 weeks from the date of consent, and the third 3 months after the date of consent. A member of the research staff will call participants once a week for a brief phone interview throughout the study. Participants will be in this study for 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ages 21 and older\n* Pain duration \\> 3 months\n* Diagnosed by physician with multiple chronic pain conditions\n* Have chronic pain related to multiple chronic pain diagnoses (headaches, joint pain, back pain, or any of the other COPCs)\n* Average 4 or greater on pain intensity scale of 0 to 10\n* Pain is not accounted for by any other progressive disease (e.g., cancer, MS)\n* Meets sensory hypersensitivity cutoffs based on QST-assessed evidence\n* Own a smartphone (iPhone or Android device) and can download the pain app (MasterMyPain) and the Quell Relief mobile app onto their device\n* Able to speak and understand English\n\nExclusion Criteria:\n\n* Diagnosis of cancer or any other malignant disease\n* Acute osteomyelitis or acute bone disease\n* Present of past DSM-V diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder that would be judged to interfere with study participation\n* Pregnancy\n* Any clinically unstable systemic illness judged to interfere with treatment\n* A pain condition requiring urgent surgery\n* An active substance use disorder, such as cocaine or IV heroin use that would interfere with study participation\n* Have an implanted cardiac pacemaker, defibrillator, or other implanted device.\n* Reynaud's syndrome\n* Open cuts/sores"}, 'identificationModule': {'nctId': 'NCT05540002', 'briefTitle': 'Efficacy of the Quell Wearable Device for Chronic Overlapping Pain Conditions', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Efficacy of the Quell Wearable Device for Treatment of Central Sensitization-related Pain Among Persons With Chronic Overlapping Pain Conditions', 'orgStudyIdInfo': {'id': '2022P002083'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High Intensity Stimulation', 'description': 'Patients will be randomly assigned to the High Intensity Quell group and will receive higher intensity stimulation every day for 12 weeks.', 'interventionNames': ['Device: High Intensity Quell']}, {'type': 'SHAM_COMPARATOR', 'label': 'Low Intensity Stimulation', 'description': 'Patients will be randomly assigned to the Low intensity Quell group and will receive lower intensity stimulation every day for 12 weeks.', 'interventionNames': ['Device: Low Intensity Quell']}], 'interventions': [{'name': 'High Intensity Quell', 'type': 'DEVICE', 'description': 'Participants will receive 1 hour of continuous stimulation during each therapy session. Subjects are asked to complete a minimum of 3 sessions per day.', 'armGroupLabels': ['High Intensity Stimulation']}, {'name': 'Low Intensity Quell', 'type': 'DEVICE', 'description': 'Participants will receive only three 2-minute periods of stimulation (at 0, 28, 58 minutes) during each 60-minute therapeutic session. Subjects are asked to complete a minimum of 3 sessions per day.', 'armGroupLabels': ['Low Intensity Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02467', 'city': 'Chestnut Hill', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital Pain Management Center", 'geoPoint': {'lat': 42.33065, 'lon': -71.16616}}], 'overallOfficials': [{'name': 'Robert N. Jamison, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'NeuroMetrix, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Robert N. Jamison, PhD', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}