Ignite Creation Date:
2025-12-25 @ 1:59 AM
Ignite Modification Date:
2026-02-08 @ 3:38 AM
Study NCT ID:
NCT01583894
Status:
COMPLETED
Last Update Posted:
2020-11-25
First Post:
2012-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multiple Areas of Pain (MAP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nitzan.mekel-bobrov@bsci.com', 'phone': '6619494537', 'title': 'Nitzan Mekel-Bobrov, Director of Scientific Communications', 'organization': 'Boston Scientific Corporation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Not applicable. Considering the non-interventional nature of this study, no adverse event data was collected.', 'description': 'Considering the non-interventional nature of this study, no adverse event data was collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Chronic Pain Patients', 'description': 'Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Multi-site Pain Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '810', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chronic Pain Patients', 'description': 'Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months'}], 'classes': [{'categories': [{'measurements': [{'value': '0.52', 'spread': '0.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'single-visit', 'description': 'Multiple Site Pain Index (MSPI) was developed by collating multiple pain descriptors into a single index. Pain descriptors used for developing this index were percent body area in pain, number of painful areas, span of painful areas, and Regional Pain Ratings (RPRs) which includes data on pain severity and pain continuity for 47 body regions.\n\nMSPI score ranged from 0 to 1; 0 representing no pain and 1 representing extreme continuous pain over entire body, except the head and face regions.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'MSPI was calculated using multiple pain descriptors which were obtained from pain drawings. 810 of the 813 patients that completed the study provided complete pain drawing data, and so MSPI could be calculated only in 810 patients.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chronic Pain Patients', 'description': 'Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '828'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '813'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '828', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Chronic Pain Patients', 'description': 'Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.3', 'spread': '13.23', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Age information available in 823 subjects', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '527', 'groupId': 'BG000'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '299', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Gender information available in 826 subjects', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 828}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-11', 'studyFirstSubmitDate': '2012-04-23', 'resultsFirstSubmitDate': '2014-12-18', 'studyFirstSubmitQcDate': '2012-04-23', 'lastUpdatePostDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-12-18', 'studyFirstPostDateStruct': {'date': '2012-04-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-12-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Multi-site Pain Index', 'timeFrame': 'single-visit', 'description': 'Multiple Site Pain Index (MSPI) was developed by collating multiple pain descriptors into a single index. Pain descriptors used for developing this index were percent body area in pain, number of painful areas, span of painful areas, and Regional Pain Ratings (RPRs) which includes data on pain severity and pain continuity for 47 body regions.\n\nMSPI score ranged from 0 to 1; 0 representing no pain and 1 representing extreme continuous pain over entire body, except the head and face regions.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'This study will collect pain-related information from chronic pain patients to gain an understanding of the prevalence of multi-site pain, and how it affects health outcomes like function, quality of life, depression, and anxiety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chronic pain patients resident in a US pain management practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Chronic pain of the trunk and/or limbs lasting at least 6 months\n* Overall pain intensity of at least 5 on a 0 to 10 scale\n* Subject is able to independently complete all assessments in English\n* 18 years of age or older\n* Subject signs an Institutional Review Board-approved informed consent form provided in English\n\nKey Exclusion Criteria:\n\n* Currently implanted with an active implantable medical device to treat pain\n* Currently exhibits any characteristic that renders the subject ineligible for current or future treatment with spinal cord stimulation for chronic pain of the trunk and/or limbs\n* Subject has undergone an interventional pain procedure less than 1 month prior to the study'}, 'identificationModule': {'nctId': 'NCT01583894', 'acronym': 'MAP', 'briefTitle': 'Multiple Areas of Pain (MAP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Multiple Areas of Pain (MAP): Epidemiology of Multisite Pain in the Chronic Pain Population', 'orgStudyIdInfo': {'id': 'A7003'}, 'secondaryIdInfos': [{'id': 'CDM00044807', 'type': 'OTHER', 'domain': 'BSC protocol number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Chronic pain patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Medical Center - Jacobs Medical Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94558', 'city': 'Napa', 'state': 'California', 'country': 'United States', 'facility': 'Neurovations', 'geoPoint': {'lat': 38.29714, 'lon': -122.28553}}, {'zip': '99123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Integrated Pain Specialists of Southern California', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '33323', 'city': 'Sunrise', 'state': 'Florida', 'country': 'United States', 'facility': 'Sheridan Clinical Research', 'geoPoint': {'lat': 26.13397, 'lon': -80.1131}}, {'zip': '61701', 'city': 'Bloomington', 'state': 'Illinois', 'country': 'United States', 'facility': 'Millennium Pain Center', 'geoPoint': {'lat': 40.4842, 'lon': -88.99369}}, {'zip': '47714', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Global Scientific Innovations - Advanced Pain Care Clinic', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '39581', 'city': 'Pascagoula', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Comprehensive Pain & Rehabilitation', 'geoPoint': {'lat': 30.36576, 'lon': -88.55613}}, {'zip': '63005', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Midwest Pain Center', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Center for Clinical Research, LLC', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals of Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Medical Center', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '29585', 'city': 'Pawleys Island', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Channel Research', 'geoPoint': {'lat': 33.43322, 'lon': -79.12143}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Pain Associates', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84604', 'city': 'Provo', 'state': 'Utah', 'country': 'United States', 'facility': 'Nexus Pain Care', 'geoPoint': {'lat': 40.23384, 'lon': -111.65853}}], 'overallOfficials': [{'name': 'Roshini Jain', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Boston Scientific Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}