Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2026-02-22 @ 11:45 PM
Study NCT ID:
NCT02710695
Status:
TERMINATED
Last Update Posted:
2018-04-26
First Post:
2016-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain in America: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059352', 'term': 'Musculoskeletal Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'whyStopped': 'Lack of available time', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-24', 'studyFirstSubmitDate': '2016-03-12', 'studyFirstSubmitQcDate': '2016-03-16', 'lastUpdatePostDateStruct': {'date': '2018-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Nkem Musculoskeletal Pain Management Comprehension Test "NMPMCT"', 'timeFrame': '15 minutes', 'description': 'Validated Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Surveys', 'timeFrame': '5 minutes'}]}, 'conditionsModule': {'conditions': ['Orthopaedic Related Pain (Musculoskeletal Pain)']}, 'descriptionModule': {'briefSummary': 'Each day orthopaedic surgeons worldwide treat patients with musculoskeletal pain. But little evidence exists about orthopaedic patient understanding of the common methods of managing musculoskeletal pain. Therefore, it is our aim to determine which discussion method best improves patient comprehension of common methods of managing pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are new to a discussion about the common methods of managing musculoskeletal pain, over the age of 18, native English speakers\n\nExclusion Criteria:\n\n* Patient with a previous orthopaedic surgery or musculoskeletal pain consultation, patients without the capacity to give consent, chronic narcotic users. Patients with a severe mental, visual, auditory or tactile impairment.'}, 'identificationModule': {'nctId': 'NCT02710695', 'briefTitle': 'Pain in America: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Missouri, Kansas City'}, 'orgStudyIdInfo': {'id': '16-026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'This group will receive a 10 minute discussion', 'interventionNames': ['Behavioral: Control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'This group will receive a 10 minute standardized discussion', 'interventionNames': ['Behavioral: Intervention']}], 'interventions': [{'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'This group will receive a standardized 10 minute discussion.', 'armGroupLabels': ['Control']}, {'name': 'Intervention', 'type': 'BEHAVIORAL', 'description': 'This group will receive a standardized 10 minute discussion', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'UMKC Department of Orthopaedic Surgery', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}], 'overallOfficials': [{'name': 'Nkem Egekeze, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMKC Department of Orthopaedic Surgery'}, {'name': 'Charles Rhoades, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UMKC Department of Orthopaedic Surgery'}, {'name': 'Mark Bernhardt, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UMKC Department of Orthopaedic Surgery'}, {'name': 'Karen Williams, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UMKC Department of Orthopaedic Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Missouri, Kansas City', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopaedic Research Fellow', 'investigatorFullName': 'Nkemakolam Egekeze', 'investigatorAffiliation': 'University of Missouri, Kansas City'}}}}