Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT04971616
Status:
UNKNOWN
Last Update Posted:
2021-07-21
First Post:
2021-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Risk Screening and Assessment of Shoulder, Neck and Lower Back Discomfort.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D020069', 'term': 'Shoulder Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D016059', 'term': 'Range of Motion, Articular'}], 'ancestors': [{'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-11', 'studyFirstSubmitDate': '2021-06-27', 'studyFirstSubmitQcDate': '2021-07-11', 'lastUpdatePostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Range of motion (ROM) of the neck', 'timeFrame': 'at least 2-week monitoring by wearable devices', 'description': "Patients' range of motion of the neck in all directions are measured using hand-held devices."}, {'measure': 'Oswestry Disability Index (ODI)', 'timeFrame': 'at least 2-week monitoring by wearable devices', 'description': 'Oswestry Disability Index of the neck is collected for the evaluation of neck functions.'}, {'measure': 'Visual Analogue Scale (VAS)', 'timeFrame': 'at least 2-week monitoring by wearable devices', 'description': 'Visual Analogue Scale is collected for pain assessment.'}, {'measure': 'Roland-Morris Disability Questionnaire (RDQ)', 'timeFrame': 'at least 2-week monitoring by wearable devices', 'description': 'Roland-Morris Disability Questionnaire is collected for the evaluation of lower back functions.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Low Back Pain', 'Neck Pain', 'Shoulder Pain']}, 'descriptionModule': {'briefSummary': 'Identifying high-risk factors that may lead to shoulder, neck and lower back discomfort and contributing to the primary prevention of disease progression.', 'detailedDescription': 'The purpose of this study is to design a self-assessment scheme for clinical assessment of shoulder, neck and lower back function and compare the consistency between clinical assessment and self-assessment. The body parameters (BMI, age, gender), daily activities (daily steps, sedentary), work and rest time (sleep time, quality) were collected through wearable devices, evaluating the risk factors of shoulder, neck and lower back discomfort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '20-40 year of age with shoulder, neck and lower back discomfort', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* 20-40 year of age with symptoms of shoulder\n* Neck and lower back discomfort\n\nExclusion Criteria\n\n* Red flag sign of the neck'}, 'identificationModule': {'nctId': 'NCT04971616', 'briefTitle': 'Risk Screening and Assessment of Shoulder, Neck and Lower Back Discomfort.', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Risk Screening and Assessment of Shoulder, Neck and Lower Back Discomfort.', 'orgStudyIdInfo': {'id': 'M2020342'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1: Patients with shoulder, neck and lower back discomfort', 'description': 'Patients with shoulder, neck and lower back discomfort.', 'interventionNames': ['Other: Demographic data and range of motion.']}], 'interventions': [{'name': 'Demographic data and range of motion.', 'type': 'OTHER', 'description': 'The body parameters (BMI, age, gender), daily activities (daily steps, sedentary), work and rest time (sleep time, quality) were collected through wearable devices. The range of motion of neck and waist was collected through hand-held devices.', 'armGroupLabels': ['Group 1: Patients with shoulder, neck and lower back discomfort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian-quan Wang, M.D.', 'role': 'CONTACT', 'email': 'keny1417@vip.sina.com', 'phone': '13801076267'}], 'facility': 'Peking University Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jian-quan Wang, M.D.', 'role': 'CONTACT', 'email': 'keny1417@vip.sina.com', 'phone': '13801076267'}], 'overallOfficials': [{'name': 'Jian-quan Wang, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}