Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-01-08 @ 7:53 PM
Study NCT ID:
NCT03166033
Status:
COMPLETED
Last Update Posted:
2017-05-24
First Post:
2017-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Case-control Study on Individual Risk Factors of CTS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003140', 'term': 'Communicable Disease Control'}], 'ancestors': [{'id': 'D015980', 'term': 'Public Health Practice'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6048}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-23', 'studyFirstSubmitDate': '2017-05-23', 'studyFirstSubmitQcDate': '2017-05-23', 'lastUpdatePostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'general risk factors', 'timeFrame': '2014-2015', 'description': 'Gender, age, smoking, wrist injury, diabetes mellitus, hypothyroidism and wrist working are all the risk factors of carpal tunnel syndrome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carpal Tunnel Syndrome', 'etiology', 'risk factor'], 'conditions': ['Carpal Tunnel Syndrome']}, 'referencesModule': {'references': [{'pmid': '29623932', 'type': 'DERIVED', 'citation': 'Gao KM, Hu JJ, Lao J, Zhao X. Evaluation of nerve transfer options for treating total brachial plexus avulsion injury: A retrospective study of 73 participants. Neural Regen Res. 2018 Mar;13(3):470-476. doi: 10.4103/1673-5374.228730.'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted to observe the characteristics of the risk factors of CTS in Chinese population.', 'detailedDescription': "Carpal tunnel syndrome (CTS), or median neuropathy at the wrist, is a medical condition in which the median nerve is compressed at the wrist, leading to paresthesia, numbness and muscle weakness in the hand. It's the most common neuro-compressive disease. With the development of the modern life, the morbidity of CTS is also raised. As a common disease, the study on etiology is very important in Carpal Tunnel Syndrome, which can improve the life quality of patients with carpal tunnel syndrome. The risk factors include individual factors such as age, gender, diabetes, Hypothyroidism, obesity, complication of systematic diseases, tobacco, injury and occupational factors.\n\nAs most of the research were based on the population in western country and the life style and the ethnicity between Chinese people and western country people is quite different, there may be some similarities and differences in epidemiology. There is seldom similar research in China so that this study was conducted to observe the characteristics of these risk factors in Chinese population."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '41 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The present case-control study was based on the single medical center in Shanghai, China, in which more than 5000 CTS patients per year are treated. The hospital involved in the study is a university teaching hospital. Cases were recruited from the surgical wards and appropriate outpatient clinics, while the controls were recruited from the outpatient clinics.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* with the symptom "numbness"\n* clinical and neural-electrophysiological diagnosed CTS\n\nExclusion Criteria:\n\n* suffered from other diseases that could cause "numbness" diagnosed clinically'}, 'identificationModule': {'nctId': 'NCT03166033', 'briefTitle': 'Case-control Study on Individual Risk Factors of CTS', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Case-control Study on Individual Risk Factors of Carpal Tunnel Syndrome', 'orgStudyIdInfo': {'id': '81572127'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case Group', 'description': 'age between 41 and 70years. People in the case group with the symptom "numbness" and then were clinical and neural-electrophysiological diagnosed CTS. People in the control group would be exclude the symptom "numbness". The case group included clinical diagnosed carpal tunnel syndrome which was divided into 4 parts every 10 years old age. The gender of the patients of the control group was matched to the case group and divided into 4 parts by age.', 'interventionNames': ['Other: the disease']}, {'label': 'Control Group', 'description': 'The present case-control study was based on the single medical center in Shanghai, China, in which more than 5000 CTS patients per year are treated. The hospital involved in the study is a university teaching hospital. Cases were recruited from the surgical wards and appropriate outpatient clinics, while the controls were recruited from the outpatient clinics. Both groups filled out a standardized questionnaire, and a standardized patient record was filled out by a hand surgeon. In addition, participants with jobs involving lifting and carrying of loads were interviewed.', 'interventionNames': ['Other: the disease']}], 'interventions': [{'name': 'the disease', 'type': 'OTHER', 'description': 'Observation the patients and non-patients', 'armGroupLabels': ['Case Group', 'Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Huashan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Natural Science Foundation of China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Guan Wenjie', 'investigatorAffiliation': 'Fudan University'}}}}