Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-28 @ 12:10 AM
Study NCT ID:
NCT04803760
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2021-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Relationship Between Neck Pain and Ergonomic Factors in Office Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1028}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-27', 'studyFirstSubmitDate': '2021-03-14', 'studyFirstSubmitQcDate': '2021-03-16', 'lastUpdatePostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'neck disability index', 'timeFrame': 'baseline', 'description': "The Neck Disability Index (NDI) is a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neck pain', 'office workers', 'ergonomic factors'], 'conditions': ['Disability Physical', 'Neck Pain', 'Ergonomic Factors']}, 'referencesModule': {'references': [{'pmid': '18204402', 'type': 'BACKGROUND', 'citation': 'Cote P, van der Velde G, Cassidy JD, Carroll LJ, Hogg-Johnson S, Holm LW, Carragee EJ, Haldeman S, Nordin M, Hurwitz EL, Guzman J, Peloso PM; Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. The burden and determinants of neck pain in workers: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Spine (Phila Pa 1976). 2008 Feb 15;33(4 Suppl):S60-74. doi: 10.1097/BRS.0b013e3181643ee4.'}, {'pmid': '21491405', 'type': 'BACKGROUND', 'citation': 'Aas RW, Tuntland H, Holte KA, Roe C, Lund T, Marklund S, Moller A. Workplace interventions for neck pain in workers. Cochrane Database Syst Rev. 2011 Apr 13;2011(4):CD008160. doi: 10.1002/14651858.CD008160.pub2.'}, {'pmid': '24765562', 'type': 'BACKGROUND', 'citation': 'Vassilaki M, Hurwitz EL. Insights in public health: perspectives on pain in the low back and neck: global burden, epidemiology, and management. Hawaii J Med Public Health. 2014 Apr;73(4):122-6. No abstract available.'}, {'pmid': '26051289', 'type': 'BACKGROUND', 'citation': 'Matsudaira K, Kawaguchi M, Isomura T, Inuzuka K, Koga T, Miyoshi K, Konishi H. Assessment of psychosocial risk factors for the development of non-specific chronic disabling low back pain in Japanese workers-findings from the Japan Epidemiological Research of Occupation-related Back Pain (JOB) study. Ind Health. 2015;53(4):368-77. doi: 10.2486/indhealth.2014-0260. Epub 2015 Jun 6.'}, {'pmid': '20466711', 'type': 'BACKGROUND', 'citation': 'McLean SM, May S, Klaber-Moffett J, Sharp DM, Gardiner E. Risk factors for the onset of non-specific neck pain: a systematic review. J Epidemiol Community Health. 2010 Jul;64(7):565-72. doi: 10.1136/jech.2009.090720. Epub 2010 May 12.'}]}, 'descriptionModule': {'briefSummary': 'Neck pain is a prevalent condition and leading causes of disability particularly in office workers compared to other occupations (1-3). Neck pain is not only a risk factor for functional disability but it is also associated with decreased productivity of workers and quality of life (4). However, the present literature is insufficient to determine the factors affecting the level of disability caused by neck pain among office workers where intensive computer use is common (5). Thus, the current study aimed to explore the associations between disability levels and of occupational risk factors in computer-using office workers with neck pain.', 'detailedDescription': 'This is a cross-sectional study. All participants will provide informed consent before participating in the study. The study will be conducted in accordance with the Helsinki Declaration criteria. Data will be collected using questionnaires, which include the Neck disability index, demographic information (including age, gender, educational level) and frequency of neck and head pain, history of general neck injuries and treatments applied. Also, years of office work at current job, sick leave, ergonomic training, duration of computer use per day and using of headphones, monitor and keyboard stand, mouse/mouse pad and number of computer screens will be determined.\n\nIn addition, based on Rapid Office Strain Assessment (ROSA) method the potential ergonomic risk factors computer position, computer screen position, head and back position and mouse position will be determined. Visual pictures of the work positions will be shown to the participants and the participants will be asked to select the appropriate pictures showing their work positions.\n\nA self-administered questionnaire will be used to screen potential participants for this study. Inclusion criteria are individuals aged between 18 and 55, working on computer, having neck pain at least three months.\n\nExclusion criteria are reporting pregnancy, having a history of accidents, trauma or surgery in the neck region, congenital anomaly of the spine, rheumatologic disease, osteoporosis, spondylosis, spondylolisthesis, infection of the spine and discs, tumor.\n\nPatients will be divided into 3 groups as mild, moderate and severe disabled according to their neck disability index values and will be analyzed statistically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'aged between 18 and 55, working on computer, having neck pain at least three months.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged between 18 and 55,\n* working on computer,\n* having neck pain at least three months.\n\nExclusion Criteria:\n\n* reporting pregnancy,\n* having a history of accidents,\n* trauma or surgery in the neck region,\n* congenital anomaly of the spine,\n* rheumatologic disease,\n* osteoporosis,\n* spondylosis,\n* spondylolisthesis,\n* infection of the spine\n* cervical disc herniation,\n* tumor.'}, 'identificationModule': {'nctId': 'NCT04803760', 'briefTitle': 'Evaluation of the Relationship Between Neck Pain and Ergonomic Factors in Office Workers', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Evaluation of the Relationship Between Neck Pain and Ergonomic Factors in Office Workers', 'orgStudyIdInfo': {'id': '2021/18'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mild disability', 'description': 'Those whose neck disability index value is 25 and below', 'interventionNames': ['Other: A self-administered questionnaire']}, {'label': 'high disability', 'description': 'Those whose neck disability index value is 25 and above', 'interventionNames': ['Other: A self-administered questionnaire']}], 'interventions': [{'name': 'A self-administered questionnaire', 'type': 'OTHER', 'description': 'A self-administered questionnaire will be used to screen Neck disability index, demographic information and ergonomic risk factors.', 'armGroupLabels': ['high disability', 'mild disability']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Physical Medicine Rehabilitation Research and Training Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'cansın medin-ceylan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'istanbul physical medicine rehabilitation research and training hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istanbul Physical Medicine and Rehabiltation Training and Research Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'specialist', 'investigatorFullName': 'Cansin Medin Ceylan', 'investigatorAffiliation': 'Istanbul Physical Medicine Rehabilitation Training and Research Hospital'}}}}