- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04803760
Evaluation of the Relationship Between Neck Pain and Ergonomic Factors in Office Workers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
In 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.
A 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.
Exclusion 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.
Patients will be divided into 3 groups as mild, moderate and severe disabled according to their neck disability index values and will be analyzed statistically.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Istanbul Physical Medicine Rehabilitation Research and Training Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- aged between 18 and 55,
- working on computer,
- having neck pain at least three months.
Exclusion Criteria:
- 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
- cervical disc herniation,
- tumor.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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mild disability
Those whose neck disability index value is 25 and below
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A self-administered questionnaire will be used to screen Neck disability index, demographic information and ergonomic risk factors.
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high disability
Those whose neck disability index value is 25 and above
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A self-administered questionnaire will be used to screen Neck disability index, demographic information and ergonomic risk factors.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
neck disability index
Time Frame: baseline
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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
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baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: cansın medin-ceylan, M.D., Istanbul Physical Medicine Rehabilitation Research and Training Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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