Disability PhysicalNCT04803760
Evaluation of the Relationship Between Neck Pain and Ergonomic Factors in Office Workers
An observational study of Disability Physical and Neck Pain, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Disability Physical, Neck Pain, Ergonomic Factors
- What is being tested?
- A self-administered questionnaire
- How many people
- 1,028 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Feb 2021to 31 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: aged between 18 and 55, working on computer, having neck pain at least three months.
Who may be able to join
- aged between 18 and 55,
- working on computer,
- having neck pain at least three months.
Who cannot join
- reporting pregnancy,
- having a history of accidents,
- trauma or surgery in the neck region,
- congenital anomaly of the spine,
- rheumatologic disease,
- osteoporosis,
Show all 11Show fewer
- spondylosis,
- spondylolisthesis,
- infection of the spine
- cervical disc herniation,
- tumor.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Research and Training Hospital
Istanbul
About this study
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.
Read the 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.
- Conditions
- Disability Physical, Neck Pain, Ergonomic Factors
- Being tested
- A self-administered questionnaire
- Keywords
- neck pain, office workers, ergonomic factors
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A self-administered questionnaireOther
A self-administered questionnaire will be used to screen Neck disability index, demographic information and ergonomic risk factors.
| Study group | Role | What they receive |
|---|---|---|
| mild disability | Those whose neck disability index value is 25 and below Receives: Other: A self-administered questionnaire | |
| high disability | Those whose neck disability index value is 25 and above Receives: Other: A self-administered questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
neck disability index
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start20 Feb 2021
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Disability PhysicalStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,028 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Responsible party
- Principal investigator, Cansin Medin Ceylan, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- cansın medin-ceylan, M.D., Principal investigator, istanbul physical medicine rehabilitation research and training hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803760
- Sponsor's protocol ID
- 2021/18
- Status last verified
- Aug 2021
- First submitted
- 14 Mar 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18204402Aas 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.
PubMed 21491405Vassilaki 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.
PubMed 24765562Matsudaira 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.
PubMed 26051289McLean 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.
PubMed 20466711
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Neck Pain and Ergonomic Factors in Office Workers
- ClinicalTrials.gov ID
- NCT04803760
- Acronym / sponsor ID
- 2021/18
- Conditions
- Disability Physical, Neck Pain, Ergonomic Factors
- Keywords
- neck pain, office workers, ergonomic factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,028 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Collaborators
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Study start
- 20 Feb 2021 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mild disability | – | Other: A self-administered questionnaireThose whose neck disability index value is 25 and below |
| high disability | – | Other: A self-administered questionnaireThose whose neck disability index value is 25 and above |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- aged between 18 and 55, working on computer, having neck pain at least three months.
Key inclusion criteria (3 listed)
- aged between 18 and 55,
- working on computer,
- having neck pain at least three months.
Key exclusion criteria (11 listed)
- reporting pregnancy,
- having a history of accidents,
- trauma or surgery in the neck region,
- congenital anomaly of the spine,
- rheumatologic disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A self-administered questionnaireA self-administered questionnaire will be used to screen Neck disability index, demographic information and ergonomic risk factors. | Other | high disability, mild disability |
Primary outcome
neck disability index
Time frame: baseline
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Background: PubMed 18204402Cote 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.
- Background: PubMed 21491405Aas 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.
- Background: PubMed 24765562Vassilaki 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.
- Background: PubMed 26051289Matsudaira 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.
- Background: PubMed 20466711McLean 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
cansın medin-ceylan, M.D. principal investigator
istanbul physical medicine rehabilitation research and training hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disability Physical and Neck Pain, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neck disability index (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04803760, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.