Musculoskeletal StrainNCT03871335
Work-related Musculoskeletal System Disorders Among Female Workers in Hazelnut Factory
An observational study of Musculoskeletal Strain and Pain, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the prevalence of work-related musculoskeletal disorders in female workers in hazelnut factory. The secondary aim is to investigate the relationship between the musculoskeletal disorders severity and working posture, work related factor, psychosocial factor. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Musculoskeletal Strain, Pain, Occupational Problems
- What is being tested?
- Investigation of the work-related musculoskeletal disorders
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2018to 27 Feb 2019
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The population of this study involved the female workers of a hazelnut factory.
Who may be able to join
- age >18 years,
- had at least 12 months of continuous working experience in hazelnut selection.
Who cannot join
- having pregnancy,
- working in a standing position or having a burden job,
- having joint disease, gout, diabetes, and trauma during the last one year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Work-related Musculoskeletal Disorders Among Female Workers in a Hazelnut Factory: Prevalence, Working Posture and Relating Factors
The aim of this study is to determine the prevalence of work-related musculoskeletal disorders in female workers in hazelnut factory. The secondary aim is to investigate the relationship between the musculoskeletal disorders severity and working posture, work related factor, psychosocial factor.
- Being tested
- Investigation of the work-related musculoskeletal disorders
- Keywords
- work-related musculoskeletal disorders, hazelnut factory, low back pain, neck pain
- Medical subject headings
- Pain, Low Back Pain, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigation of the work-related musculoskeletal disordersDiagnostic test
Structured questionnaires will be used to determine the prevalence of the work-related musculoskeletal disorders and work-related factor. Photogrammetric method will be used to evaluate working posture.
What is being measured
The primary outcome is the main question the study is designed to answer.
Nordic Musculoskeletal Questionnaire (NMQ)
NMQ will be used to determine the self-reported musculoskeletal symptoms in the different body part (neck, shoulder, elbow, wrist, upper back, lower back, hip, knee, ankle) in which suffered from aches, pain, or discomfort during the last 12 months. The states of the obtained sick leave from work, obstructing of work, taken medication and seen a doctor or physiotherapist etc. during the past 12 months regarding the work-related MSD will be questioned. The participants can be responded by "yes" or "no".
Measured: 10 minutes
Secondary outcomes (5)
Dutch Musculoskeletal Questionnaire short version (DMQ-s)
DMQ-s was used to evaluate the perceived workload, work-related risk factors, and general health status. DMQ-s involves four sections (general question, health, perceived workload, ergonomic environment). The score of the three sections except the general questions section will be summed. Higher scores means risky situation for work-related musculoskeletal disorders.
Measured: 10 minutes
Assessment of the working posture
The working posture will be assessed using the photogrammetry method which is a reliable and valid tool for postural angles analysis. The photographs were taken the lateral aspect of the workers using a digital, professional camera (Canon 4000D, Japan) from a 150cm distance, at the height of the acromion in working position. Cranio-vertebral angle (CVA), thoracic kyphosis and lumbar lordosis angles were measured on the photograph using the ImageJ program. The results will be recorded as degree.
Measured: 2 minutes
Rapid Upper Extremity Assessment
Rapid Upper Limb Assessment (RULA) is a tool to evaluate upper extremity MSD risk factors. The RULA ergonomic assessment tool considers biomechanical and postural load requirements of job tasks/demands on the neck, trunk and upper extremities. A single page worksheet is used to evaluate required body posture, force, and repetition. Based on the evaluations, scores are entered for each body region in section A for the arm and wrist, and section B for the neck and trunk. After the data for each region is collected and scored, tables on the form are then used to compile the risk factor variables, generating a single score that represents the level of MSD risk. The score means 1-2 negligible risk no change requirement, 3-4 low risk change may be needed requirement, 5-6 medium risk further investigation change soon, 6+ very high risk implement change now
Measured: 5 minutes
Short Form-12 Health Survey (SF-12 Health Survey)
SF-12 Health Survey is a multidimensional generic measure of health-related quality of life. SF-12 Health Survey includes two subdomains as physical and mental. SF-12 Health Survey has a scoring algorithm. The higher scores defines good quality of life.
Measured: 5 minutes
Pain Severity
Pain severity will be scored between 0 and 10. The pain of nine different body part (neck, shoulder, elbow, wrist, upper back, lower back, hip, knee, ankle) will be examined by the subject's perception.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start10 Jun 2018
- Primary completion15 Feb 2019
- Study completion27 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal StrainStudies of the same condition, open and under way.
- 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Collaborators
- Giresun University, Hacettepe University
- Responsible party
- Principal investigator, Sevim ACARÖZ CANDAN, Ordu University
- Investigators
- Sevim ACARÖZ CANDAN, Principal investigator, Bayan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871335
- Sponsor's protocol ID
- OrduU4
- Status last verified
- Mar 2019
- First submitted
- 11 Feb 2019
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Work-related Musculoskeletal Disorders Among Female Workers in a Hazelnut Factory: Prevalence, Working Posture and Relating Factors
- ClinicalTrials.gov ID
- NCT03871335
- Acronym / sponsor ID
- OrduU4
- Keywords
- work-related musculoskeletal disorders, hazelnut factory, low back pain, neck pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Collaborators
- Giresun University, Hacettepe University
- Study start
- 10 Jun 2018 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 27 Feb 2019 (actual)
- First posted
- 12 Mar 2019 (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.
The aim of this study is to determine the prevalence of work-related musculoskeletal disorders in female workers in hazelnut factory. The secondary aim is to investigate the relationship between the musculoskeletal disorders severity and working posture, work related factor, psychosocial factor.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of this study involved the female workers of a hazelnut factory.
Key inclusion criteria (2 listed)
- age >18 years,
- had at least 12 months of continuous working experience in hazelnut selection.
Key exclusion criteria (3 listed)
- having pregnancy,
- working in a standing position or having a burden job,
- having joint disease, gout, diabetes, and trauma during the last one year
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 |
|---|---|---|
| Investigation of the work-related musculoskeletal disordersStructured questionnaires will be used to determine the prevalence of the work-related musculoskeletal disorders and work-related factor. Photogrammetric method will be used to evaluate working posture. | Diagnostic test | – |
Primary outcome
Nordic Musculoskeletal Questionnaire (NMQ)
Time frame: 10 minutes
NMQ will be used to determine the self-reported musculoskeletal symptoms in the different body part (neck, shoulder, elbow, wrist, upper back, lower back, hip, knee, ankle) in which suffered from aches, pain, or discomfort during the last 12 months. The states of the obtained sick leave from work, obstructing of work, taken medication and seen a doctor or physiotherapist etc. during the past 12 months regarding the work-related MSD will be questioned. The participants can be responded by "yes" or "no".
5 secondary outcomes
Dutch Musculoskeletal Questionnaire short version (DMQ-s)
Time frame: 10 minutes
Assessment of the working posture
Time frame: 2 minutes
Rapid Upper Extremity Assessment
Time frame: 5 minutes
Short Form-12 Health Survey (SF-12 Health Survey)
Time frame: 5 minutes
Pain Severity
Time frame: 5 minutes
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 12 Mar 2019.
- 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.
Sevim ACARÖZ CANDAN principal investigator
Bayan
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 Musculoskeletal Strain and Pain, run by Ordu 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 2 inclusion and 3 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 12 Mar 2019. 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?
Nordic Musculoskeletal Questionnaire (NMQ) (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2019.