Musculoskeletal InjuryNCT04723615
Orebro Musculoskeletal Screening Questionnaire-12
An observational study of Musculoskeletal Injury, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The research is a study with methodological design. The validity, reliability and practicality of the Örebro Musculoskeletal System Screening Questionnaire-12 will be investigated. In this context, a questionnaire will be applied to the participants to take part in the study after the translation process is completed. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Musculoskeletal Injury
- What is being tested?
- Orebro Musculoskeletal Screening Questionnaire-12, Visual Analog Scale and The Tampa Scale of Kinesiophobia
- How many people
- 319 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Dec 2020to 18 Dec 2024
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be contacted via Google forms after the entire translation process of the questionnaire is completed. Participants will be 18-65 years and have any musculoskeletal problems (spine, upper or lower extremities).
Who may be able to join
- Having any musculoskeletal problems (spine, upper or lower extremities)
- Being in the age range of 18-65
Who cannot join
- Pregnancy
- Having of red flag signs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Turkish Validity, Reliability and Practicality of Örebro Musculoskeletal System Screening Questionnaire-12
The research is a study with methodological design. The validity, reliability and practicality of the Örebro Musculoskeletal System Screening Questionnaire-12 will be investigated. In this context, a questionnaire will be applied to the participants to take part in the study after the translation process is completed.
Read the detailed description
Musculoskeletal disorders are quite common in developed and developing countries. Musculoskeletal disorders cause economic burdens in the individual and social field. In addition, getting reports is one of the main causes of reduced productivity and work disability. Therefore, inexpensive and easily applicable screening questionnaires are needed to determine the patient population with high risk musculoskeletal disorders. The Örebro Musculoskeletal Screening Questionnaire is a practical questionnaire that can evaluate musculoskeletal disorders and is tailored to the WHO-ICF themes. For this reason, the aim of the study is to translate the Örebro Musculoskeletal System Survey-12 into Turkish intercultural translation and to investigate the construct validity, reliability and practicality.
- Conditions
- Musculoskeletal Injury
- Being tested
- Orebro Musculoskeletal Screening Questionnaire-12, Visual Analog Scale, The Tampa Scale of Kinesiophobia, Short Form-12 (SF-12)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orebro Musculoskeletal Screening Questionnaire-12Other
It is a 12-item self-report questionnaire that aims to estimate the severity of the problem, functional impairment, reporting status, cost and recovery time in musculoskeletal problems.
Visual Analog ScaleOther
A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.
The Tampa Scale of KinesiophobiaOther
The Tampa Scale of Kinesiophobia that was developed in 1990 is a 17 item scale originally developed to measure the fear of movement related to chronic lower back pain.
Short Form-12 (SF-12)Other
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Orebro Musculoskeletal Screening Questionnaire-12
It is a 12-item self-report questionnaire that aims to estimate a wide range of outcomes (severity of the problem, functional impairment, reporting status, cost and recovery time) in patients with acute and subacute work injury presenting with musculoskeletal pain involving the spine, upper and lower extremities.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start18 Dec 2020
- Primary completion18 Dec 2023 (estimated)
- Study completion18 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal InjuryStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Taşvuran Horata, Afyonkarahisar Health Sciences University
- Investigators
- EMEL TAŞVURAN HORATA, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723615
- Sponsor's protocol ID
- 2020/469
- Status last verified
- Jan 2022
- First submitted
- 17 Jan 2021
- Last updated
- 20 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tasvuran Horata E, Demir P, Yagci G, Erel S, Eken F, Gabel CP. The validity and reliability of the Turkish version of the 12-item Orebro musculoskeletal screening questionnaire (OMSQ-12-TR). Disabil Rehabil. 2023 Dec;45(25):4288-4295. doi: 10.1080/09638288.2022.2089918. Epub 2022 Jun 25.
PubMed 35758151
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Turkish Validity, Reliability and Practicality of Örebro Musculoskeletal System Screening Questionnaire-12
- ClinicalTrials.gov ID
- NCT04723615
- Acronym / sponsor ID
- 2020/469
- Conditions
- Musculoskeletal Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 18 Dec 2023 (estimated)
- Study completion
- 18 Dec 2024 (estimated)
- First posted
- 26 Jan 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.
The research is a study with methodological design. The validity, reliability and practicality of the Örebro Musculoskeletal System Screening Questionnaire-12 will be investigated. In this context, a questionnaire will be applied to the participants to take part in the study after the translation process is completed.
Detailed description
Musculoskeletal disorders are quite common in developed and developing countries. Musculoskeletal disorders cause economic burdens in the individual and social field. In addition, getting reports is one of the main causes of reduced productivity and work disability. Therefore, inexpensive and easily applicable screening questionnaires are needed to determine the patient population with high risk musculoskeletal disorders. The Örebro Musculoskeletal Screening Questionnaire is a practical questionnaire that can evaluate musculoskeletal disorders and is tailored to the WHO-ICF themes. For this reason, the aim of the study is to translate the Örebro Musculoskeletal System Survey-12 into Turkish intercultural translation and to investigate the construct validity, reliability and practicality.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be contacted via Google forms after the entire translation process of the questionnaire is completed. Participants will be 18-65 years and have any musculoskeletal problems (spine, upper or lower extremities).
Key inclusion criteria (2 listed)
- Having any musculoskeletal problems (spine, upper or lower extremities)
- Being in the age range of 18-65
Key exclusion criteria (2 listed)
- Pregnancy
- Having of red flag signs.
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 |
|---|---|---|
| Orebro Musculoskeletal Screening Questionnaire-12It is a 12-item self-report questionnaire that aims to estimate the severity of the problem, functional impairment, reporting status, cost and recovery time in musculoskeletal problems. | Other | – |
| Visual Analog ScaleA Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. | Other | – |
| The Tampa Scale of KinesiophobiaThe Tampa Scale of Kinesiophobia that was developed in 1990 is a 17 item scale originally developed to measure the fear of movement related to chronic lower back pain. | Other | – |
| Short Form-12 (SF-12)The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. | Other | – |
Primary outcome
Orebro Musculoskeletal Screening Questionnaire-12
Time frame: 10 minutes
It is a 12-item self-report questionnaire that aims to estimate a wide range of outcomes (severity of the problem, functional impairment, reporting status, cost and recovery time) in patients with acute and subacute work injury presenting with musculoskeletal pain involving the spine, upper and lower extremities.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Derived from this study: PubMed 35758151Tasvuran Horata E, Demir P, Yagci G, Erel S, Eken F, Gabel CP. The validity and reliability of the Turkish version of the 12-item Orebro musculoskeletal screening questionnaire (OMSQ-12-TR). Disabil Rehabil. 2023 Dec;45(25):4288-4295. doi: 10.1080/09638288.2022.2089918. Epub 2022 Jun 25.
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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.
EMEL TAŞVURAN HORATA principal investigator
Afyonkarahisar Health Sciences University
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 Injury, run by Afyonkarahisar Health Sciences 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 2 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: status not confirmed, as of the sponsor's last update on 20 Jan 2022. 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?
Results are not available in the source record.
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?
Orebro Musculoskeletal Screening Questionnaire-12 (time frame: 10 minutes). 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 NCT04723615, which also lists 1 linked publication.
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 20 Jan 2022.