Sports InjuryNCT05356065
The Turkish Version of the OSTRC Questionnaires
An observational study of Sports Injury, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Exposure to repetitive activities and heavy workloads makes athletes vulnerable to overuse injuries over time. Well-timed detection of these injuries is crucial to maintaining their sports career healthily. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Sports Injury
- What is being tested?
- survey administration
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jan 2021to 15 Dec 2021
- How long will I take part?
- 6 Weeks
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Athletes aged between 18 and 35, who can understand and speak Turkish fluently from various sports branches
Who may be able to join
- accepting to participate in the study
- Participating in sports
Who cannot join
- Being illiterate
- Being younger than 18 years or older than 35 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Turkish Version of the Oslo Sports Trauma Research Center (OSTRC) Questionnaire on Overuse Injuries and Health Problems; Validity and Reliability Study
Exposure to repetitive activities and heavy workloads makes athletes vulnerable to overuse injuries over time. Well-timed detection of these injuries is crucial to maintaining their sports career healthily. The Oslo Sports Trauma Research Centre questionnaires for Overuse Injury (OSTRC-O) and Health Problems (OSTRC-H) are universally used as valid and reliable tools in athlete health screening. This study aims to make them available for Turkish athletes.
The internal consistency, reproducibility, and validity of the questionnaires were analyzed. Data were obtained from 72 athletes from different sports types. 33 participants were screened weekly for six weeks to detect score changes and calculate effect sizes. Participants filled out the OSTRC-O, the OSTRC-H, the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ), and the Nottingham Health Profile (NHP) for validity analyses. The internal consistency and test-retest reliability values were very high for both questionnaires. There was a moderate correlation between OSTRC-O and OSTRC-H scores with CMDQ and NHP. The area under the curve (AUC) values were adequate for all scales. The effect size values were moderate for all scales. Turkish versions of the OSTRC-O and OSTRC-H questionnaires are valid and reliable tools for Turkish-speaking athletes in different sports branches.
Read the detailed description
Introduction and Aims All athletes are vulnerable to acute traumas or cumulative injuries throughout their sports life. Thus, screening the health levels of athletes and investigating whether they have overuse injuries is essential both to prevent acute traumas and improve health and performance. There is no valid and reliable subjective measurement tool to perform this screening in athletes in Turkish currently. However, the valid and reliable "Oslo Sports Trauma Research Centre Overuse Injury Questionnaire - (OSTRC)" questionnaires are available in English. So the investigators aimed to adapt the OSTRC- Overuse (OSTRC-O) and the OSTRC-Health Questionnaire (OSTRC-H) into Turkish.
Methods Permission was obtained from the developer authors. Then, ethical approval was acquired from the clinical researches ethics committee. Questionnaires were adapted into Turkish systematically. A pilot study was conducted to ensure the accuracy of meaning and comprehensibility of translated questionnaires. Next, the validity and reliability of the new tools were estimated. 72 athletes aged between 18 and 35, who can understand and speak Turkish fluently from various sports branches, were included. Informed consent was obtained from all athletes. The demographics of the participants were recorded. All participants were administered the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ), Nottingham Health Profile (NHP), OSTRC-O, and OSTRC-H questionnaires. The OSTRC-O OSTRC-H and CMDQ questionnaires were repeated weekly for six weeks on 33 athletes.
Reliability was analyzed by internal consistency and test-retest methods. The validity of the scale was evaluated in terms of content validity and concurrent validity. Content validity was verified with reports of participants at the end of the sixth week. To evaluate the concurrent validity, total OSTRC scores were compared with the total scores of CMDQ and NHP. Correlations of the OSTRC-O and OSTRC-H change scores with CMDQ change scores separately were assessed throughout the six weeks in point of the Effect Size (ES) for responsiveness. Receiver Operating Characteristic (ROC) Curve test based on the area under the curve (AUC) depicted to define the performance of these assessment tools. Statistical analyses were performed with the Statistical Package for Social Sciences Program.
- Conditions
- Sports Injury
- Being tested
- survey administration
- Keywords
- overuse injury, athlete health, outcome measures, validity and reliability study
- Medical subject headings
- Athletic Injuries, Cumulative Trauma Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
survey administrationOther
Outcome Measures
What is being measured
The primary outcome is the main question the study is designed to answer.
Oslo Sports Trauma Research Centre Questionnaires for Overuse Injury (OSTRC-O)
The "Oslo Sports Trauma Research Centre Questionnaires for Overuse Injury" is a self-reported outcome measure. It queries sports participation, training volume, sports performance, and pain for a selected body location-e.g. knee taking into account the last seven days. A severity score is between 0-100 points. Higher points show worse health conditions.
Measured: Baseline
Oslo Sports Trauma Research Centre questionnaires on Health Problems (OSTRC-H)
"Oslo Sports Trauma Research Centre questionnaires on Health Problems" is a self-reported outcome measure. It is applied to determine the effects of general health problems on sports participation, training volume, sports performance, and pain for the last seven days. A severity score is between 0 and 100 points. Higher points show worse health conditions.
Measured: Baseline
Cornell Musculoskeletal Discomfort Questionnaire (CMDQ)
Cornell Musculoskeletal Discomfort Questionnaire is used to ascertain the musculoskeletal problems experienced in the last week during work life. Participants marked the frequency, discomfort, and interference categories for 20 different regions on the body map diagram. The total score of the questionnaire is between 0 (best condition) and 90 (worst health status).
Measured: Baseline
Nottingham Health Profile (NHP)
Nottingham Health Profile is a self-reported outcome measure. It is a general health questionnaire consisting of 6 sub-parameters (pain, physical mobility, emotional reactions, sleep, energy level, social isolation) and 38 items. Participants marked yes or no for each item. The total score ranges from 0 to 600, and the total score is inversely proportional to the quality of life.
Measured: Baseline
Secondary outcomes (3)
Oslo Sports Trauma Research Centre Questionnaires for Overuse Injury (OSTRC-O)
The "Oslo Sports Trauma Research Centre Questionnaires for Overuse Injury" is a self-reported outcome measure. It queries sports participation, training volume, sports performance, and pain for a selected body location-e.g. knee taking into account the last seven days. A severity score is between 0-100 points. Higher points show worse health conditions
Measured: Change from baseline score at 6 weeks
Oslo Sports Trauma Research Centre questionnaires on Health Problems (OSTRC-H)
"Oslo Sports Trauma Research Centre questionnaires on Health Problems" is a self-reported outcome measure. It is applied to determine the effects of general health problems on sports participation, training volume, sports performance, and pain for the last seven days. A severity score is between 0 and 100 points. Higher points show worse health conditions.
Measured: Change from baseline score at 6 weeks
Cornell Musculoskeletal Discomfort Questionnaire (CMDQ)
Cornell Musculoskeletal Discomfort Questionnaire is used to ascertain the musculoskeletal problems experienced in the last week during work life. Participants marked the frequency, discomfort, and interference categories for 20 different regions on the body map diagram. The total score of the questionnaire is between 0 (best condition) and 90 (worst health status).
Measured: Change from baseline score at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start26 Jan 2021
- Primary completion20 Aug 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sports InjuryStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şeyda ÖZAL, Gazi University
- Investigators
- Şeyda ÖZAL, Ph.D. (c), Principal investigator, Gazi University Faculty of Health SciencesNihan KAFA, Asoc. Prof., Study director, Gazi University Faculty of Health SciencesFuat YUKSEL, Ph.D. (c), Principal investigator, Gazi University Faculty of Health SciencesNevin A GÜZEL, Prof. Dr., Study chair, Gazi University Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356065
- Sponsor's protocol ID
- GAZIUN
- Status last verified
- Apr 2022
- First submitted
- 14 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It can be shared with reasonable requirements
Publications
Bahr R, Bahr IA. Incidence of acute volleyball injuries: a prospective cohort study of injury mechanisms and risk factors. Scand J Med Sci Sports. 1997 Jun;7(3):166-71. doi: 10.1111/j.1600-0838.1997.tb00134.x.
PubMed 9200321Clarsen B, Ronsen O, Myklebust G, Florenes TW, Bahr R. The Oslo Sports Trauma Research Center questionnaire on health problems: a new approach to prospective monitoring of illness and injury in elite athletes. Br J Sports Med. 2014 May;48(9):754-60. doi: 10.1136/bjsports-2012-092087. Epub 2013 Feb 21.
PubMed 23429267Clarsen B, Myklebust G, Bahr R. Development and validation of a new method for the registration of overuse injuries in sports injury epidemiology: the Oslo Sports Trauma Research Centre (OSTRC) overuse injury questionnaire. Br J Sports Med. 2013 May;47(8):495-502. doi: 10.1136/bjsports-2012-091524. Epub 2012 Oct 4.
PubMed 23038786Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
PubMed 11124735Hunt SM, McKenna SP, McEwen J, Williams J, Papp E. The Nottingham Health Profile: subjective health status and medical consultations. Soc Sci Med A. 1981 May;15(3 Pt 1):221-9. doi: 10.1016/0271-7123(81)90005-5. No abstract available.
PubMed 6973203Erdinc O, Hot K, Ozkaya M. Turkish version of the Cornell Musculoskeletal Discomfort Questionnaire: cross-cultural adaptation and validation. Work. 2011;39(3):251-60. doi: 10.3233/WOR-2011-1173.
PubMed 21709361
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Turkish Version of the Oslo Sports Trauma Research Center (OSTRC) Questionnaire on Overuse Injuries and Health Problems; Validity and Reliability Study
- ClinicalTrials.gov ID
- NCT05356065
- Acronym / sponsor ID
- GAZIUN
- Conditions
- Sports Injury
- Keywords
- overuse injury, athlete health, outcome measures, validity and reliability study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 2 May 2022 (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.
Exposure to repetitive activities and heavy workloads makes athletes vulnerable to overuse injuries over time. Well-timed detection of these injuries is crucial to maintaining their sports career healthily. The Oslo Sports Trauma Research Centre questionnaires for Overuse Injury (OSTRC-O) and Health Problems (OSTRC-H) are universally used as valid and reliable tools in athlete health screening. This study aims to make them available for Turkish athletes.
The internal consistency, reproducibility, and validity of the questionnaires were analyzed. Data were obtained from 72 athletes from different sports types. 33 participants were screened weekly for six weeks to detect score changes and calculate effect sizes. Participants filled out the OSTRC-O, the OSTRC-H, the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ), and the Nottingham Health Profile (NHP) for validity analyses. The internal consistency and test-retest reliability values were very high for both questionnaires. There was a moderate correlation between OSTRC-O and OSTRC-H scores with CMDQ and NHP. The area under the curve (AUC) values were adequate for all scales. The effect size values were moderate for all scales. Turkish versions of the OSTRC-O and OSTRC-H questionnaires are valid and reliable tools for Turkish-speaking athletes in different sports branches.
Detailed description
Introduction and Aims All athletes are vulnerable to acute traumas or cumulative injuries throughout their sports life. Thus, screening the health levels of athletes and investigating whether they have overuse injuries is essential both to prevent acute traumas and improve health and performance. There is no valid and reliable subjective measurement tool to perform this screening in athletes in Turkish currently. However, the valid and reliable "Oslo Sports Trauma Research Centre Overuse Injury Questionnaire - (OSTRC)" questionnaires are available in English. So the investigators aimed to adapt the OSTRC- Overuse (OSTRC-O) and the OSTRC-Health Questionnaire (OSTRC-H) into Turkish.
Methods Permission was obtained from the developer authors. Then, ethical approval was acquired from the clinical researches ethics committee. Questionnaires were adapted into Turkish systematically. A pilot study was conducted to ensure the accuracy of meaning and comprehensibility of translated questionnaires. Next, the validity and reliability of the new tools were estimated. 72 athletes aged between 18 and 35, who can understand and speak Turkish fluently from various sports branches, were included. Informed consent was obtained from all athletes. The demographics of the participants were recorded. All participants were administered the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ), Nottingham Health Profile (NHP), OSTRC-O, and OSTRC-H questionnaires. The OSTRC-O OSTRC-H and CMDQ questionnaires were repeated weekly for six weeks on 33 athletes.
Reliability was analyzed by internal consistency and test-retest methods. The validity of the scale was evaluated in terms of content validity and concurrent validity. Content validity was verified with reports of participants at the end of the sixth week. To evaluate the concurrent validity, total OSTRC scores were compared with the total scores of CMDQ and NHP. Correlations of the OSTRC-O and OSTRC-H change scores with CMDQ change scores separately were assessed throughout the six weeks in point of the Effect Size (ES) for responsiveness. Receiver Operating Characteristic (ROC) Curve test based on the area under the curve (AUC) depicted to define the performance of these assessment tools. Statistical analyses were performed with the Statistical Package for Social Sciences Program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Athletes aged between 18 and 35, who can understand and speak Turkish fluently from various sports branches
Key inclusion criteria (2 listed)
- accepting to participate in the study
- Participating in sports
Key exclusion criteria (2 listed)
- Being illiterate
- Being younger than 18 years or older than 35 years
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 |
|---|---|---|
| survey administrationOutcome Measures | Other | – |
Primary outcome
Oslo Sports Trauma Research Centre Questionnaires for Overuse Injury (OSTRC-O)
Time frame: Baseline
The "Oslo Sports Trauma Research Centre Questionnaires for Overuse Injury" is a self-reported outcome measure. It queries sports participation, training volume, sports performance, and pain for a selected body location-e.g. knee taking into account the last seven days. A severity score is between 0-100 points. Higher points show worse health conditions.
Oslo Sports Trauma Research Centre questionnaires on Health Problems (OSTRC-H)
Time frame: Baseline
"Oslo Sports Trauma Research Centre questionnaires on Health Problems" is a self-reported outcome measure. It is applied to determine the effects of general health problems on sports participation, training volume, sports performance, and pain for the last seven days. A severity score is between 0 and 100 points. Higher points show worse health conditions.
Cornell Musculoskeletal Discomfort Questionnaire (CMDQ)
Time frame: Baseline
Cornell Musculoskeletal Discomfort Questionnaire is used to ascertain the musculoskeletal problems experienced in the last week during work life. Participants marked the frequency, discomfort, and interference categories for 20 different regions on the body map diagram. The total score of the questionnaire is between 0 (best condition) and 90 (worst health status).
Nottingham Health Profile (NHP)
Time frame: Baseline
Nottingham Health Profile is a self-reported outcome measure. It is a general health questionnaire consisting of 6 sub-parameters (pain, physical mobility, emotional reactions, sleep, energy level, social isolation) and 38 items. Participants marked yes or no for each item. The total score ranges from 0 to 600, and the total score is inversely proportional to the quality of life.
3 secondary outcomes
Oslo Sports Trauma Research Centre Questionnaires for Overuse Injury (OSTRC-O)
Time frame: Change from baseline score at 6 weeks
Oslo Sports Trauma Research Centre questionnaires on Health Problems (OSTRC-H)
Time frame: Change from baseline score at 6 weeks
Cornell Musculoskeletal Discomfort Questionnaire (CMDQ)
Time frame: Change from baseline score at 6 weeks
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 2 May 2022.
- Background: PubMed 9200321Bahr R, Bahr IA. Incidence of acute volleyball injuries: a prospective cohort study of injury mechanisms and risk factors. Scand J Med Sci Sports. 1997 Jun;7(3):166-71. doi: 10.1111/j.1600-0838.1997.tb00134.x.
- Background: PubMed 23429267Clarsen B, Ronsen O, Myklebust G, Florenes TW, Bahr R. The Oslo Sports Trauma Research Center questionnaire on health problems: a new approach to prospective monitoring of illness and injury in elite athletes. Br J Sports Med. 2014 May;48(9):754-60. doi: 10.1136/bjsports-2012-092087. Epub 2013 Feb 21.
- Background: PubMed 23038786Clarsen B, Myklebust G, Bahr R. Development and validation of a new method for the registration of overuse injuries in sports injury epidemiology: the Oslo Sports Trauma Research Centre (OSTRC) overuse injury questionnaire. Br J Sports Med. 2013 May;47(8):495-502. doi: 10.1136/bjsports-2012-091524. Epub 2012 Oct 4.
- Background: PubMed 11124735Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
- Background: PubMed 6973203Hunt SM, McKenna SP, McEwen J, Williams J, Papp E. The Nottingham Health Profile: subjective health status and medical consultations. Soc Sci Med A. 1981 May;15(3 Pt 1):221-9. doi: 10.1016/0271-7123(81)90005-5. No abstract available.
- Background: PubMed 21709361Erdinc O, Hot K, Ozkaya M. Turkish version of the Cornell Musculoskeletal Discomfort Questionnaire: cross-cultural adaptation and validation. Work. 2011;39(3):251-60. doi: 10.3233/WOR-2011-1173.
- Individual participant dataSharing planned: Undecided. It can be shared with reasonable requirements
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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.
Şeyda ÖZAL, Ph.D. (c) principal investigator
Gazi University Faculty of Health Sciences
Nihan KAFA, Asoc. Prof. study director
Gazi University Faculty of Health Sciences
Fuat YUKSEL, Ph.D. (c) principal investigator
Gazi University Faculty of Health Sciences
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 Sports Injury, run by Gazi 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: finished, as of the sponsor's last update on 2 May 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?
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?
Oslo Sports Trauma Research Centre Questionnaires for Overuse Injury (OSTRC-O) (time frame: Baseline). The study lists 4 primary outcomes in all. 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 NCT05356065, which also lists 6 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 2 May 2022.