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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05356065
Other study ID # GAZIUN
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 26, 2021
Est. completion date December 15, 2021

Study information

Verified date April 2022
Source Gazi University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date December 15, 2021
Est. primary completion date August 20, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - accepting to participate in the study - Participating in sports Exclusion Criteria: - Being illiterate - Being younger than 18 years or older than 35 years

Study Design


Related Conditions & MeSH terms


Intervention

Other:
survey administration
Outcome Measures

Locations

Country Name City State
Turkey Gazi University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View Citation

Beaton 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. Review. — View Citation

Clarsen 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. — View Citation

Clarsen B, Rønsen O, Myklebust G, Flørenes 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. — View Citation

Erdinc 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. — View Citation

Hunt 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline
Primary 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. Baseline
Primary 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). Baseline
Primary 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. Baseline
Secondary 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 Change from baseline score at 6 weeks
Secondary 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. Change from baseline score at 6 weeks
Secondary 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). Change from baseline score at 6 weeks
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