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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06001229
Other study ID # GO 22/540
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 18, 2023
Est. completion date June 22, 2024

Study information

Verified date August 2023
Source Hacettepe University
Contact Aynur Demirel
Phone +903123051576
Email aynur.demirel@hacettepe.edu.tr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess the reliability and validity of the "Micheli Functional Scale" in the Turkish context.


Description:

The study will include a minimum of 80 individuals who are 16 years old or above, have been engaged in the same sports activity for at least two years, participate in physically demanding activities for at least three days a week, and possess the ability to read and write Turkish. Before participating in the study, athletes will be required to sign an informed consent form. Their demographic information will then be recorded.Before conducting the test, we will gather information about the athletes' history of low back pain using the extended Nordic musculoskeletal questionnaire. We will also use this questionnaire to identify any other musculoskeletal issues that the person may have.Two Turkish translators, fluent in English, will independently translate the original Micheli Functional Scale into Turkish. They will then discuss their translations and create a common one. The resulting translation will be translated back into English by two native English speakers who are also proficient in Turkish. These translations will be reviewed and combined into a single version. A Turkish scientist will evaluate the questionnaire for its suitability in the Turkish language. The final version will be tested on a small pilot group to determine its comprehensibility. After this, the questionnaire will be administered to the entire study group. To assess the validity of the Micheli Functional Scale, we will use the Oswestry Functional Questionnaire and the Ronald Morris Disability Questionnaire. One week after the test, we will repeat these surveys.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date June 22, 2024
Est. primary completion date June 22, 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years to 25 Years
Eligibility Inclusion Criteria: - 16 years old and over - Having been doing the same sport for at least 2 years, - Participating in sports activities or activities that require a high level of effort at least 3 days a week, - Able to read and write Turkish Exclusion Criteria: - Has a cognitive problem that prevents him from understanding and answering the questions or is taking a drug that may cause them, - Having a history of orthopedic or neurological injury or pain at a level that may prevent training or competition during the evaluation, - History of spine/lower and upper extremity surgery, - Structural deformities such as scoliosis and kyphosis, - Those with trap neuropathy will be excluded from the study.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Outcome

Type Measure Description Time frame Safety issue
Primary Micheli Functional Scale Evaluates the function linked to low back pain in athletes. baseline and 1 week later
Primary Oswestry Disability Index Evaluate disability due to low back pain. the index measures perceived low back pain related dysfunction. Whether the total score increaeses, the dyscfunction increases. baseline and 1 week later
Primary Roland morris disability questionnaire It is a questionnaire used to evaluate the disability level of individuals with low back pain. This questionnaire, consisting of 24 items, questions the person's social life, walking, sitting, standing, getting up from a chair, climbing stairs, dressing, personal care, pain, appetite, sleep, and psychological impact. The person answers the questions with yes and no. Yes is scored as 1 point and no as 0 points. The maximum score is "24" and the minimum score is "0". As the total score increases, the level of physical exposure also increases. baseline and 1 week later
Secondary The musculoskeletal system problem Nordic Musculoskeletal System Questionnaire baseline
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