Low Back PainNCT06001229
The Micheli Functional Scale's Validity and Reliability
An observational study of Low Back Pain, run by Hacettepe University.
Trial summary
The purpose of this study is to assess the reliability and validity of the "Micheli Functional Scale" in the Turkish context. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Low Back Pain
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 18 Aug 2023to 22 Jun 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 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: To be eligible for the study, participants must be at least 16 years old, have been practicing the same sport for a minimum of 2 years, and engage in high-effort physical activity for at least 3 days per week. Additionally, those who are able to read and write in Turkish will be included in the study.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Micheli Functional Scale's Validity and Reliability in Turkish Sport Groups
The purpose of this study is to assess the reliability and validity of the "Micheli Functional Scale" in the Turkish context.
Read the detailed 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.
- Conditions
- Low Back Pain
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Micheli Functional Scale
Evaluates the function linked to low back pain in athletes.
Measured: baseline and 1 week later
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.
Measured: baseline and 1 week later
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.
Measured: baseline and 1 week later
Secondary outcomes (1)
The musculoskeletal system problem
Nordic Musculoskeletal System Questionnaire
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start18 Aug 2023 (estimated)
- Primary completion22 Jun 2024 (estimated)
- Study completion22 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Other
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur Demirel, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001229
- Sponsor's protocol ID
- GO 22/540
- Status last verified
- Aug 2023
- First submitted
- 14 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Micheli Functional Scale's Validity and Reliability in Turkish Sport Groups
- ClinicalTrials.gov ID
- NCT06001229
- Acronym / sponsor ID
- GO 22/540
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 18 Aug 2023 (estimated)
- Primary completion
- 22 Jun 2024 (estimated)
- Study completion
- 22 Jun 2024 (estimated)
- First posted
- 21 Aug 2023 (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 purpose of this study is to assess the reliability and validity of the "Micheli Functional Scale" in the Turkish context.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- To be eligible for the study, participants must be at least 16 years old, have been practicing the same sport for a minimum of 2 years, and engage in high-effort physical activity for at least 3 days per week. Additionally, those who are able to read and write in Turkish will be included in the study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Micheli Functional Scale
Time frame: baseline and 1 week later
Evaluates the function linked to low back pain in athletes.
Oswestry Disability Index
Time frame: baseline and 1 week later
Evaluate disability due to low back pain. the index measures perceived low back pain related dysfunction. Whether the total score increaeses, the dyscfunction increases.
Roland morris disability questionnaire
Time frame: baseline and 1 week later
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.
1 secondary outcome
The musculoskeletal system problem
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Hacettepe University.
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 4 inclusion and 5 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 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Aynur Demirel (+903123051576, aynur.demirel@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Micheli Functional Scale (time frame: baseline and 1 week later). The study lists 3 primary outcomes in all. 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 21 Aug 2023.