PainNCT03628547
Assessment of Musculoskeletal Pain and Psychosocial Status of Athletes
An observational study of Pain, run by Istanbul Medipol University Hospital.
Trial summary
The sporty performance exhibited by an athlete faces physiological, biomechanical and psychological activity of the athlete. It depends on both the psychological state and the elevation of the musculoskeletal system to a certain level so that the athlete can perform optimally and excellently. Read more about this study
- Who is it for?
- Ages 15 to 36 years
- Conditions the study is for
- Pain
- What is being tested?
- Measuring devices and questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2018to 3 Dec 2018
- 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 15 to 36 years
- All sexes
- Child, Adult
Study population: Participants will be between the ages of 15 and 36
Who may be able to join
- The athletes and their coaches must be voluntary and willing.
- During the evaluation, the athletes must give careful and relevant answers to the measuring instruments.
- They have to actively run the sport they belong to.
Who cannot join
- Having undergone a surgical operation due to sports injuries in the last 3 weeks
- The athletes do not want to answer the surveying instruments
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of Musculoskeletal Pain and Psychosocial Status of Professional and Amateur Athletes in Different Disciplines
The sporty performance exhibited by an athlete faces physiological, biomechanical and psychological activity of the athlete. It depends on both the psychological state and the elevation of the musculoskeletal system to a certain level so that the athlete can perform optimally and excellently. For this reason, we aimed to evaluate the musculoskeletal system pain of amateur and professional athletes in different disciplines and the psychosocial states such as sports confidence, depression and quality of life.
Read the detailed description
This study consists of 80 amateur and 80 professional sportsmen who are participating in sports by doing sports in soccer, basketball, volleyball, athletics, table tennis, field tennis, folk dances, kickboxing and archery branches between the ages of 15 and 36. The Expanded Scandinavian Muscle Skeleton Questionnaire (NMQ) and Visible Analogue Scale (VAS) will be used to identify and assess the symptoms of musculoskeletal discomfort as 'pain'. The participant will be evaluated with the algometer, the sporty trust will be questioned with the Sporty Trust Continuous Inventory, and the Quality of Life will be assessed with the World Health Organization Quality of Life Scale Short Form and Depression will be evaluated with Beck Depression Inventory.
- Conditions
- Pain
- Being tested
- Measuring devices and questionnaires
- Keywords
- musculoskeletal system pain, athlete, psychosocial problems, algometer
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring devices and questionnairesBehavioural
Measuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of athletes. The Expanded Scandinavian Muscle Skeleton Questionnaire (NMQ) and Visible Analogue Scale (VAS) will be used to identify and assess the symptoms of musculoskeletal discomfort as 'pain'. The participant will be evaluated with the algometer, the sporty trust will be questioned with the Sporty Trust Continuous Inventory, and the Quality of Life will be assessed with the World Health Organization Quality of Life Scale Short Form and Depression will be evaluated with Beck Depression Inventory.
| Study group | Role | What they receive |
|---|---|---|
| soccer players | Measuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of 10 amateur soccer players and10 professional soccer players. Receives: Behavioral: Measuring devices and questionnaires | |
| basketball players | Measuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of 10 amateur basketball players and10 professional basketball players. Receives: Behavioral: Measuring devices and questionnaires | |
| volleyball players | Measuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of 10 amateur volleyball players and10 professional volleyball players. Receives: Behavioral: Measuring devices and questionnaires | |
| runners | Measuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of 10 amateur runners and 10 professional runners. Receives: Behavioral: Measuring devices and questionnaires | |
| table tennis athlete | Measuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of 10 amateur table tennis athlete and 10 professional table tennis athlete. Receives: Behavioral: Measuring devices and questionnaires | |
| field tennis athlete | 10 amateur field tennis athlete 10 professional field tennis athlete Receives: Behavioral: Measuring devices and questionnaires | |
| kickboxers | Measuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of 10 amateur kickboxers and 10 professional kickboxers. Receives: Behavioral: Measuring devices and questionnaires | |
| archers | Measuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of 10 amateur archers and 10 professional archers. Receives: Behavioral: Measuring devices and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Musculoskeletal system pain
Participants' musculoskeletal system pain will asses by using Nordic and algometer.
Measured: 1 month
Secondary outcomes (3)
Sporty confidence
Participants' sporty confidence will asses by using continuous sportive trust inventory.
Measured: 1 month
Health Related Quality of Life
Participants' health Related Quality of Lifequality of life will asses by using World Health Organization Quality of Life Scale Short Form (WHOQOL-BREF)
Measured: 1 month
Depression
Participants' depression will asses by using Beck Depression Inventory
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start15 Aug 2018 (estimated)
- Primary completion17 Oct 2018 (estimated)
- Study completion3 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, amine atac, Istanbul Medipol University Hospital
- Investigators
- Mustafa Şahin, Study director, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628547
- Sponsor's protocol ID
- 10840098-604.01.01-E.30223
- Status last verified
- Aug 2018
- First submitted
- 10 Aug 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kahraman T, Genc A, Goz E. The Nordic Musculoskeletal Questionnaire: cross-cultural adaptation into Turkish assessing its psychometric properties. Disabil Rehabil. 2016 Oct;38(21):2153-60. doi: 10.3109/09638288.2015.1114034. Epub 2016 Jan 4.
PubMed 26726840Aghilinejad M, Choobineh AR, Sadeghi Z, Nouri MK, Bahrami Ahmadi A. Prevalence of Musculoskeletal Disorders among Iranian Steel Workers. Iran Red Crescent Med J. 2012 Apr;14(4):198-203. Epub 2012 Apr 1.
PubMed 22754681Wang YP, Gorenstein C. Psychometric properties of the Beck Depression Inventory-II: a comprehensive review. Braz J Psychiatry. 2013 Oct-Dec;35(4):416-31. doi: 10.1590/1516-4446-2012-1048. Epub 2013 Dec 23.
PubMed 24402217
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Musculoskeletal Pain and Psychosocial Status of Professional and Amateur Athletes in Different Disciplines
- ClinicalTrials.gov ID
- NCT03628547
- Acronym / sponsor ID
- 10840098-604.01.01-E.30223
- Conditions
- Pain
- Keywords
- musculoskeletal system pain, athlete, psychosocial problems, algometer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 15 Aug 2018 (estimated)
- Primary completion
- 17 Oct 2018 (estimated)
- Study completion
- 3 Dec 2018 (estimated)
- First posted
- 14 Aug 2018 (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 sporty performance exhibited by an athlete faces physiological, biomechanical and psychological activity of the athlete. It depends on both the psychological state and the elevation of the musculoskeletal system to a certain level so that the athlete can perform optimally and excellently. For this reason, we aimed to evaluate the musculoskeletal system pain of amateur and professional athletes in different disciplines and the psychosocial states such as sports confidence, depression and quality of life.
Detailed description
This study consists of 80 amateur and 80 professional sportsmen who are participating in sports by doing sports in soccer, basketball, volleyball, athletics, table tennis, field tennis, folk dances, kickboxing and archery branches between the ages of 15 and 36. The Expanded Scandinavian Muscle Skeleton Questionnaire (NMQ) and Visible Analogue Scale (VAS) will be used to identify and assess the symptoms of musculoskeletal discomfort as 'pain'. The participant will be evaluated with the algometer, the sporty trust will be questioned with the Sporty Trust Continuous Inventory, and the Quality of Life will be assessed with the World Health Organization Quality of Life Scale Short Form and Depression will be evaluated with Beck Depression Inventory.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| soccer players | – | Behavioral: Measuring devices and questionnairesMeasuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of 10 amateur soccer players and10 professional soccer players. |
| basketball players | – | Behavioral: Measuring devices and questionnairesMeasuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of 10 amateur basketball players and10 professional basketball players. |
| volleyball players | – | Behavioral: Measuring devices and questionnairesMeasuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of 10 amateur volleyball players and10 professional volleyball players. |
| runners | – | Behavioral: Measuring devices and questionnairesMeasuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of 10 amateur runners and 10 professional runners. |
| table tennis athlete | – | Behavioral: Measuring devices and questionnairesMeasuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of 10 amateur table tennis athlete and 10 professional table tennis athlete. |
| field tennis athlete | – | Behavioral: Measuring devices and questionnaires10 amateur field tennis athlete 10 professional field tennis athlete |
| kickboxers | – | Behavioral: Measuring devices and questionnairesMeasuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of 10 amateur kickboxers and 10 professional kickboxers. |
| archers | – | Behavioral: Measuring devices and questionnairesMeasuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of 10 amateur archers and 10 professional archers. |
Who may qualify
- Ages
- 15 to 36 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Participants will be between the ages of 15 and 36
Key inclusion criteria (3 listed)
- The athletes and their coaches must be voluntary and willing.
- During the evaluation, the athletes must give careful and relevant answers to the measuring instruments.
- They have to actively run the sport they belong to.
Key exclusion criteria (2 listed)
- Having undergone a surgical operation due to sports injuries in the last 3 weeks
- The athletes do not want to answer the surveying instruments
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 |
|---|---|---|
| Measuring devices and questionnairesMeasuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of athletes. The Expanded Scandinavian Muscle Skeleton Questionnaire (NMQ) and Visible Analogue Scale (VAS) will be used to identify and assess the symptoms of musculoskeletal discomfort as 'pain'. The participant will be evaluated with the algometer, the sporty trust will be questioned with the Sporty Trust Continuous Inventory, and the Quality of Life will be assessed with the World Health Organization Quality of Life Scale Short Form and Depression will be evaluated with Beck Depression Inventory. | Behavioural | archers, basketball players, field tennis athlete, kickboxers, runners, soccer players, table tennis athlete, volleyball players |
Primary outcome
Musculoskeletal system pain
Time frame: 1 month
Participants' musculoskeletal system pain will asses by using Nordic and algometer.
3 secondary outcomes
Sporty confidence
Time frame: 1 month
Health Related Quality of Life
Time frame: 1 month
Depression
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Results publication: PubMed 26726840Kahraman T, Genc A, Goz E. The Nordic Musculoskeletal Questionnaire: cross-cultural adaptation into Turkish assessing its psychometric properties. Disabil Rehabil. 2016 Oct;38(21):2153-60. doi: 10.3109/09638288.2015.1114034. Epub 2016 Jan 4.
- Results publication: PubMed 22754681Aghilinejad M, Choobineh AR, Sadeghi Z, Nouri MK, Bahrami Ahmadi A. Prevalence of Musculoskeletal Disorders among Iranian Steel Workers. Iran Red Crescent Med J. 2012 Apr;14(4):198-203. Epub 2012 Apr 1.
- Results publication: PubMed 24402217Wang YP, Gorenstein C. Psychometric properties of the Beck Depression Inventory-II: a comprehensive review. Braz J Psychiatry. 2013 Oct-Dec;35(4):416-31. doi: 10.1590/1516-4446-2012-1048. Epub 2013 Dec 23.
- Individual participant dataSharing planned: No
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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.
Mustafa Şahin study director
Medipol University
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Istanbul Medipol University Hospital.
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 3 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 14 Aug 2018. 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 Amine Atac (+0905454809549, aatac@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Musculoskeletal system pain (time frame: 1 month). 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 NCT03628547, which also lists 3 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 14 Aug 2018.