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PainNCT03729193

Assessment of Musculoskeletal Pain and Psychosocial Status of Athletes

An observational study of Pain, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 yearsHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
Measuring devices and questionnaires
How many people
160 participants
Where
1 siteTurkey (Türkiye)
Study dates
30 Dec 2018to 17 Jan 2019
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
  • Healthy volunteers accepted
  • 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.
  • The dominant upper extremity should be the right side.

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

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul Medipol Universıty

    Istanbul, Beykoz, 34815

Other trials in Turkey (Türkiye)

About this study

Official title: Assessment of Musculoskeletal Pain and Psychosocial Status of 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 160 sportsmen who are participating in sports by doing sports in soccer, basketball, volleyball, athletics, table tennis, field tennis, 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 for identifying their pain threshold, 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 for identifying their pain threshold, 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 groups in NCT03729193
Study groupRoleWhat they receive
soccer playersMeasuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of 20 soccer players.
Receives: Behavioral: Measuring devices and questionnaires
basketball playersMeasuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of 20 basketball players.
Receives: Behavioral: Measuring devices and questionnaires
volleyball playersMeasuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of 20 volleyball players.
Receives: Behavioral: Measuring devices and questionnaires
archersMeasuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of 20 archers.
Receives: Behavioral: Measuring devices and questionnaires
kickboxersMeasuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of 20 kickboxers.
Receives: Behavioral: Measuring devices and questionnaires
table tennis athletesMeasuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of 20 table tennis athletes.
Receives: Behavioral: Measuring devices and questionnaires
runnersMeasuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of 20 runners.
Receives: Behavioral: Measuring devices and questionnaires
field tennis athletesMeasuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of 20 field tennis athletes.
Receives: Behavioral: Measuring devices and questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Musculoskeletal system pain

    Extended Nordic Musculoskeletal Questionnaire consists of 11 questions asked from the 9 body regions. The questionnaire firstly questions the pain-pain sensation in the 9 body areas in the form of a yes / no response.

    Measured: 14 days

  2. severity of pain perception

    Visual Analogue Scale (VAS); This study will be used to understand how the athlete expresses pain on a 10 cm scale before, during and after training. Using a ruler, the score is about 10-cm in length. It have been recommended: no pain (0 and4 mm), mild pain (5-44 mm), moderate pain (45 mild74 mm), and severe pain (75 :100 mm). the VAS values of the athletes will be questioned for in the resting, before and after the training.

    Measured: 14 days

  3. pain threshold

    The pain threshold of the right hand and the left hand will be measured in kilograms (kg) with the algometer. A difference of 2 kg between the measured right and left sides, or less than 3 kg of the measured side, indicates that the pain threshold is low and abnormal.

    Measured: 14 days

Secondary outcomes (3)

  1. Sporty confidence

    Participants' sporty confidence will asses by using Continuous Sportive Trust ınventory. This sport-specific inventory consists of a 9-point Likert scale which is engaged in 1 (low) and 9 (high) items from 13 items without sub-components. The level of continuous sporty confidence is obtained by the mean score obtained by collecting the scores of 13 items and dividing them by 13. 1-3 points means low level sporting self-confidence, 4-6 points medium level sporting self-confidence, 7-9 points high level sporting self-confidence.

    Measured: 14 days

  2. 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). This scale consists of 26 questions that measure overall quality of life and overall health. The other 24 questions are divided into four areas: the physical health title consists of 7 questions, the psychological health title consists of 6 questions, the social relationship title is 3 questions and the environmental health title consists of 8 questions.

    Each title is scored independently. Each item is scored on a Likert-type scale from 1 to 5. The scores are then calculated for each quality of life subtitle and converted to 0-100 points. A high score means that the quality of life is high.

    Measured: 14 days

  3. Depression

    Participants' depression will asses by using Beck Depression Inventory. The Beck Depression Inventory was a 21-item self-drawing questionnaire to measure depressive symptoms in clinical and non-clinical populations for Beck et al. Its substance has 4 possible answers to a Likert-type scale found between 0 (none) and 3 (irresistible). High scores indicate severe depressive symptoms: 0-13 points or minimal depression, 14-19 mild, 20-28 moderate and 29-63 indicate severe depression level.

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2018
  2. Study start30 Dec 2018
  3. Primary completion17 Jan 2019
  4. Study completion17 Jan 2019

Resources

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 (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03729193
Sponsor's protocol ID
10840098-604.01.01-E.45126
Status last verified
Jan 2019
First submitted
31 Oct 2018
Last updated
18 Jan 2019
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 26726840

  • Aghilinejad 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 22754681

  • Wang 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

Questions about this trial

What is this clinical trial studying?

An observational study of Pain, run by Istanbul Medipol University Hospital 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 4 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 18 Jan 2019. 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?

Musculoskeletal system pain (time frame: 14 days). 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?

On the ClinicalTrials.gov record for NCT03729193, 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 18 Jan 2019.

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