Shoulder PainNCT04199988
Reliability of Posterior Shoulder Endurance Test in Overhead Athletes
An observational study of Shoulder Pain and Healthy, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to investigate the reliability of posterior shoulder endurance test in overhead athletes and to compare the endurance of posterior shoulder muscles between athletes with and without shoulder pain. Read more about this study
- Who is it for?
- Ages 13 to 24 years
- Conditions the study is for
- Shoulder Pain, Healthy
- What is being tested?
- Posterior Shoulder Endurance Test
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Dec 2019to 30 Sep 2022
- 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 13 to 24 years
- All sexes
- Child, Adult
Study population: Overhead athletes with and without shoulder pain
Who may be able to join
- For all athletes:
- Being between the ages of 13-24,
- Participating to overhead sports (tennis, volleyball, handball, etc.),
- Training at least 2-3 hours a week,
- Active participation in training and competitions,
- To be able to complete all assessments in the study,
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- For athletes with shoulder pain:
- Shoulder pain is 3/10 or more in the Visual Analogue Scale.
- For Athletes without shoulder pain:
- No shoulder pain (0/10 according to Visual Analog Scale)
- No history of a shoulder injury and/or shoulder symptoms requiring treatment for the past 1 year.
- Having 90/100 or higher results in Kerlan-Jobe Orthopedic Clinical Shoulder \& Elbow Score
Who cannot join
- Bilateral shoulder pain,
- Upper extremity fracture history,
- Surgical history of shoulder, cervical and thoracic region,
- Diagnosis of musculoskeletal disease in the cervical region, elbow, and wrist,
- Neck and shoulder pain with active/passive cervical spine movement,
- Frozen shoulder,
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- Multidirectional joint hypermobility,
- Having a systemic musculoskeletal disease,
- Diagnosis of chest deformity and scoliosis.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dokuz Eylul University, Sports Medicine department
Balçova, İzmir, 35340
Damla KARABAY, MSc
About this study
Official title: Reliability of Posterior Shoulder Endurance Test in Overhead Athletes and Comparison of Athletes With and Without Shoulder Pain
The purpose of this study was to investigate the reliability of posterior shoulder endurance test in overhead athletes and to compare the endurance of posterior shoulder muscles between athletes with and without shoulder pain.
Read the detailed description
A total of 40 overhead athletes, 20 with shoulder pain and 20 with no shoulder pain, will be included in the study. Shoulder endurance will be measured as isometric and isotonic on both arms of athletes using the posterior shoulder endurance test. The measurements will be repeated after 3-7 days, and the test-retest reliability of the isotonic and isometric posterior shoulder endurance test will be investigated.
- Conditions
- Shoulder Pain, Healthy
- Being tested
- Posterior Shoulder Endurance Test
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior Shoulder Endurance TestDiagnostic test
Isometric posterior shoulder endurance test: In the prone position, the athlete's shoulder will be placed at horizontal abduction, and the time for maintaining this position will be recorded.
Isotonic shoulder endurance test: In the prone position, the athlete's shoulder will be placed at horizontal abduction and asked to perform horizontal adduction-abduction, and the athlete will horizontally abducted-adducted his/her arm to 90 degrees at a cadence of 30 beats per minute. The number of repetitions will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Athletes with shoulder pain | Overhead athletes with shoulder pain Receives: Diagnostic Test: Posterior Shoulder Endurance Test | |
| Athletes without shoulder pain | Overhead athletes without shoulder pain Receives: Diagnostic Test: Posterior Shoulder Endurance Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric Posterior Shoulder Endurance Test
Isometric
Measured: Measurements will be performed in two sessions (3 to 7 days)
Isotonic Posterior Shoulder Endurance Test
Isotonic
Measured: Measurements will be performed in two sessions (3 to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start31 Dec 2019
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Karabay, Dokuz Eylul University
- Investigators
- Sevgi Sevi YESİLYAPRAK, PhD, Principal investigator, Dokuz Eylul UniversityBirsu TOPÇUGİL KIRIK, MD, Study chair, Dokuz Eylul UniversityOğuz YÜKSEL, MD, Study chair, Dokuz Eylul UniversityOğuzcan GÖKÇAY, MD, Study chair, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199988
- Sponsor's protocol ID
- 4950-GOA
- Status last verified
- Apr 2022
- First submitted
- 11 Dec 2019
- Last updated
- 13 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Posterior Shoulder Endurance Test in Overhead Athletes and Comparison of Athletes With and Without Shoulder Pain
- ClinicalTrials.gov ID
- NCT04199988
- Acronym / sponsor ID
- 4950-GOA
- Conditions
- Shoulder Pain, Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 31 Dec 2019 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 16 Dec 2019 (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 was to investigate the reliability of posterior shoulder endurance test in overhead athletes and to compare the endurance of posterior shoulder muscles between athletes with and without shoulder pain.
Detailed description
A total of 40 overhead athletes, 20 with shoulder pain and 20 with no shoulder pain, will be included in the study. Shoulder endurance will be measured as isometric and isotonic on both arms of athletes using the posterior shoulder endurance test. The measurements will be repeated after 3-7 days, and the test-retest reliability of the isotonic and isometric posterior shoulder endurance test will be investigated.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Athletes with shoulder pain | – | Diagnostic Test: Posterior Shoulder Endurance TestOverhead athletes with shoulder pain |
| Athletes without shoulder pain | – | Diagnostic Test: Posterior Shoulder Endurance TestOverhead athletes without shoulder pain |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Overhead athletes with and without shoulder pain
Key inclusion criteria (12 listed)
- Being between the ages of 13-24,
- Participating to overhead sports (tennis, volleyball, handball, etc.),
- Training at least 2-3 hours a week,
- Active participation in training and competitions,
- To be able to complete all assessments in the study,
Key exclusion criteria (9 listed)
- Bilateral shoulder pain,
- Upper extremity fracture history,
- Surgical history of shoulder, cervical and thoracic region,
- Diagnosis of musculoskeletal disease in the cervical region, elbow, and wrist,
- Neck and shoulder pain with active/passive cervical spine movement,
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 |
|---|---|---|
| Posterior Shoulder Endurance TestIsometric posterior shoulder endurance test: In the prone position, the athlete's shoulder will be placed at horizontal abduction, and the time for maintaining this position will be recorded. Isotonic shoulder endurance test: In the prone position, the athlete's shoulder will be placed at horizontal abduction and asked to perform horizontal adduction-abduction, and the athlete will horizontally abducted-adducted his/her arm to 90 degrees at a cadence of 30 beats per minute. The number of repetitions will be recorded. | Diagnostic test | Athletes with shoulder pain, Athletes without shoulder pain |
Primary outcome
Isometric Posterior Shoulder Endurance Test
Time frame: Measurements will be performed in two sessions (3 to 7 days)
Isometric
Isotonic Posterior Shoulder Endurance Test
Time frame: Measurements will be performed in two sessions (3 to 7 days)
Isotonic
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- 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.
Sevgi Sevi YESİLYAPRAK, PhD principal investigator
Dokuz Eylul University
Birsu TOPÇUGİL KIRIK, MD study chair
Dokuz Eylul University
Oğuz YÜKSEL, MD study chair
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain and Healthy, run by Dokuz Eylul University 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 12 inclusion and 9 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 13 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Damla KARABAY, PhD (+902323293535, damla.karabay@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric Posterior Shoulder Endurance Test (time frame: Measurements will be performed in two sessions (3 to 7 days)). The study lists 2 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 13 Apr 2022.