Shoulder InjuriesGIRDAhtlFMUINCT04418063
Glenohumeral Internal Rotation Deficit in Non-pitcher Overhead Athletic Athletes: Case Series Analysis of Athletes
An observational study of Shoulder Injuries and Shoulder Syndrome, run by Universitas Indonesia.
Trial summary
In this observational case series the investigators would like to investigate wether or not the strenuous activity exerted on over head athletic athletes (ie. javelin throwers, discus throwers) may incite injury on their shoulders. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Shoulder Injuries, Shoulder Syndrome, Injury;Sports
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2020to Oct 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: National athletic athletes that performed overhead throwing motion in their sports that meet the inclusion criteria within our city.
Who may be able to join
- Performed overhead throwing motions in their athletic skills
- Athletes have competed in regional and national level
- Undergoing active training
Who cannot join
- Apparent anatomical deformity
- Sustaining injury(ies)
Trial locations and contacts
No sites are listed yet.
About this study
In this observational case series the investigators would like to investigate wether or not the strenuous activity exerted on over head athletic athletes (ie. javelin throwers, discus throwers) may incite injury on their shoulders.
The investigators understood that these athletes had to perform repeated throwing motions and yet reports on their effects are very limited. This condition in the long run may contribute to injury and affecting performance of the athletes.
The investigators found that these relationships have not been looked at closely by others and largely overshadowed by athletes in other fields; such injury patterns had been described in details in baseball pitchers but not in other athletes.
Read the detailed description
Description of protocol:
In this study, the investigators would recruit athletes from the national athletics federation training in our city.
Data collection:
History taking:
- complaints of shoulder stiffness
- need for prolonged warm-up
- pain
- discomfort relating to the shoulders
Physical examination:
- Bilateral shoulder range of motion (internal and external rotation)
- Posterior shoulder flexibility test (denotes internal rotation deficit)
- Scapular malpositioning, inferior medial border prominence, coracoid pain and malposition and dyskinesis of scapular movement (SICK) scapula rating
Notes: measurements are taken by at least two investigators separately and compared to ensure accuracy.
Results are presented in a table and analysed.
- Conditions
- Shoulder Injuries, Shoulder Syndrome, Injury;Sports, Sport Injury
- Keywords
- shoulder, glenohumeral internal rotation deficit, throwing athletic athlete
- Medical subject headings
- Shoulder Injuries, Athletic Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Glenohumeral internal rotation deficit
A deficit of >20 degrees between dominant and non-dominant shoulder
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study startSep 2020 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Shoulder InjuriesStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andri Maruli Tua Lubis, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418063
- Sponsor's protocol ID
- GIRD-Ahtl-FMUI
- Acronym
- GIRDAhtlFMUI
- Status last verified
- Sep 2020
- First submitted
- 31 May 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available.
Publications
Burkhart SS, Morgan CD, Kibler WB. The disabled throwing shoulder: spectrum of pathology Part I: pathoanatomy and biomechanics. Arthroscopy. 2003 Apr;19(4):404-20. doi: 10.1053/jars.2003.50128.
PubMed 12671624Burkhart SS, Morgan CD, Kibler WB. The disabled throwing shoulder: spectrum of pathology Part III: The SICK scapula, scapular dyskinesis, the kinetic chain, and rehabilitation. Arthroscopy. 2003 Jul-Aug;19(6):641-61. doi: 10.1016/s0749-8063(03)00389-x. No abstract available.
PubMed 12861203Keller RA, De Giacomo AF, Neumann JA, Limpisvasti O, Tibone JE. Glenohumeral Internal Rotation Deficit and Risk of Upper Extremity Injury in Overhead Athletes: A Meta-Analysis and Systematic Review. Sports Health. 2018 Mar/Apr;10(2):125-132. doi: 10.1177/1941738118756577. Epub 2018 Jan 30.
PubMed 29381423Rose MB, Noonan T. Glenohumeral internal rotation deficit in throwing athletes: current perspectives. Open Access J Sports Med. 2018 Mar 19;9:69-78. doi: 10.2147/OAJSM.S138975. eCollection 2018.
PubMed 29593438
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glenohumeral Internal Rotation Deficit in Non-pitcher Overhead Athletic Athletes: Case Series Analysis of Athletes
- ClinicalTrials.gov ID
- NCT04418063
- Acronym / sponsor ID
- GIRDAhtlFMUI / GIRD-Ahtl-FMUI
- Conditions
- Shoulder Injuries, Shoulder Syndrome, Injury;Sports, Sport Injury
- Keywords
- shoulder, glenohumeral internal rotation deficit, throwing athletic athlete
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 5 Jun 2020 (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.
In this observational case series the investigators would like to investigate wether or not the strenuous activity exerted on over head athletic athletes (ie. javelin throwers, discus throwers) may incite injury on their shoulders.
The investigators understood that these athletes had to perform repeated throwing motions and yet reports on their effects are very limited. This condition in the long run may contribute to injury and affecting performance of the athletes.
The investigators found that these relationships have not been looked at closely by others and largely overshadowed by athletes in other fields; such injury patterns had been described in details in baseball pitchers but not in other athletes.
Detailed description
Description of protocol:
In this study, the investigators would recruit athletes from the national athletics federation training in our city.
Data collection:
History taking:
- complaints of shoulder stiffness
- need for prolonged warm-up
- pain
- discomfort relating to the shoulders
Physical examination:
- Bilateral shoulder range of motion (internal and external rotation)
- Posterior shoulder flexibility test (denotes internal rotation deficit)
- Scapular malpositioning, inferior medial border prominence, coracoid pain and malposition and dyskinesis of scapular movement (SICK) scapula rating
Notes: measurements are taken by at least two investigators separately and compared to ensure accuracy.
Results are presented in a table and analysed.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- National athletic athletes that performed overhead throwing motion in their sports that meet the inclusion criteria within our city.
Key inclusion criteria (3 listed)
- Performed overhead throwing motions in their athletic skills
- Athletes have competed in regional and national level
- Undergoing active training
Key exclusion criteria (2 listed)
- Apparent anatomical deformity
- Sustaining injury(ies)
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
Glenohumeral internal rotation deficit
Time frame: 1 day
A deficit of >20 degrees between dominant and non-dominant shoulder
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Background: PubMed 12671624Burkhart SS, Morgan CD, Kibler WB. The disabled throwing shoulder: spectrum of pathology Part I: pathoanatomy and biomechanics. Arthroscopy. 2003 Apr;19(4):404-20. doi: 10.1053/jars.2003.50128.
- Background: PubMed 12861203Burkhart SS, Morgan CD, Kibler WB. The disabled throwing shoulder: spectrum of pathology Part III: The SICK scapula, scapular dyskinesis, the kinetic chain, and rehabilitation. Arthroscopy. 2003 Jul-Aug;19(6):641-61. doi: 10.1016/s0749-8063(03)00389-x. No abstract available.
- Background: PubMed 29381423Keller RA, De Giacomo AF, Neumann JA, Limpisvasti O, Tibone JE. Glenohumeral Internal Rotation Deficit and Risk of Upper Extremity Injury in Overhead Athletes: A Meta-Analysis and Systematic Review. Sports Health. 2018 Mar/Apr;10(2):125-132. doi: 10.1177/1941738118756577. Epub 2018 Jan 30.
- Results publication: PubMed 29593438Rose MB, Noonan T. Glenohumeral internal rotation deficit in throwing athletes: current perspectives. Open Access J Sports Med. 2018 Mar 19;9:69-78. doi: 10.2147/OAJSM.S138975. eCollection 2018.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available.
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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 Shoulder Injuries and Shoulder Syndrome, run by Universitas Indonesia.
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 9 Sep 2020. 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 Andri Lubis, MD, PhD (+62 8161177078, andri_lubis@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glenohumeral internal rotation deficit (time frame: 1 day). 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 NCT04418063, which also lists 4 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 9 Sep 2020.