Overuse InjuryNCT05917483
Evaluation of Mechanical Characteristics of Tendons of Athletes Using Sonography
An observational study of Overuse Injury and Rotator Cuff Injuries, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The investigators analyzed the strain of the rotator cuff tendon of baseball pitchers obtained using ultrasonography and compared the change in peak tendon strain before and after the regular season. Read more about this study
- Who is it for?
- Ages 21 to 33 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overuse Injury, Rotator Cuff Injuries
- What is being tested?
- Ultrasonography
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Jan 2021to 2 Mar 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 21 to 33 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Baseball pitcher from city baseball team and actively participating season games
Who may be able to join
- Baseball pitchers in city baseball team
Who cannot join
- History of shoulder disorder or surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Mechanical Characteristics and Prevention From Overuse Injury of Tendons of Elite Athletes Using Dynamic Sonography
The investigators analyzed the strain of the rotator cuff tendon of baseball pitchers obtained using ultrasonography and compared the change in peak tendon strain before and after the regular season.
- Conditions
- Overuse Injury, Rotator Cuff Injuries
- Being tested
- Ultrasonography
- Medical subject headings
- Cumulative Trauma Disorders, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDiagnostic test
Collect shoulder rotator cuff tendon ultrasound image during isotonic motion
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak tendon strain
The peak value of tendon strain during the isotonic motion estimated from ultrasound image sequence
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start14 Jan 2021
- Primary completion2 Mar 2022
- Study completion2 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overuse InjuryStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917483
- Sponsor's protocol ID
- NTUH-REC 201812022RINC
- Status last verified
- Jan 2019
- First submitted
- 4 Jun 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mechanical Characteristics and Prevention From Overuse Injury of Tendons of Elite Athletes Using Dynamic Sonography
- ClinicalTrials.gov ID
- NCT05917483
- Acronym / sponsor ID
- NTUH-REC 201812022RINC
- Conditions
- Overuse Injury, Rotator Cuff Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 23 Jun 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 investigators analyzed the strain of the rotator cuff tendon of baseball pitchers obtained using ultrasonography and compared the change in peak tendon strain before and after the regular season.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 33 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Baseball pitcher from city baseball team and actively participating season games
Key inclusion criteria (1 listed)
- Baseball pitchers in city baseball team
Key exclusion criteria (1 listed)
- History of shoulder disorder or surgery
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 |
|---|---|---|
| UltrasonographyCollect shoulder rotator cuff tendon ultrasound image during isotonic motion | Diagnostic test | – |
Primary outcome
Peak tendon strain
Time frame: Two months
The peak value of tendon strain during the isotonic motion estimated from ultrasound image sequence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Overuse Injury and Rotator Cuff Injuries, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 23 Jun 2023. 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 Taiwan. 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?
Peak tendon strain (time frame: Two months). 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 23 Jun 2023.