Evaluation of Mechanical Characteristics of Tendons of At... | NCT05917483

Studies
Evaluation of Mechanical Characteristics of Tendons of Athletes Using Sonography

NCT05917483

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Jun 23, 2023Actual

Enrollment

10Actual

Phase

Not provided

Conditions

Overuse Injury
Rotator Cuff Injuries

Interventions

Ultrasonography

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2021Actual

Primary Completion Date

Mar 2, 2022Actual

Completion Date

Mar 2, 2022Actual

First Submitted Date

Jun 4, 2023

First Submission Date that Met QC Criteria

Jun 15, 2023

First Posted Date

Jun 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2023

Last Update Posted Date

Jun 23, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasonography	Diagnostic Test	Collect shoulder rotator cuff tendon ultrasound image during isotonic motion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak tendon strain	The peak value of tendon strain during the isotonic motion estimated from ultrasound image sequence	Two months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Baseball pitchers in city baseball team

Exclusion Criteria:

History of shoulder disorder or surgery

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

33 Years

Standard Ages

Adult

Study Population

Baseball pitcher from city baseball team and actively participating season games

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tianmu Sports Park/ Baseball Stadium		Taipei			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D012090	Cumulative Trauma Disorders
D000070636	Rotator Cuff Injuries

Ancestor Terms

ID	Term
D013180	Sprains and Strains
D014947	Wounds and Injuries
D012421	Rupture
D000070599	Shoulder Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014463	Ultrasonography

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided