UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060465 |
|---|---|
| Receipt number | R000069166 |
| Scientific Title | Assessing the elasticity of the flexor pronator muscles after pitching using ultrasound shear wave elastography |
| Date of disclosure of the study information | 2026/01/27 |
| Last modified on | 2026/01/26 10:15:18 |
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Basic information
Public title
Assessing the elasticity of the flexor pronator muscles after pitching using ultrasound shear wave elastography
Acronym
Assessing the elasticity of the flexor pronator muscles after pitching using ultrasound shear wave elastography
Scientific Title
Assessing the elasticity of the flexor pronator muscles after pitching using ultrasound shear wave elastography
Scientific Title:Acronym
Assessing the elasticity of the flexor pronator muscles after pitching using ultrasound shear wave elastography
Region
| Japan |
Condition
Condition
Ulnar collateral ligament (UCL) injury
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate changes in stiffness of the forearm pronator-flexor muscle group before and after pitching and their relationships with pitching biomechanics
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in stiffness and shear wave velocity of the flexor carpi ulnaris, flexor digitorum superficialis, pronator teres, and flexor carpi radialis before and after pitching,
Key secondary outcomes
Muscle Strength Before and After Pitching and the Radioulnar Joint Distance at the Medial Collateral Ligament Attachment Site of the Elbow Joint; Evaluation of Shoulder and Elbow Joint Movement (Joint Angle, Velocity) in Pitching Motion Analysis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The examinee will throw 60 pitches.
SWE measurement and throwing motion analysis will be performed before and after pitching.
SWE will be measured using Aixplorer (Supersonic Imagine).
Throwing motion will be analyzed using Viper.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Athletes with overthrow movements
Subjects who, after receiving a full explanation of their participation in this study and with full understanding, have given their free written consent (or that of their surrogate in the case of minors).
Key exclusion criteria
1. Individuals with significantly poor compliance
2. Other individuals deemed unsuitable as research subjects by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Itoigawa |
Organization
Juntendo University Urayasu Hospital
Division name
Orthopedics
Zip code
2790021
Address
2-1-1 Tomioka, Urayasu, Chiba, Japan
TEL
047-353-3111
yitoiga@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Yoshida |
Organization
Juntendo University Urayasu Hospital
Division name
Orthopedics
Zip code
2790021
Address
2-1-1 Tomioka, Urayasu, Chiba, Japan
TEL
047-353-3111
Homepage URL
k.yoshida.cz@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Urayasu Hospital
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Urayasu Hospital
Address
2-1-1 Tomioka, Urayasu, Chiba, Japan
Tel
047-353-3111
k.yoshida.cz@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 26 | Day |
Last modified on
| 2026 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069166
