UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050793 |
|---|---|
| Receipt number | R000057881 |
| Scientific Title | Investigation of the factors that affect the condition of the elbow joint immediately after and the day after repeated pitching |
| Date of disclosure of the study information | 2023/04/12 |
| Last modified on | 2025/04/11 10:52:48 |
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Basic information
Public title
Investigation of the factors that affect the condition of the elbow joint immediately after and the day after repeated pitching
Acronym
Investigation of the factors that affect the condition of the elbow joint immediately after and the day after repeated pitching
Scientific Title
Investigation of the factors that affect the condition of the elbow joint immediately after and the day after repeated pitching
Scientific Title:Acronym
Investigation of the factors that affect the condition of the elbow joint immediately after and the day after repeated pitching
Region
| Japan |
Condition
Condition
healthy young male
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identification of factors related to the condition of the elbow joint after repeated pitching
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Elbow joint medial cleft distance,
medial collateral ligament strain rate,
maximum elbow joint external torque
Key secondary outcomes
Muscle strength (shoulder and elbow joint),
thoracic kyphosis angle
elbow valgus angle
range of motion (shoulder and elbow joint)
ball velocity
grip strength
joint laxity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
After warming up sufficiently, throw 20 balls in a set, for a total of 100 balls in 5 sets.
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
| 16 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male
Key inclusion criteria
No pain in the shoulder or elbow joint during pitching, and Healthy young men who had no pain in the shoulder or elbow joints when pitching and who agreed to participate in the study after being informed of its contents
Key exclusion criteria
Pain in the shoulder and elbow joints while pitching
Athletes whose throwing motion is sidethrowing or underthrowing
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shun |
| Middle name | |
| Last name | Okamura |
Organization
Bunkyo Gakuin University
Division name
Department of Physical Therapy, Faculty of Health and Medical Technology
Zip code
356-8533
Address
1196 Kamekubo,Fujimino,Saitama
TEL
049-261-79723
s-okamura@bgu.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Okawa |
Organization
Bunkyo Gakuin University
Division name
Department of Physical Therapy, Faculty of Health and Medical Technology
Zip code
356-8533
Address
1196 Kamekubo,Fujimino,Saitama
TEL
049-261-7258
Homepage URL
tohkawa@bgu.ac.jp
Sponsor or person
Institute
Bunkyo Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Bunkyo Gakuin University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bunkyo Gakuin University Health Science Research Ethics Review Committee
Address
1-19-1 Mukouoka, Bunkyo-ku, Tokyo
Tel
03-3814-1661
yyamaguchi@bgu.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
| 2023 | Year | 04 | Month | 12 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/39741472/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/39741472/
Number of participants that the trial has enrolled
26
Results
The medial elbow joint width significantly increased by 0.84 mm immediately after pitching (P < .05), but this was not maintained at 24 hours. The UCL strain ratio significantly decreased by 1.64 immediately after pitching (P < .05), but this was not maintained at 18 hours after pitching. The strain ratio of the FPMs significantly decreased by 0.09 immediately after pitching (P < .05) but significantly increased by 0.13 at 24 hours (P < .05).
Results date posted
| 2025 | Year | 04 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Male high school students belonging to a baseball team
Participant flow
Recruitment Period: January 2023 to February 2024
Recruitment Location: High schools with baseball teams
Recruitment Method: Recruitment was conducted through posters, followed by an explanation of the study, and only those who provided informed consent were included.
A total of 26 individuals expressed their willingness to participate, and all 26 were ultimately included in the analysis.
Adverse events
Nothing
Outcome measures
Elbow joint medial cleft distance medial collateral ligament strain rate maximum elbow joint external torque　Muscle strength shoulder and elbow joint, thoracic kyphosis angle, elbow valgus angle, range of motion shoulder and elbow joint, ball velocity, grip strength, joint laxity
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 10 | Day |
Last modified on
| 2025 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057881
