UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059344 |
|---|---|
| Receipt number | R000067878 |
| Scientific Title | Examination of the effect of stretching the flexor carpi ulnaris muscle for preventing baseball elbow injuries |
| Date of disclosure of the study information | 2025/10/09 |
| Last modified on | 2025/10/08 20:36:53 |
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Basic information
Public title
Study on the effect of stretching the flexor carpi ulnaris muscle to prevent baseball elbow injuries
Acronym
Stretching the flexor carpi ulnaris to prevent baseball elbow injuries
Scientific Title
Examination of the effect of stretching the flexor carpi ulnaris muscle for preventing baseball elbow injuries
Scientific Title:Acronym
Examination of the effect of stretching the flexor carpi ulnaris muscle for preventing baseball elbow injuries
Region
| Japan |
Condition
Condition
baseball elbow injuries
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Increased elbow valgus load during pitching is thought to be involved in the development of baseball elbow. The forearm flexor and pronator muscles function as dynamic stabilizers against valgus stress during pitching. The flexor carpi ulnaris, in particular, is a key muscle covering the medial collateral ligament and is believed to contribute significantly to suppressing valgus during pitching. Muscles exhibit increased elasticity with repeated contraction or contraction under heavy loads. Players with medial baseball elbow injury during development have been shown to have higher flexor carpi ulnaris elasticity compared with healthy players. Furthermore, prospective studies have reported that high flexor carpi ulnaris elasticity is a risk factor for baseball elbow. Therefore, improving flexibility of the flexor carpi ulnaris may prevent baseball elbow, and stretching for this muscle is considered important. However, while there are various stretching methods for the flexor carpi ulnaris, their effectiveness has not been fully investigated, and effective stretching techniques for this muscle have not been identified. Therefore, the purpose of this study is to use ultrasound elastography to measure muscle elasticity before and after various stretching exercises for the flexor carpi ulnaris, clarify the effects, and use this as an aid in physical therapy for baseball elbow injuries.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the rate of change in elasticity of the flexor carpi ulnaris muscle before and after four types of stretching
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
With the shoulder flexed at 90 degrees, the forearm supinated at 90 degrees, and the wrist dorsiflexed at 90 degrees, stretching was performed for 20 seconds in two sets, extending the four fingers except for the thumb.
Interventions/Control_2
With the shoulder flexed at 90 degrees, the forearm pronated at 90 degrees, and the wrist dorsiflexed at 90 degrees, stretching was performed for 20 seconds in two sets, extending the four fingers except for the thumb.
Interventions/Control_3
With the shoulder flexed 90 degrees, the forearm pronated 90 degrees, and the wrist dorsiflexed 90 degrees, stretching only the ring finger and little finger is performed for 20 seconds in two sets.
Interventions/Control_4
With the shoulder flexed 90 degrees, the forearm pronated 90 degrees, and the wrist dorsiflexed 90 degrees, stretching was performed for 20 seconds in two sets, extending the ring finger and little finger and radially flexing the wrist.
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
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
A healthy baseball players who belong to a university baseball team
Key exclusion criteria
1. Individuals who have developed baseball elbow within the past year or are currently undergoing treatment.
2. Individuals with some kind of disability or injury to the dominant upper limb.
3. Individuals who are otherwise deemed inappropriate as study subjects by the principal investigator or co-investigators.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Toma |
| Middle name | |
| Last name | Maezawa |
Organization
Akita University Graduate School of Medicine and Faculty of Medicine
Division name
Rehabilitation Sciences
Zip code
0100825
Address
1-1-1 Hondou, Akita City, Akita
TEL
018-884-6505
drgns7touma@gmail.com
Public contact
Name of contact person
| 1st name | Toma |
| Middle name | |
| Last name | Maezawa |
Organization
Akita University Graduate School of Medicine and Faculty of Medicine
Division name
Rehabilitation Sciences
Zip code
0100825
Address
1-1-1 Hondou, Akita City, Akita
TEL
018-884-6505
Homepage URL
drgns7touma@gmail.com
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Toma Maezawa
Funding Source
Organization
Akita 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
Akita University Graduate School of Medicine and Faculty of Medicine
Address
1-1-1 Hondou, Akita City, Akita
Tel
018-884-6505
drgns7touma@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
秋田県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 09 | 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
25
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 08 | Day |
Last modified on
| 2025 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067878
