UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041779 |
|---|---|
| Receipt number | R000047684 |
| Scientific Title | Effect of pitching motion on dynamic elbow valgus stability |
| Date of disclosure of the study information | 2020/09/13 |
| Last modified on | 2024/09/16 12:18:01 |
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Basic information
Public title
The effects of throwing on elbow valgus stability
Acronym
The effects of throwing on elbow valgus stability
Scientific Title
Effect of pitching motion on dynamic elbow valgus stability
Scientific Title:Acronym
Effect of pitching motion on dynamic elbow valgus stability
Region
| Japan |
Condition
Condition
throwing injuries
Classification by specialty
| Rehabilitation medicine | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To see the effects of pitching motion on dynamic elbow valgus stability
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
medial joint space at elbow
Key secondary outcomes
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
100 pitches
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
normal male
Key exclusion criteria
Pain with pitching
Ulnar collateral ligament injuries, elbow dislocation
Previous history of any surgeries with hand, wrist, elbow and shoulder
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Mina |
| Middle name | |
| Last name | Samukawa |
Organization
Hokkaido University
Division name
Faculty of Health Sciences
Zip code
0600812
Address
Nishi 5, Kita 12, Kita-ku, Sapporo
TEL
011-706-3329
mina@hs.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Mina |
| Middle name | |
| Last name | Samukawa |
Organization
Hokkaido University
Division name
Faculty of Health Sciences
Zip code
060-0812
Address
Nishi 5, Kita 12, Kita-ku, Sapporo
TEL
011-706-3329
Homepage URL
mina@hs.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical committee of Faculty of Health Sciences in Hokkaido University
Address
Nishi 5, Kita 12, Kita-ku, Sapporo
Tel
011-706-3329
mina@hs.hokudai.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
| 2020 | Year | 09 | Month | 13 | Day |
Related information
URL releasing protocol
https://www.jshoulderelbow.org/article/S1058-2746(23)00358-0/abstract
Publication of results
Published
Result
URL related to results and publications
https://www.jshoulderelbow.org/article/S1058-2746(23)00358-0/abstract
Number of participants that the trial has enrolled
15
Results
FPM contraction plays a role in narrowing the medial elbow joint space; however, repetitive baseball pitching reduced the elbow valgus stability.
Results date posted
| 2024 | Year | 09 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
baseball players
Participant flow
Elbow medial stability was assessed before and after repetitive throwing 100 times.
Adverse events
N/A
Outcome measures
Elbow medial stability
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2020 | Year | 09 | Month | 13 | Day |
Last modified on
| 2024 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047684
