UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035070 |
|---|---|
| Receipt number | R000039982 |
| Scientific Title | changes in viscoelasticity of medial elbow joint during repetitive throwing in high school baseball players |
| Date of disclosure of the study information | 2018/11/30 |
| Last modified on | 2019/07/16 21:50:35 |
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Basic information
Public title
changes in viscoelasticity of medial elbow joint during repetitive throwing in high school baseball players
Acronym
changes in viscoelasticity of medial elbow joint during repetitive throwing in high school baseball players
Scientific Title
changes in viscoelasticity of medial elbow joint during repetitive throwing in high school baseball players
Scientific Title:Acronym
changes in viscoelasticity of medial elbow joint during repetitive throwing in high school baseball players
Region
| Japan |
Condition
Condition
nothing
Classification by specialty
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the changes in viscoelasticity of medial elbow joint during repetitive throwing
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tissue elasticity of medial elbow joint by ultrasound elastography
Key secondary outcomes
Medial elbow joint space gapping by ultrasound
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
| Maneuver |
Interventions/Control_1
5 sets of 20 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
| 15 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy high school students
Key exclusion criteria
1) Persons who have pain in the elbow joint
2) Persons who have an operation history at the elbow joint
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hattori |
Organization
Graduate school of Saitama Medical University
Division name
Department of Medicine
Zip code
350-0436
Address
981 Kawakado, Moroyama, Saitama, Japan
TEL
049-295-1001
hiroshi.hattori1024@gmail.com
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hattori |
Organization
Graduate school of Saitama Medical University
Division name
Department of Medicine
Zip code
350-0436
Address
981 Kawakado, Moroyama, Saitama, Japan
TEL
049-295-1001
Homepage URL
hiroshi.hattori1024@gmail.com
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical 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
Saitama Medical University
Address
1397-1 Yamane, Hidaka, Saitama, Japan
Tel
042-984-4801
h_rinri@saitama-med.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
| 2018 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
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
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 08 | 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
| 2018 | Year | 11 | Month | 29 | Day |
Last modified on
| 2019 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039982
