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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028013
Receipt No. R000032077
Scientific Title Investigation of the association between sports injuries and potential risk factors in high level young baseball players
Date of disclosure of the study information 2017/07/01
Last modified on 2019/07/02

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Basic information
Public title Investigation of the association between sports injuries and potential risk factors in high level young baseball players
Acronym Investigation of the association between sports injuries and potential risk factors in high level young baseball players
Scientific Title Investigation of the association between sports injuries and potential risk factors in high level young baseball players
Scientific Title:Acronym Investigation of the association between sports injuries and potential risk factors in high level young baseball players
Region
Japan

Condition
Condition sports injuries
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the sports injuries and verify the associated factors with injuries in high level young baseball players.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes presence and severity of the sports injuries
Key secondary outcomes occurrence of sports related complaints and
injuries, sonographic abnormality of the elbow

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
9 years-old <=
Age-upper limit
12 years-old >=
Gender Male and Female
Key inclusion criteria Young baseball players participated in the national elementary school baseball tournament in 2017 (Sixteen teams, a team is composed of 14 players )
Key exclusion criteria Participants who do not agree the study
Target sample size 224

Research contact person
Name of lead principal investigator
1st name Yoshihiro
Middle name
Last name Hagiwara
Organization Tohoku Univerisity Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code 980-8574
Address 1-1, Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7245
Email hagi@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Takuya
Middle name
Last name Sekiguchi
Organization Tohoku Univerisity Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code 980-8574
Address 1-1, Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7245
Homepage URL
Email takuya.sekiguchi.p1@dc.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine, Department of Orthopaedic Surgery
Institute
Department

Funding Source
Organization Tohoku University Graduate School of Medicine, Department of Orthopaedic Surgery
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Miyagi Amateur Sports Association
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tohoku University School of Medicine, Research Support Section
Address 1-1, Seiryo, Aoba-ku, Sendai
Tel 022-748-4105
Email med-kenkyo@grp.tohoku.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
2017 Year 07 Month 01 Day

Related information
URL releasing protocol https://www.jshoulderelbow.org/article/S1058-2746(18)30411-7/fulltext
Publication of results Partially published

Result
URL related to results and publications https://www.jshoulderelbow.org/article/S1058-2746(18)30411-7/fulltext
Number of participants that the trial has enrolled 210
Results
We examined the association of game playing and television viewing with elbow or shoulder pain among elite young baseball players. Playing video games for more than 3 hours a day was associated with elbow or shoulder pain whereas TV viewing was not.
Results date posted
2019 Year 07 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study enrolled young baseball players (age, 9-12 years) who participated in the National Junior Sports Clubs Baseball Festival held from August 3 to August 6, 2017. This national tournament is an annual event taking place in summer and sponsored by the Japan Junior Sports Clubs Association, which is the largest youth sports association in Japan. In 2017, the national tournament involved 16 baseball teams selected from among 6,378 teams (122,517 players) that had passed the regional qualifying tournaments. 
Participant flow
A self-reported questionnaire and informed consent forms (for the player and their parents) were mailed to all selected players in July 2017 (1 month before the tournament). The players were requested to fill the questionnaire themselves. Of the 210 tournament participants, 206 sent the consent forms and questionnaire before the tournament. Female players were excluded because their small number precluded statistical analysis (n = 6). Finally, 200 male players were included in the analysis.
Adverse events
None
Outcome measures
Elbow and shoulder pain
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 07 Month 01 Day
Date of IRB
2017 Year 07 Month 03 Day
Anticipated trial start date
2017 Year 08 Month 03 Day
Last follow-up date
2017 Year 08 Month 06 Day
Date of closure to data entry
2017 Year 10 Month 01 Day
Date trial data considered complete
2017 Year 11 Month 01 Day
Date analysis concluded
2020 Year 08 Month 01 Day

Other
Other related information This study is an observational study involving young baseball players participated in national tournament in 2017. The purpose of this study is to investigate the association between sports injuries and potential risk factors among high level young baseball players. The survey consists of a questionnaire (e.g., information of
baseball activity, lifestyle, and sports-related injuries), physical examination (e.g., joint flexibility and core stability), and ultrasound of the elbow.

Management information
Registered date
2017 Year 06 Month 30 Day
Last modified on
2019 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032077

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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