UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028013
Receipt number 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 15:17:20

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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 or person

Institute

Tohoku University Graduate School of Medicine, Department of Orthopaedic Surgery

Institute

Department

Personal name



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

Value
https://center6.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