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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | sports injuries | |
Classification by specialty |
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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 | |
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Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 | ||||||
hagi@med.tohoku.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 |
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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 | ||||||
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Date of IRB |
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Date analysis concluded |
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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 |
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Last modified on |
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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 | |
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Research case data | |
Registered date | File name |