UMIN-CTR Clinical Trial

Public title

A Prospective Study on Sports Injuries in Youth Baseball Players

Acronym

A Prospective Study on Sports Injuries in Youth Baseball Players

Scientific Title

A Prospective Study on Sports Injuries in Youth Baseball Players

Scientific Title:Acronym

A Prospective Study on Sports Injuries in Youth Baseball Players

Region

Japan

Asia(except Japan)

Condition

Baseball Elbow (Osteochondritis Dissecans(OCD)of the Humeral Capitellum, Avulsion Fracture of the Medial Epicondyle)
Baseball Shoulder(Epiphysiolysis of the Proximal Humerus (Little League Shoulder), Rotator Cuff Injury, Impingement Syndrome)
Osgood-Schlatter Disease
Lumbar Spondylolysis

Classification by specialty

Orthopedics

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess the presence of sports injuries in youth baseball players using medical questionnaires and ultrasonography.

Basic objectives2

Others

Basic objectives -Others

To investigate players' backgrounds and training status (including position, weekly practice frequency, and number of games) via questionnaires, and to identify risk factors associated with the onset of sports injuries.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Statistical Analysis Univariate analysis will be performed to compare factors associated with sports trauma between the injury-onset and non-onset groups. Additionally, multivariate regression analysis will be conducted to identify risk factors for the onset of sports injuries.

Assessment Methods

Questionnaire Survey: Data collection will include age, position, practice volume (days/week, games/year), conditioning habits (warm-up, cool-down, icing), current pain (shoulder, elbow, lower back, etc.), and history of medical visits. Pitchers will specifically report their pitch counts (daily/weekly) and self-evaluate their performance (0-10 scale). Mental health and physical condition, including COVID-19-related factors, will also be assessed.

Physical Examination: The shoulder, elbow, knee, and lumbar regions will be assessed for pain, tenderness, range of motion (ROM), muscle strength, and via provocation tests.

Ultrasound Examination: Screening will be conducted for: Shoulder: Humeral retroversion angle and proximal humeral physeal injuries. Elbow: Medial epicondyle physeal injuries and osteochondritis dissecans (OCD) of the humeral capitellum. Knee: Tibial tuberosity physeal injuries and Osgood-Schlatter disease.

X-ray Examination: X-ray examinations using a portable unit will be performed on players presenting with pain in the shoulder, elbow, knee, or lumbar spine, or those suspected of having baseball shoulder, baseball elbow, Osgood-Schlatter disease, or lumbar spondylolysis based on ultrasound or physical findings

Key secondary outcomes

To evaluate the effectiveness of stretching instruction on improving the range of motion (ROM) of the shoulder, elbow, trunk, hip, knee, and ankle.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

6

years-old

<

Age-upper limit

18

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Participants from whom written informed consent for participation in this study was obtained.
2. Residents of the Kanto region.
3. Students from the first grade of elementary school to the third year of high school.
4. Baseball players.

Key exclusion criteria

1.None

Target sample size

8000

Name of lead principal investigator

1st name	Tsuyoshi
Middle name
Last name	Tajika

Organization

Gunma University Graduate School of Health Sciences

Division name

Department of Applied Rehabilitation

Zip code

371-8514

Address

3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan

TEL

0272208269

Email

tajika@gunma-u.ac.jp

Name of contact person

1st name	Tsuyoshi
Middle name
Last name	Tajika

Organization

Gunma University Graduate School of Health Sciences

Division name

Department of Applied Rehabilitation

Zip code

371-8514

Address

3-39-22 Showa-machi, Maebashi, Gunma 371-8511, Japan

TEL

027-220-8269

Homepage URL

Email

tajika@gunma-u.ac.jp

Institute

Gunma University

Institute

Department

Personal name

Organization

Gunma University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Gunma University Hospital Clinical Trials Review Committee Ethics Review Committee for Medical Research Involving Human Subjects

Address

3-39-15 Showa-machi, Maebashi-shi, Gunma, Japan

Tel

027-220-8740

Email

hitotaisho-ciru@ml.gunma-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2025

Year

12

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Open public recruiting

Date of protocol fixation

2013

Year

01

Month

24

Day

Date of IRB

2013

Year

01

Month

24

Day

Anticipated trial start date

2013

Year

02

Month

01

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Study Design and Statistical Analysis Questionnaire Survey A medical questionnaire will collect data on age, playing position, number of practice days and rest days per week, number of games per year, warm-up, cool-down, and icing habits, presence of pain (shoulder, elbow, or lower back), and history of medical visits. Pitchers will additionally report daily and weekly full-effort pitch counts and self-evaluated pitching performance using a 0-10 scale. Mental health status and physical and mental conditions related to COVID-19 will also be assessed.

Physical Examination Physical examinations will evaluate the conditioning of the shoulder, elbow, knee, and lumbar region, including the presence of pain or tenderness, range of motion, muscle strength, and results of provocation tests.

Ultrasound Examination Ultrasound screening will be performed for the shoulder, elbow, and knee. Shoulder assessments will include measurement of the humeral retroversion angle and evaluation of proximal humeral physeal injuries. Elbow examinations will assess medial epicondyle physeal injuries and osteochondritis dissecans of the humeral capitellum. Knee examinations will assess tibial tuberosity physeal injuries and Osgood-Schlatter disease.

X-ray Examination X-ray examinations will be conducted using a portable X-ray unit in a screening van. Indications include pain in the shoulder, elbow, knee, or lumbar spine; suspected baseball shoulder, baseball elbow, or Osgood-Schlatter disease based on ultrasound findings; or suspected lumbar spondylolysis based on physical examination.

Final Analysis Participants will be classified according to the presence or new onset of each sports injury. Univariate and multivariate analyses will be used to determine factors associated with injury prevalence and to identify risk factors for injury onset.

Registered date

2025

Year

12

Month

14

Day

Last modified on

2025

Year

12

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068709