UMIN-ICDS Clinical Trial

Public title

Changes in Medial Elbow Joint Space Width and Shoulder Joint Function during Pitching and Their Correlation

Acronym

Changes in Medial Elbow Joint Space Width and Shoulder Joint Function during Pitching and Their Correlation

Scientific Title

Changes in Medial Elbow Joint Space Width and Shoulder Joint Function during Pitching and Their Correlation

Scientific Title:Acronym

Changes in Medial Elbow Joint Space Width and Shoulder Joint Function during Pitching and Their Correlation

Region

Japan

Condition

Adult

Classification by specialty

Rehabilitation medicine

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Overhead sports particularly baseball have been reported to increase the external rotation range of motion ROM and decrease the internal rotation ROM in the throwing shoulder joint
Restricted internal rotation range of motion in the throwing shoulder compared to the non throwing shoulder is termed Glenohumeral Internal Rotation Deficit GIRD
Burkhart et al defined GIRD as a shoulder internal rotation restriction of 20 or more
According to Tajika et al shoulder internal rotation restriction showed a mild positive correlation with the medial gap distance of the elbow joint which indicates elbow valgus laxity
Although research is needed on the relationship between GIRD and the medial gap distance of the elbow joint few reports exist to date
Takenaga et al reported a moderate negative correlation between the internal rotation angle of the throwing shoulder and the thickness of the posterior shoulder joint capsule
More detailed reports on throwing related elbow disorders and shoulder joint function are needed however few reports have evaluated posterior shoulder joint capsule thickness or shoulder joint angles through continuous throwing
Investigating the relationship between throwing related elbow injuries and shoulder function is considered to aid in the prevention of throwing related elbow injuries and in rehabilitation to prevent recurrence after injury
Therefore this study aimed to examine the relationship between the medial intercondylar distance of the elbow joint and shoulder range of motion shoulder muscle strength and posterior shoulder joint capsule thickness during continuous throwing

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Medial Elbow Joint Space Width

Measurements shall be performed under the following two conditions
Resting Condition
Supine, shoulder joint abduction 90 shoulder joint horizontal abduction 0 elbow joint flexion 90 forearm pronation/supination neutral position
Gravity-loaded condition
Supine, shoulder joint abduction 90 shoulder joint horizontal abduction 0 maximum external rotation elbow joint flexion 90 forearm in neutral position
Extend the limb distally beyond the bed edge and perform the measurement with the elbow joint under valgus stress due to body weight

Measure the distance between the tips of the echo images showing the cortical bone of the distal humeral trochlea and the ulnar margin of the proximal ulnar olecranon process as the medial joint space width. Measure in 01 mm increments on the ultrasound imaging device screen
Subjects are assigned a total of 80 pitches
Measurements are taken before pitching and after every 20 pitches

Key secondary outcomes

Posterior Shoulder Joint Capsule Thickness

The measurement position is sitting upright with the shoulder joint in 0 abduction and the hand resting on the thigh
Place the ultrasound probe on the posterior aspect of the shoulder joint and adjust it to clearly visualize the humeral head joint capsule glenoid fossa and infraspinatus muscle
On the ultrasound imaging device screen measure the joint capsule thickness beneath the infraspinatus muscle 5 mm lateral to the edge of the glenoid fossa, in increments of 01 mm

Shoulder Joint Range of Motion

Using a goniometer, measure the range of motion for external rotation and internal rotation of the throwing shoulder joint
The measurement method follows the Joint Range of Motion Indication and Measurement Methods established by the Japanese Society of Rehabilitation Medicine and others
The measurement position is supine 2nd position shoulder joint abduction 90 elbow joint flexion 90 and forearm pronated

Shoulder Joint Muscle Strength

Measure isometric muscle strength for internal and external rotation of the throwing shoulder joint using a handheld dynamometer manufactured by ANIMA
The measurement position is prone 2nd position

Subjects are assigned a total of 80 pitches
Measurements are taken before pitching and after every 20 pitches

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Pitching Task

After a 5-minute warm-up perform 80 full power pitches using a hardball toward a protective net 3 meters away
The Japanese Society of Clinical Sports Medicines Recommendations for Baseball Injuries in Youth sets the daily limit for full power pitches at 50 for elementary school students 70 for junior high school students and 100 for high school students
To reduce the burden on research subjects while maintaining a load level appropriate for junior high school students and those under high school age the number was set at 80 pitches
Consecutive pitches are limited to 20, with a 15-second interval between each pitch.
Full power pitching refers to the research subjects subjective maximum effort
As reference values subjective fatigue levels and the ball speed of each pitch are measured
While maximum effort is determined by the subjects subjective judgment if a research assistant clearly determines a pitch was not thrown with maximum effort that pitch will be repeated
Additionally the ball speed data for that pitch will be deleted
Subjective fatigue levels will be measured using the
Visual Analog Scale before pitching, after 20 pitches, after 40 pitches, after 60 pitches, and after 80 pitches.A speed gun is used to measure the ball speed for each pitch.
A 10-minute rest period is provided between each set of 20 pitches, during which all measurements are conducted. After completing the measurements, the researcher confirms the subject is ready to resume pitching before restarting the task.

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male

Key inclusion criteria

1 Healthy male individuals belonging to a university baseball team in Gunma Prefecture
2 Individuals who throw with an overhead motion
3 Individuals capable of throwing at full power
4 Individuals who can read the explanatory document and provide their own consent

Key exclusion criteria

Any individual meeting any one of the following eight criteria shall be excluded

1 Individuals currently restricted from exercise by a physician due to orthopedic conditions affecting the upper or lower limbs or trunk
2 Individuals with a history of surgery for fractures or tendon/ligament injuries in the shoulder or elbow joints
3 Individuals with a history of medial collateral ligament injury in the elbow joint
4 Individuals unable to perform a full-power throw
5 Individuals who performed a full-power throw within the 24 hours immediately preceding the measurement date
6 Individuals scheduled to play in a game the day after the measurement date
7 Individuals who are sidearm or underhand throwers
8 Individuals who, after reading the explanatory document, do not provide their consent

Target sample size

21

Name of lead principal investigator

1st name	Tsuyoshi
Middle name
Last name	Tajika

Organization

Graduate School of Health Sciences Gunma University Department of Rehabilitation Science

Division name

Graduate School of Health Sciences, Gunma University, Department of Rehabilitation Science

Zip code

3718511

Address

3-39-22 Showa cho Maebashi City Gunma Prefecture

TEL

027-220-8945

Email

tajika@gunma-u.ac.jp

Name of contact person

1st name	Koki
Middle name
Last name	Hashimoto

Organization

Graduate School of Health Sciences, Gunma University, Department of Rehabilitation Science

Division name

Graduate School of Health Sciences, Gunma University, Department of Rehabilitation Science

Zip code

3718511

Address

3-39-22 Showa cho Maebashi City Gunma Prefecture

TEL

027-220-8945

Homepage URL

Email

h241c010@gunma-u.ac.jp

Institute

Gunma university

Institute

Department

Personal name

Tsuyoshi Tajika

Organization

None

Organization

Division

Category of Funding Organization

Self funding

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

3-39-22 Showa cho Maebashi City Gunma Prefecture

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

09

Month

11

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

Enrolling by invitation

Date of protocol fixation

2025

Year

08

Month

14

Day

Date of IRB

2025

Year

08

Month

14

Day

Anticipated trial start date

2025

Year

09

Month

11

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

Registered date

2025

Year

09

Month

07

Day

Last modified on

2025

Year

09

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067504