UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033614
Receipt number R000038255
Scientific Title Influence of throwing episode on decreases shoulder internal rotation and shoulder joint external muscle and capsule
Date of disclosure of the study information 2018/08/03
Last modified on 2019/08/05 22:44:46

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Basic information

Public title

Influence of throwing episode on decreases shoulder internal rotation and shoulder joint external muscle and capsule

Acronym

Influence of throwing episode on shoulder joint

Scientific Title

Influence of throwing episode on decreases shoulder internal rotation and shoulder joint external muscle and capsule

Scientific Title:Acronym

Influence of throwing episode on shoulder joint

Region

Japan


Condition

Condition

Shoulder Injuries in the Throwing Athlete

Classification by specialty

Orthopedics Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

It is to elucidate the mechanism of shoulder joint internal rotation restriction by continuous pitching of baseball players.

Basic objectives2

Others

Basic objectives -Others

In order to acquire knowledge such as appropriate rest as conditioning of the shoulder joint and management of the number of throws

Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase



Assessment

Primary outcomes

height, weight, presence of past history
Joint range of motion(shoulder joint 2nd and 3rd internal and external rotation, scapular - spinal column distance)
Muscle hardness(supraspinous muscle, small circular muscle, posterior deltoid muscle, pectoralis muscle, superior and inferior muscle upper and lower fibers)
joint capsule hardness (posterior joint capsule of the shoulder joint)
Ball speed

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

Evaluation dominantROM and muscle stiffnes after repeated pitches 135

Interventions/Control_2

Evaluation non-dominant ROM and muscle stiffnes after repeated pitches 135

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

18 years-old <=

Age-upper limit

35 years-old >=

Gender

Male

Key inclusion criteria

A man with baseball experience

Key exclusion criteria

Person who has a history in shoulder joint
Those who have pain during the experiment
People with GIRD

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name morikazu hirose

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code


Address

2-7-5 higashifushimi nishitokyo tokyo japan

TEL

042-461-1322

Email

toitsu_hirose@waseda.jp


Public contact

Name of contact person

1st name
Middle name
Last name kaoru ogihara

Organization

waseda University

Division name

The Master's course, Graduate School of Sport Sciences

Zip code


Address

2-7-5 higashifushimi nishitokyo tokyo japan

TEL

042-461-1322

Homepage URL


Email

ogihara_tubax@toki.waseda.jp


Sponsor or person

Institute

waseda University
The Master's course, Graduate School of Sport Sciences

Institute

Department

Personal name



Funding Source

Organization

waseda University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 Year 08 Month 03 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

12

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



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 07 Month 09 Day

Date of IRB

2018 Year 08 Month 07 Day

Anticipated trial start date

2018 Year 09 Month 03 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 08 Month 02 Day

Last modified on

2019 Year 08 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038255


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name