臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 22, 2023
Last modified on	Sept. 22, 2023
Trial ID	jRCT1030230354

Scientific Title	Effects of shoulder external rotation exercises that use ultrasound imaging feedback on shoulder joint function and pitching performance in adult baseball players: a randomized controlled trial (USI-FB trial)
Public Title	Effects of shoulder external rotation exercises that use ultrasound imaging in adult baseball players (USI-FB trial)

Contact for Scientific Queries	Name	Kawabata Masashi
	Affiliation	Kitasato University
	Address	Kanagawa prefecture, Sagamihara city, Minami ward 1-15-1, 252-0373
	Telephone	+81-42-778-9968
	E-mail	mkawaba@kitasato-u.ac.jp
Contact for Public Queries	Name	Kawabata Masashi
	Affiliation	Kitasato University
	Address	Kanagawa prefecture, Sagamihara city, Minami ward 1-15-1, 252-0373
	Telephone	+81-42-778-9968
	E-mail	mkawaba@kitasato-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Sept. 19, 2023
Actual date of first enrollment		Sept. 19, 2023
Target sample size		32
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Persons aged 18 to 39 years who belong to a baseball club 2) Persons who practice or play games on two or more days a week 3) Persons who can perform external rotation exercises continuously for one month 4) Persons who freely provide informed consent prior to participation after the study is sufficiently explained to them
	Exclusion Criteria	1) Persons who have undergone surgery for a pitching-related injury and have not returned to their original level of competition 2) Persons who are currently unable to pitch with full power due to pain during pitching 3) Persons with less than 1 year of experience 4) Persons who require pain management, including anti-inflammatory analgesics, when competing 5) Other persons who the investigator determines to be inappropriate as participants
	Age Minimum	18age old over
	Age Maximum	39age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Shoulder Injuries
Intervention(s)		shoulder external rotation exercises that use ultrasound imaging feedback
Health Condition(s) Keyword		throwing injury, SLAP injuries, rotator cuff injuries
Intervention(s) Keyword		Rehabilitation, rotator cuff exercise
Health Condition(s) Code		D000070599
Intervention(s) Code		D005081
Primary Outcome(s)		Kerlan-Jobe Orthopaedic Clinic Shoulder and Elbow Score (KJOC)
Secondary Outcome(s)		1) Patient-based questionnaire (Japanese society for surgery of the hand version of the quick disability of the arm shoulder, and hand (Quick DASH-JSSH) questionnaire, Pitching performance score) 2) Physical function evaluation: joint range of motion (angle), muscle strength (Nm), and muscle activity (% maximal voluntary contraction) 3) Pitching performance evaluation: pitch speed and rotation rate, elbow valgus stress, and arm swing speed

Primary Sponsor	none

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Kitasato University School of Allied Health Sciences institutional review board
Address	Kanagawa prefecture, Sagamihara city, Minami ward 1-15-1, 252-0373, Kanagawa
Telephone	+81-42-778-8896
E-Mail	a-soumu@kitasato-u.ac.jp
Approval Status	Approval
Date of approval	Sept. 12, 2023

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none