臨床研究等提出・公開システム

Date of registration	Nov. 04, 2022
Last modified on	Nov. 04, 2022
Trial ID	jRCT1032220437

Scientific Title	Effects on soft tissue using extracorporeal shock wave therapy and vibrating massage device
Public Title	Effects on soft tissue using extracorporeal shock wave therapy and vibrating massage device

Contact for Scientific Queries	Name	kumai tsukasa
	Affiliation	Faculty of Sport Sciences, Waseda University
	Address	Mikajima, Tokorozawa city, Saitama, 359-1192, JAPAN
	Telephone	+81-429476853
	E-mail	kumakumat@waseda.jp
Contact for Public Queries	Name	LIU ZIJIAN
	Affiliation	Graduate School of Sport Sciences, Waseda University
	Address	Mikajima, Tokorozawa city, Saitama, 359-1192, JAPAN
	Telephone	+81-8021881941
	E-mail	ryuushikenn10611@fuji.waseda.jp

Recruitment status	Pending

Anticipated date of first enrollment		Nov. 04, 2022
Target sample size		50
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	basic science
Key inclusion & exclusion criteria	Inclusion Criteria	Men and women of sound physical and mental health, who are not people with diseases. Also, people who maintain a certain number of hours of practice per week.
	Exclusion Criteria	Any orthopedic or medical disease will be excluded from the experiment.
	Age Minimum	20age old over
	Age Maximum	35age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		muscle strain
Intervention(s)		Extracorporeal shock wavesand a vibration massage device are used to intervene where the subject's fascia and muscles are.
Health Condition(s) Keyword		muscle strain
Health Condition(s) Code		D009135
Primary Outcome(s)		Before and after the intervention, the softness of deep fascia, muscle, and inter muscular fascia will be evaluated by the function with shear wave using ultrasound equipment, and it will be clarified whether the change occurs by using the above equipment.
Secondary Outcome(s)		In order to see changes in ROM and tenderness range, ROM and tenderness range will also be evaluated before and after the intervention, referring to previous studies. For ROM evaluation, ROM will be measured using an angiometer and biodex. The tenderness range will be evaluated using a tenderness meter. On the other hand, since previous studies have also reported that the use of extracorporeal shock waves and vibration massage guns improve muscle blood flow and intramuscular oxygen saturation, this study will use a moxy monitor (Moxy, Fortiori Design LLC, USA) to measure intramuscular oxygen saturation in the target muscle.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Academic Research Ethical Review Committee, Waseda University
Address	1-104,Totsukamachi, Shinjuku-ku, Tokyo, Tokyo
Telephone	+81-352721639
E-Mail	rinri@list.waseda.jp
Approval Status	Approval
Date of approval	Oct. 28, 2022

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none