臨床研究等提出・公開システム

Japanese

Date of registration	June. 19, 2024
Last modified on	June. 19, 2024
Trial ID	jRCT1032240176

Scientific Title	Effects of radial pressure waves on joint range of motion - Focusing on intertissue sliding-
Public Title	Effects of radial pressure waves on joint range of motion - Focusing on intertissue sliding-

Contact for Scientific Queries	Name	Tsukasa Kumai
	Affiliation	Waseda University
	Address	2-579-15 Mikajima, Tokorozawa City, Saitama
	Telephone	+81-4-2947-6848
	E-mail	kumakumat@waseda.jp
Contact for Public Queries	Name	Yusuke Kobayashi
	Affiliation	Waseda University
	Address	2-579-15 Mikajima, Tokorozawa City, Saitama
	Telephone	+81-4-2947-6848
	E-mail	kobayashi.y@fuji.waseda.jp

Recruitment status	Pending

Anticipated date of first enrollment		June. 19, 2024
Target sample size		30
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	no treatment control/standard of care control
	assignment	crossover assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) No history of symptoms or surgery on the lower back or lower extremities 2) Not undergoing regular flexibility training 3) Able to avoid strenuous exercise for 48 hours prior to the test session
	Exclusion Criteria	1) Has a history of symptoms or surgery in the lower back or lower extremities 2) Undergoes regular flexibility training 3) Impossible to avoid strenuous exercise for 48 hours prior to the test session
	Age Minimum	18age old over
	Age Maximum	30age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		muscle strain
Intervention(s)		The intervention will be performed using a radial pressure wave therapy device to irradiate the muscles of the lower leg. Intervention group: The intervention will be performed using a radial pressure wave therapy device. The output of the device was set at 1.5 bar at 15 Hz to avoid pain caused by the intervention. A total of 4,000 shots (2,000 shots each) will be delivered using two types of pressure wave transmission tips, each with a different pressure wave transmission mode. (The output of the device can be adjusted from 1.0 bar to 5.0 bar, and the closer to 5.0 bar, the higher the output. The output of the device can be adjusted from 1.0 bar to 5.0 bar, and the closer to 5.0 bar, the higher the output. The study was conducted at 1.5 bar, which is considered low output and unlikely to cause pain.) Sham-intervention group: Intervention will be performed using a sham intervention device created by the manufacturer of the diffusion-type pressure group therapy device. The sham intervention device is designed so that pressure waves are not emitted from the tip of the device, and the device is adjusted to be the same as a normal device, except that mechanical noise, vibration, and other pressure waves are not generated by the intervention. The output of the device and the number of irradiations are the same as in the intervention group. The intervention is scheduled to be performed to the extent that it does not cause pain in the intervention group, and the subject will not be able to distinguish the difference between the intervention and the sham group.
Health Condition(s) Keyword		muscle strain
Intervention(s) Keyword		Extracorporeal Shockwave Therapy, Radial Pressure Wave Thrapy
Health Condition(s) Code		D009135
Intervention(s) Code		D000074059
Primary Outcome(s)		Evaluation of intertissue sliding in skin-subcutaneous tissue of the posterior lower leg using ultrasound imaging system
Secondary Outcome(s)		Dorsiflexion range of motion of ankle joint Muscle hardness and morphology of the triceps muscle

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Office of Research Ethics
Address	1-104 Totsukamachi, Shinjuku Ward, Tokyo, Tokyo
Telephone	+81-3-5272-4652
E-Mail	rps-management@list.waseda.jp
Approval Status	Approval
Date of approval	May. 13, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	non