The effect of shock waves on the musculoskeletal system

JRCT ID: jRCT1092220355

Registered date:19/06/2018

Basic Information

• Recruitment status: RECRUITING
• Health condition(s) or Problem(s) studied: We will investigate the effect of shock wave on the musculoskeletal system
• Date of first enrollment: 12/06/2018
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intervention type:DEVICE
Name of intervention:Before-after study
Dose form / Japanese Medical Device Nomenclature:DEVICE
Extracorporeal shock-wave therapy device (DUOLITH SD1)
Route of administration / Site of application:SOFT TISSUE
Dose per administration:NA
NA
NA
Dosing frequency / Frequency of use:QD
ONCE (once a week/once a month)
Planned duration of intervention:We will adjust the intervention period in accordance with the symptoms.
Intended dose regimen:Application of extracorporeal shock wave
detailes of teratment arms:Athlete patients with sport-related musculoskeletal injuries
Comparative intervention name:
Dose form / Japanese Medical Device Nomenclature:
Route of administration / Site of application:
Dose per administration:
Dosing frequency / Frequency of use:
Planned duration of intervention:
Intended dose regimen:

Outcome(s)

• Primary Outcome: Recovery of the affected area from injuries based on image diagnosis (ultrasonic diagnostic equipment and/or magnetic resonance imaging)
• Secondary Outcome: Improvement in subjective pain

Key inclusion & exclusion criteria

• Age minimum: >=
• Age maximum: <=
• Gender: Both
• Include criteria: Athlete patients who have chronic sport-related injuries detected on diagnostic image (ultrasonic diagnostic equipment and/or magnetic resonance imaging), voluntarily provided written informed consent, and can adhere to the study schedules during the study period
• Exclude criteria: Athlete patients who are inappropriate for participating in the study as determined by the principal investigator, are under medical treatment at a medical facility, and have any kinds of iron-containing object in their body/the fear of enclosed spaces (claustrophobia)

Related Information

• Primary Sponsor: Japan Medicalnext Co., Ltd.
• Source(s) of Monetary Support: Japan Medicalnext Co., Ltd.
• Secondary ID(s): JMA-IIA00355