Safety evaluation and therapeutic effects of exercise therapy and knee hyp erthermia using reentrant cavity resonance warmer

JRCT ID: jRCTs052220080

Registered date:25/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: osteoarthritis
• Date of first enrollment: 25/08/2022
• Target sample size: 30
• Study type: Interventional

Intervention(s)

In addition to daily exercise therapy (locomotion
training of one-legged stand, squat, calf raise, and
front lunge), a newly developed reentrant cavity re
sonant heating device (unapproved medical devic
e) is used for both knee joints, and thermal irradiat
ion is performed once a week for about 20 minute
s at an output of 40 degree, which increases the m
etabolism of articular cartilage. Thermal
irradiation is performed once a week for about 20
minutes at an output of 40 degree, which increase
s the metabolism of articular cartilage.

Outcome(s)

• Primary Outcome: Articular cartilage T1rho values by MRI T1 rho mapping before and after treatment

Secondary Outcome

Pre- and post-treatment assessment of movement capability
Presence of burns

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1) Patients participating in exercise therapy for locomotive syndrome at Kanai Hospital
2) Patients with early stage osteoarthritis of the knee (radiographs: Kellgren-Lawrence classification grade 1-2)
3) Gender: male and female
4) Age: between 40 and 80 years old
5) BMI: 30 or less
6) Patients who can provide written consent for free participation in the study

Exclude criteria

1) Patients who cannot walk without the assistance of others
2) Persons whose cognitive ability is recognized as declining (persons scoring 23 or below on the Hasegawa Dementia Scale are excluded).
3) Those residing in a special nursing home for the elderly, long-term care health facility for the elderly, or long-term care medical facility (convalescent beds)
4) Patients with a history of hospitalization within 1 month of the date of consent
5) Those with a history of trauma or surgery to the lower limb or spine within 3 months of the date of consent
6) Has a pacemaker inserted
7) Pregnant women
8) Patients who are unable to perform MRI examinations (metal in the body, claustrophobia, etc.)
9) Patients who are unable to hold the position for 20 minutes
10) Persons who have a conflict of interest with the principal investigator or co-investigator of this study
11) Any other person whom the physician deems inappropriate.

Related Information

• Primary Sponsor: Ryu Kazuteru
• Secondary Sponsor: Takahashi Kenji
• Source(s) of Monetary Support: Harmonize Inc.