Multicenter study for morning stiffness in Rheumatoid Arthritis using low temperature warmers

JRCT ID: jRCTs052230138

Registered date:29/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rheumatoid Arthritis
• Date of first enrollment: 28/12/2023
• Target sample size: 40
• Study type: Interventional
• Intervention(s): For a defined period of 2 weeks, participants are requested to wear the holders whith the specific disposable warmers inside on their bilateral hands during sleeping (warmer adapted on dorsal side of the wrist). The time for wearing the warmers rely on the participant. If the participant feels uncomfortable or notices any problem on the skin, he or she may stop wearing the warmer of his or her free will.

Outcome(s)

Primary Outcome

Differences between the Morning Stiffness severity (MS severity) in the period of wearing the tested device and in the period of not wearing.
MS severity is defined the 0-10 numerical scale for the intensity of morning stiffness on his/her hands assessed by a participant himself/herself and recorded in the diary.
The difference of MS severity is defined as the difference between "the average of MS severity in the period of wearing the device" and "the average of MS severity in the period of not wearing the device".

Secondary Outcome

1. Differences between morning stiffness duration in the period of wearing the tested device and in the period of not wearing.
2. Differences in gripping strength of the dominant hand between bedtime and waking.
3. Disease activity of rheumatoid arthritis (DAS28-CRP and CDAI)
4. Safety assessment of the tested device ( frequency and severity of burns associated with the warmers).

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 90age old
• Gender: Both

Include criteria

1. Patients over 20 years old and under 90 years old when the consent is obtained.
2.Patients who were diagnosed with rheumatoid arthritis (RA) by the 2010 EULAR-ACR classification criteria for rheumatoid arthritis.
3.Patients who usually have Morning Stiffness (MS) on their hands for 15 minutes or longer during 4 weeks before giving their consent.
4.Patients who have not changed or started the treatment for RA within 4 weeks prior to the enrolment.
5.Patients who give written informed consent.

Exclude criteria

1.Patients who have any skin disease at the site of wearing the warmer.
2.Patiens under chronic febrile disease including infectious disease.
3.Patients who have diabetes mellitus.
4.Patients who have peripheral neuropathy of upper extremities.
5.Patients who are incapable of wearing or taking off the warmer by themselves.
6.Patients who have vascular shunt on the arm for hemodialysis.
7.Other Patients who are judged as ineligible by the responsible researcher.

Related Information

• Primary Sponsor: Shima Yoshihito
• Source(s) of Monetary Support: Kobayashi pharmaceutical Co,. Ltd.