RA morning stiffness study

JRCT ID: jRCTs052210155

Registered date:17/01/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Rheumatoid Arthritis
• Date of first enrollment: 17/01/2022
• Target sample size: 20
• 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 wrists 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 score (MS score) in the period of wearing the tested device and in the period of not wearing.
MS score 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.
Difference of MS score is defined as difference between "average of MS score in the period of wearing the device" and "average of RCSs 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 between gripping strength on waking in the period of wearing the tested device and in the period of not wearing.
3.Disease activity of rheumatoid arthritis (DAS28-CRP and CDAI)
4.Findings of muscle-skeltal ultrasonography on finger and wrist joints.
5.Correlation between weather and morning stiffness.
6.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.
4.Patients who have not changed or started the treatment for RA within 4 weeks prior to the consent.
5.Patients who give written informed consent.
6.Patients currently attending the department of clinical immunology, Osaka University Hospital.

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.