Rheumatoid Arthritis Rheumatoid arthritis, morning stiffness
Conditions
Interventions
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
Sponsors
Shima Yoshihito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). | — |
Contacts
Public ContactAkane Watanabe
Graduate school of medicine, Osaka University
Outcome results
None listed