RA morning stiffness study

Phase 1

• Conditions: Rheumatoid Arthritis; Rheumatoid arthritis, morning stiffness; D001172

• Registration Number: JPRN-jRCTs052210155
• Lead Sponsor: Shima Yoshihito

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-17
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

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.
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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences between the Morning Stiffness score (MS score) in the period of wearing the tested device and in the period of not wearing.<br>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.<br>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 Measures

Name	Time	Method
1.Differences between morning stiffness duration in the period of wearing the tested device and in the period of not wearing.<br>2.Differences between gripping strength on waking in the period of wearing the tested device and in the period of not wearing.<br>3.Disease activity of rheumatoid arthritis (DAS28-CRP and CDAI)<br>4.Findings of muscle-skeltal ultrasonography on finger and wrist joints.<br>5.Correlation between weather and morning stiffness.<br>6.Safety assessment of the tested device ( frequency and severity of burns associated with the warmers).