Systemic sclerosis systemic sclerosis, systemic scleroderma, Raynaud's phenomenon
Conditions
Interventions
Following a one-week of no-treatment observation period, study participants are instructed to insert the applied disposable warmers into holders antd place them on the both upper arms near the elbow f
Sponsors
Shima Yoshihito
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients attending Osaka University Hospital 2.20 years old or older and under 80 years old 3.Patients with systemic sclerosis who meet the classification criteria by the ACR/EULAR 2013 and have Raynaud's phenomenon. 4.Patients who have been fully informed of the study and who have given written consent of their own free wil.
Exclusion criteria
Exclusion criteria: 1. Patients chronically febrile due to primary disease or comorbidities 2. Patients with Diabetes mellitus 3. Patients with another skin disease except systemic sclerosis at the site of wearing the warmer 4. Patients who are incapable of taking off the warmer by themselves 5. Patients with peripheral neuropathy of upper extremities or past medical history of that 6. Patients with vascular shunt on the arm for hemodialysis 7. Patients who are judged as ineligible by the responsible researcher for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the average Raynaud Condition Score (RCS) recorded in the participants' diary between the warmer-applied period and non-warmer-applied period for each of the three temperature of the warmer. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number and frequency of Raynaud's phenomenon as recorded in the diary (times/day) 2. Total duration of Raynaud's phenomenon per day (minutes/day) 3. Number and frequency of adverse events | — |
Contacts
Public ContactAkane Watanabe
Osaka Uversity Hospital
Outcome results
None listed