Systemic sclerosis/scleroderma Skin and Connective Tissue Diseases
Conditions
Interventions
Control group: standard of care (i.e. standard pharmacological treatment according to the EULAR/ACR recommendations on the management of systemic sclerosis, education, and materials for regular daily
Sponsors
Revmatologický ústav
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent form signed and dated 2. Reliable and capable of adhering to the protocol and visit schedule 3. At least 18 years of age 4. Fulfilled the 2013 EULAR/ACR classification criteria for systemic sclerosis 5. Skin involvement at least of the fingers/hands and the face 6. Regularly followed at our out-patient department and adheres to the standard-of-care pharmacological therapy indicated by his treating rheumatologist 7. Willing to participate in the study and undergo all planned examinations
Exclusion criteria
Exclusion criteria: Subject has any other condition, including medical or psychiatric, which in the investigator's judgment would make the subject unsuitable for inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at baseline, week 12, week 24, week 48: 1. Function of the hands assessed by: - HAMIS test (Hand Mobility in Scleroderma) - delta finger to palm distance - hand grip strength measured by dynamometry - CHFS questionnaire (Cochin Hand Function Scale) 2. Function of the face: - inter-lip and inter-incisor distance - MHISS questionnaire (Mouth Handicap in Systemic Sclerosis) | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline, week 12, week 24, week 48: 1. Assessment of health/disability: - HAQ questionnaire (Health Assessment Questionnaire) - SHAQ questionnaire (Scleroderma Health Assessment Questionnaire) 2. Quality of life: - SF-36 questionnaire (Medical Outcomes Short Form-36) | — |
Countries
Czech Republic
Outcome results
None listed