scleroderma Systemic sclerosis
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: For the patient group: 1. Age >18 years 2a. Diagnosis of SSc according to the 2013 EULAR-ACR classification criteria for SSc, 2b. Diagnosis of VEDOSS, which is defined as the presence of RP, puffy fingers, SSc specific autoantibodies and abnormal nailfold capillaroscopy. 3. Written informed consent For the healthy controls: 1. Age >18 years 2. Written informed consent
Exclusion criteria
Exclusion criteria: For the patient population: 1. Age 85 4. Active smoking 5. Diabetes 6. Obesity (BMI >30) 7. Past operations on hands 8. Not being able to put both hands flat on the table while all fingers make contact
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - The change in hand function over time and development of impairment at 2 years, measured with: - Range of motion (ROM) wrists - Range of motion (ROM) finger joints - Delta finger to palm distance (dFTP) - The modified HAMIS (mHAMIS) - Hand grip strength (JAMAR, JAMAR punch 1-2 and lateral grip) - The Cochin Hand Function Scale (CHFS). - Predictive value of imaging features and biomarkers in serum and tissue at baseline for (change in) extent of hand impairment at follow-up - Predictive value of biomarkers in serum and tissue; immunological markers and markers for fibrogenesis in serum, in relation to features on ultrasound, elastography and MRI for (change in) level of hand impairment at follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| - Imaging characteristics on US and MRI images: - Compared between groups (SSc patients with versus without hand impairment, SSc versus VEDOSS patients) - Compared between patients with and without developing hand impairment at follow-up - related to each other - Hand impairment (measured as described above) in dominant versus non-dominant hand. - health-related quality of life (EQ5D-5L), daily functioning (S-HAQ), hand function (CHFS) and hand function measures over time - Change in PASTUL (skin self-assessment) over time and relation to mRSS and hand function measures - Disease severity; Progression from VEDOSS to SSc established disease (according to the 2013 EULAR-ACR criteria) - Shear wave elastography and hand function measures at baseline and at 2 years follow-up - Normal values for elastography of hand tendons | — |
Countries
Netherlands
Outcome results
None listed