Hand Function Impairment in Systemic Sclerosis: Outcomes, Mechanisms and Experience (HANDSOME)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Imaging, blood samples, fuctional tests and physical examination.
- Who it may be relevant to
- Registry conditions: Systemic Sclerosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Hand Function Impairment in Systemic Sclerosis: Outcomes, Mechanisms and Experience (HANDSOME) Study
Overview
Almost 90% of systemic sclerosis (SSc) patients experience hand function limitation, which leads to impaired daily functioning and work participation. An important cause of impaired hand function are contractures of the hand, which are reported in up to a half of patients. With this longitudinal cohort study in patients with SSc and VEDOSS (very early diagnosis of systemic sclerosis) the investigators aim to gain more insight into processes involved in hand function impairment.
Interventions
- Diagnostic test Imaging, blood samples, fuctional tests and physical examination
Imaging, blood samples, fuctional tests and physical examination
Primary outcome measures
- Determination of risk factors for hand function impairment in systemic sclerosis (SSc) patients with early disease, very early disease and established hand impairment (contractures) at 2 years follow-up [Time frame: 2 years]
Secondary outcome measures (2)
- Identify underlying mechanisms [Time frame: 2 years]
- - Validation of the Dutch PASTUL questionnaire [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Age > 18 years
Exclusion criteria
- Patients with diabetic cheiroarthropathy and Dupuytren's disease, based on expert opinion
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- UMC Utrecht — Utrecht
Publications
- Greveling M, Ong VH, Denton C, Foppen W, Herman A, Jeffries-Owen N, Kortekaas M, Masselink I, Mulder DJ, Schriemer R, Vonk MC, de Vries-Bouwstra JK, Welsing P, Mastbergen S, Spierings J. Hand function impairment in Systemic sclerosis: Outcomes, Mechanisms and Experience (HANDSOME) - a longitudinal observational multicentre study protocol. BMJ Open. 2025 Mar 13;15(3):e095283. doi: 10.1136/bmjopen-2 PMID 40082008
Identifiers
NCT: NCT06133244 · NL85445.041.23