Evaluating Tools to Communicate Scleroderma Research Results to Patients - Trial #1
NCT06373263
Connective Tissue Diseases, Scleroderma
View Trial DetailsNCT Number: NCT06776575
The goal of this research is to assess quality of life and hand function in systemic sclerosis patients via specific questionnaires, and to determine the main contributors to hand dysfunction via a thorough hand ultrasound study and electrophysiology study.
Trial opening soon.
Get Notified18 year–60 year
All sexes
Observational
Systemic Sclerosis (SSc) is a rare multiorgan autoimmune disease characterized by vasculopathy and fibrosis. Its prevalence rates vary greatly by geographic area from 9.3 to 660 per million.
The disease is primarily observed in individuals aged 35 to 55 years, with females being four to six times more affected than males. Hand involvement is an early manifestation of systemic SSc. It's recognized as a major driver of disability and diminished quality of life .
Managing hand pain can be particularly challenging due to the coexistence of non-inflammatory arthralgia, inflammatory arthritis, acro-osteolysis, tenosynovitis, joint contractures, tendon friction rubs, nerve entrapment, Raynaud's phenomenon, digital ulcers, sclerodactyly, calcinosis and chronic pain. Due to the multifactorial etiology of hand functional disability in SSc, it is important to define the contribution of each factor or structure to this issue. This understanding is essential for developing a rehabilitation and medical treatment oriented approach to disease management. While physical examination and radiographs are the first line methods for evaluating hand pain, they are limited in scope and miss many underlying etiologies of hand impairment.
Musculoskeletal ultrasound (MSUS) is rapidly becoming a mainstay diagnostic tool in the assessment of rheumatic diseases due to its low cost, portability, and safety as a non-ionizing imaging modality. The Outcome Measures in Rheumatology (OMERACT) Ultrasound working group has provided definitions for pathologic lesions seen in rheumatic disorders, which offers a valuable framework for the assessment of hand impairment in SSc.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Adult SSc Patients ( >18 yrs ) who are fulfilling the The EULAR/ACR 2013 classification criteria
Exclusion criteria
Time frame: 2 years
Investigators will assess quality of life in systemic sclerosis patients using scleroderma health assessment questionnaire in order to help them improve their quality of life.
Time frame: 2 years
Hand function in systemic sclerosis patients will be assessed using modified hand mobility score.
Contact information is provided by the study sponsor or research team.
Assiut University
Other
Musculoskeletal Ultrasound and Electrophysiological Evaluation of the Hand in Patients With Systemic Sclerosis: Relation to Hand Dysfunction and Quality of Life
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