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Not Yet RecruitingNCT06776575

Ultrasound and Electrophysiology Study of Hand in Systemic Sclerosis Patients and Contributors of Hand Dysfunction

Musculoskeletal Ultrasound and Electrophysiological Evaluation of the Hand in Patients With Systemic Sclerosis: Relation to Hand Dysfunction and Quality of Life

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
45 (estimated)
Sponsor
Assiut University · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Timeline

Start date
2025-03-01
Primary completion
2028-01-01
Completion
2028-03-01
First posted
2025-01-15
Last updated
2025-01-15

Source: ClinicalTrials.gov record NCT06776575. Inclusion in this directory is not an endorsement.