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

Not yet recruiting

• Conditions: Scleroderma; Hand Functionality; Quality of Life (QOL)

• Registration Number: NCT06776575
• Lead Sponsor: Assiut University

Brief 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.

Study Timeline

• Study First Submitted: 2024-10-29
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-13
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15
• Study Start: 2025-03-01
• Primary Completion: 2028-01-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Adult SSc Patients ( >18 yrs ) who are fulfilling the The EULAR/ACR 2013 classification criteria

Exclusion Criteria

1. Individuals with other autoimmune diseases (systemic lupus, sjogren syndrome, rheumatoid arthritis dermatomyositis, mixed connective tissue disease).
2. Usage of drugs that can cause peripheral neuropathy and chronic alcohol abuse history.
3. Presence of diabetes mellitus, thyroid dysfunction and renal failure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life in systemic sclerosis patients	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.
Hand function in systemic sclerosis patients .	2 years	Hand function in systemic sclerosis patients will be assessed using modified hand mobility score.