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

NCT ID: NCT06776575

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2028-03-01

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.

Conditions

Scleroderma; Hand Functionality; Quality of Life (QOL)

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Reem Hossam Abdelrahman

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Reem Hossam Abd el rahman, assistant lecturer

Role: CONTACT

reemhossam374@gmail.com

00201090913556

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Other Identifiers

hand ultrasound SSc patients

Identifier Type: -

Identifier Source: org_study_id