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Clinical Trials/NCT06776575
NCT06776575
Not yet recruiting
Not Applicable

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

Assiut University0 sites45 target enrollmentMarch 1, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Assiut University
Enrollment
45
Primary Endpoint
Quality of life in systemic sclerosis patients
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2025
End Date
March 1, 2028
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Reem Hossam Abdelrahman

Assistant Lecturer

Assiut University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Quality of life in systemic sclerosis patients

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.

Hand function in systemic sclerosis patients .

Time Frame: 2 years

Hand function in systemic sclerosis patients will be assessed using modified hand mobility score.

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