Clinical trial NCT06776575: Ultrasound and Electrophysiology Study of Hand in Systemic Sclerosis Patients and Contributors of Hand Dysfunction
Official title: Musculoskeletal Ultrasound and Electrophysiological Evaluation of the Hand in Patients With Systemic Sclerosis: Relation to Hand Dysfunction and Quality of Life
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Scleroderma
Hand Functionality
Quality of Life (QOL)
Keywords: hand dysfunction
musculoskeletal ultrasound
electrophysiology
quality of life
scleroderma
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the Rheumatology, Rehabilitation and Physical medicine department, Assuit University hospitals. Informed consent will be obtained from all patients

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.

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

Primary outcomes:
measure: Quality of life in systemic sclerosis patients
timeFrame: 2 years
measure: Hand function in systemic sclerosis patients .
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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