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

January 13, 2025 updated by: Reem Hossam Abdelrahman, Assiut University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years
Hand function in systemic sclerosis patients .
Time Frame: 2 years
Hand function in systemic sclerosis patients will be assessed using modified hand mobility score.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

October 29, 2024

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hand ultrasound SSc patients

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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