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

NCT06776575 | Not Yet Recruiting DMC

• 1 other identifier: hand ultrasound SSc patients
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Scleroderma; Hand Functionality; Quality of Life (QOL)

Keywords

hand dysfunction; musculoskeletal ultrasound; electrophysiology; quality of life; scleroderma

Outcome Measures

Primary Outcomes (2)

• Quality of life in systemic sclerosis patients

  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 .

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

  2 years

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (16)

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  RESULT

• De Lorenzis E, Kakkar V, Di Donato S, Wilson M, Barnes T, Denton C, Derrett-Smith E, Douglas K, Helliwell P, Herrick AL, Saleem B, Nisar M, Morley C, Green L, Alcacer-Pitarch B, Del Galdo F. Clinical trajectories of hand function impairment in systemic sclerosis: an unmet clinical need across disease subsets. RMD Open. 2024 Jan 12;10(1):e003216. doi: 10.1136/rmdopen-2023-003216.

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  RESULT

• Cevik R, Em S, Nas K, Toprak M, Cengiz G, Calis M, Sezer I, Unal Enginar A, Bora Karsli P, Sag S, Sargin B, Alkan Melikoglu M, Aydin Y, Duruoz MT, Gezer HH, Ecesoy H. Association of pain and clinical factors on disability and quality of life in systemic sclerosis: A cross-sectional study from Turkish League Against Rheumatism Network. Arch Rheumatol. 2022 Nov 11;38(1):9-21. doi: 10.46497/ArchRheumatol.2023.9243. eCollection 2023 Mar.

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• Balbach ML, Corty R, Hill B, Frech T, Aslam F, Chew EY. Development of a Musculoskeletal Ultrasound Protocol to Evaluate Hand Pain in Systemic Sclerosis Patients. Diagnostics (Basel). 2024 Mar 22;14(7):669. doi: 10.3390/diagnostics14070669.

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MeSH Terms

Conditions

Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Scleroderma, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Reem Hossam Abd el rahman, assistant lecturer

CONTACT

00201090913556; reemhossam374@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: January 15, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 15, 2025

Record last verified: 2025-01