Scleroderma: Functional Disability Between the Dominant and Contralateral Hand. (SCLERO-HAND)

University of Limoges (UL)

Status: Completed

Conditions: Scleroderma, Systemic

Treatments: Diagnostic Test: Measurement of joint amplitudes

Study type: Interventional

Funder types: Other

Identifiers

NCT05171114

87RI21_0029

Details and patient eligibility

About

Systemic sclerosis is an autoimmune disease in which the hand is responsible for 75% of the overall disability. Management is based on systemic treatments combined with kinesitherapy aimed at maintaining joint amplitudes, improving muscle strength and preventing stiffness. The aim of this study is to describe and compare the average spontaneous and attempted reduction range of motion limitations between the dominant and contralateral hand.

Full description

Systemic sclerosis is an autoimmune disease in which the hand is responsible for 75% of the overall disability. In case of limitation, the level of skin fibrosis, Raynaud's syndrome and its complications, the search for painful joints with or without synovitis, and the presence of calcifications must therefore be assessed. Management is based on systemic treatments combined with kinesitherapy aimed at maintaining joint amplitudes, improving muscle strength and preventing stiffness. No study to date has compared the functionality of one hand to the other. The hypothesis is that there is a difference in range of motion limitations between the dominant hand and the contralateral hand.

Patients in the active file of the Internal Medicine A department of the Limoges University Hospital who meet the inclusion criteria will be offered the study by telephone. Patients wishing to participate will be given an appointment on a dedicated consultation slot. During this visit, Patients will be given an information note and their consent will be collected. The study examinations will be performed and the questionnaire completed. At the end of this visit, the study will be completed for the patient.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Group 1 :
• Major patient
• Diagnosis of diffuse or limited cutaneous systemic sclerosis according to the new ACR/EULAR criteria
• Cochin hand score less than or equal to 16
• Group 2 :
• Major patient
• Diagnosis of diffuse or limited cutaneous systemic sclerosis according to the new ACR/EULAR criteria
• Cochin hand score greater than 16.

Exclusion criteria

• Overlap syndrome (Sharp or scleromyositis 2)
• Patient with another autoimmune disease
• History of surgery or trauma to the hand with proven functional sequelae
• Presence of synovitis
• Patient with Dupuytren's disease

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

moderate Scleroderma

Experimental group

Description:

Patients with Cochin hand score less than or equal to 16

Treatment:

Diagnostic Test: Measurement of joint amplitudes

severe Scleroderma

Experimental group

Description:

Patients with Cochin hand score greater than 16

Treatment:

Diagnostic Test: Measurement of joint amplitudes