Scleroderma: Functional Disability Between the Dominant and Contralateral Hand.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Scleroderma: Description of Functional Disability Between the Dominant and Contralateral Hand, a Single-centre Descriptive Cohort.

Conditions
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Scleroderma, Systemic

Intervention / Treatment
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* Diagnostic Test: Measurement of joint amplitudes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, descriptive and comparative, monocentric pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: moderate Scleroderma<br>Patients with Cochin hand score less than or equal to 16 | Diagnostic Test: Measurement of joint amplitudes<br>* Measurement of joint amplitudes by goniometry of the MCP, IPP, IPD for 2, 3, 4 and 5th radii, 1st commissure spacing and Kapandji score for the thumb<br>|
| Experimental: severe Scleroderma<br>Patients with Cochin hand score greater than 16 | Diagnostic Test: Measurement of joint amplitudes<br>* Measurement of joint amplitudes by goniometry of the MCP, IPP, IPD for 2, 3, 4 and 5th radii, 1st commissure spacing and Kapandji score for the thumb<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of joint amplitudes | Measurement of joint amplitudes by goniometry | at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digital skin score | Measure with modified Rodnan skin score. The value of this score varies from 0 (no cuntaneous sclerosis) to 51(severe cutaneous sclerosis). | at inclusion | 
| Digital pressure | use of Finger Systolic Blood Pressure Index (FBPI) proposed by Blaise et al. | at inclusion | 
| Number of digital ulcers |  | at inclusion | 
| Number of subcutaneous calcifications |  | at inclusion | 
| Visual Analog Score for pain | Score varie from 0 (no pain) to 10 (worst pain possible) | at inclusion | 
| number of painful joints |  | at inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scleroderma, dermatology