Scleroderma: Functional Disability Between the Dominant and Contralateral Hand.
- Conditions
- Scleroderma, Systemic
- Interventions
- Diagnostic Test: Measurement of joint amplitudes
- Registration Number
- NCT05171114
- Lead Sponsor
- University Hospital, Limoges
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description moderate Scleroderma Measurement of joint amplitudes Patients with Cochin hand score less than or equal to 16 severe Scleroderma Measurement of joint amplitudes Patients with Cochin hand score greater than 16
- Primary Outcome Measures
Name Time Method Measurement of joint amplitudes at inclusion Measurement of joint amplitudes by goniometry
- Secondary Outcome Measures
Name Time Method Number of subcutaneous calcifications at inclusion Number of digital ulcers at inclusion Visual Analog Score for pain at inclusion Score varie from 0 (no pain) to 10 (worst pain possible)
Digital skin score at inclusion Measure with modified Rodnan skin score. The value of this score varies from 0 (no cuntaneous sclerosis) to 51(severe cutaneous sclerosis).
Digital pressure at inclusion use of Finger Systolic Blood Pressure Index (FBPI) proposed by Blaise et al.
number of painful joints at inclusion
Trial Locations
- Locations (1)
CHU de Limoges
🇫🇷Limoges, France