Clinical trial NCT05171114: Scleroderma: Functional Disability Between the Dominant and Contralateral Hand.
Official title: Scleroderma: Description of Functional Disability Between the Dominant and Contralateral Hand, a Single-centre Descriptive Cohort.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scleroderma, Systemic
Keywords: scleroderma
dermatology
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2021-12-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, descriptive and comparative, monocentric pilot study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of joint amplitudes
timeFrame: at inclusion
Secondary outcomes:
measure: Digital skin score
timeFrame: at inclusion
measure: Digital pressure
timeFrame: at inclusion
measure: Number of digital ulcers
timeFrame: at inclusion
measure: Number of subcutaneous calcifications
timeFrame: at inclusion
measure: Visual Analog Score for pain
timeFrame: at inclusion
measure: number of painful joints
timeFrame: at inclusion
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU de Limoges
Study officials:
References: