Scleroderma: Functional Disability Between the Dominant and Contralateral Hand.

Scleroderma, Systemic Clinical Trial

— SCLERO-HAND  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05171114
• Other study ID #: 87RI21_0029
• Status: Completed
• Phase: N/A
• Start date: December 28, 2021
• Est. completion date: April 22, 2022

Study information

• Verified date: May 2022
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 22, 2022
• Est. primary completion date: April 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic

Intervention

Diagnostic Test:
• Measurement of joint amplitudes
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

Locations

Country	Name	City	State
France	CHU de Limoges	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of joint amplitudes	Measurement of joint amplitudes by goniometry	at inclusion
Secondary	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
Secondary	Digital pressure	use of Finger Systolic Blood Pressure Index (FBPI) proposed by Blaise et al.	at inclusion
Secondary	Number of digital ulcers		at inclusion
Secondary	Number of subcutaneous calcifications		at inclusion
Secondary	Visual Analog Score for pain	Score varie from 0 (no pain) to 10 (worst pain possible)	at inclusion
Secondary	number of painful joints		at inclusion