Scleroderma: Functional Disability Between the Dominant and Contralateral Hand.

NCT ID: NCT05171114

Last Updated: 2022-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-28
• Study Completion Date: 2022-04-22

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.

Conditions

Scleroderma, Systemic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

moderate Scleroderma

Patients with Cochin hand score less than or equal to 16

Group Type: EXPERIMENTAL

Measurement of joint amplitudes

Intervention Type: DIAGNOSTIC_TEST

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

severe Scleroderma

Patients with Cochin hand score greater than 16

Group Type: EXPERIMENTAL

Measurement of joint amplitudes

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Limoges

Limoges, , France

Countries

France

Other Identifiers

87RI21_0029

Identifier Type: -

Identifier Source: org_study_id