Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis

Not Applicable

• Conditions: Face; Systemic Sclerosis; Rehabilitation; Facial Involvement

• Registration Number: NCT05177380
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

Systemic sclerosis is a rare autoimmune disorder characterized by microangiopathy, activation of the immune system, and sclerosis of tissues including the skin. Facial involvement is frequent and disabling. It causes significant functional and aesthetic discomfort, and a major deterioration in quality of life. It results in a loss of suppleness of the skin and subcutaneous tissues, dysfunction of the temporomandibular joint, peribuccal rhagades, microstomia, and dry mouth causing difficulties in mouth opening, feeding, dental care, and weight loss.

Facial involvement in systemic sclerosis can be assessed using the Mouth Handicap in Systemic Sclerosis (MHISS) score, a validated patient questionnaire assessing the functional and aesthetic consequences of systemic sclerosis on the face.

Although common and disabling, facial involvement is underestimated and poorly managed. Immunosuppressive and/or anti-fibrosis drugs are not very effective. Facial rehabilitation could significantly improve the mouth handicap but facial rehabilitation is not currently performed in standard care in systemic sclerosis patients.

The aim of the study is to evaluate the efficacy of a personalized rehabilitation program vs standard care in facial involvement of systemic sclerosis patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2022-01-04
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-18
• Study Start: 2022-09
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age ≥ 18 yo
• Systemic sclerosis according to the 2013 ACR/EULAR (American College of Rheumatology) classification criteria
• Systemic sclerosis with facial involvement defined by a MHISS score > 6
• Immunosuppressive and/or anti-fibrosis treatment stable for at least 1 month
• Subject able to understand the objectives and risks of research and to give informed consent
• Subject enrolment in the health insurance scheme

Exclusion Criteria

• Pregnancy
• Previous participation in a rehabilitation program of facial involvement
• Patient under legal protection
• Impossibility to give clear information of subject

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Mouth Handicap In Systemic Sclerosis (MHISS) score	Week 6	A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis

Secondary Outcome Measures

Name	Time	Method
Mouth Handicap In Systemic Sclerosis (MHISS) score	Week12	A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis
Rodnan skin score on the face	Week 12	a measure of skin thickness
Visual Analog Scale (VAS) for pain	Week12
Interincisal distance measurement	Week 12	Interincisal distance measurement in mm
HAQ questionnaire	Week 12	Health Assessment Questionnaire
Total number of rehabilitation sessions	Week 12
Total duration of rehabilitation sessions	Week 12
Weight	Week 12	Weight in kg
SF12 questionnaire (12-item Short Form Survey)	Week 12	a 12-item general health questionnaire