Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis (PREVISS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Systemic Sclerosis; Rehabilitation; Face; Facial Involvement
• Intervention / Treatment: Procedure: Personalized rehabilitation program of facial involvement in systemic sclerosis; Other: Delivery of a standard prescription for facial rehabilitation

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emmanuel CHATELUS, MD; Phone Number: +33 3 88 12 71 40; Email: emmanuel.chatelus@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized rehabilitation program of facial involvement in systemic sclerosis; 3 sessions of 2 hours of facial rehabilitation in hospital over 2 weeks including: Physiotherapy with facial and endo-oral massages, self-massages, active and passive exercises of the face and mouth, tongue exercises; Speech therapy with mobilization of the orofacial sphere applied to swallowing and speech difficulties; Individual workshop on the theme of dry mouth, dry mouth, swallowing disorders, and oral care; Individual therapeutic makeup workshop; A motivational interview; A patient notebook with a personalized protocol for self-rehabilitation of the face; A video tutorial for self-rehabilitation of the face Facial self-rehabilitation sessions at home	Procedure: Personalized rehabilitation program of facial involvement in systemic sclerosis; Personalized rehabilitation program of facial involvement in systemic sclerosis
Other: Routine care; Delivery of a standard prescription for facial rehabilitation	Other: Delivery of a standard prescription for facial rehabilitation; Delivery of a standard prescription for facial rehabilitation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mouth Handicap In Systemic Sclerosis (MHISS) score	A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis	Week 2
Mouth Handicap In Systemic Sclerosis (MHISS) score	A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis	Week12
Interincisal distance measurement	Interincisal distance measurement in mm	Week 6
Interincisal distance measurement	Interincisal distance measurement in mm	Week 12
Rodnan skin score on the face	a measure of skin thickness	Week 6
Rodnan skin score on the face	a measure of skin thickness	Week 12
Visual Analog Scale (VAS) for pain		Week 2
Visual Analog Scale (VAS) for pain		Week 6
Visual Analog Scale (VAS) for pain		Week12
HAQ questionnaire	Health Assessment Questionnaire	Week 6
HAQ questionnaire	Health Assessment Questionnaire	Week 12
SF12 questionnaire (12-item Short Form Survey)	a 12-item general health questionnaire	Week 6
SF12 questionnaire (12-item Short Form Survey)	a 12-item general health questionnaire	Week 12
Weight	Weight in kg	Week 12
Total number of rehabilitation sessions		Week 6
Total duration of rehabilitation sessions		Week 6
Total number of rehabilitation sessions		Week 12
Total duration of rehabilitation sessions		Week 12

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Actual): August 18, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Systemic sclerosis; Face; Facial involvement
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Disease Attributes; Connective Tissue Diseases; Sclerosis; Scleroderma, Systemic; Scleroderma, Diffuse; Facies
• Other Study ID Numbers: 8072; 2020-A03314-35 (Other Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No