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

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05177380

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Sclerosis Face Facial Involvement Rehabilitation	Procedure: Personalized rehabilitation program of facial involvement in systemic sclerosis Other: Delivery of a standard prescription for facial rehabilitation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Mouth Handicap In Systemic Sclerosis (MHISS) score [Week 2]
A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis
Mouth Handicap In Systemic Sclerosis (MHISS) score [Week12]
A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis
Interincisal distance measurement [Week 6]
Interincisal distance measurement in mm
Interincisal distance measurement [Week 12]
Interincisal distance measurement in mm
Rodnan skin score on the face [Week 6]
a measure of skin thickness
Rodnan skin score on the face [Week 12]
a measure of skin thickness
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 [Week 6]
Health Assessment Questionnaire
HAQ questionnaire [Week 12]
Health Assessment Questionnaire
SF12 questionnaire (12-item Short Form Survey) [Week 6]
a 12-item general health questionnaire
SF12 questionnaire (12-item Short Form Survey) [Week 12]
a 12-item general health questionnaire
Weight [Week 12]
Weight in kg
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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