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

Rehabilitation Clinical Trial

— PREVISS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05177380
• Other study ID #: 8072
• Secondary ID: 2020-A03314-35
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: April 2024

Study information

• Verified date: August 2022
• Source: University Hospital, Strasbourg, France
• Contact: Emmanuel CHATELUS, MD
• Phone: +33 3 88 12 71 40
• Email: emmanuel.chatelus[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Face
• Facies
• Rehabilitation
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Procedure:
• Personalized rehabilitation program of facial involvement in systemic sclerosis
Personalized rehabilitation program of facial involvement in systemic sclerosis

Other:
• Delivery of a standard prescription for facial rehabilitation
Delivery of a standard prescription for facial rehabilitation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Outcome

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