Face, Facial Involvement, Rehabilitation, Systemic Sclerosis
Conditions
Keywords
Face, Facial involvement, Rehabilitation, Systemic sclerosis
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.
Interventions
PROCEDUREPersonalized rehabilitation program of facial involvement in systemic sclerosis
Personalized rehabilitation program of facial involvement in systemic sclerosis
OTHERDelivery of a standard prescription for facial rehabilitation
Delivery of a standard prescription for facial rehabilitation
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mouth Handicap In Systemic Sclerosis (MHISS) score | Week 6 | A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mouth Handicap In Systemic Sclerosis (MHISS) score | Week 2 | A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis |
| Interincisal distance measurement | Week 6 | Interincisal distance measurement in mm |
| Rodnan skin score on the face | Week 6 | a measure of skin thickness |
| Visual Analog Scale (VAS) for pain | Week 2 | — |
| HAQ questionnaire | Week 6 | Health Assessment Questionnaire |
| SF12 questionnaire (12-item Short Form Survey) | Week 6 | 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 | — |
Countries
France
Contacts
CONTACTEmmanuel CHATELUS, MD
Outcome results
None listed