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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Personalized rehabilitation program of facial involvement in systemic sclerosis
Delivery of a standard prescription for facial rehabilitation
Mouth Handicap In Systemic Sclerosis (MHISS) score
A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis
Time frame: Week 6
Mouth Handicap In Systemic Sclerosis (MHISS) score
A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis
Time frame: Week 2
Mouth Handicap In Systemic Sclerosis (MHISS) score
A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis
Time frame: Week12
Interincisal distance measurement
Interincisal distance measurement in mm
Time frame: Week 6
Interincisal distance measurement
Interincisal distance measurement in mm
Time frame: Week 12
Rodnan skin score on the face
a measure of skin thickness
Time frame: Week 6
Rodnan skin score on the face
a measure of skin thickness
Time frame: Week 12
Visual Analog Scale (VAS) for pain
Time frame: Week 2
Visual Analog Scale (VAS) for pain
Time frame: Week 6
Visual Analog Scale (VAS) for pain
Time frame: Week12
HAQ questionnaire
Health Assessment Questionnaire
Time frame: Week 6
HAQ questionnaire
Health Assessment Questionnaire
Time frame: Week 12
SF12 questionnaire (12-item Short Form Survey)
a 12-item general health questionnaire
Time frame: Week 6
SF12 questionnaire (12-item Short Form Survey)
a 12-item general health questionnaire
Time frame: Week 12
Weight
Weight in kg
Time frame: Week 12
Total number of rehabilitation sessions
Time frame: Week 6
Total duration of rehabilitation sessions
Time frame: Week 6
Total number of rehabilitation sessions
Time frame: Week 12
Total duration of rehabilitation sessions
Time frame: Week 12
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