Clinical trial NCT05177380: Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis
Official title: Efficacy of a Personalized Rehabilitation Program of Facial Involvement in Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Systemic Sclerosis
Face
Facial Involvement
Rehabilitation
Keywords: Face
Facial involvement
Rehabilitation
Systemic sclerosis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mouth Handicap In Systemic Sclerosis (MHISS) score
timeFrame: Week 6
Secondary outcomes:
measure: Mouth Handicap In Systemic Sclerosis (MHISS) score
timeFrame: Week 2
measure: Mouth Handicap In Systemic Sclerosis (MHISS) score
timeFrame: Week12
measure: Interincisal distance measurement
timeFrame: Week 6
measure: Interincisal distance measurement
timeFrame: Week 12
measure: Rodnan skin score on the face
timeFrame: Week 6
measure: Rodnan skin score on the face
timeFrame: Week 12
measure: Visual Analog Scale (VAS) for pain
timeFrame: Week 2
measure: Visual Analog Scale (VAS) for pain
timeFrame: Week 6
measure: Visual Analog Scale (VAS) for pain
timeFrame: Week12
measure: HAQ questionnaire
timeFrame: Week 6
measure: HAQ questionnaire
timeFrame: Week 12
measure: SF12 questionnaire (12-item Short Form Survey)
timeFrame: Week 6
measure: SF12 questionnaire (12-item Short Form Survey)
timeFrame: Week 12
measure: Weight
timeFrame: Week 12
measure: Total number of rehabilitation sessions
timeFrame: Week 6
measure: Total duration of rehabilitation sessions
timeFrame: Week 6
measure: Total number of rehabilitation sessions
timeFrame: Week 12
measure: Total duration of rehabilitation sessions
timeFrame: Week 12
Other outcomes:
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