Hôpitaux Universitaire de Strasbourg
Strasbourg, Bas-Rhin, 67300, France
Location status: Recruiting
NCT Number: NCT05177380
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Strasbourg, Bas-Rhin, 67300, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Personalized rehabilitation program of facial involvement in systemic sclerosis
Delivery of a standard prescription for facial rehabilitation
Time frame: Week 6
A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis
Time frame: Week 2
A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis
Time frame: Week12
A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis
Time frame: Week 6
Interincisal distance measurement in mm
Time frame: Week 12
Interincisal distance measurement in mm
Time frame: Week 6
a measure of skin thickness
Time frame: Week 12
a measure of skin thickness
Time frame: Week 2
Time frame: Week 6
Time frame: Week12
Time frame: Week 6
Health Assessment Questionnaire
Time frame: Week 12
Health Assessment Questionnaire
Time frame: Week 6
a 12-item general health questionnaire
Time frame: Week 12
a 12-item general health questionnaire
Time frame: Week 12
Weight in kg
Time frame: Week 6
Time frame: Week 6
Time frame: Week 12
Time frame: Week 12
Contact information is provided by the study sponsor or research team.
University Hospital, Strasbourg, France
Other
Acronym: PREVISS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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