RecruitingNot ApplicableNCT05177380

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


Sponsor

University Hospital, Strasbourg, France

Enrollment

60 participants

Start Date

Oct 13, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria4

  • Pregnancy
  • Previous participation in a rehabilitation program of facial involvement
  • Patient under legal protection
  • Impossibility to give clear information of subject

Interested in this trial?

Get notified about updates and connect with the research team.

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


Locations(1)

Hôpitaux Universitaire de Strasbourg

Strasbourg, Bas-Rhin, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05177380


Related Trials