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

Overview

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2024

Interventions

  • Procedure: Personalized rehabilitation program of facial involvement in systemic sclerosis
    • Personalized rehabilitation program of facial involvement in systemic sclerosis
  • Other: Delivery of a standard prescription for facial rehabilitation
    • Delivery of a standard prescription for facial rehabilitation

Arms, Groups and Cohorts

  • Experimental: Personalized rehabilitation program of facial involvement in systemic sclerosis
    • 3 sessions of 2 hours of facial rehabilitation in hospital over 2 weeks including: Physiotherapy with facial and endo-oral massages, self-massages, active and passive exercises of the face and mouth, tongue exercises Speech therapy with mobilization of the orofacial sphere applied to swallowing and speech difficulties Individual workshop on the theme of dry mouth, dry mouth, swallowing disorders, and oral care Individual therapeutic makeup workshop A motivational interview A patient notebook with a personalized protocol for self-rehabilitation of the face A video tutorial for self-rehabilitation of the face Facial self-rehabilitation sessions at home
  • Other: Routine care
    • Delivery of a standard prescription for facial rehabilitation

Clinical Trial Outcome Measures

Primary Measures

  • Mouth Handicap In Systemic Sclerosis (MHISS) score
    • Time Frame: Week 6
    • A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis

Secondary Measures

  • Mouth Handicap In Systemic Sclerosis (MHISS) score
    • Time Frame: Week 2
    • A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis
  • Mouth Handicap In Systemic Sclerosis (MHISS) score
    • Time Frame: Week12
    • A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis
  • Interincisal distance measurement
    • Time Frame: Week 6
    • Interincisal distance measurement in mm
  • Interincisal distance measurement
    • Time Frame: Week 12
    • Interincisal distance measurement in mm
  • Rodnan skin score on the face
    • Time Frame: Week 6
    • a measure of skin thickness
  • Rodnan skin score on the face
    • Time Frame: Week 12
    • a measure of skin thickness
  • 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
    • Time Frame: Week 6
    • Health Assessment Questionnaire
  • HAQ questionnaire
    • Time Frame: Week 12
    • Health Assessment Questionnaire
  • SF12 questionnaire (12-item Short Form Survey)
    • Time Frame: Week 6
    • a 12-item general health questionnaire
  • SF12 questionnaire (12-item Short Form Survey)
    • Time Frame: Week 12
    • a 12-item general health questionnaire
  • Weight
    • Time Frame: Week 12
    • Weight in kg
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Strasbourg, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Emmanuel CHATELUS, MD, +33 3 88 12 71 40, emmanuel.chatelus@chru-strasbourg.fr

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