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Recruiting NCT05177380

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

No phase Interventional Systemic Sclerosis Face Facial Involvement Rehabilitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Personalized rehabilitation program of facial involvement in systemic sclerosis, Delivery of a standard prescription for facial rehabilitation.
Who it may be relevant to
Registry conditions: Systemic Sclerosis, Face, Facial Involvement, Rehabilitation. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

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

Primary outcome measures

  • Mouth Handicap In Systemic Sclerosis (MHISS) score [Time frame: Week 6]
Secondary outcome measures (12)
  • Mouth Handicap In Systemic Sclerosis (MHISS) score [Time frame: Week 2]
  • Mouth Handicap In Systemic Sclerosis (MHISS) score [Time frame: Week12]
  • Interincisal distance measurement [Time frame: Week 6]
  • Interincisal distance measurement [Time frame: Week 12]
  • Rodnan skin score on the face [Time frame: Week 6]
  • Rodnan skin score on the face [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 [Time frame: Week 6]
  • HAQ questionnaire [Time frame: Week 12]
  • SF12 questionnaire (12-item Short Form Survey) [Time frame: Week 6]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Hôpitaux Universitaire de Strasbourg — Strasbourg

Identifiers

NCT: NCT05177380 · 8072 · 2020-A03314-35

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗