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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Previous participation in a rehabilitation program of facial involvement

Patient under legal protection

Impossibility to give clear information of subject

Trial design

Design model

Parallel

Treatments tested in this trial

  • Personalized rehabilitation program of facial involvement in systemic sclerosis

    Procedure/Surgery

    Personalized rehabilitation program of facial involvement in systemic sclerosis

  • Delivery of a standard prescription for facial rehabilitation

    Other intervention

    Delivery of a standard prescription for facial rehabilitation

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Personalized rehabilitation program of facial involvement in systemic sclerosisExperimental treatment 1 intervention
Group B: Routine careOther 1 intervention

Trial outcomes

Primary outcomes

1

Mouth Handicap In Systemic Sclerosis (MHISS) score

A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis

Time frame
Week 6

Secondary outcomes

1

Mouth Handicap In Systemic Sclerosis (MHISS) score

A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis

Time frame
Week 2
2

Mouth Handicap In Systemic Sclerosis (MHISS) score

A 12-item questionnaire specifically quantifying mouth disability in systemic sclerosis

Time frame
Week12
3

Interincisal distance measurement

Interincisal distance measurement in mm

Time frame
Week 6
4

Interincisal distance measurement

Interincisal distance measurement in mm

Time frame
Week 12

Other outcomes

Sponsors and contacts

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