Systemic sclerosis/scleroderma, temporomandibular joint, temporomandibular disorders Musculoskeletal Diseases
Conditions
Interventions
Control group: standard of care (i.e. standard pharmacological treatment according to the generally accepted recommendations on the management of systemic sclerosis) + collecting data and relevant exa
Sponsors
Revmatologický Ústav
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. An Independent Ethics Committee-approved written Informed Consent form is signed and dated by the subject. 2. Subject reports at least one of the symptoms of dysfunction TMJ according to the Helkimo index. 3. Subject is considered reliable and capable of adhering to the protocol and visit schedule. 4. Subject is at least 18 years of age. 5. Subject fulfilled the 2013 EULAR/ACR classification criteria for systemic sclerosis. 6. Subject is regularly followed at our department and adheres to the standard-of-care pharmacological therapy indicated by his/her treating rheumatologist. 6. Subject is willing to participate in the study and undergo all planned examinations.
Exclusion criteria
Exclusion criteria: 1. Subject has any other condition, including medical or psychiatric, which in the investigator´s judgment would make the subject unsuitable for inclusion in the study. 2. Participant has had a recent dental surgery. 3. The patient undergoes any similar physiotherapeutic intervention during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Symmetry and pain during palpation of the masticatory muscles are measured using palpation at week 0, 12, and 24 2. Symmetry of the joint condyles during movement and pain provoked by palpation are measured using palpation at week 0, 12, and 24 3. Symmetry of the jaw, maximum interincisal value, protrusion, and laterotrusion are measured using the measurement of mouth opening at week 0, 12, and 24 4. TMJ structure is measured using panoramic X-ray image at week 0, 12, and 24 5. TMJ structure is measured using magnetic resonance in standardized projections at week 0, 12, and 24 6. Manifestation of TMJ dysfunction is measured using Helkimo index at week 0, 12, and 24 7. Mouth handicap in systemic sclerosis is measured using MHISS at week 0, 12, and 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health/disability is measured using SHAQ questionnaire at week 0, 12, and 24 2. Quality of life is measured using SF-36 questionnaire at week 0, 12, and 24 3. Depression is measured using BDI II questionnaire at week 0, 12, and 24 4. Fatigue is measured using FIS at week 0, 12, and 24 5. Anxiety is measured using Beck Anxiety Inventory at week 0, 12, and 24 6. Function of gastrointestinal tract is measured using UCLA GIT 2.0 at week 0, 12, and 24 | — |
Countries
Czech Republic
Contacts
Public ContactMichal Gála
Outcome results
None listed