Status:
COMPLETED
A Comparison Between Two Educational Methods in the Rehabilitation of the Microstomia in Systemic Sclerosis
Lead Sponsor:
IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti
Collaborating Sponsors:
Centro di Eccellenza per la Cultura e la Ricerca Infermieristica (CECRI)
Ministry of Health, Italy
Conditions:
Scleroderma, Systemic
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Background: A typical feature of SSc is the fibrotic involvement of the connectival tissue of the face, which causes microstomia. Objectives: To test the effectiveness of an educational intervention ...
Detailed Description
The study was designed as a single-blind, two-arm, randomized controlled study with a 12-month follow-up period. Recruitment started in February 2013 and it continued until January 2015. After recruit...
Eligibility Criteria
Inclusion
- diagnosis of SSc, according to the ACR/EULAR criteria;
- age \>18 years;
- ability to understand the Italian language;
- subjective perception of problems with opening the mouth, such as hardened tissues, reduced mobility, pain - confirmed by a dermatologist;
- signed informed consent.
Exclusion
- edentulous patients,
- presence of dental conditions,
- documented dysfunction of the temporo-mandibular joint,
- oral neoplasia,
- sub-mandibular inflammatory conditions,
- patients already undergoing face massages or face physiotherapy,
- patients who had undergone mouth lipofilling,
- patients with severe hand disability (including deep ulcers, and severe pain),
- patients with documented psychiatric conditions or taking psychotropic medications.
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2015
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03766243
Start Date
February 1 2013
End Date
January 31 2015
Last Update
December 6 2018
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