Scleroderma, Systemic Clinical Trial
Official title:
A Comparison Between Two Educational Methods in the Rehabilitation of the Microstomia in Systemic Sclerosis: a Randomized Controlled Trial
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 with "face to face"
training, compared to a standard information program, to reduce microstomia in women with
SSc.
Methods: SSc patients were randomized to the experimental and control group. Both groups
received written and audiovisual information for self-management of microstomia; in addition,
the experimental group received a reinforced training at baseline and at follow-up. Primary
outcome: change in inter-incisal distance; secondary outcome: patient-reported mouth
disability.
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 recruitment, the patients were seen quarterly (i.e., follow-up visits at
3, 6, 9, and 12 months). Before follow-up visits, patients were contacted by phone to remind
them of their appointment.
The participants were inpatients, mainly from Central and Southern Italy, and they were
enrolled in a single center, the IDI-IRCCS, FLMM, in Rome, a large dermatological reference
center.
Inclusion criteria were diagnosis of Systemic Sclerosis, according to the American College of
Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria;23 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 criteria were 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), and patients with documented psychiatric conditions or taking psychotropic
medications.
Randomization The assignment to the intervention and control group was made according to a
random sequence generated by a computer program. The randomization list was maintained by an
investigator who was not involved in patient recruitment nor in outcome measurement.
Each entry of the randomization list was placed in a sealed envelope, numbered in ascending
order, and given to a research nurse after the inclusion/exclusion criteria were verified and
the informed consent was obtained.
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