Clinical trial NCT03766243: A Comparison Between Two Educational Methods in the Rehabilitation of the Microstomia in Systemic Sclerosis
Official title: A Comparison Between Two Educational Methods in the Rehabilitation of the Microstomia in Systemic Sclerosis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scleroderma, Systemic
Keywords: Microstomia
Rehabilitation
Self-Management
Lead sponsor: IRCSS Istituto Dermopatico dell'Immacolata, Fondazione Luigi Maria Monti
Sponsor class: OTHER
Collaborators: name: Centro di Eccellenza per la Cultura e la Ricerca Infermieristica (CECRI)
name: Ministry of Health, Italy
First posted: 2018-12-06
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Interincisal distance
timeFrame: 1 year
Secondary outcomes:
measure: Self-reported severity of mouth disability
timeFrame: 1 year
measure: Dermatological life quality
timeFrame: 1 year
measure: Disease-specific life quality
timeFrame: 1 year
measure: Psychological well-being
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: IDI-IRCCS, Fondazione Luigi Maria Monti
name: Damiano DC Abeni, MD, MPH
role: STUDY_CHAIR
References:
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citation: Kroon FP, van der Burg LR, Buchbinder R, Osborne RH, Johnston RV, Pitt V. Self-management education programmes for osteoarthritis. Cochrane Database Syst Rev. 2014 Jan 15;2014(1):CD008963. doi: 10.1002/14651858.CD008963.pub2.
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