A Comparison Between Two Educational Methods in the Rehabilitation of the Microstomia in Systemic Sclerosis: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 39
- Primary Endpoint
- Interincisal distance
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Brochure and DVD plus nursing training
In addition to the "control intervention", see below, the experimental group was closely followed by the research nurse, an expert in Adult Education, who held 20-minute "face to face" meetings at baseline and at follow-up with the patients allocated to the experimental group. The nurse provided theoretical explanations on the exercises, watched the explanatory DVD with the patients, answering questions and commenting relevant points, and then had the patients repeat the exercises in front of a mirror under direct observation, so that any errors could be pointed out and corrected.
Intervention: Brochure and DVD plus nursing training (Behavioral)
Brochure and DVD only
After recruitment, in a 30-minute meeting, a clinical nurse measured the opening of the mouth. She gave each participant the information brochure, the audio-visual DVD for self-management of oral exercises, diary card, and the research questionnaires, and explained their content and use. At the same time, she contacted the research nurse to obtain the random allocation to one of the study groups for that patient.
These exercises had to be done every day for the entire duration of the program (12 months) and registered in the diary with any comments.
Intervention: Brochure and DVD only (Behavioral)
Outcomes
Primary Outcomes
Interincisal distance
Time Frame: 1 year
Change in the maximum distance between the tip of the upper and lower incisors, from baseline to 1-year follow-up.
Secondary Outcomes
- Self-reported severity of mouth disability(1 year)
- Dermatological life quality(1 year)
- Disease-specific life quality(1 year)
- Psychological well-being(1 year)