Sjögren's Syndrome
Conditions
Interventions
This is a randomized, double-blind study. Randomization will be carried out randomly in a 1:1 distribution, where patients will be allocated to the acupuncture group (30 patients) or the placebo group
E02.594.540
Sponsors
Universidade Federal de Pernambuco
Hospital das Clínicas da Universidade Federal de Pernambuco
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Volunteers with minimum age of 18 years-old and no maximum age limit; diagnosed with Sjögren's Syndromes according to the American College of Rheumatology and the European League Against Rheumatism
Exclusion criteria
Exclusion criteria: Patients with xerostomia that can not be related to Sjögren's Syndromes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As the primary outcome, Visual Analogue Scale will be used to evaluate pre- and post-treatment xerostomia. It is expected to find an improvement in the patient's perception of dry mouth, where a decrease of 14mm will be considered clinically significant. | — |
Secondary
| Measure | Time frame |
|---|---|
| The variation in the patient's salivary flow will be evaluated through sialometry. The stimulated salivary flow is collected after the patient chews paraffin wax for 60 seconds, and is then asked to discard the saliva and wax from this first minute. Subsequently, the patient tilts his head forward and discards the saliva accumulated after 5 minutes in a previously weighed sterile disposable container. For analysis purposes, the density of human saliva is equal to water (d=1g/ml).;Using the Xerostomia Inventory (XI), the patient's perception of the quality of life regarding the severity of their Xerostomia will be evaluated. In the XI score, a decrease of 6 points will be considered clinically significant. | — |
Countries
Brazil
Contacts
Public ContactMatheus Linares
Hospital das Clínicas da Universidade Federal de Pernambuco
Outcome results
None listed