The prevalence of Sjogren's syndrome (SS) in rheumatoid arthritis (RA) patients varies from 3.5 to 31%. Between 30% and 90% of patients with (RA) have dry eye and/or mouth syndrome. To date, no studies have assessed whether RA patients have echostructural changes in their salivary glands suggestive of SS and the factors associated with these changes.The aim of this study is to investigate if there are changes in the echostructure of the salivary glands of RA patients, especially in patients with dry syndrome.
The EchoPR study is an exploratory pathophysiology, cross-sectional, case-control study. The aim is to study the echo-structure of the salivary glands of patients with RA ( group of 70 patients), in comparison to patients with SS (suspected of strong alteration of the echo-structure)(group of 70 patients) and patients with sicca, asthenia, polyalgia syndrome (SAPS)(group of 70 patients). After a standard consultation with the rheumatologist, patients in each group will have an salivary gland ultrasound to assess the homogeneity of the echostructure of the parotid and submandibular salivary glands. A salivary flow measurement for 15 minutes and a Schirmer test to determine tear secretion for 5 minutes are also performed. All of these tests are performed during a single visit, so the total study time for the patient is one hour. Patient recruitment is expected to last 1 year.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
210
Salivary gland ultrasound is, a non-invasive, non-irradiating and easily accessible examination, offers promising results for the diagnosis of primary SS. It allows the identification of changes in the homogeneity of the echostructure of the main salivary glands in the parotid and submandibular region.The patient lies on the examination table with the head slightly turned to the side opposite the gland being examined. The examination will be done on the parotid and submandibular glands on both sides.The parotid glands will be measured in length and width.The surface of the gland will be calculated: (length x width)/2.The sub-maxillary glands will be measured in length and surface. The exam will be performed in 10 minutes.
Saliva flow measurement, which consists of measuring the quantity of saliva that the patient can emit in 15 minutes
A strip of blotting paper graduated from five to five millimeters is placed in the eye for 5 minutes, avoiding any corneal contact.
CHU de Clermont-Ferrand
Clermont-Ferrand, France
RECRUITINGOMERACT (Outcome Measures in Rheumatology) B-mode ultrasound homogeneity score greater than or equal to 2 in at least one of the 4 salivary glands
The echostructure of the gland will be graded from 0 to 4 according to the OMERACT score : * 0: normal appearance * Grade 1: minimal inhomogeneity without hypoechoic/anechoic areas * Grade 2: moderate inhomogeneity with focal hypoechoic or anechoic areas * Grade 3 severe inhomogeneity with diffuse hypoechoic or anechoic areas of the whole gland or fibrous gland
Time frame: 10 minutes
Color Doppler ultrasound vascularity score of OMERACT greater than or equal to 2 on at least one of the 4 salivary glands
For each patient, 4 grades will be obtained (1 per gland); the highest grade obtained and the sum of the 4 grades will be combined. A rating of the Doppler vascularization according to the OMERACT criteria will then be performed: * 0: no Doppler signal in the parenchyma of the gland * 1 : focal or scattered Doppler signal in the gland parenchyma * 2 : diffuse Doppler signal \<50% of the gland parenchyma * 3 : diffuse Doppler signal \>50 % of the gland parenchyma
Time frame: 10 minutes
Surface of the submandibular salivary glands
The surface of the gland will be calculated: (length x width)/2.
Time frame: 2 minutes
Length and width of the parotid glands
During the ultrasound, the examination will be done bilaterally on the parotid and submandibular glands in B mode with measurement of the dimensions of the glands (length and width in the longitudinal and axial plane for the parotids, longitudinal for the submandibular)
Time frame: 2 minutes
Length of the submandibular glands
During the ultrasound, the examination will be done bilaterally on the parotid and submandibular glands in B mode with measurement of the dimensions of the glands (length and width in the longitudinal and axial plane for the parotids, longitudinal for the submandibular)
Time frame: 2 minutes
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