NCT05782049

Ultrasound Characteristics of the Salivary Glands in Patients With Rheumatoid Arthritis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Rheumatoid Arthritis
• Sjogren's Syndrome
• Sicca, Asthenia, Polyalgia Syndrome (SAPS)

Interventions

Type	Name	Description
OTHER	Ultrasound of the salivary glands	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.
OTHER	Measurement of salivary flow	Saliva flow measurement, which consists of measuring the quantity of saliva that the patient can emit in 15 minutes
OTHER	A Schirmer test	A strip of blotting paper graduated from five to five millimeters is placed in the eye for 5 minutes, avoiding any corneal contact.

Timeline

• Start date: 2023-02-02
• Primary completion: 2025-02-02
• Completion: 2026-02-02
• First posted: 2023-03-23
• Last updated: 2023-03-23

Locations

1 site across 1 country: France