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Dysphagia in Rheumatoid Arthritis

ConditionRheumatoid Arthritis (RA
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTanta University

About this trial

The primary goal of this cross-sectional study is to assess risk factors/predictors for dysphagia in RA.

The secondary goals include demonstrating whether flexible fiberoptic pharyngolaryngoscopy can detect joint-affection-induced dysphagia in patients with rheumatoid arthritis (RA) and whether both oropharyngeal and esophageal dysphagia are present among these patients.

The main questions it aims to answer are

* What are the predictors that are associated with dysphagia via flexible fiberoptic pharyngolaryngoscopy in rheumatoid arthritis patients? * Whether flexible fiberoptic pharyngolaryngoscopy can detect joint-affection-induced dysphagia in patients with RA? * Whether both oropharyngeal and esophageal dysphagia are present in patients with RA?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with Rheumatoid arthritis defined by the American College of Rheumatology/European League Against Rheumatism collaborative initiative (ACR/EULAR) 2010 classification criteria.

Patients aged above 18 years old, well-orientated, and cooperative.

Disqualifiers

concomitant thyroid dysfunction.

concomitant hypovitaminosis D.

concomitant cancer diagnosis, pregnancy.

jaw-related traumas, teeth, and gum diseases.

Trial population

Patients with RA defined by the American College of Rheumatology/European League Against Rheumatism collaborative initiative (ACR/EULAR) 2010 classification criteria.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

  • flexible fiberoptic pharyngolaryngoscopy

    Diagnostic test

    Flexible Endoscopic Evaluations of Swallowing (FEES) will be used to examine the nose, throat, and airway to diagnose possible causes of dysphagia. The dysphagia severity scale via FEES will be scored. It is a flexible process that may be applied to a variety of situations and objectives (named as flexible pharyngolaryngoscopy). Following the routine oropharyngeal examination, its versatility can enable it to be used as a laryngoscope for examining the larynx and adjacent regions.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Interventional Study Model1 intervention

Trial outcomes

Primary outcomes

1

Identifying potential predictors of dysphagia severity in rheumatoid arthritis patients.

Demonstrating the associations between the dysphagia severity scale (DSS) via flexible/fibre-optic endoscopic evaluations of swallowing (FEES) and the following: 1. Active disease by disease activity score in 28 joints with C-reactive protein (DAS28-CRP ): low if DAS28-CRP score was less than 3.2, moderate if the score between 3.2 and 5.1, or high if the score \> 5.1. 2. RA patient's malfunction by Modified Health Assessment Questionnaire (MHAQ): mild functional loss if score less than 1.3, moderate if score between 1.3 and 1.8, severe loss if \> 1.8 3. Temporomandibular dysfunction: mild TMJ dysfunction if score from 20 to 40, moderate dysfunction if score from 45 to 65 and severe TMJ dysfunction if the score from 70 to 100. 4. Cricoarytenoid joint dysfunction. 5. Specific change in temporomandibular (TMJ) joints by cone beam CT imaging.

Time frame
The assessment of dysphagia severity via FEES typically will take nearly 25 minutes. The duration of clinical, laboratory, and radiological tests will take 1 to 2 days and may vary depending on the specific circumstances.

Secondary outcomes

1

Demonstrating whether flexible fiberoptic pharyngolaryngoscopy can diagnose Joint-Affection-Induced dysphagia in patients with RA.

Flexible Endoscopic Evaluations of Swallowing (FEES) will be used to examine the nose, throat, and airway to diagnose possible causes of dysphagia. It is a flexible process that may be applied to a variety of situations and objectives (named as flexible pharyngolaryngoscopy). Following the routine oropharyngeal examination, its versatility can enable it to be used as a laryngoscope for examining the larynx and adjacent regions.

Time frame
Assessment of rheumatoid arthritis patients by FEES will take 10 to 25 minutes. The duration may vary depending on the specific circumstances and the complexity of the assessment.
2

Demonstrating whether both oropharyngeal and oesophageal dysphagia are present among patients with RA?

An upper oesophagus examination by FEES may provide a useful screening tool for oesophageal dysphagia in addition to the routine oropharyngeal and laryngeal examination.

Time frame
up to 2 minutes following routine FEES.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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