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Recruiting NCT07401732

Dysphagia in Rheumatoid Arthritis

— Observational Rheumatoid Arthritis (RA

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: flexible fiberoptic pharyngolaryngoscopy.
Who it may be relevant to
Registry conditions: Rheumatoid Arthritis (RA. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Prediction of Dysphagia and Its Possible Causes in Rheumatoid Arthritis: A Cross-Sectional Study

Overview

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?

Detailed description

This cross-sectional study will comprise RA patients during their visits to inpatient and outpatient clinics. The inclusion criterion is patients with RA 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.

Interventions

  • Diagnostic test flexible fiberoptic pharyngolaryngoscopy
    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.

Primary outcome measures

  • Identifying potential predictors of dysphagia severity in rheumatoid arthritis patients. [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 outcome measures (2)
  • Demonstrating whether flexible fiberoptic pharyngolaryngoscopy can diagnose Joint-Affection-Induced dysphagia in patients with RA. [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.]
  • Demonstrating whether both oropharyngeal and oesophageal dysphagia are present among patients with RA? [Time frame: up to 2 minutes following routine FEES.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • concomitant thyroid dysfunction.
  • concomitant hypovitaminosis D.
  • concomitant cancer diagnosis, pregnancy.
  • jaw-related traumas, teeth, and gum diseases.
  • other rheumatologic conditions
  • other comorbidities.
  • other causes of TMJ arthritis, patients with TMJ, palatal or tongue congenital abnormalities, and patients who underwent TMJ injections in the last six months.
  • Patients with any language disorders or intellectually handicapped (as certain questions depend on the patient's ability to comprehend and express their emotions regarding their issue) and patients with anatomical anomalies impeding the functionality of flexible nasofibroscopy.
  • Any apparent causes of dysphagia other than RA.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Egypt · 2 centers
  • Faculty of medicine, Tanta University — Tanta
  • Rheumatology, rehabilitation, and physical medicine department Faculty of medicine, Tanta — Tanta

Identifiers

NCT: NCT07401732 · 36264PR772/7/24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗