Dysphagia in Rheumatoid Arthritis

May 7, 2026 updated by: Aliaa Mamdouh Abdelaziz Farag, Tanta University

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

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

The secondary goals include demonstrating whether flexible fiberoptic pharyngolaryngoscopy can diagnose 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 severity via flexible fiberoptic pharyngolaryngoscopy in rheumatoid arthritis patients?
  • Whether flexible fiberoptic pharyngolaryngoscopy can diagnose joint-affection-induced dysphagia in patients with RA?
  • Whether both oropharyngeal and esophageal dysphagia are present in patients with RA?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

137

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Elgharbia
      • Tanta, Elgharbia, Egypt, 31151
        • Recruiting
        • Faculty of medicine, Tanta University
        • Sub-Investigator:
          • Ayman Fouad, MD
        • Sub-Investigator:
          • El Sayed M Rageh, MD
        • Sub-Investigator:
          • Basma ES Elmorshidy, MD
        • Sub-Investigator:
          • MennatAllah EA Gahgah, MD
        • Sub-Investigator:
          • Heba AH Hanout, MD
        • Sub-Investigator:
          • Dina HM Abdella, MD
        • Sub-Investigator:
          • Lina Hablas, MD
        • Principal Investigator:
          • Aliaa MA Farag, MD
        • Sub-Investigator:
          • Nehal Abdelaziz, Demonstrator
      • Tanta, Elgharbia, Egypt, 31151
        • Recruiting
        • Rheumatology, rehabilitation, and physical medicine department Faculty of medicine, Tanta University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Interventional Study Model
Single Group Assignment (rheumatoid arthritis patients)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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. Increased serum thyroid-stimulating hormone (TSH) > 5 mU/L
  5. Erosion in temporomandibular (TMJ) and/or cricoarytenoid (CAJ) joints by cone beam CT imaging.
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

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
An upper oesophagus examination by FEES may provide a useful screening tool for oesophageal dysphagia in addition to the routine oropharyngeal and laryngeal examination.
up to 2 minutes following routine FEES.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Aliaa MA Farag, MD, Tanta University Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36264PR772/7/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data is available with corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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