Dysphagia in Rheumatoid Arthritis

NCT07401732 | Recruiting

• 1 other identifier: 36264PR772/7/24
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 2

Brief Summary

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?

Conditions

Rheumatoid Arthritis (RA

Keywords

Flexible Endoscopic Evaluations of Swallowing; Temporomandibular joint; Deglutition disorders; cricoarytenoid

Outcome Measures

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. 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 Outcomes (2)

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

  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?

  up to 2 minutes following routine FEES.

Study Arms (1)

Interventional Study Model

Single Group Assignment (rheumatoid arthritis patients)

Diagnostic Test: flexible fiberoptic pharyngolaryngoscopy

Interventions

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.

Interventional Study Model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (2)

Faculty of medicine, Tanta University

Tanta, Elgharbia, 31151, Egypt

RECRUITING

Rheumatology, rehabilitation, and physical medicine department Faculty of medicine, Tanta University

Tanta, Elgharbia, 31151, Egypt

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid; Deglutition Disorders

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Aliaa MA Farag, MD

  Tanta University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aliaa MA Farag, MD

CONTACT

+201069468486; aliaa.mamdouh@med.tanta.edu.eg

Ayman Fouad, MD

CONTACT

+20 10 04398763; aymanfouadtanta@med.tanta.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 10, 2026
• Study Start: February 7, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)