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NCT Number: NCT07401732

Dysphagia in Rheumatoid Arthritis

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?

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Key information

Conditions

Rheumatoid Arthritis (RA Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of medicine, Tanta University, Tanta, Elgharbia, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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:

    • 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.
    • 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
    • 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.
    • Cricoarytenoid joint dysfunction.
    • Specific change in temporomandibular (TMJ) joints by cone beam CT imaging.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aliaa MA Farag, MD

CONTACT

[email protected]

+201069468486

Ayman Fouad, MD

CONTACT

[email protected]

+20 10 04398763

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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