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Dysphagia in Rheumatoid Arthritis

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07401732
Enrollment
30
Registered
2026-02-10
Start date
2026-02-07
Completion date
2026-08-01
Last updated
2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis (RA

Keywords

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

Brief summary

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_TESTflexible 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.

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Identifying potential predictors of dysphagia severity in rheumatoid arthritis patients.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. Cricoarytenoid joint dysfunction. 5. Specific change in temporomandibular (TMJ) joints by cone beam CT imaging.

Secondary

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

Countries

Egypt

Contacts

CONTACTAliaa MA Farag, MD
aliaa.mamdouh@med.tanta.edu.eg+201069468486
CONTACTAyman Fouad, MD
aymanfouadtanta@med.tanta.edu.eg+20 10 04398763
PRINCIPAL_INVESTIGATORAliaa MA Farag, MD

Tanta University Faculty of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026