Swallowing problems in rheumatoid arthritis
Prediction of Dysphagia Severity and Diagnosis of Its Possible Causes in Rheumatoid Arthritis: A Cross-Sectional Study
This study will test whether a flexible fiberoptic throat exam can find joint-related swallowing problems and what predicts swallowing severity in adults with rheumatoid arthritis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 137 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 2 sites (Tanta, Elgharbia and 1 other locations) |
| Trial ID | NCT07401732 on ClinicalTrials.gov |
What this trial studies
This is a cross-sectional study of adult patients with rheumatoid arthritis seen at inpatient and outpatient clinics who meet the ACR/EULAR 2010 criteria. Participants will undergo a flexible fiberoptic pharyngolaryngoscopy (a bedside endoscopic throat exam) to document presence and severity of dysphagia. The study will analyze clinical and joint-related factors to identify predictors of swallowing severity and will note whether both oropharyngeal and esophageal dysphagia occur. Data will be collected during routine clinic visits without experimental treatments.
Who should consider this trial
Good fit: Adults over 18 with rheumatoid arthritis defined by the ACR/EULAR 2010 criteria who are alert and able to cooperate with a bedside throat endoscopy are the ideal candidates.
Not a fit: Patients with other clear causes of dysphagia (such as cancer, other rheumatologic diseases, jaw trauma, recent TMJ injections, congenital oral abnormalities), pregnancy, or those unable to cooperate or with anatomical barriers to nasofibroscopy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the findings could help clinicians detect and address joint-related swallowing problems in RA earlier using a simple endoscopic exam.
How similar studies have performed: Flexible endoscopic swallowing exams are widely used to detect dysphagia in other conditions, but using them specifically to diagnose joint-affection-induced dysphagia in rheumatoid arthritis is relatively novel and not yet extensively validated.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Tanta, Elgharbia and 1 other locations
- Faculty of medicine, Tanta University — Tanta, Elgharbia, Egypt (Recruiting)
- Rheumatology, rehabilitation, and physical medicine department Faculty of medicine, Tanta University — Tanta, Elgharbia, Egypt (Recruiting)
Study contacts
- Principal investigator: Aliaa MA Farag, MD — Tanta University Faculty of Medicine
- Study coordinator: Aliaa MA Farag, MD
- Email: aliaa.mamdouh@med.tanta.edu.eg
- Phone: +201069468486
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.