Prediction of Dysphagia and Its Possible Causes in Rheumatoid Arthritis: A Cross-Sectional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Identifying potential predictors of dysphagia severity in rheumatoid arthritis patients.
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Interventional Study Model
Single Group Assignment (rheumatoid arthritis patients)
干预措施: flexible fiberoptic pharyngolaryngoscopy (Diagnostic Test)
结局指标
主要结局
Identifying potential predictors of dysphagia severity in rheumatoid arthritis patients.
时间窗: 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.
次要结局
- 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.)
研究者
Aliaa Mamdouh Abdelaziz Farag
Lecturer
Tanta University