Bump the Lump: Creation and Validation of Speech Language Pathology Intervention for the Treatment of Globus Pharyngeus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Laryngopharyngeal Measure of Perceived Sensation (LUMP)
研究概览
简要总结
To develop a standardized speech-language pathology treatment protocol to systematically address Globus pharyngeus (GP) as a proof of concept
详细描述
Globus pharyngeus (GP), often described as a persistent lump or tightness in the throat, accounting for 4% of new referrals to Ear, Nose, and Throat (ENT) clinics. This condition is reported in the literature in up to 46% of healthy individuals and has been shown to significantly impact patients' quality of life. The key diagnostic criteria for GP include at least 12 weeks duration of symptoms without dysphagia or gastroesophageal reflux as the causative symptom, and in the absence of major esophageal motor disorders. While the exact etiology of GP remains elusive, research suggests a multifactorial nature involving physical, psychological, and functional components. Behavioral therapy with a Speech-language pathologist is often recommended as a treatment option for patients with GP. A review of the literature examining SLP interventions for GP shows that SLP treatments lack standardization, leading to inconsistency and limited efficacy across therapeutic interventions. Therefore, there is an urgent need to further investigate behavioral interventions for GP and develop a standardized treatment protocol to address the condition systematically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Volunteer adult patients (age 18 and over) evaluated at the Atrium Health Wake Forest Baptist Center for Voice and Swallowing Disorders who report a complaint of globus pharyngeus
排除标准
- •Patients diagnosed with a swallowing disorder will be excluded from the study
研究组 & 干预措施
The SLP intervention protocol
The SLP intervention protocol consists of six components, all of which will be implemented by the treating speech-language pathologist
干预措施: Speech-language pathologist (SLP) protocol (Behavioral)
结局指标
主要结局
Laryngopharyngeal Measure of Perceived Sensation (LUMP)
时间窗: Year 1
Laryngopharyngeal Measure of Perceived Sensation (LUMP) to assess GP symptom severity - The Laryngopharyngeal Measure of Perceived Sensation (LUMP) scoring system is a patient-reported questionnaire used to assess the severity of throat sensations like globus sensation (lump in the throat) - where each item on the scale is rated 0 (never) to 4 (always), with a higher score indicating greater symptom severity - A LUMP score greater than or equal to 3 should be considered abnormal and warrants additional attention.
Eating Assessment Tool-10 (EAT-10)
时间窗: Year 1
Eating Assessment Tool-10 (EAT-10) to assess for dysphagia complaints - The Eating Assessment Tool (EAT-10) is increasingly used to screen for self-perceived oropharyngeal dysphagia (OD) in community-dwelling elders. A summated EAT-10 total score ranges from 0 to 40, with a score ≥ 3 is abnormal
Numeric Rating Scale for throat pain
时间窗: Year 1
0-10 Numeric Rating Scale for throat pain to assess for throat pain - a scale from 0 to 10, where "0" represents "no throat pain" and "10" represents "the worst throat pain imaginable
Voice Handicap Index-10 (VHI-10)
时间窗: Year 1
Voice Handicap Index-10 (VHI-10) to measure voice-related quality of life - The Voice Handicap Index-10 (VHI-10) is a patient-reported outcome measure that scores voice-related handicap on a scale of 0-40: Normal or nearly normal: Scores of 0-10 Abnormal: Scores above 11 Greater handicap: Higher scores indicate a greater voice-related handicap
Generalized Anxiety Disorder-7 (GAD-7)
时间窗: Year 1
Generalized Anxiety Disorder-7 (GAD-7) to assess for anxiety - The Generalized Anxiety Disorder 7-item (GAD-7) is a self-report scale that assesses anxiety and worry symptoms. The GAD-7 score is calculated by adding up the scores for each of the seven items, with scores ranging from 0 to 21 - Score 0-4: Minimal Anxiety. Score 5-9: Mild Anxiety. Score 10-14: Moderate Anxiety. Score greater than 15: Severe Anxiety
次要结局
未报告次要终点