Clinical trial NCT06762444: Bump the Lump - Intervention for the Treatment of Globus Pharyngeus
Official title: Bump the Lump: Creation and Validation of Speech Language Pathology Intervention for the Treatment of Globus Pharyngeus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Globus Pharyngeus
Keywords: Speech-language pathologist
laryngeal hygiene
voice therapy techniques
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The Speech-language pathologist (SLP) intervention protocol consists of six components, all of which will be implemented by the treating speech-language pathologist
Primary purpose: SUPPORTIVE_CARE

Brief summary: To develop a standardized speech-language pathology treatment protocol to systematically address Globus pharyngeus (GP) as a proof of concept

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Patients diagnosed with a swallowing disorder will be excluded from the study

Primary outcomes:
measure: Laryngopharyngeal Measure of Perceived Sensation (LUMP)
timeFrame: Year 1
measure: Eating Assessment Tool-10 (EAT-10)
timeFrame: Year 1
measure: Voice Handicap Index-10 (VHI-10)
timeFrame: Year 1
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Year 1
measure: Numeric Rating Scale for throat pain
timeFrame: Year 1
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Lyndsay Madden, DO
role: PRINCIPAL_INVESTIGATOR
References: