Bump the Lump - Intervention for the Treatment of Globus Pharyngeus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Speech-language pathologist (SLP) protocol.
- Who it may be relevant to
- Registry conditions: Globus Pharyngeus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Bump the Lump: Creation and Validation of Speech Language Pathology Intervention for the Treatment of Globus Pharyngeus
Overview
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.
Interventions
- Behavioral Speech-language pathologist (SLP) protocol
The SLP intervention protocol consists of six components, all of which will be implemented by the treating speech-language pathologist
Primary outcome measures
- Laryngopharyngeal Measure of Perceived Sensation (LUMP) [Time frame: Year 1]
- Eating Assessment Tool-10 (EAT-10) [Time frame: Year 1]
- Voice Handicap Index-10 (VHI-10) [Time frame: Year 1]
- Generalized Anxiety Disorder-7 (GAD-7) [Time frame: Year 1]
- Numeric Rating Scale for throat pain [Time frame: Year 1]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Wake Forest University Health Sciences — Winston-Salem
Identifiers
NCT: NCT06762444 · IRB00103445