Bump the Lump - Intervention for the Treatment of Globus Pharyngeus

NCT ID: NCT06762444

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-28

Study Completion Date

2026-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Globus Pharyngeus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The Speech-language pathologist (SLP) intervention protocol consists of six components, all of which will be implemented by the treating speech-language pathologist
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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The SLP intervention protocol

The SLP intervention protocol consists of six components, all of which will be implemented by the treating speech-language pathologist

Group Type EXPERIMENTAL

Speech-language pathologist (SLP) protocol

Intervention Type BEHAVIORAL

The SLP intervention protocol consists of six components, all of which will be implemented by the treating speech-language pathologist

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lyndsay Madden, DO

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lyndsay Madden, DO

Role: CONTACT

(336) 716-4161

Kathryn Ruckart, MS

Role: CONTACT

336.713.2657

Facility Contacts

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Lyndsay Madden, DO

Role: primary

336-716-4161

Other Identifiers

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IRB00103445

Identifier Type: -

Identifier Source: org_study_id

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