Bump the Lump - Intervention for the Treatment of Globus Pharyngeus

NCT06762444 | Recruiting

• 1 other identifier: IRB00103445
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Globus Pharyngeus

Keywords

Speech-language pathologist; laryngeal hygiene; voice therapy techniques

Outcome Measures

Primary Outcomes (5)

• Laryngopharyngeal Measure of Perceived Sensation (LUMP)

  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.

  Year 1

• Eating Assessment Tool-10 (EAT-10)

  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

  Year 1

• Voice Handicap Index-10 (VHI-10)

  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

  Year 1

• Generalized Anxiety Disorder-7 (GAD-7)

  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

  Year 1

• Numeric Rating Scale for throat pain

  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

  Year 1

Study Arms (1)

The SLP intervention protocol

EXPERIMENTAL

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

Behavioral: Speech-language pathologist (SLP) protocol

Interventions

Speech-language pathologist (SLP) protocol BEHAVIORAL

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

The SLP intervention protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Globus Sensation

Interventions

Complement C4a; Clinical Protocols

Condition Hierarchy (Ancestors)

Conversion Disorder; Somatoform Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Anaphylatoxins; Complement System Proteins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Complement C4; Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Lyndsay Madden, DO

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lyndsay Madden, DO

CONTACT

(336) 716-4161; lmadden@wakehealth.edu

Kathryn Ruckart, MS

CONTACT

336.713.2657; kathryn.ruckart@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 7, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)