Globus PharyngeusNCT06762444
Bump the Lump - Intervention for the Treatment of Globus Pharyngeus
A study testing Speech-language pathologist (SLP) protocol in people with Globus Pharyngeus, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
To develop a standardized speech-language pathology treatment protocol to systematically address Globus pharyngeus (GP) as a proof of concept Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Globus Pharyngeus
- What is being tested?
- Speech-language pathologist (SLP) protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients diagnosed with a swallowing disorder will be excluded from the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Lyndsay Madden, DO, 336-716-4161, lmadden@wakehealth.edu
About this study
Official title: Bump the Lump: Creation and Validation of Speech Language Pathology Intervention for the Treatment of Globus Pharyngeus
To develop a standardized speech-language pathology treatment protocol to systematically address Globus pharyngeus (GP) as a proof of concept
Read the 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.
- Conditions
- Globus Pharyngeus
- Being tested
- Speech-language pathologist (SLP) protocol
- Keywords
- Speech-language pathologist, laryngeal hygiene, voice therapy techniques
- Medical subject headings
- Globus Sensation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speech-language pathologist (SLP) protocolBehavioural
The SLP intervention protocol consists of six components, all of which will be implemented by the treating speech-language pathologist
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Speech-language pathologist (SLP) protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start28 Aug 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Globus PharyngeusStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lyndsay Madden, DO, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06762444
- Sponsor's protocol ID
- IRB00103445
- Status last verified
- Dec 2025
- First submitted
- 30 Dec 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bump the Lump: Creation and Validation of Speech Language Pathology Intervention for the Treatment of Globus Pharyngeus
- ClinicalTrials.gov ID
- NCT06762444
- Acronym / sponsor ID
- IRB00103445
- Conditions
- Globus Pharyngeus
- Keywords
- Speech-language pathologist, laryngeal hygiene, voice therapy techniques
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| The SLP intervention protocol | Experimental | Behavioral: Speech-language pathologist (SLP) protocolThe SLP intervention protocol consists of six components, all of which will be implemented by the treating speech-language pathologist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients diagnosed with a swallowing disorder will be excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Speech-language pathologist (SLP) protocolThe SLP intervention protocol consists of six components, all of which will be implemented by the treating speech-language pathologist | Behavioural | The SLP intervention protocol |
Primary outcome
Laryngopharyngeal Measure of Perceived Sensation (LUMP)
Time frame: 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)
Time frame: 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
Voice Handicap Index-10 (VHI-10)
Time frame: 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)
Time frame: 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
Numeric Rating Scale for throat pain
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Globus Pharyngeus
Recruiting
Optimizing Parameters of Low-Intensity Focused Ultrasound for Pallidal Modulation in Huntington's Disease
Huntington Disease
Enrolling by invitation
Intrapatient Comparison of STN and GPi tTIS in PD
Parkinson Disease
Enrolling by invitation
Effects of Stimulation Patterns of Deep Brain Stimulation
Parkinson Disease, Essential Tremor
Active, not recruiting
ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease
Parkinson Disease
RecruitingObservational study
Observational Database on Deep Brain Stimulation in Tourette Syndrome
Tourette Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lyndsay Madden, DO principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speech-language pathologist (SLP) protocol in people with Globus Pharyngeus, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lyndsay Madden, DO ((336) 716-4161, lmadden@wakehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laryngopharyngeal Measure of Perceived Sensation (LUMP) (time frame: Year 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.