Health TrialsbyHealthPanel

Bump the Lump - Intervention for the Treatment of Globus Pharyngeus

ConditionGlobus Pharyngeus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: The SLP intervention protocolExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Year 1
2

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

Time frame
Year 1
3

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

Time frame
Year 1
4

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

Time frame
Year 1

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

Source ClinicalTrials.gov
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