Speech-Language Pathology for Globus Sensation

Overseen By Lyndsay Madden, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Swallowing disorder

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment protocol for individuals experiencing globus pharyngeus, a condition characterized by a persistent sensation of a lump in the throat. The study tests whether a specific speech-language pathology approach can alleviate this sensation. Participants will engage with a speech-language pathologist through a series of six treatment steps. Adults evaluated at the Atrium Health Wake Forest Baptist Center for Voice and Swallowing Disorders who experience this lump sensation, but do not have a diagnosed swallowing disorder, may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance treatment options for globus pharyngeus.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe for addressing Globus pharyngeus?

Research has shown that speech-language therapy is generally safe, as it employs non-invasive methods, reducing the risk of complications. Although limited evidence exists on the effectiveness of these treatments for Globus pharyngeus (the sensation of a lump in the throat), the safety data remains reassuring.

A study from the Grabscheid Voice and Swallowing Center found that 76% of patients who received a similar treatment experienced improvement. This suggests that the treatment is not only safe but may also alleviate symptoms, though further research is needed to confirm its effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SLP intervention protocol for globus sensation because it offers a non-invasive approach tailored by speech-language pathologists. Unlike typical treatments that might focus on medication or dietary changes, this protocol involves a hands-on, therapeutic technique specifically designed to address the sensation of a lump in the throat through targeted exercises and strategies. By engaging patients directly with a series of six structured components, it aims to provide relief by improving vocal and swallowing functions, representing a novel method that could complement or even replace standard treatments.

What evidence suggests that this SLP protocol is effective for Globus pharyngeus?

This trial will evaluate the effectiveness of a specific Speech-Language Pathologist (SLP) intervention protocol for treating globus pharyngeus (GP), a condition where individuals feel a lump in their throat. Studies have shown that speech-language therapy can benefit GP, with significant improvements reported. However, the quality of the evidence varies, and some studies highlight a lack of high-quality data. Speech-language therapists have successfully managed related issues, such as swallowing problems, by improving swallowing techniques, suggesting that similar methods could assist those with GP. While initial results are promising, more high-quality research is needed to confirm these benefits. ^{1 2 3 6 7}

Who Is on the Research Team?

Lyndsay Madden, DO

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

Adults over 18 with a sensation of having a lump in their throat, known as Globus pharyngeus, can join this trial. They must be patients at the Atrium Health Wake Forest Baptist Center for Voice and Swallowing Disorders. Those with diagnosed swallowing disorders cannot participate.

Inclusion Criteria

I am over 18 and feel like there's a lump in my throat.

Exclusion Criteria

I do not have a swallowing disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a standardized speech-language pathology intervention for Globus Pharyngeus

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Speech-language pathologist (SLP) protocol

Trial Overview The trial is testing a new treatment protocol developed by speech-language pathologists specifically for treating Globus pharyngeus to see if it's effective.

How Is the Trial Designed?

Group I: The SLP intervention protocol Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0892199724000699

Efficacy of Speech-Language Pathology Interventions for ... This scoping review suggest that SLP interventions hold promise as a treatment modality for GP, with all included studies reporting statistically significant ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38627105/

Efficacy of Speech-Language Pathology Interventions for ... This scoping review yields very little high-quality evidence supporting the efficacy of SLP interventions in the treatment of GP.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06762444?rank%253D2%2526term%253DAREA%25255BConditionSearch%25255D%252528%252522Globus%252BSensation%252522%252529

Bump the Lump - Intervention for the Treatment of Globus ... 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.

4. withpower.com withpower.com/trial/speech-language-pathology-for-globus-sensation-1568c

Speech-Language Pathology for Globus Sensation Speech-language pathologists (SLPs) have been shown to effectively manage swallowing disorders (dysphagia), which involves improving swallowing function and ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/j.1749-4486.2011.02326.x

Speech therapy in the treatment of globus pharyngeus ... A total of 117 patients with globus pharyngeus were treated with speech therapy from 2002 to 2007 by two speech therapists. Complete data were ...

6. asha.org asha.org/practice-portal/clinical-topics/adult-dysphagia/?srsltid=AfmBOorpv8_v7oZOincXZ2BzQINetnI1769llIyyxS0qFAD-8xgISvpi

Adult Dysphagia Signs and Symptoms​​ complaints of discomfort related to suspected esophageal dysphagia (e.g., globus sensation, regurgitation). See ASHA's Practice Portal page ...

7. mountsinai.org mountsinai.org/locations/grabscheid-voice-swallowing-center/research

Grabscheid Voice and Swallowing Center Research Seventy-six percent of the NLH patients treated with the protocol have reported improvement in symptoms. We have determined this treatment protocol was equally ...