NCT04436146

Brief Summary

The purpose of this study is to assess the effect of laryngeal manual therapies in the treatment of globus (sensation of a lump in the throat).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
1.7 years until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

1.3 years

First QC Date

June 16, 2020

Last Update Submit

August 2, 2022

Conditions

Globus

Outcome Measures

Primary Outcomes (1)

  • Change From symptomatic to asymptomatic patient

    after one therapy session we will evaluate the effect of the therapy on the patients .

    baseline and week 1

Study Arms (1)

laryngeal manual therapies

OTHER

The laryngeal manual therapy incorporates massaging the laryngeal muscles thus reducing excessive tension in the laryngeal and perilaryngeal musculature in patients with globus .

Other: laryngeal manual therapies

Interventions

laryngeal manual therapiesOTHER

The laryngeal manual therapy incorporates massaging the laryngeal muscles thus reducing excessive tension in the laryngeal and perilaryngeal musculature in patients with globus .

laryngeal manual therapies

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients more than 18 years old
  • male and females
  • patients complaning from Globus without an organic cause
  • patients who underwent throat endoscopy and was normal.
  • Patients who received conventional drug therapy without benefit.
  • Globus complaints more than two months .

You may not qualify if:

  • below 18
  • Patients diagnosed with reflux(as a cause to globus)
  • Patients who considered at high risk of reflux according to REFLUX SYMPTOM INDEX (RSI) more than 13
  • patients who diagnosed with reflux and improved after anti-reflux manegment .
  • patients with laryngeal disease/finding that can explain the globus.
  • patients with organic cause that can explain the globus .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haemek Medical Center

Afula, Israel

RECRUITING

MeSH Terms

Conditions

Globus Sensation

Condition Hierarchy (Ancestors)

Conversion DisorderSomatoform DisordersMental Disorders

Study Officials

  • Miki Paker, MD

    HaEmek Medical Center, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rami Ghanayim, MD

CONTACT

00972543443190rami115@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 17, 2020

Study Start

March 1, 2022

Primary Completion

June 1, 2023

Study Completion

July 1, 2023

Last Updated

August 3, 2022

Record last verified: 2022-08

Locations

IL(1)