The Effect of Laryngeal Manual Therapy as a Management of Globus

The Effect of Laryngeal Manual Therapy as a Management of Globus(Sensation of a Lump in the Throat )- COMPARATIVE PROSPECTIVE STUDY

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).

Study Overview

• Status: Recruiting
• Conditions: Globus
• Intervention / Treatment: Other: laryngeal manual therapies

Detailed Description

This is a prospective study that include patients who met the inclusion criteria.

Data collection includes patients age,gender,clinical manifistations,laboratory parameters and treatment.

An endoscopic examination will be done by an expert Otolaryngologist. for each patients we will perform one session of laryngeal manual massage therapy by an expert in the field .

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rami Ghanayim, MD; Phone Number: 00972543443190; Email: rami115@hotmail.com

Study Locations

• Israel
  • Afula, Israel
    • Recruiting
    • Haemek Medical Center
    • Contact: Miki Paker, MD; Phone Number: 972-4-6494311; Email: MIKI_PA@clalit.org.il
    • Principal Investigator: Miki Paker, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 .

Exclusion Criteria:

• 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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: laryngeal manual therapies; 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; The laryngeal manual therapy incorporates massaging the laryngeal muscles thus reducing excessive tension in the laryngeal and perilaryngeal musculature in patients with globus .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel
• Investigators: Principal Investigator: Miki Paker, MD, HaEmek Medical Center, Israel

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Conversion Disorder; Somatoform Disorders; Globus Sensation
• Other Study ID Numbers: EMC-20-0014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No