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The Effect of Laryngeal Manual Therapy as a Management of Globus

Primary Purpose

Globus

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
laryngeal manual therapies
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Globus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 .

Sites / Locations

  • Haemek Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

laryngeal manual therapies

Arm Description

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

Outcomes

Primary Outcome Measures

Change From symptomatic to asymptomatic patient
after one therapy session we will evaluate the effect of the therapy on the patients .

Secondary Outcome Measures

Full Information

First Posted
June 16, 2020
Last Updated
August 2, 2022
Sponsor
HaEmek Medical Center, Israel
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1. Study Identification

Unique Protocol Identification Number
NCT04436146
Brief Title
The Effect of Laryngeal Manual Therapy as a Management of Globus
Official Title
The Effect of Laryngeal Manual Therapy as a Management of Globus(Sensation of a Lump in the Throat )- COMPARATIVE PROSPECTIVE STUDY
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HaEmek Medical Center, Israel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Globus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
laryngeal manual therapies
Arm Type
Other
Arm Description
The laryngeal manual therapy incorporates massaging the laryngeal muscles thus reducing excessive tension in the laryngeal and perilaryngeal musculature in patients with globus .
Intervention Type
Other
Intervention Name(s)
laryngeal manual therapies
Intervention Description
The laryngeal manual therapy incorporates massaging the laryngeal muscles thus reducing excessive tension in the laryngeal and perilaryngeal musculature in patients with globus .
Primary Outcome Measure Information:
Title
Change From symptomatic to asymptomatic patient
Description
after one therapy session we will evaluate the effect of the therapy on the patients .
Time Frame
baseline and week 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rami Ghanayim, MD
Phone
00972543443190
Email
rami115@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miki Paker, MD
Organizational Affiliation
HaEmek Medical Center, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haemek Medical Center
City
Afula
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miki Paker, MD
Phone
972-4-6494311
Email
MIKI_PA@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Miki Paker, MD

12. IPD Sharing Statement

Learn more about this trial

The Effect of Laryngeal Manual Therapy as a Management of Globus

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