The Effect of Laryngeal Manual Therapy as a Management of... | NCT04436146

Studies
The Effect of Laryngeal Manual Therapy as a Management of Globus

NCT04436146

Sponsor

HaEmek Medical Center, Israel

Status

Unknown status

Last Update Posted

Aug 3, 2022Actual

Enrollment

70Estimated

Phase

Not Applicable

Conditions

Globus

Interventions

laryngeal manual therapies

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2022Actual

Primary Completion Date

Jun 1, 2023Estimated

Completion Date

Jul 1, 2023Estimated

First Submitted Date

Jun 16, 2020

First Submission Date that Met QC Criteria

Jun 16, 2020

First Posted Date

Jun 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2022

Last Update Posted Date

Aug 3, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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 .

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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 .

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rami Ghanayim, MD	Contact	00972543443190		rami115@hotmail.com

Overall Officials

Name	Affiliation	Role
Miki Paker, MD	HaEmek Medical Center, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haemek Medical Center	Recruiting	Afula			Israel

Condition Browse Module

MeSH Terms

ID	Term
D000079564	Globus Sensation

Ancestor Terms

ID	Term
D003291	Conversion Disorder
D013001	Somatoform Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided