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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04436146
Other study ID # EMC-20-0014
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date July 1, 2023

Study information

Verified date August 2022
Source HaEmek Medical Center, Israel
Contact Rami Ghanayim, MD
Phone 00972543443190
Email rami115@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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 .


Recruitment information / eligibility

Status Recruiting
Enrollment 70
Est. completion date July 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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 .

Locations

Country Name City State
Israel Haemek Medical Center Afula

Sponsors (1)

Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT00439439 - ACHAT-STUDY, Alternative Treatment of Chronic Globus Sensations N/A
Completed NCT03205228 - Treatment in Patients With Globus: Psychoeducation, Anxiolytics or Proton Pump Inhibitors Phase 3