<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04436146</url>
  </required_header>
  <id_info>
    <org_study_id>EMC-20-0014</org_study_id>
    <nct_id>NCT04436146</nct_id>
  </id_info>
  <brief_title>The Effect of Laryngeal Manual Therapy as a Management of Globus</brief_title>
  <official_title>The Effect of Laryngeal Manual Therapy as a Management of Globus(Sensation of a Lump in the Throat )- COMPARATIVE PROSPECTIVE STUDY</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HaEmek Medical Center, Israel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HaEmek Medical Center, Israel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the effect of laryngeal manual therapies in the&#xD;
      treatment of globus (sensation of a lump in the throat).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective study that include patients who met the inclusion criteria.&#xD;
&#xD;
      Data collection includes patients age,gender,clinical manifistations,laboratory parameters&#xD;
      and treatment.&#xD;
&#xD;
      An endoscopic examination will be done by an expert Otolaryngologist. for each patients we&#xD;
      will perform one session of laryngeal manual massage therapy by an expert in the field .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2022</start_date>
  <completion_date type="Anticipated">July 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From symptomatic to asymptomatic patient</measure>
    <time_frame>baseline and week 1</time_frame>
    <description>after one therapy session we will evaluate the effect of the therapy on the patients .</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Globus</condition>
  <arm_group>
    <arm_group_label>laryngeal manual therapies</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The laryngeal manual therapy incorporates massaging the laryngeal muscles thus reducing excessive tension in the laryngeal and perilaryngeal musculature in patients with globus .</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>laryngeal manual therapies</intervention_name>
    <description>The laryngeal manual therapy incorporates massaging the laryngeal muscles thus reducing excessive tension in the laryngeal and perilaryngeal musculature in patients with globus .</description>
    <arm_group_label>laryngeal manual therapies</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients more than 18 years old&#xD;
&#xD;
          -  male and females&#xD;
&#xD;
          -  patients complaning from Globus without an organic cause&#xD;
&#xD;
          -  patients who underwent throat endoscopy and was normal.&#xD;
&#xD;
          -  Patients who received conventional drug therapy without benefit.&#xD;
&#xD;
          -  Globus complaints more than two months .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  below 18&#xD;
&#xD;
          -  Patients diagnosed with reflux(as a cause to globus)&#xD;
&#xD;
          -  Patients who considered at high risk of reflux according to REFLUX SYMPTOM INDEX (RSI)&#xD;
             more than 13&#xD;
&#xD;
          -  patients who diagnosed with reflux and improved after anti-reflux manegment .&#xD;
&#xD;
          -  patients with laryngeal disease/finding that can explain the globus.&#xD;
&#xD;
          -  patients with organic cause that can explain the globus .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Miki Paker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HaEmek Medical Center, Israel</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rami Ghanayim, MD</last_name>
    <phone>00972543443190</phone>
    <email>rami115@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Haemek Medical Center</name>
      <address>
        <city>Afula</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Miki Paker, MD</last_name>
      <phone>972-4-6494311</phone>
      <email>MIKI_PA@clalit.org.il</email>
    </contact>
    <investigator>
      <last_name>Miki Paker, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>August 2, 2022</last_update_submitted>
  <last_update_submitted_qc>August 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>HaEmek Medical Center, Israel</investigator_affiliation>
    <investigator_full_name>Paker Miki</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Globus Sensation</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04436146
org study id: EMC-20-0014
nct id: NCT04436146
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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).
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 .
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From symptomatic to asymptomatic patient
time frame: baseline and week 1
description: after one therapy session we will evaluate the effect of the therapy on the patients .
arm group label: laryngeal manual therapies
arm group type: Other
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: laryngeal manual therapies
description: The laryngeal manual therapy incorporates massaging the laryngeal muscles thus reducing excessive tension in the laryngeal and perilaryngeal musculature in patients with globus .
arm group label: laryngeal manual therapies
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Miki Paker, MD
role: Principal Investigator
affiliation: HaEmek Medical Center, Israel
last name: Rami Ghanayim, MD
phone: 00972543443190
email: rami115@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: HaEmek Medical Center, Israel
investigator full name: Paker Miki
investigator title: MD
mesh term: Globus Sensation