NCT04768205

Brief Summary

Globus pharyngeus or sensation may be defined as a feeling of something a lump in the throat without dysphagia. Kinesio tex tape is a medical tap developed by Dr. Kase for therapeutic purposes and has been widely used in physical therapy applications in recent years. Although it is not a treatment with full consensus, the patient's complaints can be corrected with a small number of different therapy techniques or regulations on life.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

August 30, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

February 20, 2021

Last Update Submit

July 28, 2021

Conditions

Globus Pharyngeus

Keywords

kinesio tapingglobusglobus pharyngeussensationtherapy

Outcome Measures

Primary Outcomes (12)

  • The outcomes of Glasgow Edinburg Throat Scale

    It was assessed by Turkish validated Glasgow Edinburg Throat Scale that a self questionnaire in globus pharyngeus patients. The minimum score is 0 and maximum score is 7 per question. The high scores were worst low scores were good.

    Baseline

  • The outcomes of Glasgow Edinburg Throat Scale

    It was assessed by Turkish validated Glasgow Edinburg Throat Scale that a self questionnaire in globus pharyngeus patients. The minimum score is 0 and maximum score is 7 per question. The high scores were worst low scores were good.

    4 weeks

  • The outcomes of Glasgow Edinburg Throat Scale

    It was assessed by Turkish validated Glasgow Edinburg Throat Scale that a self questionnaire in globus pharyngeus patients. The minimum score is 0 and maximum score is 7 per question. The high scores were worst low scores were good.

    2 months

  • The outcomes of Beck depression inventory

    It was assessed by Turkish validated depression inventory that a questionnaire about psychosocial situations. The minimum score is 0 and maximum score is 3 per question. The high scores were worst low scores were good.

    Baseline

  • The outcomes of Beck depression inventory

    It was assessed by Turkish validated Beck depression inventory that a questionnaire about psychosocial situations. The minimum score is 0 and maximum score is 3 per question. The high scores were worst low scores were good.

    4 weeks

  • The outcomes of Beck depression inventory

    It was assessed by Turkish validated Beck depression inventory that a questionnaire about psychosocial situations. The minimum score is 0 and maximum score is 3 per question. The high scores were worst low scores were good.

    2 months

  • The outcomes of Beck anxiety inventory

    It was assessed by Turkish validated Beck anxiety inventory that a questionnaire about psychosocial situations. The minimum score is 0 and maximum score is 3 per question. The high scores were worst low scores were good.

    Baseline

  • The outcomes of Beck anxiety inventory

    It was assessed by Turkish validated Beck anxiety inventory that a questionnaire about psychosocial situations. The minimum score is 0 and maximum score is 3 per question. The high scores were worst low scores were good.

    4 weeks

  • The outcomes of Beck anxiety inventory

    It was assessed by Beck anxiety inventory that a questionnaire about psychosocial situations. The minimum score is 0 and maximum score is 3 per question. The high scores were worst low scores were good.

    2 months

  • The visual analog scale

    The globus sense was assessed by visual analog scale. The minimum score is 0 and maximum score is 100 on a line as 100 millimetres . The high scores were worst low scores were good.

    Baseline

  • The visual analog scale

    The globus sense was assessed by visual analog scale. The minimum score is 0 and maximum score is 100 on a line as 100 millimetres. The high scores were worst low scores were good.

    4 weeks

  • The visual analog scale

    The globus sense was assessed by visual analog scale. The minimum score is 0 and maximum score is 100 on a line as 100 millimetres. The high scores were worst low scores were good.

    2 months

Secondary Outcomes (11)

  • Eating Assessment Tool

    Baseline

  • Eating Assessment Tool

    4 weeks

  • Eating Assessment Tool

    2 months

  • The outcomes of voice handicap index - 10

    Baseline

  • The outcomes of voice handicap index - 10

    4 weeks

  • +6 more secondary outcomes

Other Outcomes (1)

  • Subject demographics

    Baseline

Study Arms (2)

Study group

ACTIVE COMPARATOR

The therapy and Kinesio tex gold tape that was affixed to stretched and neck localised were applied

Device: Kinesio tape

Sham control group

PLACEBO COMPARATOR

The therapy and Kinesio tex gold tape that was affixed to different neck localised as no-stretched were applied

Device: Kinesio tape

Interventions

Kinesio tapeDEVICE

The Kinesio tex tape is a medical tape that had been certified and patented.

Sham control groupStudy group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with globus pharyngeus
  • years
  • give a consent form

You may not qualify if:

  • patients with dysphagia or odynophagia
  • laryngeal organic pathologies
  • pharyngeal organic pathologies
  • epiglottic retroversion
  • malignancy
  • pregnancy
  • mental disorders
  • neurological disorders
  • major psychiatric disorders
  • give not a consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof Dr Cemil Tascioglu City Hospital

Istanbul, 34384, Turkey (Türkiye)

Location

Related Publications (2)

  • Khalil HS, Bridger MW, Hilton-Pierce M, Vincent J. The use of speech therapy in the treatment of globus pharyngeus patients. A randomised controlled trial. Rev Laryngol Otol Rhinol (Bord). 2003;124(3):187-90.

    PMID: 14725135BACKGROUND

  • Morris D, Jones D, Ryan H, Ryan CG. The clinical effects of Kinesio(R) Tex taping: A systematic review. Physiother Theory Pract. 2013 May;29(4):259-70. doi: 10.3109/09593985.2012.731675. Epub 2012 Oct 22.

    PMID: 23088702BACKGROUND

MeSH Terms

Conditions

Globus Sensation

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Conversion DisorderSomatoform DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • Yavuz Atar, Asso Prof,MD

    University of Health Sciences, ENT Clinic, Prof Dr Cemil Tascioglu City Hospital

    STUDY CHAIR

  • Sevgi Atar, MD

    University of Health Sciences, PMR Clinic, Prof Dr Cemil Tascioglu City Hospital

    STUDY DIRECTOR

Central Study Contacts

Yavuz Atar, Asso Prof,MD

CONTACT

+905052123297yavuzatar@gmail.com

Sevgi Atar, MD

CONTACT

+905052123296sevgiatar@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, M.D.

Study Record Dates

First Submitted

February 20, 2021

First Posted

February 24, 2021

Study Start

August 30, 2021

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

July 29, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)