The Efficacy of Kinesio Taping With Therapy in the Treatment of Globus Pharyngeus

The Efficacy of Kinesio Taping With Therapy in the Treatment of Globus Pharyngeus: a Randomized Sham-controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Globus Pharyngeus
• Intervention / Treatment: Device: Kinesio tape

Detailed Description

We conducted a therapy program with kinesio taping on patients who diagnosed with globus pharyngeus for 8 session with sham kinesio taping controlled group. This study aimed to assess of efficacy of the kinesio taping with therapy on patients patients who diagnosed with globus pharyngeus.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yavuz Atar, Asso Prof,MD; Phone Number: +905052123297; Email: yavuzatar@gmail.com
• Study Contact Backup: Name: Sevgi Atar, MD; Phone Number: +905052123296; Email: sevgiatar@gmail.com

Study Locations

• Turkey
  • Istanbul, Turkey, 34384
    • Prof Dr Cemil Tascioglu City Hospital
    • Contact: Yavuz Atar, Asso Prof,MD; Phone Number: +905052123297; Email: yavuzatar@gmail.com
    • Contact: Sevgi Atar, MD; Phone Number: +905052123296; Email: sevgiatar@gmail.com
    • Sub-Investigator: Hasan Sami Bircan, MD
    • Sub-Investigator: Yavuz Uyar, Prof., MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diagnosed with globus pharyngeus
• 18 -65 years
• give a consent form

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study group; The therapy and Kinesio tex gold tape that was affixed to stretched and neck localised were applied	Device: Kinesio tape; The Kinesio tex tape is a medical tape that had been certified and patented.
Placebo Comparator: Sham control group; The therapy and Kinesio tex gold tape that was affixed to different neck localised as no-stretched were applied	Device: Kinesio tape; The Kinesio tex tape is a medical tape that had been certified and patented.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eating Assessment Tool	The Turkish validated questionnaire consists of 10 questions that scores are from 0 to 40. Low score is better, higher score is worse.	Baseline
Eating Assessment Tool	The Turkish validated questionnaire consists of 10 questions that scores are from 0 to 40. Low score is better, higher score is worse.	4 weeks
Eating Assessment Tool	The Turkish validated questionnaire consists of 10 questions that scores are from 0 to 40. Low score is better, higher score is worse.	2 months
The outcomes of voice handicap index - 10	It was assessed by Turkish validated voice handicap index - 10 that a self questionnaire in patients. The minimum score is 0 and maximum score is 4 per question. The high scores were worst low scores were good.	Baseline
The outcomes of voice handicap index - 10	It was assessed by Turkish validated voice handicap index - 10 that a self questionnaire in patients. The minimum score is 0 and maximum score is 4 per question. The high scores were worst low scores were good.	4 weeks
The outcomes of voice handicap index - 10	It was assessed by Turkish validated voice handicap index - 10 that a self questionnaire in patients. The minimum score is 0 and maximum score is 4 per question. The high scores were worst low scores were good.	2 months
The outcomes of reflux symptom index	The laryngopharyngeal reflux was assessed by Turkish validated reflux symptom index - 10 that a self questionnaire in patients. The minimum score is 0 and maximum score is 5 per question. The high scores were worst low scores were good.	Baseline
The outcomes of reflux symptom index	The laryngopharyngeal reflux was assessed by Turkish validated reflux symptom index - 10 that a self questionnaire in patients. The minimum score is 0 and maximum score is 5 per question. The high scores were worst low scores were good.	4 weeks
The outcomes of reflux symptom index	The laryngopharyngeal reflux was assessed by Turkish validated reflux symptom index - 10 that a self questionnaire in patients. The minimum score is 0 and maximum score is 5 per question. The high scores were worst low scores were good.	2 months
Penetration and aspiration scale	The scale consists of 8 levels for assessment of penetration and aspiration. The scores are from 0 to 8. Low score is better, higher score is worse.	Baseline
Yale pharyngeal residue severity rating scale	The scale consists of 5 assessment units for pharyngeal residue. The scores are from 1 to 5. Low score is better, higher score is worse.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject demographics	The median values of age and ratio of gender in all groups	Baseline

Collaborators and Investigators

• Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
• Investigators: Study Chair: Yavuz Atar, Asso Prof,MD, University of Health Sciences, ENT Clinic, Prof Dr Cemil Tascioglu City Hospital; Study Director: Sevgi Atar, MD, University of Health Sciences, PMR Clinic, Prof Dr Cemil Tascioglu City Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 30, 2021
• Primary Completion (Anticipated): December 30, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: February 20, 2021
• First Submitted That Met QC Criteria: February 20, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): July 29, 2021
• Last Update Submitted That Met QC Criteria: July 28, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: kinesio taping; therapy; sensation; globus pharyngeus; globus
• Additional Relevant MeSH Terms: Mental Disorders; Conversion Disorder; Somatoform Disorders; Globus Sensation
• Other Study ID Numbers: 60

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes