Back to resultsThe Efficacy of Kinesio Taping With Therapy in the Treatment of Globus Pharyngeus
Primary Purpose
Globus Pharyngeus
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Kinesio tape
Sponsored by
About this trial
This is an interventional treatment trial for Globus Pharyngeus focused on measuring kinesio taping, globus, globus pharyngeus, sensation, therapy
Eligibility Criteria
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
Sites / Locations
- Prof Dr Cemil Tascioglu City Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Study group
Sham control group
Arm Description
The therapy and Kinesio tex gold tape that was affixed to stretched and neck localised were applied
The therapy and Kinesio tex gold tape that was affixed to different neck localised as no-stretched were applied
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04768205
First Posted
February 20, 2021
Last Updated
July 28, 2021
Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
1. Study Identification
Unique Protocol Identification Number
NCT04768205
Brief Title
The Efficacy of Kinesio Taping With Therapy in the Treatment of Globus Pharyngeus
Official Title
The Efficacy of Kinesio Taping With Therapy in the Treatment of Globus Pharyngeus: a Randomized Sham-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 30, 2021 (Anticipated)
Primary Completion Date
December 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Globus Pharyngeus
Keywords
kinesio taping, globus, globus pharyngeus, sensation, therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Active Comparator
Arm Description
The therapy and Kinesio tex gold tape that was affixed to stretched and neck localised were applied
Arm Title
Sham control group
Arm Type
Placebo Comparator
Arm Description
The therapy and Kinesio tex gold tape that was affixed to different neck localised as no-stretched were applied
Intervention Type
Device
Intervention Name(s)
Kinesio tape
Intervention Description
The Kinesio tex tape is a medical tape that had been certified and patented.
Primary Outcome Measure Information:
Title
The outcomes of Glasgow Edinburg Throat Scale
Description
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.
Time Frame
Baseline
Title
The outcomes of Glasgow Edinburg Throat Scale
Description
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.
Time Frame
4 weeks
Title
The outcomes of Glasgow Edinburg Throat Scale
Description
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.
Time Frame
2 months
Title
The outcomes of Beck depression inventory
Description
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.
Time Frame
Baseline
Title
The outcomes of Beck depression inventory
Description
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.
Time Frame
4 weeks
Title
The outcomes of Beck depression inventory
Description
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.
Time Frame
2 months
Title
The outcomes of Beck anxiety inventory
Description
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.
Time Frame
Baseline
Title
The outcomes of Beck anxiety inventory
Description
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.
Time Frame
4 weeks
Title
The outcomes of Beck anxiety inventory
Description
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.
Time Frame
2 months
Title
The visual analog scale
Description
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.
Time Frame
Baseline
Title
The visual analog scale
Description
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.
Time Frame
4 weeks
Title
The visual analog scale
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Eating Assessment Tool
Description
The Turkish validated questionnaire consists of 10 questions that scores are from 0 to 40. Low score is better, higher score is worse.
Time Frame
Baseline
Title
Eating Assessment Tool
Description
The Turkish validated questionnaire consists of 10 questions that scores are from 0 to 40. Low score is better, higher score is worse.
Time Frame
4 weeks
Title
Eating Assessment Tool
Description
The Turkish validated questionnaire consists of 10 questions that scores are from 0 to 40. Low score is better, higher score is worse.
Time Frame
2 months
Title
The outcomes of voice handicap index - 10
Description
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.
Time Frame
Baseline
Title
The outcomes of voice handicap index - 10
Description
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.
Time Frame
4 weeks
Title
The outcomes of voice handicap index - 10
Description
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.
Time Frame
2 months
Title
The outcomes of reflux symptom index
Description
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.
Time Frame
Baseline
Title
The outcomes of reflux symptom index
Description
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.
Time Frame
4 weeks
Title
The outcomes of reflux symptom index
Description
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.
Time Frame
2 months
Title
Penetration and aspiration scale
Description
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.
Time Frame
Baseline
Title
Yale pharyngeal residue severity rating scale
Description
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.
Time Frame
Baseline
Other Pre-specified Outcome Measures:
Title
Subject demographics
Description
The median values of age and ratio of gender in all groups
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yavuz Atar, Asso Prof,MD
Phone
+905052123297
Email
yavuzatar@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sevgi Atar, MD
Phone
+905052123296
Email
sevgiatar@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yavuz Atar, Asso Prof,MD
Organizational Affiliation
University of Health Sciences, ENT Clinic, Prof Dr Cemil Tascioglu City Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sevgi Atar, MD
Organizational Affiliation
University of Health Sciences, PMR Clinic, Prof Dr Cemil Tascioglu City Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Prof Dr Cemil Tascioglu City Hospital
City
Istanbul
ZIP/Postal Code
34384
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yavuz Atar, Asso Prof,MD
Phone
+905052123297
Email
yavuzatar@gmail.com
First Name & Middle Initial & Last Name & Degree
Sevgi Atar, MD
Phone
+905052123296
Email
sevgiatar@gmail.com
First Name & Middle Initial & Last Name & Degree
Hasan Sami Bircan, MD
First Name & Middle Initial & Last Name & Degree
Yavuz Uyar, Prof., MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
14725135
Citation
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.
Results Reference
background
PubMed Identifier
23088702
Citation
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.
Results Reference
background
Learn more about this trial
The Efficacy of Kinesio Taping With Therapy in the Treatment of Globus Pharyngeus
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