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

July 28, 2021 updated by: Yavuz Atar, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey, 34384
        • Prof Dr Cemil Tascioglu City Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Hasan Sami Bircan, MD
        • Sub-Investigator:
          • Yavuz Uyar, Prof., MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The outcomes of Glasgow Edinburg Throat Scale
Time Frame: Baseline
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
Time Frame: 4 weeks
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
Time Frame: 2 months
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
Time Frame: Baseline
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
Time Frame: 4 weeks
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
Time Frame: 2 months
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
Time Frame: Baseline
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
Time Frame: 4 weeks
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
Time Frame: 2 months
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
Time Frame: Baseline
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
Time Frame: 4 weeks
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
Time Frame: 2 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Eating Assessment Tool
Time Frame: Baseline
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
Time Frame: 4 weeks
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
Time Frame: 2 months
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
Time Frame: Baseline
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
Time Frame: 4 weeks
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
Time Frame: 2 months
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
Time Frame: Baseline
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
Time Frame: 4 weeks
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
Time Frame: 2 months
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
Time Frame: Baseline
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
Time Frame: Baseline
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subject demographics
Time Frame: Baseline
The median values of age and ratio of gender in all groups
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Globus Pharyngeus

Clinical Trials on Kinesio tape

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings