Globus PharyngeusNCT04768205
The Efficacy of Kinesio Taping With Therapy in the Treatment of Globus Pharyngeus
A study testing Kinesio tape in people with Globus Pharyngeus, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Globus Pharyngeus
- What is being tested?
- Kinesio tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2021to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with globus pharyngeus
- 18 -65 years
- give a consent form
Who cannot join
- patients with dysphagia or odynophagia
- laryngeal organic pathologies
- pharyngeal organic pathologies
- epiglottic retroversion
- malignancy
- pregnancy
Show all 10Show fewer
- mental disorders
- neurological disorders
- major psychiatric disorders
- give not a consent form
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof Dr Cemil Tascioglu City Hospital
Istanbul, 34384
Yavuz Atar, Asso Prof,MD, +905052123297, yavuzatar@gmail.com
Sevgi Atar, MD, +905052123296, sevgiatar@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Globus Pharyngeus
- Being tested
- Kinesio tape
- Keywords
- kinesio taping, globus, globus pharyngeus, sensation, therapy
- Medical subject headings
- Globus Sensation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tapeDevice
The Kinesio tex tape is a medical tape that had been certified and patented.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | The therapy and Kinesio tex gold tape that was affixed to stretched and neck localised were applied Receives: 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 Receives: Device: Kinesio tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 months
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start30 Aug 2021 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Globus PharyngeusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yavuz Atar, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Investigators
- Yavuz Atar, Asso Prof,MD, Study chair, University of Health Sciences, ENT Clinic, Prof Dr Cemil Tascioglu City HospitalSevgi Atar, MD, Study director, University of Health Sciences, PMR Clinic, Prof Dr Cemil Tascioglu City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768205
- Sponsor's protocol ID
- 60
- Status last verified
- Jul 2021
- First submitted
- 20 Feb 2021
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 14725135Morris 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.
PubMed 23088702
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Kinesio Taping With Therapy in the Treatment of Globus Pharyngeus: a Randomized Sham-controlled Trial
- ClinicalTrials.gov ID
- NCT04768205
- Acronym / sponsor ID
- 60
- Conditions
- Globus Pharyngeus
- Keywords
- kinesio taping, globus, globus pharyngeus, sensation, therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 30 Aug 2021 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Device: Kinesio tapeThe therapy and Kinesio tex gold tape that was affixed to stretched and neck localised were applied |
| Sham control group | Placebo comparator | Device: Kinesio tapeThe therapy and Kinesio tex gold tape that was affixed to different neck localised as no-stretched were applied |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosed with globus pharyngeus
- 18 -65 years
- give a consent form
Key exclusion criteria (10 listed)
- patients with dysphagia or odynophagia
- laryngeal organic pathologies
- pharyngeal organic pathologies
- epiglottic retroversion
- malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesio tapeThe Kinesio tex tape is a medical tape that had been certified and patented. | Device | Sham control group, Study group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
11 secondary outcomes
Eating Assessment Tool
Time frame: Baseline
Eating Assessment Tool
Time frame: 4 weeks
Eating Assessment Tool
Time frame: 2 months
The outcomes of voice handicap index - 10
Time frame: Baseline
The outcomes of voice handicap index - 10
Time frame: 4 weeks
The outcomes of voice handicap index - 10
Time frame: 2 months
The outcomes of reflux symptom index
Time frame: Baseline
The outcomes of reflux symptom index
Time frame: 4 weeks
The outcomes of reflux symptom index
Time frame: 2 months
Penetration and aspiration scale
Time frame: Baseline
Yale pharyngeal residue severity rating scale
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Background: PubMed 14725135Khalil 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.
- Background: PubMed 23088702Morris 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yavuz Atar, Asso Prof,MD study chair
University of Health Sciences, ENT Clinic, Prof Dr Cemil Tascioglu City Hospital
Sevgi Atar, MD study director
University of Health Sciences, PMR Clinic, Prof Dr Cemil Tascioglu City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio tape in people with Globus Pharyngeus, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yavuz Atar, Asso Prof,MD (+905052123297, yavuzatar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The outcomes of Glasgow Edinburg Throat Scale (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04768205, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.