GlobusNCT04436146
The Effect of Laryngeal Manual Therapy as a Management of Globus
A study testing laryngeal manual therapies in people with Globus, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
The purpose of this study is to assess the effect of laryngeal manual therapies in the treatment of globus (sensation of a lump in the throat). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Globus
- What is being tested?
- laryngeal manual therapies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2022to 1 Jul 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients more than 18 years old
- male and females
- patients complaning from Globus without an organic cause
- patients who underwent throat endoscopy and was normal.
- Patients who received conventional drug therapy without benefit.
- Globus complaints more than two months .
Who cannot join
- below 18
- Patients diagnosed with reflux(as a cause to globus)
- Patients who considered at high risk of reflux according to REFLUX SYMPTOM INDEX (RSI) more than 13
- patients who diagnosed with reflux and improved after anti-reflux manegment .
- patients with laryngeal disease/finding that can explain the globus.
- patients with organic cause that can explain the globus .
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Haemek Medical Center
Afula
Miki Paker, MD, 972-4-6494311, MIKI_PA@clalit.org.il
Miki Paker, MD
About this study
Official title: The Effect of Laryngeal Manual Therapy as a Management of Globus(Sensation of a Lump in the Throat )- COMPARATIVE PROSPECTIVE STUDY
The purpose of this study is to assess the effect of laryngeal manual therapies in the treatment of globus (sensation of a lump in the throat).
Read the detailed description
This is a prospective study that include patients who met the inclusion criteria.
Data collection includes patients age,gender,clinical manifistations,laboratory parameters and treatment.
An endoscopic examination will be done by an expert Otolaryngologist. for each patients we will perform one session of laryngeal manual massage therapy by an expert in the field .
- Conditions
- Globus
- Being tested
- laryngeal manual therapies
- Medical subject headings
- Globus Sensation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laryngeal manual therapiesOther
The laryngeal manual therapy incorporates massaging the laryngeal muscles thus reducing excessive tension in the laryngeal and perilaryngeal musculature in patients with globus .
| Study group | Role | What they receive |
|---|---|---|
| laryngeal manual therapies | Other | The laryngeal manual therapy incorporates massaging the laryngeal muscles thus reducing excessive tension in the laryngeal and perilaryngeal musculature in patients with globus . Receives: Other: laryngeal manual therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From symptomatic to asymptomatic patient
after one therapy session we will evaluate the effect of the therapy on the patients .
Measured: baseline and week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start1 Mar 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlobusStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paker Miki, HaEmek Medical Center, Israel
- Investigators
- Miki Paker, MD, Principal investigator, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436146
- Sponsor's protocol ID
- EMC-20-0014
- Status last verified
- Aug 2022
- First submitted
- 16 Jun 2020
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laryngeal Manual Therapy as a Management of Globus(Sensation of a Lump in the Throat )- COMPARATIVE PROSPECTIVE STUDY
- ClinicalTrials.gov ID
- NCT04436146
- Acronym / sponsor ID
- EMC-20-0014
- Conditions
- Globus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 17 Jun 2020 (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.
The purpose of this study is to assess the effect of laryngeal manual therapies in the treatment of globus (sensation of a lump in the throat).
Detailed description
This is a prospective study that include patients who met the inclusion criteria.
Data collection includes patients age,gender,clinical manifistations,laboratory parameters and treatment.
An endoscopic examination will be done by an expert Otolaryngologist. for each patients we will perform one session of laryngeal manual massage therapy by an expert in the field .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| laryngeal manual therapies | Other | Other: laryngeal manual therapiesThe laryngeal manual therapy incorporates massaging the laryngeal muscles thus reducing excessive tension in the laryngeal and perilaryngeal musculature in patients with globus . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients more than 18 years old
- male and females
- patients complaning from Globus without an organic cause
- patients who underwent throat endoscopy and was normal.
- Patients who received conventional drug therapy without benefit.
Key exclusion criteria (6 listed)
- below 18
- Patients diagnosed with reflux(as a cause to globus)
- Patients who considered at high risk of reflux according to REFLUX SYMPTOM INDEX (RSI) more than 13
- patients who diagnosed with reflux and improved after anti-reflux manegment .
- patients with laryngeal disease/finding that can explain the globus.
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 |
|---|---|---|
| laryngeal manual therapiesThe laryngeal manual therapy incorporates massaging the laryngeal muscles thus reducing excessive tension in the laryngeal and perilaryngeal musculature in patients with globus . | Other | laryngeal manual therapies |
Primary outcome
Change From symptomatic to asymptomatic patient
Time frame: baseline and week 1
after one therapy session we will evaluate the effect of the therapy on the patients .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
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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.
Miki Paker, MD principal investigator
HaEmek Medical Center, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laryngeal manual therapies in people with Globus, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 6 inclusion and 6 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 3 Aug 2022. 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 Israel. 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. 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 Rami Ghanayim, MD (00972543443190, rami115@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From symptomatic to asymptomatic patient (time frame: baseline and week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2022.