Gastroesophageal Reflux DiseaseNCT03871426
Manual Therapy Effects on Upper and Lower Esophageal Sphincter Pressures
An observational study of Gastroesophageal Reflux Disease and Globus Pharyngeus, run by University Hospital, Motol at 1 site in Czechia.
Trial summary
The aim of this study is to test the influence of manual cervical traction and chest stabilization maneuvers on pressures in upper and lower esophageal sphincters. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroesophageal Reflux Disease, Globus Pharyngeus
- What is being tested?
- manual therapy
- Type of treatment
- Surgery or procedure
- How many people
- 54 participants
- Where
- 1 siteCzechia
- Study dates
- 18 Mar 2019to 13 Jun 2019
- Phase
- Observational
- 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 70 years
- All sexes
- Adult, Older adult
Study population: Gastroesophageal reflux disease
Who may be able to join
- Gastroesophageal reflux disease
Who cannot join
- Previous gastro- esophageal surgery
- Concomitant other chronic disease that would affect esophageal motility
- Esophageal structural pathology
- Massive hiatus hernia
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Rehabilitation and Sports Medicine, University Hospital Motol, Prague, Czech Republic
Prague, 15006
About this study
Official title: Manual Cervical Traction and Trunk Stabilization Causes Significant Changes in Lower and Upper Esophageal Sphincter
The aim of this study is to test the influence of manual cervical traction and chest stabilization maneuvers on pressures in upper and lower esophageal sphincters.
Read the detailed description
High Resolution Manometry (HRM) will be used to measure pressure changes in upper esophageal sphincter (UES) and lower esophageal sphincter (LES) during manual cervical traction and trunk stabilization maneuvers. 50-55 gastroesophageal reflux disease (GERD) subjects will participate in the study. UES and pressures will first be measured in relaxed supine position then, during manual cervical traction and finally, the subjects will undergo manual positioning of the trunk into neutral position and LES and UES pressures will be measured again.
- Conditions
- Gastroesophageal Reflux Disease, Globus Pharyngeus
- Being tested
- manual therapy
- Keywords
- High resolution manometry, globus pharyngeus, gastroesophageal reflux disease, manual cervical traction, trunk stabilization maneuver
- Medical subject headings
- Gastroesophageal Reflux, Globus Sensation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manual therapyProcedure or surgery
Manual Cervical Traction, Trunk Stabilization Maneuver
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure in upper and lower esophageal sphincter
Pressure in upper and lower esophageal sphincter at rest, during cervical manual traction, and during trunk stabilization maneuver
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start18 Mar 2019
- Primary completion13 Jun 2019
- Study completion13 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alena Kobesova, University Hospital, Motol
- Investigators
- Alena Kobesova, MD, PhD, Principal investigator, Department of Rehabilitation and Sports Medicine, University Hospital Motol, Prague, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871426
- Sponsor's protocol ID
- GERD2_2019
- Status last verified
- Jun 2019
- First submitted
- 8 Mar 2019
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bitnar P, Stovicek J, Andel R, Arlt J, Arltova M, Smejkal M, Kolar P, Kobesova A. Leg raise increases pressure in lower and upper esophageal sphincter among patients with gastroesophageal reflux disease. J Bodyw Mov Ther. 2016 Jul;20(3):518-24. doi: 10.1016/j.jbmt.2015.12.002. Epub 2015 Dec 17.
PubMed 27634073
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Cervical Traction and Trunk Stabilization Causes Significant Changes in Lower and Upper Esophageal Sphincter
- ClinicalTrials.gov ID
- NCT03871426
- Acronym / sponsor ID
- GERD2_2019
- Conditions
- Gastroesophageal Reflux Disease, Globus Pharyngeus
- Keywords
- High resolution manometry, globus pharyngeus, gastroesophageal reflux disease, manual cervical traction, trunk stabilization maneuver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 13 Jun 2019 (actual)
- Study completion
- 13 Jun 2019 (actual)
- First posted
- 12 Mar 2019 (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 aim of this study is to test the influence of manual cervical traction and chest stabilization maneuvers on pressures in upper and lower esophageal sphincters.
Detailed description
High Resolution Manometry (HRM) will be used to measure pressure changes in upper esophageal sphincter (UES) and lower esophageal sphincter (LES) during manual cervical traction and trunk stabilization maneuvers. 50-55 gastroesophageal reflux disease (GERD) subjects will participate in the study. UES and pressures will first be measured in relaxed supine position then, during manual cervical traction and finally, the subjects will undergo manual positioning of the trunk into neutral position and LES and UES pressures will be measured again.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Gastroesophageal reflux disease
Key inclusion criteria (1 listed)
- Gastroesophageal reflux disease
Key exclusion criteria (4 listed)
- Previous gastro- esophageal surgery
- Concomitant other chronic disease that would affect esophageal motility
- Esophageal structural pathology
- Massive hiatus hernia
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 |
|---|---|---|
| manual therapyManual Cervical Traction, Trunk Stabilization Maneuver | Procedure or surgery | – |
Primary outcome
Pressure in upper and lower esophageal sphincter
Time frame: up to 6 months
Pressure in upper and lower esophageal sphincter at rest, during cervical manual traction, and during trunk stabilization maneuver
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
- Background: PubMed 27634073Bitnar P, Stovicek J, Andel R, Arlt J, Arltova M, Smejkal M, Kolar P, Kobesova A. Leg raise increases pressure in lower and upper esophageal sphincter among patients with gastroesophageal reflux disease. J Bodyw Mov Ther. 2016 Jul;20(3):518-24. doi: 10.1016/j.jbmt.2015.12.002. Epub 2015 Dec 17.
- Individual participant dataSharing planned: Undecided
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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.
Alena Kobesova, MD, PhD principal investigator
Department of Rehabilitation and Sports Medicine, University Hospital Motol, Prague, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease and Globus Pharyngeus, run by University Hospital, Motol at 1 site in Czechia.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 14 Jun 2019. 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 Czechia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure in upper and lower esophageal sphincter (time frame: up to 6 months). 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 NCT03871426, which also lists 1 linked publication.
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 14 Jun 2019.