Reflux, GastroesophagealNCT05326113
The Effect of Physiotherapy on Post POEM Reflux
A study testing Physiotherapy in people with Reflux, Gastroesophageal and Achalasia, run by Institute for Clinical and Experimental Medicine at 1 site in Czechia.
Trial summary
Per-oral endoscopic myotomy has been used as a treatment method of esophageal achalasia. Patients who undergo POEM as a treatment of achalasia are often presented with development of reflux as a side effect of the surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Reflux, Gastroesophageal, Achalasia, Esophagitis
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- 31 Oct 2021to 18 Jan 2025
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- esophageal achalasia (or other primary motility disease) treated by per oral endoscopic myotomy (POEM)
- symptomatic post-POEM reflux and/or esophagitis LA A/B/C (grade by The Los Angeles Classification) present 3 months after POEM surgery
- positive finding on esophageal 24hours pH Test 3 months after POEM surgery
- signed informed consent
Who cannot join
- reflux symptoms previously to the POEM surgery (except regurgitation)
- repeated POEM surgery
- Esophagitis of LA grade D
- asymptomatic pathologic reflux without signs of esophagitis 3 months post POEM surgery (patient is not indicated to use proton pump inhibitor "PPI" drugs)
- previous gastric surgery
- patients undergoing cancer treatment
Show all 10Show fewer
- pregnancy
- known allergy or intolerance of proton pump inhibitor drugs
- other circumstances preventing participation in the study
- Inability to obtain informed consent
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Institute for Clinical and Experimental Medicine
Prague, Prague, 14021
Jan Martínek, MD. PhD., +420723708839, jan.martinek@volny.cz
About this study
Official title: Effect of Physiotherapy on the Usage of Proton Pump Inhibitors and Changes in the Pressure of the Lower Esophageal Sphincter in Patients With Achalasia After Per Oral Endoscopic Myotomy
Per-oral endoscopic myotomy has been used as a treatment method of esophageal achalasia. Patients who undergo POEM as a treatment of achalasia are often presented with development of reflux as a side effect of the surgery. Patients are then in need to use proton pump inhibitor drugs as a long term treatment of the reflux symptoms.
Physiotherapy aimed on the strengthening of diaphragm and lower esophageal region is effective in gastroesophageal reflux disease. Therefore we are expecting positive effect of physiotherapy in post POEM patients with reflux symptoms and the possible reduction of PPI drug usage need.
The aim of the study is to objectify the effect of physiotherapy, to describe in detail the used physiotherapeutic techniques and to develop practical guidelines for the treatment of patients after POEM with GERD.
Read the detailed description
The goal per-oral endoscopic myotomy (POEM) is to release a non-relaxing, often spastic lower esophageal sphincter (LES). During POEM an incision of the esophageal muscle layer (m.propria) is performed using the submucosal tunnel technique.
A complication of POEM is the development of reflux, which occurs in up to 50% of patients (within 12 months), with the occurrence of severe esophagitis being rare. However, patients are treated with proton pump inhibitors (PPIs) after POEM, either daily or on-demand. As a result, patients after POEM are regularly monitored for the possible development of symptomatic or asymptomatic reflux, which (if left untreated) can lead to the development of complications, including Barrett's esophagus, a known precancerous lesion.
The main reason for reflux in patients after POEM is an insufficient function of the LES, which is formed not only by the smooth muscle of the esophagus, but also by the skeletal muscle- diaphragm, which remains intact during the POEM itself. Together, these two structures form a major component of antireflux barriers. Since the crural part of the diaphragm is a skeletal striated muscle, it is a trainable muscle.
The study will involve 30 patients after POEM with diagnosed reflux. Three months after POEM patients undergo follow-up examinations using high resolution manometry, 24hours pH test for reflux and gastroscopy. Based on the results of the examination in the 3rd month after the POEM, those who meet the inclusion criteria, will be offered to participate in this study. Patients will be asked to fill in the quality of life questionnaire of patients after POEM and the validated questionnaire for patients with reflux disease. Patients will be randomized in 2 groups (15 in both arms, ratio 1:1), one group will undergo 4 months of physiotherapy treatment using PPI on demand, second group will be a control group undergoing standard treatment of reflux symptoms with PPI on demand.
This study will evaluate the effect of standard treatment of post-POEM esophageal reflux compared to the effect of physiotherapy using dynamic neuromuscular stabilization in post-POEM patients with esophageal reflux.
There is currently no study looking at the effect of physiotherapy in post-POEM patients, we believe this could be a beneficial study.
If this study demonstrates that physiotherapy alleviates the symptoms of post-POEM reflux, it could be one of the official methods of treatment for this group of patients and thus significantly increase their quality of life.
- Conditions
- Reflux, Gastroesophageal, Achalasia, Esophagitis
- Being tested
- Physiotherapy, Control group
- Keywords
- Per-oral endoscopic myotomy, Reflux, Physiotherapy, Proton pump inhibitors, Diapraghm, Achalasia, Lower esophageal sphincter
- Medical subject headings
- Gastroesophageal Reflux, Esophageal Achalasia, Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
After POEM, patient underwent physiotherapy consisting of diaphragmatic breathing and dynamic stabilization exercises and PPIs
Control groupDrug
All patients will be treated with standard course of PPIs after POEM without physiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy | Experimental | Patients will undergo physiotherapy and will be regularly examined by an assigned physician.
Initial physiotherapy will last 60minutes, other therapies will last 30minutes. Physiotherapy will aim on diaphragmatic breathing and dynamic neuromuscular stabilization exercises. In the 1st month, the patient attends physiotherapy once a week In the 2nd, 3rd and 4th month, the patient attends physiotherapy once every 14 days.
Symptomatic patients will take PPIs based on the recommendation of the treating physician who will recommend a dose of PPIs. Used PPIs will be Emanera 1x40mg (standard dose), 2x40mg (higher dose) or 1x40mg on demand.
During the follow-up period, patients may, in agreement with the attending physician, reduce the dose of PPIs (from twice a day to once a day, from once a day to an "on-demand" regime or discontinue them altogether).
The use of PPIs will be accurately documented. Receives: Other: Physiotherapy |
| Control group | Active comparator | Control group will undergo standard treatment of reflux with PPIs and will be regularly examined by an assigned physician.
Symptomatic patients will take PPIs based on the recommendation of the treating physician who will recommend a dose of PPIs. Used PPIs will be Emanera 1x40mg (standard dose), 2x40mg (higher dose) or 1x40mg on demand.
All patients with esophagitis LA A/B/C will be treated with IPP-Emanera 1x40mg for at least 6 weeks at the start of the study.
During the follow-up period, patients may, in agreement with the attending physician, reduce the dose of PPIs (from twice a day to once a day, from once a day to an "on-demand" regime or discontinue them altogether).
The use of PPIs will be accurately documented. Receives: Drug: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of proton pump inhibitor drugs usage in experimental and control group
Rate of use of IPP and only Emanera 2x40mg (higher dose), 1X40mg (standard dose), or 1x40 mg in case of problems or completely discontinue IPP
Measured: 9-10 months
Secondary outcomes (2)
Comparison of diagnostic examinations
The secondary outputs will be the results of high resolution manometry examinations, where we monitor changes in pressure in the lower esophageal sphincter area and esophageal motility. The positivity and reflux rate will be demonstrated by 24hours pH testing and evaluated according to the De Meester score. Gastroscopy to evaluate the absence or presence of esophagitis.
Measured: 9-10 month
Comparison of questionnaires
Evaluation of the Quality of life questionnaire of patients after POEM. Evaluation of the validated questionnaire for gastroesophageal reflux disease.
Measured: 9-10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start31 Oct 2021
- Primary completion18 Aug 2024 (estimated)
- Study completion18 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reflux, GastroesophagealStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Doc. (Ass. prof.) Jan Martinek, MD, PhD, AGAF, Institute for Clinical and Experimental Medicine
- Investigators
- Kateřina Mádle, Principal investigator, Charles University 2nd faculty of medicine, Prague, Czech RepublicJan Martínek, Principal investigator, Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech RepublicZuzana Vacková, Principal investigator, Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech RepublicMilan Martínek, Principal investigator, Charles University Faculty of Physical Education and SportLucie Zdrhová, Principal investigator, Department of Internal Medicine, Pilsen, Czech RepublicAlena Kobesová, Principal investigator, Charles University 2nd faculty of medicine, Prague, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326113
- Sponsor's protocol ID
- IClinicalEM4
- Status last verified
- Mar 2024
- First submitted
- 15 Mar 2022
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Physiotherapy on the Usage of Proton Pump Inhibitors and Changes in the Pressure of the Lower Esophageal Sphincter in Patients With Achalasia After Per Oral Endoscopic Myotomy
- ClinicalTrials.gov ID
- NCT05326113
- Acronym / sponsor ID
- IClinicalEM4
- Conditions
- Reflux, Gastroesophageal, Achalasia, Esophagitis
- Keywords
- Per-oral endoscopic myotomy, Reflux, Physiotherapy, Proton pump inhibitors, Diapraghm, Achalasia, Lower esophageal sphincter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Study start
- 31 Oct 2021 (actual)
- Primary completion
- 18 Aug 2024 (estimated)
- Study completion
- 18 Jan 2025 (estimated)
- First posted
- 13 Apr 2022 (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.
Per-oral endoscopic myotomy has been used as a treatment method of esophageal achalasia. Patients who undergo POEM as a treatment of achalasia are often presented with development of reflux as a side effect of the surgery. Patients are then in need to use proton pump inhibitor drugs as a long term treatment of the reflux symptoms.
Physiotherapy aimed on the strengthening of diaphragm and lower esophageal region is effective in gastroesophageal reflux disease. Therefore we are expecting positive effect of physiotherapy in post POEM patients with reflux symptoms and the possible reduction of PPI drug usage need.
The aim of the study is to objectify the effect of physiotherapy, to describe in detail the used physiotherapeutic techniques and to develop practical guidelines for the treatment of patients after POEM with GERD.
Detailed description
The goal per-oral endoscopic myotomy (POEM) is to release a non-relaxing, often spastic lower esophageal sphincter (LES). During POEM an incision of the esophageal muscle layer (m.propria) is performed using the submucosal tunnel technique.
A complication of POEM is the development of reflux, which occurs in up to 50% of patients (within 12 months), with the occurrence of severe esophagitis being rare. However, patients are treated with proton pump inhibitors (PPIs) after POEM, either daily or on-demand. As a result, patients after POEM are regularly monitored for the possible development of symptomatic or asymptomatic reflux, which (if left untreated) can lead to the development of complications, including Barrett's esophagus, a known precancerous lesion.
The main reason for reflux in patients after POEM is an insufficient function of the LES, which is formed not only by the smooth muscle of the esophagus, but also by the skeletal muscle- diaphragm, which remains intact during the POEM itself. Together, these two structures form a major component of antireflux barriers. Since the crural part of the diaphragm is a skeletal striated muscle, it is a trainable muscle.
The study will involve 30 patients after POEM with diagnosed reflux. Three months after POEM patients undergo follow-up examinations using high resolution manometry, 24hours pH test for reflux and gastroscopy. Based on the results of the examination in the 3rd month after the POEM, those who meet the inclusion criteria, will be offered to participate in this study. Patients will be asked to fill in the quality of life questionnaire of patients after POEM and the validated questionnaire for patients with reflux disease. Patients will be randomized in 2 groups (15 in both arms, ratio 1:1), one group will undergo 4 months of physiotherapy treatment using PPI on demand, second group will be a control group undergoing standard treatment of reflux symptoms with PPI on demand.
This study will evaluate the effect of standard treatment of post-POEM esophageal reflux compared to the effect of physiotherapy using dynamic neuromuscular stabilization in post-POEM patients with esophageal reflux.
There is currently no study looking at the effect of physiotherapy in post-POEM patients, we believe this could be a beneficial study.
If this study demonstrates that physiotherapy alleviates the symptoms of post-POEM reflux, it could be one of the official methods of treatment for this group of patients and thus significantly increase their quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy | Experimental | Other: PhysiotherapyPatients will undergo physiotherapy and will be regularly examined by an assigned physician. Initial physiotherapy will last 60minutes, other therapies will last 30minutes. Physiotherapy will aim on diaphragmatic breathing and dynamic neuromuscular stabilization exercises. In the 1st month, the patient attends physiotherapy once a week In the 2nd, 3rd and 4th month, the patient attends physiotherapy once every 14 days. Symptomatic patients will take PPIs based on the recommendation of the treating physician who will recommend a dose of PPIs. Used PPIs will be Emanera 1x40mg (standard dose), 2x40mg (higher dose) or 1x40mg on demand. During the follow-up period, patients may, in agreement with the attending physician, reduce the dose of PPIs (from twice a day to once a day, from once a day to an "on-demand" regime or discontinue them altogether). The use of PPIs will be accurately documented. |
| Control group | Active comparator | Drug: Control groupControl group will undergo standard treatment of reflux with PPIs and will be regularly examined by an assigned physician. Symptomatic patients will take PPIs based on the recommendation of the treating physician who will recommend a dose of PPIs. Used PPIs will be Emanera 1x40mg (standard dose), 2x40mg (higher dose) or 1x40mg on demand. All patients with esophagitis LA A/B/C will be treated with IPP-Emanera 1x40mg for at least 6 weeks at the start of the study. During the follow-up period, patients may, in agreement with the attending physician, reduce the dose of PPIs (from twice a day to once a day, from once a day to an "on-demand" regime or discontinue them altogether). The use of PPIs will be accurately documented. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- esophageal achalasia (or other primary motility disease) treated by per oral endoscopic myotomy (POEM)
- symptomatic post-POEM reflux and/or esophagitis LA A/B/C (grade by The Los Angeles Classification) present 3 months after POEM surgery
- positive finding on esophageal 24hours pH Test 3 months after POEM surgery
- signed informed consent
Key exclusion criteria (10 listed)
- reflux symptoms previously to the POEM surgery (except regurgitation)
- repeated POEM surgery
- Esophagitis of LA grade D
- asymptomatic pathologic reflux without signs of esophagitis 3 months post POEM surgery (patient is not indicated to use proton pump inhibitor "PPI" drugs)
- previous gastric surgery
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 |
|---|---|---|
| PhysiotherapyAfter POEM, patient underwent physiotherapy consisting of diaphragmatic breathing and dynamic stabilization exercises and PPIs | Other | Physiotherapy |
| Control groupAll patients will be treated with standard course of PPIs after POEM without physiotherapy. | Drug | Control group |
Primary outcome
Comparison of proton pump inhibitor drugs usage in experimental and control group
Time frame: 9-10 months
Rate of use of IPP and only Emanera 2x40mg (higher dose), 1X40mg (standard dose), or 1x40 mg in case of problems or completely discontinue IPP
2 secondary outcomes
Comparison of diagnostic examinations
Time frame: 9-10 month
Comparison of questionnaires
Time frame: 9-10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- 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.
Kateřina Mádle principal investigator
Charles University 2nd faculty of medicine, Prague, Czech Republic
Jan Martínek principal investigator
Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
Zuzana Vacková principal investigator
Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Reflux, Gastroesophageal and Achalasia, run by Institute for Clinical and Experimental Medicine 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 4 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 7 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kateřina Mádle (00420606613462, katerina.madle@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of proton pump inhibitor drugs usage in experimental and control group (time frame: 9-10 months). 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 7 Mar 2024.