The Effect of Physiotherapy on Post POEM Reflux

NCT ID: NCT05326113

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-31
• Study Completion Date: 2025-01-18

Brief 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. 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.

Conditions

Reflux, Gastroesophageal; Achalasia; Esophagitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Physiotherapy

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.

Group Type: EXPERIMENTAL

Physiotherapy

Intervention Type: OTHER

After POEM, patient underwent physiotherapy consisting of diaphragmatic breathing and dynamic stabilization exercises and PPIs

Control group

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.

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: DRUG

All patients will be treated with standard course of PPIs after POEM without physiotherapy.

Interventions

Physiotherapy

After POEM, patient underwent physiotherapy consisting of diaphragmatic breathing and dynamic stabilization exercises and PPIs

Intervention Type: OTHER

Control group

All patients will be treated with standard course of PPIs after POEM without physiotherapy.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. esophageal achalasia (or other primary motility disease) treated by per oral endoscopic myotomy (POEM)

2. symptomatic post-POEM reflux and/or esophagitis LA A/B/C (grade by The Los Angeles Classification) present 3 months after POEM surgery

3. positive finding on esophageal 24hours pH Test 3 months after POEM surgery

4. signed informed consent

Exclusion Criteria

1. reflux symptoms previously to the POEM surgery (except regurgitation)

2. repeated POEM surgery

3. Esophagitis of LA grade D

4. asymptomatic pathologic reflux without signs of esophagitis 3 months post POEM surgery (patient is not indicated to use proton pump inhibitor "PPI" drugs)

5. previous gastric surgery

6. patients undergoing cancer treatment

7. pregnancy

8. known allergy or intolerance of proton pump inhibitor drugs

9. other circumstances preventing participation in the study

10. Inability to obtain informed consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute for Clinical and Experimental Medicine

OTHER_GOV

Sponsor Role: lead

Responsible Party

Doc. (Ass. prof.) Jan Martinek, MD, PhD, AGAF

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kateřina Mádle

Role: PRINCIPAL_INVESTIGATOR

Charles University 2nd faculty of medicine, Prague, Czech Republic

Jan Martínek

Role: PRINCIPAL_INVESTIGATOR

Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic

Zuzana Vacková

Role: PRINCIPAL_INVESTIGATOR

Department of Hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic

Milan Martínek

Role: PRINCIPAL_INVESTIGATOR

Charles University Faculty of Physical Education and Sport

Lucie Zdrhová

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine, Pilsen, Czech Republic

Alena Kobesová

Role: PRINCIPAL_INVESTIGATOR

Charles University 2nd faculty of medicine, Prague, Czech Republic

Locations

Institute for Clinical and Experimental Medicine

Prague, Prague, Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Kateřina Mádle

Role: CONTACT

katerina.madle@gmail.com

00420606613462

Jan Martínek

Role: CONTACT

jan.martinek@volny.cz

00420723708839

Facility Contacts

Jan Martínek, MD. PhD.

Role: primary

jan.martinek@volny.cz

+420723708839

Other Identifiers

IClinicalEM4

Identifier Type: -

Identifier Source: org_study_id