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

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.