The Effect of Physiotherapy on Post POEM Reflux

NCT05326113 | Recruiting DMC

• 1 other identifier: IClinicalEM4
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Reflux, Gastroesophageal; Achalasia; Esophagitis

Keywords

Per-oral endoscopic myotomy; Reflux; Physiotherapy; Proton pump inhibitors; Diapraghm; Achalasia; Lower esophageal sphincter

Outcome Measures

Primary Outcomes (1)

• 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

  9-10 months

Secondary Outcomes (2)

• Comparison of diagnostic examinations

  9-10 month

• Comparison of questionnaires

  9-10 months

Study Arms (2)

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.

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.

Drug: Control group

Interventions

Physiotherapy OTHER

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

Physiotherapy

Control group DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• pregnancy
• known allergy or intolerance of proton pump inhibitor drugs
• other circumstances preventing participation in the study
• Inability to obtain informed consent

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Study Sites (1)

Institute for Clinical and Experimental Medicine

Prague, Prague, 14021, Czechia

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux; Esophageal Achalasia; Esophagitis

Interventions

Physical Therapy Modalities; Control Groups

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Kateřina Mádle

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

  PRINCIPAL INVESTIGATOR

• Jan Martínek

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

  PRINCIPAL INVESTIGATOR

• Zuzana Vacková

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

  PRINCIPAL INVESTIGATOR

• Milan Martínek

  Charles University Faculty of Physical Education and Sport

  PRINCIPAL INVESTIGATOR

• Lucie Zdrhová

  Department of Internal Medicine, Pilsen, Czech Republic

  PRINCIPAL INVESTIGATOR

• Alena Kobesová

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kateřina Mádle

CONTACT

00420606613462; katerina.madle@gmail.com

Jan Martínek

CONTACT

00420723708839; jan.martinek@volny.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: April 13, 2022
• Study Start: October 31, 2021
• Primary Completion: August 18, 2024
• Study Completion: January 18, 2025
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

CZ (1)