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Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease

NCT03299985 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-10-05

No results posted yet for this study

Summary

This study is a double blinded randomized clinical trial with two arms which aims to study the effects of diaphragmatic myofascial release in patients with gastroesophageal reflux disease (GERD).

GERD has become in the last decades a common disease at the occidental world affecting between 10 to 15% of this population. That implies a high socio-health cost and the decline of the quality of life of those patients.

The diaphragm muscle surrounds the lower esophageal sphincter, and helps to prevent gastroesophageal reflux. If one or both structures become incompetent, it may appear GERD. Until the moment, the treatment for GERD begins by lifestyle modification, and if it fails, the treatment becomes medical and, in selected cases, surgical.

It exists some studies that have demonstrate that diaphragmatic breathing training can have a positive effect in GERD and the need of drug usage. But until the moment, the effects of a myofascial release of the diaphragm haven't been explored on these patients.

Thirty patients with GERD referred from different hospitals of Valencia will be randomized into two groups:

* Intervention with myofascial release for the diaphragm
* Sham treatment group which is going to receive the same number of session treatments with the same manual techniques, but without the myofascial stimulus The protocol that will be applied consists of 4 identical sessions of myofascial release techniques aimed to normalize the myofascial tension of the diaphragmatic muscle. These sessions will be distributed in two weeks.

The study focuses on the analysis of the following variables:

* Frequency and intensity of the symptoms of GERD: Reflux Disease Questionnaire (RDQ)
* Specific quality of life for gastrointestinal disease: Gastrointestinal Quality of life Index (GIQLI)
* Drug usage: weekly milligrams usage of proton pomp inhibitors (PPI) The results of these pre-intervention and post-intervention variables will be compared between the two groups at baseline (first session), at week 3 and at week 6.

Conditions

  • Gastroesophageal Reflux Disease

Interventions

OTHER

Diaphragmatic myofascial release

Subjects in this arm will receive different myofascial release techniques aimed to normalize the myofascial tension of the diaphragmatic muscle

OTHER

Sham myofascial release

Subjects in this arm will receive the same manual techniques of the diaphragmatic myofascial release group, but without the myofascial stimulus

Sponsors & Collaborators

  • Cardenal Herrera University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-05
Primary Completion
2018-03-15
Completion
2018-03-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03299985 on ClinicalTrials.gov