Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease (GERD)

October 4, 2018 updated by: Juan F. Lisón Párraga, Dr, Cardenal Herrera University

Effects of Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46113
        • Universidad CEU Cardenal Herrera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with the diagnostic of GERD

Exclusion Criteria:

  • hiatal hernia >2 cm
  • previous operation at the LES
  • actual erosive esophagitis
  • Congenital or acquired immune disorders.
  • Allergic status of any kind.
  • Systemic diseases (rheumatic, infectious conditions, febrile state, vascular alterations, endocrine including diabetes, metabolic and neoplastic).
  • Leukemia.
  • Severe psychiatric disorders.
  • Neuromuscular or neurological injuries.
  • Aneurysms.
  • Abdominal or spine surgery.
  • Vertebral fractures.
  • Osteoporosis (advanced stage).
  • Acute lesions of soft tissues or in an inflammatory state.
  • Open wounds.
  • Pregnancy.
  • Intrauterine device.
  • Patients with corticosteroid therapy.
  • Hemophilia or treatment with anticoagulant therapy.
  • Hypersensitivity of the skin or dermatological diseases in the trunk that impossibilities the application of the techniques.
  • Rejection of manual contact.
  • Non-Spanish speaking patients.
  • Patients who have previously received some treatment of myofascial release.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diaphragmatic myofascial release
Subjects in this arm will receive different myofascial release techniques aimed to normalize the myofascial tension of the diaphragmatic muscle
Other: Diaphragmatic myofascial release
Subjects in this arm will receive different myofascial release techniques aimed to normalize the myofascial tension of the diaphragmatic muscle
Sham Comparator: Sham myofascial release
Subjects in this arm will receive the same manual techniques of the diaphragmatic myofascial release group, but without the myofascial stimulus
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GERD symptoms
Time Frame: 6 weeks
Frequency and intensity of GERD symptoms measured by the Reflux Disease questionnaire (RDQ)
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specific quality of life for gastrointestinal disease
Time Frame: 6 weeks
Gastrointestinal Quality of life Index (GIQLI)
6 weeks
Drug Usage
Time Frame: 6 weeks
Weekly milligrams usage of proton pomp inhibitors (PPI)
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardenal Herrera University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2017

Primary Completion (Actual)

March 15, 2018

Study Completion (Actual)

March 15, 2018

Study Registration Dates

First Submitted

September 25, 2017

First Submitted That Met QC Criteria

September 27, 2017

First Posted (Actual)

October 3, 2017

Study Record Updates

Last Update Posted (Actual)

October 5, 2018

Last Update Submitted That Met QC Criteria

October 4, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JParraga

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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