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NCT Number: NCT03299985

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.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad CEU Cardenal Herrera

Valencia, 46113, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diaphragmatic Myofascial Release

Other

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

Sham myofascial release

Other

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

Primary outcomes

  1. GERD symptoms

    Time frame: 6 weeks

    Frequency and intensity of GERD symptoms measured by the Reflux Disease questionnaire (RDQ)

Secondary outcomes

  1. Specific quality of life for gastrointestinal disease

    Time frame: 6 weeks

    Gastrointestinal Quality of life Index (GIQLI)

  2. Drug Usage

    Time frame: 6 weeks

    Weekly milligrams usage of proton pomp inhibitors (PPI)

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Official study title

Effects of Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease

Acronym: GERD

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 3, 2017
Registry last updated
Oct 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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