Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional

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.
    


Intervention name(s): Diaphragmatic myofascial release; Sham myofascial release
Intervention type(s): Other; Other
Intervention description(s): Subjects in this arm will receive different myofascial release techniques aimed to normalize the myofascial tension of the diaphragmatic muscle; Subjects in this arm will receive the same manual techniques of the diaphragmatic myofascial release group, but without the myofascial stimulus
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double blinded randomized clinical trial
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gastroesophageal reflux Disease; Myofascial release; Diaphragm