<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03299985</url>
  </required_header>
  <id_info>
    <org_study_id>JParraga</org_study_id>
    <nct_id>NCT03299985</nct_id>
  </id_info>
  <brief_title>Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease</brief_title>
  <acronym>GERD</acronym>
  <official_title>Effects of Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cardenal Herrera University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cardenal Herrera University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a double blinded randomized clinical trial with two arms which aims to study&#xD;
      the effects of diaphragmatic myofascial release in patients with gastroesophageal reflux&#xD;
      disease (GERD).&#xD;
&#xD;
      GERD has become in the last decades a common disease at the occidental world affecting&#xD;
      between 10 to 15% of this population. That implies a high socio-health cost and the decline&#xD;
      of the quality of life of those patients.&#xD;
&#xD;
      The diaphragm muscle surrounds the lower esophageal sphincter, and helps to prevent&#xD;
      gastroesophageal reflux. If one or both structures become incompetent, it may appear GERD.&#xD;
      Until the moment, the treatment for GERD begins by lifestyle modification, and if it fails,&#xD;
      the treatment becomes medical and, in selected cases, surgical.&#xD;
&#xD;
      It exists some studies that have demonstrate that diaphragmatic breathing training can have a&#xD;
      positive effect in GERD and the need of drug usage. But until the moment, the effects of a&#xD;
      myofascial release of the diaphragm haven't been explored on these patients.&#xD;
&#xD;
      Thirty patients with GERD referred from different hospitals of Valencia will be randomized&#xD;
      into two groups:&#xD;
&#xD;
        -  Intervention with myofascial release for the diaphragm&#xD;
&#xD;
        -  Sham treatment group which is going to receive the same number of session treatments&#xD;
           with the same manual techniques, but without the myofascial stimulus The protocol that&#xD;
           will be applied consists of 4 identical sessions of myofascial release techniques aimed&#xD;
           to normalize the myofascial tension of the diaphragmatic muscle. These sessions will be&#xD;
           distributed in two weeks.&#xD;
&#xD;
      The study focuses on the analysis of the following variables:&#xD;
&#xD;
        -  Frequency and intensity of the symptoms of GERD: Reflux Disease Questionnaire (RDQ)&#xD;
&#xD;
        -  Specific quality of life for gastrointestinal disease: Gastrointestinal Quality of life&#xD;
           Index (GIQLI)&#xD;
&#xD;
        -  Drug usage: weekly milligrams usage of proton pomp inhibitors (PPI) The results of these&#xD;
           pre-intervention and post-intervention variables will be compared between the two groups&#xD;
           at baseline (first session), at week 3 and at week 6.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2017</start_date>
  <completion_date type="Actual">March 15, 2018</completion_date>
  <primary_completion_date type="Actual">March 15, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>double blinded randomized clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>GERD symptoms</measure>
    <time_frame>6 weeks</time_frame>
    <description>Frequency and intensity of GERD symptoms measured by the Reflux Disease questionnaire (RDQ)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Specific quality of life for gastrointestinal disease</measure>
    <time_frame>6 weeks</time_frame>
    <description>Gastrointestinal Quality of life Index (GIQLI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug Usage</measure>
    <time_frame>6 weeks</time_frame>
    <description>Weekly milligrams usage of proton pomp inhibitors (PPI)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Gastroesophageal Reflux Disease</condition>
  <arm_group>
    <arm_group_label>Diaphragmatic myofascial release</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this arm will receive different myofascial release techniques aimed to normalize the myofascial tension of the diaphragmatic muscle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham myofascial release</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Subjects in this arm will receive the same manual techniques of the diaphragmatic myofascial release group, but without the myofascial stimulus</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Diaphragmatic myofascial release</intervention_name>
    <description>Subjects in this arm will receive different myofascial release techniques aimed to normalize the myofascial tension of the diaphragmatic muscle</description>
    <arm_group_label>Diaphragmatic myofascial release</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham myofascial release</intervention_name>
    <description>Subjects in this arm will receive the same manual techniques of the diaphragmatic myofascial release group, but without the myofascial stimulus</description>
    <arm_group_label>Sham myofascial release</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with the diagnostic of GERD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hiatal hernia &gt;2 cm&#xD;
&#xD;
          -  previous operation at the LES&#xD;
&#xD;
          -  actual erosive esophagitis&#xD;
&#xD;
          -  Congenital or acquired immune disorders.&#xD;
&#xD;
          -  Allergic status of any kind.&#xD;
&#xD;
          -  Systemic diseases (rheumatic, infectious conditions, febrile state, vascular&#xD;
             alterations, endocrine including diabetes, metabolic and neoplastic).&#xD;
&#xD;
          -  Leukemia.&#xD;
&#xD;
          -  Severe psychiatric disorders.&#xD;
&#xD;
          -  Neuromuscular or neurological injuries.&#xD;
&#xD;
          -  Aneurysms.&#xD;
&#xD;
          -  Abdominal or spine surgery.&#xD;
&#xD;
          -  Vertebral fractures.&#xD;
&#xD;
          -  Osteoporosis (advanced stage).&#xD;
&#xD;
          -  Acute lesions of soft tissues or in an inflammatory state.&#xD;
&#xD;
          -  Open wounds.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Intrauterine device.&#xD;
&#xD;
          -  Patients with corticosteroid therapy.&#xD;
&#xD;
          -  Hemophilia or treatment with anticoagulant therapy.&#xD;
&#xD;
          -  Hypersensitivity of the skin or dermatological diseases in the trunk that&#xD;
             impossibilities the application of the techniques.&#xD;
&#xD;
          -  Rejection of manual contact.&#xD;
&#xD;
          -  Non-Spanish speaking patients.&#xD;
&#xD;
          -  Patients who have previously received some treatment of myofascial release.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Universidad CEU Cardenal Herrera</name>
      <address>
        <city>Valencia</city>
        <zip>46113</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmulling C, Neugebauer E, Troidl H. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg. 1995 Feb;82(2):216-22. doi: 10.1002/bjs.1800820229.</citation>
    <PMID>7749697</PMID>
  </reference>
  <reference>
    <citation>Quintana JM, Cabriada J, Lopez de Tejada I, Varona M, Oribe V, Barrios B, Perdigo L, Bilbao A. Translation and validation of the gastrointestinal Quality of Life Index (GIQLI). Rev Esp Enferm Dig. 2001 Nov;93(11):693-706. English, Spanish.</citation>
    <PMID>11995369</PMID>
  </reference>
  <reference>
    <citation>Shaw M, Dent J, Beebe T, Junghard O, Wiklund I, Lind T, Johnsson F. The Reflux Disease Questionnaire: a measure for assessment of treatment response in clinical trials. Health Qual Life Outcomes. 2008 Apr 30;6:31. doi: 10.1186/1477-7525-6-31.</citation>
    <PMID>18447946</PMID>
  </reference>
  <reference>
    <citation>Nuevo J, Tafalla M, Zapardiel J. [Validation of the Reflux Disease Questionnaire (RDQ) and Gastrointestinal Impact Scale (GIS) in patients with gastroesophageal reflux disease in the Spanish population]. Gastroenterol Hepatol. 2009 Apr;32(4):264-73. doi: 10.1016/j.gastrohep.2008.12.004. Epub 2009 Apr 16. Spanish.</citation>
    <PMID>19371971</PMID>
  </reference>
  <results_reference>
    <citation>da Silva RC, de Sa CC, Pascual-Vaca AO, de Souza Fontes LH, Herbella Fernandes FA, Dib RA, Blanco CR, Queiroz RA, Navarro-Rodriguez T. Increase of lower esophageal sphincter pressure after osteopathic intervention on the diaphragm in patients with gastroesophageal reflux. Dis Esophagus. 2013 Jul;26(5):451-6. doi: 10.1111/j.1442-2050.2012.01372.x. Epub 2012 Jun 7.</citation>
    <PMID>22676647</PMID>
  </results_reference>
  <results_reference>
    <citation>Eherer AJ, Netolitzky F, Hogenauer C, Puschnig G, Hinterleitner TA, Scheidl S, Kraxner W, Krejs GJ, Hoffmann KM. Positive effect of abdominal breathing exercise on gastroesophageal reflux disease: a randomized, controlled study. Am J Gastroenterol. 2012 Mar;107(3):372-8. doi: 10.1038/ajg.2011.420. Epub 2011 Dec 6.</citation>
    <PMID>22146488</PMID>
  </results_reference>
  <results_reference>
    <citation>Arguisuelas MD, Lison JF, Sanchez-Zuriaga D, Martinez-Hurtado I, Domenech-Fernandez J. Effects of Myofascial Release in Nonspecific Chronic Low Back Pain: A Randomized Clinical Trial. Spine (Phila Pa 1976). 2017 May 1;42(9):627-634. doi: 10.1097/BRS.0000000000001897.</citation>
    <PMID>28441294</PMID>
  </results_reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>October 4, 2018</last_update_submitted>
  <last_update_submitted_qc>October 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cardenal Herrera University</investigator_affiliation>
    <investigator_full_name>Juan F. Lisón Párraga, Dr</investigator_full_name>
    <investigator_title>Head of medicine department</investigator_title>
  </responsible_party>
  <keyword>Gastroesophageal reflux Disease</keyword>
  <keyword>Myofascial release</keyword>
  <keyword>Diaphragm</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <mesh_term>Esophagitis, Peptic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03299985
org study id: JParraga
nct id: NCT03299985
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: double blinded randomized clinical trial
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: GERD symptoms
time frame: 6 weeks
description: Frequency and intensity of GERD symptoms measured by the Reflux Disease questionnaire (RDQ)
measure: Specific quality of life for gastrointestinal disease
time frame: 6 weeks
description: Gastrointestinal Quality of life Index (GIQLI)
measure: Drug Usage
time frame: 6 weeks
description: Weekly milligrams usage of proton pomp inhibitors (PPI)
arm group label: Diaphragmatic myofascial release
arm group type: Experimental
description: Subjects in this arm will receive different myofascial release techniques aimed to normalize the myofascial tension of the diaphragmatic muscle
arm group label: Sham myofascial release
arm group type: Sham Comparator
description: Subjects in this arm will receive the same manual techniques of the diaphragmatic myofascial release group, but without the myofascial stimulus
intervention type: Other
intervention name: Diaphragmatic myofascial release
description: Subjects in this arm will receive different myofascial release techniques aimed to normalize the myofascial tension of the diaphragmatic muscle
arm group label: Diaphragmatic myofascial release
intervention type: Other
intervention name: Sham myofascial release
description: Subjects in this arm will receive the same manual techniques of the diaphragmatic myofascial release group, but without the myofascial stimulus
arm group label: Sham myofascial release
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Spain
citation: Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmulling C, Neugebauer E, Troidl H. Gastrointestinal Quality of Life Index: development, validation and application of a new instrument. Br J Surg. 1995 Feb;82(2):216-22. doi: 10.1002/bjs.1800820229.
PMID: 7749697
citation: Quintana JM, Cabriada J, Lopez de Tejada I, Varona M, Oribe V, Barrios B, Perdigo L, Bilbao A. Translation and validation of the gastrointestinal Quality of Life Index (GIQLI). Rev Esp Enferm Dig. 2001 Nov;93(11):693-706. English, Spanish.
PMID: 11995369
citation: Shaw M, Dent J, Beebe T, Junghard O, Wiklund I, Lind T, Johnsson F. The Reflux Disease Questionnaire: a measure for assessment of treatment response in clinical trials. Health Qual Life Outcomes. 2008 Apr 30;6:31. doi: 10.1186/1477-7525-6-31.
PMID: 18447946
citation: Nuevo J, Tafalla M, Zapardiel J. [Validation of the Reflux Disease Questionnaire (RDQ) and Gastrointestinal Impact Scale (GIS) in patients with gastroesophageal reflux disease in the Spanish population]. Gastroenterol Hepatol. 2009 Apr;32(4):264-73. doi: 10.1016/j.gastrohep.2008.12.004. Epub 2009 Apr 16. Spanish.
PMID: 19371971
citation: da Silva RC, de Sa CC, Pascual-Vaca AO, de Souza Fontes LH, Herbella Fernandes FA, Dib RA, Blanco CR, Queiroz RA, Navarro-Rodriguez T. Increase of lower esophageal sphincter pressure after osteopathic intervention on the diaphragm in patients with gastroesophageal reflux. Dis Esophagus. 2013 Jul;26(5):451-6. doi: 10.1111/j.1442-2050.2012.01372.x. Epub 2012 Jun 7.
PMID: 22676647
citation: Eherer AJ, Netolitzky F, Hogenauer C, Puschnig G, Hinterleitner TA, Scheidl S, Kraxner W, Krejs GJ, Hoffmann KM. Positive effect of abdominal breathing exercise on gastroesophageal reflux disease: a randomized, controlled study. Am J Gastroenterol. 2012 Mar;107(3):372-8. doi: 10.1038/ajg.2011.420. Epub 2011 Dec 6.
PMID: 22146488
citation: Arguisuelas MD, Lison JF, Sanchez-Zuriaga D, Martinez-Hurtado I, Domenech-Fernandez J. Effects of Myofascial Release in Nonspecific Chronic Low Back Pain: A Randomized Clinical Trial. Spine (Phila Pa 1976). 2017 May 1;42(9):627-634. doi: 10.1097/BRS.0000000000001897.
PMID: 28441294
responsible party type: Principal Investigator
investigator affiliation: Cardenal Herrera University
investigator full name: Juan F. Lisón Párraga, Dr
investigator title: Head of medicine department
mesh term: Gastroesophageal Reflux
mesh term: Esophagitis, Peptic
sharing ipd: No