Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease

NCT03299985 | Completed

• 1 other identifier: JParraga
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gastroesophageal reflux Disease; Myofascial release; Diaphragm

Outcome Measures

Primary Outcomes (1)

• GERD symptoms

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

  6 weeks

Secondary Outcomes (2)

• Specific quality of life for gastrointestinal disease

  6 weeks

• Drug Usage

  6 weeks

Study Arms (2)

Diaphragmatic myofascial release

EXPERIMENTAL

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

Other: Diaphragmatic myofascial release

Sham myofascial release

SHAM COMPARATOR

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

Interventions

Diaphragmatic myofascial release OTHER

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

Diaphragmatic myofascial release

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

Sham myofascial release

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with the diagnostic of GERD

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Universidad CEU Cardenal Herrera

Valencia, 46113, Spain

Location

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of medicine department

Model Details: double blinded randomized clinical trial

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: October 3, 2017
• Study Start: October 5, 2017
• Primary Completion: March 15, 2018
• Study Completion: March 15, 2018
• Last Updated: October 5, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)