Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease

Gastroesophageal Reflux Disease Clinical Trial

— GERD  

Official title:

Effects of Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03299985
• Other study ID #: JParraga
• Status: Completed
• Phase: N/A
• Start date: October 5, 2017
• Est. completion date: March 15, 2018

Study information

• Verified date: October 2018
• Source: Cardenal Herrera University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 15, 2018
• Est. primary completion date: March 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

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

Locations

Country	Name	City	State
Spain	Universidad CEU Cardenal Herrera	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

References & Publications (7)

Arguisuelas MD, Lisón JF, Sánchez-Zuriaga D, Martínez-Hurtado I, Doménech-Fernández 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.00000 — View Citation

da Silva RC, de Sá CC, Pascual-Vaca ÁO, 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 gastroe — View Citation

Eherer AJ, Netolitzky F, Högenauer 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 M — View Citation

Eypasch E, Williams JI, Wood-Dauphinee S, Ure BM, Schmülling 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. — View 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. — View Citation

Quintana JM, Cabriada J, López 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GERD symptoms	Frequency and intensity of GERD symptoms measured by the Reflux Disease questionnaire (RDQ)	6 weeks
Secondary	Specific quality of life for gastrointestinal disease	Gastrointestinal Quality of life Index (GIQLI)	6 weeks
Secondary	Drug Usage	Weekly milligrams usage of proton pomp inhibitors (PPI)	6 weeks