CompletedNCT03299985GERDUpdated Oct 5, 2018

Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease

An interventional study of Diaphragmatic myofascial release and Sham myofascial release in Gastroesophageal Reflux Disease, sponsored by Cardenal Herrera University. Completed at 1 site in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-10-05.

Sponsored by Cardenal Herrera University · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 30
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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 studied

Gastroesophageal Reflux Disease

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Keywords

Gastroesophageal reflux Disease
Myofascial release
Diaphragm

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Patients with the diagnostic of GERD

Exclusion criteria

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 30 participants (actual)

Study arms

Experimental
Diaphragmatic myofascial release
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 comparator
Sham myofascial release
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

OtherDiaphragmatic myofascial release
Subjects in this arm will receive different myofascial release techniques aimed to normalize the myofascial tension of the diaphragmatic muscle
OtherSham myofascial release
Subjects in this arm will receive the same manual techniques of the diaphragmatic myofascial release group, but without the myofascial stimulus

What researchers measure

Primary outcomes

GERD symptoms
Frequency and intensity of GERD symptoms measured by the Reflux Disease questionnaire (RDQ)
Time frame: 6 weeks

Secondary outcomes

Specific quality of life for gastrointestinal disease
Gastrointestinal Quality of life Index (GIQLI)
Time frame: 6 weeks
Drug Usage
Weekly milligrams usage of proton pomp inhibitors (PPI)
Time frame: 6 weeks

Study locations

1 site

Universidad CEU Cardenal Herrera
Valencia, 46113, Spain

References and documents

Publications

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. PubMed 7749697 ↗
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. PubMed 11995369 ↗
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. PubMed 18447946 ↗
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. PubMed 19371971 ↗
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. PubMed 22676647 ↗
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. PubMed 22146488 ↗
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. PubMed 28441294 ↗

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03299985
Lead sponsor: Cardenal Herrera University
Responsible party: Juan F. Lisón Párraga, Dr (Head of medicine department, Cardenal Herrera University) — Principal investigator
First posted: Oct 3, 2017
Start date: Oct 5, 2017
Primary completion: Mar 15, 2018
Completion: Mar 15, 2018
Last update: Oct 5, 2018

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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