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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:
The study focuses on the analysis of the following variables:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diaphragmatic myofascial release | Experimental | Subjects in this arm will receive different myofascial release techniques aimed to normalize the myofascial tension of the diaphragmatic muscle |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diaphragmatic myofascial release | Other | Subjects in this arm will receive different myofascial release techniques aimed to normalize the myofascial tension of the diaphragmatic muscle |
| Measure | Description | Time Frame |
|---|---|---|
| GERD symptoms | Frequency and intensity of GERD symptoms measured by the Reflux Disease questionnaire (RDQ) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Specific quality of life for gastrointestinal disease | Gastrointestinal Quality of life Index (GIQLI) | 6 weeks |
| Drug Usage | Weekly milligrams usage of proton pomp inhibitors (PPI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad CEU Cardenal Herrera | Valencia | 46113 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7749697 | Background | 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. | |
| 11995369 | 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. |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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double blinded randomized clinical trial
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| 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 |
|
| 6 weeks |
| 18447946 | 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. |
| 19371971 | 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. |
| 22676647 | Result | 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. |
| 22146488 | 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. |
| 28441294 | 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. |
| D004066 | Digestive System Diseases |