Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease (GERD)
Primary Purpose
Gastroesophageal Reflux Disease
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Diaphragmatic myofascial release
Sham myofascial release
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring Gastroesophageal reflux Disease, Myofascial release, Diaphragm
Eligibility Criteria
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.
Sites / Locations
- Universidad CEU Cardenal Herrera
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Diaphragmatic myofascial release
Sham myofascial release
Arm Description
Subjects in this arm will receive different myofascial release techniques aimed to normalize the myofascial tension of the diaphragmatic muscle
Subjects in this arm will receive the same manual techniques of the diaphragmatic myofascial release group, but without the myofascial stimulus
Outcomes
Primary Outcome Measures
GERD symptoms
Frequency and intensity of GERD symptoms measured by the Reflux Disease questionnaire (RDQ)
Secondary Outcome Measures
Specific quality of life for gastrointestinal disease
Gastrointestinal Quality of life Index (GIQLI)
Drug Usage
Weekly milligrams usage of proton pomp inhibitors (PPI)
Full Information
NCT ID
NCT03299985
First Posted
September 25, 2017
Last Updated
October 4, 2018
Sponsor
Cardenal Herrera University
1. Study Identification
Unique Protocol Identification Number
NCT03299985
Brief Title
Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease
Acronym
GERD
Official Title
Effects of Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 5, 2017 (Actual)
Primary Completion Date
March 15, 2018 (Actual)
Study Completion Date
March 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cardenal Herrera University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
Gastroesophageal reflux Disease, Myofascial release, Diaphragm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
double blinded randomized clinical trial
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diaphragmatic myofascial release
Arm Type
Experimental
Arm Description
Subjects in this arm will receive different myofascial release techniques aimed to normalize the myofascial tension of the diaphragmatic muscle
Arm Title
Sham myofascial release
Arm Type
Sham Comparator
Arm 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(s)
Diaphragmatic myofascial release
Intervention Description
Subjects in this arm will receive different myofascial release techniques aimed to normalize the myofascial tension of the diaphragmatic muscle
Intervention Type
Other
Intervention Name(s)
Sham myofascial release
Intervention Description
Subjects in this arm will receive the same manual techniques of the diaphragmatic myofascial release group, but without the myofascial stimulus
Primary Outcome Measure Information:
Title
GERD symptoms
Description
Frequency and intensity of GERD symptoms measured by the Reflux Disease questionnaire (RDQ)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Specific quality of life for gastrointestinal disease
Description
Gastrointestinal Quality of life Index (GIQLI)
Time Frame
6 weeks
Title
Drug Usage
Description
Weekly milligrams usage of proton pomp inhibitors (PPI)
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Universidad CEU Cardenal Herrera
City
Valencia
ZIP/Postal Code
46113
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
7749697
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.
Results Reference
background
PubMed Identifier
11995369
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.
Results Reference
background
PubMed Identifier
18447946
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.
Results Reference
background
PubMed Identifier
19371971
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.
Results Reference
background
PubMed Identifier
22676647
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.
Results Reference
result
PubMed Identifier
22146488
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.
Results Reference
result
PubMed Identifier
28441294
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.
Results Reference
result
Learn more about this trial
Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease
We'll reach out to this number within 24 hrs