Ignite Creation Date:
2024-05-06 @ 10:34 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03299985
Status:
COMPLETED
Last Update Posted:
2018-10-05
First Post:
2017-09-25
Brief Title:
Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease
Sponsor:
Cardenal Herrera University
Organization:
Cardenal Herrera University
Study Overview
Official Title:
Effects of Diaphragmatic Myofascial Release in Gastroesophageal Reflux Disease
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GERD
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 havent 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
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 havent 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None