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
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Among 23 studies in Gastroesophageal Reflux with a site in Spain — 2 open to participants now, 3 under way, none of them phase 3. Gastroesophageal Reflux · Spain.
Among the 23 studies in Gastroesophageal Reflux with a site in Spain, this one is the 17th largest by enrollment of the 18 interventional ones that give a count, is one of 2 that started in 2017, is one of 11 with no phase, and was the 12th registered.
1,213 studies on the registry are indexed under Gastroesophageal Reflux; 203 are open to participants now.
Browse Gastroesophageal Reflux studies →2 of the 23 studies in Gastroesophageal Reflux with a site in Spain are open now. Recruiting first, the newest first:
Medtronic Cardiovascular · Sites in Spain, Denmark, France and 5 more countries
Ages 18+
Implantica CE Reflux Ltd. · Sites in Spain, Germany
Ages 18+
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 133 Gastroesophageal Reflux studies recruiting now, 57 (43%) set no upper age limit and 53 (40%) stop at 75 or younger; 22 take children under 18; 20 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 30 is below the median of 68 across 799 interventional studies indexed under Gastroesophageal Reflux.
Median enrollment 172 across the 18 interventional studies, 300 across the 5 observational. Of the 18 that completed or were terminated, 1 (6%) have results posted.
This tab as a report to print or save as PDF → With an account.
14 of 23 have an industry lead sponsor. The 10 most frequent:
Cardenal Herrera University is the lead sponsor of 108 studies on the registry; 22 are open to participants now.
Cardenal Herrera University has 1 study filed under Gastroesophageal Reflux — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 23 studies in Gastroesophageal Reflux with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in this arm will receive different myofascial release techniques aimed to normalize the myofascial tension of the diaphragmatic muscle
Other: Diaphragmatic 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
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
GERD symptoms
Frequency and intensity of GERD symptoms measured by the Reflux Disease questionnaire (RDQ)
Time frame: 6 weeks
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
Plan to share: No
Ran from Oct 2017 to primary completion in Mar 2018, 5 months.
Of 193 non-industry interventional studies with no phase under Gastroesophageal Reflux, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 68. This study's 5 months is below that.
Counting every sponsor, half of 227 studies reached it within 31 months; a quarter within 12 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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