An interventional study of Osteopathic Medicine and Control in Gastroesophageal Reflux, sponsored by Escoles Universitaries Gimbernat. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by Escoles Universitaries Gimbernat · Not applicable, Interventional, and Treatment
Introduction: Gastroesophageal reflux disease (GERD) is highly prevalent in our society. The association between GERD and hiatal hernia has been shown to be etiologically critical in the onset or worsening of these patients' clinic. Pharmacological treatment with proton pump inhibitors (IBPs) and H2 blockers is commonly prescribed and will be followed for many patients for life. The cost of health care and the effects of prolonged consumption of PPIs are questionable, and other therapeutic alternatives are being considered. Only in exceptional cases and in patients with GERD and certain types of hiatal hernia is surgery the treatment of choice. Physiotherapy at the time proposed respiratory and diaphragmatic training as a therapeutic alternative that would improve the function of anti-reflux barriers. Recently, other studies evaluating the effectiveness of manual techniques on the crural diaphragm or osteopathic maneuvers on the cervical and thoracic region have obtained good results in the improvement of the MRGE clinic. In this context, the clinical trial presented specifically treats those with reflux disease associated with a Type I hiatal hernia with manual therapy.
Material and methods: The aim of the clinical study is to evaluate the effects of a clinical intervention protocol on patients with GERD for type I hiatal hernia.
The variables are assessed: GERD impact using the GIS MRG Impact Scale, and the EVA format scale for the Reflux Clinic (IEPT) used by the Surgery Service of the Parc Taulí Hospital in Sabadell . The productivity and quality of life of these patients is also assessed using the QOLRAD reflux and dyspepsia patient quality of life questionnaire.
The randomized, double-blind clinical trial has a sample of 44 patients, divided into an intervention group treated with the protocol under study, and a control group undergoing treatment that does not affect the hernia. hiatus and reflux. A total of three treatment sessions are performed on each subject. The participants answer the different questionnaires, before the start of the treatment and for each session, one week after the treatment and one month later. In the protocol, maneuvers are performed on the epigastric region, thoracic diaphragm, mediastinum and anterior face of the neck.
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
This study's enrollment of 44 is below the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Escoles Universitaries Gimbernat is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
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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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Specific manual therapy for GERD and hiatal hernia
Other: Osteopathic Medicine
Manual therapy unrelated to GERD and hiatal hernia
Other: Control
The clinical protocol subject to analysis for the intervention group consists of manual approach techniques for the myofascial and viscerofascial structures of the anterior face of the neck, maneuvers for the mediastinal region, techniques for normalizing the tone of the thoracic diaphragm and its pillars, on the peritoneal ligaments, and caudal traction of the stomach for manual correction of hiatal hernia.
The physiotherapeutic treatment on the control group consists of an approach to the lumbopelvic joint restrictions and a massage on the inframesocolic abdominal region with minimal pressure, which does not affect the activity and position of the stomach.
Impact of GERD (Gastro-oesophageal Reflux Disease)
Using "The Gastro-oesophageal Reflux Disease Impact scale" (GIS).The GIS impact assessment scale consists of 9 items that refer to the frequency during the last week of 5 possible symptoms of GERD, the impact on sleep, food or drink intake, work or activities of daily living and the need to use medications in addition to those prescribed by your doctor (from "daily" to "never" on a 4-point Likert-type scale). The Gis scale score ranges from 1 to 4, the higher the score, the better the patient's condition. The scale was validated in Spanish in 2008. (New, Tafalla et al, 2008).
Time frame: 8 weeks
Impact of GERD (Gastro-oesophageal Reflux Disease)
Using the "Gastro-oesophageal Reflux Disease impact assessment scale" used by gastroenterology team of the CSPT (Corporación Sanitaria Parc Taulí), aims to objectify GERD symptoms using a 0-10 range. The symptoms generated exclusively by the Reflux will be chosen: heartburn, regurgitation, cough, aphonia, epigastralgia. The maximum sum of the items on the scale is 50 points, indicating maximum severity. The value 0 points would indicate a minimal impact of the disease.
Time frame: 8 weeks
Quality of life in patients with GERD
For the collection of specific data on the quality of life of the patients, the QOLRAD scale will be used, this scale contains 25 items, in which the patient is asked about the effect of gastrointestinal symptoms on quality of life. Establishing the relationship with: emotional well-being, sleep, vitality, food and drink, and physical/social functioning. The patient answers the questionnaire about the frequency of these effects in relation to the last week, using a 7-point Likert scale ranging from "all the time/very much" to "never/not at all". Low scores indicate significant impairment in daily functioning (Kulich KR et al, 2005)
Time frame: 8 weeks
Plan to share: Undecided — The pandemic has delayed the completion of the study and no publication date for the information has been proposed.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Escoles Universitaries Gimbernat