Manual Therapy and Gastroesophageal Reflux Disease in Patients With Hiatal Hernia

Gastroesophageal Reflux Clinical Trial

Official title:

Effectiveness of Manual Therapy in the Treatment of Gastroesophageal Reflux Disease in Patients With Type I Hiatal Hernia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05283447
• Other study ID #: 2018308
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 15, 2018
• Est. completion date: June 2023

Study information

• Verified date: March 2022
• Source: Escoles Universitaries Gimbernat
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 44
• Est. completion date: June 2023
• Est. primary completion date: December 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with Gastroesophageal Reflux disease (Vakil et al, 2006)

• Age between 18 and 90 years.

• Patients with GERD due to hiatal hernia type I, without surgical indication.

• Patients with GERD due to hiatal hernia type I, with surgical indication on the waiting list.

• Patients with GERD due to hiatal hernia type I, with surgical contraindication.

Exclusion Criteria:

• That fail to meet inclusion criteria.

• Patients treated with Benzodiazepines (BZD)

• Patients with previous surgical interventions at the abdominal level, especially of supramesocolic structures

• Patients diagnosed with Barrett's esophagus

• Patients with paraesophageal and mixed hiatus hernias

• Diagnosed erosive esophagitis

• Active neoplasm

• Serious psychiatric disorders

• Neuromuscular or neurological injuries

• Aneurysms

• Pregnancy

• Hemophilia or treatment with anticoagulant therapy

• Hypersensitivity of the skin or dermatological diseases in the trunk that prevent the performance of the techniques

• Rejection of manual contact

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• Hernia
• Hernia, Hiatal

Intervention

Other:
• Osteopathic Medicine
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.
• Control
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.

Locations

Country	Name	City	State
Spain	Ricard Tutusaus Homs	Sant Cugat Del Vallès	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Escoles Universitaries Gimbernat	Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	8 weeks
Secondary	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.	8 weeks
Secondary	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)	8 weeks