NCT05283447

Manual Therapy and Gastroesophageal Reflux Disease in Patients With Hiatal Hernia

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Escoles Universitaries Gimbernat · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroesophageal Reflux

Interventions

Type	Name	Description
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.
OTHER	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.

Timeline

• Start date: 2022-05-15
• Primary completion: 2022-12-16
• Completion: 2023-06-30
• First posted: 2022-03-17
• Last updated: 2025-07-09

Locations

1 site across 1 country: Spain