Clinical trial NCT05283447: Manual Therapy and Gastroesophageal Reflux Disease in Patients With Hiatal Hernia
Official title: Effectiveness of Manual Therapy in the Treatment of Gastroesophageal Reflux Disease in Patients With Type I Hiatal Hernia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastroesophageal Reflux
Keywords: Hernia, Hiatal
Osteopathic Medicine
Musculoskeletal Manipulations
Gastroesophageal Reflux
Lead sponsor: Escoles Universitaries Gimbernat
Sponsor class: OTHER
Collaborators: name: Corporacion Parc Tauli
First posted: 2022-03-17
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Impact of GERD (Gastro-oesophageal Reflux Disease)
timeFrame: 8 weeks
Secondary outcomes:
measure: Impact of GERD (Gastro-oesophageal Reflux Disease)
timeFrame: 8 weeks
measure: Quality of life in patients with GERD
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Sant Cugat Del Vallès
country: Spain
facility: Ricard Tutusaus Homs
state: Barcelona
Study officials:
affiliation: EU Gimbernat
name: Ricard Tutusaus Homs, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Corporación Parc Taulí
name: Salvador Navarro Soto, PhD
role: STUDY_DIRECTOR
affiliation: Corporación Parc Taulí
name: Alexis Luna Aufroy, PhD
role: STUDY_DIRECTOR
affiliation: Universidad de Barcelona
name: Josep Maria Potau Ginés
role: STUDY_DIRECTOR
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