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临床试验/NCT05283447
NCT05283447已完成不适用

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

Escoles Universitaries Gimbernat2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2022年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
2
主要终点
Impact of GERD (Gastro-oesophageal Reflux Disease)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Impact of GERD (Gastro-oesophageal Reflux Disease)

时间窗: 8 weeks

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).

次要结局

  • Quality of life in patients with GERD(8 weeks)
  • Impact of GERD (Gastro-oesophageal Reflux Disease)(8 weeks)

研究者

发起方
Escoles Universitaries Gimbernat
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ricard Tutusaus

Principal Investigator

Escoles Universitaries Gimbernat

研究点 (2)

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