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The Efficacy of Neiguan (P6 Point) Acupressure in Patients With Gastroesophageal Reflux Disease (GERD)

Primary Purpose

Gastroesophageal Reflux Disease

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Acupressure wristband
Sham wristband
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastroesophageal Reflux Disease focused on measuring GERD, Neiguan, Acupressure, P6

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female
  2. Age of 20-60 years
  3. Suffered from heartburn with or without acid regurgitation

Exclusion Criteria:

  1. Suffered from peptic ulcer, gallstones, cancer, and Barrett's esophagus
  2. previously underwent the esophagus, stomach or duodenum surgery
  3. Lactating women or pregnant women
  4. patients with severe cardiovascular disease

Sites / Locations

  • China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Acupressure

Sham-Acupressure

Arm Description

Patients will band a acupressure wristband over Neiguan (P6 point) and acupressure for seven days.

Patients will band a sham wristband over wrist but no acupressure for seven days.

Outcomes

Primary Outcome Measures

Reflux disease questionnaire(RDQ)
RDQ to assess the severity of GERD for each patient over the past 7 days before study and after banding a wristband for 7days.

Secondary Outcome Measures

World Health Organization Quality of Life Questionnaire Taiwan condensed version(WHOQOL-REF)
WHOQOL-REF(Taiwan version) to assess the Quality of Life for each patient before study and after banding a wristband for 7days.

Full Information

First Posted
September 30, 2014
Last Updated
June 8, 2015
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02255071
Brief Title
The Efficacy of Neiguan (P6 Point) Acupressure in Patients With Gastroesophageal Reflux Disease (GERD)
Official Title
The Efficacy of Neiguan (P6 Point) Acupressure in Patients With Gastroesophageal Reflux Disease (GERD)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In recent years, there is an increasing trend in the number of patients with Gastroesophageal reflux disease (GERD). The poor response to medicine was noticed in patients with non-erosive reflux disease. According to the theory of traditional Chinese medicine, acupuncture Neiguan (P6 point) could improve the uncomfortable symptoms of the chest and upper abdomen. Therefore, the aim of this study is to investigate the clinical efficacy of Neiguan (P6 point) acupressure in patients with GERD.
Detailed Description
In recent years, there is an increasing trend in the number of patients with GERD. GERD mainly related to the reflux of stomach content induced by the dysfunction of lower esophageal sphincter. The common symptoms of GERD are heartburn, acid regurgitation, and chest pain. The methods to treat GERD are changes of lifestyle, pharmacotherapy, antireflux surgery and endoscopy. However, the poor response to medicine was still noticed in patients with non-erosive reflux disease. And long-term use of medicine will result in many side effects including infectious, abdominal pain, diarrhea and osteoporosis. According to the theory of traditional Chinese medicine, acupuncture Neiguan (P6 point) could improve the uncomfortable symptoms of the chest and upper abdomen. Therefore, the aim of this study is to investigate the clinical efficacy of Neiguan (P6 point) acupressure in patients with GERD. 64 patients with GERD were randomly divided into two groups：the acupressure and control. In the acupressure group, in addition to receiving standard treatment, patients will band a hand ring over Neiguan (P6 point) and acupressure for seven days. In the control group, in addition to receiving standard treatment, patients will band a hand ring but no acupressure for seven days. Data was collected by self-recorded symptoms before and after the intervention, according to the Reflux disease questionnaire(RDQ) and the World Health Organization Quality of Life Questionnaire Taiwan condensed version. Data was analyzed by Student's t-tests, Paired Student's t-test, Chi-square, and Fisher exact tests for quantitative and qualitative variables. We anticipate the treatment of Neiguan (P6 point) acupressure will reduce the symptoms of gastroesophageal reflux and improve the quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
GERD, Neiguan, Acupressure, P6

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupressure
Arm Type
Experimental
Arm Description
Patients will band a acupressure wristband over Neiguan (P6 point) and acupressure for seven days.
Arm Title
Sham-Acupressure
Arm Type
Sham Comparator
Arm Description
Patients will band a sham wristband over wrist but no acupressure for seven days.
Intervention Type
Device
Intervention Name(s)
Acupressure wristband
Intervention Description
A acupressure wristband over Neiguan (P6 point) and acupressure for seven days.
Intervention Type
Device
Intervention Name(s)
Sham wristband
Intervention Description
A wristband over wrist but no acupressure for seven days.
Primary Outcome Measure Information:
Title
Reflux disease questionnaire(RDQ)
Description
RDQ to assess the severity of GERD for each patient over the past 7 days before study and after banding a wristband for 7days.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
World Health Organization Quality of Life Questionnaire Taiwan condensed version(WHOQOL-REF)
Description
WHOQOL-REF(Taiwan version) to assess the Quality of Life for each patient before study and after banding a wristband for 7days.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female Age of 20-60 years Suffered from heartburn with or without acid regurgitation Exclusion Criteria: Suffered from peptic ulcer, gallstones, cancer, and Barrett's esophagus previously underwent the esophagus, stomach or duodenum surgery Lactating women or pregnant women patients with severe cardiovascular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Ti Hsu, MD
Organizational Affiliation
China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

The Efficacy of Neiguan (P6 Point) Acupressure in Patients With Gastroesophageal Reflux Disease (GERD)

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