NCT02358486

The Effect and Mechanism of Acupuncture on Functional Dyspepsia

Effect and Mechanism of Acupuncture on Patients With Functional Dyspepsia: a Protocol for a Randomized, Assessor-blind, Sham-controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Kyunghee University Medical Center · Academic / Other
• Sex: All
• Age: 30 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to investigate the effect of acupuncture on functional dyspepsia compared with sham control. The study aims to clarify the mechanism of acupuncture by assessing functional magnetic resonance imaging and metabolomics.

Detailed description

Functional dyspepsia (FD) is a functional gastrointestinal disorder without any structural lesion. Due to the lack of satisfactory effect of conventional treatments, many FD patients turn to alternative treatments such as acupuncture. Acupuncture, one of the most sought therapeutic modalities in traditional Korean Medicine, has been commonly used for treating gastrointestinal disorders. However, the effect and mechanism of acupuncture on FD has not been rigorously evaluated. In the present study, we will investigate whether 10 sessions of acupuncture over 4 weeks, in comparison with sham acupuncture, improve symptoms of FD and activate regions of brain area. We will also perform metabolomics study to find the mechanism of acupuncture to FD. Outcome measures include proportion of responder, Korean version of Nepean Dyspepsia Index, Functional Dyspepsia-Related Quality of Life, Ways of Coping Question, Coping Strategy Questionnaire, Perception of bodily sensation, The State-Trait Anxiety Inventory, Center for Epidemiologic Studies Depression Scale, functional magnetic resonance imaging and metabolomic study.

Conditions

• Dyspepsia

Interventions

Type	Name	Description
DEVICE	Acupuncture	1. Acupuncture rationale 1a) Style of acupuncture: body acupuncture (in accordance with meridian theory) 2. Needling details 2a) Number of needle insertions per subject per session: 13 2b) Acupoints: Basic points - Large Intestine(LI)4, Stomach(ST)36, Liver(LR)3, Pericardium(PC)3, Spleen(SP)4, Stomach(ST)34, Conception Vessel(CV)12, 2c) Depth: 5 \~ 30mm 2d) Response sought: 'De qi' sensation; 2e) Needle stimulation: Manipulation 2f) Retention time: 15 minutes 2g) Needle type: 0.2 X 40 mm, sterilized stainless steel needle, Dongbang Inc., Korea
DEVICE	Sham acupuncture	The participants in sham acupuncture group are given sham acupuncture treatment at the same acupoints in the same times and method as acupuncture arm. The sham device would be a Streitberger device.

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2015-02-09
• Last updated: 2017-08-18

Locations

1 site across 1 country: South Korea