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Effect of acupuncture and its influence on cerebral activity infunctional dyspepsia patients: study protocol for a randomizedcontrolled trial
- Source :
- TRIALS(17), Trials
- Publication Year :
- 2016
-
Abstract
- Functional dyspepsia (FD) is a prevalent gastric disorder that is difficult to manage due to lack of satisfactory treatments. Acupuncture has been studied with regard to the rising need for treating FD, but the mechanism verifying its efficacy has not yet been fully revealed. The aim of this study is to explore the efficacy and mechanism of acupuncture for FD compared with a sham group. We describe a proposal for a randomized, assessor-blind, sham-controlled trial with 70 eligible participants who will be randomly allocated either into an acupuncture or a sham group. Participants in the acupuncture group will receive 10 sessions of real acupuncture treatment and those in the sham group will be treated with identical sessions using a Streitberger needle. Functional magnetic resonance imaging (fMRI) and metabolomics studies will be implemented before and after 4 weeks of treatment to investigate the mechanism of acupuncture. The primary outcome is a proportion of responders with adequate symptom relief and the secondary outcomes include the Nepean Dyspepsia Index - Korean version, Functional Dyspepsia-Related Quality of Life questionnaire, Ways of Coping Questionnaire, Coping Strategies Questionnaire, perception of bodily sensation questionnaire, State-Trait Anxiety Inventory, and the Center for Epidemiological Studies - Depression Scale. The outcomes will be evaluated before and after the treatment. This is the first large-scale trial evaluating the efficacy and mechanism of acupuncture with fMRI and metabolomic methods. We will compare real acupuncture with the Streitberger sham needle to verify the specific effect of acupuncture. The results of this trial are expected to be relevant evidences affecting policy and decision-makers associated with routine healthcare. ClinicalTrials.gov Identifier: NCT02358486 . Date of Registration: 21 January 2015.
- Subjects :
- Male
Coping (psychology)
Functional dyspepsia
Time Factors
Functional magnetic resonance imaging
Alternative medicine
Acupuncture Therapy
Medicine (miscellaneous)
law.invention
Study Protocol
0302 clinical medicine
Randomized controlled trial
Quality of life
Clinical Protocols
law
Surveys and Questionnaires
Epidemiology
Adaptation, Psychological
Pharmacology (medical)
Brain Mapping
Remission Induction
Brain
Middle Aged
Magnetic Resonance Imaging
Acupuncture
Streitberger needle
Functionalmagnetic resonance imaging
Metabolomics
Treatment Outcome
Research Design
Anxiety
030211 gastroenterology & hepatology
Female
medicine.symptom
Adult
medicine.medical_specialty
03 medical and health sciences
Sensation
Republic of Korea
medicine
Humans
Dyspepsia
business.industry
Brain Waves
Surgery
Physical therapy
Quality of Life
business
030217 neurology & neurosurgery
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- TRIALS(17), Trials
- Accession number :
- edsair.doi.dedup.....50367037bb329ed0312d06d9fea3bc31