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The Effect and Mechanism of Acupuncture on Functional Dyspepsia

Primary Purpose

Dyspepsia

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Acupuncture

Sham acupuncture

About this trial

This is an interventional treatment trial for Dyspepsia focused on measuring Functional Dyspepsia, Acupuncture, Functional MRI

Eligibility Criteria

30 Years - 49 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

Participants should meet following conditions:

Aged of 30 - 49
Individuals who meet FD and postprandial distress syndrome (PDS) criteria in Rome III
Individuals who complain the degree of dyspepsia for more than 40 points of visual analogue scale (VAS; 0, no symptom at all; 100, the most severe symptom one ever had)
At least 3 questions show more than 2 points in Gastrointestinal impact scale
Individuals who have normal esophagogastroduodenoscopy results within a year and no organic diseases which can explain current symptoms such as peptic ulcer, dysplasia, mucosa-associated, lymphoid tissue lymphoma, esophageal cancer, gastric cancer
Individuals who are not supposed to take any other treatments associated with FD during the study
Individuals who voluntarily agree with a study protocol and sign a written informed consent

Exclusion Criteria

Participants who report the followings will be excluded:

Individuals who have organic diseases such as gastroesophageal reflux disease
Individuals who have obvious signs of irritable bowel syndrome
Individuals who have alarm symptoms (weight loss, black or tar stool or dysphagia)
Individuals who have serious structural disease (disease of heart, lung, liver or kidney) or mental illness
Individuals who have had surgery related with the gastrointestinal tract , except for appendectomy more than six months ago
Individuals who are pregnant or breastfeeding
Individuals who are taking drugs which might affect gastrointestinal tract; minimum wash-out period of 2 weeks is required before participating in the trial
Individuals who are HIV-positive
Individuals who have a problem of mal-absorption
Individuals who have difficulties in attending the trial (eg. paralysis, serious mental illness, dementia, drug addiction, time constraint, severe disorder in vision or hearing, illiteracy, etc.)
Individuals who do not want to sign the informed consent
Individuals who have other diseases that could interfere acupuncture treatment, e.g. clotting disorders or leukopenia, pace-maker, epilepsy, or anticoagulant therapy
Individuals who have metal implants or fragments which might influence fMRI examination

Sites / Locations

Kyung Hee University Hospital at GangdongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Acupuncture

Sham acupuncture

Arm Description

Participants in this group are given 10 times of real acupuncture treatment for 4 weeks.

Participants in this group are given 10 times of sham acupuncture treatment for 4 weeks.

Outcomes

Primary Outcome Measures

Proportion of responders

The proportion of patients who answer "Yes" to more than half of adequate relief questions in the treatment period. Patients are expected to report their response to the acupuncture treatment by answering the following question at each visit: "After the last visit, have you had adequate relief of your stomach pain or discomfort?" Questions will be asked at each visit during treatment period (Twice a week for 4 wks, total 10 times - 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5 wks). Responders are defined as patients reporting adequate relief for at least 50% of the study period (more than 5 times of "Yes" to adequate relief question out of total 10 questions). The proportion of responder will be compared statistically between intervention groups.

Secondary Outcome Measures

Nepean Dyspepsia Index - Korean version (NDI-K)

The Nepean Dyspepsia Index is a reliable and valid measure of quality of life in FD. The Nepean Dyspepsia Index originally contains 42 items designed to measure impairment of a subjective ability engaged in relevant aspects of their life because of dyspepsia. It was subsequently shortened to 25 items, yielding 5 sub-scales. NDI-K, validated in 2003 by Lee at al., made up of 2 sections which are about symptom-based questions and quality of life. In this trial, symptom-based questions, i.e. questions about period, severity and distressful degree of 15 symptoms, will be evaluated.

Functional Dyspepsia-Related Quality of Life (FD-QoL) Questionnaire

The FD-QoL scale is a 21-item Likert-type questionnaire that can easily be completed within 5 min. Short administration time and high comprehensibility supports the feasibility of measuring health-related quality of life.

Ways of Coping Question (WCQ)

The Ways of Coping Questionnaire (WCQ) (Folkman & Lazarus, 1988) assessed the parents' coping strategies. It has 66-items, each with a 4-point Likert scale indicating the frequency with which the strategy was used. The measure comprises eight scales representing theoretically different coping strategies: confrontative coping, distancing, self-controlling, seeking social support, accepting responsibility, escape-avoidance, problem solving, and positive reappraisal.

Coping Strategy Questionnaire (CSQ)

Coping Strategy questionnaire is one of models for measuring stress and coping to help explain the differences in adjustment found among persons who experience chronic pain. It consists of 48 items, each with a 7-point Likert scale (0:never; 3: sometimes; 6:always) and divide into eight scales of six items each; (1) Catastrophizing, (2) Distractor behaviors, (3) Self-instructions, (4) Ignoring the pain, (5) Reinterpreting the pain, (6) Hoping, (7) Faith and praying, (8) Cognitive distraction.

Functional Magnetic Resonance Imaging ; 3.0T MRI system(Achieva, Philips)

A measure of steady state (REST and PAIN) and blood oxygenation level dependent (BOLD) under the condition of event related design (ACUP) scan run.

Metabolic profiling of plasma and urine

In order to investigate the biological effects of FD and the effect of acupuncture on metabolism, the blood and urine sample will be analyzed using nuclear magnetic resonance (NMR)-based metabolomic techniques to compare the metabolites such as amino acids, organic acids, and blood sugar of FD patients.

The Center for Epidemiologic Studies Depression Scale (CES-D)

The Center for Epidemiological Studies-Depression (CES-D), originally published by Radloff in 1977, is a 20-item measure that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or little of the time, 2 = Moderately or much of the time, 3 = Most or almost all the time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.

The State-Trait Anxiety Inventory (STAI)

The State-Trait Anxiety Inventory (STAI) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety (anxiety triggered by a specific event), and trait anxiety (anxiety derived from personal characteristic). Higher scores are positively correlated with higher levels of anxiety.

Perception of bodily sensation (PDS)

This scale is a 10-item questionnaire with 6(1-7) point Likert scale. Patients with higher Perception of bodily sensation (PBS) could have a higher emotional or cognitive intolerance to bodily reactions.

Full Information

NCT ID

NCT02358486

First Posted

January 21, 2015

Last Updated

August 15, 2017

Sponsor

Kyunghee University Medical Center

Collaborators

Korea Institute of Oriental Medicine, Kyung Hee University Hospital at Gangdong

1. Study Identification

Unique Protocol Identification Number

NCT02358486

Brief Title

The Effect and Mechanism of Acupuncture on Functional Dyspepsia

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 2015 (undefined)

Primary Completion Date

January 2018 (Anticipated)

Study Completion Date

January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kyunghee University Medical Center

Collaborators

Korea Institute of Oriental Medicine, Kyung Hee University Hospital at Gangdong

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyspepsia

Keywords

Functional Dyspepsia, Acupuncture, Functional MRI

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture

Arm Type

Experimental

Arm Description

Participants in this group are given 10 times of real acupuncture treatment for 4 weeks.

Arm Title

Sham acupuncture

Arm Type

Sham Comparator

Arm Description

Participants in this group are given 10 times of sham acupuncture treatment for 4 weeks.

Intervention Type

Device

Intervention Name(s)

Acupuncture

Other Intervention Name(s)

Acupuncture treatment

Intervention Description

Acupuncture rationale 1a) Style of acupuncture: body acupuncture (in accordance with meridian theory) 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

Intervention Type

Device

Intervention Name(s)

Sham acupuncture

Other Intervention Name(s)

Streitberger Device

Intervention Description

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.

Primary Outcome Measure Information:

Title

Proportion of responders

Description

Time Frame

Once in treatment period (4 wks)

Secondary Outcome Measure Information:

Title

Nepean Dyspepsia Index - Korean version (NDI-K)

Description

Time Frame

treatment (0 wks), After treatment (4 wks)

Title

Functional Dyspepsia-Related Quality of Life (FD-QoL) Questionnaire

Description

Time Frame

Before treatment (0 wks), After treatment (4 wks)

Title

Ways of Coping Question (WCQ)

Description

Time Frame

treatment (0 wks), After treatment (4 wks)

Title

Coping Strategy Questionnaire (CSQ)

Description

Time Frame

Before treatment (0 wks), After treatment (4 wks)

Title

Functional Magnetic Resonance Imaging ; 3.0T MRI system(Achieva, Philips)

Description

A measure of steady state (REST and PAIN) and blood oxygenation level dependent (BOLD) under the condition of event related design (ACUP) scan run.

Time Frame

Before treatment (0 wks), After treatment (4 wks)

Title

Metabolic profiling of plasma and urine

Description

Time Frame

Time Frame: Before treatment (0 wks), After treatment (4 wks)

Title

The Center for Epidemiologic Studies Depression Scale (CES-D)

Description

Time Frame

Before treatment (0 wks), After treatment (4 wks)

Title

The State-Trait Anxiety Inventory (STAI)

Description

Time Frame

Before treatment (0 wks), After treatment (4 wks)

Title

Perception of bodily sensation (PDS)

Description

Time Frame

Before treatment (0 wks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria Participants should meet following conditions: Aged of 30 - 49 Individuals who meet FD and postprandial distress syndrome (PDS) criteria in Rome III Individuals who complain the degree of dyspepsia for more than 40 points of visual analogue scale (VAS; 0, no symptom at all; 100, the most severe symptom one ever had) At least 3 questions show more than 2 points in Gastrointestinal impact scale Individuals who have normal esophagogastroduodenoscopy results within a year and no organic diseases which can explain current symptoms such as peptic ulcer, dysplasia, mucosa-associated, lymphoid tissue lymphoma, esophageal cancer, gastric cancer Individuals who are not supposed to take any other treatments associated with FD during the study Individuals who voluntarily agree with a study protocol and sign a written informed consent Exclusion Criteria Participants who report the followings will be excluded: Individuals who have organic diseases such as gastroesophageal reflux disease Individuals who have obvious signs of irritable bowel syndrome Individuals who have alarm symptoms (weight loss, black or tar stool or dysphagia) Individuals who have serious structural disease (disease of heart, lung, liver or kidney) or mental illness Individuals who have had surgery related with the gastrointestinal tract , except for appendectomy more than six months ago Individuals who are pregnant or breastfeeding Individuals who are taking drugs which might affect gastrointestinal tract; minimum wash-out period of 2 weeks is required before participating in the trial Individuals who are HIV-positive Individuals who have a problem of mal-absorption Individuals who have difficulties in attending the trial (eg. paralysis, serious mental illness, dementia, drug addiction, time constraint, severe disorder in vision or hearing, illiteracy, etc.) Individuals who do not want to sign the informed consent Individuals who have other diseases that could interfere acupuncture treatment, e.g. clotting disorders or leukopenia, pace-maker, epilepsy, or anticoagulant therapy Individuals who have metal implants or fragments which might influence fMRI examination

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Seok-Jae Ko, KMD, PhD

Phone

+82-2-440-6245

kokokoko119@hanmail.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seok-Jae Ko, KMD, PhD

Organizational Affiliation

Kyung Hee University Hospital at Gangdong

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kyung Hee University Hospital at Gangdong

City

Seoul

State/Province

Gangdong-gu

ZIP/Postal Code

130-701

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Seok-Jae Ko, KMD, PhD

Phone

+82-2-440-6245

kokokoko119@hanmail.net

First Name & Middle Initial & Last Name & Degree

Seok-Jae Ko, KMD, PhD

First Name & Middle Initial & Last Name & Degree

Jae-Woo Park, KMD, PhD

First Name & Middle Initial & Last Name & Degree

Il-Hyun Baek, MD, PhD

First Name & Middle Initial & Last Name & Degree

In-Kwon Yeo

First Name & Middle Initial & Last Name & Degree

Jeong-Chan Lee, KMD, PhD

First Name & Middle Initial & Last Name & Degree

Kyung-Mo Park, KMD, PhD

First Name & Middle Initial & Last Name & Degree

Hi-Joon Park, KMD, PhD

First Name & Middle Initial & Last Name & Degree

Jun-Hwan Lee, KMD, PhD

First Name & Middle Initial & Last Name & Degree

Seul-Ki Kim, KMD

First Name & Middle Initial & Last Name & Degree

Min-Ji Kim, KMD

First Name & Middle Initial & Last Name & Degree

Geon-Ho Jahng, MD, PhD

First Name & Middle Initial & Last Name & Degree

Seul-Ki Eun

First Name & Middle Initial & Last Name & Degree

Jae-Young Shin

First Name & Middle Initial & Last Name & Degree

MOHAMED ABDALLA ZEINELABDEIN ABDALLA

First Name & Middle Initial & Last Name & Degree

Eun-Young Lee

First Name & Middle Initial & Last Name & Degree

Joo-hee Kim, KMD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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The Effect and Mechanism of Acupuncture on Functional Dyspepsia

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