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Trial record 4 of 40 for:    Recruiting, Not yet recruiting, Available Studies | "Dyspepsia"

The Effect and Mechanism of Acupuncture on Functional Dyspepsia

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ClinicalTrials.gov Identifier: NCT02358486
Recruitment Status : Recruiting
First Posted : February 9, 2015
Last Update Posted : August 18, 2017
Sponsor:
Collaborators:
Korea Institute of Oriental Medicine
Kyung Hee University Hospital at Gangdong
Information provided by (Responsible Party):
Seok-Jae Ko, Kyunghee University Medical Center

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.

Condition or disease Intervention/treatment Phase
Dyspepsia Device: Acupuncture Device: Sham acupuncture Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect and Mechanism of Acupuncture on Patients With Functional Dyspepsia: a Protocol for a Randomized, Assessor-blind, Sham-controlled Trial
Study Start Date : January 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Acupuncture
Participants in this group are given 10 times of real acupuncture treatment for 4 weeks.
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
Other Name: Acupuncture treatment

Sham Comparator: Sham acupuncture
Participants in this group are given 10 times of sham acupuncture treatment for 4 weeks.
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.
Other Name: Streitberger Device




Primary Outcome Measures :
  1. Proportion of responders [ Time Frame: Once in treatment period (4 wks) ]
    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 :
  1. Nepean Dyspepsia Index - Korean version (NDI-K) [ Time Frame: treatment (0 wks), After treatment (4 wks) ]
    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.

  2. Functional Dyspepsia-Related Quality of Life (FD-QoL) Questionnaire [ Time Frame: Before treatment (0 wks), After treatment (4 wks) ]
    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.

  3. Ways of Coping Question (WCQ) [ Time Frame: treatment (0 wks), After treatment (4 wks) ]
    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.

  4. Coping Strategy Questionnaire (CSQ) [ Time Frame: Before treatment (0 wks), After treatment (4 wks) ]
    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.

  5. Functional Magnetic Resonance Imaging ; 3.0T MRI system(Achieva, Philips) [ Time Frame: Before treatment (0 wks), After treatment (4 wks) ]
    A measure of steady state (REST and PAIN) and blood oxygenation level dependent (BOLD) under the condition of event related design (ACUP) scan run.

  6. Metabolic profiling of plasma and urine [ Time Frame: Time Frame: Before treatment (0 wks), After treatment (4 wks) ]
    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.

  7. The Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Before treatment (0 wks), After treatment (4 wks) ]
    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.

  8. The State-Trait Anxiety Inventory (STAI) [ Time Frame: Before treatment (0 wks), After treatment (4 wks) ]
    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.

  9. Perception of bodily sensation (PDS) [ Time Frame: Before treatment (0 wks) ]
    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.



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Ages Eligible for Study:   30 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

Participants should meet following conditions:

  1. Aged of 30 - 49
  2. Individuals who meet FD and postprandial distress syndrome (PDS) criteria in Rome III
  3. 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)
  4. At least 3 questions show more than 2 points in Gastrointestinal impact scale
  5. 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
  6. Individuals who are not supposed to take any other treatments associated with FD during the study
  7. Individuals who voluntarily agree with a study protocol and sign a written informed consent

Exclusion Criteria

Participants who report the followings will be excluded:

  1. Individuals who have organic diseases such as gastroesophageal reflux disease
  2. Individuals who have obvious signs of irritable bowel syndrome
  3. Individuals who have alarm symptoms (weight loss, black or tar stool or dysphagia)
  4. Individuals who have serious structural disease (disease of heart, lung, liver or kidney) or mental illness
  5. Individuals who have had surgery related with the gastrointestinal tract , except for appendectomy more than six months ago
  6. Individuals who are pregnant or breastfeeding
  7. Individuals who are taking drugs which might affect gastrointestinal tract; minimum wash-out period of 2 weeks is required before participating in the trial
  8. Individuals who are HIV-positive
  9. Individuals who have a problem of mal-absorption
  10. 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.)
  11. Individuals who do not want to sign the informed consent
  12. Individuals who have other diseases that could interfere acupuncture treatment, e.g. clotting disorders or leukopenia, pace-maker, epilepsy, or anticoagulant therapy
  13. Individuals who have metal implants or fragments which might influence fMRI examination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02358486


Contacts
Contact: Seok-Jae Ko, KMD, PhD +82-2-440-6245 kokokoko119@hanmail.net

Locations
Korea, Republic of
Kyung Hee University Hospital at Gangdong Recruiting
Seoul, Gangdong-gu, Korea, Republic of, 130-701
Contact: Seok-Jae Ko, KMD, PhD    +82-2-440-6245    kokokoko119@hanmail.net   
Principal Investigator: Seok-Jae Ko, KMD, PhD         
Sub-Investigator: Jae-Woo Park, KMD, PhD         
Sub-Investigator: Il-Hyun Baek, MD, PhD         
Sub-Investigator: In-Kwon Yeo         
Sub-Investigator: Jeong-Chan Lee, KMD, PhD         
Sub-Investigator: Kyung-Mo Park, KMD, PhD         
Sub-Investigator: Hi-Joon Park, KMD, PhD         
Sub-Investigator: Jun-Hwan Lee, KMD, PhD         
Sub-Investigator: Seul-Ki Kim, KMD         
Sub-Investigator: Min-Ji Kim, KMD         
Sub-Investigator: Geon-Ho Jahng, MD, PhD         
Sub-Investigator: Seul-Ki Eun         
Sub-Investigator: Jae-Young Shin         
Sub-Investigator: MOHAMED ABDALLA ZEINELABDEIN ABDALLA         
Sub-Investigator: Eun-Young Lee         
Sub-Investigator: Joo-hee Kim, KMD, PhD         
Sponsors and Collaborators
Kyunghee University Medical Center
Korea Institute of Oriental Medicine
Kyung Hee University Hospital at Gangdong
Investigators
Principal Investigator: Seok-Jae Ko, KMD, PhD Kyung Hee University Hospital at Gangdong

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seok-Jae Ko, PhD, Professor, Department of Korean Internal Medicine, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT02358486     History of Changes
Other Study ID Numbers: KHNMCOH 2014-08-002
First Posted: February 9, 2015    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Seok-Jae Ko, Kyunghee University Medical Center:
Functional Dyspepsia
Acupuncture
Functional MRI

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms