The Effect and Mechanism of Acupuncture on Functional Dyspepsia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02358486|
Recruitment Status : Recruiting
First Posted : February 9, 2015
Last Update Posted : August 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dyspepsia||Device: Acupuncture Device: Sham acupuncture||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
Participants in this group are given 10 times of real acupuncture treatment for 4 weeks.
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Seok-Jae Ko, KMD, PhDfirstname.lastname@example.org|
|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 email@example.com|
|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|
|Principal Investigator:||Seok-Jae Ko, KMD, PhD||Kyung Hee University Hospital at Gangdong|