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  • Status : Approved
    • First Submitted Date : 2013/10/24
    • Registered Date : 2013/11/04
    • Last Updated Date : 2013/10/24
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1. Background

Background Information
CRIS
Registration Number
KCT0000905 
Unique Protocol ID KHU IRB 2010-012 
Public/Brief Title Sham Acupuncture for Exploring Acupuncture Specific effects in central and peripheral nervous system 
Scientific Title Phantom Acupuncture for Exploring Acupuncture Specific effects in central and peripheral nervous system  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol No
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
 

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number KHU IRB 2010-012 
Approval Date 2010-09-07 
Institutional Review Board  
Name Kyung Hee University Institutional Review Board 
Address  
Telephone  
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Kyungmo Park 
Title Professor 
Telephone  
Affiliation Kyung Hee University 
Address  
Contact Person for Public Queries
Name Jeungchan Lee 
Title Researcher/Graduate 
Telephone  
Affiliation Kyung Hee University 
Address  
Contact Person for Updating Information
Name Jeungchan Lee 
Title Researcher/Graduate 
Telephone  
Affiliation Kyung Hee University 
Address  

4. Status

Status Information
Study Site Single
Overall Recruitment Status Completed  
Date of First Enrollment 2011-04-11 , Actual
Target Number of Participant 60
Primary Completion Date 2013-04-04 , Actual
Study Completion Date 2013-04-04 , Actual
Recruitment Status by Participating Study Site 1
Name of Study Site Kyung Hee University 
Recruitment Status Completed  
Date of First Enrollment 2011-04-11 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Ministry of Education and Science Technology 
Organization Type Government  
Project ID NRF-2009-0076345 

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Kyung Hee University 
Organization Type University  

7. Study Summary

Study Summary Information
Lay Summary To investigate the effect of coping strategy to acupuncture stimulation on the change in pain and sensory threshold, we tested sensory threshold before and after the acupuncture stimulation in healthy subjects with no disease.
Research hypothesis: Active and passive coping strategy to acupuncture stimulation will cause different change in pain and sensory threshold in healthy subjects.  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Supportive Care    
Phase Not applicable 
Intervention Model Parallel  
Blinding/Masking Single 
Blinded Subject Subject 
Allocation RCT 
Intervention Type Others (Acupuncture stimulation)
Intervention Description Electroacupuncture stimulation was applied in the right lower leg (acupoint: ST36, GB39; stimulation frequency: 16 Hz; stimulation intensity: below individual pain threshold). One group (i.e., passive coping group) was instructed to endure the stimulation, while another group (i.e., active coping group) was instructed to press button whenever they want to reduce the stimulation intensity. So we designed two kinds of coping strategy condition (active and passive) to acupuncture stimulation. From this design, we can verify the psychological effect of coping strategy to the stimulation intensity on pain and sensory threshold.  
Number of Arms
Arm 1 Arm Label Active coping group 
Target Number of Participant 30 
Arm Type Experimental 
Arm Description Active coping group was instructed to press button whenever they want to reduce the stimulation intensity (16Hz, below individual pain threshold). However the actual intensity of the stimulation was not reduced so that only the active coping strategy was induced experimentally to acupuncture stimulation. 
Arm 2 Arm Label Passive coping group 
Target Number of Participant 30 
Arm Type Experimental 
Arm Description Passive coping group was instructed to endure the applied stimulation intensity. The intensity of the stimulation was maintained same with active coping group, however this group was introduced to have passive coping strategy to acupuncture stimulation. 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Not Applicable
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 18 Year ~ 30 Year
Description Healthy male and female volunteer (18 to 30 years old)  
Exclusion Criteria 1. Subject who have trait and psychological disorder
2. Subject who have disease in cardiovascular (e.g. hypertension), opthalmological system, and who have diabetis mellitus
3. Subject who was administered medical drug within 48 hours
4. Subject who is suffering from chronic or acute pain disease, for example, headache and low back pain
5. Subject who has panic disorder
6. Subject who has claustrophobia
7. Subject who had alcohol and caffein within a day, and who has fatigues
8. Subject who is pregnent, breast-feed a baby, or is about to pregnent
9. Subject who participated in another clinical trial or experiment within a month
10. Subject who was excluded by the experimenter due to the possible danger or influence on the experiment according to their medical history and conditions.  
Healthy Volunteers Yes

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Not applicable 
Primary Outcome(s) 1 
Outcome Change in pain and sensory threshold after acupuncture stimulation 
Timepoint Before and after the acupuncture stimulation 
Secondary Outcome(s) 1 
Outcome Subjective intensity and its change of acupuncture stimulation during experiment 
Timepoint After the second (after acupunctuer stimulation) sensory threshold test 

11. Study Results and Publication

Study Results and Publication Information
Result Registerd  

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement Not provided at time of Registration 
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