Stimulation of Gastric Slow Waves With Acupuncture at St36 and Pe6 - a Randomized Single-blind Controlled Trial

Study Overview
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Brief Summary
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Aim of the study is to investigate specific effects of acupuncture points.

Official Title
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Stimulation of Gastric Slow Waves by Acupuncture of St36 and Pe6 - a Randomized Single-blind Controlled Trial

Conditions
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Acupuncture

Intervention / Treatment
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* Procedure: verum acupuncture
* Procedure: sham acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy volunteers BMI between 17.5 and 25 3 hours before the experiment no food 3 hours before the experiment only water, and 1 hour before the experiment no fluid intake 4 hours before the experiment no smoking informed consent Exclusion Criteria: acupuncture treatment during the last 12 months chronic disease regular intake of medication which influence autonomic nervous system or GI tract pregnant or breast feeding drug or substance abuse

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>verum acupuncture | Procedure: verum acupuncture<br>* acupuncture at St36 and Pe6<br>|
| Sham Comparator: 2<br>sham acupuncture | Procedure: sham acupuncture<br>* superficial needling at sham points<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase of percentage of regular gastric slow waves in the acupuncture group compared to the control group |  | baseline, acupuncture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase of percentage of regular gastric slow waves in acupuncture with stimulation compared to no stimulation |  | baseline, acupuncture | 
| half cycles |  | baseline, acupuncture | 
| systolic blood pressure |  | baseline, acupuncture | 
| diastolic blood pressure |  | baseline, acupuncture | 
| mean blood pressure |  | baseline, acupuncture | 
| variability of heart rate |  | baseline, acupuncture | 
| heart rate |  | baseline, acupuncture | 
| breathing rate |  | baseline, acupuncture | 
| skin conductance level |  | baseline, acupuncture | 
| total vascular resistance |  | baseline, acupuncture | 
| stroke volume |  | baseline, acupuncture | 
| correlation between percentage of regular gastric slow waves and secondary outcome measures |  | baseline, acupuncture | 
| impact of needle sensation on gastric slow waves |  | baseline, acupuncture | 
| impact of expectation on gastric slow waves |  | baseline, acupuncture | 
| impact of anxiety (state-trait-anxiety-inventory) on gastric slow waves |  | baseline, acupuncture | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, Acupuncture points