Clinical trial NCT00636012: Stimulation of Gastric Slow Waves With Acupuncture at St36 and Pe6 - a Randomized Single-blind Controlled Trial
Official title: Stimulation of Gastric Slow Waves by Acupuncture of St36 and Pe6 - a Randomized Single-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acupuncture
Keywords: acupuncture
Acupuncture points
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2008-03-14
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Aim of the study is to investigate specific effects of acupuncture points.


Eligibility criteria: 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

Primary outcomes:
measure: increase of percentage of regular gastric slow waves in the acupuncture group compared to the control group
timeFrame: baseline, acupuncture
Secondary outcomes:
measure: increase of percentage of regular gastric slow waves in acupuncture with stimulation compared to no stimulation
timeFrame: baseline, acupuncture
measure: half cycles
timeFrame: baseline, acupuncture
measure: systolic blood pressure
timeFrame: baseline, acupuncture
measure: diastolic blood pressure
timeFrame: baseline, acupuncture
measure: mean blood pressure
timeFrame: baseline, acupuncture
measure: variability of heart rate
timeFrame: baseline, acupuncture
measure: heart rate
timeFrame: baseline, acupuncture
measure: breathing rate
timeFrame: baseline, acupuncture
measure: skin conductance level
timeFrame: baseline, acupuncture
measure: total vascular resistance
timeFrame: baseline, acupuncture
measure: stroke volume
timeFrame: baseline, acupuncture
measure: correlation between percentage of regular gastric slow waves and secondary outcome measures
timeFrame: baseline, acupuncture
measure: impact of needle sensation on gastric slow waves
timeFrame: baseline, acupuncture
measure: impact of expectation on gastric slow waves
timeFrame: baseline, acupuncture
measure: impact of anxiety (state-trait-anxiety-inventory) on gastric slow waves
timeFrame: baseline, acupuncture
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Medical Center
Study officials:
affiliation: Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany
name: Claudia M. Witt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department Psychosomatics and Psychotherapy, Charité University Medical Center, Berlin, Germany
name: Frank Zimmermann-Viehoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Witt CM, Meissner K, Pach D, Thiele C, Ludtke R, Ghadiyali Z, Deter HC, Zimmermann-Viehoff F. Stimulation of gastric slow waves with manual acupuncture at acupuncture points ST36 and PC6--a randomized single blind controlled trial. Neurogastroenterol Motil. 2012 May;24(5):438-45, e211-2. doi: 10.1111/j.1365-2982.2012.01877.x. Epub 2012 Feb 6.