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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Claudia M. Witt, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00636012
First received: March 11, 2008
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

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


Condition Intervention
Acupuncture
Procedure: verum acupuncture
Procedure: sham acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: Stimulation of Gastric Slow Waves by Acupuncture of St36 and Pe6 - a Randomized Single-blind Controlled Trial

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • increase of percentage of regular gastric slow waves in the acupuncture group compared to the control group [ Time Frame: baseline, acupuncture ] [ Designated as safety issue: No ]

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

Enrollment: 65
Study Start Date: March 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
verum acupuncture
Procedure: verum acupuncture
acupuncture at St36 and Pe6
Sham Comparator: 2
sham acupuncture
Procedure: sham acupuncture
superficial needling at sham points

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636012

Locations
Germany
Charité University Medical Center
Berlin, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Claudia M. Witt, MD Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Berlin, Germany
Principal Investigator: Frank Zimmermann-Viehoff, MD Department Psychosomatics and Psychotherapy, Charité University Medical Center, Berlin, Germany
  More Information

Publications:
Responsible Party: Claudia M. Witt, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00636012     History of Changes
Other Study ID Numbers: GSW-08
Study First Received: March 11, 2008
Last Updated: July 9, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
acupuncture
Acupuncture points

ClinicalTrials.gov processed this record on April 14, 2014