Placebo control in acupuncture research is challenging and difficult. The primary objective
of the study is to explore a study design comparing stimulation by real acupuncture needle,
sham acupuncture needle and laser. The research question is whether a patient is capable of
discriminate different stimulation modality when studying acupuncture stimulation for nausea
in early pregnancy. The study is planned as a pilot study including 20 women in each of the
three study groups, all-together 60 pregnant women. Intervention will consist of standardised
15 minutes stimulation of acupuncture point pericardium 6 by, either two acupuncture needles,
two sham acupuncture needle or two laser devices. All participating women are told that they
will get different stimulation at an acupuncture point with potential effect on nausea. The
women will record their daily symptoms during a 4 day run-in period, a 3 day intervention
period, and thereafter a 4 day follow-up period after treatment in accordance with previous
research methodology. In addition, the women will record how they experience the three
different stimulations of acupuncture points. The results from the study could be important
for planning of future studies where the blinding issue with regard to acupuncture is
challenged.
Phase:
Phase 2
Details
Lead Sponsor:
National Research Centre of Complementary and Alternative Medicine, Norway