Placebo in Acupuncture

Summary

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.

Conditions

• Nausea
• Vomiting

Interventions

DRUG

Acupuncture

The acupuncture needles are inserted in PC 6 bilaterally at the acupuncture point Pericardium 6 (PC6) on each forearm (fig 2). According to the "cun" measurement system of Traditional Chinese Medicine (TCM), the points are located on the palmar surface of anterior forearm at a distance equivalent to the combined width of the women's middle three fingers, proximal to the most prominent wrist crease, and between the tendons of palmaris longus and flexor carpi radialis. We try to keep the depth of the needling to approximately 1,5 cm. At insertion of the acupuncture needle, DeQi is obtained and the needle is then left without any further manipulation/ stimulation (even method) in situ for 15 minutes.

DEVICE

Sham acupuncture

A sham acupuncture needle is placed at PC 6 bilaterally and the tactile stimuli of the skin during the procedure should be obtained. The sham acupuncture needle is then left at site for 15 minutes without any further manipulation/stimulation.

DEVICE

Laser acupuncture

A laser is placed in a stand, pointing at PC 6 bilaterally, and left at site for 15 minutes without any further manipulation/stimulation.

Sponsors & Collaborators

• Norwegian Acupuncture College

  collaborator UNKNOWN

• National Research Centre of Complementary and Alternative Medicine, Norway

  lead OTHER

Principal Investigators

• Arne Johan Norheim, PhD · The National research center in Complementary and Alternative Medicine

Study Design

Allocation

RANDOMIZED

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2010-02-28

Primary Completion

2010-06-30

Completion

2010-06-30

Countries

• Norway

Study Locations