Placebo in Acupuncture

• Status: Unknown status
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Research Centre of Complementary and Alternative Medicine, Norway
• Collaborator: Norwegian Acupuncture College

Criteria

Inclusion Criteria:

• Positive urine test for pregnancy by the patients themselves or by their doctor.

• Gestational length of 7-12 weeks estimated according to the Naegele method.

• Nausea related to pregnancy must have lasted for at least one week

Exclusion Criteria:

• Any pre-pregnant underlying disease predisposing for nausea

• Women who has been pregnant by infertility treatment

• The woman can not be treated in hospital for nausea or other diseases during pregnancy.

• Women with any pregnancy related disease or abnormalities discovered at regular pregnancy follow-up.