Placebo in Acupuncture

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01054495
Recruitment Status : Unknown
Verified January 2010 by National Research Centre of Complementary and Alternative Medicine, Norway.
Recruitment status was:  Not yet recruiting
First Posted : January 22, 2010
Last Update Posted : January 29, 2010
Norwegian Acupuncture College
Information provided by:
National Research Centre of Complementary and Alternative Medicine, Norway

Brief 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.

Condition or disease Intervention/treatment Phase
Nausea Vomiting Drug: Acupuncture Device: Sham acupuncture Device: Laser acupuncture Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Evaluating Placebo Interventions in Acupuncture Research
Study Start Date : February 2010
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Acupuncture
Needle acupuncture at acupuncture point pericardium 6
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.

Sham Comparator: Sham acupuncture
Non-penetrating sham needling at acupuncture point pericardium 6
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.

Placebo Comparator: Laser acupuncture
Laser stimulation at acupuncture point pericardium 6
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.

Primary Outcome Measures :
  1. To determine the importance of best practice of point stimulation with regards to the patient's experience of different acu-stimulation. [ Time Frame: imidiately after treatment ]

Secondary Outcome Measures :
  1. To evaluate the effectiveness of different acu-stimulation for nausea and vomiting in early pregnancy. [ Time Frame: 4 days after intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01054495

Contact: Arne Johan Norheim, PhD +47 48 00 55 35

Norwegian Acupuncture College Not yet recruiting
Oslo, Norway
Contact: Hilde Skjerve, Director    +4722701900   
Principal Investigator: Hilde Skjerve, Director         
The National Research Center in Complementary and Alternative Medicine Not yet recruiting
Tromso, Norway, N-9037
Contact: Vinjar Fonnebo, Professor   
Principal Investigator: Vinjar Fonnebo, Professor         
Sponsors and Collaborators
National Research Centre of Complementary and Alternative Medicine, Norway
Norwegian Acupuncture College
Principal Investigator: Arne Johan Norheim, PhD The National research center in Complementary and Alternative Medicine

Responsible Party: Arne Johan Norheim, MD PhD, National Research Centre of Complementary and Alternative Medicine, Norway Identifier: NCT01054495     History of Changes
Other Study ID Numbers: 2009/1-7
First Posted: January 22, 2010    Key Record Dates
Last Update Posted: January 29, 2010
Last Verified: January 2010

Keywords provided by National Research Centre of Complementary and Alternative Medicine, Norway:
Sham acupuncture
Control intervention
Nausea and vomiting in early pregnancy
Patient's experience of different acu-stimulation
Blinding in acupuncture research

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms