Placebo in Acupuncture

NCT01054495 | Unknown Phase 2 DMC

• 1 other identifier: 2009/1-7
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Nausea; Vomiting

Keywords

Acupuncture; Sham acupuncture; Laser; Methodology; Control intervention; Pilot; Nausea and vomiting in early pregnancy; Patient's experience of different acu-stimulation; Blinding in acupuncture research

Outcome Measures

Primary Outcomes (1)

• To determine the importance of best practice of point stimulation with regards to the patient's experience of different acu-stimulation.

  imidiately after treatment

Secondary Outcomes (1)

• To evaluate the effectiveness of different acu-stimulation for nausea and vomiting in early pregnancy.

  4 days after intervention

Study Arms (3)

Acupuncture

ACTIVE COMPARATOR

Needle acupuncture at acupuncture point pericardium 6

Drug: Acupuncture

Sham acupuncture

SHAM COMPARATOR

Non-penetrating sham needling at acupuncture point pericardium 6

Device: Sham acupuncture

Laser acupuncture

PLACEBO COMPARATOR

Laser stimulation at acupuncture point pericardium 6

Device: Laser acupuncture

Interventions

Acupuncture DRUG

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.

Acupuncture

Sham acupuncture DEVICE

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.

Sham acupuncture

Laser acupuncture DEVICE

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

Laser acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Research Centre of Complementary and Alternative Medicine, Norway: lead
• Norwegian Acupuncture College: collaborator

Study Sites (2)

The National Research Center in Complementary and Alternative Medicine

Tromsø, Tromso, N-9037, Norway

Location

Norwegian Acupuncture College

Oslo, Norway

Location

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Arne Johan Norheim, PhD

  The National research center in Complementary and Alternative Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arne Johan Norheim, PhD

CONTACT

+47 48 00 55 35; arne.johan.norheim@hlink.no

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 21, 2010
• First Posted: January 22, 2010
• Study Start: February 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: January 29, 2010

Record last verified: 2010-01

Locations

NO (2)