Trial record 5 of 146 for:
Open Studies | acupuncture
Placebo in Acupuncture
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by National Research Centre of Complementary and Alternative Medicine, Norway.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
National Research Centre of Complementary and Alternative Medicine, Norway
Collaborator:
Norwegian Acupuncture College
Information provided by:
National Research Centre of Complementary and Alternative Medicine, Norway
ClinicalTrials.gov Identifier:
NCT01054495
First received: January 21, 2010
Last updated: January 28, 2010
Last verified: January 2010
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Nausea Vomiting |
Drug: Acupuncture Device: Sham acupuncture Device: Laser acupuncture |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) |
| Official Title: | Evaluating Placebo Interventions in Acupuncture Research |
Resource links provided by NLM:
Further study details as provided by National Research Centre of Complementary and Alternative Medicine, Norway:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To evaluate the effectiveness of different acu-stimulation for nausea and vomiting in early pregnancy. [ Time Frame: 4 days after intervention ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01054495
Contacts
| Contact: Arne Johan Norheim, PhD | +47 48 00 55 35 | arne.johan.norheim@hlink.no |
Locations
| Norway | |
| Norwegian Acupuncture College | Not yet recruiting |
| Oslo, Norway | |
| Contact: Hilde Skjerve, Director +4722701900 hilde@akhs.no | |
| 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 vinjar.fonnebo@uit.no | |
| Principal Investigator: Vinjar Fonnebo, Professor | |
Sponsors and Collaborators
National Research Centre of Complementary and Alternative Medicine, Norway
Norwegian Acupuncture College
Investigators
| Principal Investigator: | Arne Johan Norheim, PhD | The National research center in Complementary and Alternative Medicine |
More Information
No publications provided
| Responsible Party: | Arne Johan Norheim, MD PhD, National Research Centre of Complementary and Alternative Medicine, Norway |
| ClinicalTrials.gov Identifier: | NCT01054495 History of Changes |
| Other Study ID Numbers: | 2009/1-7 |
| Study First Received: | January 21, 2010 |
| Last Updated: | January 28, 2010 |
| Health Authority: | Norway: Ethics Committee Norway: Data Protection Authority |
Keywords provided by National Research Centre of Complementary and Alternative Medicine, Norway:
|
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 |
Additional relevant MeSH terms:
|
Nausea Vomiting Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013