Evaluating Placebo Interventions in Acupuncture Research
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- To determine the importance of best practice of point stimulation with regards to the patient's experience of different acu-stimulation.
研究概览
简要总结
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.
详细描述
STUDY DESIGN
The study will be a randomized, prospective pilot study testing if acupuncture, sham acupuncture, and laser stimulation all are useful means in preventing nausea and/or vomiting in early pregnancy.
The acu-stimulation will be performed during at a standardised regimen using acupuncture point PC 6 bilaterally. The placebo needle will be placed in the same position at PC 6 bilaterally, however not penetrating the surface of the skin. The third group of women will have a laser pointing at PC 6. All the patients will achieve exactly the same, standardised information and counselling.
Study participants
According to birth rate-statistics there should be approximately 7000 annual pregnancies in Oslo area. Prevalence is estimated to be approximately 0,75. According to this, there should be at least 5000 pregnant women suffering from nausea and/or vomiting each year, and at least 400 each month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Acupuncture
Needle acupuncture at acupuncture point pericardium 6
干预措施: Acupuncture (Drug)
Sham acupuncture
Non-penetrating sham needling at acupuncture point pericardium 6
干预措施: Sham acupuncture (Device)
Laser acupuncture
Laser stimulation at acupuncture point pericardium 6
干预措施: Laser acupuncture (Device)
结局指标
主要结局
To determine the importance of best practice of point stimulation with regards to the patient's experience of different acu-stimulation.
时间窗: imidiately after treatment
次要结局
- To evaluate the effectiveness of different acu-stimulation for nausea and vomiting in early pregnancy.(4 days after intervention)