Study on the Effects of Acupuncture on Pain, Acupoint Surface Temperature, and Meridian Energy Values in Patients with Cyclic Mastalgia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 主要终点
- the change in the daily average Visual Analog Scale (VAS) score for overall breast pain
研究概览
简要总结
This study is designed to evaluate the effectiveness of acupuncture in treating cyclic mastalgia (breast pain that occurs in a cyclical pattern, often related to the menstrual cycle). The study will take place at the Pinggu District Traditional Chinese Medicine Hospital in Beijing and also included volunteers who are interested in participating. Sixty-six patients who meet the criteria for cyclic mastalgia will be chosen to take part in the study.The patients will be randomly divided into two groups: Observation Group (Acupuncture Group): 33 patients receive real acupuncture treatments.
Control Group (Sham Acupuncture Group): 33 patients receive sham acupuncture treatments.
This means that neither the participants nor the researchers know who is receiving the real or fake treatment, ensuring a fair comparison.
The study will last for 16 weeks. The main thing researchers look at is the change in daily average overall breast pain. Researchers also observe changes in:Infrared temperature at specific acupoints (Danzhong CV17, Rugen ST18, and Tianzong SI11).Meridian energy values of the Liver, Spleen, and Stomach meridians, which are concepts in Traditional Chinese Medicine related to the flow of energy in the body.
This study helps us understand whether acupuncture is an effective treatment for cyclic mastalgia. By comparing real acupuncture to sham acupuncture, researchers can determine if the improvements seen are due to the acupuncture treatment itself or other factors like the placebo effect.
What does this mean for patients? If you suffer from cyclic mastalgia, this study provides valuable information about the potential benefits of acupuncture as a treatment option. It's important to discuss any treatment options with your health care provider to determine the best approach for your specific situation.
What does this mean for health care providers? This study contributes to the evidence-base for treating cyclic mastalgia with acupuncture. Understanding the results of this study can help health care providers make informed decisions when discussing treatment options with their patients.
Overall, this well-designed study offers insights into the use of acupuncture for cyclic mastalgia, which can be beneficial for both patients and health care providers in making informed decisions about treatment.
详细描述
A randomized, single-blind, sham acupuncture-controlled trial design was employed, targeting patients with cyclic mastalgia who sought treatment at the Pinggu District Traditional Chinese Medicine Hospital in Beijing, as well as volunteers willing to participate in the trial. Sixty-six patients meeting the inclusion criteria were randomly assigned to two groups: the observation group (acupuncture group) and the control group (sham acupuncture group), with 33 patients in each. The study spanned 16 weeks, divided into two phases: a 4-week baseline period and a 12-week treatment period. The primary outcome measure was the change in daily average overall breast pain assessed using a Visual Analog Scale (VAS). Additionally, infrared temperature changes at the Danzhong (CV17), Rugen (ST18), and Tianzong (SI11) acupoints were observed, and the meridian energy values of the Liver, Spleen, and Stomach meridians were evaluated in the participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •（1） 18-45 years old; （2）Clinical diagnosis of Cyclic Mastalgia： Breast pain occurs 2 weeks before menstruation, improves after menstruation；（3）The basic rules of menstrual cycle are (28 ± 7) days and 3-7 days （4）Breast X-ray or breast ultrasound examination excludes malignant breast lesions.
排除标准
- •（1） Received relevant treatment within the past month; （2） with serious cardiovascular and cerebrovascular diseases, severe liver and kidney dysfunction, or coagulation dysfunction; （3）with diseases such as rib cartilage inflammation, chest wall injury, rib fractures, and other external breast pain; （4） in pregnancy or lactation stage; （5）There is a serious skin disease or infection at the intended acupuncture site.
结局指标
主要结局
the change in the daily average Visual Analog Scale (VAS) score for overall breast pain
时间窗: 1 year
the change in visual analog scale (VAS) of overall breast pain on a daily basis within the first two weeks before the baseline period and the end of treatment.
次要结局
- the changes in infrared temperature at the acupoints of Danzhong, Rugen, and Tianzong(1 year)
- the meridian energy values(1year)
研究者
Chuan Yu
Dr.
Pinggu Hospital of Beijing Traditional Chinese Medicine Hospital