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NCT06713980
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Study on the Effects of Acupuncture in Patients with Cyclic Mastalgia

Sponsor: Chuan Yu

View on ClinicalTrials.gov

Summary

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.

Official title: Study on the Effects of Acupuncture on Pain, Acupoint Surface Temperature, and Meridian Energy Values in Patients with Cyclic Mastalgia

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

66

Start Date

2024-12-01

Completion Date

2025-07-31

Last Updated

2024-12-03

Healthy Volunteers

No

Conditions

Interventions

OTHER

sham acupuncture

In the sham acupuncture group, sham acupuncture was applied at 14 specific non-acupuncture points on the back.

OTHER

acupuncture

acupuncture:the choice of acupoints was based on the theory of traditional Chinese medicine (TCM). All needles were manually manipulated to achieve the deqi sensation