NCT06713980: CM

Study on the Effects of Acupuncture in Patients with Cyclic Mastalgia

Not yet recruiting NA Last updated 3 December 2024

What this trial tests

NA trial testing sham acupuncture in Breast Pain in 66 participants. Not yet recruiting.

Timeline

1 December 2024

Primary endpoint
31 May 2025

31 July 2025

Quick facts

Lead sponsor	Chuan Yu
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	66
Start date	1 December 2024
Primary completion	31 May 2025
Estimated completion	31 July 2025

Drugs / interventions tested

• sham acupuncture
• acupuncture — full drug profile →

Conditions studied

• Breast Pain — all drugs for Breast Pain →

Sponsor

Chuan Yu

Who can join

Adults 18 to 45, female only, with Breast Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.