Acupuncture for cyclical breast pain relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a multi-center, randomized controlled trial designed to evaluate the effectiveness of acupuncture in treating cyclical mastalgia (CM). A total of 108 eligible patients will be randomly assigned to receive either manual acupuncture or sham acupuncture, with treatments administered three times a week for three consecutive menstrual cycles. The primary outcome will be measured by changes in breast pain scores during menstruation, while secondary outcomes will assess additional pain metrics and quality of life. The study aims to provide insights into the efficacy of acupuncture as a non-pharmacological treatment for CM.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged 18-45 years old;
* Breast pain starts within 2 weeks before menses, and improves after onset, dull, heavy, or aching, bilateral, poorly localized, and extends into the axilla ;
* Fulfilling all conditions mentioned below: a. Moderate or severe breast pain as indicating 3 or more on scale of 1-10 on the VAS;b. History of CM for at least the past three consecutive cycles;c. Days of premenstrual breast pain≥3 days and≤14 days; d.A history of regular menstrual cycles of 28 plus/minus 3 days;
* Breast X-ray or breast ultrasound examination is excluded from malignant breast lesions;
* The patient signed the informed consent and voluntarily participated in the study.

Exclusion Criteria:

* Accepted acupuncture or drugs to treat breast pain within 1 month before entering the study;
* With breast inflammation, breast fibroma, breast cystic hyperplasia, and other benign breast lesions；
* With severe primary diseases in the cardiovascular system, pulmonary system, liver, kidney, and hematopoietic system;
* History of breast cancer among first-degree relatives;
* Breast pain caused by Costochondritis, chest wall injury, rib fracture, and other extramammary pain diseases;
* The patient is pregnant or lactating;
* with serious mental illness;
* Poor compliance;
* Patient has participated in other clinical trials within 1 month;
* with serious skin disease or infection at the acupuncture site.

Where it's running

• Chuanyu
  Beijing, Beijing, China Recruiting

Study contacts

• Study coordinator: chuan yu
• Email: yuchuan106@126.com
• Phone: 010-69970907

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.