Acupuncture for cyclical breast pain relief

Effectiveness of Acupuncture for Cyclical Mastalgia （CM）

This study is testing if acupuncture can help relieve breast pain during menstruation for women who experience cyclical breast pain.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Pinggu Hospital of Beijing Traditional Chinese Medicine Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05408377 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are women aged 18-45 who experience moderate to severe breast pain before menstruation.

Not a fit: Patients with certain benign breast conditions or those who have recently undergone acupuncture treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a non-invasive treatment option for women suffering from cyclical mastalgia.

How similar studies have performed: Previous studies have shown promising results for acupuncture in treating various pain conditions, suggesting potential success for this approach in cyclical mastalgia.

Eligibility criteria

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 this trial is running

Beijing, Beijing

• Chuanyu — Beijing, Beijing, China (Recruiting)

Study contacts

• Study coordinator: chuan yu

Conditions Mastalgia; mastalgia