Acupuncture for Breast Pain

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Enrolling

Conditions: Acupuncture; Mastodynia

Treatments: Device: Sham acupuncture; Device: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05548374

2022-007-KY

Details and patient eligibility

About

This study is conducted to assess the efficacy and safety of acupuncture in moderate to severe cyclic breast pain.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meeting the diagnosis criteria of cyclic breast pain.
• Female patients aged between 18 and 55.
• Relatively regular menstrual cycle.
• Cyclic breast pain lasting for 3 consecutive menstrual cycles or more.
• The score of worst pain ≥5 on Numerical Rating Scale and any level of breast pain lasting 5-21 days during the run-in period of one menstrual cycle.
• No previous experience of acupuncture for breast diseases.
• Willing to use nonhormonal contraceptives if any risk of pregnancy.
• Volunteer to the trial and signing written informed consent.

Exclusion criteria

• Noncyclic breast pain.
• Extramammary pain only.
• A history of breast cancer or suspicious of malignancy breast disease by examinations.
• The Breast Imaging Reporting and Data System (BI-RADS) category 4-6 in ultrasound or mammography examinations.
• Combined with mastitis.
• Breast pain following injury, surgery, hormones, and/or other drugs.
• Usage of hormones (including hormonal contraceptives) in the past three months.
• Combined with severe diseases in the cardiac, respiratory, renal, liver, and hematopoietic systems, psychiatric disorder and/or cognitive disorders.
• A history of bilateral ovariectomy or premature ovarian failure.
• Pregnancy, lactation, or wishing to conceive before the end of the trial.
• Poor adherence.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Acupucnture

Experimental group

Description:

Treatment will start 2 weeks before the onset of menstruation in 3 consecutive menstrual cycles, three sessions per week (ideally every other day) in the first two menstrual cycles and two sessions per week in the last menstrual cycle, 16 sessions in total.

Treatment:

Device: Acupuncture

Sham Acupuncture

Sham Comparator group

Description:

Treatment will start 2 weeks before the onset of menstruation in 3 consecutive menstrual cycles, three sessions per week (ideally every other day) in the first two menstrual cycles and two sessions per week in the last menstrual cycle, 16 sessions in total.

Treatment:

Device: Sham acupuncture