Acupuncture for Breast Pain

Last updated: February 24, 2023
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05548374
2022-007-KY
  • Ages 18-55
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

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 painlasting 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

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 ormammography 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, andhematopoietic 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.

Study Design

Total Participants: 60
Study Start date:
March 01, 2023
Estimated Completion Date:
September 30, 2024

Connect with a study center

  • Yuanjie Sun

    Beijing, Beijing 100053
    China

    Active - Recruiting

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