Status:
RECRUITING
Effectiveness of Acupuncture for Cyclical Mastalgia （CM）
Lead Sponsor:
Pinggu Hospital of Beijing Traditional Chinese Medicine Hospital
Collaborating Sponsors:
Pinggu huangsongyu Community hospital
Pinggu Xiagezhuang Community hospital
Conditions:
Mastalgia
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
This study is a multi-center 2-arm randomized controlled trial. According to the ratio of 1：1 and block randomization, a total of 108 eligible CM patients will be randomly allocated to either MA(n=54)...
Detailed Description
Sample size Sample size estimation was based on changes in the breast pain VAS(VAS-BP) score. According to the pre-trial, the VAS-BP score significantly decreased by 2.98 ±0.95 in MA group compared to...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT05408377
Start Date
July 20 2022
End Date
December 31 2024
Last Update
April 9 2024
Active Locations (1)
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1
Chuanyu
Beijing, Beijing Municipality, China, 101200