Effectiveness of Acupuncture for Cyclical Mastalgia （CM）
Pinggu Hospital of Beijing Traditional Chinese Medicine Hospital
108 participants
Jul 20, 2022
INTERVENTIONAL
Conditions
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) or SA(n=54). All patients will undergo treatment two weeks before menstruation and treatment will be stopped at the onset of menstruation. Three times a week, six times a menstrual cycle, 3consecutive menstrual cycles for a total of 18 sessions after baseline. The primary outcome will be the change in the average daily breast pain VAS(VAS-BP) scores during the first 2 weeks of menstruation from baseline at weeks 4,8,12. Additionally, VAS-BP scores at weeks 24 and 36 will also be assessed. Secondary outcomes will include the number of nominal days of breast pain (NDBP) 2 weeks before menstruation, WHOQOL-BREF scores, patient global assessment, breast glandular section thickness, and breast duct width three days before menstruation from baseline at weeks 12. This study will evaluate the effectiveness and safety of acupuncture to alleviate cyclic breast pain and to further explore the possible mechanisms underlying the effect.
Eligibility
Inclusion Criteria5
- 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 Criteria10
- 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.
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Interventions
We will select Ashi points (the most obvious local pain over the breast), Tanzhong(CV17), bilateral Wuyi (ST15), Rugen (ST18), Tianzong(SI11), Geshu (BL17), Ganshu(BL18), Hegu(LI4), Sanyinjiao (SP6) and Taichong (LR3)in this trial.After insertion, all needles will be manually manipulated (equal manipulations of twirling, lifting, and thrusting)to achieve De qi sensation.
The SA group will use a special needle in which the tip is blunt and the pedestal is opaque. There is an adhesive pad below the base to ensure that the whole pedestal can adhere to the points. Participants will receive superficial touch at bilateral sham GV8(Jinsuo), sham GV7(Zhongshu), sham GV6(Jizhong), sham GV5(Xuanshu), sham GV4(Mingmen), sham BL37(Yinmen), and sham BL57(Chengshan), the needles will touch the skin and not be inserted into the skin, then lift and twist each point evenly for 3 times, make the subject feel the similar sensation of deqi.
Locations(1)
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NCT05408377