Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2023-03-01
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Acupucnture
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.
Acupuncture
The acupoints of Shangyintang, Danzhong(RNl7), Jvque(RN14), Liangmen(ST21), Zhongwan(RNl2), Hegu(LI4), Waiguan(SJ5), Zusanli(ST36), Sanyinjiao(SP6), Taichong(LR3) are selected as main acupoints and used per treatment. The other three acupoints will be chosen one each session according to the syndrome differentiation: Taixi (KI3) for liver and kidney deficiency, Fenglong (ST40) for spleen deficiency and phlegm coagulation, and Xuehai (SP10) for qi-stagnation and blood-stasis. Sterile adhesive pads will be placed on the acupoints after skin disinfection. Hwato-brand disposable acupuncture needles (size 0.30×40mm) will be inserted into the acupoints through the adhesive pads. Afterwards, the acupuncture will be lifted, thrusted and twirled gently for 3 times to achieve deqi sensation and manipulated every ten minutes during 30-minute maintenance.
Sham Acupuncture
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.
Sham acupuncture
The acupoints of Shangyintang, Danzhong(RNl7), Jvque(RN14), Liangmen(ST21), Zhongwan(RNl2), Hegu(LI4), Waiguan(SJ5), Zusanli(ST36), Sanyinjiao(SP6), Taichong(LR3) are selected as main acupoints and used per treatment. The other three acupoints will be chosen one each session according to the syndrome differentiation: Taixi (KI3) for liver and kidney deficiency, Fenglong (ST40) for spleen deficiency and phlegm coagulation, and Xuehai (SP10) for qi-stagnation and blood-stasis. Sterile adhesive pads will be placed on the acupoints after skin disinfection. The needles (with the handle identical to the needles in the acupuncture group and the body at a size 0.30 × 25 mm) will be inserted into adhesive pads without skin penetration. Needles will be lifted, thrusted and twirled gently for 3 times to mimic real acupuncture. No manipulation will be conducted during 30-minute maintenance.
Interventions
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Acupuncture
The acupoints of Shangyintang, Danzhong(RNl7), Jvque(RN14), Liangmen(ST21), Zhongwan(RNl2), Hegu(LI4), Waiguan(SJ5), Zusanli(ST36), Sanyinjiao(SP6), Taichong(LR3) are selected as main acupoints and used per treatment. The other three acupoints will be chosen one each session according to the syndrome differentiation: Taixi (KI3) for liver and kidney deficiency, Fenglong (ST40) for spleen deficiency and phlegm coagulation, and Xuehai (SP10) for qi-stagnation and blood-stasis. Sterile adhesive pads will be placed on the acupoints after skin disinfection. Hwato-brand disposable acupuncture needles (size 0.30×40mm) will be inserted into the acupoints through the adhesive pads. Afterwards, the acupuncture will be lifted, thrusted and twirled gently for 3 times to achieve deqi sensation and manipulated every ten minutes during 30-minute maintenance.
Sham acupuncture
The acupoints of Shangyintang, Danzhong(RNl7), Jvque(RN14), Liangmen(ST21), Zhongwan(RNl2), Hegu(LI4), Waiguan(SJ5), Zusanli(ST36), Sanyinjiao(SP6), Taichong(LR3) are selected as main acupoints and used per treatment. The other three acupoints will be chosen one each session according to the syndrome differentiation: Taixi (KI3) for liver and kidney deficiency, Fenglong (ST40) for spleen deficiency and phlegm coagulation, and Xuehai (SP10) for qi-stagnation and blood-stasis. Sterile adhesive pads will be placed on the acupoints after skin disinfection. The needles (with the handle identical to the needles in the acupuncture group and the body at a size 0.30 × 25 mm) will be inserted into adhesive pads without skin penetration. Needles will be lifted, thrusted and twirled gently for 3 times to mimic real acupuncture. No manipulation will be conducted during 30-minute maintenance.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
FEMALE
No
Sponsors
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Yuanjie Sun
Principal Investigator
Locations
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Yuanjie Sun
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-007-KY
Identifier Type: -
Identifier Source: org_study_id
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