Acupuncture for Breast Pain

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

Official Title
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The Safety and Efficacy of Acupuncture in Moderate to Severe Cyclic Breast Pain

Conditions
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Acupuncture, Mastodynia

Intervention / Treatment
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* Device: Acupuncture
* Device: Sham acupuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupucnture<br>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. | Device: Acupuncture<br>* 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.<br>|
| Sham Comparator: Sham Acupuncture<br>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. | Device: Sham acupuncture<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in the numerical rating scale (NRS) score on the worst breast pain. | Participants will fill in the Cardiff Breast Pain Chart to assess the intensity of worst and average pain daily in the form of NRS score ranging from 0-10. 0 refers to no pain and 10 refers to the worst pain imaginable. The highest NRS score on the worst breast pain during the cycle is defined as the final score on the worst pain. | Through the Cycle 3 (each cycle is 25-35 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in the numerical rating scale (NRS) score on the worst breast pain. | Participants will fill in the Cardiff Breast Pain Chart to assess the intensity of worst and average pain daily in the form of NRS score ranging from 0-10. 0 refers to no pain and 10 refers to the worst pain imaginable. The highest NRS score on the worst breast pain during the cycle is defined as the final score on the worst pain. | Through the Cycle 1, Cycle 2, Cycle 6 and Cycle 9 (each cycle is 25-35 days) | 
| The change from baseline in the numerical rating scale (NRS) score on the average breast pain. | Participants will fill in the Cardiff Breast Pain Chart to assess the intensity of worst and average pain daily in the form of NRS score ranging from 0-10. 0 refers to no pain and 10 refers to the worst pain imaginable. The average NRS score on the average breast pain during the cycle is defined as the mean of the average pain score during the cycle. | Through the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days) | 
| Proportion of participants with at least 50% reduction of NRS score on the worst breast pain. | Participants will fill in the Cardiff Breast Pain Chart to assess the intensity of worst and average pain daily in the form of NRS score ranging from 0-10. 0 refers to no pain and 10 refers to the worst pain imaginable. The highest NRS score on the worst breast pain during the cycle is defined as the final score on the worst pain. | Through the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days) | 
| Proportion of participants with at least 50% reduction of NRS score on the average breast pain. | Participants will fill in the Cardiff Breast Pain Chart to assess the intensity of worst and average pain daily in the form of NRS score ranging from 0-10. 0 refers to no pain and 10 refers to the worst pain imaginable. The average NRS score on the average breast pain during the cycle is defined as the mean of the average pain score during the cycle. | Through the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days) | 
| The change from baseline in the number of days with a NRS score of 5 or over on the worst breast pain. | Participants will fill in the Cardiff Breast Pain Chart to assess the intensity of worst and average pain daily in the form of NRS score ranging from 0-10. 0 refers to no pain and 10 refers to the worst pain imaginable. The highest NRS score on the worst breast pain during the cycle is defined as the final score on the worst pain. | Through the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days) | 
| The change from baseline in the number of days with breast pain. | Participants will fill in the Cardiff Breast Pain Chart to assess the intensity of worst and average pain daily in the form of NRS score ranging from 0-10. 0 refers to no pain and 10 refers to the worst pain imaginable. | Through the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days) | 
| The proportion of patients reported very much improved or much improved per the Patient Global Impression of Change (PGIC). | PGIC is a 7-point scale reflecting patient's self-rating of overall improvement: very much improved, much improved, minimally improved, no change, minimally worse, much worse or very much worse. | At the end of the Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days) | 
| The impact of breast pain on sexual life, daily life, mood and sleep rated by NRS scale. | NRS ranges from 0 to 10, with 0 indicating no impact and 10 indicating influence completely, and higher scores represent severer impact. | At the end of the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days) | 
| The change from baseline in the Sort Form 12-item Health Survey (SF-12). | The SF-12 is a general health questionnaire consisting of 12 questions. It investigates the patient's state of health via 8 different dimensions of general health perception, physical health, limited physical role function, physical pain, vitality, mental health, limited emotional role function, and social functioning. The sores of SF-12 range from 0 to 100, with higher scores indicating better physical and mental health functioning. | At the end of the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days) | 
| The change from baseline in the total and sub scores of Hospital Anxiety and Depression Scale (HADS). | HADS consists of 14 items, which are divided into two 7-item subscales to reflect a state of generalized anxiety and the depression. The respondent rates each item on a 4-point scale ranging from 0 (absence) to 3 (extreme presence). The total scores of HADS ranges from 0 to 42, with higher scores indicating severer symptoms. | At the end of the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Breast Pain, Female