Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is conducted to assess the efficacy and safety of acupuncture in moderate to severe cyclic breast pain.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupucnture | Experimental | 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 | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Device | 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. |
| 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) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Expectance assessment | Patients will be asked what do you think the condition of breast pain will be in three menstrual cycles. | At the end of Cycle 0 (each cycle is 25-35 days) |
| Assessment of belief in acupuncture |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuanjie Sun | Contact | 86 18810337542 | puzhisun@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yuanjie Sun | Recruiting | Beijing | Beijing Municipality | 100053 | China |
Deidentified participant data and data dictionary will be available with publication until six months after publication.
Formal request should be sent to puzhisun@163.com with a methodologically sound proposal.
Researchers whose proposal has been approved will sign a data access agreement.
The data will be available with publication until six months after publication.
Formal request should be sent to puzhisun@163.com with a methodologically sound proposal. Researchers whose proposal has been approved will sign a data access agreement.
Not provided
Not provided
| ID | Term |
|---|---|
| D059373 | Mastodynia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sham acupuncture | Device | 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. |
|
| 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) |
Patients will be asked do you think acupuncture can help to treat your breast pain.
| At the end of the Cycle 0 and Cycle 3 (each cycle is 25-35 days) |
| Blinding assessment | Participants will be ask do you think you have received traditional acupuncture in the past 3 menstrual cycles. | Within 5 minutes after the last treatment |
| Adherence assessment | Adherence will be assessed via counting treatment sessions. Those complete over 80% treatment sessions will be defined as of good adherence. | Through the Cycle 1, cycle 2, and cycle 3 (each cycle is 25-35 days) |
| Proportion of participants using rescue medicine. | Through study completion, an average of one and a half years. |
| Proportion of participants using concomitant medicine or therapy that might impact breast pain. | Through study completion, an average of one and a half years. |