The Safety and Efficacy of Acupuncture in Moderate to Severe Cyclic Breast Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The change from baseline in the numerical rating scale (NRS) score on the worst breast pain.
研究概览
简要总结
This study is conducted to assess the efficacy and safety of acupuncture in moderate to severe cyclic breast pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meeting the diagnosis criteria of cyclic breast pain.
- •Female patients aged between 18 and
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Acupuncture (Device)
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.
干预措施: Sham acupuncture (Device)
结局指标
主要结局
The change from baseline in the numerical rating scale (NRS) score on the worst breast pain.
时间窗: Through the Cycle 3 (each cycle is 25-35 days)
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.
次要结局
- The change from baseline in the number of days with a NRS score of 5 or over on the worst breast pain.(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).(At the end of the Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days))
- The change from baseline in the numerical rating scale (NRS) score on the worst breast 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.(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.(Through the Cycle 1, Cycle 2, 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.(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).(At the end of 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.(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 Sort Form 12-item Health Survey (SF-12).(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 number of days with breast pain.(Through the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days))
研究者
Yuanjie Sun
Principal Investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences