Back to resultsAcupuncture for Breast Pain
Primary Purpose
Acupuncture, Mastodynia
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture
Sham acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Acupuncture focused on measuring Chronic Breast Pain, Female
Eligibility Criteria
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.
Sites / Locations
- Yuanjie SunRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Acupucnture
Sham Acupuncture
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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".
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.
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.
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.
Full Information
NCT ID
NCT05548374
First Posted
September 13, 2022
Last Updated
February 24, 2023
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05548374
Brief Title
Acupuncture for Breast Pain
Official Title
The Safety and Efficacy of Acupuncture in Moderate to Severe Cyclic Breast Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Anticipated)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is conducted to assess the efficacy and safety of acupuncture in moderate to severe cyclic breast pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture, Mastodynia
Keywords
Chronic Breast Pain, Female
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupucnture
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Acupuncture
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham acupuncture
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change from baseline in the numerical rating scale (NRS) score on the worst breast pain.
Description
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.
Time Frame
Through the Cycle 3 (each cycle is 25-35 days)
Secondary Outcome Measure Information:
Title
The change from baseline in the numerical rating scale (NRS) score on the worst breast pain.
Description
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.
Time Frame
Through the Cycle 1, Cycle 2, Cycle 6 and Cycle 9 (each cycle is 25-35 days)
Title
The change from baseline in the numerical rating scale (NRS) score on the average breast pain.
Description
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.
Time Frame
Through the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days)
Title
Proportion of participants with at least 50% reduction of NRS score on the worst breast pain.
Description
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.
Time Frame
Through the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days)
Title
Proportion of participants with at least 50% reduction of NRS score on the average breast pain.
Description
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.
Time Frame
Through the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days)
Title
The change from baseline in the number of days with a NRS score of 5 or over on the worst breast pain.
Description
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.
Time Frame
Through the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days)
Title
The change from baseline in the number of days with breast pain.
Description
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.
Time Frame
Through the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days)
Title
The proportion of patients reported "very much improved" or "much improved" per the Patient Global Impression of Change (PGIC).
Description
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".
Time Frame
At the end of the Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days)
Title
The impact of breast pain on sexual life, daily life, mood and sleep rated by NRS scale.
Description
NRS ranges from 0 to 10, with 0 indicating no impact and 10 indicating influence completely, and higher scores represent severer impact.
Time Frame
At the end of the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days)
Title
The change from baseline in the Sort Form 12-item Health Survey (SF-12).
Description
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.
Time Frame
At the end of the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days)
Title
The change from baseline in the total and sub scores of Hospital Anxiety and Depression Scale (HADS).
Description
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.
Time Frame
At the end of the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days)
Other Pre-specified Outcome Measures:
Title
Expectance assessment
Description
Patients will be asked what do you think the condition of breast pain will be in three menstrual cycles.
Time Frame
At the end of Cycle 0 (each cycle is 25-35 days)
Title
Assessment of belief in acupuncture
Description
Patients will be asked do you think acupuncture can help to treat your breast pain.
Time Frame
At the end of the Cycle 0 and Cycle 3 (each cycle is 25-35 days)
Title
Blinding assessment
Description
Participants will be ask do you think you have received traditional acupuncture in the past 3 menstrual cycles.
Time Frame
Within 5 minutes after the last treatment
Title
Adherence assessment
Description
Adherence will be assessed via counting treatment sessions. Those complete over 80% treatment sessions will be defined as of good adherence.
Time Frame
Through the Cycle 1, cycle 2, and cycle 3 (each cycle is 25-35 days)
Title
Proportion of participants using rescue medicine.
Time Frame
Through study completion, an average of one and a half years.
Title
Proportion of participants using concomitant medicine or therapy that might impact breast pain.
Time Frame
Through study completion, an average of one and a half years.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanjie Sun
Phone
86 18810337542
Email
puzhisun@163.com
Facility Information:
Facility Name
Yuanjie Sun
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuanjie Sun, PhD
Phone
86 18810337542
Email
puzhisun@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
The data will be available with publication until six months after publication.
IPD Sharing Access Criteria
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.
Learn more about this trial
Acupuncture for Breast Pain
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