AcupunctureNCT05548374
Acupuncture for Breast Pain
A study testing Acupuncture in people with Acupuncture and Mastodynia, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
This study is conducted to assess the efficacy and safety of acupuncture in moderate to severe cyclic breast pain. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Acupuncture, Mastodynia
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yuanjie Sun
Beijing, Beijing Municipality, 100053
Yuanjie Sun, PhD, 86 18810337542, puzhisun@163.com
About this study
Official title: The Safety and Efficacy of Acupuncture in Moderate to Severe Cyclic Breast Pain
This study is conducted to assess the efficacy and safety of acupuncture in moderate to severe cyclic breast pain.
- Conditions
- Acupuncture, Mastodynia
- Being tested
- Acupuncture, Sham acupuncture
- Keywords
- Chronic Breast Pain, Female
- Medical subject headings
- Mastodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
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 acupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Acupuncture |
| 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. Receives: Device: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through the Cycle 3 (each cycle is 25-35 days)
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the end of the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start1 Mar 2023 (estimated)
- Primary completion31 Mar 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuanjie Sun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05548374
- Sponsor's protocol ID
- 2022-007-KY
- Status last verified
- Feb 2023
- First submitted
- 13 Sep 2022
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Acupuncture in Moderate to Severe Cyclic Breast Pain
- ClinicalTrials.gov ID
- NCT05548374
- Acronym / sponsor ID
- 2022-007-KY
- Conditions
- Acupuncture, Mastodynia
- Keywords
- Chronic Breast Pain, Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is conducted to assess the efficacy and safety of acupuncture in moderate to severe cyclic breast pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupucnture | Experimental | Device: AcupunctureTreatment 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 | Device: Sham acupunctureTreatment 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureThe 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. | Device | Acupucnture |
| Sham acupunctureThe 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. | Device | Sham Acupuncture |
Primary outcome
The change from baseline in the numerical rating scale (NRS) score on the worst breast pain.
Time frame: 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.
10 secondary outcomes
The change from baseline in the numerical rating scale (NRS) score on the worst breast pain.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: At the end of the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Acupuncture and Mastodynia, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuanjie Sun (86 18810337542, puzhisun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline in the numerical rating scale (NRS) score on the worst breast pain. (time frame: Through the Cycle 3 (each cycle is 25-35 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.