Breast PainCMNCT06713980
Study on the Effects of Acupuncture in Patients with Cyclic Mastalgia
A study testing acupuncture in people with Breast Pain, run by Chuan Yu.
Trial summary
This study is designed to evaluate the effectiveness of acupuncture in treating cyclic mastalgia (breast pain that occurs in a cyclical pattern, often related to the menstrual cycle). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breast Pain
- What is being tested?
- acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- （1） Received relevant treatment within the past month; （2） with serious cardiovascular and cerebrovascular diseases, severe liver and kidney dysfunction, or coagulation dysfunction; （3）with diseases such as rib cartilage inflammation, chest wall injury, rib fractures, and other external breast pain; （4） in pregnancy or lactation stage; （5）There is a serious skin disease or infection at the intended acupuncture site.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Study on the Effects of Acupuncture on Pain, Acupoint Surface Temperature, and Meridian Energy Values in Patients with Cyclic Mastalgia
This study is designed to evaluate the effectiveness of acupuncture in treating cyclic mastalgia (breast pain that occurs in a cyclical pattern, often related to the menstrual cycle). The study will take place at the Pinggu District Traditional Chinese Medicine Hospital in Beijing and also included volunteers who are interested in participating. Sixty-six patients who meet the criteria for cyclic mastalgia will be chosen to take part in the study.The patients will be randomly divided into two groups: Observation Group (Acupuncture Group): 33 patients receive real acupuncture treatments.
Control Group (Sham Acupuncture Group): 33 patients receive sham acupuncture treatments.
Read more
This means that neither the participants nor the researchers know who is receiving the real or fake treatment, ensuring a fair comparison.
The study will last for 16 weeks. The main thing researchers look at is the change in daily average overall breast pain. Researchers also observe changes in:Infrared temperature at specific acupoints (Danzhong CV17, Rugen ST18, and Tianzong SI11).Meridian energy values of the Liver, Spleen, and Stomach meridians, which are concepts in Traditional Chinese Medicine related to the flow of energy in the body.
This study helps us understand whether acupuncture is an effective treatment for cyclic mastalgia. By comparing real acupuncture to sham acupuncture, researchers can determine if the improvements seen are due to the acupuncture treatment itself or other factors like the placebo effect.
What does this mean for patients? If you suffer from cyclic mastalgia, this study provides valuable information about the potential benefits of acupuncture as a treatment option. It's important to discuss any treatment options with your health care provider to determine the best approach for your specific situation.
What does this mean for health care providers? This study contributes to the evidence-base for treating cyclic mastalgia with acupuncture. Understanding the results of this study can help health care providers make informed decisions when discussing treatment options with their patients.
Overall, this well-designed study offers insights into the use of acupuncture for cyclic mastalgia, which can be beneficial for both patients and health care providers in making informed decisions about treatment.
Read the detailed description
A randomized, single-blind, sham acupuncture-controlled trial design was employed, targeting patients with cyclic mastalgia who sought treatment at the Pinggu District Traditional Chinese Medicine Hospital in Beijing, as well as volunteers willing to participate in the trial. Sixty-six patients meeting the inclusion criteria were randomly assigned to two groups: the observation group (acupuncture group) and the control group (sham acupuncture group), with 33 patients in each. The study spanned 16 weeks, divided into two phases: a 4-week baseline period and a 12-week treatment period. The primary outcome measure was the change in daily average overall breast pain assessed using a Visual Analog Scale (VAS). Additionally, infrared temperature changes at the Danzhong (CV17), Rugen (ST18), and Tianzong (SI11) acupoints were observed, and the meridian energy values of the Liver, Spleen, and Stomach meridians were evaluated in the participants.
- Conditions
- Breast Pain
- Being tested
- sham acupuncture, acupuncture
- Medical subject headings
- Mastodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham acupunctureOther
In the sham acupuncture group, sham acupuncture was applied at 14 specific non-acupuncture points on the back.
acupunctureOther
acupuncture:the choice of acupoints was based on the theory of traditional Chinese medicine (TCM). All needles were manually manipulated to achieve the deqi sensation
| Study group | Role | What they receive |
|---|---|---|
| sham acupuncture group | Sham comparator | In the SA group, non-penetrating sham acupuncture was applied at 14 specific non-acupuncture points on the back. A pedestal was affixed to each non-acupuncture point. Blunt-tip needles were then inserted into the pedestal at a depth of 3-5 mm, and it was ensured that they only touched the skin without penetration Receives: Other: sham acupuncture |
| acupuncture group | Experimental | the choice of acupoints was based on the theory of traditional Chinese medicine (TCM), as follows: Ashi point, Tanzhong (CV17), bilateral Wuyi (ST15), Rugen (ST18), Tianzong (SI11), Geshu (BL17), Ganshu (BL18), Hegu (LI4), Sanyinjiao (SP6), and Taichong (LR3). Receives: Other: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in the daily average Visual Analog Scale (VAS) score for overall breast pain
the change in visual analog scale (VAS) of overall breast pain on a daily basis within the first two weeks before the baseline period and the end of treatment.
Measured: 1 year
Secondary outcomes (2)
the changes in infrared temperature at the acupoints of Danzhong, Rugen, and Tianzong
the changes in infrared temperature at the acupoints of Danzhong, Rugen, and Tianzong
Measured: 1 year
the meridian energy values
Evaluate the meridian energy values of the Liver Meridian, Spleen Meridian, and Stomach Meridian in points, with a maximum score of 100 points, using a meridian detector
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast PainStudies 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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chuan Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chuan Yu, Pinggu Hospital of Beijing Traditional Chinese Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713980
- Sponsor's protocol ID
- 2024pgzyy01
- Other IDs
- 2024pgzyy01
- Acronym
- CM
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the research is completed on December 31, 2026，it will be made available to others upon request to the person in charge (yuchuan106@126.com), only for research, and non-commercial purposes toindividuals affiliated with academic or public health institutions.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effects of Acupuncture on Pain, Acupoint Surface Temperature, and Meridian Energy Values in Patients with Cyclic Mastalgia
- ClinicalTrials.gov ID
- NCT06713980
- Acronym / sponsor ID
- CM / 2024pgzyy01
- Conditions
- Breast Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Chuan YuUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 3 Dec 2024 (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 designed to evaluate the effectiveness of acupuncture in treating cyclic mastalgia (breast pain that occurs in a cyclical pattern, often related to the menstrual cycle). The study will take place at the Pinggu District Traditional Chinese Medicine Hospital in Beijing and also included volunteers who are interested in participating. Sixty-six patients who meet the criteria for cyclic mastalgia will be chosen to take part in the study.The patients will be randomly divided into two groups: Observation Group (Acupuncture Group): 33 patients receive real acupuncture treatments.
Control Group (Sham Acupuncture Group): 33 patients receive sham acupuncture treatments.
This means that neither the participants nor the researchers know who is receiving the real or fake treatment, ensuring a fair comparison.
The study will last for 16 weeks. The main thing researchers look at is the change in daily average overall breast pain. Researchers also observe changes in:Infrared temperature at specific acupoints (Danzhong CV17, Rugen ST18, and Tianzong SI11).Meridian energy values of the Liver, Spleen, and Stomach meridians, which are concepts in Traditional Chinese Medicine related to the flow of energy in the body.
This study helps us understand whether acupuncture is an effective treatment for cyclic mastalgia. By comparing real acupuncture to sham acupuncture, researchers can determine if the improvements seen are due to the acupuncture treatment itself or other factors like the placebo effect.
What does this mean for patients? If you suffer from cyclic mastalgia, this study provides valuable information about the potential benefits of acupuncture as a treatment option. It's important to discuss any treatment options with your health care provider to determine the best approach for your specific situation.
What does this mean for health care providers? This study contributes to the evidence-base for treating cyclic mastalgia with acupuncture. Understanding the results of this study can help health care providers make informed decisions when discussing treatment options with their patients.
Overall, this well-designed study offers insights into the use of acupuncture for cyclic mastalgia, which can be beneficial for both patients and health care providers in making informed decisions about treatment.
Detailed description
A randomized, single-blind, sham acupuncture-controlled trial design was employed, targeting patients with cyclic mastalgia who sought treatment at the Pinggu District Traditional Chinese Medicine Hospital in Beijing, as well as volunteers willing to participate in the trial. Sixty-six patients meeting the inclusion criteria were randomly assigned to two groups: the observation group (acupuncture group) and the control group (sham acupuncture group), with 33 patients in each. The study spanned 16 weeks, divided into two phases: a 4-week baseline period and a 12-week treatment period. The primary outcome measure was the change in daily average overall breast pain assessed using a Visual Analog Scale (VAS). Additionally, infrared temperature changes at the Danzhong (CV17), Rugen (ST18), and Tianzong (SI11) acupoints were observed, and the meridian energy values of the Liver, Spleen, and Stomach meridians were evaluated in the participants.
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 |
|---|---|---|
| sham acupuncture group | Sham comparator | Other: sham acupunctureIn the SA group, non-penetrating sham acupuncture was applied at 14 specific non-acupuncture points on the back. A pedestal was affixed to each non-acupuncture point. Blunt-tip needles were then inserted into the pedestal at a depth of 3-5 mm, and it was ensured that they only touched the skin without penetration |
| acupuncture group | Experimental | Other: acupuncturethe choice of acupoints was based on the theory of traditional Chinese medicine (TCM), as follows: Ashi point, Tanzhong (CV17), bilateral Wuyi (ST15), Rugen (ST18), Tianzong (SI11), Geshu (BL17), Ganshu (BL18), Hegu (LI4), Sanyinjiao (SP6), and Taichong (LR3). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- （1） Received relevant treatment within the past month; （2） with serious cardiovascular and cerebrovascular diseases, severe liver and kidney dysfunction, or coagulation dysfunction; （3）with diseases such as rib cartilage inflammation, chest wall injury, rib fractures, and other external breast pain; （4） in pregnancy or lactation stage; （5）There is a serious skin disease or infection at the intended acupuncture site.
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 |
|---|---|---|
| sham acupunctureIn the sham acupuncture group, sham acupuncture was applied at 14 specific non-acupuncture points on the back. | Other | sham acupuncture group |
| acupunctureacupuncture:the choice of acupoints was based on the theory of traditional Chinese medicine (TCM). All needles were manually manipulated to achieve the deqi sensation | Other | acupuncture group |
Primary outcome
the change in the daily average Visual Analog Scale (VAS) score for overall breast pain
Time frame: 1 year
the change in visual analog scale (VAS) of overall breast pain on a daily basis within the first two weeks before the baseline period and the end of treatment.
2 secondary outcomes
the changes in infrared temperature at the acupoints of Danzhong, Rugen, and Tianzong
Time frame: 1 year
the meridian energy values
Time frame: 1year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Individual participant dataSharing planned: Yes. After the research is completed on December 31, 2026，it will be made available to others upon request to the person in charge (yuchuan106@126.com), only for research, and non-commercial purposes toindividuals affiliated with academic or public health institutions.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Breast Pain, run by Chuan Yu.
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 0 inclusion and 1 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: opening soon, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bin Shen Doc. Shen (8613811578685, Apricot069@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change in the daily average Visual Analog Scale (VAS) score for overall breast pain (time frame: 1 year). 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 3 Dec 2024.