Study on the Effects of Acupuncture in Patients with Cyclic Mastalgia

ConditionBreast Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorChuan Yu

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • sham acupuncture

    Other intervention

    In the sham acupuncture group, sham acupuncture was applied at 14 specific non-acupuncture points on the back.

  • acupuncture

    Other intervention

    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

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: sham acupuncture groupSham comparator 1 intervention
Group B: acupuncture groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year

Secondary outcomes

1

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

Time frame
1 year
2

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

Time frame
1year

Other outcomes

1

effectiveness of the acupuncture blinding

Effectiveness of acupuncture blinding assessed using Jame's BI Index (JBI),The range of JBI values is 0-1, and the larger the JBI value, the more successful the blind method is.

Time frame
1 year
2

Treatment-Emergent Adverse Events

Safety was determined by recording any adverse reactions or events such as needle sickness, infection, subcutaneous hematoma, subcutaneous nodules, and post-acupuncture pain-including time, severity, treatment measures, and resolution time

Time frame
1year

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chuan Yu

Lead sponsor

Pinggu Hospital of Beijing Traditional Chinese Medicine Hospital

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: