Study on the Effects of Acupuncture in Patients with Cyclic Mastalgia

NCT06713980 | Not Yet Recruiting DMC

• 1 other identifier: 2024pgzyy01
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Breast Pain

Outcome Measures

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.

  1 year

Secondary Outcomes (2)

• the changes in infrared temperature at the acupoints of Danzhong, Rugen, and Tianzong

  1 year

• the meridian energy values

  1year

Other Outcomes (2)

• effectiveness of the acupuncture blinding

  1 year

• Treatment-Emergent Adverse Events

  1year

Study Arms (2)

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

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).

Other: acupuncture

Interventions

sham acupuncture OTHER

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

sham acupuncture group

acupuncture OTHER

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

acupuncture group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• （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.

Sponsors & Collaborators

• Chuan Yu: lead

MeSH Terms

Conditions

Mastodynia

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Bin Shen Doc. Shen

CONTACT

8613811578685; Apricot069@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 24, 2024
• First Posted: December 3, 2024
• Study Start: December 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: July 31, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR