MedDataX Logo

Study on the Effects of Acupuncture in Patients with Cyclic Mastalgia

NCT ID: NCT06713980

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2025-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

sham acupuncture group

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

Group Type SHAM_COMPARATOR

sham acupuncture

Intervention Type OTHER

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

acupuncture group

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).

Group Type EXPERIMENTAL

acupuncture

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

sham acupuncture

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

Intervention Type OTHER

acupuncture

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

（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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chuan Yu

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chuan Yu

Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Bin Shen Doc. Shen

Role: CONTACT

[email protected]
8613811578685

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024pgzyy01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024pgzyy01

Identifier Type: -

Identifier Source: org_study_id