Acupuncture for Breast Pain

February 24, 2023 updated by: Yuanjie Sun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Yuanjie Sun
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acupucnture
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.
Device: Acupuncture
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 Comparator: Sham Acupuncture
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.
Device: Sham acupuncture
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through the Cycle 3 (each cycle is 25-35 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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.
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)
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".
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)
NRS ranges from 0 to 10, with 0 indicating no impact and 10 indicating influence completely, and higher scores represent severer impact.
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 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.
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)
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.
At the end of the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expectance assessment
Time Frame: At the end of Cycle 0 (each cycle is 25-35 days)
Patients will be asked what do you think the condition of breast pain will be in three menstrual cycles.
At the end of Cycle 0 (each cycle is 25-35 days)
Assessment of belief in acupuncture
Time Frame: At the end of the Cycle 0 and Cycle 3 (each cycle is 25-35 days)
Patients will be asked do you think acupuncture can help to treat your breast pain.
At the end of the Cycle 0 and Cycle 3 (each cycle is 25-35 days)
Blinding assessment
Time Frame: Within 5 minutes after the last treatment
Participants will be ask do you think you have received traditional acupuncture in the past 3 menstrual cycles.
Within 5 minutes after the last treatment
Adherence assessment
Time Frame: Through the Cycle 1, cycle 2, and cycle 3 (each cycle is 25-35 days)
Adherence will be assessed via counting treatment sessions. Those complete over 80% treatment sessions will be defined as of good adherence.
Through the Cycle 1, cycle 2, and cycle 3 (each cycle is 25-35 days)
Proportion of participants using rescue medicine.
Time Frame: Through study completion, an average of one and a half years.
Through study completion, an average of one and a half years.
Proportion of participants using concomitant medicine or therapy that might impact breast pain.
Time Frame: Through study completion, an average of one and a half years.
Through study completion, an average of one and a half years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2023

Primary Completion (Anticipated)

March 31, 2024

Study Completion (Anticipated)

September 30, 2024

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 16, 2022

First Posted (Actual)

September 21, 2022

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 24, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-007-KY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

The data will be available with publication until six months after publication.

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mastodynia

Clinical Trials on Acupuncture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe