Acupuncture for Breast Pain

NCT05548374 | Unknown

• 1 other identifier: 2022-007-KY
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted to assess the efficacy and safety of acupuncture in moderate to severe cyclic breast pain.

Conditions

Acupuncture; Mastodynia

Keywords

Chronic Breast Pain; Female

Outcome Measures

Primary Outcomes (1)

• The change from baseline in the numerical rating scale (NRS) score on the worst breast pain.

  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 Outcomes (10)

• The change from baseline in the numerical rating scale (NRS) score on the worst breast 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.

  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.

  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.

  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.

  Through the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days)

Other Outcomes (6)

• Expectance assessment

  At the end of Cycle 0 (each cycle is 25-35 days)

• Assessment of belief in acupuncture

  At the end of the Cycle 0 and Cycle 3 (each cycle is 25-35 days)

• Blinding assessment

  Within 5 minutes after the last treatment

Study Arms (2)

Acupucnture

EXPERIMENTAL

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

Sham Acupuncture

SHAM COMPARATOR

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

Interventions

Acupuncture DEVICE

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.

Acupucnture

Sham acupuncture DEVICE

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.

Sham Acupuncture

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Yuanjie Sun

Beijing, Beijing Municipality, 100053, China

RECRUITING

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

Yuanjie Sun

CONTACT

86 18810337542; puzhisun@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: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 21, 2022
• Study Start: March 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: September 30, 2024
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available with publication until six months after publication.
• 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.

Locations

CN (1)