Effectiveness of Acupuncture for Cyclical Mastalgia （CM）

NCT05408377 | Recruiting DMC

• 1 other identifier: CFH2022-3-7132
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multi-center 2-arm randomized controlled trial. According to the ratio of 1：1 and block randomization, a total of 108 eligible CM patients will be randomly allocated to either MA(n=54) or SA(n=54). All patients will undergo treatment two weeks before menstruation and treatment will be stopped at the onset of menstruation. Three times a week, six times a menstrual cycle, 3consecutive menstrual cycles for a total of 18 sessions after baseline. The primary outcome will be the change in the average daily breast pain VAS(VAS-BP) scores during the first 2 weeks of menstruation from baseline at weeks 4,8,12. Additionally, VAS-BP scores at weeks 24 and 36 will also be assessed. Secondary outcomes will include the number of nominal days of breast pain (NDBP) 2 weeks before menstruation, WHOQOL-BREF scores, patient global assessment, breast glandular section thickness, and breast duct width three days before menstruation from baseline at weeks 12. This study will evaluate the effectiveness and safety of acupuncture to alleviate cyclic breast pain and to further explore the possible mechanisms underlying the effect.

Conditions

Mastalgia

Keywords

mastalgia

Outcome Measures

Primary Outcomes (1)

• Breast Pain Visual Analog Scale score

  the change in the average ofBreast Pain Visual Analog Scale( VAS-BP )scores in the first 2 weeks of menstruation，The VAS-BP will be measured using a 10cm linear VAS with 0 representing no pain and 10 the worst imaginable pain, a higher score denotes more severe pain

  from baseline at weeks 4, 8, 12,24,and36

Secondary Outcomes (4)

• number of nominal days of breast pain

  from baseline at weeks 4,8,12,24,and36

• World Health Organization Quality Of Life Scale-Short Form

  from baseline at weeks 12

• breast glandular section thickness, and breast duct width

  baseline at weeks 12

• Patients' global improvement assessment

  at weeks 12

Other Outcomes (2)

• Patients' acceptability toward acupuncture

  at the end of the 1st treatment at week1 and the last treatment at week12.

• Blindness assessment

  the last treatment session at week 12

Study Arms (2)

MA group

EXPERIMENTAL

Manual Acupuncture

Other: MA group

SA group

PLACEBO COMPARATOR

Sham acupuncture

Other: SA group

Interventions

MA group OTHER

We will select Ashi points (the most obvious local pain over the breast), Tanzhong(CV17), bilateral Wuyi (ST15), Rugen (ST18), Tianzong(SI11), Geshu (BL17), Ganshu(BL18), Hegu(LI4), Sanyinjiao (SP6) and Taichong (LR3)in this trial.After insertion, all needles will be manually manipulated (equal manipulations of twirling, lifting, and thrusting)to achieve De qi sensation.

MA group

SA group OTHER

The SA group will use a special needle in which the tip is blunt and the pedestal is opaque. There is an adhesive pad below the base to ensure that the whole pedestal can adhere to the points. Participants will receive superficial touch at bilateral sham GV8(Jinsuo), sham GV7(Zhongshu), sham GV6(Jizhong), sham GV5(Xuanshu), sham GV4(Mingmen), sham BL37(Yinmen), and sham BL57(Chengshan), the needles will touch the skin and not be inserted into the skin, then lift and twist each point evenly for 3 times, make the subject feel the similar sensation of deqi.

SA group

Eligibility Criteria

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

You may qualify if:

• Aged 18-45 years old;
• Breast pain starts within 2 weeks before menses, and improves after onset, dull, heavy, or aching, bilateral, poorly localized, and extends into the axilla ;
• Fulfilling all conditions mentioned below: a. Moderate or severe breast pain as indicating 3 or more on scale of 1-10 on the VAS;b. History of CM for at least the past three consecutive cycles;c. Days of premenstrual breast pain≥3 days and≤14 days; d.A history of regular menstrual cycles of 28 plus/minus 3 days;
• Breast X-ray or breast ultrasound examination is excluded from malignant breast lesions;
• The patient signed the informed consent and voluntarily participated in the study.

You may not qualify if:

• Accepted acupuncture or drugs to treat breast pain within 1 month before entering the study;
• With breast inflammation, breast fibroma, breast cystic hyperplasia, and other benign breast lesions；
• With severe primary diseases in the cardiovascular system, pulmonary system, liver, kidney, and hematopoietic system;
• History of breast cancer among first-degree relatives;
• Breast pain caused by Costochondritis, chest wall injury, rib fracture, and other extramammary pain diseases;
• The patient is pregnant or lactating;
• with serious mental illness;
• Poor compliance;
• Patient has participated in other clinical trials within 1 month;
• with serious skin disease or infection at the acupuncture site.

Sponsors & Collaborators

• Pinggu Hospital of Beijing Traditional Chinese Medicine Hospital: lead
• Pinggu huangsongyu Community hospital: collaborator
• Pinggu Xiagezhuang Community hospital: collaborator

Study Sites (1)

Chuanyu

Beijing, Beijing Municipality, 101200, China

RECRUITING

Related Publications (1)

• Yu C, Wang J, Shen B, Li X, Zhang R, Qin Y, Jian G, Guo J. Effectiveness of acupuncture in the treatment of cyclic mastalgia: a study protocol for a randomized controlled trial. BMC Complement Med Ther. 2022 Nov 18;22(1):297. doi: 10.1186/s12906-022-03779-8.

  PMID: 36401325 DERIVED

MeSH Terms

Conditions

Mastodynia

Condition Hierarchy (Ancestors)

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

Study Officials

• Bin Shen

  Beijing Traditional Chinese Medicine Hospital Pinggu Hospital

  STUDY DIRECTOR

Central Study Contacts

chuan yu

CONTACT

010-69970907; yuchuan106@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Considering the particularity of acupuncture manipulation, acupuncturists in this trial cannot be blinded. The patients, evaluators, and statistical analysts will be blinded to the group allocation. The manipulation of needles will be similar in both groups. Unblinding will only be performed in cases of an emergency event.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study is a 2-arm randomized controlled trial. According to the ratio of 1：1 and block randomization, a total of 108 eligible CM patients will be randomly allocated to either MA(n=54) or SA(n=54).

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 7, 2022
• Study Start: July 20, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: After December 31, 2024

Locations

CN (1)