Clinical trial NCT05548374: Acupuncture for Breast Pain
Official title: The Safety and Efficacy of Acupuncture in Moderate to Severe Cyclic Breast Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acupuncture
Mastodynia
Keywords: Chronic Breast Pain
Female
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: The change from baseline in the numerical rating scale (NRS) score on the worst breast pain.
timeFrame: Through the Cycle 3 (each cycle is 25-35 days)
Secondary outcomes:
measure: The change from baseline in the numerical rating scale (NRS) score on the worst breast pain.
timeFrame: Through the Cycle 1, Cycle 2, Cycle 6 and Cycle 9 (each cycle is 25-35 days)
measure: The change from baseline in the numerical rating scale (NRS) score on the average breast pain.
timeFrame: Through the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days)
measure: Proportion of participants with at least 50% reduction of NRS score on the worst breast pain.
timeFrame: Through the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days)
measure: Proportion of participants with at least 50% reduction of NRS score on the average breast pain.
timeFrame: Through the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days)
measure: The change from baseline in the number of days with a NRS score of 5 or over on the worst breast pain.
timeFrame: Through the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days)
measure: The change from baseline in the number of days with breast pain.
timeFrame: Through the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days)
measure: The proportion of patients reported "very much improved" or "much improved" per the Patient Global Impression of Change (PGIC).
timeFrame: At the end of the Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days)
measure: The impact of breast pain on sexual life, daily life, mood and sleep rated by NRS scale.
timeFrame: At the end of the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days)
measure: The change from baseline in the Sort Form 12-item Health Survey (SF-12).
timeFrame: At the end of the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days)
measure: The change from baseline in the total and sub scores of Hospital Anxiety and Depression Scale (HADS).
timeFrame: At the end of the Cycle 1, Cycle 2, Cycle 3, Cycle 6 and Cycle 9 (each cycle is 25-35 days)
Other outcomes:
measure: Expectance assessment
timeFrame: At the end of Cycle 0 (each cycle is 25-35 days)
measure: Assessment of belief in acupuncture
timeFrame: At the end of the Cycle 0 and Cycle 3 (each cycle is 25-35 days)
measure: Blinding assessment
timeFrame: Within 5 minutes after the last treatment
measure: Adherence assessment
timeFrame: Through the Cycle 1, cycle 2, and cycle 3 (each cycle is 25-35 days)
measure: Proportion of participants using rescue medicine.
timeFrame: Through study completion, an average of one and a half years.
measure: Proportion of participants using concomitant medicine or therapy that might impact breast pain.
timeFrame: Through study completion, an average of one and a half years.
Locations:
city: Beijing
country: China
facility: Yuanjie Sun
state: Beijing
Study officials:
References: