Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Enrolling

Conditions: Dysmenorrhea; Adenomyosis; Electroacupuncture

Treatments: Device: Sham Electroacupuncture; Device: Electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06364592

2024-011-KY

Details and patient eligibility

About

The aim of this study is to preliminarily evaluate the is to assess the effects and safety of electroacupuncture for moderate to severe dysmenorrhea secondary to adenomyosis.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meeting the diagnosis criteria of dysmenorrhea secondary to adenomyosis.
• Female patients aged between 18 and 50.
• Dysmenorrhea lasting for 3 consecutive menstrual cycles or more.
• At least three consecutive menstrual cycles with an interval of 24 to 38 days, differing by less than 7 days, and menstrual periods lasting 2 to 8 days before screening.
• At least 2 days of worst pain score ≥4 on Numerical Rating Scale during the screening period.
• Having not used medications, other than rescue medicine, or therapies for dysmenorrhea secondary to adenomyosis for at least 1 month before randomization, and consenting not to use throughout the process of the research.
• Volunteering to participate the trial and signing written informed consent.

Exclusion criteria

• Diagnosed with Endometriosis or having a history of endometriosis-related surgery
• Currently taking hormonal medications, including: a.use of GnRH agonists within 6 months before the screening period; b. use of progestins or danazol and other long-acting hormones within 3 months before the screening period; c. use of oral contraceptive-like short-acting hormones within one month before the screening period;
• Having clinically significant gynecologic condition such as clinically significant endometrial pathology, persistent complex ovarian cyst larger than 3 cm or simple ovarian cyst larger than 5 cm, or single fibroid 4 cm or larger or more than 4 fibroids measuring at least 2 cm or symptomatic submucosal fibroid of any size.
• having an IUD.
• HB < 90G/L.
• Having any other chronic pain syndrome that required chronic analgesic or other chronic therapy.
• Having a current history of undiagnosed abnormal genital bleeding.
• Malignant tumors (including the reproductive system and other systems).
• Combined with severe diseases in the cardiac, respiratory, renal, liver, and hematopoietic systems, psychiatric disorder and/or cognitive disorders.
• Pregnant, breast feeding, planning a pregnancy within the next 7 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Electroacupuncture, Then Sham Electroacupuncture

Experimental group

Description:

Fifteen participants will first receive electroacupuncture for two consecutive menstrual cycles. After a washout period of one menstrual cycle, they then will receive sham electroacupuncture for another two consecutive menstrual cycles.

Treatment:

Device: Electroacupuncture

Device: Sham Electroacupuncture

Sham Electroacupuncture, Then Electroacupuncture

Sham Comparator group

Description:

Fifteen participants will receive sham electroacupuncture for two consecutive menstrual cycles. After a washout period of one menstrual cycle, they then will receive electroacupuncture for another two consecutive menstrual cycles.

Treatment:

Device: Electroacupuncture

Device: Sham Electroacupuncture