Actively Recruiting
Effect of Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis: an Exploratory Pilot Study
Led by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Updated on 2025-08-06
30
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the effects and safety of electroacupuncture in women with moderate to severe menstrual pain caused by adenomyosis. It focuses on how this treatment may impact pain levels and associated symptoms over several menstrual cycles. The study is exploratory and designed to gather preliminary data on this approach. Participants are randomly assigned to one of two groups. One group first receives electroacupuncture treatments during two consecutive menstrual cycles, followed by a one-cycle break, then sham electroacupuncture for two cycles. The other group receives these treatments in the reverse order. Electroacupuncture involves using specific acupuncture needles and an electrical device applied to targeted points for 30 minutes per session, three times per cycle. During the study, participants will track their pain using a numerical rating scale across six menstrual cycles and complete questionnaires related to menstrual symptoms, blood loss, and mental health. Researchers will monitor changes in pain intensity, symptom severity, and quality of life. The total study duration includes treatment, washout, and follow-up cycles, allowing detailed evaluation of treatment effects and safety.
CONDITIONS
Brief Title
Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged between 18 and 50 years
- Diagnosed with dysmenorrhea secondary to adenomyosis
- Experiencing dysmenorrhea for 3 or more consecutive menstrual cycles
- Having at least three consecutive menstrual cycles with intervals of 24 to 38 days, differing by less than 7 days
- Menstrual periods lasting between 2 and 8 days before screening
- At least 2 days during screening with worst pain score of 4 or higher on the Numerical Rating Scale
- No use of medications or therapies for dysmenorrhea other than rescue medicine for at least 1 month before randomization
- Willing to participate and able to provide written informed consent
You will not qualify if you...
- Diagnosed with endometriosis or history of endometriosis-related surgery
- Currently taking hormonal medications including GnRH agonists within 6 months, progestins, danazol, or other long-acting hormones within 3 months, or oral contraceptive-like hormones within 1 month before screening
- Having clinically significant gynecologic conditions such as certain ovarian cysts larger than 3-5 cm, or fibroids 4 cm or larger or symptomatic submucosal fibroids
- Presence of an intrauterine device (IUD)
- Hemoglobin less than 90 g/L
- Having other chronic pain syndromes requiring chronic analgesics or therapy
- Current undiagnosed abnormal genital bleeding
- Malignant tumors affecting reproductive or other systems
- Severe cardiac, respiratory, renal, liver, hematopoietic diseases, psychiatric or cognitive disorders
- Pregnant, breastfeeding, or planning pregnancy within the next 7 months
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 to 7 months (6 menstrual cycles total including washout)
Participants receive electroacupuncture or sham electroacupuncture treatment during their menstrual cycles. Each treatment lasts for two consecutive menstrual cycles, with three sessions per cycle starting within one week before menstruation and ending before menstruation ends. After two cycles, there is a washout period of one menstrual cycle before crossing over to the other treatment for another two consecutive menstrual cycles.
3 sessions per menstrual cycle for 4 menstrual cycles, plus assessments during washout menstrual cycle
Trial Site Locations
Total: 1 location
1
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, China
Actively Recruiting
Research Team
Z
Zhishun Liu
M
Min Yang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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