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Clinical Trials in China / NCT06364592
Recruiting Not applicable

Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis

NCT06364592 · tracked via the Priya Life Science China tracker
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Phase
Not applicable
Started
2024-07-21
Last updated
2025-08-06

Condition(s) studied

DysmenorrheaAdenomyosisElectroacupuncture

Investigational drug(s) / intervention(s)

ElectroacupunctureSham Electroacupuncture

Electroacupuncture: Hwato brand disposable acupuncture needles (size 0.30 × 40 mm and 0.30 × 75 mm) and SDZ-V electroacupuncture apparatus will be used. Acupoints of Ciliao (BL32), Shiqizhui (EX-B8), and Sanyinjiao (SP6) will be used for participants. The needles will be inserted to 60-70mm in BL32 and 25-30mm in EX-B8 and SP6. Needle manipulation will be conducted (except for BL32) to achieve deqi sensation. Then paired electrodes from the electroacupuncture apparatus will be attached transversely to the needle handles at bilateral BL32 and SP6. The electroacupuncture stimulation will last for 30 minutes with a continuous wave of 5Hz and a current intensity of 1 to 5mA. Current intensity was adjusted according to the patients' individual tolerance.Treatment will start within one week before the onset of menstruation and stop before the end of menstruation, three sessions per menstrual cycle in total (ideally every two to three days and at least one session during menstruation period).

Sham Electroacupuncture: Hwato brand disposable acupuncture needles (size 0.25 × 40 mm and 0.30 × 25 mm) and SDZ-V electroacupuncture apparatus will be used. Sham acupoints of BL32, EX-B8 and SP6 will be used for every participants. The needles will be inserted to 2-3mm in sham acupoints. Procedures, electrode placements, and other treatment settings were the same as in the electroacupuncture group but with no electricity output or needle manipulation for de qi.

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • The change from baseline in the numerical rating scale (NRS) score on the worst pain — The menstruation period of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5 and Cycle 6 (each cycle is 24-38 days)]
    Participants will rate their worst pain during menstruation period of each menstrual cycle on a 0-10 NRS scale, where 0 refers to no pain and 10 refers to the worst pain imaginable. The highest worst pain score of the each cycle will be taken as final NRS score on the worst pain.

Trial sites (1)

FacilityCityRegionStatus
Guang'anmen Hospital, China Academy of Chinese Medical Sciences Beijing China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06364592 on ClinicalTrials.gov ↗ ← All trials in China