Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis

NCT06364592 | Recruiting DMC

• 1 other identifier: 2024-011-KY
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysmenorrhea; Adenomyosis; Electroacupuncture

Keywords

Dysmenorrhea; Adenomyosis; Electroacupuncture

Outcome Measures

Primary Outcomes (1)

• The change from baseline in the numerical rating scale (NRS) score on the worst pain

  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.

  The menstruation period of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5 and Cycle 6 (each cycle is 24-38 days)]

Secondary Outcomes (8)

• The change from baseline in the numerical rating scale (NRS) score on the average pain

  The menstruation period of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 and Cycle 7 (each cycle is 24-38 days)]

• The change from baseline in the numerical rating scale (NRS) score on the worst pain.

  The menstruation period of Cycle 1, Cycle 4 and Cycle 7 (each cycle is 24-38 days)]

• Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on average pain.

  The menstruation period of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 and Cycle 7 (each cycle is 24-38 days)]

• Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on the worst pain.

  The menstruation period of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 and Cycle 7 (each cycle is 24-38 days)]

• The change from baseline in the Pictorial Blood Loss Assessment Chart (PBAC) score.

  The menstruation period of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 and Cycle 7 (each cycle is 24-38 days)]

Other Outcomes (4)

• Proportion of participants with positive expectance assessment

  Before the first treatment session of electroacupuncture and sham electroacupuncture.

• Blinding assessment

  Within 5 minutes after the last treatment in Cycle 3 and Cycle 6 (each cycle is 24-38 days).

• Adherence assessment

  The menstruation period of Cycle 2, Cycle 3, Cycle 5 and Cycle 6 (each cycle is 24-38 days).

Study Arms (2)

Electroacupuncture, Then Sham Electroacupuncture

EXPERIMENTAL

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.

Device: Electroacupuncture; Device: Sham Electroacupuncture

Sham Electroacupuncture, Then Electroacupuncture

SHAM COMPARATOR

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.

Device: Electroacupuncture; Device: Sham Electroacupuncture

Interventions

Electroacupuncture DEVICE

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).

Electroacupuncture, Then Sham Electroacupuncture; Sham Electroacupuncture, Then Electroacupuncture

Sham Electroacupuncture DEVICE

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.

Electroacupuncture, Then Sham Electroacupuncture; Sham Electroacupuncture, Then Electroacupuncture

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Dysmenorrhea; Adenomyosis

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Zhishun Liu

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhishun Liu

CONTACT

+861088002331; zhishunjournal@163.com

Min Yang

CONTACT

+8618810268077; yangmin2019@yeah.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Dean of Acupuncture Department

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 15, 2024
• Study Start: July 21, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available with the publication until six months after publication.
• Access Criteria: A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal. Researchers whose proposal has been approved. Researchers whose proposal has been approved will sign a data access agreement.

Locations

CN (1)