Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis

Official title

Effect of Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis: an Exploratory Pilot Study

Overview

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.

Interventions

• Device 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 h
• Device 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.

Primary outcome measures

• The change from baseline in the numerical rating scale (NRS) score on the worst pain [Time frame: The menstruation period of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5 and Cycle 6 (each cycle is 24-38 days)]]

Secondary outcome measures (8)

• The change from baseline in the numerical rating scale (NRS) score on the average pain [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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 the Cox Menstrual Symptom Scale (CMSS). [Time frame: 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 Short Form Endometriosis Health Profile Questionnaire (EHP-5). [Time frame: The last week 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 total and sub scores of Hospital Anxiety and Depression Scale (HADS). [Time frame: The last week of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 and Cycle 7 (each cycle is 24-38 days)]]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Triple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Guang'anmen Hospital, China Academy of Chinese Medical Sciences — Beijing

Identifiers

NCT: NCT06364592 · 2024-011-KY

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗