Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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
• Устройство 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.

Первичные конечные точки

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

Вторичные конечные точки (8)

• The change from baseline in the numerical rating scale (NRS) score on the average pain [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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)]]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

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

Идентификаторы

NCT: NCT06364592 · 2024-011-KY

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗