Clinical trial NCT06364592: Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis
Official title: Effect of Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis: an Exploratory Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dysmenorrhea
Adenomyosis
Electroacupuncture
Keywords: Dysmenorrhea
Adenomyosis
Electroacupuncture
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The change from baseline in the numerical rating scale (NRS) score on the worst pain
timeFrame: 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:
measure: The change from baseline in the numerical rating scale (NRS) score on the average pain
timeFrame: 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)]
measure: The change from baseline in the numerical rating scale (NRS) score on the worst pain.
timeFrame: The menstruation period of Cycle 1, Cycle 4 and Cycle 7 (each cycle is 24-38 days)]
measure: Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on average pain.
timeFrame: 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)]
measure: Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on the worst pain.
timeFrame: 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)]
measure: The change from baseline in the Pictorial Blood Loss Assessment Chart (PBAC) score.
timeFrame: 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)]
measure: The change from baseline in the the Cox Menstrual Symptom Scale (CMSS).
timeFrame: 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)]
measure: The change from baseline in the Short Form Endometriosis Health Profile Questionnaire (EHP-5).
timeFrame: 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)]
measure: The change from baseline in the total and sub scores of Hospital Anxiety and Depression Scale (HADS).
timeFrame: 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)]
Other outcomes:
measure: Proportion of participants with positive expectance assessment
timeFrame: Before the first treatment session of electroacupuncture and sham electroacupuncture.
measure: Blinding assessment
timeFrame: Within 5 minutes after the last treatment in Cycle 3 and Cycle 6 (each cycle is 24-38 days).
measure: Adherence assessment
timeFrame: The menstruation period of Cycle 2, Cycle 3, Cycle 5 and Cycle 6 (each cycle is 24-38 days).
measure: The change from baseline in the dose of rescue medicine.
timeFrame: 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)]
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Zhishun Liu
role: PRINCIPAL_INVESTIGATOR
References: