Effect of Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis: an Exploratory Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- The change from baseline in the numerical rating scale (NRS) score on the worst pain
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Meeting the diagnosis criteria of dysmenorrhea secondary to adenomyosis.
- •Female patients aged between 18 and
- •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.
Arms & Interventions
Electroacupuncture, Then Sham Electroacupuncture
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.
Intervention: Electroacupuncture (Device)
Electroacupuncture, Then Sham Electroacupuncture
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.
Intervention: Sham Electroacupuncture (Device)
Sham Electroacupuncture, Then Electroacupuncture
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.
Intervention: Electroacupuncture (Device)
Sham Electroacupuncture, Then Electroacupuncture
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.
Intervention: Sham Electroacupuncture (Device)
Outcomes
Primary Outcomes
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)]
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.
Secondary Outcomes
- 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)])
- The change from baseline in the the Cox Menstrual Symptom Scale (CMSS).(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 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 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)])
- The change from baseline in the Short Form Endometriosis Health Profile Questionnaire (EHP-5).(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).(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)])
Investigators
Liu Zhishun
Chief Physician, Dean of Acupuncture Department
Guang'anmen Hospital of China Academy of Chinese Medical Sciences