Dysmenorrhea Clinical Trial
Official title:
Effect of Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis: an Exploratory Pilot Study
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | May 2026 |
Est. primary completion date | February 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Guang'anmen Hospital, China Academy of Chinese Medical Sciences | Beijing |
Lead Sponsor | Collaborator |
---|---|
Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Proportion of participants with positive expectance assessment | Participants will be asked what do you think the condition of dysmenorrhea will be in two menstrual cycles? | Before the first treatment session of electroacupuncture and sham electroacupuncture. | |
Other | Blinding assessment | Participants will be ask "do you think you have received traditional electroacupuncture in the past two cycles?" | Within 5 minutes after the last treatment in Cycle 3 and Cycle 6 (each cycle is 24-38 days). | |
Other | Adherence assessment | Adherence will be assessment via counting treatment sessions. Those complete over 80% treatment sessions will be defined as of good adherence. | The menstruation period of Cycle 2, Cycle 3, Cycle 5 and Cycle 6 (each cycle is 24-38 days). | |
Other | The change from baseline in the dose of rescue medicine. | The dose of rescue medicine that participants use to relieve dysmenorrhea-related 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)] | |
Primary | 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 | The change from baseline in the numerical rating scale (NRS) score on the average pain | Participants will rate their average 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 final NRS score on average pain is defined as the mean of the average pain scores of each cycle. | 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)] | |
Secondary | 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 4 and Cycle 7 (each cycle is 24-38 days)] | |
Secondary | Proportion of participants with at least 30% reduction of numerical rating scale (NRS) score on average pain. | Participants will rate their average 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 final NRS score on average pain is defined as the mean of the average pain scores of each cycle. | 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)] | |
Secondary | Proportion of participants with at least 30% reduction of 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, Cycle 6 and Cycle 7 (each cycle is 24-38 days)] | |
Secondary | The change from baseline in the Pictorial Blood Loss Assessment Chart (PBAC) score. | After using each piece of sanitary napkin from the beginning to the end of each menstrual period, participants record it in a diary card according to the Pictorial Blood Loss Assessment Chart (PBAC) score. To ensure accuracy, participants are instructed to use sanitary napkins of the same size. The PBAC includes two parts of scoring records: the size of blood stain area in a sanitary napkin and lost blood clots. | 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)] | |
Secondary | The change from baseline in the the Cox Menstrual Symptom Scale (CMSS). | The Cox Menstrual Symptom Scale (CMSS) consists of 18 items related to dysmenorrhea symptoms, such as lower abdominal pain, nausea, and headache, and each item is scored on a 5-point scale to measure severity and duration. Higher score corresponds to more severe dysmenorrhea symptoms. | 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)] | |
Secondary | The change from baseline in the Short Form Endometriosis Health Profile Questionnaire (EHP-5). | The Short Form Endometriosis Health Profile Questionnaire (EHP-5) is also commonly used to assess quality of life in patients with adenomyosis. The Questionnaire consists of 12 questions answered by a score of 1-5 points, the higher the score, the lower the quality of life. | 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)] | |
Secondary | The change from baseline in the total and sub scores of Hospital Anxiety and Depression Scale (HADS). | Hospital Anxiety and Depression Scale (HADS) consists of 14 items, divided into two 7 item subscales to reeect a state of generalized anxiety and the depression. The respondent rates each item on a 4-point scale ranging from 0 (absence) to 3 (extreme presence). | 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)] |
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