An interventional study of Electroacupuncture and Sham Electroacupuncture in Dysmenorrhea, Adenomyosis and Electroacupuncture, sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences. Recruiting at 1 site in China. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-08-06.
Sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Not applicable, Interventional, and Treatment
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.
430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.
This study's planned enrollment of 30 is below the median of 62 across 363 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →Guang'anmen Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 137 studies on the registry; 37 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
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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.
Device: Electroacupuncture · Device: Sham 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.
Device: Electroacupuncture · Device: Sham 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 handles at bilateral BL32 and SP6. The electroacupuncture stimulation will last for 30 minutes with a continuous wave of 5Hz and a current intensity of 1 to 5mA. Current intensity was adjusted according to the patients' individual tolerance.Treatment will start within one week before the onset of menstruation and stop before the end of menstruation, three sessions per menstrual cycle in total (ideally every two to three days and at least one session during menstruation period).
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.
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.
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)]
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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).
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.
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).
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).
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)]
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?
Time frame: Before the first treatment session of electroacupuncture and sham electroacupuncture.
Blinding assessment
Participants will be ask "do you think you have received traditional electroacupuncture in the past two cycles?"
Time frame: Within 5 minutes after the last treatment in Cycle 3 and Cycle 6 (each cycle is 24-38 days).
Adherence assessment
Adherence will be assessment via counting treatment sessions. Those complete over 80% treatment sessions will be defined as of good adherence.
Time frame: The menstruation period of Cycle 2, Cycle 3, Cycle 5 and Cycle 6 (each cycle is 24-38 days).
The change from baseline in the dose of rescue medicine.
The dose of rescue medicine that participants use to relieve dysmenorrhea-related 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)]
Plan to share: Yes — Deidentified participant data and data dictionary will be available with the publication until six months after publication. A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal. Researchers whose proposal has been approved will sign a data access agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: The data will be available with the publication until six months after publication.
Access criteria: A formal request should be sent to zhishunjournal@163.com with a methodologically sound proposal. Researchers whose proposal has been approved. Researchers whose proposal has been approved will sign a data access agreement.
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