DysmenorrheaNCT06364592
Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis
A study testing Electroacupuncture in people with Dysmenorrhea and Adenomyosis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Dysmenorrhea, Adenomyosis, Electroacupuncture
- What is being tested?
- Electroacupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 21 Jul 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing
Zhishun Liu, PhD, +861088002331, zhishunjournal@163.com
Min Yang, +8618810268077, yangmin2019@yeah.net
About this study
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.
- Conditions
- Dysmenorrhea, Adenomyosis, Electroacupuncture
- Being tested
- Electroacupuncture, Sham Electroacupuncture
- Keywords
- Dysmenorrhea, Adenomyosis, Electroacupuncture
- Medical subject headings
- Dysmenorrhea, Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureDevice
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).
Sham ElectroacupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture, Then Sham Electroacupuncture | Experimental | 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. Receives: Device: Electroacupuncture; Device: Sham Electroacupuncture |
| Sham Electroacupuncture, Then Electroacupuncture | Sham comparator | 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. Receives: Device: Electroacupuncture; Device: Sham Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start21 Jul 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Zhishun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Zhishun Liu, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364592
- Sponsor's protocol ID
- 2024-011-KY
- Status last verified
- Aug 2025
- First submitted
- 2 Apr 2024
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Electroacupuncture for Dysmenorrhea Secondary to Adenomyosis: an Exploratory Pilot Study
- ClinicalTrials.gov ID
- NCT06364592
- Acronym / sponsor ID
- 2024-011-KY
- Conditions
- Dysmenorrhea, Adenomyosis, Electroacupuncture
- Keywords
- Dysmenorrhea, Adenomyosis, Electroacupuncture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 21 Jul 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture, Then Sham Electroacupuncture | Experimental | Device: Electroacupuncture, Device: Sham ElectroacupunctureFifteen 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. |
| Sham Electroacupuncture, Then Electroacupuncture | Sham comparator | Device: Electroacupuncture, Device: Sham ElectroacupunctureFifteen 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureHwato 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). | Device | Electroacupuncture, Then Sham Electroacupuncture, Sham Electroacupuncture, Then Electroacupuncture |
| Sham ElectroacupunctureHwato 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. | Device | Electroacupuncture, Then Sham Electroacupuncture, Sham Electroacupuncture, Then Electroacupuncture |
Primary outcome
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.
8 secondary outcomes
The change from baseline in the numerical rating scale (NRS) score on the average 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 numerical rating scale (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.
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.
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.
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).
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).
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).
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)]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhishun Liu principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Dysmenorrhea and Adenomyosis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhishun Liu (+861088002331, zhishunjournal@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.