Menstrually Related MigraineNCT07023926
The Efficacy and Safety of Acupuncture for Prophylaxis of Menstrually Related Migraine
A study testing electroacupuncture in people with Menstrually Related Migraine and Electroacupuncture, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
Acupuncture is commonly used for the prevention of migraine and tension-type headaches, and has been found to be effective in reducing both the frequency and severity of these conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Menstrually Related Migraine, 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
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 31 Jan 2028
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- meet the diagnostic criteria for MRM according to the ICHD-3, with a documented history of MRM for at least 12 months;
- have a confirmed diagnosis of migraine by a neurologist;
- aged 18-45 years;
- have regular menstrual cycles (28 ± 7 days) with menstruation lasting 3-7 days;
- have experienced ≥3 headache days during each menstrual cycle (days -2 to +3) and ≥5 total headache days per cycle over the past 3 months and baseline period; migraine attacks must last 4-72 hours without acute medication, or at least 2 hours when treated;
- have completed a headache diary during the screening period (covering at least one full menstrual cycle), demonstrating good compliance;
- headache diary data during screening period must meet the ICHD-3 criteria for MRM and fulfill criteria (4) and (5);
- voluntarily sign the informed consent.
Who cannot join
- irregular menstrual cycles, defined as cycle length outside the range of 28±7 days or menstruation duration <3 days or >7 days;
- presence of secondary headache disorders, facial neuralgia, or cranial neuralgia;
- combined with serious primary diseases such as cardiovascular, hepatic, renal, gastrointestinal, or hematological disorders that may interfere with the treatment protocol, or comorbid neurological conditions such as epilepsy, parkinson's disease, or other central nervous system disorders;
- headache symptoms caused by other conditions, such as moderate to severe head or neck trauma, perimenstrual infections, intracranial tumors, intracranial infections, endocrine or metabolic disorders;
- receipt of preventive treatment for headache within 1 month prior to the screening visit;
- afraid of needles or received acupuncture treatment within 3 months;
- unwillingness to undergo the study intervention or failure to sign the informed consent.
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
Department of Acupuncture, China Academy of Chinese Medical Sciences Guang'anmen Hospital
Beijing, Beijing Municipality, 100053
Xinkun Liu, +8613876859860, liuxinkunleo@qq.com
About this study
Official title: The Efficacy and Safety of Acupuncture for Prophylaxis of Menstrually Related Migraine: a Pilot Randomized Controlled Trial
Acupuncture is commonly used for the prevention of migraine and tension-type headaches, and has been found to be effective in reducing both the frequency and severity of these conditions. However, studies on acupuncture for menstrually related migraine (MRM) are limited, and current research has not been able to determine whether its efficacy is due to the actual therapeutic effects of acupuncture or psychological benefits. To address this issue, the investigators have designed a clinical trial to evaluate the efficacy of acupuncture for MRM.
- Conditions
- Menstrually Related Migraine, Electroacupuncture
- Being tested
- electroacupuncture, Sham electroacupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electroacupunctureDevice
The supine position, the local skin of the acupoints was routinely sterilized, and the selected acupoints were pasted with Acupuncture auxiliary device. The main acupuncture points are DU20, bilateral EX-HN5, ST8, GB20, GB20, LI4, LR3, ST40. Select compatible acupoints based on the patient's accompanying symptoms: 1.Discomfort in the neck: EX-B2 of Cervical 3-4; 2.Emotional anxiety, depression or sleep disorders: GV29, HT7; 3.Stomach or abdominal discomfort: CV12, ST25 and CV6. The disposable acupuncture needles and the electronic acupuncture treatment instrument SDZ-V nerve and muscle intimulator both manufactured by Suzhou Medical Appliance Factory Co., Ltd., China.The specifications of acupuncture needles are Φ0.30×25mm, Φ0.30×40mm. The needles will be inserted into the skin of acupuncture points and manipulated manually by using the techniques such as lifting, thrusting, and twirling, until the internal compound sensation known as deqi.
Sham electroacupunctureDevice
The SEA group will use Hua Tuo brand disposable blunt-tip sham needles (Φ0.3mm×25mm) and the electronic acupuncture treatment instrument SDZ-V nerve and muscle intimulator both manufactured by Suzhou Medical Appliance Factory Co., Ltd., China. Sham points 1-2, 3-4, 5-6, and 7-8 are bilaterally located at the midpoints between the following pairs of acupoints: SP19 and EX-UE12, SP6 and LR5, EX-UE1 and HT1, and HT7 and SI8. sham LI4: Bilateral of midpoint between acupoint LI4 and LU9; sham LR3: Bilateral of midpoint between acupoint LR3 and ST44; sham ST40: Bilateral of midpoint between acupoint ST40 and GB35. Compatible acupoints: EX-B2 of Cervical 3-4 horizontal side by 0.5 cun; sham GV29: midpoint between acupoint GV29 and BL2. sham CV12: midpoint between acupoint CV12 and ST21; sham ST25: Bilateral of midpoint between acupoint ST25 and SP15; sham CV6: 3 cun lateral to the level of the CV6; The width of the interphalangeal joint of the patient's thumb was 1 "cun".
| Study group | Role | What they receive |
|---|---|---|
| elecrtoacupuncture group (EA group) | Experimental | Participants will be treated by electroacupuncture. During the first week (from day -3 to +4 of menstruation), they will receive 1-2 sessions, followed by 2-3 sessions per week for the next three weeks. This treatment schedule will be repeated for three consecutive menstrual cycles, totaling a 12-week treatment period and 30 sessions. All treatment sessions will be monitored and recorded using a treatment diary. Receives: Device: electroacupuncture |
| Sham elecrtoacupuncture group (sham EA group) | Sham comparator | Participants will be treated by sham electroacupuncture. The treatment frequency and sessions will be the same as in EA group, and the treatment diary will also be used in SEA group. Receives: Device: Sham electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in standardized monthly headache days (SMHD) compared with baseline.
The primary outcome is the change in standardized monthly headache days (SMHD). SMHD are calculated by adjusting the actual number of headache days to a standard 28-day menstrual cycle using the following formula: SMHD = (actual headache days × 28) ÷ individual menstrual cycle length
Measured: At Week 12 post-treatment
Secondary outcomes (13)
change in standardized monthly headache days (SMHD) compared with baseline
Measured: At Weeks 4 and 8 post-treatment, and at Weeks 16, 20, and 24 during follow-up
The proportion of patients with cured MRM
Patients are defined as cured if they no longer met the diagnostic criteria for MRM.
Measured: At Week 12 post-treatment, and at weeks 16, 20, and 24 during follow-up
The responder rate
The responder rate is defined as a minimum of 50 % reduction in SMHD compared with baseline.
Measured: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
Change in standardized monthly headache severity score from baseline
Standardized monthly headache severity score = (Actual monthly severity score × 28) ÷ Individual menstrual cycle length.
Measured: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
Change in standardized monthly use of rescue medication from baseline
Rescue medication taken standardized monthly = (Actual doses × 28) ÷ Individual menstrual cycle length
Measured: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
Headache diary completion rate
Headache diary completion rate
Measured: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
Overall recruitment rate at End of recruitment phase
Recruitment rate = (Number of enrolled participants ÷ Total number of eligible patients) × 100%.
Measured: At end of the recruitment phase
Overall retention rate
Retention rate = (Number of participants who completed the study ÷ Total enrolled participants) × 100%.
Measured: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
Change in Hospital Anxiety and Depression Scale (HADS) score from baseline
The HADS is a validated self-report questionnaire used to assess symptoms of anxiety and depression over the past week. It consists of 14 items divided into two subscales: anxiety and depression, each containing 7 items. Each item is rated on a 4-point scale (0-3), yielding subscale scores ranging from 0 to 21. Higher scores reflect greater symptom severity.
Measured: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
Change in Headache Impact Test-6 (HIT-6) score from baseline
The HIT-6 is a validated, self-reported instrument used to assess the impact of headaches on health-related quality of life. It includes six items covering domains such as pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. Each item is scored on a 5-point Likert scale (6 = never, 8 = rarely, 10 = sometimes, 11 = very often, 13 = always). The total score ranges from 36 to 78, with higher scores indicating greater headache-related disability.
Measured: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
Change in Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) score from baseline
The MSQ v2.1 assesses migraine-related quality of life across three domains: Role Function-Restrictive , Role Function-Preventive , and Emotional Function. Each item is rated on a 6-point Likert scale from 1 ("All the time") to 6 ("None of the time"). Domain scores are calculated and transformed to a 0-100 scale, with higher scores indicating better quality of life.
Measured: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
Patient's Global Impression of Change (PGIC)
The PGIC scale will be used to assess participants' subjective perception of overall improvement. It is a 7-point scale with the following categories: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. Lower scores indicate greater perceived improvement.
Measured: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
Participants' expectation for acupuncture
Participants will be asked the following question to assess their expectations regarding acupuncture for MRM: "What level of improvement do you expect from acupuncture for your MRM?" Response options will include: "no improvement," "slight improvement," "moderate improvement," "marked improvement," and "unclear." The association between participants' expectations and the primary outcome will be examined using statistical analysis.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Jul 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menstrually Related MigraineStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 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, weiming wang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Weiming Wang, Ph.D, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023926
- Sponsor's protocol ID
- 2025-031-KY-01
- Status last verified
- Sep 2026
- First submitted
- 29 May 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data are available on reasonable request. You can send e-mail to us if you have any question
Publications
Liu X, Jiao R, Zheng Y, Liu Y, Yu G, Shi J, Wang W, Wang W. The Efficacy and Safety of Electroacupuncture for Prophylaxis of Menstrually Related Migraine: Study Protocol for a Pilot Randomized Controlled Trial. Int J Womens Health. 2025 Oct 8;17:3541-3555. doi: 10.2147/IJWH.S548053. eCollection 2025.
PubMed 41084597
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Acupuncture for Prophylaxis of Menstrually Related Migraine: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07023926
- Acronym / sponsor ID
- 2025-031-KY-01
- Conditions
- Menstrually Related Migraine, Electroacupuncture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 17 Jun 2025 (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.
Acupuncture is commonly used for the prevention of migraine and tension-type headaches, and has been found to be effective in reducing both the frequency and severity of these conditions. However, studies on acupuncture for menstrually related migraine (MRM) are limited, and current research has not been able to determine whether its efficacy is due to the actual therapeutic effects of acupuncture or psychological benefits. To address this issue, the investigators have designed a clinical trial to evaluate the efficacy of acupuncture for MRM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| elecrtoacupuncture group (EA group) | Experimental | Device: electroacupunctureParticipants will be treated by electroacupuncture. During the first week (from day -3 to +4 of menstruation), they will receive 1-2 sessions, followed by 2-3 sessions per week for the next three weeks. This treatment schedule will be repeated for three consecutive menstrual cycles, totaling a 12-week treatment period and 30 sessions. All treatment sessions will be monitored and recorded using a treatment diary. |
| Sham elecrtoacupuncture group (sham EA group) | Sham comparator | Device: Sham electroacupunctureParticipants will be treated by sham electroacupuncture. The treatment frequency and sessions will be the same as in EA group, and the treatment diary will also be used in SEA group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- meet the diagnostic criteria for MRM according to the ICHD-3, with a documented history of MRM for at least 12 months;
- have a confirmed diagnosis of migraine by a neurologist;
- aged 18-45 years;
- have regular menstrual cycles (28 ± 7 days) with menstruation lasting 3-7 days;
- have experienced ≥3 headache days during each menstrual cycle (days -2 to +3) and ≥5 total headache days per cycle over the past 3 months and baseline period; migraine attacks must last 4-72 hours without acute medication, or at least 2 hours when treated;
Key exclusion criteria (7 listed)
- irregular menstrual cycles, defined as cycle length outside the range of 28±7 days or menstruation duration <3 days or >7 days;
- presence of secondary headache disorders, facial neuralgia, or cranial neuralgia;
- combined with serious primary diseases such as cardiovascular, hepatic, renal, gastrointestinal, or hematological disorders that may interfere with the treatment protocol, or comorbid neurological conditions such as epilepsy, parkinson's disease, or other central nervous system disorders;
- headache symptoms caused by other conditions, such as moderate to severe head or neck trauma, perimenstrual infections, intracranial tumors, intracranial infections, endocrine or metabolic disorders;
- receipt of preventive treatment for headache within 1 month prior to the screening visit;
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 |
|---|---|---|
| electroacupunctureThe supine position, the local skin of the acupoints was routinely sterilized, and the selected acupoints were pasted with Acupuncture auxiliary device. The main acupuncture points are DU20, bilateral EX-HN5, ST8, GB20, GB20, LI4, LR3, ST40. Select compatible acupoints based on the patient's accompanying symptoms: 1.Discomfort in the neck: EX-B2 of Cervical 3-4; 2.Emotional anxiety, depression or sleep disorders: GV29, HT7; 3.Stomach or abdominal discomfort: CV12, ST25 and CV6. The disposable acupuncture needles and the electronic acupuncture treatment instrument SDZ-V nerve and muscle intimulator both manufactured by Suzhou Medical Appliance Factory Co., Ltd., China.The specifications of acupuncture needles are Φ0.30×25mm, Φ0.30×40mm. The needles will be inserted into the skin of acupuncture points and manipulated manually by using the techniques such as lifting, thrusting, and twirling, until the internal compound sensation known as deqi. | Device | elecrtoacupuncture group (EA group) |
| Sham electroacupunctureThe SEA group will use Hua Tuo brand disposable blunt-tip sham needles (Φ0.3mm×25mm) and the electronic acupuncture treatment instrument SDZ-V nerve and muscle intimulator both manufactured by Suzhou Medical Appliance Factory Co., Ltd., China. Sham points 1-2, 3-4, 5-6, and 7-8 are bilaterally located at the midpoints between the following pairs of acupoints: SP19 and EX-UE12, SP6 and LR5, EX-UE1 and HT1, and HT7 and SI8. sham LI4: Bilateral of midpoint between acupoint LI4 and LU9; sham LR3: Bilateral of midpoint between acupoint LR3 and ST44; sham ST40: Bilateral of midpoint between acupoint ST40 and GB35. Compatible acupoints: EX-B2 of Cervical 3-4 horizontal side by 0.5 cun; sham GV29: midpoint between acupoint GV29 and BL2. sham CV12: midpoint between acupoint CV12 and ST21; sham ST25: Bilateral of midpoint between acupoint ST25 and SP15; sham CV6: 3 cun lateral to the level of the CV6; The width of the interphalangeal joint of the patient's thumb was 1 "cun". | Device | Sham elecrtoacupuncture group (sham EA group) |
Primary outcome
Change in standardized monthly headache days (SMHD) compared with baseline.
Time frame: At Week 12 post-treatment
The primary outcome is the change in standardized monthly headache days (SMHD). SMHD are calculated by adjusting the actual number of headache days to a standard 28-day menstrual cycle using the following formula: SMHD = (actual headache days × 28) ÷ individual menstrual cycle length
13 secondary outcomes
change in standardized monthly headache days (SMHD) compared with baseline
Time frame: At Weeks 4 and 8 post-treatment, and at Weeks 16, 20, and 24 during follow-up
The proportion of patients with cured MRM
Time frame: At Week 12 post-treatment, and at weeks 16, 20, and 24 during follow-up
The responder rate
Time frame: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
Change in standardized monthly headache severity score from baseline
Time frame: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
Change in standardized monthly use of rescue medication from baseline
Time frame: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
Headache diary completion rate
Time frame: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
Overall recruitment rate at End of recruitment phase
Time frame: At end of the recruitment phase
Overall retention rate
Time frame: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
Change in Hospital Anxiety and Depression Scale (HADS) score from baseline
Time frame: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
Change in Headache Impact Test-6 (HIT-6) score from baseline
Time frame: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
Change in Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) score from baseline
Time frame: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
Patient's Global Impression of Change (PGIC)
Time frame: At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up
Participants' expectation for acupuncture
Time frame: At baseline
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 14 Sep 2026.
- Derived from this study: PubMed 41084597Liu X, Jiao R, Zheng Y, Liu Y, Yu G, Shi J, Wang W, Wang W. The Efficacy and Safety of Electroacupuncture for Prophylaxis of Menstrually Related Migraine: Study Protocol for a Pilot Randomized Controlled Trial. Int J Womens Health. 2025 Oct 8;17:3541-3555. doi: 10.2147/IJWH.S548053. eCollection 2025.
- Individual participant dataSharing planned: Yes. Individual participant data are available on reasonable request. You can send e-mail to us if you have any question
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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.
Weiming Wang, Ph.D 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 Menstrually Related Migraine and Electroacupuncture, 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 8 inclusion and 7 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 14 Sep 2026. 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 Weiming Wang, Ph.D (+8613426424993, wangweiming1a1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in standardized monthly headache days (SMHD) compared with baseline. (time frame: At Week 12 post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07023926, which also lists 1 linked publication.
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 14 Sep 2026.