An interventional study of electroacupuncture and Sham electroacupuncture in Menstrually Related Migraine 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 45 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Not applicable, Interventional, and Treatment
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.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 40 is below the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders 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.
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.
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.
Device: electroacupuncture
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.
Device: Sham electroacupuncture
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.
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".
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
Time frame: At Week 12 post-treatment
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
Patients are defined as cured if they no longer met the diagnostic criteria for MRM.
Time frame: 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.
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
Standardized monthly headache severity score = (Actual monthly severity score × 28) ÷ Individual menstrual cycle length.
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
Rescue medication taken standardized monthly = (Actual doses × 28) ÷ Individual menstrual cycle length
Time frame: 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
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
Recruitment rate = (Number of enrolled participants ÷ Total number of eligible patients) × 100%.
Time frame: At end of the recruitment phase
Overall retention rate
Retention rate = (Number of participants who completed the study ÷ Total enrolled participants) × 100%.
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
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.
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
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.
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
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.
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)
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.
Time frame: 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.
Time frame: At baseline
Plan to share: Yes — Individual participant data are available on reasonable request. You can send e-mail to us if you have any question
Supporting information: Study protocol, Statistical analysis plan
Time frame: It depends
Access criteria: It depends
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