Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electroacupuncture | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At Week 12 post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| change in standardized monthly headache days (SMHD) compared with baseline | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weiming Wang, Ph.D | Contact | +8613426424993 | wangweiming1a1@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Weiming Wang, Ph.D | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Acupuncture, China Academy of Chinese Medical Sciences Guang'anmen Hospital | Beijing | Beijing Municipality | 100053 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41084597 | Derived | 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. |
Not provided
Not provided
Individual participant data are available on reasonable request. You can send e-mail to us if you have any question
It depends
It depends
Not provided
Not provided
| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sham electroacupuncture | Device | 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". |
|
| 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. | 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. | 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 | 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 | 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%. | At end of the recruitment phase |
| Overall retention rate | Retention rate = (Number of participants who completed the study ÷ Total enrolled participants) × 100%. | 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. | 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. | 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. | 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. | 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. | At baseline |
| D004599 |
| Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |