The Efficacy and Safety of Acupuncture for Prophylaxis of Menstrually Related Migraine

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Electroacupuncture; Menstrually Related Migraine
• Intervention / Treatment: Device: electroacupuncture; Device: Sham electroacupuncture

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weiming Wang, Ph.D; Phone Number: +8613426424993; Email: wangweiming1a1@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Department of Acupuncture, China Academy of Chinese Medical Sciences Guang'anmen Hospital
      • Contact: Xinkun Liu; Phone Number: +8613876859860; Email: liuxinkunleo@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. meet the diagnostic criteria for MRM according to the ICHD-3, with a documented history of MRM for at least 12 months;
2. have a confirmed diagnosis of migraine by a neurologist;
3. aged 18-45 years;
4. have regular menstrual cycles (28 ± 7 days) with menstruation lasting 3-7 days;
5. 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;
6. have completed a headache diary during the screening period (covering at least one full menstrual cycle), demonstrating good compliance;
7. headache diary data during screening period must meet the ICHD-3 criteria for MRM and fulfill criteria (4) and (5);
8. voluntarily sign the informed consent.

Exclusion Criteria:

1. irregular menstrual cycles, defined as cycle length outside the range of 28±7 days or menstruation duration <3 days or >7 days;
2. presence of secondary headache disorders, facial neuralgia, or cranial neuralgia;
3. 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;
4. 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;
5. receipt of preventive treatment for headache within 1 month prior to the screening visit;
6. afraid of needles or received acupuncture treatment within 3 months;
7. unwillingness to undergo the study intervention or failure to sign the informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: elecrtoacupuncture group (EA group); 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; 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 Comparator: Sham elecrtoacupuncture group (sham EA group); 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 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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Investigators: Principal Investigator: Weiming Wang, Ph.D, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: May 29, 2025
• First Submitted That Met QC Criteria: June 14, 2025
• First Posted (Actual): June 17, 2025

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: June 14, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 2025-031-KY-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data are available on reasonable request. You can send e-mail to us if you have any question
• IPD Sharing Time Frame: It depends
• IPD Sharing Access Criteria: It depends
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No