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

NCT07023926 | Not Yet Recruiting

• 1 other identifier: 2025-031-KY-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

  At Week 12 post-treatment, and at weeks 16, 20, and 24 during follow-up

• The responder rate

  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

  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

  At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up

Study Arms (2)

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.

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.

Device: Sham electroacupuncture

Interventions

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.

elecrtoacupuncture group (EA group)

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".

Sham elecrtoacupuncture group (sham EA group)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Department of Acupuncture, China Academy of Chinese Medical Sciences Guang'anmen Hospital

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (1)

• 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.

  PMID: 41084597 DERIVED

MeSH Terms

Interventions

Electroacupuncture

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Weiming Wang, Ph.D

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiming Wang, Ph.D

CONTACT

+8613426424993; wangweiming1a1@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 17, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: It depends
• Access Criteria: It depends

Locations

CN (1)