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

Official title

The Efficacy and Safety of Acupuncture for Prophylaxis of Menstrually Related Migraine: a Pilot Randomized Controlled Trial

Overview

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.

Interventions

• 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 ac
• 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: Bi

Primary outcome measures

• Change in standardized monthly headache days (SMHD) compared with baseline. [Time frame: At Week 12 post-treatment]

Secondary outcome measures (12)

• 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]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

China · 1 center

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

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. PMID 41084597

Identifiers

NCT: NCT07023926 · 2025-031-KY-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗