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NCT Number: NCT07023926

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

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.

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Key information

Conditions

Menstrually Related Migraine Electroacupuncture

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Beijing, Beijing Municipality, 100053, China

Location contact

Xinkun Liu

CONTACT

[email protected]

+8613876859860

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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".

Primary outcomes

  1. Change in standardized monthly headache days (SMHD) compared with baseline.

    Time frame: At Week 12 post-treatment

    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

Secondary outcomes

  1. 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

  2. The proportion of patients with cured MRM

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

    Patients are defined as cured if they no longer met the diagnostic criteria for MRM.

  3. The responder rate

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

    The responder rate is defined as a minimum of 50 % reduction in SMHD compared with baseline.

  4. 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

    Standardized monthly headache severity score = (Actual monthly severity score × 28) ÷ Individual menstrual cycle length.

  5. 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

    Rescue medication taken standardized monthly = (Actual doses × 28) ÷ Individual menstrual cycle length

  6. Headache diary completion rate

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

    Headache diary completion rate

  7. Overall recruitment rate at End of recruitment phase

    Time frame: At end of the recruitment phase

    Recruitment rate = (Number of enrolled participants ÷ Total number of eligible patients) × 100%.

  8. Overall retention rate

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

    Retention rate = (Number of participants who completed the study ÷ Total enrolled participants) × 100%.

  9. 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

    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.

  10. 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

    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.

  11. 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

    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.

  12. 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

    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.

  13. Participants' expectation for acupuncture

    Time frame: At baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Weiming Wang, Ph.D

CONTACT

[email protected]

+8613426424993

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jun 17, 2025
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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