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

Not Applicable

Not yet recruiting

• Conditions: Menstrually Related Migraine; Electroacupuncture

• Registration Number: NCT07023926
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-29
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-14
• Last Update Submitted: 2025-06-14
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-17
• Study Start: 2025-07-01
• Primary Completion: 2026-12-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in standardized monthly headache days (SMHD) compared with baseline.	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 Outcome Measures

Name	Time	Method
The responder rate	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.
Patient's Global Impression of Change (PGIC)	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.
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	Standardized monthly headache severity score = (Actual monthly severity score × 28) ÷ Individual menstrual cycle length.
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	Patients are defined as cured if they no longer met the diagnostic criteria for MRM.
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	Rescue medication taken standardized monthly = (Actual doses × 28) ÷ Individual menstrual cycle length
Headache diary completion rate	At Weeks 4, 8, and 12 post-treatment, and at Weeks 16, 20, and 24 during follow-up	Headache diary completion rate
Overall recruitment rate at End of recruitment phase	At end of the recruitment phase	Recruitment rate = (Number of enrolled participants ÷ Total number of eligible patients) × 100%.
Overall retention rate	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%.
Change in Hospital Anxiety and Depression Scale (HADS) score from baseline	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.
Change in Headache Impact Test-6 (HIT-6) score from baseline	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.
Change in Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) score from baseline	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.
Participants' expectation for acupuncture	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.

Trial Locations

Locations (1)

Department of Acupuncture, China Academy of Chinese Medical Sciences Guang'anmen Hospital; 🇨🇳 Beijing, Beijing, China