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A clinical trial of acupuncture as prophylaxis for Menstrually Related Migraine (MRM)

To assess the therapeutic effects on acupuncture as prophylaxis for menstrually related migraine: a multicentre randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN57133712
Enrollment
184
Registered
2012-12-19
Start date
2011-12-30
Completion date
Unknown
Last updated
2022-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menstrually related migraine (MRM)

Interventions

A total of 184 patients are randomly divided into two different groups: 1. Treatment group: Acupuncture (preventive treatment on migraine and premenstrual conditioning) and placebo me

Sponsors

Beijing Municipal Science and Technology Commission (China)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patients who met diagnostic criteria for menstrually related migraine (International Headache Society Classification of Menstrually Related Migraine, 2nd edn, 2004) 2. Regular menstrual cycle lasting 30±10 days 3. Be able to predict the cycle and the onset period of menstrual related migraine 4. Patients suffered a repeated migraine attacks, frequency of non-menstrual migraine is more than once a month 5. Effective contraception and no plan to become pregnant during the study 6. Patients who took part in the trial voluntarily and signed the informed consent form

Exclusion criteria

Exclusion criteria: 1. Patients who are diagnosed as chronic migraine(headache caused by drug abuse is included), tension-type headache, cluster headache, algopsychalia tension-type headache, cluster headache, other primary headache disorders 2. Patients suffered relatively severe systemic disease, such as cardiovascular diseases, acute infectious disease, hematopathy, endocrinopathy, allergy and methysis 3. Patients suffered otorhinolaryngology diseases which may cause headache, such as glaucoma, otitis, sinusitis, pericoronitis of wisdom tooth 4. Patients who suffered headache caused by intracranial pathological changes, such as intracranial infection, brain tumours, subarachnoid hemorrhage 5. The blood pressure is not controlled ideally 6. The menses cycle is erratical because of polycystic ovary and other gynecologic diseases, and the time of which is hard to predict 7. Patients who have been taking contraceptives or accepting other hormone therapy during the last 3 months

Design outcomes

Primary

MeasureTime frame
1. The change of migraine days inside the menstrual cycle 2. The proportion of responders (defined as the proportion of patients with at least a 50% reduction in the number of menstrual migraine days) Recording headache diaries for four continuous menstrual cycles that included three months (consecutive menstrual cycles) during treatment and one month (menstrual cycle) after treatment. All assessments will be conducted at the baseline and at week 12 and 16 follow-up.

Secondary

MeasureTime frame
1. The change of migraine days outside the menstrual cycle 2. Duration of migraine attack 3. Visual analogue scale (VAS, 0 to 10 cm) for pain 4. Amount of migraine medication used Recording headache diaries for four continuous menstrual cycles that included three months (consecutive menstrual cycles) during treatment and one month (menstrual cycle) after treatment. All assessments will be conducted at the baseline and at week 12 and 16 follow-up.

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 22, 2026