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Efficacy and safety of Acupuncture for Migraine Prophylaxis - a multicenter, randomized, controlled clinical trial

Efficacy and safety of Acupuncture for Migraine Prophylaxis - a multicenter, randomized, controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN49839714
Enrollment
140
Registered
2007-06-26
Start date
2007-06-01
Completion date
Unknown
Last updated
2019-07-29

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

Conditions

Migraine Nervous System Diseases Migraine

Interventions

The 140 migraine sufferers are randomly allocated to two different groups: 1. Treatment group: At least three acupuncture sessions per week and placebo medicine once a day for 4 weeks.

Sponsors

The Beijing Administration of Traditional Chinese Medicine (China)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients suffering from migraine without frequent aura (more than 2 migraine attacks in 4 weeks), diagnosed according to criteria of the International Headache Society 2. Male or female 3. Aged 18-65 years 4. Patients who had not used acupuncture or drugs with migraine prophylactic effects within the last 3 months

Exclusion criteria

Exclusion criteria: 1.Tension-type headache, Cluster headache and other primary headaches 2. Secondary headache and other neurological diseases 3. Neuralgia of the face or head 4. Pregnancy, nursing mother or insufficient contraception 5. Use of prophylactic migraine medication in the last 3 months 6. Therapy with beta-blocker in the last 3 months 7. Intake of antipsychotic or antidepressant drugs 8. Participation in another clinical trial 9. Have family history of depression, Parkinson?s disease and other extrapyramidal diseases

Design outcomes

Primary

MeasureTime frame
The efficacy of acupuncture for migraine prophylaxis was assessed by the following: 1. Visual Analogue Scale (VAS) to assess the severity of migraine pain 2. Short-From of McGill Pain Questionnaire (SF-MPQ) 3. Change in frequency and duration of migraine attacks The outcome measures above will be assessed before the treatment, at 1 week, 2 and 4 weeks during the treatment, and then every month for 3 months. If necessary, the assessments will be repeated 6 months after the treatment.

Secondary

MeasureTime frame
1. Intake of acute-medication 2. Severity of adverse effects 3. Change in the frequency of nausea, vomiting and other correlative symptoms The outcome measures above will be assessed before the treatment, at 1 week, 2 and 4 weeks during the treatment, and then every month for 3 months. If necessary, the assessments will be repeated 6 months after the treatment.

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026