Evaluation of acupuncture efficacy for prophylaxis of migraine attacks - phase II trial
Completed
- Conditions
- Nervous System DiseasesMigraine
- Registration Number
- ISRCTN93327878
- Lead Sponsor
- State of São Paulo Research Foundation (FAPESP) (Brazil)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 37
Inclusion Criteria
1. Patients suffering from migraine with or without aura for at least one year were diagnosed according to criteria of the International Headache Society
2. Male or female, aged 18-50 years
3. Patients with only one type of headache (exclusively migraine)
4. Patients who had not used acupuncture or drugs with migraine prophylactic effects within the last three months
5. Patients who could come to the hospital for 17 times in the following twelve weeks (acupuncture evaluation and acupuncture treatment period)
Exclusion Criteria
Patients with any other chronic pain syndrome, who were misusing drugs or alcohol and who occasionally, used a minor tranquilizer or sedative.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of patients with a greater than 50% reduction in their migraine attacks frequency in the second, third, fourth, fifth and sixth headache diaries compared with the first one (baseline period).
- Secondary Outcome Measures
Name Time Method 1. The number of the migraine days per month<br>2. The percentage of patients with reduction =40% in migraine attacks frequency<br>3. Frequency of migraine attacks<br>4. Average duration of a migraine attack<br>5. Average headache severity<br>6. Total duration of migraine pain in hours per diary<br>7. Rate of rescue medication used<br>8. Nausea and vomiting frequency, all of them comparing the first diary (baseline period) with others headache diaries