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Evaluation of acupuncture efficacy for prophylaxis of migraine attacks - phase II trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN93327878
Enrollment
37
Registered
2006-06-05
Start date
2001-12-07
Completion date
Unknown
Last updated
2015-01-13

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

In the pilot study, patients were randomized into two different groups, real and sham acupuncture groups. Both groups received 16 sessions of acupuncture in three months. Eight sessions in the first m

Sponsors

State of São Paulo Research Foundation (FAPESP) (Brazil)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Patients with any other chronic pain syndrome, who were misusing drugs or alcohol and who occasionally, used a minor tranquilizer or sedative.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. The number of the migraine days per month 2. The percentage of patients with reduction =40% in migraine attacks frequency 3. Frequency of migraine attacks 4. Average duration of a migraine attack 5. Average headache severity 6. Total duration of migraine pain in hours per diary 7. Rate of rescue medication used 8. Nausea and vomiting frequency, all of them comparing the first diary (baseline period) with others headache diaries

Countries

Brazil

Outcome results

None listed

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