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Evaluation of acupuncture efficacy for migraine attacks prophylaxis - a phase III trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN74335441
Enrollment
67
Registered
2006-06-05
Start date
2003-03-01
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

The 67 patients were randomized into two differents groups: real and sham acupuncture groups. Both groups were treated with 16 acupuncture sessions in twelve weeks. Eight in the first four weeks of th

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 reduction of =50% in migraine attack frequency and the total of the migraine days compared with the baseline period.

Secondary

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

Countries

Brazil

Outcome results

None listed

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