Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SF-2005-2
Study information
Scientific title
Acronym
AMP
Study hypothesis
Acupuncture could be an option to prevent migraine attacks in comparison to standard medicine therapy (flunarizine).
Ethics approval
Approved by the Research Ethical Committee of the Beijing Hospital of Traditional Chinese Medicine on 24/05/2007 (ref: 200704)
Study design
Multicentre randomised single blind controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Migraine
Intervention
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.
2. Control group: At least three sham-acupuncture sessions per week and medicine (flunarizine) once a day for 4 weeks.
The patients are asked to receive acupuncture 3 times a week. However, those who require will receive extra acupuncture sessions.
Each acupuncture session lasts for 30 min. The dose of flunarizine / placebo is 10 mg per day for 2 weeks and 5 mg per day in the next 2 weeks.
Intervention type
Drug
Phase
Not Specified
Drug names
flunarizine
Primary outcome measures
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 outcome measures
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.
Overall trial start date
01/06/2007
Overall trial end date
30/06/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
140
Participant 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, Parkinsons disease and other extrapyramidal diseases
Recruitment start date
01/06/2007
Recruitment end date
30/06/2009
Locations
Countries of recruitment
China
Trial participating centre
No.23 Meishuguanhou Street
Beijing
100010
China
Sponsor information
Organisation
The Beijing Administration of Traditional Chinese Medicine (China)
Sponsor details
No.5 Xiaoqudeng lane
Meishuguanhoujie
Dongcheng Districk
Beijing
100010
China
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Beijing Administration of Traditional Chinese Medicine, Capital Medical Development Research Fund (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19389262
Publication citations
-
Protocol
Zhang Y, Wang L, Liu H, Li N, Li J, Yi J, The design and protocol of acupuncture for migraine prophylaxis: a multicenter randomized controlled trial., Trials, 2009, 10, 25, doi: 10.1186/1745-6215-10-25.