Condition category
Nervous System Diseases
Date applied
24/05/2007
Date assigned
26/06/2007
Last edited
20/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Linpeng Wang

ORCID ID

Contact details

No.23 Meishuguanhou Street
Dongcheng District
Beijing
100010
China

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, Parkinson’s 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

http://www.bjtcm.gov.cn/index.jsp

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

  1. 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.

Additional files

Editorial Notes