Efficacy and safety of Acupuncture for Migraine Prophylaxis - a multicenter, randomized, controlled clinical trial

ISRCTN	ISRCTN49839714
DOI	https://doi.org/10.1186/ISRCTN49839714
Protocol serial number	SF-2005-2
Sponsor	The Beijing Administration of Traditional Chinese Medicine (China)
Funder	The Beijing Administration of Traditional Chinese Medicine, Capital Medical Development Research Fund (China)

Submission date: 24/05/2007
Registration date: 26/06/2007
Last edited: 11/07/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Linpeng Wang
Scientific

No.23 Meishuguanhou Street
Dongcheng District
Beijing
100010
China

Study information

Primary study design	Interventional
Study design	Multicentre randomised single blind controlled study
Secondary study design	Randomised controlled trial
Scientific title	Efficacy and safety of Acupuncture for Migraine Prophylaxis - a multicenter, randomized, controlled clinical trial
Study acronym	AMP
Study objectives	Acupuncture could be an option to prevent migraine attacks in comparison to standard medicine therapy (flunarizine).
Ethics approval(s)	Approved by the Research Ethical Committee of the Beijing Hospital of Traditional Chinese Medicine on 24/05/2007 (ref: 200704)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	flunarizine
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	30/06/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	140
Total final enrolment	140
Key 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
Key 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
Date of first enrolment	01/06/2007
Date of final enrolment	30/06/2009

Locations

Countries of recruitment

China

Study participating centre

No.23 Meishuguanhou Street

Beijing
100010
China

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2011	11/07/2019	Yes	No
Protocol article	protocol	24/04/2009		Yes	No

Editorial Notes

11/07/2019: Publication reference and total final enrolment added.