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

Not Applicable

Completed

• Conditions: Migraine; Nervous System Diseases

• Registration Number: ISRCTN49839714
• Lead Sponsor: The Beijing Administration of Traditional Chinese Medicine (China)

Brief Summary

1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19389262 2. 2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/21616596 (added 11/07/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-26
• Study Completion: 2009-06-30
• Last Update Posted: 29 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The efficacy of acupuncture for migraine prophylaxis was assessed by the following:<br> 1. Visual Analogue Scale (VAS) to assess the severity of migraine pain<br> 2. Short-From of McGill Pain Questionnaire (SF-MPQ)<br> 3. Change in frequency and duration of migraine attacks<br><br> 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.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Intake of acute-medication<br> 2. Severity of adverse effects<br> 3. Change in the frequency of nausea, vomiting and other correlative symptoms<br><br> 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.<br>