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Clinical and Economic Evaluation of Acupuncture for Migraine

Not Applicable
Completed
Conditions
MigraineEfficacy of acupuncture for migraineAdverse events from acupuncture treatmentCost of acupuncture treatment
Migraine
Acupuncture
Economics
Registration Number
TCTR20170612002
Lead Sponsor
Department for Development of Thai Traditional and Alternative Medicine, Ministry of Public Health
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
240
Inclusion Criteria

1. Participants had history of headache for at least 1 year, and had frequency of headache at least 2 times per month.
2. Participants have fulfilled the criteria of migraine disease according to the International Classification of Headache (ICH 2013), both migraine with aura, migraine without aura and chronic migraine.
3. Participants can read Thai language and sign inform consent.

Exclusion Criteria

1. Having been treated with acupuncture for headache during the last 3 months
2. Pregnancy
3. Presentation of severe underlying disease
4. Bleeding tendency
5. Skin infection in the acupoints area
6. Psychosis i.e. schizophrenia

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Average per subject reduction in migraine days/4 weeks Baseline and 4 weeks after treatment Headache diary (days)
Secondary Outcome Measures
NameTimeMethod
Headache intensity Baseline, at visit 5th, visit 10th and 4 weeks after treatment Average of the Numeric Pain Rating Scale each migraine attack, scale of 0-10, from headache diary,Acute Migraine Medication Use Baseline, at visit 5th, visit 10th and 4 weeks after treatment Total amount and type of medication use from headache diary,Quality of Life Baseline, at visit 5th, visit 10th and 4 weeks after treatment EQ-5D-5L questionnaire,Migraine Disability Assessment Baseline and three months after the last treatment The MIDAS (Migraine Disability Assessment) questionnaire ,Proportion of responders Comparing baseline and 4 weeks after treatment of the two groups Proportion of participants who have at least 50% reduction in migraine days of the two groups.,Related Adverse Events from acupuncture Every treatment session Details of adverse events from headache diary and interviewing
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