Migraine (with or without aura) Nervous System Diseases Migraine (with or without aura)
Conditions
Interventions
Participants are randomly allocated to one of the three groups below:
1. Verum acupuncture (de-qi-inducing needling at specified points)
2. Placebo acupuncture (shallow needle stimulation a specifie
Sponsors
National Research Institute of Chinese Medicine, Ministry of Health and Welfare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed with migraine (with or without aura, according to ICHD-II criteria) 2. Patient has given consent to receive acupuncture treatment 3. Age (20-65) 4. Patient has provided informed consent to participate (informed about possibility of receiving placebo treatment or no acupuncture treatment, informed about the use of NIRS during acupuncture sessions)
Exclusion criteria
Exclusion criteria: 1. Patient refuses acupuncture treatment 2. Patient has contra-indications for acupuncture 3. Patient suffers from hemophilia, skin infections or has other conditions that preclude the use of acupuncture 4. Suffers mental illness 5. Pregnant or lactating 6. Patient is currently participating in another clinical study or has participated in another clinical trial within 3 months to enrolling in the study 7. Patient opts or drops out of study 8. Patient has received acupuncture treatment within the past 3 months 9. Patient fails to follow the parameters of the study, such as number of acupuncture treatments per week
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary clinical measures: 1. Headache duration (headache hours/day) 2. Headache frequency (headache days/month) 3. Headache intensity (VAS score) These are recorded in headache diaries covering the 12-week duration of the study and apply to all treatment arms Primary hemodynamic measures: 1. Regional oxygenation of the cerebral cortex (Oxy/Deoxy-Hb ratio) 2. Regional oxygenation of the upper trapezius (Oxy/Deoxy-Hb ratio) These are measured by near-infrared spectroscopy (NIRS) during each acupuncture treatment session and apply only to the two acupuncture arms, verum and placebo | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Medications (name, type, usage), recorded in headache diary 2. Presence of migraine aura (Yes/No), noted by attending physician during treatment session 3. Headache intensity (VAS score), noted by attending physician during treatment session 4. Headache site (Left/Right), noted by attending physician during treatment session 5. Body movement (duration of movement per 10-min interval), recorded by video of treatment session Except the measure for medications (#1), the above apply only to the acupuncture arms, verum and placebo. | — |
Countries
Taiwan
Outcome results
None listed