Migraine Nervous System Diseases Migraine
Conditions
Interventions
A. Verum acupuncture, 30 min per session, 8 sessions over 8 weeks: Individualized treatment on the basis of diagnosis in accordance with Traditional Chinese Medicine (TCM), which the acupuncture physi
Sponsors
Carlos III Health Institute (Spain)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. At least 18 years old 2. Diagnosed with migraine, in accordance with the principles of the International Headache Society and the recommendations for clinical trials published by the same Society 3. With or without aura 4. With a frequency of migraine attacks of 2-6 times per month 5. With a minimum chronicity of one year 6. Onset of symptoms at an age of less than 50 years 7. Have completed the headache diary 8. Have signed informed consent
Exclusion criteria
Exclusion criteria: 1. Acupuncture during the previous 12 months 2. Incapacity to distinguish between tensional headache and migraine 3. Secondary headaches 4. Contraindication to acupuncture (pregnancy, generalised dermopathy, treatment with anticoagulants, thrombocytopenia) or to the performance of Single-Photon Emission Computed Tomography (SPECT) techniques (cerebrovascular accident, traumatic brain injury, alcohol or drug abuse, severe psychiatric disorders) 5. Inability to complete the questionnaires or to reply to the assessor's questions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in the number of Days With Migraine (DWM) between the baseline period and the period spanning weeks 9-12 (DWM1). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. DWM between the baseline period and the period spanning weeks 21-24 (DWM2) after randomization. 2. Change in the health-related quality of life between the baseline, final and follow-up periods, assessed by the 12-item Short Form health survey 3. Days free from pain 4. Proportion of patients with at least 50% fewer headaches during the period spanning weeks 9-12, in comparison with the baseline situation 5. Days off work, or of incapacity to perform daily activities 6. Change in the consumption of symptomatic/analgesic and prophylactic medication for migraine attacks, according to the patient's record of the name of the drug and the daily dose consumed, between the baseline period, the end of treatment and after 6 months 7. Change recorded on Goldberg's Depression/Anxiety Scale between the baseline period, the end of treatment and after the follow-up period 8. Difference in the results of the Spanish version of the Headache Impact Test, between the baseline period, the end of treatment and after the follow-up period 9. SPECT: The following values will be calculated for the semi-quantitative analysis of the images: 9.1. Percentage change of the mean value of counts per pixel for each region of interest 9.2. We shall also calculate an Index of Laterality (IL) | — |
Countries
Spain
Outcome results
None listed