Migraine Without Aura Clinical Trial
Official title:
Evaluating the Prophylactic Efficacy of Acupuncture for Migraine Without Aura (MWoA) : A Randomized Controlled Trial
Verified date | September 2019 |
Source | Huazhong University of Science and Technology |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Acupuncture is commonly used for the prevention of migraine, while the evidence for its efficacy is still uncertain. Current studies have not been able to determine whether the efficacy of acupuncture is due to the actual therapeutic effect of acupuncture, or a result of psychological benefits. To address this issue, we designed a clinical trial to evaluate the prophylactic efficacy of acupuncture for migraine without aura (MWoA). Furthermore, we will evaluate the impact of Chinese medicine factors and psychological factors on the efficacy of acupuncture.
Status | Completed |
Enrollment | 150 |
Est. completion date | November 20, 2018 |
Est. primary completion date | November 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Diagnosed as migraine without aura according to the International Classification of Headache Disorders,3rd edition beta version (ICHD-3ß); 2. Aged between 15 and 65 years old, with initial onset of migraines before the age of 50 years; and 3. Experienced migraine attacks for at least 1 year; and 4. Experienced migraine attacks with 2-8 times per month during the last 3 months and baseline period, and the duration of migraine attacks lasting 4-72h without intake of acute drugs or at least 2h with intake of acute drugs; and 5. the mean headache Visual Analogue Scale (VAS) scores 4-8 at baseline; and 6. Had not taken any acupuncture treatment before study entry; and 7. Able to complete the baseline headache diary; and 8. Able to signing a informed consent. Exclusion Criteria: 1. Tension-type headache, cluster headache, and other primary headache disorders, secondary headache disorders, neuralgia of the face or head; and 2. Combined with cardiovascular, liver, kidney, gastrointestinal tract, blood system and other serious primary diseases affecting the implementation of treatment programs, or combined with epilepsy, Parkinson or other nervous system diseases; and 3. Patients with severe mental illness, such as severe anxiety and depression; and 4. Pregnant women, women in lactation, and those planning to become pregnant; and 5. Participation in other clinical trials; and 6. Illiterate, or patients unable to read and understand scales; 7. Have experience of acupuncture. |
Country | Name | City | State |
---|---|---|---|
China | Department of Neurology of Tongji Hospital, Huazhong University of Science and Technology | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Wei Wang | Hubei College of Traditional Chinese Medicine, Hubei Hospital of Traditional Chinese Medicine, The Second Hospital of Huangshi, University Hospital of Huang Jia Lake Campus, Hubei University of Chinese Medicine, Wuhan Integrated Traditional Chinese and Western Medicine Hospital, Xiangyang No.1 People's Hospital, Hubei University of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The Chinese Version of the Massachusetts General Hospital Acupuncture Sensation Scale | Acupuncture sensations will be measured by the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS) | Immediately following each session of acupuncture treatment. | |
Other | Change in Beck Anxiety Inventory(BAI). | At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization. | ||
Other | Change in Beck Depression Inventory II(BDI- II). | At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization. | ||
Other | 60-item NEO Personality Inventory-Short Form (NEO-FFI) | At baseline (four weeks before randomization) only once. | ||
Other | Chinese medicine constitution classification | Patients' Chinese medicine constitution classification will be measured by the score obtained from Constitution in Chinese Medicine Questionnaire (CCMQ) | At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization. | |
Other | Acupuncture Expectancy Scale | Before treatment, after the third session of treatment, and after the twentieth session of treatment. | ||
Other | Change in Patient-Doctor Relationship Questionnaire(PDRQ-9) . | At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization. | ||
Other | Change in Difficult Doctor-Patient Relationship Questionnaire(DDPRQ-10). | At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization. | ||
Primary | Change in the number of migraine days | The changes in the mean number of migraine days per 4-week cycle | At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. | |
Primary | Change in the frequency of migraine attacks | The changes in the mean number of migraine attacks per 4-week cycle | At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. | |
Secondary | The proportion of responders | The proportion of patients with at least a 50% reduction of the number of migraine days | At weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. | |
Secondary | Change in visual analogue scale | The changes in the mean visual analogue scale scores per 4-week cycle | At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. | |
Secondary | Change in Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2). | The changes in the scores of Short-Form McGill Pain Questionnaire 2 (SF-MPQ-2) per 4-week cycle | At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. | |
Secondary | Change in Migraine Disability Assessment questionnaire(MIDAS). | The changes in the scores of Migraine Disability Assessment questionnaire(MIDAS) | At baseline (four weeks before randomization), weeks 5-8 after randomization and weeks 17-20 after randomization. | |
Secondary | Change in Migraine-Specific Quality of Life Questionnaire(MSQ) Version 2.1. | The changes in the scores of Migraine-Specific Quality of Life Questionnaire(MSQ) per 4-week cycle | At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. | |
Secondary | Change in 36-Item Short-Form Health Survey(SF-36). | The changes in the scores of 36-Item Short-Form Health Survey(SF-36) per 4-week cycle | At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. | |
Secondary | Change in Pittsburgh Sleep Quality Index(PSQI). | The changes in the scores of Pittsburgh Sleep Quality Index(PSQI) per 4-week cycle | At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. | |
Secondary | Change in the dose of intake of acute medication. | The changes in the dose of intake of acute medication per 4-week cycle | At baseline (four weeks before randomization), weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization. |
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