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| Name | Class |
|---|---|
| Hunan University of Traditional Chinese Medicine | OTHER |
| Chongqing Medical University | OTHER |
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Hypothesis: Acupuncture obtains an abiding effect on migraine prophylaxis Design: A open-label randomized controlled trial. 249 participants will be included. Three arms: acupuncture in acupoint-meridian, non-acupoint-meridian group, and waiting list.
Aim: to attest the abiding efficacy and safety of acupuncture for migraine prophylaxis Design: A open-label randomized controlled trial will be performed in Chengdu, Hunan and Chongqing province. Two hundred and forty-three participants will be randomly assign to acupoint-meridian group, non-acupoint-meridian group, and wait-and-see group. Each participants will receive 20 sessions of acupuncture in 4 weeks, with a duration of 30 minutes in a session. After all the treatments was accomplished, there will be 5 times follow-ups in the impending every 4 weeks. The primary outcome is frequency of migraine attacks 16 weeks after inclusion. Secondary outcomes include frequency of migraine attacks at the 4th and 24th week, headache severity, MSQ(Migraine Specific Quality of Life Questionnaire MSQ Version2.1), etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acupoint-meridian group | Experimental | Apply traditional acupuncture to prevent the migraine attack according to TCM theory |
|
| sham-acupoint group | Other | sham-acupoint will be penetrated for migraine prophylaxis. |
|
| waiting list | No Intervention | No acupuncture nor other methods will be conducted in this group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Other | apply acupuncture to prevent the migraine attack |
|
| Measure | Description | Time Frame |
|---|---|---|
| frequency of migraine attacks | to assess the frequency of migraine attacks at the 16th week after inclusion | 16th week after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| frequency of migraine attacks | to assess the frequency of migraine attacks at the 4th and 24th week respectively | 4th and 24th week after inclusion |
| headache severity | to evaluate the change of severity of headache |
| Measure | Description | Time Frame |
|---|---|---|
| MSQ(Migraine Specific Quality of Life Questionnaire MSQ Version2.1) | to observe the change of MSQ | the day of inclusion and 4th week after inclusion |
| acupuncture expectation scale | an outcome to indicate the expectation of patient towards acupuncture treatment for migraine |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fanrong Liang, Professor | Chengdu University of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chengdu University of TCM | Chengdu | Sichuan | 610075 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28241154 | Derived | Zhao L, Chen J, Li Y, Sun X, Chang X, Zheng H, Gong B, Huang Y, Yang M, Wu X, Li X, Liang F. The Long-term Effect of Acupuncture for Migraine Prophylaxis: A Randomized Clinical Trial. JAMA Intern Med. 2017 Apr 1;177(4):508-515. doi: 10.1001/jamainternmed.2016.9378. | |
| 24171782 | Derived | Chen J, Zhao L, Zheng H, Li Y, Yang M, Chang X, Gong B, Huang Y, Liu Y, Liang F. Evaluating the prophylaxis and long-term effectiveness of acupuncture for migraine without aura: study protocol for a randomized controlled trial. Trials. 2013 Oct 30;14:361. doi: 10.1186/1745-6215-14-361. |
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| ID | Term |
|---|---|
| D020326 | Migraine without Aura |
| D006261 | Headache |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| 0 day, 4th, 8th, 12th, 16th, 20th, 24th week after inclusion |
| 1 day |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |