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The goal of this randomized controlled study in Thailand. is to find if there is a role of local anesthetic greater occipital nerve block at Cervical spine level 2 under ultrasound guide in prophylaxis of episodic migraine and chronic migraine in patients with failed oral prophylaxis medication.
According to guidelines of the International Headache Society for controlled trials of preventive treatment of migraine attacks in episodic and chronic migraine,the primary and secondary outcome were monitoring followed by these research guideline
After informed consent, volunteer will be stratified random into 2 groups of injection agent at unilateral greater occipital nerve block on headache site under US guide by pain physician
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Use Normal saline 3 ml as the injection agent |
|
| Bupivacaine | Experimental | Use 0.5% Bupivacaine 3ml as the injection agent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Unilateral Greater occipital nerve block at C2 level under ultrasound guide with needle in plane technique during ultrasound using normal saline 3 mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| change of Frequency headache day /month | by using headache diary | at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure |
| change of migraine attack day /month from headache diary | by using headache diary | at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure |
| Measure | Description | Time Frame |
|---|---|---|
| change in severity of headache day per month (decrease of moderate-severe pain) | decrease of moderate-severe pain day per month compare to baseline by using headache diary | at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure |
| Thai-Migraine Disability Assessment |
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Inclusion Criteria:
Exclusion Criteria:
Had these type of headache in combination with migraine
Had contraindication on greater occipital nerve block injection at cervical spine level 2 under ultrasound-guided such as skin infection in needle site
Allergy to local anesthetic
Uncontrolled psychiatric disorder in 3 months before attending research
Cannot understand or reading, writing Thai language
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| RAVIWON ATISOOK, M.D. | Contact | +66819140784 | raviwon.ati@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| RAVIWON ATISOOK, M.D. | Siriraj Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raviwon Atisook | Bangkok | 10700 | Thailand |
will be consider again after data collection
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine | Drug | Unilateral Greater occipital nerve block at C2 level under ultrasound guide with needle in plane technique during ultrasound using 0.5% Bupivacaine 3 mL |
|
Thai-Migraine Disability Assessment (MIDAS) ,Score 0 to 21+ ( 0-5 marks = little or no disability and more than 21+ =severe disability |
| at Week 12,24 compare to baseline |
| Thai-Hospital Anxiety and Depression Scale | Thai-Hospital Anxiety and Depression Scale (Thai HADS) , divided into anxiety and depression part ,if either of the score in each depression or anxiety more than 11 mean abnormal | at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure |
| Healthcare outcomes/quality of life | by EuroQoL- (EQ-5D) measured health-related quality of life with 5 dimension (mobility, health care, usual activity, Pain, Anxiety/depression and in each of them had 5 grading 1-5 by 1 means no problem and 5 means extreme problem) after having score in each dimension, calculated utility score would be done | at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure |
| Patient's reported outcome measurement (PGI-C) | Patient's reported outcome measurement (PGI-C), score grading 1-7 by 1 very much worse to very much improved , 7 means very much worse | at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure |
| D009422 | Nervous System Diseases |
| D000588 |
| Amines |