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 * Normal saline * 0.5% bupivacaine the injection was done 2 times between Week 0 and week 4 as to wean off placebo effect the volunteer will be monitor by pain diary at 1 month before intervention at week 0,4,8,12 and follow up at week 24 for Migraine Disability Assessment Test (MIDAS) ,Thai Hospital-Anxiety-depression index(Thai-HADS)
* Neurologist screening candidate volunteers for this study, following the inclusion and exclusion criteria * Candidate volunteers attended pain clinic for he protocol detail about this research and informed consent * After signing consent, Volunteers would be stratified randomization into 2 groups between Normal saline and bupivacaine * Volunteers would be done base line headache diary for 1 month before performing the procedure (Week -4 to week0) * At Week 0, Volunteers would be applied local anesthetic cream at skin injection site before done the procedure * According to stratified randomization, Pain interventionist and also volunteers would be blinded to the group * First Unilateral greater occipital nerve block at Cervical spine level 2 (C2) was done under ultrasound guide (Week0) * Telemedicine Follow up at week 2 * Second Unilateral greater occipital nerve block at C2 level was done under ultrasound guide (Week4) * Volunteers would be follow up via telemedicine and done headache diary until 3 months after 1st injection * Volunteers would be follow up according to outcome monitoring protocol in Week 0,4,8,12,24
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
108
Unilateral Greater occipital nerve block at C2 level under ultrasound guide with needle in plane technique during ultrasound using normal saline 3 mL
Unilateral Greater occipital nerve block at C2 level under ultrasound guide with needle in plane technique during ultrasound using 0.5% Bupivacaine 3 mL
Raviwon Atisook
Bangkok, Thailand
change of Frequency headache day /month
by using headache diary
Time frame: 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
Time frame: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
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
Time frame: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
Thai-Migraine Disability Assessment
Thai-Migraine Disability Assessment (MIDAS) ,Score 0 to 21+ ( 0-5 marks = little or no disability and more than 21+ =severe disability
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at Week 0,4,8,12,24 compared to base line at 1 months before injection procedure
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