Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432127
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-15
Brief Title:
Role of Ultrasound Guide Greater Occipital Nerve Block at Second Cervical Vertebra in Migraine Headache Prophylaxis
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
Role of Ultrasound Guide Greater Occipital Nerve Block at Second Cervical Vertebra in Migraine Headache Prophylaxis in Patients With Failed Oral Prophylaxis Medication A Randomized Controlled Study in Thailand
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 migrainethe 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
05 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 04812 and follow up at week 24 for Migraine Disability Assessment Test MIDAS Thai Hospital-Anxiety-depression indexThai-HADS
According to guidelines of the International Headache Society for controlled trials of preventive treatment of migraine attacks in episodic and chronic migrainethe 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
05 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 04812 and follow up at week 24 for Migraine Disability Assessment Test MIDAS Thai Hospital-Anxiety-depression indexThai-HADS
Detailed Description:
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 0481224
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 0481224
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None