Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06243874
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2024-01-17
Brief Title:
Comparison of Occipital Nerve and Sphenopalatine Ganglion Blockade
Sponsor:
Ankara University
Organization:
Ankara University
Study Overview
Official Title:
Comparison of Greater Occipital Nerve Blockade and Sphenopalatine Ganglion Blockade in Patients With Episodic Migraine
Status:
COMPLETED
Status Verified Date:
2024-02
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:
Migraine is a chronic disorder that causes disability Episodic migraine can be managed by prophylactic medical treatment or interventional pain procedures Interventional methods used in migraine treatment are greater occipital nerve blockade lesser occipital nerve blockade supraorbital nerve blockade infraorbital nerve blockade sphenopalatine ganglion blockade botulinum toxin injection and various radiofrequency applications The effectiveness of greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade in the treatment of migraine has been proven in various studiesWe aimed to evaluate the effects of repetitive greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade in patients with episodic migraine
Detailed Description:
Migraine is a common primary headache and causes a significant personal social and financial burden Migraine is characterized by a semi-headache lasting 4-72 hours accompanied by nauseavomiting and photophobiaphonophobia Migraine can be episodic or chronic Non-steroidal anti-inflammatory drugs triptan and ergotamine derivatives can be used in the treatment of acute migraine attacks Beta-blockers calcium channel blockers antiepileptic drugs and antidepressant drugs are among the prophylactic medical treatments When medical treatment cannot provide adequate pain palliation in case of side effects or when the patient does not prefer medical treatment interventional methods come to the fore Interventional methods that applied in migraine treatment are greater occipital nerve blockade lesser occipital nerve blockade supraorbital nerve blockade infraorbital nerve blockade sphenopalatine ganglion blockade botulinum toxin injection and various radiofrequency applications The effectiveness of greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade in the treatment of migraine has been proven in various studies
It is stated that sphenopalatine ganglion blockade reduces the number of headache days and is effective in the treatment of acute migraine attacks Although there are studies on the effectiveness of greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade in migraine treatment there are no studies comparing their superiority over each other This study aims to evaluate the effects of repetitive greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade on headache severity number of days with headache headache duration functionality and medication use in patients with episodic migraine and to compare whether they are superior to each other
In this single center randomised study participants episodic migraine will be diagnosed according to the International Classification of Headache Disorders 3rd version ICHD-3 criteria Demographic information of the patients including age gender comorbidities educational status marital status and migraine duration will be recorded Pain intensity of patients will be evaluated using the Numeric Rating Scala NRS 11 scale and functionality will be evaluated using MIDAS Before the procedure the number of headache days in a 1-month period headache severity duration amount of medication use non-steroidal anti-inflammatory analgesic triptan and MIDAS score will be recorded Participants will be randomized into 2 groups When 21 participants are randomized in each group participant 26 will be excluded from the list because it is in both groups Group 1 greater occipital nerve block It will be applied for participants 37 27 35 13 36 18 34 33 6 12 3 25 19 1 14 9 21 38 10 2 Group 2 sphenopalatine block It will be applied to patients 22 1 24 11 35 33 17 14 8 31 39 5 2 28 41 36 15 7 34 27 Greater occipital nerve block will be applied to participant number 26 by repeating the procedure order since the number of participants in each group is equally divided
Participants will receive greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade once a week for the first month and then once a week for a further 1 month At the 1st month 2nd month and 3rd month follow-up visits of the participants the number of headache days average pain intensity and pain duration MIDAS scores and the amount of medication used non-steroidal anti-inflammatory analgesic triptan will be recorded with pain diaries Participants pain diaries MIDAS scores and the amount of medication they use will be recorded Additionally possible complications in patients will also be recorded
It is stated that sphenopalatine ganglion blockade reduces the number of headache days and is effective in the treatment of acute migraine attacks Although there are studies on the effectiveness of greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade in migraine treatment there are no studies comparing their superiority over each other This study aims to evaluate the effects of repetitive greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade on headache severity number of days with headache headache duration functionality and medication use in patients with episodic migraine and to compare whether they are superior to each other
In this single center randomised study participants episodic migraine will be diagnosed according to the International Classification of Headache Disorders 3rd version ICHD-3 criteria Demographic information of the patients including age gender comorbidities educational status marital status and migraine duration will be recorded Pain intensity of patients will be evaluated using the Numeric Rating Scala NRS 11 scale and functionality will be evaluated using MIDAS Before the procedure the number of headache days in a 1-month period headache severity duration amount of medication use non-steroidal anti-inflammatory analgesic triptan and MIDAS score will be recorded Participants will be randomized into 2 groups When 21 participants are randomized in each group participant 26 will be excluded from the list because it is in both groups Group 1 greater occipital nerve block It will be applied for participants 37 27 35 13 36 18 34 33 6 12 3 25 19 1 14 9 21 38 10 2 Group 2 sphenopalatine block It will be applied to patients 22 1 24 11 35 33 17 14 8 31 39 5 2 28 41 36 15 7 34 27 Greater occipital nerve block will be applied to participant number 26 by repeating the procedure order since the number of participants in each group is equally divided
Participants will receive greater occipital nerve blockade and transnasal sphenopalatine ganglion blockade once a week for the first month and then once a week for a further 1 month At the 1st month 2nd month and 3rd month follow-up visits of the participants the number of headache days average pain intensity and pain duration MIDAS scores and the amount of medication used non-steroidal anti-inflammatory analgesic triptan will be recorded with pain diaries Participants pain diaries MIDAS scores and the amount of medication they use will be recorded Additionally possible complications in patients will also be recorded
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