Clinical trial NCT06243874: Comparison of Occipital Nerve and Sphenopalatine Ganglion Blockade
Official title: Comparison of Greater Occipital Nerve Blockade and Sphenopalatine Ganglion Blockade in Patients With Episodic Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: pain
migraine
nerve block
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 studies.We 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 nausea/vomiting and photophobia/phonophobia. 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.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-65
* Diagnosing migraine according to the International Classification of Headache Disorders 3rd version (ICHD-3) criteria
* Patients diagnosed with episodic migraine
* Failure to provide pain palliation with at least 1 prophylactic medication

Exclusion Criteria:

* Presence of psychiatric disease that is unstable/not controlled by medical treatment
* Pregnant patients
* Those with bleeding diathesis
* Patients who are allergic to local anesthetics given during the procedure
* Patients with open skull defects who have undergone craniotomy
* Patients with previous nasal/sinus surgery
* Patients with medication overuse headaches
* Presence of causes such as hypertension, vasculitis, malignancy, etc. that may cause headaches
* Patients who have received interventional headache treatment in the last 6 months

Primary outcomes:
measure: Numeric Rating Scale
timeFrame: Post treatment 3 months
measure: Migraine attack duration
timeFrame: Post treatment 3 months
measure: Number of migraine days
timeFrame: Post treatment 3 months
Secondary outcomes:
measure: Migraine Disability Assessment (MIDAS) questionnaire
timeFrame: Post treatment 3 months
measure: medication use
timeFrame: Post treatment 3 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
affiliation: Ankara University
name: Hanzade A Unal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marmura MJ, Silberstein SD, Schwedt TJ. The acute treatment of migraine in adults: the american headache society evidence assessment of migraine pharmacotherapies. Headache. 2015 Jan;55(1):3-20. doi: 10.1111/head.12499.
citation: Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.
citation: Cady RK, Saper J, Dexter K, Cady RJ, Manley HR. Long-term efficacy of a double-blind, placebo-controlled, randomized study for repetitive sphenopalatine blockade with bupivacaine vs. saline with the Tx360 device for treatment of chronic migraine. Headache. 2015 Apr;55(4):529-42. doi: 10.1111/head.12546. Epub 2015 Mar 31.
citation: Binfalah M, Alghawi E, Shosha E, Alhilly A, Bakhiet M. Sphenopalatine Ganglion Block for the Treatment of Acute Migraine Headache. Pain Res Treat. 2018 May 7;2018:2516953. doi: 10.1155/2018/2516953. eCollection 2018.
citation: Malekian N, Bastani PB, Oveisgharan S, Nabaei G, Abdi S. Preventive effect of greater occipital nerve block on patients with episodic migraine: A randomized double-blind placebo-controlled clinical trial. Cephalalgia. 2022 May;42(6):481-489. doi: 10.1177/03331024211058182. Epub 2021 Nov 17.