NCT06243874

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

January 17, 2024

Last Update Submit

February 5, 2024

Conditions

Migraine

Keywords

painmigrainenerve block

Outcome Measures

Primary Outcomes (3)

  • Numeric Rating Scale

    Range pain severity 0-10, 0: No pain, 10: Worst Pain

    Post treatment 3 months

  • Migraine attack duration

    mean migraine attack duration (hours) that patients suffer in a month.

    Post treatment 3 months

  • Number of migraine days

    Number of migraine days that patients suffer in a month.

    Post treatment 3 months

Secondary Outcomes (2)

  • Migraine Disability Assessment (MIDAS) questionnaire

    Post treatment 3 months

  • medication use

    Post treatment 3 months

Study Arms (2)

greater occipital nerve block

ACTIVE COMPARATOR

Following intravenous access and monitoring, participants are placed in the prone position. The medial 1/3 of the line between the protuberance occipital externa and the mastoid process is palpated. The intervention area is cleaned with antiseptic solution. Then, 2 cc of 2% lidocaine is injected into the palpated area after confirming that it is not in the vascular area by negative aspiration. Participants are observed for 30 minutes for possible complications. The participant will receive a block once a week for the first month and then once a month for the next 2 months.

Procedure: greater occipital nerve block

transnasal sphenopalatine ganglion block

OTHER

Following intravenous access and monitoring, patients are placed in the supine position. A cotton swab impregnated with 2 cc of 2% lidocaine is advanced from the nostril along the upper edge of the middle turbinate until it reaches the posterior wall of the nasopharynx. The stick impregnated with local anesthetic is kept in the target area for 20 minutes. Participants are observed for 30 minutes for possible complications. The participant will receive a block once a week for the first month and then once a month for the next 2 months.

Procedure: transnasal sphenopalatine ganglion block

Interventions

greater occipital nerve blockPROCEDURE

greater occipital nerve block

greater occipital nerve block
transnasal sphenopalatine ganglion blockPROCEDURE

transnasal sphenopalatine ganglion block

transnasal sphenopalatine ganglion block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University

Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 25600718BACKGROUND

  • 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.

    PMID: 29368949BACKGROUND

  • 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.

    PMID: 25828648BACKGROUND

  • 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.

    PMID: 29862074BACKGROUND

  • 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.

    PMID: 34786992BACKGROUND

  • Unal HA, Basari A, Celiker OS, Cakar Turhan KS, Asik I, Ozgencil GE. Comparison of Greater Occipital Nerve Blockade and Sphenopalatine Ganglion Blockade in Patients with Episodic Migraine. J Clin Med. 2024 May 21;13(11):3027. doi: 10.3390/jcm13113027.

    PMID: 38892738DERIVED

MeSH Terms

Conditions

Migraine DisordersPain

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hanzade A Unal, MD

    Ankara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 17, 2024

First Posted

February 6, 2024

Study Start

September 1, 2023

Primary Completion

November 1, 2023

Study Completion

January 1, 2024

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)