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Sphenopalatine Ganglion Blockade in Migraine

Primary Purpose

Episodic Migraine

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Lidocaine Hydrochloride 1% Solution for Injection_#2
Placebo
Sponsored by
Afyonkarahisar Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Episodic Migraine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Having a diagnosis of episodic migraine (according to ICD-III)
  • Receiving any prophylaxis treatment in the last 3 months,

Exclusion Criteria:

  • Being pregnant and lactating
  • Neurological and psychiatric conditions (
  • Contraindications to the use of local anesthetics
  • Other chronic painful conditions,
  • Having a history of malignancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    placebo arm

    lidocaine arm

    Arm Description

    Injection into the sphenopalatine ganglion of the patients in both groups will be made by entering the arcus zygomaticum and oriented at a 45 degree angle towards the opposite tooth. Injections will be made with a dental injector. Placebo group will be injected with 4ml of 0.9% saline. Injections will be repeated weekly for the first 4 weeks, then monthly. At the end of the 1st and 3rd months of the treatment, the patients will be evaluated in the routine outpatient clinic control, and the two groups will be compared statistically by questioning the frequency of pain, the number of attacks, the severity of pain (VAS), and the duration of pain.

    Injection into the sphenopalatine ganglion of the patients in both groups will be made by entering the arcus zygomaticum and oriented at a 45 degree angle towards the opposite tooth. Injections will be made with a dental injector. Lidocaine group will be injected with 4ml of 0.1%Lidocaine. Injections will be repeated weekly for the first 4 weeks, then monthly. At the end of the 1st and 3rd months of the treatment, the patients will be evaluated in the routine outpatient clinic control, and the two groups will be compared statistically by questioning the frequency of pain, the number of attacks, the severity of pain (VAS), and the duration of pain.

    Outcomes

    Primary Outcome Measures

    Frequency and Pain Level of Migraines Post-Treatment
    The frequency and pain level of subjects' migraines will be assessed upon the conclusion of the study through surveying and comparing to previous survey data.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 3, 2021
    Last Updated
    January 26, 2022
    Sponsor
    Afyonkarahisar Health Sciences University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05210192
    Brief Title
    Sphenopalatine Ganglion Blockade in Migraine
    Official Title
    Sphenopalatine Ganglion Blockade With Local Analgesic in Episodic Migraine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2022 (Anticipated)
    Primary Completion Date
    October 1, 2022 (Anticipated)
    Study Completion Date
    January 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Afyonkarahisar Health Sciences University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Migraine is a fairly common disease that is a leading cause of disability worldwide. 15% of the general population suffer from migraine headaches. Although there are currently many options for the treatment of acute migraine, these treatment options, such as acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDS), triptans, combinations analgesics and antiemetics, have insufficient efficacy and significant side effects. Therefore, there is a need for new treatment modalities in migraine. Sphenopalatine ganglion (SPG) block is gaining interest as an effective treatment for migraine, other headaches and facial pain syndromes. In our study, we aimed to block the Sphenopalatine ganglion with a local anesthetic drug and compare it with the placebo control group.
    Detailed Description
    Between 1 May and 1 December 2021, 50 patients aged 18-50 years, who were diagnosed with episodic migraine according to ICD III criteria, who applied to the headache outpatient clinic of Afyonkarahisar Health Sciences University Medical Faculty Hospital, are planned to be included in the study. Patients with similar age, gender and disease duration will be randomly divided into 2 groups using the closed envelope method. Demographic information of the patients, chronic disease history, medications used, and duration of disease will be questioned. Before the treatment, the frequency of pain, the number of attacks, the severity of pain (VAS), and the duration of pain will be questioned. VAS (visual analog scale) is a scale that evaluates the severity of pain. This scale consists of numerical values between 0 and 10. 0 is considered no pain, and 10 is considered the most severe pain. Routine attack treatment of the patients will continue. Injection into the sphenopalatine ganglion of the patients in both groups will be made by entering the arcus zygomaticum and oriented at a 45 degree angle towards the opposite tooth. Injections will be made with a dental injector. The first group will be injected with 4ml of 1% lidocaine, and the second group will be injected with 4ml of 0.9% saline. Injections will be repeated weekly for the first 4 weeks, then monthly. At the end of the 1st and 3rd months of the treatment, the patients will be evaluated in the routine outpatient clinic control, and the two groups will be compared statistically by questioning the frequency of pain, the number of attacks, the severity of pain (VAS), and the duration of pain.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Episodic Migraine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Injection into the sphenopalatine ganglion of the patients in both groups will be made by entering the arcus zygomaticum and oriented at a 45 degree angle towards the opposite tooth. Injections will be made with a dental injector. The first group will be injected with 4ml of 1% lidocaine, and the second group will be injected with 4ml of 0.9% saline. Injections will be repeated weekly for the first 4 weeks, then monthly. At the end of the 1st and 3rd months of the treatment, the patients will be evaluated in the routine outpatient clinic control, and the two groups will be compared statistically by questioning the frequency of pain, the number of attacks, the severity of pain (VAS), and the duration of pain.
    Masking
    ParticipantInvestigator
    Masking Description
    Double-blind placebo-controlled study
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    placebo arm
    Arm Type
    Placebo Comparator
    Arm Description
    Injection into the sphenopalatine ganglion of the patients in both groups will be made by entering the arcus zygomaticum and oriented at a 45 degree angle towards the opposite tooth. Injections will be made with a dental injector. Placebo group will be injected with 4ml of 0.9% saline. Injections will be repeated weekly for the first 4 weeks, then monthly. At the end of the 1st and 3rd months of the treatment, the patients will be evaluated in the routine outpatient clinic control, and the two groups will be compared statistically by questioning the frequency of pain, the number of attacks, the severity of pain (VAS), and the duration of pain.
    Arm Title
    lidocaine arm
    Arm Type
    Active Comparator
    Arm Description
    Injection into the sphenopalatine ganglion of the patients in both groups will be made by entering the arcus zygomaticum and oriented at a 45 degree angle towards the opposite tooth. Injections will be made with a dental injector. Lidocaine group will be injected with 4ml of 0.1%Lidocaine. Injections will be repeated weekly for the first 4 weeks, then monthly. At the end of the 1st and 3rd months of the treatment, the patients will be evaluated in the routine outpatient clinic control, and the two groups will be compared statistically by questioning the frequency of pain, the number of attacks, the severity of pain (VAS), and the duration of pain.
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine Hydrochloride 1% Solution for Injection_#2
    Intervention Description
    Injection into the sphenopalatine ganglion of the patients in both groups will be made by entering the arcus zygomaticum and oriented at a 45 degree angle towards the opposite tooth. Injections will be made with a dental injector. The first group will be injected with 4ml of 1% lidocaine. Injections will be repeated weekly for the first 4 weeks, then monthly. At the end of the 1st and 3rd months of the treatment, the patients will be evaluated in the routine outpatient clinic control, and the two groups will be compared statistically by questioning the frequency of pain, the number of attacks, the severity of pain (VAS), and the duration of pain.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Injection into the sphenopalatine ganglion of the patients in both groups will be made by entering the arcus zygomaticum and oriented at a 45 degree angle towards the opposite tooth. Injections will be made with a dental injector. The second group will be injected with 4ml of 0.9% saline. Injections will be repeated weekly for the first 4 weeks, then monthly. At the end of the 1st and 3rd months of the treatment, the patients will be evaluated in the routine outpatient clinic control, and the two groups will be compared statistically by questioning the frequency of pain, the number of attacks, the severity of pain (VAS), and the duration of pain.
    Primary Outcome Measure Information:
    Title
    Frequency and Pain Level of Migraines Post-Treatment
    Description
    The frequency and pain level of subjects' migraines will be assessed upon the conclusion of the study through surveying and comparing to previous survey data.
    Time Frame
    3-6 months after start

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Having a diagnosis of episodic migraine (according to ICD-III) Receiving any prophylaxis treatment in the last 3 months, Exclusion Criteria: Being pregnant and lactating Neurological and psychiatric conditions ( Contraindications to the use of local anesthetics Other chronic painful conditions, Having a history of malignancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    gökçe zeytin demiral
    Phone
    05547250675
    Email
    gokce_zeytin@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Sphenopalatine Ganglion Blockade in Migraine

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