Research Study of Greater Occipital Nerve Block As A Treatment For Prolonged Migraine Attacks
Double-Blind, Placebo Controlled Trial Of Greater Occipital Nerve Block For The Treatment Of Migraine Status
Greater Occipital Nerve Blocks (GONB) are a common procedure used for the treatment of headache. The GONB procedure involves a series of injections into the greater occipital nerve (a spinal nerve located at the back of your head). The purpose of this study is to determine whether GONB is effective for the treatment of prolonged migraine attacks. This study is placebo controlled, which means that half of the patients participating will receive injections of active study drug (lidocaine plus bupivicaine) and half of the patients will receive injections of saline (placebo). The study is also blinded which means that neither you nor the study staff will know whether you received active study drug or placebo. The study remains blinded only for the first 30 minutes, at which point additional treatments (including GONB) can be administered at the discretion of your treating physician.
40 patients are expected to participate in this research study. This study is being conducted at Thomas Jefferson University only.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19107
- Jefferson Headache Center/Thomas Jefferson University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Subjects, male or female, between the ages of 18 and 80 years old (inclusive) with a previous diagnosis fulfilling IHS criteria for episodic migraine
- Presenting to clinic in migraine status, meaning the migraine has continued for greater than or equal to 3 days but less than 3 months.
- Pain must be reported as at least moderate pain level at time of injections
Exclusion Criteria:
A subject is ineligible to participate in this study if he/she satisfies any of the following criteria:
- Subjects who have received greater occipital nerve blocks in the past
- Subjects who in their own or the investigator's opinion are unable to describe their symptoms
- Subjects who are pregnant or lactating
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Lidocaine/Bupivicaine
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The injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion.
If the subject has a bilateral headache or the headache is known to switch sides then the block will be performed bilaterally.
If the headache is strictly unilateral, the block will be performed only on the side of the headache
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Placebo-vergelijker: saline
matching volume of saline injected
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matching volume of saline (placebo)
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Percentage of Patients Experiencing Significant Change on a 4 Point Pain Scale at 30 Minutes Post-injection, Active Drug Versus Placebo. Significant Change is Defined as a Change on the 4 Point Pain Scale From Moderate or Severe to Mild. No Pain Equals 0.
Tijdsspanne: 30 minutes
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30 minutes
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Secondary Measures Include:Percentage of Subjects Achieving a Significant Change on a 10 Point Pain Scale at 30 Minutes Post-injection, Active Drug Versus Placebo;
Tijdsspanne: 30 minutes
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30 minutes
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Percentage of Subjects Achieving a Significant Change on a 100mm Visual Analogue Scale (VAS) at 30 Minutes Post-injection, Active Drug Versus Placebo. Significant Change is Defined as a Greater Than or Equal to 2cm Change.
Tijdsspanne: 30 minutes
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30 minutes
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Percentage of Subjects Achieving Resolution of Associated Symptoms of Nausea, Vomiting, Photophobia, Phonophobia, Osmophobia, Allodynia Measured During the First 30 Minutes Post-injection, Active Drug Versus Placebo;
Tijdsspanne: 30 minutes
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30 minutes
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: William B Young, M.D., Jefferson Headache Center
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Hersenziekten
- Ziekten van het centrale zenuwstelsel
- Ziekten van het zenuwstelsel
- Hoofdpijnaandoeningen, primair
- Hoofdpijn aandoeningen
- Migraine-stoornissen
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Middelen tegen aritmie
- Depressiva van het centrale zenuwstelsel
- Agenten van het perifere zenuwstelsel
- Sensorische systeemagenten
- Anesthesie
- Membraantransportmodulatoren
- Anesthesie, lokaal
- Spanningsafhankelijke natriumkanaalblokkers
- Natriumkanaalblokkers
- Lidocaïne
- Bupivacaine
Andere studie-ID-nummers
- GON-DBPC/WBY
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