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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Jefferson Headache Center/Thomas Jefferson University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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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Comparador de placebos: saline
matching volume of saline injected
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matching volume of saline (placebo)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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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.
Periodo de tiempo: 30 minutes
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30 minutes
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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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;
Periodo de tiempo: 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.
Periodo de tiempo: 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;
Periodo de tiempo: 30 minutes
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30 minutes
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: William B Young, M.D., Jefferson Headache Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Trastornos de cefalea primaria
- Trastornos de dolor de cabeza
- Trastornos de migraña
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antiarrítmicos
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Agentes del sistema sensorial
- Anestésicos
- Moduladores de transporte de membrana
- Anestésicos Locales
- Bloqueadores de canales de sodio activados por voltaje
- Bloqueadores de canales de sodio
- Lidocaína
- Bupivacaína
Otros números de identificación del estudio
- GON-DBPC/WBY
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