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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01515540
Brain Imaging of Lidoderm for Chronic Back Pain
Descripción general del estudio
Descripción detallada
Previous data showed that Lidoderm patches that contain 5% Lidocaine applied to the affected area for a period of 1-2 weeks decreased chronic pain. We conducted a preliminary open-label trial in chronic back pain patients and found that the patients reported reduction in pain intensity and associated brain activity (measured with fMRI). As a next step, we conducted a double blind clinical trial where the drug was tested against placebo to determine whether the effects on CBP were mediated by a pharmacological mechanism. For this we obtained psychophysical measurements of pain and measures of brain activity using fMRI. Two scans after treatment (6 hour and 2 weeks after treatment) were conducted to observe the effects of short term and long term use.
Brain activity was measured by the non-invasive method of functional imaging (fMRI), which enables examination of cortical blood flow during pain rating. These brain scans were acquired in chronic back pain patients while they rated their ongoing chronic pain using a finger span device. In a control task, each patient also rated the changes in the length of a bar n a screen (a visual control task). Anatomical scans were also acquired.
The general design of the study was that CBP subjects were assesses with fmri for brain responses for ongoing pain at three time points. The initial (baseline) scan occurred after a minimum of 48 hour period during which the patients refrained from taking analgesic medication. The patients were next scanned at 6 hours after treatment and again after 2 weeks of continuous treatment. Subjects were randomised to placebo or Lidoderm (both Lidoderm and placebo patches were supplied by Endo Pharmaceuticals).
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern 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:
- Male or Female 18 years or older of age
- Pain in the location of the lower back
- Pain duration for a minimum of 6 months on a continuous basis
- Pain intensity of at least 3 out of 10 on most days of the week over the past six months
- Manifestations of radicular element of pain: radiation below knee (examples towards thigh, buttocks).
- Right handedness
Exclusion Criteria:
- Applying for or currently receiving workers' compensation or disability status.
- Back pain secondary to spinal cord injury
- Back pain secondary to any systemic condition (e.g ankylosing spondylitis0
- Diabetes mellitus
- Back pain secondary to tumors.
- Standard MRI criteria re: claustrophobia, metal objects etc.
- Subjects with cognitive deficits such as dementia, psychiatric illness including depression with a BDI score of more than 19 (moderate to severe depression), history of brain injury, history of chronic disease
- Pregnant and/or lactating women
- Left handedness
- Active cancer
- Other serious painful condition (e.g., arthritis)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: lidocaine
5% lidoderm patch
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5% lidoderm patch
Otros nombres:
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Comparador de placebos: control
placebo patch
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placebo
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pain Intensity on a Visual Analog Scale (VAS) The Scale Had Values From 0-100, Where 0 Represents "no Pain" and 100 Was the "Worst Pain Imaginable".
Periodo de tiempo: 2 weeks
|
the primary hypothesis was that the lidoderm 5% patch was expected to decrease pain intensity post treatment greater than placebo patch. A lower value on the 0-100 scale is considered to represent less pain. Higher values represent more pain. Greater than 20%-30% decrease in pain is considered clinically meaningful. |
2 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Apkar V. Apkarian, PhD, Northwestern University
Publicaciones y enlaces útiles
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
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Dolor de espalda
- Lumbalgia
- 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
Otros números de identificación del estudio
- STU00022968
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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