- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01401660
Study of Low Back Pain Using CERSR® Imaging Technology
29 de julio de 2011 actualizado por: Verium Diagnostics, Inc.
Observational Study of the Electrophysiological Course of Low Back Pain Using CERSR® Imaging Technology
The purpose of this research study is to measure with CERSR® (Computerized Electrophysiological Reconstruction of the Spinal Regions) the electrical signals made by the muscles in the lower back 1) when the subject has no low back pain 2) during the time low back pain begins, or 3) during the treatment and resolution of the low back pain, and 4) to study the changes which take place in these muscles as the pain improves with physical therapy treatment as an intervention.
The hypotheses to be tested are 1) The CERSR® scan parameters for normal (pain-free) subjects are different from those of subjects with low back pain.
2) CERSR® scan aids the physician in determining a directed physical therapy treatment which leads to relief of low back pain following no more than eight weeks of physical therapy, as measured by relief of pain using a Visual Analog Scale and symptom improvement as measured using the Oswestry Disability Index.
Descripción general del estudio
Descripción detallada
The purpose of this research study is to measure with CERSR® (Computerized Electrophysiological Reconstruction of the Spinal Regions) the electrical signals made by the muscles in the lower back 1) when the subject has no low back pain 2) during the time low back pain begins, or 3) during the treatment and resolution of the low back pain, and 4) to study the changes which take place in these muscles as the pain improves with physical therapy treatment as an intervention.
The hypotheses to be tested are 1) The CERSR® scan parameters for normal (pain-free) subjects are different from those of subjects with low back pain.
2) CERSR® scan aids the physician in determining a directed physical therapy treatment which leads to relief of low back pain following no more than eight weeks of physical therapy, as measured by relief of pain using a Visual Analog Scale and symptom improvement as measured using the Oswestry Disability Index.
Tipo de estudio
De observación
Inscripción (Anticipado)
290
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Ohio
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Akron, Ohio, Estados Unidos, 44304-1619
- Summa Center for Clinical Trials
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Akron, Ohio, Estados Unidos, 44310-3110
- Summa St. Thomas Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
The subjects will be selected from employees of Summa Health System.
Current employees as well as new hires will be eligible to participate in the study.
Descripción
Inclusion Criteria Groups A, B and C:
- Male and female employees of the study center.
- Between the ages of 18 and 70 years.
- Current employees as well as new hires.
Exclusion Criteria Group A:
1. Low back pain.
Exclusion Criteria Group B:
- Low back pain due to fracture, tumor, infection, cauda equina, severe neurological deficit.
- Pregnant.
- Sensitivity to isopropyl alcohol used to prepare the low back surface.
- Inability to complete the required collection positions for the CERSR® scan.
- Inability or unwillingness to adhere to the protocol and follow-up schedule.
- Anyone under care of a physician for active liability or workman compensation cases.
- Anyone who has had an open spinal procedure in the last three months.
- Anyone who has undergone spine injections within the last two months.
Exclusion Criteria Group C:
- Low back pain due to fracture, tumor, infection, cauda equina, severe neurological deficit
- Pregnant.
- Sensitivity to isopropyl alcohol used to prepare the low back surface.
- Inability to complete the required collection positions for the CERSR scan.
- Inability or unwillingness to adhere to the protocol and follow-up schedule.
- Anyone under care of a physician for active liability or workman compensation cases.
- Anyone who has had an open spinal procedure in the last three months.
- Anyone who has undergone spine injections within the last two months.
- Anyone who is currently undergoing physical therapy or chiropractic treatments.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Group A
Subjects who do not currently have low back pain.
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Group B
Subjects who have low back pain at the time of the study, and who are currently being treated or have been previously treated for their low back pain and do not wish to receive further treatment for their pain.
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Group C
Subjects who have low back pain at the time of the study, and wish to receive physical therapy to reduce their low back pain.
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The physician will complete a physical exam as well as analyze a completed CERSR® scan study to determine the root cause of the low back pain.
The physician will then prescribe a targeted physical therapy regime to address the cause of the low back pain.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from Baseline in Pain Visual Analog Scale
Periodo de tiempo: Upon enrollment (day 1 - baseline) and four weeks and eight weeks
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The subjects will complete a form indicating their pain level upon enrollment.
Subjects will then be scanned again at four weeks and at eight weeks.
At the time of the scan subjects will also be asked to complete a follow up VAS.
Upon completion of the study the change in VAS scores will be analyzed.
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Upon enrollment (day 1 - baseline) and four weeks and eight weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from Baseline Oswestry Disability Index (ODI)
Periodo de tiempo: Upon enrollment (day 1 - baseline) and at four weeks and at eight weeks
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The subjects will complete the Oswestry Disability Index upon enrollment.
Subjects will then be scanned again at four weeks and at eight weeks.
At the time of the scan subjects will also be asked to complete a follow up ODI.
Upon completion of the study the change in ODI scores will be analyzed.
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Upon enrollment (day 1 - baseline) and at four weeks and at eight weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Nilesh Shah, M.D., Summa Health Systems
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Finneran MT, Mazanec D, Marsolais ME, Marsolais EB, Pease WS. Large-array surface electromyography in low back pain: a pilot study. Spine (Phila Pa 1976). 2003 Jul 1;28(13):1447-54. doi: 10.1097/01.BRS.0000067565.16832.B9.
- Pease WS, Clairmont AC, Finneran MT. High resolution large-array surface electromyography in acute low back pain. White Paper
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de mayo de 2011
Fechas de registro del estudio
Enviado por primera vez
29 de marzo de 2011
Primero enviado que cumplió con los criterios de control de calidad
21 de julio de 2011
Publicado por primera vez (Estimar)
25 de julio de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
1 de agosto de 2011
Última actualización enviada que cumplió con los criterios de control de calidad
29 de julio de 2011
Última verificación
1 de julio de 2011
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SMI-2010-002
- RP# 11002 (Otro identificador: Summa Health Systems IRB)
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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