Study of Low Back Pain Using CERSR® Imaging Technology
29 de julho de 2011 atualizado 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.
Visão geral do estudo
Descrição detalhada
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 estudo
Observacional
Inscrição (Antecipado)
290
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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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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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 70 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline in Pain Visual Analog Scale
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from Baseline Oswestry Disability Index (ODI)
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Nilesh Shah, M.D., Summa Health Systems
Publicações e links úteis
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Publicações Gerais
- 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
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de maio de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
29 de março de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de julho de 2011
Primeira postagem (Estimativa)
25 de julho de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
1 de agosto de 2011
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de julho de 2011
Última verificação
1 de julho de 2011
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- SMI-2010-002
- RP# 11002 (Outro identificador: Summa Health Systems IRB)
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