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Clinical, Morphological and Functional Success Predictors Following Lumbar Spinal Surgery in Patients With Chronic Low Back Pain and Degenerative Disorders.

21 de marzo de 2018 actualizado por: Meir Medical Center
The long term goal of this project is dual fold. First, the investigators wish to derive, validate and then test the impact of a clinical prediction rule to determine which patients who suffer from CLBP with degenerative changes of the lumbar spine and referred pain to the legs are likely to require surgery and have successful outcomes in the long term. Second, the investigators would like to establish robust methodology and statistical analysis guidelines for creating clinical prediction rules in physical therapy research. This observational cohort project is a first step towards those goals. Here the investigators specifically aim to identify personal, behavioral, psychological, morphological, and physical factors that can predict the need for surgery as well as level of participation restriction in patients who suffer from CLBP with degenerative conditions of the lumbar spine and referred pain to the legs. The investigators will also explore which parameters can predict success after 1 month, 6 and 12 months in patients who underwent decompression/fusion surgery.

Descripción general del estudio

Estado

Desconocido

Condiciones

Descripción detallada

A classification-based approach to identify specific characteristics of patients who seriously suffer from chronic low back pain (CLBP) with referred pain to the legs who are likely to respond to certain interventions has become a research priority in the medical milieu in general and in physical therapy in particularly.While several classifications have been developed to predict success following physical therapy interventions, some have methodological flaws and no clinical prediction rules have been created for patients with CLBP with degenerative changes of the lumbar spine and referred pain to the legs who are likely to require surgery and have successful outcome post-surgery. CLBP is multifactorial and morphological findings such as degenerative changes of the lumbar spine may not explain the phenomenon in full. The international classification of functioning, disability and health allows for a comprehensive description of the patient as a whole and can be used to classify patients according to their anatomy, pathology, impairments and capacity One-hundred and fifty patients who suffer from CLBP with degenerative conditions of the lumbar spine and referred pain to the legs and are candidates for lumbar decompression/fusion surgery will be recruited from a physician office at the Meir medical center, department of orthopaedic surgery, "Kfar-Saba", Israel. The structure and pathology of their lumbar spine will be analyzed in detail from CT and MRI imaging (morphological measurements of their vertebra and the intervertebral discs). Another one-hundred and fifty CT and MRI imaging of non symptomatic low back group will be taken from the "Meir medical center" in order to characterize the symptomatic group and their degenerative changes.

Tipo de estudio

De observación

Inscripción (Anticipado)

200

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.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Avihai Soroka, MscPT
  • Número de teléfono: 972-522982802
  • Correo electrónico: yossefm@post.tau.ac.il

Ubicaciones de estudio

      • Tel Aviv, Israel
        • Reclutamiento
        • Assuta hospital
        • Contacto:
          • Eli Ashkenazy, Dr.
          • Número de teléfono: 972-0546666008
          • Correo electrónico: ashkenazy@isc.co.il
        • Contacto:
        • Investigador principal:
          • Eli Ashkenazy, Dr.

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

40 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Participants with CLBP (>12 weeks) and degenerative changes of the lumbar spine confirmed by CT imaging who were recommended surgery and chose to undergo surgery will be recruited from the department of Orthopedic Surgery at the Meir Medical Center, Kfar-Saba, and in Assuta hospital, Tel Aviv, Israel. Included participants will be men or women, aged 40-80 years, of any race or ethnic background. Participants' diagnosis may include unstable degenerative spondylolisthesis, radicular pain, or documented stenosis with referred pain

Descripción

Inclusion Criteria:

  • Participants' diagnosis may include unstable degenerative spondylolisthesis, radicular pain, or documented stenosis with referred pain

Exclusion Criteria:

  • Psychiatric illness
  • Previous spine surgery
  • Painful arthritic hip
  • Hospitalization or surgery in the previous 6 months
  • Alcohol consumption > 10 drinks/week
  • Diabetes or other causes for poly neuropathy
  • Metabolic bone disease, tumor, spinal deformity or contraindications to MRI

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
CLBP and degenerative lumbar spine
Participants with CLBP (>12 weeks) and degenerative changes of the lumbar spine confirmed by CT imaging who were recommended surgery and chose to undergo surgery will be recruited from the department of Orthopedic Surgery at the Meir Medical Center, Kfar-Saba, Israel. Included participants will be men or women, aged 40-80 years, of any race or ethnic background. Participants' diagnosis may include unstable degenerative spondylolisthesis, radicular pain, or documented stenosis with referred pain.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The change in Oswestry Disability Index (ODI) score which is equal to or greater than 50% has been used consistently in Physical Therapy literature as the definition of success following an intervention
Periodo de tiempo: 6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op
6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op
The Roland Morris Disability Questionnaire (RMQ)
Periodo de tiempo: up to 1 year
Commonly used in CLBP research as measures of patients' participation restrictions
up to 1 year

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The Fear Avoidance Beliefs questionnaire (FABQ)
Periodo de tiempo: 6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op
The FABQ was found to be an important prognostic factor for work-related outcomes in patients with sub-acute LBP and a component of clinical predictors rules predicting changes in ODI following physical therapy interventions for patients with LBP
6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op
The International Physical Activity Questionnaire (IPAQ)
Periodo de tiempo: 6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op
The IPAQ was designed to provide a set of well-developed instruments that can be used internationally to obtain comparable estimates of physical activity
6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op
The Visual Analog Scale (VAS)
Periodo de tiempo: 6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op
The VAS is one of the most commonly used pain measures in CLBP research and has been shown to be reliable in this population
6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op
Lumbar myotomes function
Periodo de tiempo: 6 weeks pre-op, 6 months post op and 1 year post op
Will be taken by the Hand-held dynamometry (HHD) in order to assess the lower extremity muscle force output
6 weeks pre-op, 6 months post op and 1 year post op
The Long Distance Corridor Walk (LDCW)
Periodo de tiempo: 6 weeks pre-op, 6 months post op and 1 year
comprised of a 2 minute warm up and a 400 meter walk as fast as possible
6 weeks pre-op, 6 months post op and 1 year
The 8 foot up and go
Periodo de tiempo: 6 weeks pre-op, 6 months post op and 1 year
The 8-foot version of the Time-up-and-go test is part of the reliable and valid senior fitness test. Performance on the test indicates on sensory, motor, strength and balance function
6 weeks pre-op, 6 months post op and 1 year
The 30-seconds chair stand test
Periodo de tiempo: 6 weeks pre-op, 6 months post op and 1 year
for lower body strength
6 weeks pre-op, 6 months post op and 1 year
Grip strength
Periodo de tiempo: 6 weeks pre-op, 6 months post op and 1 year
Hand grip strength was found to be associated with changes in disability and pain following aquatic therapy in patients with CLBP
6 weeks pre-op, 6 months post op and 1 year
single leg stance test
Periodo de tiempo: 6 weeks pre-op, 6 months post op and 1 year
measures static balance
6 weeks pre-op, 6 months post op and 1 year
The four square step test
Periodo de tiempo: 6 weeks pre-op, 6 months post op and 1 year
measures dynamic balance
6 weeks pre-op, 6 months post op and 1 year
Passive straight leg raise (PSLR)
Periodo de tiempo: 6 weeks pre-op, 6 months post op and 1 year
Passive straight leg raise (PSLR) up to first sensation of pain will be measured with an inclinometer
6 weeks pre-op, 6 months post op and 1 year

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Morphological parameters
Periodo de tiempo: 6 weeks pre-op
morphological parameters in the lumbar spine will be analyzed from the CT imaging : a) Lumbar lordosis b) Sacral angle orientation, c) Pelvic tilt , d) Pelvis width e) Lumbar vertebral body and disc shape- the vertebral body and inter-vertebral disc lengths, widths, heights and wedging ,Lumbar vertebral arch shape
6 weeks pre-op

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Silla de estudio: Youssef Masharawi, DPT, Tel Aviv University

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

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 (Actual)

15 de junio de 2015

Finalización primaria (Anticipado)

1 de mayo de 2018

Finalización del estudio (Anticipado)

1 de diciembre de 2018

Fechas de registro del estudio

Enviado por primera vez

12 de mayo de 2015

Primero enviado que cumplió con los criterios de control de calidad

13 de mayo de 2015

Publicado por primera vez (Estimar)

14 de mayo de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de marzo de 2018

Última actualización enviada que cumplió con los criterios de control de calidad

21 de marzo de 2018

Última verificación

1 de marzo de 2018

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 0006-15-MMC

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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