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临床试验/NCT02444702
NCT02444702Unknown不适用

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

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2015年6月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
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

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op

The Roland Morris Disability Questionnaire (RMQ)

时间窗: up to 1 year

Commonly used in CLBP research as measures of patients' participation restrictions

次要结局

  • Lumbar myotomes function(6 weeks pre-op, 6 months post op and 1 year post op)
  • The International Physical Activity Questionnaire (IPAQ)(6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op)
  • The Long Distance Corridor Walk (LDCW)(6 weeks pre-op, 6 months post op and 1 year)
  • The 30-seconds chair stand test(6 weeks pre-op, 6 months post op and 1 year)
  • The four square step test(6 weeks pre-op, 6 months post op and 1 year)
  • Passive straight leg raise (PSLR)(6 weeks pre-op, 6 months post op and 1 year)
  • The Fear Avoidance Beliefs questionnaire (FABQ)(6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op)
  • The Visual Analog Scale (VAS)(6 weeks pre-op, 1 month post op, 6 months post op and 1 year post op)
  • The 8 foot up and go(6 weeks pre-op, 6 months post op and 1 year)
  • Grip strength(6 weeks pre-op, 6 months post op and 1 year)
  • single leg stance test(6 weeks pre-op, 6 months post op and 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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