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临床试验/NCT04974229
NCT04974229已完成不适用

Sensory Profiles as Predictors of Central Sensitization in Low Back Pain: A Prospective Cohort Study.

Vrije Universiteit Brussel1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
1
主要终点
Central Sensitization Inventory score

研究概览

简要总结

A longitudinal observational cohort study to investigate the value of prognostic factors, here sensory profiles , and others, in the development of central sensitization in the low back pain population. A type 2 prognostic factor research following the PROGRESS framework. Sensory profiles are identified a prognostic factors which can predict the development of central sensitization in the low back pain population.

详细描述

After performing an univariable linear regression analyses the regression model predicts the dependent variable, central sensitization, significantly, and the models are significant prediction factors of the development of central sensitization. In unadjusted analyses, all four sensory profiles were significantly associated with the development of central sensitization (P<0.001).

After adjusting for pain, disability, age, and duration of low back pain, baseline sensory profiles remained significant predictors of central sensitization. On the other hand, all other predictor variables did not contribute to the prediction of central sensitization.

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
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • acute low back pain (< 6 weeks)
  • with or without radiating pain
  • aged 18 to 60 years
  • a pain-free episode for at least 3 months before the onset of their current back pain
  • read and understand the Dutch language.

排除标准

  • previous lumbar spinal surgery
  • lumbar radicular syndrome
  • specific cause of low back pain
  • lumbar spinal stenosis
  • current malignancy
  • spondyloarthropathy
  • osteoporosis
  • spondylolisthesis
  • major trauma
  • infection
  • systemic disease.

结局指标

主要结局

Central Sensitization Inventory score

时间窗: 12 weeks

The validated questionnaire Central Sensitization Inventory which scores on a 5 point scale ranging from 0-100. A higher score indicated a higher degree of central sensitization.

Adolescent/Adult Sensory Profile score

时间窗: 0 weeks

Adolescent/Adult Sensory Profile measures 4 sensory profiles (sensation avoiding, sensation sensitive, sensation seeking, low registration) on ad 5 point scale, and is validated in the low back pain population. Scores range from 15-60 points per variable. A higher score means a higher degree of sensitivity for the specific sensory profile.

次要结局

  • Numeric Pain Rating Scale score(Baseline (0 weeks))
  • Pain Disability Index score(Baseline (0 weeks))
  • age(Baseline (0 weeks))
  • duration of low back pain(Baseline (0 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pieter Graper

Principal Investigator

Vrije Universiteit Brussel

研究点 (1)

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