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临床试验/NCT03409562
NCT03409562已完成不适用

Efficacy of Pain Neurophysiology Education in Combination With Motor Control Training for Patients With Unspecific Low Back Pain

Universidad Complutense de Madrid4 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2018年2月14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
62
试验地点
4
主要终点
Change in pain at different time points

研究概览

简要总结

The purpose of the present study is to evaluate whether the addition of two pain neurophysiology education sessions to motor control training may result in an improvement of the outcome measures of pain and disability, compared to motor control training alone.

详细描述

Sixty-two subjects with unspecific low-back pain were randomly recruited for the present study. The subjects were randomly allocated to a control group (which received only motor control training) and an intervention group (which underwent two pain neurophysiology education sessions prior to motor control training). Primary outcome measures were pain (measured with the Visual Analogical Scale) and disability (measured with the Oswestry Disability Index). Secondary outcome measures are kinesiophobia (Tampa Scale for Kinesiophobia), the global perceived effect (Global Perceived Effect Scale) and quality of life (SF-12). These will be measured before the intervention, at the end of the intervention, and 3 and 6 months after ending the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Unspecific low back pain for at least 3 months
  • Patients must be knowledgeable in the language in which the educational sessions will be provided (Spanish)

排除标准

  • Specific low back pain (e.g. infection, tumor, fracture, radiculopathy).
  • Signs and symptoms of neuropathic pain or generalized chronic pain.
  • History of lumbar or cervical spine surgery.
  • Pregnancy.
  • Concomitant pathologies that impede the performance of exercises.
  • Psychiatric treatment.

结局指标

主要结局

Change in pain at different time points

时间窗: Assessed before the intervention, at the end of the 4-week motor control intervention and 3 and 6 months after the end of the intervention

Visual Analogic Scale

Change in disability at different time points

时间窗: Assessed before the intervention, at the end of the 4-week motor control intervention and 3 and 6 months after the end of the intervention

Oswestry Disability Index

次要结局

  • Change in quality of life at different time points(Assessed before the intervention, at the end of the 4-week motor control intervention and 3 and 6 months after the end of the intervention)
  • Change in kinesiophobia at different time points(Assessed before the intervention, at the end of the 4-week intervention and 3 and 6 months after the end of the intervention)
  • Change in Global Perceived Effect at different time points(Assessed before the intervention, at the end of the 4-week motor control intervention and 3 and 6 months after the end of the intervention)

研究者

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

Gustavo Plaza Manzano

Director

Universidad Complutense de Madrid

研究点 (4)

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