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临床试验/DRKS00015109
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A test procedure for the evaluation of cortical somatosensory evoked potentials as a measure of cortical excitability in people with chronic low back pain: an explorative study

Hochschule für Gesundheit Bochum0 个研究点目标入组 30 人开始时间: 2018年8月1日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
30

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
N/a: Single Arm Study
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 50 Years(—)
性别
All

入选标准

  • Age:=18 years and = 50 years
  • Sufficient cognitive and German language skills/ability to understand both oral and written instructions and to give informed consent.
  • Intact skin on the lower back region.
  • Successful thermal skin sensation test of either feet
  • Diagnosis: CLBP with or without leg pain. For those with leg pain the back pain will have to be more dominant and the leg pain should not spread beyond the knee
  • Duration of symptoms: = 6 months

排除标准

  • ‘Red flags’ indicating serious spinal or peripheral nerve root pathologies or signs of malignancy, fracture, infection, inflammatory joint or bone disease
  • any condition affecting sensation in the regions served by the sural nerve (bilaterally)
  • previous surgery with metal implants in the trunk, pelvis or lower limbs
  • pregnancy (Stöhr et al., 2013)
  • heart pacemaker (Stöhr et al., 2013)
  • Allergy to disinfection spray (Octenisept, Schuelke, Germany), skin preparation paste (Skin Pure Fo20, Nihon Kohden, Tokyo, Japan), adhesive conductive paste (Elefix F509, Nihon Kohden, Tokyo, Japan), shampoo (Sebamed Trockene Haut Pflege Shampoo, Sebapharma GmbH & Co.KG, Germany) skin cream (Sebamed Lotion, Sebapharma GmbH & Co.KG, Germany)
  • Communicable foot condition
  • Current or history of altered thermal sensation of either foot
  • Unsuccessful thermal skin sensation test of the foot

研究者

发起方
Hochschule für Gesundheit Bochum

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