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临床试验/NCT03832036
NCT03832036已完成不适用

The Diagnostic and Prognostic Value of Two Quantitative Clinical Tests in Patients

Spine Centre of Southern Denmark2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2018年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
102
试验地点
2
主要终点
The diagnostic value of Paraspinal Mapping and Quantitative Sensory Pain Testing

研究概览

简要总结

This study will investigate whether two clinical tests can be used to diagnose and predict the outcome in patients with lumbar disc herniation undergoing surgery and non-surgery treatment.

The two quantitative clinical tests include: electromyographic measurements using Paraspinal Mapping and pain responses using Quantitative Sensory Pain Testing.

详细描述

150 patients will be included for the prospective cohort study. Patients will be recruited from the Region of Southern Denmark and Capital Region. Participants will undergo MRI scanning of the lumbar spine, fillout a questionnaire and undergo assessment with the two clinical tests. An 8-week follow-up will be made with patients completing a questionnaire. The two quantitative clinical tests include: electromyographic measurements using Paraspinal Mapping and pain responses using Quantitative Sensory Pain Testing.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Clinical and radiologically diagnosed lumbar disc herniation.
  • Low back pain with pain below the knee or anterior thigh pain in one or both legs.
  • Dermatomal leg pain.
  • Average pain intensity of 3 or more on a Numerical Rating Scale (0-10 NRS).

排除标准

  • History of previous lumbar spine surgery.
  • Surgery in general in the past 4 months.
  • Current use of anticoagulants.
  • Diagnoses which could confound with the diagnosis e.g. lumbar spinal stenosis, local muscle trauma, cancer metastases, fibromyalgia, neuropathy.

结局指标

主要结局

The diagnostic value of Paraspinal Mapping and Quantitative Sensory Pain Testing

时间窗: 8 week follow-up

次要结局

未报告次要终点

研究者

发起方
Spine Centre of Southern Denmark
申办方类型
Other
责任方
Sponsor

研究点 (2)

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