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临床试验/NCT01726881
NCT01726881Unknown不适用

Predicting Central Pain Among People With a Spinal Cord Injury by Evaluating Mechanisms Regulating Pain and Efficacy Testing of the TENS Apparatus

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Sensitivity to thermic pain

研究概览

简要总结

People with a Spinal Cord Injury can develop chronic pain within months of the injury. Up to 80% of the patients will develop chronic pain called "central pain" and describe the pain as: burning, stabbing, or "like electricity." Central pain mechanism is unknown and therefore treatment is currently not effective.

It is hypothesized that chronic pain is associated with impaired function of the systems regulating pain, however, this hypothesis has not been tested among Spinal Cord Injury patients. Presence of such a connection, between the regulating system dysfunction and central pain, will help both predicting the risk of central pain and develop a treatment.

The current research objective is to make several sensory measurements which will measure the functioning mechanisms of regulation and control of the pain. These measurements are accepted throughout the world and are based on psychophysical assessment of patients. these Measurements are designed to assess whether Spinal Cord Injury chronic central pain patients demonstrate impairment in the regulation of pain. Finding such a link between central pain and impaired regulation could shed light on the mechanism of central pain. In addition, these measurements are designed to assess whether fresh spinal cord injury patients that have not yet developed central pain demonstrate impairment in the regulation of pain immediately after the injury. By repeated assessments of pain regulation capabilities, which will be made to fresh Spinal Cord Injury patients during the first months of injury, and comparing the results of these measurements between those who will develop center pain and those who will not, we could identify indicators for predicting the risk of central pain. Another goal of the study is to investigate the efficacy of central pain treatment, using a TENS, when the parameters of the TENS treatment will be built according to the level of functioning of the regulating systems of the individual.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • for all subjects:
  • age - 18-70
  • Cognitive status that allows voluntary cooperation understanding of instruction
  • for chronic Spinal Cord Injury subjects:
  • spinal cord injury (complete and incomplete)
  • height of injury - under 7th cervical vertebra
  • time since injury - one year or more.
  • for chronic Spinal Cord Injury subjects:
  • spinal cord injury (complete and incomplete)
  • height of injury - under under 7th cervical vertebra
  • time since injury - three weeks or less

排除标准

  • subjects suffering from the following conditions: pacemaker,pregnancy,cancer, tuberculosis, thrombosis, metallic implants
  • systemic diseases that affect the sensory perception (such as diabetes)
  • patients with other neurological pathologies (such as head injury-TBI)
  • Pregnancy

研究组 & 干预措施

Fresh Spinal Cord Injury patients

Experimental

Spinal Cord Injury patients that are currently admitted to the rehabilitation unit with three weeks or less since injury that will over go several tests and will fill out several questionnaires.

干预措施: Thermal stimulation (Device)

Fresh Spinal Cord Injury patients

Experimental

Spinal Cord Injury patients that are currently admitted to the rehabilitation unit with three weeks or less since injury that will over go several tests and will fill out several questionnaires.

干预措施: Mechanical stimulation (Device)

Chronic Spinal Cord Injury patients

Experimental

Spinal Cord Injury patients with one year or more since injury that will over go several tests and will fill out several questionnaires

干预措施: Thermal stimulation (Device)

Chronic Spinal Cord Injury patients

Experimental

Spinal Cord Injury patients with one year or more since injury that will over go several tests and will fill out several questionnaires

干预措施: Mechanical stimulation (Device)

Chronic Spinal Cord Injury patients

Experimental

Spinal Cord Injury patients with one year or more since injury that will over go several tests and will fill out several questionnaires

干预措施: Transcutaneous Electrical Nerve Stimulator (TENS) (Device)

Healthy volunteers

Active Comparator

Healthy subjects that will over go several tests and will fill out several questionnaires

干预措施: Thermal stimulation (Device)

Healthy volunteers

Active Comparator

Healthy subjects that will over go several tests and will fill out several questionnaires

干预措施: Mechanical stimulation (Device)

结局指标

主要结局

Sensitivity to thermic pain

时间窗: 5 minutes

Minimum temperature at which the patient reported pain. The subject will press a button once feeling pain. pain will be reported using a visual analog scale - a pain scale between 1-10.

Temporal summation of pain

时间窗: 5 minutes

Standard rating of pain among several stimuli. pain will be reported using a visual analog scale - a pain scale between 1-10.

Pain suppression capability

时间窗: 5 minutes

Reduction of pain in the presence of another stimulus. pain will be reported using a visual analog scale - a pain scale between 1-10.

Habituation to tonic stimulation

时间窗: 5 minutes

Gradient decrease in pain rating. pain will be reported using a visual analog scale - a pain scale between 1-10.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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