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临床试验/NCT01359514
NCT01359514已完成不适用

Mechanism-based Choice of Therapy for Neuropathic Pain: Can Treatments Success in Neuropathic Post-operative Pain be Coupled to Psychophysical Pain Modulation Profile?

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
clinical pain

研究概览

简要总结

Mechanism-based choice of therapy for neuropathic pain:

Can treatments success in neuropathic post-operative pain be coupled to psychophysical pain modulation profile?

详细描述

Neuropathic or idiopathic pain patients will be assessed with the variety of pain tests including the conditioned pain modulation (CPM) and temporal summation (TS). Then, they will be offered on the double-blind design a several weeks treatment with either pregabalin or duloxetine. Patients will be followed-up weekly by phone for their pain relief and will be re-assessed in the lab toward the end of the treatment. The investigators suggest that patients with less-efficient CPM (deficient pain inhibition) will "earn" more pain relief from the treatment with duloxetine, while the patients with the enhanced pain summation will response better to pregabalin.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients planned for thoracotomy

排除标准

  • age below 18 and above 75 years
  • patients with psychiatric or cognitive dysfunction precluding use of psychophysics
  • those who cannot communicate in Hebrew
  • patients with existing thoracic or other current chronic pain

研究组 & 干预措施

Duloxetine

Active Comparator

干预措施: Pregabalin (Drug)

Pregabalin

Active Comparator

干预措施: Duloxetine (Drug)

结局指标

主要结局

clinical pain

时间窗: One year

The pain relief will be achieved by treatment with duloxetine or pregabalin. We propose that the patients with deficient pain inhibition (As assessed by conditioned pain modulation lab test) will have better drug efficacy of cymbalta which restores the deficient level of serotonin and noradrenalin. In turn, pregabalin will be more effective in patients with enhance central sensitization of pain as measured by temporal summation assessment. In line, CPM and TS will be modulated by the treatment, in parallel with the analgesic effect.

次要结局

未报告次要终点

研究者

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

d_yarnitsky

Head of Neurology Department

Rambam Health Care Campus

研究点 (1)

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