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临床试验/NCT02180880
NCT02180880已完成4 期

Symptom-Based Treatment for Neuropathic Pain in Spinal Cord Injured Patients, Randomized Clinical Trial

Ju Seok Ryu1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2012年11月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
63
试验地点
1
主要终点
Symptom based treatment of neuropathic pain

研究概览

简要总结

  1. Neuropathic pain in spinal cord injured patients

  2. Inclusion criteria

  • pain intensity, visual analogue scale > 3
  • a LANSS (Leeds assessment of neuropathic symptoms and signs) score of 12 and above
  • aged ≥20
  1. Method
  • Stop pain medications
  • Test oxcarbazepine (150mg twice daily) and pregabalin (150mg twice daily)
  • Check pain intensity (VAS score) with Baron's classification

详细描述

In the present study, pharmacologic treatment included pregabalin and oxcarbazepine.

Stop medications such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), tramadol and anti-spastic drugs (baclofen, tizanidine) and other medications known to have effect on pain and the central nervous system prior to the study for at least 3 days.

  1. Pain intensity (VAS score)

  2. 4 spontaneous characters

  • electric
  • burning
  • pricking
  • numbness
  1. evoked pain

研究设计

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

入排标准

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

入选标准

  • aged than 20 years
  • Neuropathic pain symptoms : LANSS (Leeds assessment of neuropathic symptoms and signs) score of 12 and above
  • Visual analogue scale score of 3 and above

排除标准

  • No pregnancy
  • systemic disease
  • psychiatric disease

研究组 & 干预措施

Pregabalin and Oxcarbazpepine

Experimental

Pregabalin and Oxcarbazepine

干预措施: Pregabalin and Oxcarbazepine (Drug)

结局指标

主要结局

Symptom based treatment of neuropathic pain

时间窗: 2 week later

Pain intensity using Visual analogue scale (0\~100)

次要结局

未报告次要终点

研究者

发起方
Ju Seok Ryu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ju Seok Ryu

Assistant professor

CHA University

研究点 (1)

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