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临床试验/NCT01811888
NCT01811888已完成不适用

Painful Knee Prosthesis. Relationship Between Endogenous Analgesia and Persistent Post Surgical Pain.

Parc de Salut Mar1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
180
试验地点
1
主要终点
Presence of pain in the operated knee, 6 months after surgery.

研究概览

简要总结

This is a prospective, observational study, aimed to establish the relationship between an inefficient endogenous pain modulation before surgery (total knee arthroplasty; TKA) and the probability to develop chronic pain after surgery (persistent post surgical pain). Endogenous analgesia efficiency will be measured during the month previous to surgery using quantitative sensory testing (QST). Persistent post surgical pain will be defined as presence of pain in movement greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Older than 18 patients
  • Scheduled for primary total knee arthroplasty
  • Disposition to visits and scheduled tests

排除标准

  • Previous surgery on knee to be operated
  • Documented peripheral neuropathy
  • Severe disease or condition that could potentially interfere with interpretation of tests.

结局指标

主要结局

Presence of pain in the operated knee, 6 months after surgery.

时间窗: Presence of pain greater than 3 points in a 0-10 numerical scale in the operated knee, 6 months after surgery.

次要结局

  • Endogenous Analgesia efficiency measured with QST (Quantitative sensory testing) techniques.(From start of recruitment untill day 180.)

研究者

发起方
Parc de Salut Mar
申办方类型
Other
责任方
Principal Investigator
主要研究者

CDursteler

MD

Parc de Salut Mar

研究点 (1)

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