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临床试验/NCT01299818
NCT01299818Unknown不适用

Assessment of Central Pain in Patients Who Undergo Spinal Surgery and Influence in Surgery Outcome

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
evaluation of surgery outcome including pain and functionnal ability

研究概览

简要总结

  • Pain is one of the most common concerns for which patients seek medical attention.
  • Pain is usually understood as symptom that reflects peripheral organic damage. Many patients experience pain, often chronically, independently of any underlying cause such as chronic regional pain syndromes (irritable bowel syndrome, temporo-mandibular pain syndrome, chronic headache or chronic low back pain)or diffuse like in fibromyalgia. In all those "functional" syndromes, accumulated evidence supports involvement of central pain processing systems, hypothalamic pituitary adrenal axes and autonomic nervous system, and are now referred as central pain conditions.
  • Other patients suffers from chronic pain caused by damage or inflammation in peripheral tissues, but also experienced more diffuse pain, not directly explained by peripheral damage, that further aggravates pain and function. This is illustrated by the high prevalence of fibromyalgia observed in patients with rheumatoid arthritis, osteoarthritis or ankylosing spondylitis for example.

These pain conditions are now understood as combinations of peripheral, neuropathic and central pain.

The investigators aimed to focus in this study in patients that are candidates to spinal surgery and suffer from low back pain and/or radiculopathy. Pain in these patients may arise from damage to nerves - neuropathic pain- , to musculoskeletal structures - peripheral pain-, and may also reflects alteration in central pain processes.

In these patients, spine surgery is usually performed to improve quality of life, decrease pain and avoid neurological deficits. Evaluation of surgical outcome includes objective measures such as neurological findings and radiographic evaluation, and subjective measures including patient self-assessments for pain and quality of life and psychological changes.

The aim of this study is to evaluate patients who undergo spinal surgery for presence of central pain and central sensitization symptoms and evaluate their influence on these surgical outcomes

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

  • candidates to spinal surgery attending the spine clinic
  • able to give inform consent

排除标准

  • pregnant women
  • children under 18
  • current infection in spine

结局指标

主要结局

evaluation of surgery outcome including pain and functionnal ability

时间窗: 3 months

evaluation of course of surgery, use of analgesics medications, report of pain intensity, length of hospital stay, questionnaires of health status and functionnal index, physical examination and dolorimetric evaluation

次要结局

未报告次要终点

研究者

申办方类型
Other Gov

研究点 (1)

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