慢性疼痛侵入性治疗临床试验的独特方面。
Unique aspects of clinical trials of invasive therapies for chronic pain.
作者信息
Cohen Steven P, Wallace Mark, Rauck Richard L, Stacey Brett R
机构信息
Department of Anesthesiology, Johns Hopkins School of Medicine, Baltimore, MD, United States.
Department of Anesthesiology, Walter Reed National Military Medical Center, Bethesda, MD, United States.
出版信息
Pain Rep. 2018 Sep 10;4(3):e687. doi: 10.1097/PR9.0000000000000687. eCollection 2019 May-Jun.
Abstract
Nearly all who review the literature conclude that the role of invasive procedures to treat chronic pain is poorly characterized because of the lack of "definitive" studies. The overt nature of invasive treatments, along with the risks, technical skills, and costs involved create challenges to study them. However, these challenges do not completely preclude evaluating invasive procedure effectiveness and safety using well-designed methods. This article reviews the challenges of studying outcomes of invasive therapies to treat pain and discuss possible solutions. Although the following discussion can apply to most invasive therapies to treat chronic pain, it is beyond the scope of the article to individually cover every invasive therapy used. Therefore, most of the examples focus on injection therapies to treat spine pain, spinal cord stimulation, and intrathecal drug therapies.
摘要
几乎所有查阅文献的人都得出结论，由于缺乏“确定性”研究，侵入性程序治疗慢性疼痛的作用难以确切描述。侵入性治疗的明显性质，以及所涉及的风险、技术技能和成本，给研究它们带来了挑战。然而，这些挑战并不能完全排除使用精心设计的方法来评估侵入性程序的有效性和安全性。本文回顾了研究侵入性疼痛治疗结果的挑战，并讨论了可能的解决方案。尽管以下讨论适用于大多数治疗慢性疼痛的侵入性疗法，但单独涵盖每种使用的侵入性疗法超出了本文的范围。因此，大多数例子集中在治疗脊柱疼痛的注射疗法、脊髓刺激和鞘内药物疗法上。
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