Unique aspects of clinical trials of invasive therapies for chronic pain

Steven P Cohen; Mark Wallace; Richard L Rauck; Brett R Stacey

doi:10.1097/PR9.0000000000000687

Unique aspects of clinical trials of invasive therapies for chronic pain

Pain Rep. 2018 Sep 10;4(3):e687. doi: 10.1097/PR9.0000000000000687. eCollection 2019 May-Jun.

Authors

Steven P Cohen^{1

2}, Mark Wallace³, Richard L Rauck⁴, Brett R Stacey⁵

Affiliations

¹ Department of Anesthesiology, Johns Hopkins School of Medicine, Baltimore, MD, United States.
² Department of Anesthesiology, Walter Reed National Military Medical Center, Bethesda, MD, United States.
³ Division of Pain Medicine, Department of Anesthesiology, University of California San Diego, San Diego, CA, United States.
⁴ Center for Clinical Research, Carolinas Pain Institute, Wake Forest University, Winston-Salem, NC, United States.
⁵ University of Washington Center for Pain Relief, Department of Anesthesiology, University of Washington, Seattle, WA, United States.

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.

Keywords: Chronic pain; Clinical trial; Design; Invasive; Procedures.