Research design considerations for randomized controlled trials of spinal cord stimulation for pain: IMMPACT/ION/INS recommendations

Katz, N. et al. (2021) Research design considerations for randomized controlled trials of spinal cord stimulation for pain: IMMPACT/ION/INS recommendations. Pain, 162(7), pp. 1935-1956. (doi: 10.1097/j.pain.0000000000002204) (PMID:33470748) (PMCID:PMC8208090)

Abstract

Spinal cord stimulation (SCS) is an interventional non-pharmacologic treatment used for chronic pain and other indications. Methods for evaluating the safety and efficacy of SCS have evolved from uncontrolled and retrospective studies to prospective randomized controlled trials (RCTs). While randomization overcomes certain types of bias, additional challenges to the validity of RCTs of SCS include blinding, choice of control groups, non-specific effects of treatment variables (e.g., paresthesia, device programming and recharging, psychological support, and rehabilitative techniques), and safety considerations. In order to address these challenges, three professional societies (IMMPACT, ION, INS) convened a meeting to develop consensus recommendations on the design, conduct, analysis, and interpretation of RCTs of SCS for chronic pain. This paper summarizes the results of this meeting. Highlights of our recommendations include disclosing all funding source and potential conflicts; incorporating mechanistic objectives when possible; avoiding non-inferiority designs without internal demonstration of assay sensitivity; achieving and documenting double-blinding whenever possible; documenting investigator and site experience; keeping all information provided to patients balanced with respect to expectation of benefit; disclosing all information provided to patients, including verbal scripts; using placebo/sham controls when possible; capturing a complete set of outcome assessments; accounting for ancillary pharmacologic and non-pharmacologic treatments in a clear manner; providing a complete description of intended and actual programming interactions; making a prospective ascertainment of SCS-specific safety outcomes; training patients and researchers on appropriate expectations, outcome assessments, and other key aspects of study performance; and providing transparent and complete reporting of results according to applicable reporting guidelines.

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Taylor, Professor Rod
• Authors: Katz, N., Dworkin, R. H., North, R., Thomson, S., Eldabe, S., Hayek, S. M., Kopell, B. H., Markman, J., Rezai, A., Taylor, R. S., Turk, D. C., Buchser, E., Fields, H., Fiore, G., Ferguson, M., Gewandter, J., Hilker, C., Jain, R., Leitner, A., Loeser, J., McNicol, E., Nurmikko, T., Shipley, J., Singh, R., Trescot, A., van Dongen, R., and Venkatesan, L.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > MRC/CSO SPHSU
• Journal Name: Pain
• Publisher: Lippincott, Williams & Wilkins
• ISSN: 0304-3959
• ISSN (Online): 1872-6623
• Published Online: 18 January 2021
• Copyright Holders: Copyright © 2021 The Authors
• First Published: First published in Pain 162(7): 1935-1956
• Publisher Policy: Reproduced under a Creative Commons license