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Papers: 16 Jan 2021 - 22 Jan 2021

2021 Jan 18


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


Katz N, Dworkin RH, North R, Thomson S, Eldabe S, Hayek SM, Kopell BH, Markman J, Rezai A, Taylor RS, Turk DC, Buchser E, Fields H, Fiore G, Ferguson MK, Gewandter J, Hilker C, Jain R, Leitner A, Loeser J, et al.
Pain. 2021 Jan 18.
PMID: 33470748.


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.