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.
About The Expert
Nathaniel Katz
Robert H Dworkin
Richard North
Simon Thomson
Sam Eldabe
Salim M Hayek
Brian H Kopell
John Markman
Ali Rezai
Rod S Taylor
Dennis C Turk
Eric Buchser
Howard Fields
Gregory Fiore
McKenzie Ferguson
Jennifer Gewandter
Chris Hilker
Roshini Jain
Angela Leitner
John Loeser
Ewan McNicol
Turo Nurmikko
Jane Shipley
Rahul Singh
Andrea Trescot
Robert van Dongen
Lalit Venkatesan
References
PubMed