Pain Management Commons^™

Drug-Free Noninvasive Thermal Nerve Block: Validation Of Sham Devices, Michael Fishman, Ahish Chitneni, Alaa Abd-Elsayed, Samuel Grodofsky, Ashley Scherer, Brendan Schetzner, Malvina Klusek, Stephen Popielarski, Stephen Meloni, Steven Falowski, Philip Kim, Konstantin Slavin, Stephen Silberstein

Department of Jefferson Headache Center papers and presentations

Headache is a leading cause of disability and suffering. One major challenge in developing device treatments is demonstrating their efficacy given devices' often-high placebo rate. This paper reviews the importance of validating sham devices as part of finalizing the design for larger-scale prospective randomized controlled trials in patients with chronic headache as well as the results of a prospective, single-blind trial to validate two potential sham noninvasive thermal nerve block devices. Study participants were trained to self-administer thermal nerve block treatment using sham devices in an office visit. Two different sham systems with different temperature profiles were assessed. Devices were …