Abstract

BackgroundSelf-reported pain levels, while easily measured, are often not reliable for quantifying pain. More objective methods are needed that supplement self-report without adding undue burden or cost to a study. Methods that integrate multiple measures, such as combining self-report with physiology in a structured and specific-to-pain protocol may improve measures.MethodWe propose and study a novel measure that combines the timing of the peak pain measured by an electronic visual-analog-scale (eVAS) with continuously-measured changes in electrodermal activity (EDA), a physiological measure quantifying sympathetic nervous system activity that is easily recorded with a skin-surface sensor. The new pain measure isolates and specifically quantifies three temporal regions of dynamic pain experience: I. Anticipation preceding the onset of a pain stimulus, II. Response rising to the level of peak pain, and III. Recovery from the peak pain level. We evaluate the measure across two pain models (cold pressor, capsaicin), and four types of treatments (none, A=pregabalin, B=oxycodone, C=placebo). Each of 24 patients made four visits within 8 weeks, for 96 visits total: A training visit (TV), followed by three visits double-blind presenting A, B, or C (randomized order). Within each visit, a participant experienced the cold pressor, followed by an hour of rest during which one of the four treatments was provided, followed by a repeat of the cold pressor, followed by capsaicin.ResultsThe novel method successfully discriminates the pain reduction effects of the four treatments across both pain models, confirming maximal pain for no-treatment, mild pain reduction for placebo, and the most pain reduction with analgesics. The new measure maintains significant discrimination across the test conditions both within a single-day's visit (for relative pain relief within a visit) and across repeated visits spanning weeks, reducing different-day-physiology affects, and providing better discriminability than using self-reported eVAS.ConclusionThe new method combines the subjectively-identified time of peak pain with capturing continuous physiological data to quantify the sympathetic nervous system response during a dynamic pain experience. The method accurately discriminates, for both pain models, the reduction of pain with clinically effective analgesics.

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