Treister Roi, Eaton Thomas A, Trudeau Jeremiah J, Elder Harrison, Katz Nathaniel P
Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston; Analgesic Solutions, Natick, MA.
Department of Psychology, University of Connecticut, Storrs.
J Pain Res. 2017 Feb 9;10:319-326. doi: 10.2147/JPR.S121455. eCollection 2017.
Clinical trials of analgesics have been plagued with poor assay sensitivity due, in part, to variability in subjects' pain reporting. Herein, we develop and evaluate the focused analgesia selection test (FAST), a method to measure patients' pain reporting skills. Subjects with osteoarthritis of the hip, knee, and/or ankle with pain intensity of ≥3/10 on a 0-10 numerical rating scale were enrolled. Subjects underwent the FAST procedure, which consists of recording subjects' pain reports in response to repeated administration of thermal noxious stimuli of various intensities applied on the arm with the Medoc Thermal Sensory Analyzer II. Subjects also rated non-noxious stimuli consisting of visual contrast rating. After performing an exercise task, subjects also rated clinical pain and were asked to report whether their pain had increased, decreased, or stayed the same. Overall, 88 subjects were enrolled, and 83 were included in the analyses. FAST's outcomes including the , intraclass correlation coefficient (ICC), and coefficient of variation (CoV) indicated that subjects' pain reporting skills were widely distributed. Higher FAST ICC significantly predicted greater changes in clinical pain following exercise (=0.017), whereas the visual contrast test did not predict postexercise pain. FAST is the first method that measures subjects' pain reporting skills. Using FAST to enrich clinical trials with "good" pain reporters (with high FAST ICC) could increase assay sensitivity. Further evaluation of FAST is ongoing.
镇痛药的临床试验一直受到检测灵敏度低的困扰，部分原因是受试者疼痛报告的变异性。在此，我们开发并评估了聚焦镇痛选择测试（FAST），这是一种测量患者疼痛报告技能的方法。纳入了髋、膝和/或踝关节骨关节炎且在0至10数字评分量表上疼痛强度≥3/10的受试者。受试者接受FAST程序，该程序包括使用Medoc热感觉分析仪II对施加在手臂上的各种强度的热有害刺激进行重复给药时记录受试者的疼痛报告。受试者还对由视觉对比度评分组成的非有害刺激进行评分。在执行一项运动任务后，受试者还对临床疼痛进行评分，并被要求报告他们的疼痛是增加、减少还是保持不变。总体而言，共纳入88名受试者，83名被纳入分析。FAST的结果包括组内相关系数（ICC）和变异系数（CoV）表明受试者的疼痛报告技能分布广泛。较高的FAST ICC显著预测运动后临床疼痛的更大变化（=0.017），而视觉对比度测试不能预测运动后疼痛。FAST是第一种测量受试者疼痛报告技能的方法。使用FAST来富集具有“良好”疼痛报告者（FAST ICC高）的临床试验可以提高检测灵敏度。对FAST的进一步评估正在进行中。
