Dornsife Center for Self-Report Science, University of Southern California, California.
Dornsife Center for Self-Report Science, University of Southern California, California.
J Pain. 2021 Apr;22(4):386-399. doi: 10.1016/j.jpain.2020.10.003. Epub 2020 Oct 24.
Pain intensity represents the primary outcome in most pain clinical trials. Identifying methods to measure aspects of pain that are most sensitive to treatment may facilitate discovery of effective interventions. In this third of 3 articles examining alternative indices of pain intensity derived from ecological momentary assessments (EMA), we compare treatment effects based on Average Pain, Maximum Pain, Minimum Pain, Pain Variability, Time in High Pain, Time in Low Pain, and Pain After Wake-Up. We also examine which indices contribute to Patient Global Impressions of Change (PGIC). Data came from 2 randomized, double-blind, placebo-controlled trials examining the efficacy of milnacipran for fibromyalgia treatment; 2,084 patients provided >1 million EMA pain intensity ratings over 24 (Study 1) or 26 (Study 2) treatment weeks. Pain Variability and Time in High Pain produced significantly smaller treatment effects than Average Pain; other pain indices showed effects that were numerically smaller, but not significantly different from Average Pain. Changes in all pain indices were significantly associated with PGIC, with improvements in Maximum Pain and in Pain Variability offering small incremental contributions to understanding PGIC over Average Pain. Results suggest that different pain indices could be used to detect treatment effects in pain clinical trials. PERSPECTIVE: Alternative summary measures of pain intensity derived from EMA may broaden the scope of outcomes useful in pain clinical trials. In this analysis of a pharmacological treatment for fibromyalgia, most pain summary measures indicated similar effects; improvements in Maximum Pain and Pain Variability contributed to understanding PGIC over Average Pain.
疼痛强度是大多数疼痛临床试验的主要结果。确定能够衡量对治疗最敏感的疼痛方面的方法，可能有助于发现有效的干预措施。在这三篇文章中的第三篇中，我们研究了从生态瞬时评估（EMA）中得出的替代疼痛强度指标，比较了基于平均疼痛、最大疼痛、最小疼痛、疼痛变异性、高疼痛时间、低疼痛时间和醒来后疼痛的治疗效果。我们还研究了哪些指数有助于患者整体印象变化（PGIC）。数据来自两项随机、双盲、安慰剂对照的临床试验，研究米那普仑治疗纤维肌痛的疗效；2084 名患者在 24（研究 1）或 26（研究 2）个治疗周内提供了超过 100 万次 EMA 疼痛强度评分。疼痛变异性和高疼痛时间的治疗效果明显小于平均疼痛；其他疼痛指数的效果虽然较小，但与平均疼痛无显著差异。所有疼痛指数的变化都与 PGIC 显著相关，最大疼痛和疼痛变异性的改善对理解 PGIC 相对于平均疼痛有较小的增量贡献。结果表明，不同的疼痛指数可用于检测疼痛临床试验中的治疗效果。观点：从 EMA 得出的疼痛强度替代综合衡量标准可能会拓宽疼痛临床试验中有用的结果范围。在对纤维肌痛的药物治疗进行的这项分析中，大多数疼痛综合衡量标准表明了相似的效果；最大疼痛和疼痛变异性的改善有助于理解 PGIC 相对于平均疼痛的改善。
