Pilitsis Julie G, Fahey Marie, Custozzo Amanda, Chakravarthy Krishnan, Capobianco Robyn
Department of Neurosurgery, Albany Medical Center, Albany, NY, USA.
Department of Neuroscience and Experimental Therapeutics, Albany Medical College, Albany, NY, USA.
Neuromodulation. 2021 Jan;24(1):68-75. doi: 10.1111/ner.13212. Epub 2020 Jun 27.
The pain Numeric Rating Scale (NRS) score became standard when pain was introduced as the fifth vital sign in the 1990s. Although plagued with issues, it remains the basis for primary outcome measures in clinical trials for chronic pain therapies. Multidimensional composite scoring that considers all aspects of the chronic pain experience may provide a more meaningful response measure. Herein we propose a multidimensional responder index.
Data were extracted from an ongoing prospective, multicenter study on DeRidder Burst spinal cord stimulation (B-SCS) for chronic back and/or leg pain (NCT03082261). The analysis cohort consisted of subjects who completed the NRS, Pain Catastrophizing Scale (PCS), EuroQol-5D (EQ-5D), and eight-item Patient-Reported Outcomes Measurement Information System Physical Function preoperatively and at 12 months after implant.
A principal component analysis showed that each of the four measures contributed equally to the variance in the data set, confirming that pain score should not be used alone. Subjects who failed to respond on NRS responded on both PCS and EQ-5D. Eighty-one percent of subjects responded on at least two measures. The responder algorithm yielded an 84% success rate at both 6- and 12-month time points.
Our study suggests that therapeutic response, similar to the chronic pain experience, is multidimensional. Careful consideration should be made to incorporate composite endpoints in future SCS clinical trials.
疼痛数字评定量表（NRS）评分在20世纪90年代疼痛被引入作为第五生命体征时成为标准。尽管存在问题，但它仍是慢性疼痛治疗临床试验主要结局指标的基础。考虑慢性疼痛体验所有方面的多维综合评分可能会提供更有意义的反应指标。在此我们提出一个多维反应指数。
数据取自一项正在进行的关于DeRidder爆裂型脊髓刺激（B-SCS）治疗慢性背痛和/或腿痛的前瞻性多中心研究（NCT03082261）。分析队列由术前及植入后12个月完成NRS、疼痛灾难化量表（PCS）、欧洲五维健康量表（EQ-5D）以及八项患者报告结局测量信息系统身体功能量表的受试者组成。
主成分分析表明这四项指标中的每一项对数据集中的方差贡献相同，证实疼痛评分不应单独使用。在NRS上无反应的受试者在PCS和EQ-5D上有反应。81%的受试者在至少两项指标上有反应。反应者算法在6个月和12个月时间点的成功率均为84%。
我们的研究表明，与慢性疼痛体验类似，治疗反应是多维的。在未来的脊髓刺激临床试验中应谨慎考虑纳入综合终点指标。
