Department of Oncology, Mayo Clinic, Rochester, Minnesota, USA.
Department of Health Sciences Research, Section of Cancer Center Statistics, Mayo Clinic, Rochester, Minnesota, USA.
J Pain Symptom Manage. 2021 Jun;61(6):1247-1253. doi: 10.1016/j.jpainsymman.2020.11.025. Epub 2020 Nov 27.
Preliminary trials report that Scrambler Therapy, a form of electroanalgesia, may improve discomfort from chemotherapy-induced peripheral neuropathy (CIPN).
The objective of this phase II, randomized controlled trial was to evaluate the efficacy of Scrambler therapy vs. transcutaneous electrical nerve stimulation (TENS) in treating CIPN.
Fifty patients were accrued for the first half of this two-part, crossover trial consisting of a 2-week treatment period with either Scrambler or TENS, followed by an 8-week observation period, and then crossover treatment. Twenty-two patients proceeded to the crossover phase. The primary means of assessment was patient-reported outcomes, including symptom severity scales and Global Impression of Change questionnaires. Symptoms were assessed daily during the treatment period and weekly during an 8-week observation period.
A 50% or greater reduction in primary symptom (pain or tingling) score on the last day of treatment was achieved by 6 of 10 Scrambler-treated patients (60%) and 3 of 12 TENS-treated patients (25%) after crossover (P = 0.11). By day 4 of treatment, the two arms diverged with respect to mean change in primary symptom score; this effect was largely carried through to the end of the two-week treatment period. Similarly, Scrambler therapy appeared better than TENS when assessed by Global Impression of Change for neuropathy, pain, and overall quality of life.
Similar findings from the initial randomization and crossover phases of this study support further evaluation of the efficacy of Scrambler therapy in alleviating CIPN symptoms. Evaluation in a larger, randomized controlled trial with standardized treatment is warranted.
初步试验报告称， scrambler 疗法（一种电镇痛形式）可能改善化疗引起的周围神经病变（CIPN）引起的不适。
本 II 期随机对照试验的目的是评估 scrambler 疗法与经皮神经电刺激（TENS）治疗 CIPN 的疗效。
这项两部分交叉试验的前半部分共纳入 50 例患者，包括 2 周的 scrambler 或 TENS 治疗期，随后进行 8 周的观察期，然后进行交叉治疗。22 例患者进入交叉阶段。主要评估方法是患者报告的结果，包括症状严重程度量表和总体变化印象问卷。在治疗期间每天评估症状，在 8 周观察期每周评估一次。
在交叉后的最后一天，10 例 scrambler 治疗患者中有 6 例（60%）和 12 例 TENS 治疗患者中有 3 例（25%）的主要症状（疼痛或刺痛）评分降低 50%或更多。治疗第 4 天，两条治疗线在主要症状评分的平均变化方面出现分歧；这种效应在两周治疗期结束时基本保持不变。同样，在评估神经病变、疼痛和总体生活质量时，scrambler 疗法的总体变化印象也优于 TENS。
本研究初始随机化和交叉阶段的类似发现支持进一步评估 scrambler 疗法缓解 CIPN 症状的疗效。需要进行更大规模、标准化治疗的随机对照试验进行评估。
