Smith Thomas J, Razzak A Rab, Blackford Amanda L, Ensminger Jennifer, Saiki Catherine, Longo-Schoberlein Denise, Loprinzi Charles L
Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD, USA.
Mayo Clinic Comprehensive Cancer Center, Rochester, MN, USA.
J Palliat Care. 2020 Jan;35(1):53-58. doi: 10.1177/0825859719827589. Epub 2019 Feb 3.
Chemotherapy-induced peripheral neuropathy (CIPN) affects 30% to 40% of patients with cancer with long-lasting disability. Scrambler therapy (ST) appeared to benefit patients in uncontrolled trials, so we performed a randomized sham-controlled Phase II trial of ST.
The primary end point was "average pain" after 28 days on the Numeric Rating Scale. Each received ten 30-minute sessions of ST on the dermatomes above the painful areas, or sham treatment on the back, typically at L3-5 where the nerve roots would enter the spinal cord. Outcomes included the Brief Pain Inventory (BPI)-CIPN and the EORTC CIPN-20 scale. Patients were evaluated before treatment (day 0), day 10, and days 28, 60, and 90.
Data regarding pain as a primary outcome were collected for 33 of the 35 patients. There were no significant differences between the sham and the "real" ST group at day 10, 28, 60, or 90, for average pain, the BPI, or EORTC CIPN-20. Individual responses were noted during the ST treatment on the real arm, but most dissipated by day 30. There was improvement in the sensory subscale of the CIPN-20 at 2 months in the "real" group ( = .14). All "real" patients wanted to continue treatment if available.
We observed no difference between sham and real ST CIPN treatment. Potential reasons include at least the following: ST does not work; the sham treatment had some effect; small sample size with heterogeneous patients; misplaced electrodes on an area of nonpainful but damaged nerves; or a combination of these factors.
化疗引起的周围神经病变（CIPN）影响30%至40%的癌症患者，会导致长期残疾。在非对照试验中，扰频器疗法（ST）似乎对患者有益，因此我们开展了一项ST的随机假对照II期试验。
主要终点是数字评定量表上28天后的“平均疼痛”。每组患者在疼痛区域上方的皮节接受10次30分钟的ST治疗，或在背部进行假治疗，通常在L3 - 5水平，即神经根进入脊髓的部位。结局指标包括简明疼痛问卷（BPI）-CIPN和欧洲癌症研究与治疗组织（EORTC）CIPN-20量表。在治疗前（第0天）、第10天以及第28、60和90天对患者进行评估。
35例患者中的33例收集了以疼痛作为主要结局的数据。在第10、28、60或90天，假治疗组与“真实”ST组在平均疼痛、BPI或EORTC CIPN-20方面均无显著差异。在“真实”组治疗期间观察到个体有反应，但大多数在第30天消失。“真实”组在2个月时CIPN-20的感觉子量表有所改善（P = 0.14）。所有“真实”组患者若有机会都希望继续治疗。
我们观察到假治疗与真实的ST治疗CIPN之间没有差异。潜在原因至少包括以下几点：ST不起作用；假治疗有一定效果；样本量小且患者异质性大；电极放置在无痛但受损神经区域；或这些因素的综合作用。
