From the Departments of Neurology (M.A.M., R.A.S., M.L.) and Oncology (T.J.S.), Johns Hopkins University School of Medicine; Johns Hopkins University School of Nursing (M.A.M., S.L.K., L.T., J.K.A., M.T.N.), Baltimore, MD; Department of Pediatrics (L.J.C.), University of Utah, Salt Lake City; and Department of Neurology (M.L.), Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Neurology. 2020 May 5;94(18):e1900-e1907. doi: 10.1212/WNL.0000000000009370. Epub 2020 Apr 8.
To determine whether Scrambler therapy is an effective, acceptable, and feasible treatment of persistent central neuropathic pain in patients with neuromyelitis optica spectrum disorder (NMOSD) and to explore the effect of Scrambler therapy on co-occurring symptoms.
We conducted a randomized single-blind, sham-controlled trial in patients with NMOSD who have central neuropathic pain using Scrambler therapy for 10 consecutive weekdays. Pain severity, pain interference, anxiety, depression, and sleep disturbance were assessed at baseline, at the end of treatment, and at the 30- and 60-day follow-up.
Twenty-two patients (11 per arm) were enrolled in and completed this trial. The median baseline numeric rating scale (NRS) pain score decreased from 5.0 to 1.5 after 10 days of treatment with Scrambler therapy, whereas the median NRS score did not significantly decrease in the sham arm. Depression was also reduced in the treatment arm, and anxiety was decreased in a subset of patients who responded to treatment. These symptoms were not affected in the sham arm. The safety profiles were similar between groups.
Scrambler therapy is an effective, feasible, and safe intervention for central neuropathic pain in patients with NMOSD. Decreasing pain with Scrambler therapy may additionally improve depression and anxiety.
NCT03452176.
This study provides Class II evidence that Scrambler therapy significantly reduces pain in patients with NMOSD and persistent central neuropathic pain.
确定 scrambler 疗法是否对视神经脊髓炎谱系障碍(NMOSD)患者的持续性中枢神经性疼痛有效、可接受和可行,并探讨 scrambler 疗法对并存症状的影响。
我们对 NMOSD 合并中枢神经性疼痛的患者进行了一项随机、单盲、假对照试验,采用 scrambler 疗法连续治疗 10 天。在基线、治疗结束时以及 30 天和 60 天随访时评估疼痛严重程度、疼痛干扰、焦虑、抑郁和睡眠障碍。
共有 22 名患者(每组 11 名)入组并完成了这项试验。接受 scrambler 疗法治疗 10 天后,中位数基线数字评分量表(NRS)疼痛评分从 5.0 降至 1.5,而假治疗组的 NRS 评分无显著下降。治疗组的抑郁评分也降低,且在对治疗有反应的患者亚组中焦虑评分降低。假治疗组则未出现这些症状变化。两组的安全性特征相似。
scrambler 疗法是 NMOSD 合并持续性中枢神经性疼痛患者的一种有效、可行且安全的干预措施。 scrambler 疗法减轻疼痛可能还会改善抑郁和焦虑。
临床试验.gov 标识符:NCT03452176。
本研究提供了 II 级证据,表明 scrambler 疗法可显著减轻 NMOSD 患者的疼痛和持续性中枢神经性疼痛。