Karri Jay, Marathe Anuj, Smith Thomas J, Wang Eric J
Department of Anesthesiology and Critical Care Medicine, Division of Pain Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Baylor College of Medicine, Houston, TX, USA.
Neuromodulation. 2023 Dec;26(8):1499-1509. doi: 10.1016/j.neurom.2022.04.045. Epub 2022 Jun 9.
Scrambler therapy (ST) is a noninvasive method of transcutaneous neuromodulation that has 510(K) clearance from the United States Food and Drug Administration for treating acute pain, postoperative pain, and intractable chronic pain. Since its inception, ST has been used to treat many chronic pain syndromes in a variety of patient populations. We synthesized the available literature for ST to delineate its overall evidence basis.
We performed a systematic review based on conventional Preferred Reporting Items for Systematic Reviews and Meta-Analyses methods by surveying multiple data sources from January 1950 through October 2021. Two review authors, independently and in a standardized, unblinded fashion, conducted a systematic review to identify relevant studies and extract the necessary outcome measures. A conservative search strategy was implemented to identify all ST studies for the treatment of chronic pain syndromes. Primary outcome parameters collected were analgesic benefit, adverse effects, and other metrics such as sensorimotor testing.
A total of 21 studies met the final criteria for study inclusion and comprised randomized controlled trials (n = 8), prospective observational studies (n = 10), and retrospective cohort studies (n = 3). Nearly all the reported studies explored the use of ST for the treatment of neuropathic pain, with chemotherapy-induced peripheral neuropathy being the most studied condition. Most studies were limited by small cohorts but reported ST being safe, well tolerated, and providing clinically meaningful pain reduction. The duration of posttreatment follow-up ranged from ten to 14 days (concordant with completion of typical ST protocols) to three months. Secondary benefits such as medication reduction and improvement of sensory and motor symptoms were noted by some studies.
ST is regarded as a safe intervention with potential for significant analgesic benefit for neuropathic pain conditions. Although the available evidence is most robust for treating chemotherapy-induced peripheral neuropathy, ST has also been shown to be effective in treating other neuropathic pain syndromes. Evidence for ST use in nociceptive pain conditions is limited but appears promising. The favorable safety profile and increasing evidence basis for ST warrant more extensive recognition and consideration for use in clinical care.
扰频器疗法(ST)是一种经皮神经调节的非侵入性方法,已获得美国食品药品监督管理局的510(K)许可,用于治疗急性疼痛、术后疼痛和顽固性慢性疼痛。自问世以来,ST已被用于治疗各种患者群体中的多种慢性疼痛综合征。我们综合了有关ST的现有文献,以描述其总体证据基础。
我们基于传统的系统评价和Meta分析首选报告项目方法进行了一项系统评价,通过检索1950年1月至2021年10月的多个数据源。两名评价作者以标准化、非盲法独立进行了系统评价,以识别相关研究并提取必要的结局指标。实施了保守的检索策略,以识别所有治疗慢性疼痛综合征的ST研究。收集的主要结局参数为镇痛效果、不良反应以及其他指标,如感觉运动测试。
共有21项研究符合纳入标准,包括随机对照试验(n = 8)、前瞻性观察性研究(n = 10)和回顾性队列研究(n = 3)。几乎所有报告的研究都探讨了ST用于治疗神经性疼痛,其中化疗引起的周围神经病变是研究最多的病症。大多数研究因样本量小而受到限制,但报告称ST安全、耐受性良好,并能在临床上显著减轻疼痛。治疗后随访时间从10至14天(与典型的ST方案完成时间一致)到3个月不等。一些研究指出了诸如减少用药以及改善感觉和运动症状等次要益处。
ST被认为是一种安全的干预措施,对神经性疼痛病症具有显著的镇痛潜力。尽管现有证据在治疗化疗引起的周围神经病变方面最为充分,但ST也已被证明对治疗其他神经性疼痛综合征有效。ST用于伤害性疼痛病症的证据有限,但似乎很有前景。ST良好的安全性和越来越多的证据基础值得在临床护理中得到更广泛的认可和考虑。