MJHS Institute for Innovation in Palliative Care, New York, NY, USA; Department of Family and Social Medicine, Albert Einstein College of Medicine, Bronx, NY, USA.
Division of Neurosurgery, Sunnybrook Health Sciences Centre, Sunnybrook Research Institute, Harquail Centre for Neuromodulation, University of Toronto, Toronto, ON, Canada.
Lancet. 2021 May 29;397(10289):2111-2124. doi: 10.1016/S0140-6736(21)00794-7.
Neuromodulation is an expanding area of pain medicine that incorporates an array of non-invasive, minimally invasive, and surgical electrical therapies. In this Series paper, we focus on spinal cord stimulation (SCS) therapies discussed within the framework of other invasive, minimally invasive, and non-invasive neuromodulation therapies. These therapies include deep brain and motor cortex stimulation, peripheral nerve stimulation, and the non-invasive treatments of repetitive transcranial magnetic stimulation, transcranial direct current stimulation, and transcutaneous electrical nerve stimulation. SCS methods with electrical variables that differ from traditional SCS have been approved. Although methods devoid of paraesthesias (eg, high frequency) should theoretically allow for placebo-controlled trials, few have been done. There is low-to-moderate quality evidence that SCS is superior to reoperation or conventional medical management for failed back surgery syndrome, and conflicting evidence as to the superiority of traditional SCS over sham stimulation or between different SCS modalities. Peripheral nerve stimulation technologies have also undergone rapid development and become less invasive, including many that are placed percutaneously. There is low-to-moderate quality evidence that peripheral nerve stimulation is effective for neuropathic pain in an extremity, low quality evidence that it is effective for back pain with or without leg pain, and conflicting evidence that it can prevent migraines. In the USA and many areas in Europe, deep brain and motor cortex stimulation are not approved for chronic pain, but are used off-label for refractory cases. Overall, there is mixed evidence supporting brain stimulation, with most sham-controlled trials yielding negative findings. Regarding non-invasive modalities, there is moderate quality evidence that repetitive transcranial magnetic stimulation does not provide meaningful benefit for chronic pain in general, but conflicting evidence regarding pain relief for neuropathic pain and headaches. For transcranial direct current stimulation, there is low-quality evidence supporting its benefit for chronic pain, but conflicting evidence regarding a small treatment effect for neuropathic pain and headaches. For transcutaneous electrical nerve stimulation, there is low-quality evidence that it is superior to sham or no treatment for neuropathic pain, but conflicting evidence for non-neuropathic pain. Future research should focus on better evaluating the short-term and long-term effectiveness of all neuromodulation modalities and whether they decrease health-care use, and on refining selection criteria and treatment variables.
神经调节是疼痛医学中一个不断发展的领域，它包含了一系列非侵入性、微创和手术性的电疗方法。在本系列论文中，我们专注于脊髓刺激（SCS）疗法，这些疗法是在其他侵入性、微创性和非侵入性神经调节疗法的框架内讨论的。这些疗法包括深部脑和运动皮层刺激、周围神经刺激以及非侵入性治疗方法，如重复经颅磁刺激、经颅直流电刺激和经皮电神经刺激。已经批准了具有不同于传统 SCS 的电变量的 SCS 方法。虽然没有感觉异常（例如高频）的方法在理论上应该允许进行安慰剂对照试验，但很少有这样的试验。有低到中等质量的证据表明，SCS 对于失败的背部手术综合征的再手术或常规医学管理具有优越性，而传统 SCS 优于假刺激或不同 SCS 模式之间的优越性则存在矛盾的证据。外周神经刺激技术也得到了快速发展，变得更加微创，包括许多经皮放置的技术。有低到中等质量的证据表明，外周神经刺激对于肢体的神经性疼痛有效，低质量的证据表明对于伴有或不伴有腿部疼痛的背部疼痛有效，并且有矛盾的证据表明它可以预防偏头痛。在美国和欧洲的许多地区，深部脑和运动皮层刺激不适用于慢性疼痛，但用于难治性病例的标签外使用。总的来说，有混合证据支持脑刺激，大多数假刺激对照试验得出阴性结果。关于非侵入性方式，有中等质量的证据表明，重复经颅磁刺激一般不会为慢性疼痛提供有意义的益处，但对于神经性疼痛和头痛的缓解则存在矛盾的证据。对于经颅直流电刺激，有低质量的证据支持其对慢性疼痛的益处，但对于神经性疼痛和头痛的小治疗效果存在矛盾的证据。对于经皮电神经刺激，有低质量的证据表明它优于假刺激或无治疗对于神经性疼痛，但对于非神经性疼痛则存在矛盾的证据。未来的研究应侧重于更好地评估所有神经调节方式的短期和长期效果，以及它们是否减少医疗保健的使用，并侧重于细化选择标准和治疗变量。
