Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain
Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain
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DOI：
10.1097/aln.0000000000000774
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发表时间：
2015-10-01
期刊：
影响因子：
8.8
通讯作者：
Burgher, Abram H.
中科院分区：
文献类型：
--
作者：
Kapural, Leonardo;Yu, Cong;Burgher, Abram H.
背景：目前对慢性疼痛的治疗效果有限，并且有众所周知的副作用。鉴于顽固性疼痛的普遍性和负担，需要额外的治疗方法。10khz的脊髓刺激（如HF10治疗）可以缓解疼痛，而不会产生传统低频脊髓刺激的典型感觉异常。这项随机、平行、非劣效性研究的目的是比较SCS治疗背部和腿部疼痛患者的长期安全性和有效性。方法：在10个综合疼痛治疗中心，以1:1的比例随机分配198名背部和腿部疼痛的受试者到治疗组。其中171人通过了临时试验，植入了SCS系统。应答者（主要结局）定义为背痛减轻50%或以上，无刺激相关的神经功能缺损。结果：在3个月时，84.5%的植入HF10治疗组对背部疼痛有反应，83.1%对腿部疼痛有反应；43.8%的传统SCS治疗组对背部疼痛有反应，55.5%对腿部疼痛有反应（背部和腿部疼痛比较P < 0.001）。腰痛应答者的相对比值为1.9 (95% CI, 1.4 - 2.5)，腿痛应答者的相对比值为1.5 （95% CI, 1.2 - 1.9）。HF10治疗腿部和背部疼痛优于传统SCS治疗，持续12个月（P < 0.001）。HF10治疗的受试者没有出现感觉异常。结论：HF10治疗有望对背部和腿部疼痛的管理产生实质性影响，对患者、医生和付款人具有广泛的适用性。
Background: Current treatments for chronic pain have limited effectiveness and commonly known side effects. Given the prevalence and burden of intractable pain, additional therapeutic approaches are desired. Spinal cord stimulation (SCS) delivered at 10 kHz (as in HF10 therapy) may provide pain relief without the paresthesias typical of traditional low-frequency SCS. The objective of this randomized, parallel-arm, noninferiority study was to compare long-term safety and efficacy of SCS therapies in patients with back and leg pain.Methods: A total of 198 subjects with both back and leg pain were randomized in a 1: 1 ratio to a treatment group across 10 comprehensive pain treatment centers. Of these, 171 passed a temporary trial and were implanted with an SCS system. Responders (the primary outcome) were defined as having 50% or greater back pain reduction with no stimulation-related neurological deficit.Results: At 3 months, 84.5% of implanted HF10 therapy subjects were responders for back pain and 83.1% for leg pain, and 43.8% of traditional SCS subjects were responders for back pain and 55.5% for leg pain (P < 0.001 for both back and leg pain comparisons). The relative ratio for responders was 1.9 (95% CI, 1.4 to 2.5) for back pain and 1.5 (95% CI, 1.2 to 1.9) for leg pain. The superiority of HF10 therapy over traditional SCS for leg and back pain was sustained through 12 months (P < 0.001). HF10 therapy subjects did not experience paresthesias.Conclusion: HF10 therapy promises to substantially impact the management of back and leg pain with broad applicability to patients, physicians, and payers.