Purpose

Intractable upper limb and neck pain has traditionally been a challenging pain condition to treat, with conventional spinal cord stimulation (SCS) often inducing positional variation in paraesthesia and/or inadequate coverage of axial neck pain. The purpose of this Australian multi-centre prospective, clinical trial was to assess the safety and effectiveness of paraesthesia-independent 10 kHz SCS for the treatment of upper limb and neck pain.

Methods

Subjects with chronic, intractable neck and/or upper limb pain of ≥ 5 cm (on a 0–10-cm visual analogue scale) were enrolled (ACTRN12614000153617) following human research ethics committee approval. Subjects were implanted with two epidural leads spanning C2–C6 vertebral bodies. Subjects with successful trial stimulation were implanted with a Senza^® system (Nevro Corp., Redwood City, CA, USA) and included in the safety and effectiveness evaluation at 3 months post-implant (primary endpoint assessment, PEA) and followed to 12 months.

Results

Overall, 31/38 (82.6%) subjects reported a successful 10 kHz SCS trial and proceeded to a permanent implant. Twenty-three of 30 subjects (76.7%) met the PEA. Subjects reported a reduction in neck pain and upper limb pain from baseline at the PEA (8.1 ± 0.2 cm vs. 2.9 ± 0.5 cm, 7.3 ± 0.3 cm vs. 2.5 ± 0.5 cm, respectively, p ≤ 0.0001). Disability, as measured by pain disability index score, decreased from 42.6 ± 2.6 at baseline to 22.7 ± 3.2 at PEA. Results were maintained 12 months post-implant. No neurological deficits, nor reports of paraesthesia, were observed.

Conclusions

Stable, long-term results demonstrated that 10 kHz SCS is a promising therapy option for intractable chronic upper limb and neck pain.

中文翻译：

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10 kHz脊髓刺激治疗慢性上肢和颈部疼痛：澳大利亚经验。

目的

顽固性上肢和颈部疼痛传统上一直是一种具有挑战性的疼痛状况，传统的脊髓刺激（SCS）常常会引起感觉异常的位置变化和/或轴向颈部疼痛的覆盖范围不足。这项澳大利亚多中心前瞻性临床试验的目的是评估与麻醉无关的10 kHz SCS在治疗上肢和颈部疼痛中的安全性和有效性。

方法

经人类研究伦理委员会批准，患有慢性，顽固性颈部和/或上肢疼痛≥5 cm（0-10 cm视觉模拟量表）的受试者入选（ACTRN12614000153617）。受试者被植入了跨越C2–C6椎体的两条硬膜外导线。与试制成功刺激受试者用指数Senza植入^® 3个月时，植入后（主要终点评估，PEA）系统（Nevro公司，红木城，CA，USA），并包含在安全性和有效性评价，随后至12个月。

结果

总体而言，有31/38（82.6％）位受试者报告成功进行了10 kHz SCS试验并进行了永久性植入。30名受试者中有23名（76.7％）达到了PEA。受试者报告从基线在颈部疼痛和上肢疼痛减轻在PEA（8.1±0.2厘米对比2.9±0.5厘米，7.3±0.3厘米比2.5±0.5厘米，分别p  ≤0.0001）。通过疼痛残疾指数评分衡量的残疾从基线时的42.6±2.6降低到PEA时的22.7±3.2。植入后12个月维持结果。没有观察到神经系统缺陷，也没有感觉异常的报道。

结论

稳定的长期结果表明，10 kHz SCS是治疗顽固性慢性上肢和颈部疼痛的有前途的治疗选择。