Metro Pain Group, Clayton, VIC, Australia.
PainCare, Perth, WA, Australia.
Eur Spine J. 2020 Nov;29(11):2786-2794. doi: 10.1007/s00586-020-06480-x. Epub 2020 Jun 30.
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.
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.
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.
Stable, long-term results demonstrated that 10 kHz SCS is a promising therapy option for intractable chronic upper limb and neck pain.
传统上，难以治疗的上肢和颈部疼痛是一种具有挑战性的疼痛病症，常规脊髓刺激（SCS）常常导致感觉异常的位置变化和/或轴向颈部疼痛覆盖不足。本项澳大利亚多中心前瞻性临床试验的目的是评估 10kHz 感觉无关 SCS 治疗上肢和颈部疼痛的安全性和有效性。
经人类研究伦理委员会批准后，招募了慢性、难治性颈痛和/或上肢痛（视觉模拟量表 0-10cm 为≥5cm）的受试者（ACTRN12614000153617）。受试者被植入两个跨越 C2-C6 椎体的硬膜外导联。在试验刺激成功的受试者中，植入了 Senza 系统（Nevro Corp.，加利福尼亚州雷德伍德市），并在植入后 3 个月（主要终点评估，PEA）和 12 个月时进行安全性和有效性评估。
总体而言，38 名受试者中有 31 名（82.6%）报告了成功的 10kHz 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。受试者报告在 PEA 时颈痛和上肢痛减轻（分别为 8.1±0.2cm 比基线时的 2.9±0.5cm，7.3±0.3cm 比基线时的 2.5±0.5cm，p≤0.0001）。疼痛残疾指数评分衡量的残疾程度从基线时的 42.6±2.6 下降到 PEA 时的 22.7±3.2。植入后 12 个月结果保持不变。未观察到神经功能缺损或感觉异常的报告。
稳定的长期结果表明，10kHz SCS 是治疗难治性慢性上肢和颈部疼痛的一种有前途的治疗选择。
