Pijncentrum AZ Delta, Roeselare, 8800, Belgium.
Department of Clinical and Regulatory Affairs, Nevro Corp., Redwood City, CA 94065, USA.
Pain Manag. 2022 Jan;12(1):75-85. doi: 10.2217/pmt-2021-0045. Epub 2021 Jul 22.
Chronic postsurgical pain (CPSP) is a common complication of surgery. This study was conducted to evaluate the efficacy and safety of paresthesia-free, 10-kHz spinal cord stimulation (SCS) as a treatment for CPSP. Subjects in this prospective, single-arm study had an average pain intensity of ≥5 cm on a 10-cm visual analog scale. The subjects who had pain relief of ≥50% (response) with temporary trial stimulation were permanently implanted with 10-kHz SCS and assessed for 1 year. At 12 months, 94% of subjects were responders to 10-kHz SCS, and 88% had pain remission (visual analog scale ≤2.5 cm). The pain relief was durable in CPSP subjects and the safety profile of 10-kHz SCS was as expected. VT005076953 (Privacy Commission of Belgium).
慢性术后疼痛（CPSP）是手术的常见并发症。本研究旨在评估无痛、10kHz 脊髓刺激（SCS）作为 CPSP 治疗方法的疗效和安全性。本前瞻性、单臂研究的受试者平均疼痛强度为 10cm 视觉模拟量表上的≥5cm。对临时试验刺激有≥50%（反应）缓解的受试者，可永久性植入 10kHz SCS，并进行 1 年评估。在 12 个月时，94%的受试者对 10kHz SCS 有反应，88%的受试者疼痛缓解（视觉模拟量表≤2.5cm）。CPSP 受试者的疼痛缓解是持久的，10kHz SCS 的安全性与预期相符。
