Department of Anesthesiology and Pain Medicine, UZ Brussel, Brussels, Belgium.
Department of Anesthesia and Pain Management, AZ Nikolaas, Sint-Niklaas, Belgium.
Pain Pract. 2021 Feb;21(2):215-225. doi: 10.1111/papr.12952. Epub 2020 Oct 21.
Spinal cord stimulation (SCS) is effective for patients with failed back surgery syndrome (FBSS). SCS improves their pain, as well as their functionality and health-related quality of life. Different waveforms for SCS have emerged that show improvement in small prospective studies. Analysis of real-world data shows the clinical implementation and the effect of different waveforms in SCS.
A real-world analysis was performed of 208 patients with FBSS who were treated over 3 years. Stimulators with tonic, burst, high-density, and 10-kHz high-frequency (HF10) waveforms were implanted in patients with FBSS who had predominant pain in the back, legs, or both back and legs. Pain as measured by the VAS, functional disability as measured by the Oswestry Disability Index (ODI), and health-related quality of life as measured by the 3-level EuroQol 5-Dimension (EQ5D-3L) questionnaire were determined at baseline and for outcome assessment.
SCS is effective for patients with FBSS. This analysis showed a change in baseline VAS score from 8.0 to 4.7 (P < 0.0001) at 24 months. The EQ5D-3L score improved from 0.29 to 0.49 (P < 0.0001) at 24 months. The ODI score improved from 54% to 42% (P < 0.0001) at 24 months. The unanticipated explantation rate was only 1.6%.
This study of SCS showed significant long-term improvement in pain, disability, and quality of life in a large dataset of patients with FBSS. Strict selection procedures and a strong opioid policy contributed to the high success rate and low unanticipated explantation rate. There was no difference in pain reduction between tonic and HF10 stimulation. Further investigation is necessary to detect any difference between other waveforms of SCS.
脊髓刺激（SCS）对失败的腰椎手术综合征（FBSS）患者有效。SCS 可改善患者的疼痛、功能和健康相关生活质量。在小型前瞻性研究中，出现了不同的 SCS 波形，这些波形显示出改善。对真实世界数据的分析表明了不同波形在 SCS 中的临床应用和效果。
对 208 例 FBSS 患者进行了 3 年的真实世界分析。在 FBSS 患者中植入具有持续性、爆发性、高密度和 10kHz 高频（HF10）波形的刺激器，这些患者的主要疼痛位于背部、腿部或背部和腿部。通过视觉模拟评分（VAS）测量疼痛，通过 Oswestry 残疾指数（ODI）测量功能障碍，通过 3 级欧洲五维健康量表（EQ5D-3L）问卷测量健康相关生活质量。在基线和结果评估时进行测量。
SCS 对 FBSS 患者有效。这项分析显示，24 个月时 VAS 评分从基线的 8.0 分降至 4.7 分（P<0.0001）。EQ5D-3L 评分从基线的 0.29 分提高到 0.49 分（P<0.0001）。ODI 评分从 54%降至 42%（P<0.0001）。意外取出率仅为 1.6%。
这项 SCS 研究显示，在 FBSS 患者的大型数据集，疼痛、残疾和生活质量得到了显著的长期改善。严格的选择程序和强有力的阿片类药物政策有助于提高成功率和降低意外取出率。在持续性刺激和 HF10 刺激之间，疼痛缓解没有差异。需要进一步研究以检测 SCS 中其他波形之间的任何差异。
