De Negri Pasquale, Paz-Solis Jose Francisco, Rigoard Philippe, Raoul Sylvie, Kallewaard Jan-Willem, Gulve Ashish, Thomson Simon, Canós-Verdecho Maria Angeles, Love-Jones Sarah, Williams Adam, Rascón-Ramírez Fernando J, Bayerl Simon, Llopis-Calatayud José Emilio, Peña Vergara Isaac, Matis Georgios K, Vesper Jan, Abejón David, Maino Paolo, Papa Alfonso, Pei Yu, Jain Roshini
Department of Anesthesia, Sant'Anna and San Sebastiano Hospital, Caserta, Italy.
Department of Neurosurgery, University Hospital La Paz, Madrid, Spain.
Interv Pain Med. 2023 Jun 24;2(3):100263. doi: 10.1016/j.inpm.2023.100263. eCollection 2023 Sep.
Spinal cord stimulation (SCS) is effective in treating chronic neuropathic pain. A screening trial is typically conducted prior to implantation to evaluate whether a patient is a good candidate for SCS. However, the need for a screening trial has been debated. We evaluated real-world clinical outcomes in patients who underwent a single-stage procedure to receive SCS therapy (i.e., no screening trial period) (SS-SCS).
This observational, multicentre, real-world consecutive case series evaluated SS-SCS chronic pain patients. Pain and other functional outcomes were collected as part of standard care by site personnel with no sponsor involvement. Assessments included Numerical rating scale (NRS), Percent Pain Relief (PPR) and EQ-5D-5L (EuroQol 5 Dimensions-5L), recorded prior to SCS and following implantation.
A total of 171 chronic pain patients (mean age: 59.4; 53.2% females) underwent a single-stage procedure (mean last follow-up, 408 days) and were included in the analysis. A 5.0 ± 2.1-point improvement in overall pain was reported at 3 months and sustained until the last follow-up post-implantation (p < 0.0001). At last follow-up, 50.3% (86/171) of patients reported an NRS pain score ≤3. Additionally, quality of life also improved (46.1-point change, from 70.2 to 25) at the last follow-up, based on EQ-5D-5L scores.
In routine clinical practice, SS-SCS can provide significant long-term pain relief and improve quality of life in chronic pain patients. Our results suggest that effective long-term outcomes and success may be achieved without a trial period prior to permanent implantation of an SCS system.
脊髓刺激（SCS）在治疗慢性神经性疼痛方面有效。通常在植入前进行筛选试验，以评估患者是否是SCS的合适人选。然而，筛选试验的必要性一直存在争议。我们评估了接受单阶段手术接受SCS治疗（即无筛选试验期）（SS-SCS）的患者的真实世界临床结局。
本观察性、多中心、真实世界连续病例系列评估了SS-SCS慢性疼痛患者。疼痛和其他功能结局由现场人员作为标准护理的一部分收集，无申办方参与。评估包括数字评分量表（NRS）、疼痛缓解百分比（PPR）和EQ-5D-5L（欧洲五维健康量表-5L），在SCS之前和植入后进行记录。
共有171例慢性疼痛患者（平均年龄：59.4岁；53.2%为女性）接受了单阶段手术（平均末次随访，408天）并纳入分析。据报告，3个月时总体疼痛改善了5.0±2.1分，并持续至植入后的最后一次随访（p<0.0001）。在最后一次随访时，50.3%（86/171）的患者报告NRS疼痛评分≤3。此外，根据EQ-5D-5L评分，在最后一次随访时生活质量也有所改善（变化46.1分，从70.2降至25）。
在常规临床实践中，SS-SCS可以为慢性疼痛患者提供显著的长期疼痛缓解并改善生活质量。我们的结果表明，在永久植入SCS系统之前无需试验期即可实现有效的长期结局和成功。
