Mol Frederique M U, Roumen Rudi M, Scheltinga Marc R
Department of Surgery, Maxima Medical Center, de Run 4600, PO Box 7777, 5500, MB, Veldhoven, The Netherlands.
BMC Surg. 2018 Mar 27;18(1):18. doi: 10.1186/s12893-018-0349-8.
A significant number of patients who undergo a standard inguinal hernia repair or a Pfannenstiel incision develop chronic (> 3 months) post-surgical inguinal pain (PSIP) due to nerve entrapment. If medication or peripheral nerve blocks fail, surgery including neurectomies may offer relief. However, some patients do not respond to any of the currently available remedial treatment modalities. Targeted spinal cord stimulation (SCS) of the dorsal root ganglion (DRG) is a relatively new type of therapy that has a potential to significantly reduce chronic PSIP. The Axium® SCS System (Spinal Modulation Inc., NY, USA) has been shown to be safe and successful in small cohorts of PSIP patients. Aim of this study is to evaluate targeted spinal cord stimulation therapy in patients with PSIP.
A prospective, multicentre, randomized controlled trial with optional one-way crossover will assess the efficacy of the Axium® SCS system for the treatment of PSIP. Seventy-eight patients with intractable PSIP following open hernia repair or Pfannenstiel incision who did not respond favorably to previous pain treatment regimens including a neurectomy will be randomized to either an Axium® SCS arm or a control arm receiving only conventional medical management (CMM). Primary outcome is the difference in percentage of subjects with ≥50% pain relief after 6 months using a Numerical Pain Rating Scale (NPRS). Data are collected using a daily pain/sleep diary and a number needed to treat (NNT) analysis is performed. Various secondary outcomes will be collected.
Targeted SCS stimulation of the DRG using the Axium® SCS system will possibly offer significant pain reduction in patients with PSIP who are refractory to other treatment modalities.
The study protocol is registered at the NIH Clinical Trials Registry ( http://clinicaltrials.gov , ClinicalTrials.gov identifier: NCT02349659 ) on January 29, 2015.
相当数量接受标准腹股沟疝修补术或Pfannenstiel切口手术的患者，因神经受压而出现慢性（>3个月）术后腹股沟疼痛（PSIP）。若药物治疗或外周神经阻滞无效，包括神经切除术在内的手术可能会缓解疼痛。然而，一些患者对目前可用的任何治疗方式均无反应。背根神经节（DRG）的靶向脊髓刺激（SCS）是一种相对新型的治疗方法，有可能显著减轻慢性PSIP。Axium® SCS系统（美国纽约州Spinal Modulation公司）已在小样本PSIP患者队列中显示出安全性和有效性。本研究的目的是评估PSIP患者的靶向脊髓刺激疗法。
一项前瞻性、多中心、随机对照试验，采用可选的单向交叉设计，将评估Axium® SCS系统治疗PSIP的疗效。78例开放性疝修补术或Pfannenstiel切口术后出现顽固性PSIP且对包括神经切除术在内的先前疼痛治疗方案反应不佳的患者，将被随机分为Axium® SCS组或仅接受传统药物治疗（CMM）的对照组。主要结局是使用数字疼痛评分量表（NPRS）在6个月后疼痛缓解≥50%的受试者百分比差异。通过每日疼痛/睡眠日记收集数据，并进行治疗所需人数（NNT）分析。将收集各种次要结局。
使用Axium® SCS系统对DRG进行靶向SCS刺激，可能会使对其他治疗方式难治的PSIP患者疼痛显著减轻。
该研究方案于2015年1月29日在美国国立卫生研究院临床试验注册中心（http://clinicaltrials.gov，ClinicalTrials.gov标识符：NCT02349659）注册。
