Mol Frédérique, Scheltinga Marc, Roumen Rudi, Wille Frank, Gültuna Ismail, Kallewaard Jan-Willem, Elzinga Lars, van de Minkelis Johan, Nijhuis Harold, Stronks Dirk L, Huygen Frank J P M
Maxima Medical Center, Eindhoven, The Netherlands.
Maxima Medical Center, Eindhoven, The Netherlands.
Neuromodulation. 2023 Dec;26(8):1788-1794. doi: 10.1016/j.neurom.2022.09.014. Epub 2022 Nov 29.
Approximately 10% of patients who undergo inguinal hernia repair or Pfannenstiel incision develop chronic (> three months) postsurgical inguinal pain (PSIP). If medication or peripheral nerve blocks fail, a neurectomy is the treatment of choice. However, some patients do not respond to this treatment. In such cases, stimulation of the dorsal root ganglion (DRG) appears to significantly reduce chronic PSIP in selected patients.
In this multicenter, randomized controlled study, DRG stimulation was compared with conventional medical management (CMM) (noninvasive treatments, such as medication, transcutaneous electric neurostimulation, and rehabilitation therapy) in patients with PSIP that was resistant to a neurectomy. Patients were recruited at a tertiary referral center for groin pain (SolviMáx, Eindhoven, The Netherlands) between March 2015 and November 2016. Suitability for implantation was assessed according to the Dutch Neuromodulation Association guidelines. The sponsor discontinued the study early owing to slow enrollment. Of 78 planned patients, 18 were randomized (DRG and CMM groups each had nine patients). Six patients with CMM (67%) crossed over to DRG stimulation at the six-month mark.
Fifteen of the 18 patients met the six-month primary end point with a complete data set for a per-protocol analysis. Three patients with DRG stimulation had a negative trial and were lost to follow-up. The average pain reduction was 50% in the DRG stimulation and crossover group (from 6.60 ± 1.24 to 3.28 ± 2.30, p = 0.0029). Conversely, a 13% increase in pain was observed in patients with CMM (from 6.13 ± 2.24 to 6.89 ± 1.24, p = 0.42). Nine patients with DRG stimulation experienced a total of 19 adverse events, such as lead dislocation and pain at the implantation site.
DRG stimulation is a promising effective therapy for pain relief in patients with PSIP resistant to conventional treatment modalities; larger studies should confirm this. The frequency of side effects should be a concern in a new study.
The Clinicaltrials.gov registration number for the study is NCT02349659.
接受腹股沟疝修补术或耻骨联合上横切口手术的患者中，约10%会出现慢性（超过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，神经切除术是首选治疗方法。然而，部分患者对此治疗无反应。在此类情况下，刺激背根神经节（DRG）似乎能显著减轻部分患者的慢性PSIP。
在这项多中心随机对照研究中，将DRG刺激与传统药物治疗（CMM）（非侵入性治疗，如药物、经皮电神经刺激和康复治疗）在对神经切除术耐药的PSIP患者中进行比较。2015年3月至2016年11月期间，在一家腹股沟疼痛三级转诊中心（荷兰埃因霍温的SolviMáx）招募患者。根据荷兰神经调节协会指南评估植入的适宜性。由于入组缓慢，申办方提前终止了研究。在计划的78例患者中，18例被随机分组（DRG组和CMM组各9例）。6例接受CMM治疗的患者（67%）在6个月时转而接受DRG刺激。
18例患者中有15例达到6个月的主要终点，有完整数据集用于符合方案分析。3例接受DRG刺激的患者试验结果为阴性且失访。DRG刺激组和交叉组的平均疼痛减轻了50%（从6.60±1.24降至3.28±2.30，p = 0.0029）。相反，接受CMM治疗的患者疼痛增加了13%（从6.13±2.24升至6.89±1.24，p = 0.42）。9例接受DRG刺激的患者共经历了19次不良事件，如导线移位和植入部位疼痛。
DRG刺激对于对传统治疗方式耐药的PSIP患者缓解疼痛是一种有前景的有效疗法；更大规模的研究应证实这一点。副作用的发生率在新研究中应予以关注。
该研究在Clinicaltrials.gov上的注册号为NCT02349659。
