• Frédérique Mol, Marc Scheltinga, Rudi Roumen, Frank Wille, Ismail Gültuna, Jan-Willem Kallewaard, Lars Elzinga, Johan van de Minkelis, Harold Nijhuis, Dirk L Stronks, and HuygenFrank J P MFJPMMaxima Medical Center, Eindhoven, The Netherlands..
• Maxima Medical Center, Eindhoven, The Netherlands. Electronic address: frederique.mol89@gmail.com.
• Neuromodulation. 2023 Dec 1; 26 (8): 178817941788-1794.

ObjectivesApproximately 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.Materials And MethodsIn 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.ResultsFifteen 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.ConclusionsDRG 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.Clinical Trial RegistrationThe Clinicaltrials.gov registration number for the study is NCT02349659.Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.

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