Tibial nerve stimulation with a miniature, wireless stimulator in chronic peripheral neuropathic pain

Abstract

Peripheral neuropathic pain (PNP) and complex regional pain syndrome (CRPS) can be effectively treated with peripheral nerve stimulation. In this clinical trial report, effectiveness of novel, miniature, wirelessly controlled microstimulator of tibial nerve in PNP and CRPS was evaluated. In this pilot study the average preoperative visual analog scale (VAS) score in six patients was 7.5, with 1, 3 and 6 months: 2.6 (p=0.03), 1.6 (p=0.03), and 1.3 (p=0.02), respectively. The mean average score in the six patients a week preceding the baseline visit was 7.96, preceding the 1, 3 and 6 month visits: 3.32 (p=0.043), 3.65 (p=0.045), and 2.49 (p=0.002), respectively. The average short-form McGill pain score before surgery was 23.8, and after 1, 3 and 6 months it was 11.0 (p=0.45), 6.3 (p=0.043), and 4.5 (p=0.01), respectively. Applied therapy caused a reduction of pain immediately after its application and clinical improvement was sustained on a similar level in all patients for six months. No complications of the treatment were observed. Intermittent tibial nerve stimulation by using a novel, miniature, wirelessly controlled device can be effective and feasible in PNP and CRPS. It is a safe, minimally invasive, and convenient neuromodulative method.

Evidence-Based Clinical Guidelines from the American Society of Pain and Neuroscience for the Use of Implantable Peripheral Nerve Stimulation in the Treatment of Chronic Pain

“…A number of retrospective case studies and small case series have been published reporting clinical benefit of PNS in the lower extremity, including many conducted within larger, heterogenous patient cohorts. 2,[65][66][67][68][69][70][71][72][73][74][75][76][77][78][79][80][81][82]…”

ReStore: A wireless peripheral nerve stimulation system

“…Removing the battery and leads from the IPG would eliminate these two common IPG failure modes. Multiple groups have demonstrated proofs of concept of such miniaturized battery-less IPGs in animal models and in humans using various power transfer modalities [15][16][17][18][19][20][21][22][23][24][25][26][27]. Despite this, only two of such devices, the Bioness StimRouter and the Stimwave Freedom, have been approved for use in humans by the FDA.…”

A novel leadless, miniature implantable Tibial Nerve Neuromodulation System for the management of overactive bladder complaints

“…Thereafter, the implant was sutured to the fascia. The procedure was described in details by Sokal et al and van Breda et al All 36 procedures were performed without intraprocedural complications.…”