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.

Keywords:

• tibial nerve stimulation
• peripheral nerve stimulation
• miniature stimulator
• peripheral neuropathic pain
• complex regional pain syndrome

Acknowledgments

This study was sponsored by BlueWind Co. The authors thank the staff of BlueWind Co., especially Limor Kuznits for her support and knowledge.

Author contributions

The study was designed by BlueWind. Paweł Sokal, Sara Kierońska, Piotr Zieliński, and Marek Harat conducted the study including recruitment of patients. Data collection and data analysis were performed by Paweł Sokal and Sara Kierońska. Manuscript was prepared by Paweł Sokal with substantial intellectual input of Marek Harat and Sara Kierońska. All authors contributed toward data analysis, drafting and revising the paper and agree to be accountable for all aspects of the work.

Disclosure

The authors received payment for conduction of this study. The authors report no other conflicts of interest in this work.