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

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          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.

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          Most cited references 26

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          The dorsal root ganglion in chronic pain and as a target for neuromodulation: a review.

           Elliot Krames (2015)
          In the not-too-distant past, the dorsal root ganglion (DRG) was portrayed as a passive neural structure without involvement in the development or maintenance of chronic neuropathic pain (NP). The DRG was thought of as a structure that merely "supported" physiologic communication between the peripheral nervous system (PNS) and the central nervous system (CNS). Newer scientific information regarding the anatomic and physiologic changes that occur within the DRG as a result of environmental pressures has dispelled this concept and suggests that the DRG is an active participant in the development of NP. This new information, along with new clinical data showing that stimulation of the DRG reduces intensity of pain, suggests that the DRG can be a robust target for neuromodulation therapies.
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            Electrical spinal-cord stimulation for painful diabetic peripheral neuropathy.

            Conventional treatment for painful peripheral diabetic neuropathy is largely symptomatic and often ineffective, with unacceptable side-effects. We tested electrical spinal-cord stimulation for the management of chronic neuropathic pain. Ten diabetic patients who did not respond to conventional treatment (mean age 51 [SD 9.3] years, six with type II diabetes, mean duration of diabetes 12 [6.3] years, mean duration of neuropathy 5 [2.1] years) were studied. The electrode was implanted in the thoracic/lumbar epidural space. Immediate neuropathic pain relief was assessed by visual analogue scale (VAS) after connecting the electrode, in a random order, to a percutaneous electrical stimulator or to a placebo stimulator. Exercise tolerance was assessed on a treadmill. Eight subjects had statistically significant pain relief with the electrical stimulator (p < 0.02) and were therefore converted to a permanent system. Statistically significant relief of both background and peak neuropathic pain was achieved at 3 months (n = 7, p = 0.016), at 6 months (n = 7, p = 0.03), and at the end of the study (14 months, n = 7, background pain p = 0.06, peak pain p = 0.03). One patient died 2 months after the start of the study of unrelated cause while continuing to benefit from treatment and another patient ceased to benefit at 4 months. McGill pain questionnaire scores with the stimulator turned off did not change significantly from baseline scores, indicating that the severity of the underlying pain was unaltered. However, with the stimulator turned on, there was a statistically significant (p < 0.05) improvement in all four components of the score, by the end of the study. At the end of the study, six patients continued to gain significant pain relief and used the stimulator as the sole treatment for their neuropathic pain. For example, median background and peak pain scores at the end of study, were, respectively, 77 and 81 with the stimulator off and 23 and 20 with the stimulator on. Exercise tolerance significantly improved at 3 months (n = 7, median % increase 85 [IQR, 62-360], p = 0.015) and at 6 months (n = 6, 163 [61-425], p = 0.0007). Electrophysiological tests, vibration perception-threshold, and glycaemic control were unchanged. Electrical spinal-cord stimulation offers a new and effective way of relieving chronic diabetic neuropathic pain and improves exercise tolerance. The technique should be considered in patients with neuropathic pain who do not respond to conventional treatment.
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              Long-term results of peripheral nerve stimulation for reflex sympathetic dystrophy.

              This prospective, consecutive series describes peripheral nerve stimulation (PNS) for treatment of severe reflex sympathetic dystrophy (RSD) or complex regional pain syndrome, in patients with symptoms entirely or mainly in the distribution of one major peripheral nerve. Plate-type electrodes were placed surgically on affected nerves and tested for 2 to 4 days. Programmable generators were implanted if 50% or more pain reduction and objective improvement in physical changes were achieved. Patients were followed for 2 to 4 years and a disinterested third-party interviewer performed final patient evaluations. Of 32 patients tested, 30 (94%) underwent permanent PNS placement. Long-term good or fair relief was experienced in 19 (63%) of 30 patients. In successfully treated patients, allodynic and spontaneous pain was reduced on a scale of 10 from 8.3 +/- 0.3 preimplantation to 3.5 +/- 0.4 (mean +/- standard error of the mean) at latest follow up (p<0.001). Changes in vasomotor tone and patient activity levels were markedly improved but motor weakness and trophic changes showed less improvement. Six (20%) of the 30 patients undergoing PNS placement returned to part-time or full-time work after being unemployed prestimulator implantation. Initial involvement of more than one major peripheral nerve correlated with a poor or no relief rating (p<0.01). Operative modifications that minimize technical complications are described. This study indicates that PNS can provide good relief for RSD that is limited to the distribution of one major nerve.
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                Author and article information

                Journal
                J Pain Res
                J Pain Res
                Journal of Pain Research
                Journal of Pain Research
                Dove Medical Press
                1178-7090
                2017
                15 March 2017
                : 10
                : 613-619
                Affiliations
                [1 ]Department of Neurosurgery, Military Research Hospital, Bydgoszcz
                [2 ]Department of Public Health, Ludwik Rydygier Collegium Medicum, Bydgoszcz, Nicolaus Copernicus University, Toruń
                [3 ]Department of Sports Medicine, University of Physical Education and Sport, Gdansk, Poland
                Author notes
                Correspondence: Paweł Sokal, Department of Neurosurgery, The 10th Military Research Hospital, Powstancow Warszawy Street 5, 85-681 Bydgoszcz, Poland, Tel +48 261 417 093, Fax +48 261 417 094, Email psokal@ 123456wp.pl
                Article
                jpr-10-613
                10.2147/JPR.S128861
                5359134
                © 2017 Sokal et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Categories
                Clinical Trial Report

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