Safety Of Peripheral Nerve Stimulation Research Articles

ID: 222501 Early Outcomes From a Randomized Control Trial for the Treatment of Peripheral Neuralgia

A battery-free, peripheral nerve stimulation (PNS) system with a micro-implantable pulse generator (mIPG; Nalu Medical, Inc., Carlsbad, CA) delivers stimulation to peripheral nerves to treat chronic peripheral neuralgia. An ongoing, randomized clinical trial (RCT) was initiated to document the comparative effectiveness and safety of peripheral nerve stimulation plus conventional medical management (CMM; active arm) versus CMM alone (control arm) in the treatment of chronic, intractable peripheral neuralgia of post-traumatic or post-surgical origin.

Temporomandibular joint syndrome treatment with peripheral nerve stimulation

Introduction: Temporomandibular joint syndrome is defined by a triad of intense joint pain together with restriction of mouth opening and jaw clicking. The objective of this study is to evaluate the efficacy and safety of peripheral nerve stimulation for the treatment of this pathology. Material and Methods: A retrospective study was conducted. All patients met selection criteria that include prior resistance to medical or surgical treatment and completion of a series of pre-surgical tests. An octopolar electrode was implanted in the affected preauricular region. The results were measured using the Analog Pain Scale, a short questionnaire on pain, improvement of restriction in mouth opening and reduction of analgesic medication.Results: A total of 10 patients with 14 performed procedures were included. The mean reduction in pain measured by VAS was 86.2% at one month and 79% at one year after surgery. All patients experienced a drastic improvement in pain and its impact according to the Brief Pain Inventory, the mean improvement being 90% at 4 weeks and 82% at one year. There was an improvement in the mean oral opening of 10.14 mm (minimum of 4 and maximum of 13 mm). One case was excluded due to the complication demanding the system removal.Conclusions: Patients with temporomandibular joint syndrome who do not respond to conventional treatments are ideal candidates for peripheral nerve stimulation, showing improvement in pain, oral restriction, and quality of life with a low percentage of serious complications.

Peripheral Nerve Stimulation in Pain Management: A Systematic Review

Peripheral nerve stimulation (PNS) has been increasingly used to manage acute and chronic pain. However, the level of clinical evidence to support its use is not clear. To assess the clinical evidence of PNS in the treatment of acute or chronic pain. A systematic review of the efficacy and safety of PNS in managing acute or chronic pain. Data sources were PubMed, Cochrane Library, Scopus, CINAHL Plus, Google Scholar, and reference lists. The literature search was performed up to December 2019. Study selection included randomized trials, observational studies, and case reports of PNS in acute or chronic pain. Data extraction and methodological quality assessment were performed utilizing Cochrane review methodologic quality assessment and Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB) and Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment for Nonrandomized Studies (IPM-QRBNR). The evidence was summarized utilizing principles of best evidence synthesis on a scale of 1 to 5. Data syntheses: 227 studies met inclusion criteria and were included in qualitative synthesis. Evidence synthesis based on randomized controlled trials (RCTs) and observational studies showed Level I and II evidence of PNS in chronic migraine headache; Level II evidence in cluster headache, postamputation pain, chronic pelvic pain, chronic low back and lower extremity pain; and Level IV evidence in peripheral neuropathic pain, and postsurgical pain. Peripheral field stimulation has Level II evidence in chronic low back pain, and Level IV evidence in cranial pain. Lack of high-quality RCTs. Meta-analysis was not possible due to wide variations in experimental design, research protocol, and heterogeneity of study population. The findings of this systematic review suggest that PNS may be effective in managing chronic headaches, postamputation pain, chronic pelvic pain, and chronic low back and lower extremity pain, with variable levels of evidence in favor of this technique.

Safety and efficacy of peripheral nerve stimulation of the occipital nerves for the management of chronic migraine: long-term results from a randomized, multicenter, double-blinded, controlled study.

Recent studies evaluated short-term efficacy and safety of peripheral nerve stimulation (PNS) of the occipital nerves for managing chronic migraine. We present 52-week safety and efficacy results from an open-label extension of a randomized, sham-controlled trial. In this institutional review board-approved, randomized, multicenter, double-blinded study, patients were implanted with a neurostimulation system, randomized to an active or control group for 12 weeks, and received open-label treatment for an additional 40 weeks. Outcomes collected included number of headache days, pain intensity, migraine disability assessment (MIDAS), Zung Pain and Distress (PAD), direct patient reports of headache pain relief, quality of life, satisfaction and adverse events. Statistical tests assessed change from baseline to 52 weeks using paired t-tests. Intent-to-treat (ITT) analyses of all patients (N = 157) and analyses of only patients who met criteria for intractable chronic migraine (ICM; N = 125) were performed. Headache days were significantly reduced by 6.7 (±8.4) days in the ITT population (p < 0.001) and by 7.7 (±8.7) days in the ICM population (p < 0.001). The percentages of patients who achieved a 30% and 50% reduction in headache days and/or pain intensity were 59.5% and 47.8%, respectively. MIDAS and Zung PAD scores were significantly reduced for both populations. Excellent or good headache relief was reported by 65.4% of the ITT population and 67.9% of the ICM population. More than half the patients in both cohorts were satisfied with the headache relief provided by the device. A total of 183 device/procedure-related adverse events occurred during the study, of which 18 (8.6%) required hospitalization and 85 (40.7%) required surgical intervention; 70% of patients experienced an adverse event. Our results support the 12-month efficacy of PNS of the occipital nerves for headache pain and disability associated with chronic migraine. More emphasis on adverse event mitigation is needed in future research. Clinical trials.gov (NCT00615342).