Implantation Of Peripheral Nerve Stimulation Research Articles

Is Response to a Pre-implant Diagnostic Peripheral Nerve Block Associated With Efficacy After Peripheral Nerve Stimulation Implantation? A Ten-Year Enterprise-Wide Analysis

ObjectivesThis study aimed to assess whether patient response to targeted diagnostic peripheral nerve block before peripheral nerve stimulator (PNS) device implantation is associated with efficacy after PNS implantation. Materials and MethodsThe electronic medical records from the Mayo Clinic Enterprise (three quarternary care medical centers and additional satellite medical centers) were reviewed to identify patients who underwent PNS implantation between January 2014 and January 2023. A primary outcome of interest was to assess whether administration of a preimplant diagnostic peripheral nerve block predicted pain relief at three months and six months after temporary and permanent PNS implantation. Another primary outcome was to investigate whether there was an association between the pain relief from a preimplant diagnostic peripheral nerve block and pain relief after three and six months after temporary or permanent PNS therapy. Linear regression analysis was conducted for outcomes of interest. ResultsOf 193 eligible patients who underwent PNS therapy, a total of 173 patients were included in the final analysis and were stratified into either the temporary PNS cohort (n = 112) or the permanent PNS cohort (n = 61). Overall, 77.5% of all patients (134/173) underwent a preimplant diagnostic peripheral nerve block and reported a mean percentage relief of 70.1 ± 27.0 from the diagnostic block. Of patients in the temporary PNS cohort, there was no difference in postimplant percentage pain relief between patients who received a diagnostic block (n = 93) and control patients (n = 19) at three months (35.4 ± 36.0 vs 49.8 ± 36.1, respectively; β −14.45, 95% CI −32.98 to 4.07, p = 0.125) or at six months (23.3 ± 30.8 vs 45.7 ± 40.0, respectively; β −22.39, 95% CI −46.86 to 2.08, p = 0.072). Of patients in the permanent PNS cohort, there was no difference in postimplant percentage pain relief between patients who received a diagnostic block (n = 41) and control patients (n = 20) at three months (42.4 ± 34.3 vs 43.2 ± 42.4, respectively; β −0.79, 95% CI −23.56 to 21.99, p = 0.945) or at six months (44.3 ± 35.0 vs 38.8 ± 40.9, respectively; β 5.42, 95% CI −20.04 to 30.88, p = 0.669). Pain relief from preimplant diagnostic blocks was associated with postimplant pain relief from temporary PNS at three months (β 0.33, 95% CI 0.04–0.61, p = 0.025). However, pain relief from preimplant diagnostic blocks did not predict postimplant pain relief from temporary PNS at six months, or permanent PNS at three months and six months. ConclusionsAdministration of a diagnostic block is not associated with superior pain relief at three or six months after PNS implantation to that of an approach without diagnostic block. Pain relief from a diagnostic block may potentially predict short-term pain relief after temporary PNS therapy, although future prospective studies are warranted to evaluate the prognostic utility of diagnostic blocks.

Genitofemoral peripheral nerve stimulator implantation for refractory groin pain: a case report.

Genitofemoral neuralgia (GFN) is a chronic pain condition that may be refractory to commonly employed treatment modalities. Implantation of a peripheral nerve stimulator (PNS) may provide significant pain relief; however, few reports have described placement of and response to a GFN PNS implant. We implanted a StimRouter® PNS in a 42-yr-old male with severe GFN that did not respond to pharmacologic and interventional pain management modalities and impaired all aspects of his function and quality of life. The often-challenging sonographic visualization of the genitofemoral nerve was aided by intraprocedural sensory mapping using a stimulating probe. Preoperatively, the patient's average pain was rated as 7 on a 0 to 10 numeric rating scale. Following the procedure, the patient experienced over 90% pain relief after one week. At one and five months post implantation, the patient's average pain scores were 1 and 0.5, respectively. The patient also reported substantial improvement in the physical component scores on the 12-Item Short Form Survey (SF-12), which remained similar at the five-month follow-up (from 26.1 preop to 57.2 at one month and 49.7 at five months). Peripheral nerve stimulator implantation may be a promising intervention when other analgesic modalities fail to manage refractory GFN. Further research to verify the effectiveness of this intervention and evaluate for appropriate integration in patient care is required.

Real-world evidence of sustained improvement following 60-day peripheral nerve stimulation treatment for pain: a cross-sectional follow-up survey.

Objective: This study presents real-world data from a cross-sectional follow-up survey of patients who previously received 60-day peripheral nerve stimulation (PNS) treatment for pain. Materials & methods: A survey including validated pain and other related outcome measures was distributed to patients who previously underwent implantation of temporary PNS leads for 60-day PNS treatment. Results: Among survey respondents who were at least 3months from the start of treatment, mostreported sustained clinically significant improvements in pain and/or quality of life, with the length of follow-up at the time of survey completion ranging from 3 to30months. Conclusion: These real-world data support recent prospective studies indicating that 60-day percutaneous PNS provides significant and sustained relief across a wide range of pain conditions.

Considerations in permanent implantation of peripheral nerve stimulation (PNS) for chronic neuropathic pain: An international cross-sectional survey of implanters.

Novel minimally invasive short-term and long-term peripheral nerve stimulation (PNS) systems have revolutionized targeted treatment of chronic neuropathic pain. We present an international survey of PNS-implanting pain physicians to assess what factors they consider when offering permanent PNS. This cross-sectional study consisted of a survey (Qualtrics) that was distributed to PNS-implanting physicians in a device supplier's entire email database on November 13, 2020, with 3weeks of response time. Physicians' contact information in the form of their email addresses had been previously collected by the supplier upon device distribution with permission to use survey responses for research. Of 2032 database physicians, 40 physicians representing 37 institutions responded to the survey. The most common application of PNS was mononeuropathic pain (57%). The most frequently targeted nerve was the suprascapular nerve (29%). 14% of physicians reported 81-100% of their implants were dual-lead. The representative physicians ranged broadly in their most frequently targeted nerves. Although mononeuropathic pain was the most common indication for PNS, there was still varied response regarding other indications such as CRPS and post-surgical chronic pain. In context of a low response rate, identifying such factors can help update the prevailing treatment algorithm for interventional therapies, assist pain physicians in better identifying which patients are the best candidates for PNS, and inform future clinical trial design on PNS efficacy.

Successful Treatment of Occipital Neuralgia in a Pediatric Patient with the Use of Peripheral Nerve Stimulator: A Case Report

BACKGROUND: Neuromodulation is a commonly used technique in adult pain management, with current off-label use of peripheral nerve stimulators for the treatment of occipital neuralgia. This targeted therapy can help avoid systemic medications and treat refractory symptoms. CASE REPORT: We present a 17-year-old boy with significant lesser occipital neuralgia and hydrocephalus status post ventriculoperitoneal shunt placement. He had occipital neuralgia treatment failures with both medication trials and surgical decompression in conjunction with physical and psychological therapies, eventually requiring weekly lesser occipital nerve blocks for pain relief. Our patient experienced a substantial reduction in pain and increase in functional recovery after the placement of a permanent peripheral nerve stimulator without disruption of his ventriculoperitoneal shunt. CONCLUSION: Peripheral nerve stimulator implantation can be safe and efficacious for the treatment of refractory occipital neuralgia in a pediatric patient with an ipsilateral ventriculoperitoneal shunt. KEY WORDS: Peripheral nerve stimulation, occipital neuralgia, pediatric, chronic pain, neuromodulation

Techniques for Peripheral Nerve Stimulator Implantation of the Upper Extremity.

To present a technical note on how to perform upper extremity peripheral nerve stimulators for three major nerves: median, ulnar, and radial. Literature review and expert opinion. Single academic center. Peripheral nerve stimulation has recently become popular with the development and availability of peripheral nerve stimulators with an external pulse generator. Here, we describe ultrasound anatomy and technical details for peripheral nerve stimulation in the upper extremity for three major nerves: median, ulnar, and radial. Upper extremity peripheral nerve stimulation can be considered as an option for refractory neuropathic upper extremity pain.

Ultrasound-Guided Intercostal Peripheral Nerve Stimulator Implantation: Technique Report and Feasibility Study in a Cadaver.

This study aimed to describe and validate a novel ultrasound-guided intercostal peripheral nerve stimulator implantation technique. The fifth to tenth ribs on both sides of an unembalmed cadaveric specimen were localized using a 15-6-MHz linear array transducer, counting distally from T-1 bilaterally. A single interventionist then implanted 12 peripheral nerve stimulators on the fifth through tenth ribs, six MicroLeads on the left side and six StimRouters on the right side, using an in-plane lateral to medial approach to the inferior border of the corresponding rib. After all the stimulators were implanted, their location was confirmed using fluoroscopy. Gross anatomic dissection was later performed for each of the stimulators placed, and the distance of the lead from the intercostal nerve and pleura was noted. All leads were noted in an accurate position in the plane between the inner and innermost intercostal muscle, without any intrapleural placement. The distance of the leads from the intercostal nerves was on average 2.3 mm and 1.1 mm for MicroLead and StimRouter, respectively. To our knowledge, this study is the first to determine the feasibility of ultrasound-guided peripheral nerve stimulator placement in close proximity to the pleura. All the stimulator leads were accurately placed using our ultrasound-guided technique and were within 0.5-3 mm from the intercostal nerve. Although this technique might prove technically challenging, the use of ultrasound for intercostal peripheral nerve stimulator implantation appears feasible and warrants further investigation to establish this as an acceptable technique for patients.

Novel technique for trialing peripheral nerve stimulation: ultrasonography-guided StimuCath trial.

OBJECTIVE Peripheral nerve stimulation (PNS) has been used for the treatment of neuropathic pain for many decades. Despite the specific indications for PNS, clinicians often have difficulty screening for candidates likely to have a good or fair outcome. Given the expense of a permanent implant, most insurance companies will not pay for the implant without a successful PNS trial. And since PNS has only recently been approved by the US Food and Drug Administration, many insurance companies will not pay for a conventional trial of PNS. The objective of this study is to describe a short low-cost method for trialing and screening patients for peripheral nerve stimulator implantation. Additionally, this study demonstrates the long-term efficacy of PNS in the treatment of chronic neuropathic pain and the relative effectiveness of this novel screening method. METHODS The records of all patients who had undergone trialing and implantation of a PNS system for chronic refractory pain at the authors' institution over a 1-year period (August 1, 2012-July 31, 2013) were examined in this retrospective case series. The search revealed 17 patients, 13 who had undergone a novel in-office ultrasonography-guided StimuCath screening technique and 4 who had undergone a traditional week-long screening procedure. All 17 patients experienced a successful PNS trial and proceeded to permanent PNS system implantation. Patients were followed up for a mean duration of 3.0 years. Visual analog scale (VAS) pain scores were used to assess pain relief in the short-term (< 6 weeks), at 1 year, and at the last follow-up. Final outcome was also characterized as good, fair, poor, or bad. RESULTS Of these 17 patients, 10 were still using their stimulator at the last follow-up, with 8 of them obtaining good relief (classified as ≥ 50% pain relief, with an average 81% reduction in the VAS score) and 2 patients attaining fair relief (< 50% relief but still using stimulation therapy). Among the remaining 7 patients, the stimulator had been explanted in 4 and there had been no relief in 3. Excluding explanted cases, follow-up ranged from 14 to 46 months, with an average of 36 months. Patients with good or fair relief had experienced pain prior to implantation for an average of 5.1 years (range 1.8-15.2 years). A longer duration of pain trended toward a poorer outcome (bad outcome 7.6 years vs good outcome 4.1 years, p = 0.03). Seven (54%) of the 13 patients with the shorter trial experienced a good or fair outcome with an average 79% reduction in the VAS score; however, all 4 of the bad outcome cases came from this group. Three (75%) of the 4 patients with the longer trial experienced a good or fair outcome at the last follow-up, with an average 54% reduction in the VAS score. There was no difference between the trialing methods and the proportion of favorable (good or fair) outcomes (p = 0.71). CONCLUSIONS Short, ultrasonography-guided StimuCath trials were feasible in screening patients for permanent implantation of PNS, with efficacy similar to the traditional week-long screening noted at the 3-year follow-up.

Long-Term Clinical Outcome of Peripheral Nerve Stimulation for Chronic Headache and Complication Prevention.

BackgroundSubcutaneous peripheral nerve stimulation (PNS) has emerged as a useful tool in the treatment of intractable headaches. However, complications such as skin erosion, infection and lead migration have adversely affected clinical outcome, and occasionally led to treatment cessation.ObjectivesHere we report the results of peripheral nerve stimulator implantation performed on 24 patients with various chronic headaches at our center over a period of 9 years. We describe the complications of the procedure and their prevention with a modified surgical technique.Patients and MethodsWe searched our database for patients with chronic refractory headaches who had undergone PNS. Patients were assessed before being considered for PNS, and their pain characteristics were reviewed. Following a successful trial, patients were implanted with a permanent peripheral nerve stimulator. Selection of target nerves was based on headache diagnosis and head pain characteristics. Patients were followed for an average of 4.9 years. Headache characteristics before and after treatment were compared.ResultsTwenty four patients were included in the study. All patients reported on improvement in head pain intensity, duration and frequency three months after permanent device implantation Mean total pain index (TPI) decreased significantly, from 516 ± 131 before the procedure to 74.8 ± 61.6 at the last follow up (P < 0.00001). There were no acute post-operative infections. Three patients had their stimulator removed. The self-rated treatment satisfaction was excellent in 54% of the patients, very good or good in 42%, and fair in 4%.ConclusionsOur results support the use of PNS in some patients with refractory chronic headaches. Appropriate surgical planning and technique are important to achieve good clinical outcome and to minimize complications.

Challenges of Peripheral Nerve Stimulator Implantation in a Patient with New Onset Thrombocytopenia

Interventional procedures in the setting of multimodal practice are an often used treatment approach to chronic pain. Advanced technologies such as neuromodulation by way of peripheral nerve stimulation (PNS) is a promising frontier. Patients offered this technique have often failed conservative management, a series of injections and are not favorable candidates for pursuing spinal cord stimulation (SCS). A major goal for chronic pain treatment is the improvement of quality of life, return to work and activity. The spectrum of clinical situations where PNS has been successfully used includes chronic pain in extremities, neck, lower back, chest and abdominal wall, and head and face regions. It is also a widely accepted technique in the management of postsurgical neuropathy. We present a patient with complex regional pain syndrome (CRPS)-like symptoms of the lateral femoral cutaneous nerve after laparoscopic hysterectomy who underwent successful ultrasound-guided PNS trial using SCS leads and unfortunate delayed implantation due to thrombocytopenia. From this case we learned the following: positioning for laparoscopic hysterectomy may not be a readily attributed etiology for injury to the lateral femoral cutaneous nerve amongst some nonsurgical specialties; PNS is a viable option where SCS use is unfavorable; the use of spinal cord stimulator leads are useful in PNS trials, but may be less desirable for long term therapy; institution of basic coagulation screening at the time of trial rather than implantation in low risk candidates remains controversial.

A Systematic Review of Peripheral Nerve Interventional Treatments for Chronic Headaches

This study aimed to systematically compare the outcomes of different types of interventional procedures offered for the treatment of headaches and targeted toward peripheral nerves based on available published literature. Multiple procedural modalities targeted at peripheral nerves are being offered to patients for the treatment of chronic headaches. However, few resources exist to compare the effectiveness of these modalities. The objective of this study was to systematically review the literature to compare the published outcomes and effectiveness of peripheral nerve surgery, radiofrequency (RF) therapy, and peripheral nerve stimulators for chronic headaches, migraines, and occipital neuralgia. A broad literature search of the MEDLINE and CENTRAL (Cochrane) databases was undertaken. Relevant studies were selected by 2 independent reviewers and these results were narrowed further by the application of predetermined inclusion and exclusion criteria. Studies were assessed for quality, and data were extracted regarding study characteristics (study type, level of evidence, type of intervention, and number of patients) and objective outcomes (success rate, length of follow-up, and complications). Pooled analysis was performed to compare success rates and complications between modality types. Of an initial 250 search results, 26 studies met the inclusion criteria. Of these, 14 articles studied nerve decompression, 9 studied peripheral nerve stimulation, and 3 studied RF intervention. When study populations and results were pooled, a total of 1253 patients had undergone nerve decompression with an 86% success rate, 184 patients were treated by nerve stimulation with a 68% success rate, and 131 patients were treated by RF with a 55% success rate. When compared to one another, these success rates were all statistically significantly different. Neither nerve decompression nor RF reported complications requiring a return to the operating room, whereas implantable nerve stimulators had a 31.5% rate of such complications. Minor complication rates were similar among all 3 procedures. Of the 3 most commonly encountered interventional procedures for chronic headaches, peripheral nerve surgery via decompression of involved peripheral nerves has been the best-studied modality in terms of total number of studies, level of evidence of published studies, and length of follow-up. Reported success rates for nerve decompression or excision tend to be higher than those for peripheral nerve stimulation or for RF, although poor study quantity and quality prohibit an accurate comparative analysis. Of the 3 procedures, peripheral nerve stimulator implantation was associated with the greatest number of complications. Although peripheral nerve surgery seems to be the interventional treatment modality that is currently best supported by the literature, better controlled and normalized high-quality studies will help to better define the specific roles for each type of intervention.

Ultrasound-Guided Permanent Implantation of Peripheral Nerve Stimulation (PNS) System for Neuropathic Pain of the Extremities: Original Cases and Outcomes

Our objective is to describe our experience applying a minimally invasive, ultrasound-assisted technique for peripheral nerve stimulation (PNS) trial and permanent implantation in patients with neuropathic extremity pain. Retrospective case series and review of the literature. Setting. Tertiary referral center and academic medical center. Patients with upper or lower extremity neuropathic pain resistant to other therapies who responded to an ultrasound-guided peripheral nerve block at a proximal location. Interventions. Ultrasound-assisted through-the-needle placement of percutaneous neurostimulation electrodes on target major peripheral nerves for fully percutaneous trial, staged trial or permanent implantation of PNS system. A PNS trial period of 3-7 days was used. Pain relief at last follow-up, complications, therapeutic limitations due to technique as applied. Results. Six of eight (75%) patients and 7/9 (78%) peripheral nerves had a successful trial and underwent permanent PNS system implantation using a minimally invasive, ultrasound-assisted technique from November 2007 to December 2008. All but one patient with an implanted PNS system had > or =50% pain relief at last follow-up and 3/7 (43%) permanent systems were associated with > or =80% relief. Loss of paresthesia required revision to dual-lead systems in upper extremity radial nerve PNS. Infection led to explant in one case. In a small series of patients, a minimally invasive, ultrasound-assisted technique for PNS trial, and permanent PNS implantation proved feasible. Patients without adequate analgesia during neurostimulation trial avoided surgical incision and those undergoing permanent implantation were not subjected to the potential morbidity associated with nerve dissection.

A retrospective analysis of reasons for reoperation following initially successful peripheral nerve stimulation

The authors investigated the causes for surgical reexploration in patients with complex regional pain syndrome Type II who received initial relief of pain from implantation of a peripheral nerve stimulator (PNS). The authors reviewed the charts of 11 consecutive patients who underwent a total of 27 PNS-related operations at one institution. Duration of follow up ranged from 5 days to more than 24 months. Of 11 patients who received PNS implants, seven (64%) required one or more additional surgeries to relocate the PNS because initial pain relief following stimulation was lost and not restored by changing pulse generator settings. Loss of analgesia was attributed to migration of the sutured electrode strip paddle (nine [33%] of 27 surgeries), infection (four [15%] of 27), and the need for placement in an alternative location (three [11%] of 27). Although infection is attributable to surgical technique, most complications requiring repeated surgery (nine [33%] of 27) are caused by equipment design. Changes in PNS design or in implantation technique might substantially reduce the need for reoperation after PNS implantation.