The Neurostimulation Appropriateness Consensus Committee (NACC)®: Recommendations for the Mitigation of Complications of Neurostimulation.

INTRODUCTION: The International Neuromodulation Society convened a multispecialty group of physicians based on expertise and international representation to establish evidence-based guidance on the mitigation of neuromodulation complications. This Neurostimulation Appropriateness Consensus Committee (NACC)® project intends to update evidence-based guidance and offer expert opinion that will improve efficacy and safety. MATERIALS AND METHODS: Authors were chosen on the basis of their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature. Section leaders supervised literature searches of MEDLINE, BioMed Central, Current Contents Connect, Embase, International Pharmaceutical Abstracts, Web of Science, Google Scholar, and PubMed from 2017 (when NACC last published guidelines) to October 2023. Identified studies were graded using the United States Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on the strength of evidence or consensus when evidence was scant. RESULTS: The NACC examined the published literature and established evidence- and consensus-based recommendations to guide best practices. Additional guidance will occur as new evidence is developed in future iterations of this process. CONCLUSIONS: The NACC recommends best practices regarding the mitigation of complications associated with neurostimulation to improve safety and efficacy. The evidence- and consensus-based recommendations should be used as a guide to assist decision-making when clinically appropriate.

Blunted cardiovascular responses to exercise by inhibiting afferent feedback via spinal cord stimulation in heart failure.

This case study investigated the impact of SCS on alterations in blood pressure during constant-load exercise in a female patient with heart failure. Three different SCS frequencies [No SCS (~0 Hz), Low SCS (~100 Hz), and High SCS (~1000 Hz)] with and without ischaemic stimulation of the legs (cuffs) were randomly applied during constant-load exercise. To determine cardiovascular and ventilatory responses to exercise following SCS frequencies, BP, heart rate (HR), and respiratory gas exchange were measured. This experiment was duplicated in visit 1 and visit 2 with a random application of SCS frequency order and the data were averaged. There were no significant differences among three frequencies with no leg ischaemia. However, High SCS demonstrated lower BP, HR, and respiratory gas exchange relative to No SCS and Low SCS. SCS may be effective in improving cardiovascular and ventilatory responses in HF and high-frequency stimulation provides more clinical benefit; however, further studies are needed.

The current state of training in pain medicine fellowships: An Association of Pain Program Directors (APPD) survey of program directors.

INTRODUCTION: The Accreditation Council for Graduate Medical Education (ACGME) approved the first pain medicine fellowship programs over three decades ago, designed around a pharmacological philosophy. Following that, there has been a rise in the transition of pain medicine education toward a multidisciplinary interventional model based on a tremendous surge of contemporaneous literature in these areas. This trend has created variability in clinical experience and education amongst accredited pain medicine programs with minimal literature evaluating the differences and commonalities in education and experience of different pain medicine fellowships through Program Director (PD) experiences. This study aims to gather insight from pain medicine fellowship program directors across the country to assess clinical and interventional training, providing valuable perspectives on the future of pain medicine education. METHODS: This study involved 56 PDs of ACGME-accredited pain fellowship programs in the United States. The recruitment process included three phases: advanced notification, invitation, and follow-up to maximize response rate. Participants completed a standard online questionnaire, covering various topics such as subcategory fields, online platforms for supplemental education, clinical experience, postgraduate practice success, and training adequacy. RESULTS: Surveys were completed by 39/56 (69%) standing members of the Association of Pain Program Directors (APPD). All PDs allowed fellows to participate in industry-related and professional society-related procedural workshops, with 59% encouraging these workshops. PDs emphasized the importance of integrity, professionalism, and diligence for long-term success. Fifty-four percent of PDs expressed the need for extension of fellowship training to avoid supplemental education by industry or pain/spine societies. CONCLUSION: This study highlights the challenge of providing adequate training in all Pain Medicine subtopics within a 12-month pain medicine fellowship. PDs suggest the need for additional training for fellows and discuss the importance of curriculum standardization.

Quantitative assessment of painful diabetic peripheral neuropathy after high-frequency spinal cord stimulation: a pilot study.

OBJECTIVE: Randomized trials have demonstrated efficacy of spinal cord stimulation (SCS) for treatment of painful diabetic neuropathy (PDN). Preliminary data suggested that treatment of PDN with high-frequency SCS resulted in improvements on neurological examination. The purpose of the present study was to explore whether patients with PDN treated with high-frequency SCS would have improvements in lower-extremity peripheral nerve function. DESIGN: Prospective cohort study in an outpatient clinical practice at a tertiary care center. METHODS: Patients with PDN were treated with high-frequency SCS and followed up for 12 months after SCS implantation with clinical outcomes assessments of pain intensity, neuropathic symptoms, and neurological function. Small-fiber sudomotor function was assessed with the quantitative sudomotor axon reflex test (QSART), and large-fiber function was assessed with nerve conduction studies (NCS). Lower-extremity perfusion was assessed with laser Doppler flowmetry. RESULTS: Nine patients completed 12-month follow-up visits and were observed to have improvements in lower-extremity pain, weakness, and positive sensory symptoms. Neuropathy impairment scores were improved, and 2 patients had recovery of sensory responses on NCS. A reduction in sweat volume on QSART was observed in the proximal leg but not at other sites. No significant differences were noted in lower-extremity perfusion or NCS as compared with baseline. CONCLUSIONS: The improvement in pain relief was concordant with improvement in neuropathy symptoms. The findings from this study provide encouraging preliminary data in support of the hypothesis of a positive effect of SCS on peripheral neuropathy, but the findings are based on small numbers and require further evaluation. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT03769675.

MRI-guided focused ultrasound ablation of painful lumbar facet joints: a retrospective assessment of safety and tolerability in human subjects.

OBJECTIVE: To evaluate the safety and tolerability of MRI-guided focused ultrasound (MRgFUS) for the treatment of facet joint-mediated pain in human subjects for whom conventional treatment had failed. Secondarily, to evaluate effectiveness of the procedure. METHODS: Consecutive patients who underwent MRgFUS at our institution were retrospectively identified. Chart review was performed to obtain relevant clinical and technical data. All patients had chronic low back pain and positive comparative medial branch blocks. RESULTS: Twenty-six MRgFUS treatments in 20 patients were included. Mean sonication energy was 1436.6 Joules. The procedure was technically successful in all patients. Of the treated patients, 29.6% experienced short-term worsening of low back pain immediately after the procedure, all by 1-4 points on a 0-10 scale. One patient (3.8%) reported temporary worsening of preexisting radicular symptoms after the procedure. Of 21 treatments with clinical follow-up of at least 3 months available, 12 (57.1%) had >3 months' pain relief, 2 (10%) had <3 months' benefit, 6 (30%) reported no benefit, and 1 (5%) patient was lost to follow-up. In patients who reported at least some benefit with prior conventional radiofrequency ablation, 8/10 (80%) benefited from the MRgFUS procedure. CONCLUSION: The present study demonstrates that MRgFUS ablation of the lumbar facet joints is a safe and tolerable procedure in human subjects and could provide another option for patients for whom radiofrequency ablation had failed. More than half of all patients received significant durable pain relief, which jumped to 80% for patients who had experienced at least some benefit from prior radiofrequency ablations.

Best Practices for Dorsal Root Ganglion Stimulation for Chronic Pain: Guidelines from the American Society of Pain and Neuroscience.

With continued innovations in neuromodulation comes the need for evolving reviews of best practices. Dorsal root ganglion stimulation (DRG-S) has significantly improved the treatment of complex regional pain syndrome (CRPS), and it has broad applicability across a wide range of other conditions. Through funding and organizational leadership by the American Society for Pain and Neuroscience (ASPN), this best practices consensus document has been developed for the selection, implantation, and use of DRG stimulation for the treatment of chronic pain syndromes. This document is composed of a comprehensive narrative literature review that has been performed regarding the role of the DRG in chronic pain and the clinical evidence for DRG-S as a treatment for multiple pain etiologies. Best practice recommendations encompass safety management, implantation techniques, and mitigation of the potential complications reported in the literature. Looking to the future of neuromodulation, DRG-S holds promise as a robust intervention for otherwise intractable pain.

A Bibliometric Analysis of Top-Cited Journal Articles Related to Neuromodulation for Chronic Pain.

OBJECTIVES: Since its foundation in the 1960s, neuromodulation has become an increasingly used treatment option for chronic pain. This bibliometric analysis examines the most cited research in this field with the aim of uncovering existing trends and future directions. MATERIALS AND METHODS: Clarivate's Web of Science data base was searched for the top 25 most cited studies focusing on neuromodulation for chronic pain. Various bibliometric parameters were then extracted and analyzed. Randomized controlled trials (RCTs) were compared with non-RCTs. RESULTS: The top 25 articles had a mean of 347 citations and 22.2 citations per year, with more recent articles having a higher citation rate. Most were published in the last two decades and predominantly originated from the United States. There were 13 RCTs, which were significantly more recent (p = 0.004) and more cited per year (p = 0.001) than the 12 non-RCTs. Sources included 15 journals with a mean impact factor of 13.896. The most studied modality was spinal cord stimulation with 20 articles (76.9%), followed by intrathecal drug delivery (15.4%), dorsal root ganglion stimulation (3.8%), and peripheral nerve stimulation (3.8%). CONCLUSIONS: Analysis of the most cited articles on neuromodulation reveals a focal shift from historical reports to innovative RCTs that have increasingly guided pain practice in the recent years. As novel techniques and technologies continue to develop, high-quality evidence coupled with broadening indications will likely direct further expansion of this field.

Best Practices for Minimally Invasive Lumbar Spinal Stenosis Treatment 2.0 (MIST): Consensus Guidance from the American Society of Pain and Neuroscience (ASPN).

Introduction: Lumbar spinal stenosis (LSS) is a common spinal disease of aging with a growing patient population, paralleling population growth. Minimally invasive treatments are evolving, and the use of these techniques needs guidance to provide the optimal patient safety and efficacy outcomes. Methods: The American Society of Pain and Neuroscience (ASPN) identified an educational need for guidance on the prudent use of the innovative minimally invasive surgical therapies for the treatment of symptomatic LSS. The executive board nominated experts spanning anesthesiology, physiatry, orthopedic surgery, and neurosurgery based on expertise, publications, research, diversity and field of practice. Evidence was reviewed, graded using the United States Preventive Services Task Force (USPSTF) criteria for evidence and recommendation strength and grade, and expert opinion was added to make consensus points for best practice. Results: The world literature in English was searched using Medline, EMBASE, Cochrane CENTRAL, BioMed Central, Web of Science, Google Scholar, PubMed, Current Contents Connect, Scopus, and meeting abstracts to identify and compile the evidence (per section) for LSS-related pain. Search words were selected based upon the section represented. Identified peer-reviewed literature was critiqued using USPSTF criteria and consensus points are presented. Discussion: The algorithm for patient selection in the management of symptomatic spinal stenosis is evolving. Careful consideration of patient selection and anatomic architecture variance is critical for improved outcomes and patient safety. Conclusion: ASPN created a guidance for best practice for minimally invasive surgical treatment of symptomatic spinal stenosis.

The Neurostimulation Appropriateness Consensus Committee (NACC): Recommendations on Best Practices for Cervical Neurostimulation.

INTRODUCTION: The International Neuromodulation Society convened a multispecialty group of physicians based on expertise with international representation to establish evidence-based guidance on the use of neurostimulation in the cervical region to improve outcomes. This Neurostimulation Appropriateness Consensus Committee (NACC) project intends to provide evidence-based guidance for an often-overlooked area of neurostimulation practice. MATERIALS AND METHODS: Authors were chosen based upon their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature. Section leaders supervised literature searches of MEDLINE, BioMed Central, Current Contents Connect, Embase, International Pharmaceutical Abstracts, Web of Science, Google Scholar, and PubMed from 2017 (when NACC last published guidelines) to the present. Identified studies were graded using the US Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on the strength of evidence or consensus when evidence was scant. RESULTS: The NACC examined the published literature and established evidence- and consensus-based recommendations to guide best practices. Additional guidance will occur as new evidence is developed in future iterations of this process. CONCLUSIONS: The NACC recommends best practices regarding the use of cervical neuromodulation to improve safety and efficacy. The evidence- and consensus-based recommendations should be utilized as a guide to assist decision making when clinically appropriate.

Antibacterial Envelope Use for the Prevention of Surgical Site Infection in Spinal Cord Stimulator Implantation Surgery: A Retrospective Review of 52 Cases.

OBJECTIVE: Surgical site infection in patients who undergo spinal cord stimulator implant surgery represents a significant concern in terms of increased health care costs and patient morbidity. The use of antibacterial envelopes in spinal cord stimulator implant surgeries has not been previously described. The aim of this retrospective review was to evaluate the effectiveness of the antibacterial envelope in reducing surgical site infection in spinal cord stimulator implant surgeries when used adjunctively to standard infection prevention measures. MATERIALS AND METHODS: The study included 52 patients, all of whom were implanted with a spinal cord stimulator between January 2015 and November 2020. To be included, patients were required to have had an antibacterial envelope utilized at the time of surgery. Patient records were retrospectively reviewed. All patients who received an antibacterial envelope at the time of implant surgery were included. RESULTS: Data was collected and analyzed on 52 permanent SCS implantations, including primary implantation (n=26) and revision surgery (n=26). All patients were at least three months post-operative from the implant surgery (average follow-up time period was 518.4 days). There were no surgical site infections reported in the 52 patient cohort. CONCLUSION: Antibiotic impregnated envelopes appear to be a safe and effective modality to decrease surgical site infection risk in spinal cord stimulation implant surgeries.

Radiation safety and knowledge: an international survey of 708 interventional pain physicians.

INTRODUCTION: Interventional pain procedures have increased in complexity, often requiring longer radiation exposure times and subsequently higher doses. The practicing physician requires an in-depth knowledge and evidence-based knowledge of radiation safety to limit the health risks to themselves, patients and healthcare staff. The objective of this study was to examine current radiation safety practices and knowledge among interventional pain physicians and compare them to evidence-based recommendations. MATERIALS AND METHODS: A 49-question survey was developed based on an extensive review of national and international guidelines on radiation safety. The survey was web-based and distributed through the following professional organizations: Association of Pain Program Directors, American Academy of Pain Medicine, American Society of Regional Anesthesia and Pain Medicine, European Society of Regional Anesthesia and Pain Therapy, International Neuromodulation Society, and North American Neuromodulation Society. Responses to radiation safety practices and knowledge questions were evaluated and compared with evidence-based recommendations. An exploratory data analysis examined associations with radiation safety training/education, geographical location, practice type, self-perceived understanding, and fellowship experience. RESULTS: Of 708 responding physicians, 93% reported concern over the health effects of radiation, while only 63% had ever received radiation safety training/education. Overall, ≥80% physician compliance with evidence-based radiation safety practice recommendations was demonstrated for only 2/15 survey questions. Physician knowledge of radiation safety principles was low, with 0/10 survey questions having correct response rates ≥80%. CONCLUSION: We have identified deficiencies in the implementation of evidence-based practices and knowledge gaps in radiation safety. Further education and training are warranted for both fellowship training and postgraduate medical practice. The substantial gaps identified should be addressed to better protect physicians, staff and patients from unnecessary exposure to ionizing radiation during interventional pain procedures.

Dorsal Root Ganglion Stimulation for Erythromelalgia Related Foot Pain: A Case Report and Review of the Literature.

Erythromelalgia is a rare neurovascular disorder characterized by erythema, warmth, and episodic burning pain, often felt in the face, hands, and feet. Symptoms are typically worse with heat, exercise, stress, and during the overnight hours. Management often requires a multidisciplinary approach, including pain trigger avoidance, cool water baths, and topical and oral neuropathic medications. The use of spinal cord stimulation has been described in multiple case reports with success reported out to 24 months. To our knowledge, the use of dorsal root ganglion (DRG) stimulation for erythromelalgia-related pain has not been described. Herein, we present a case of erythromelalgia-related pain at the bilateral plantar surfaces of the feet, which was treated successfully with bilateral sacral S1 nerve root DRG stimulation.

Trends in Utilization and Cost of Inpatient Spinal Cord Stimulation: Analysis of Data from 2008 to 2014.

OBJECTIVE: In this study, we sought to characterize contemporary trends in cost and utilization of spinal cord stimulation (SCS). METHODS: The Healthcare Cost and Utilization Project-National Inpatient Sample was queried for inpatient admissions from 2008 to 2014 where SCS was performed. We then determined the rates and costs of SCS performed in this time frame to treat diagnoses that we classified as device-related complications, degenerative spine disease, pain syndromes, and neuropathies/neuritis/nerve lesions. Least-squares regression was performed to determine the yearly trends for each indication adjusted by the total number of yearly hospitalizations for that diagnosis. RESULTS: We identified a total of 6876 admissions in whom an SCS was performed. The overall rate of inpatient SCS procedures performed has decreased by 45% from 2008 to 2014 (14.0 to 7.7 procedures per 100,000 admissions). Adjusted analysis for yearly trends also demonstrated a declining trend for all indications; however, this was not found to be statistically significant, except for device-related complications (P = 0.004). The median inflation-adjusted cost of an admission where SCS was performed increased slightly by 7.4% from $26,200 (IQR: $16,700-$33,800) in 2008 to $28,100 (IQR: $19,600-$36,900) in 2014. Billed hospital charges demonstrated a significant increase with median inflation-adjusted admission charge of $66,068 in 2008 to $110,672 in 2014. CONCLUSIONS: Despite a declining contemporary trend in inpatient SCS, an increase was noted in admission costs and hospital charges. A significant declining trend was noted in revision SCS implantations due to device-related complications.

Peripheral Nerve Stimulation and Clinical Outcomes: A Retrospective Case Series.

PURPOSE: Peripheral nerve stimulation (PNS) is a rapidly expanding field within neuromodulation; however, there is limited data on therapeutic efficacy. This study describes the indications and clinical outcomes for patients undergoing PNS for chronic pain states. PATIENTS AND METHODS: This is a retrospective case series of adults undergoing PNS implantation from 2004 to 2017 at an academic medical center. The primary outcomes were changes in numeric rating scale (NRS) pain scores, opioid utilization in oral morphine milligram equivalent (MME), and self-reported patient functioning at 6 months postoperatively. Infectious and device-related complications were also assessed. RESULTS: A total of 72 patients underwent PNS implantation, including 59 patients that received a preceding PNS trial (59/78; 76% progression rate) and 13 that did not receive a PNS trial. The most common indication for stimulation was occipital neuralgia (47%) followed by lower-extremity neuropathies (17%). PNS implantation was associated with 6-month reductions in pain scores (7 [6, 8] baseline vs. 4 [2, 5] 6 months; P < 0.001) and opioid utilization (eg, median 60 [31, 104] vs. 18 [0, 52] MME among those with baseline opioid use; P < 0.001). Median functional improvement was 73% (50%, 88%). Seven patients (10%) suffered a postoperative surgical site infection at a median of 50 (30, 124) days, of which five devices were removed. CONCLUSION: Peripheral nerve stimulation was associated with reduced pain scores, lower opioid utilization, and improved patient function at 6 months. These data support PNS as a potentially effective nonopioid analgesic modality in chronic pain, though prospective multicenter evaluation is warranted to evaluate longer-term outcomes.

Current Perspectives on Spinal Cord Stimulation for the Treatment of Cancer Pain.

Cancer and cancer treatment-related chronic pain affect a significant number of patients. The etiology of this pain is diverse and may include nociceptive and/or neuropathic characteristics. Treatment is often multifactorial and may require advanced interventional techniques, such as spinal cord stimulation (SCS). This narrative review provides a thorough overview of cancer-related pain mechanisms and the use of SCS for cancer-related pain. Additionally, a review of the precautions that should be considered when caring for this patient population is provided with recommendations for safe care when utilizing these techniques.

A Systematic Literature Review of Peripheral Nerve Stimulation Therapies for the Treatment of Pain.

OBJECTIVE: To conduct a systematic literature review of peripheral nerve stimulation (PNS) for pain. DESIGN: Grade the evidence for PNS. METHODS: An international interdisciplinary work group conducted a literature search for PNS. Abstracts were reviewed to select studies for grading. Inclusion/exclusion criteria included prospective randomized controlled trials (RCTs) with meaningful clinical outcomes that were not part of a larger or previously reported group. Excluded studies were retrospective, had less than two months of follow-up, or existed only as abstracts. Full studies were graded by two independent reviewers using the modified Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment, the Cochrane Collaborations Risk of Bias assessment, and the US Preventative Services Task Force level-of-evidence criteria. RESULTS: Peripheral nerve stimulation was studied in 14 RCTs for a variety of painful conditions (headache, shoulder, pelvic, back, extremity, and trunk pain). Moderate to strong evidence supported the use of PNS to treat pain. CONCLUSION: Peripheral nerve stimulation has moderate/strong evidence. Additional prospective trials could further refine appropriate populations and pain diagnoses.

A Systematic Literature Review of Dorsal Root Ganglion Neurostimulation for the Treatment of Pain.

OBJECTIVE: To conduct a systematic literature review of dorsal root ganglion (DRG) stimulation for pain. DESIGN: Grade the evidence for DRG stimulation. METHODS: An international, interdisciplinary work group conducted a literature search for DRG stimulation. Abstracts were reviewed to select studies for grading. General inclusion criteria were prospective trials (randomized controlled trials and observational studies) that were not part of a larger or previously reported group. Excluded studies were retrospective, too small, or existed only as abstracts. Studies were graded using the modified Interventional Pain Management Techniques-Quality Appraisal of Reliability and Risk of Bias Assessment, the Cochrane Collaborations Risk of Bias assessment, and the US Preventative Services Task Force level-of-evidence criteria. RESULTS: DRG stimulation has Level II evidence (moderate) based upon one high-quality pivotal randomized controlled trial and two lower-quality studies. CONCLUSIONS: Moderate-level evidence supports DRG stimulation for treating chronic focal neuropathic pain and complex regional pain syndrome.