Validation of a holistic composite outcome measure for the evaluation of chronic pain interventions.

Introduction: Chronic pain is a personal experience influenced by multiple biopsychosocial factors. Using a pain intensity measure alone to assess the effectiveness of a chronic pain intervention fails to fully evaluate its impact on the multifaceted chronic pain experience. The holistic minimal clinically important difference (MCID) is a composite outcome developed to provide a comprehensive assessment of chronic pain in response to intervention, across 5 outcome domains: pain intensity, health-related quality of life, sleep quality, physical, and emotional function. To focus on domains where the individual need is greatest, the holistic MCID reflects the cumulative MCID averaged over only the domains where subjects were impaired preintervention. Objectives: To assess the internal and construct validity of the Holistic MCID score to inform its future use as an evidence-based tool. Methods: This validation study was undertaken using data from the EVOKE trial with 111 patients up to 24-month follow-up. Internal consistency of the holistic MCID was assessed using Cronbach alpha statistic and dimensional exploration using principal component analysis. Results: The holistic MCID measure demonstrated strong internal consistency with Cronbach alpha >0.7 at all follow-ups. Principal component analysis showed one overarching holistic dimension to be present in the composite. Construct validity was demonstrated by an increase in the holistic MCID score being associated with both increased Patients' Global Impression of Change, EuroQol visual analogue scale score, and each of the outcome domains in a "leave-one-out" analysis (all P < 0.001). Conclusion: The holistic MCID provides a valid measure for the comprehensive, personalized assessment of response after a chronic pain intervention. The validity of the holistic MCID requires further confirmation in other chronic pain populations and with different interventions.

Pain Education and Knowledge (PEAK) Consensus Guidelines for Neuromodulation: A Proposal for Standardization in Fellowship and Training Programs.

The need to be competent in neuromodulation is and should be a prerequisite prior to completing a fellowship in interventional pain medicine. Unfortunately, many programs lack acceptable candidates for these advanced therapies, and fellows may not receive adequate exposure to neuromodulation procedures. The American Society of Pain and Neuroscience (ASPN) desires to create a consensus of experts to set a minimum standard of competence for neurostimulation procedures, including spinal cord stimulation (SCS), dorsal root ganglion stimulation (DRG-S), and peripheral nerve stimulation (PNS). The executive board of ASPN accepted nominations for colleagues with excellence in the subject matter of neuromodulation and physician education. This diverse group used peer-reviewed literature and, based on grading of evidence and expert opinion, developed critical consensus guides for training that all accredited fellowship programs should adopt. For each consensus point, transparency and recusal were used to eliminate bias, and an author was nominated for evidence grading oversight and bias control. Pain Education and Knowledge (PEAK) Consensus Guidelines for Neuromodulation sets a standard for neuromodulation training in pain fellowship training programs. The consensus panel has determined several recommendations to improve care in the United States for patients undergoing neuromodulation. As neuromodulation training in the United States has evolved dramatically, these therapies have become ubiquitous in pain medicine. Unfortunately, fellowship programs and the Accreditation Council for Graduate Medical Education (ACGME) pain program requirements have not progressed training to match the demands of modern advancements. PEAK sets a new standard for fellowship training and presents thirteen practice areas vital for physician competence in neuromodulation.

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.

Cannabinoids as a Potential Alternative to Opioids in the Management of Various Pain Subtypes: Benefits, Limitations, and Risks.

INTRODUCTION: Pain is a global phenomenon encompassing many subtypes that include neuropathic, musculoskeletal, acute postoperative, cancer, and geriatric pain. Traditionally, opioids have been a mainstay pharmacological agent for managing many types of pain. However, opioids have been a subject of controversy with increased addiction, fatality rates, and cost burden on the US healthcare system. Cannabinoids have emerged as a potentially favorable alternative or adjunctive treatment for various types of acute and chronic pain. This narrative review seeks to describe the efficacy, risks, and benefits of cannabinoids as an adjunct or even potential replacement for opioids in the treatment of various subtypes of pain. METHODS: In June of 2022, we performed a comprehensive search across multiple databases for English-language studies related to the use of cannabinoids in the treatment of various types pain: neuropathic pain, musculoskeletal pain, acute postoperative pain, cancer pain, and geriatric pain. Data from meta-analyses, systematic reviews, and randomized control trials (RCTs) were prioritized for reporting. We sought to focus our reported analysis on more recent literature as well as include older relevant studies with particularly notable findings. RESULTS: There is conflicting evidence for the use of cannabinoids in the management of pain. While cannabinoids have shown efficacy in treating specific chronic pain subtypes such as neuropathic pain, fibromyalgia pain, and geriatric pain, they do not show as clear benefit in acute postoperative and the majority of musculoskeletal pain syndromes. Data trends towards cannabinoids having a positive effect in treating cancer pain, but results are not as conclusive. To date, there is a paucity of data comparing cannabinoids directly to opioids for pain relief. Overall, the side effects of cannabinoids appear to be relatively mild. However, there is still potential for addiction, altered brain development, psychiatric comorbidities, and drug-drug interactions. CONCLUSION: Cannabinoids may be effective in specific subtypes of pain, but current evidence and guidelines do not yet support its use as the first-line treatment for any type of acute or chronic pain. Rather, it may be considered a good adjunct or alternative for patients who have failed more typical or conservative measures. Additional studies are needed with standardized forms of cannabinoids, route of delivery, and dosing for greater-powered analysis. Providers must weigh the individualized patient risks, benefits, and concurrent medication list in order to determine whether cannabinoids are appropriate for a patient's pain treatment plan.

Best Practice Guidelines on the Diagnosis and Treatment of Vertebrogenic Pain with Basivertebral Nerve Ablation from the American Society of Pain and Neuroscience.

Chronic low back pain is a worldwide leading cause of pain and disability. Degenerative disc disease has been the presumptive etiology in the majority of cases of chronic low back pain (CLBP). More recent study and treatments have discovered that the vertebral endplates play a large role in CLBP in a term defined as vertebrogenic back pain. As the vertebral endplates are highly innervated via the basivertebral nerve (BVN), this has resulted in a reliable target in treating patients suffering from vertebrogenic low back pain (VLBP). The application of BVN ablation for patients suffering from VLBP is still in its early stages of adoption and integration into spine care pathways. BVN ablation is grounded in a solid foundation of both pre-clinical and clinical evidence. With the emergence of this therapeutic option, the American Society of Pain and Neuroscience (ASPN) identified the need for formal evidence-based guidelines for the proper identification and selection of patients for BVN ablation in patients with VLBP. ASPN formed a multidisciplinary work group tasked to examine the available literature and form best practice guidelines on this subject. Based on the United States Preventative Task Force (USPSTF) criteria for grading evidence, gives BVN ablation Level A grade evidence with high certainty that the net benefit is substantial in appropriately selected individuals.

Dorsal Root Ganglion Stimulation as a Salvage Therapy Following Failed Spinal Cord Stimulation.

INTRODUCTION: Spinal cord stimulation (SCS) can provide long-term pain relief for various chronic pain conditions, but some patients have no relief with trial stimulation or lose efficacy over time. To "salvage" relief in patients who do not respond or have lost efficacy, alternative stimulation paradigms or anatomical targets can be considered. Dorsal root ganglion stimulation (DRG-S) has a different mechanism of action and anatomical target than SCS. OBJECTIVES: We assessed DRG-S salvage therapy outcomes in patients who did not respond to SCS or had lost SCS efficacy. MATERIALS AND METHODS: We retrospectively included consecutive patients from 2016 to 2020 who were salvaged with DRG-S after failed SCS trials (<50% pain reduction) or who had lost efficacy after permanent SCS. We compared numerical rating scale (NRS) pain, Oswestry disability index (ODI), health-related quality of life (EuroQol five-dimensions five-level), and oral morphine equivalent (OME) opioid requirements before DRG-S salvage and at patients' last follow-up. RESULTS: A total of 60 patients who had failed SCS were salvaged with DRG-S. The mean age was 56 ± 12 years, and the most common diagnoses were complex regional pain syndrome (n = 24) and failed back surgery syndrome (n = 24). The most common failed modalities included tonic (n = 32), Burst (n = 18), and high-frequency (n = 10) SCS. The median follow-up duration of salvage DRG-S was 34 months. With DRG-S, NRS decreased (8.7 ± 1.2 to 3.8 ± 2.1), and OME declined (median 23 mg to median 15 mg), whereas EuroQol 5D scores increased (0.40 ± 0.15 to 0.71 ± 0.15), and ODI improved (64 ± 14% to 31 ± 18%) (all p < 0.05). CONCLUSIONS: DRG-S can be used in patients with chronic pain who have previously failed to receive persistent benefit from SCS.

Dorsal root ganglion stimulation device explantation: A multicenter pooled data analysis.

INTRODUCTION: Dorsal root ganglion stimulation (DRG-S) is a relatively new neuromodulation modality. Therefore, data on long-term device explantation rates is limited. This investigation aimed to assess DRG-S device explantation rates at long-term follow-up. METHODS: We retrospectively reviewed individuals implanted with DRG-S in four pain centers from different continuous periods between April 2016 to September 2020. We recorded patient demographics, diagnoses, duration to explantation or last follow-up, treatment complications, and failure etiologies. RESULTS: A total of 249 patients with 756 leads and a mean 27-month follow-up were included. The mean age was 55 ± 15 years; 148 (63%) were female. Leading diagnoses were CRPS (n = 106, 43%), followed by FBSS (n = 64, 26%), and non-surgical low back pain (n = 23, 9%). The explantation rate was ~2% per year (n = 10 total). At explantation, the average time from implantation was 13 ± 10 months. Six patients were explanted for inadequate pain relief. Two patients were explanted due to device-related complications. One patient was explanted secondary to infection and subsequently reimplanted. Five explanted patients experienced a therapy-related complication before eventual explantation: one transient post-procedural neuritis and pocket site pain, one lead fracture, two lead migrations, and one experienced a fracture, a migration, and pocket site pain. DISCUSSION: This large retrospective study of DRG-S revealed a low therapy-termination rate. The rate of infection leading to explantation was objectively very low at 0.4%. The leading cause of explantation was inadequate pain relief. Explanted patients often had a therapy-related complication. Therefore, minimizing adverse treatment events may reduce ultimate explantation rates.

An Anatomy-Informed, Novel Technique for S1 Dorsal Root Ganglion Stimulation Lead Placement.

OBJECTIVE: A heightened and organized understanding of sacral anatomy could potentially lead to a more effective and safe method of dorsal root ganglion stimulation (DRG-S) lead placement. The aim of this technical note is to describe a standardized access method for S1 DRG-S lead placement. DESIGN: Technical note. METHODS: The described approach utilizes alignment of the lumbosacral prominence and is measurement-based, allowing for standardized sacral access, even when visualization is suboptimal. The medial-to-lateral needle trajectory is designed to limit interaction with the sensitive neural structures and allows for a more parallel orientation of the lead to the DRG and nerve root. CONCLUSIONS: The described technique potentially improves the safety of S1 DRG-S lead placement. The parallel lead orientation to the DRG may also increase efficacy while lowering energy requirements.

Enhanced Recovery After Surgery (ERAS) for Cranial Tumor Resection: A Review.

Enhanced Recovery After Surgery (ERAS) protocols describe a standardized method of preoperative, perioperative, and postoperative care to enhance outcomes and minimize complication risks surrounding elective surgical intervention. A growing body of evidence is being generated as we learn to apply principles of ERAS standardization to neurosurgical patients. First applied in spinal surgery, ERAS protocols have been extended to cranial neuro-oncologic procedures. This review synthesizes recent findings to generate evidence-based guidelines to manage neurosurgical oncology patients with standardized systems and assess ability of these systems to coordinate multidisciplinary, patient-centric care efforts. Furthermore, we highlight the potential usefulness of multimedia, app-based communication platforms to facilitate patient education, autonomy, and team communication within each of the 3 settings.

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.

A paramedian approach for dorsal root ganglion stimulation placement developed to limit lead migration and fracture.

INTRODUCTION: Dorsal root ganglion stimulation (DRG-S), has demonstrated superiority in the treatment of complex regional pain syndrome and causalgia. Lead migration and fracture impact DRG-S therapeutic stability. Lead anchoring reduces DRG-S lead migration without increasing lead fracture. Lead fracture may be related to lead entrapment in the superficial fascial plane. A novel medialized approach for lead placement and anchoring is presented to address these issues. METHODS: We suggest an alternative technique for implanting percutaneous DRG-S leads at the T10-L5 levels. RESULTS: A novel medialized ipsilateral technique for lead placement and anchoring for single, bilateral, and adjacent segment placement is presented. The Tuohy needle puncture site is medial to the pedicle and adjacent to the spinous process, two vertebral levels caudad to the target foramen. Trajectory is maintained in the sagittal plane, to access the caudad interlaminar space near the midline. This technique allows for ipsilateral or contralateral lead placement. After epidural access, the introducer sheath is rotated toward the targeted foramen and advanced. The guidewire followed by the lead is passed, and once lead position is confirmed, tension "S" loops are created, followed by anchoring to the deep fascia. CONCLUSION: We describe a new paramedian technique for DRG-S lead placement. We propose it will decrease DRG-S complication rates through anchoring to reduce migration and by avoiding the fascial planes thought to be responsible for fracture. Long-term outcomes applying our proposed techniques are required for determining the true impact, however, early anecdotal results suggest that these new techniques are favorable.

Lead migration and fracture rate in dorsal root ganglion stimulation using anchoring and non-anchoring techniques: A multicenter pooled data analysis.

INTRODUCTION: Dorsal root ganglion stimulation (DRG-S) is a neuromodulation technique introduced in the last decade with evolving implant methods. Initial prospective research found low incidences of lead migration and lead fracture with DRG-S. However, several recent studies have highlighted high lead migration and lead fracture rates with DRG-S. We investigated the influence of lead anchoring on migrations and fractures. METHODS: We performed a retrospective review between 2016 and 2020 of individuals implanted with DRG-S leads by 4 experienced implanters. The implanters independently changed their standard practice regarding lead anchoring over time, with opposing trends (no anchoring > anchoring, anchoring > no anchoring). We compared lead migration and lead fracture rates between anchored and unanchored DRG-S leads in the entire study cohort. Cox regression was performed on lead migration and fracture distributions. RESULTS: We included 756 leads (n = 565 anchored and n = 191 unanchored) from 249 patients. In unanchored leads, migration occurred in 16 leads (8.4%) from 13 patients (21.0%). In anchored leads, migration occurred in 8 leads (1.4%) from 5 patients (2.7%). Fracture in unanchored leads occurred in 6 leads (3.1%) from 6 patients (9.7%). Fractures in anchored leads occurred in 11 leads (1.9%) from 9 patients (4.8%). The migration survival distributions for the anchored and unanchored leads were statistically significantly different (p < 0.01) with decreased survival for unanchored leads (hazard ratio = 5.8, 95% confidence interval [CI] = 2.2-15.5). DISCUSSION: We found that anchoring DRG-S leads significantly reduces lead migration when compared to leads placed without an anchor. There was no significant difference in fracture rate between anchored and unanchored leads.

Dorsal Root Ganglion Stimulation Lead Fracture Within the Superficial Fascial Layers in 4 Cases.

We present 4 cases of dorsal root ganglion stimulation lead fracture. In these cases, the surgical technique involved (1) traversing fascial layers for placement of leads via a Tuohy needle in the upper low back, (2) subcutaneous tunneling from the implantable pulse generator site to the lead puncture site without dissecting below the superficial fascial plane at the puncture site, and (3) connection of the lead/extension with the generator. All fractures occurred adjacent to the original lead puncture site. These cases suggest lead entrapment within the membranous fascial plane, with tension on a thin lead, is a mechanism underlying lead fracture.

Lumbar Dorsal Root Ganglion Stimulation Lead Placement Using an Outside-In Technique in 4 Patients With Failed Back Surgery Syndrome: A Case Series.

Dorsal root ganglion stimulation (DRG-S) has shown promise as a treatment for low back pain. The traditional anterograde placement of DRG-S leads can be challenging in patients with anatomical changes from prior back surgery. We describe an "outside-in" placement technique of DRG-S leads in 4 patients with histories of multiple lumbar surgeries, which made the traditional anterograde placement not feasible. At long-term follow-up, the patients experienced substantial pain relief and improvement in quality of life, with no complications. The outside-in lead placement technique may be an efficacious alternative to the traditional techniques in patients with anomalous anatomy from prior surgery.

T12 Dorsal Root Ganglion Stimulation to Treat Chronic Low Back Pain: A Case Series.

INTRODUCTION: Dorsal root ganglion stimulation (DRG-S) is a neuromodulation technique for treating neuropathic pain syndromes. Research has demonstrated DRG-S to be more effective than conventional SCS in treating RSD/CRPS, particularly of the lower extremities. Results from recent case series and prospective studies suggest that DRG-S may be effective in treatment of pain syndromes considered to have non-neuropathic components and characteristics (e.g. nociceptive). There have been multiple, small studies demonstrating efficacy of DRG-S for axial low back pain. There has, however, been no consensus regarding the best location for DRG lead placement in the treatment of low back pain. METHODS: Patients presenting with refractory low back pain in a private pain management practice were considered for DRG-S. Patients were provided a trial stimulator prior to potential implantation. Per standard practice, pain intensity, disability, general health status, and quality of life were followed using the visual analog scale (VAS), Oswestry Disability Index, EQ-5D index, and the SF-36 survey, respectively. Data were collected prior to implantation and at variable follow-ups after DRG-S initiation. RESULTS: Seventeen consecutive patients presented with predominantly axial low back pain with/without a secondary component of lower extremity pain. All were trialed and subsequently implanted for DRG-S. Leads were placed at T12 to target the low back. Stimulation levels were set very low, below that of which patients experienced paresthesias. Last follow-up times averaged 8.3 months. More than half of the patients experienced pain relief ≥80%, with an average low back pain relief of 78% at last follow-up. Additionally, substantial improvements in physical and mental functioning, disability, and quality of life were reported. CONCLUSIONS: T12 DRG-S can be an effective treatment for chronic axial low back pain. Stimulation results in reduced pain and disability, while improving quality of life. These outcomes can be achieved without paresthesias.