Leonardo Kapural's research while affiliated with North Carolina Clinical Research and other places
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Publications (219)
Introduction
Painful diabetic neuropathy (PDN) is a leading cause of pain and disability globally with a lack of consensus on the appropriate treatment of those suffering from this condition. Recent advancements in both pharmacotherapy and interventional approaches have broadened the treatment options for PDN. There exists a need for a comprehensiv...
INTRODUCTION
Chronic refractory back pain causes significant disability and is one of the most common reasons for patients seeking health care. Few treatment options exist for chronic back pain patients who have failed conventional medical management (CMM) and who have not had and are not candidates for spine surgery, a condition we refer to as non...
In this article, we propose a new diagnostic paradigm known as Chronic Abdominal Discomfort Syndrome (CADS). Patient’s presentation centers around chronic abdominal pain not explained by acute pathology with or without accompanying dyspepsia, bloating, nausea and vomiting among other symptoms. The pathophysiology is noted to be neurogenic, possibly...
Introduction
A novel, spinal cord stimulation (SCS) system with a physiologic closed-loop (CL) feedback mechanism controlled by evoked compound action potentials (ECAPs) enables the optimization of physiologic neural dose and the accuracy of the stimulation, not possible with any other commercially available SCS systems. The report of objective spi...
Background:
Nonsurgical refractory back pain (NSRBP) is broadly defined as chronic refractory back pain in patients who have not had previous spine surgery and, because they are deemed inappropriate candidates for surgery, are reliant on conventional medical management (CMM), which often provides poor long-term outcomes. High-frequency spinal cord...
Aim
Visceral pain, characterized by pain that is diffuse and challenging to localize, occurs frequently and is difficult to treat. In cases where the pain becomes intractable despite optimal medical management, it can affect patients’ Quality of Life (QoL). Spinal Cord Stimulation (SCS) has emerged as a potential solution for intractable visceral p...
OBJECTIVE
The objective of this study was to evaluate the 24-month durability of pain relief, function, quality of life, and safety outcomes for patients with nonsurgical refractory back pain (NSRBP) treated with high-frequency spinal cord stimulation (SCS) within a large, national, multicenter randomized controlled trial (RCT).
METHODS
Following...
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...
Introduction
The evidence for spinal cord stimulation (SCS) has been criticized for the absence of blinded, parallel randomized controlled trials (RCTs) and limited evaluations of the long-term effects of SCS in RCTs. The aim of this study was to determine whether evoked compound action potential (ECAP)-controlled, closed-loop SCS (CL-SCS) is assoc...
Objective:
Emerging spinal cord stimulation (SCS) remote monitoring and programming technologies provide a unique opportunity to address challenges of in-person visits and improve patient care, although clinical guidance on implementation is needed. The goal of this document is to establish best clinical practices for integration of remote device...
Objective:
This study aimed to assess the safety and effectiveness of a new charge-distributed multiphase stimulation paradigm during an extended spinal cord stimulation (SCS) trial.
Materials and methods:
This prospective, multicenter, randomized, single-blind, feasibility study included participants with chronic low back and/or leg pain and ba...
Introduction
Chronic pain patients may experience impairments in multiple health-related domains. The design and interpretation of clinical trials of chronic pain interventions, however, remains primarily focused on treatment effects on pain intensity. This study investigates a novel, multidimensional holistic treatment response to evoked compound...
Introduction
Low back pain is the leading cause of disability worldwide, with sacroiliac joint pain comprising up to 30% of cases of axial lower back pain. Conservative therapies provide only modest relief. Although placebo-controlled trials show efficacy for sacral lateral branch cooled radiofrequency ablation, there are no comparative effectivene...
INTRODUCTION
A large multicenter RCT was undertaken to provide high level evidence of the clinical effectiveness of 10kHz SCS over conventional medical management (CMM) for the treatment of nonsurgical refractory back pain (NSRBP), and the 12-month results were recently published (Kapural et al, 2022).
METHODS
Patients were enrolled if ineligible...
Objective
Spinal cord stimulation (SCS) is considered an effective interventional nonpharmacologic treatment option for several chronic pain conditions. Here we present the effects of the novel evoked compound action potential (ECAP) controlled closed-loop (ECAP-CL) SCS system on long-term sleep quality outcomes from the EVOKE study.
Materials and...
Objective:
This analysis evaluated if spinal cord stimulation (SCS) at 10 kHz plus conventional medical management (CMM) is cost-effective compared with CMM alone for the treatment of nonsurgical refractory back pain (NSRBP).
Methods:
NSRBP subjects were randomized 1:1 into the 10-kHz SCS (n = 83) or CMM (n = 76) group. Outcomes assessed at 6 mo...
Lateral femoral and lateral obturator sensory nerves radiofrequency (RF) ablation provides a significant, clinically meaningful long‐term improvement in pain scores for patients with advanced osteoarthritis, avascular necrosis or even previous arthroplasty of the hip joint. Currently, hip denervation techniques include conventional and cooled RF de...
Background:
Chronic pain that follows amputation of a limb is reported as "one of the most severe pains in the human experience," due to the magnitude of tissue injury and the multiple potential of pain generators at the local peripheral, spinal, and cortical levels. The Altius® System was developed to deliver high-frequency nerve block (HFNB) the...
Spinal cord stimulation (SCS) has been used for several decades and just recently is considered a superior treatment for patients with chronic, intractable pain. Historically, using traditional low-frequency (40–90 Hz) SCS, the patient feels paresthesia located over the painful area and pain relief due to spinal and supraspinal mechanisms. About 30...
Background
Patients with chronic nausea and vomiting often also have chronic abdominal pain. Spinal cord stimulation (SCS) may provide pain control, but scarce data are available regarding the effect of SCS on chronic nausea and vomiting.AimsWe aimed to determine the effect of SCS in patients with chronic nausea, vomiting, and refractory abdominal...
OBJECTIVE
Spinal cord stimulation (SCS) at 10 kHz (10-kHz SCS) is a safe and effective therapy for treatment of chronic low-back pain. However, it is unclear from existing evidence whether these findings can be generalized to patients with chronic back pain that is refractory to conventional medical management (CMM) and who have no history of spine...
Importance
Chronic pain is debilitating and profoundly affects health-related quality of life. Spinal cord stimulation (SCS) is a well-established therapy for chronic pain; however, SCS has been limited by the inability to directly measure the elicited neural response, precluding confirmation of neural activation and continuous therapy. A novel SCS...
Background:
Genicular radiofrequency ablation is an established therapy for chronic knee pain. An analysis comparing different probe sizes and technologies has not yet been undertaken for this indication. This large retrospective, comparison study from a single-center comprehensive pain management practice aims to do that.
Methods:
Outcomes of 1...
Background:
Non-surgical refractory back pain (NSRBP) is persistent, severe back pain that is not considered surgically correctable. Published studies have demonstrated clinically important long-term improvement in pain and functional capacity when 10kHz spinal cord stimulation (SCS) is used to treat NSRBP. This study examines if real-world patien...
Abdominal pain lasting 3 months or longer is defined as chronic abdominal pain (CAP). CAP affects about 1–2% of the adult population with women being affected more frequently. CAP can originate either from the abdominal wall or the viscera. In about 35% to 51% of patients, the cause of abdominal pain remains a mystery. Chronic pancreatitis (CP) has...
Intractable itch is a severe, relentless, and debilitating chronic itch that is not curable by any known means. Ordinary medical measures usually are not helpful for these patients who often suffer from neural hypersensitization. These patients have often exhausted numerous treatments and still suffer from intractable pruritus. As chronic pain and...
A workshop was sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases to focus on research gaps and opportunities in pancreatic pain. The event was held on July 21, 2021, and structured into 4 sessions: (1) pathophysiology; (2) biomarkers, mediators, and pharmacology of pain; (3) pain assessment; and (4) pain treatment ch...
Background:
We previously reported on a combined technique and initial data of hip denervation using an anterior approach and cooled radiofrequency.
Objectives:
A large retrospective study to evaluate the long-term effectiveness of cooled radiofrequency ablation (CRFA) in the general chronic hip pain population.
Study design:
Retrospective ele...
Background and objectives:
A randomized clinical trial demonstrated that 10 kHz SCS (10kHz-SCS) therapy is superior to traditional low-frequency SCS (LF-SCS) at 12- and 24-month clinical follow-ups and led to Food and Drug Administration (FDA) approval of the therapy. The results of the study led our practices to trial 10kHz-SCS in patients who ha...
Objective: Exploring the potential role of clonidine as an alternative to the currently available neuraxial medication options for the management of chronic pain. Methods: A comprehensive literature search was conducted investigating the treatment of chronic pain using clonidine over the past 73 years. A stepwise filtering approach was used to obta...
Background
Spinal cord stimulation (SCS) has been shown to provide pain relief for chronic back and leg pain due to failed back surgery syndrome (FBSS). But many patients with chronic back pain have not had major back surgery, are not good candidates for surgery, and conventional medical management (CMM) provides limited relief. We have termed this...
Knee osteoarthritis (OA) is a painful and sometimes debilitating condition affecting an estimated 14 million people in the USA alone. Management of knee OA begins with conservative medical treatments and progresses to total knee arthroplasty. Managing pain until a patient is eligible for arthroplasty remains a key part of the treatment algorithm fo...
Introduction:
Chronic abdominal pain (CAP) can arise from multiple conditions, including inflammatory disorders, trauma because of injury or surgery, or structural or functional causes. This prospective, single-arm study was designed to evaluate the safety and efficacy of 10-kHz spinal cord stimulation (SCS) in patients with intractable CAP over a...
Background:
Therapeutic approaches to spinal cord stimulation (SCS) continue to evolve and improve patient outcomes in patients receiving SCS therapy secondary to failed back surgery syndrome.
Objectives:
The aim of this study was to evaluate pain relief and other patient outcomes of SCS using selected high-dose programming parameters.
Study de...
Background:
Spinal cord stimulation has been an established treatment for chronic back and leg pain for more than 50 years; however, outcomes are variable and unpredictable, and objective evidence of the mechanism of action is needed. A novel spinal cord stimulation system provides the first in vivo, real-time, continuous objective measure of spin...
Introduction:
Percutaneous peripheral nerve stimulation (PNS) provides an opportunity to relieve chronic low back pain and reduce opioid analgesic consumption as an alternative to radiofrequency ablation and permanently implanted neurostimulation systems. Traditionally, the use of neurostimulation earlier in the treatment continuum has been limite...
Chronic pain is a common condition that affects the physical, emotional, and mental well‐being of patients and can significantly diminish their quality of life. Due to growing concerns about the substantial risks of long‐term opioid use, both governmental agencies and professional societies have recommended prioritizing the use of nonpharmacologic...
Objective:
The primary objective of this observational, prospective, multicenter study was to evaluate the long-term outcomes, including pain, function, and perceived effect of treatment, in cooled radiofrequency ablation (CRFA) subjects who have pain due to osteoarthritis (OA) of the knee.
Methods:
This analysis included a subset of subjects pr...
Background:
Cooled radiofrequency ablation (CRFA) in a randomized, prospective study demonstrated significantly greater improvements in pain, functional, and global outcome measures.
Objectives:
This large, real-life, retrospective study evaluated the long-term effectiveness of CRFA in the general chronic knee pain population.
Study design:
Re...
INTRODUCTION
Over 85% of patients experience residual limb (RLP) and/or phantom limb (PLP) pain following amputation. Peripheral nerve stimulation (PNS) is a non-opioid approach to relieve postamputation neuropathic pain. A recent multicenter, randomized, double-blind, placebo-controlled study using a novel percutaneous PNS system demonstrated clin...
The ACCURATE randomized, controlled trial compared outcomes of dorsal root ganglion (DRG) stimulation versus tonic spinal cord stimulation (SCS) in 152 subjects with chronic lower extremity pain due to complex regional pain syndrome (CRPS) type I or II. This ACCURATE substudy was designed to evaluate whether therapy habituation occurs with DRG stim...
Chronic pain, including chronic low back and leg pain are prominent causes of disability worldwide. While patient management aims to reduce pain and improve daily function, prescription of opioids remains widespread despite significant adverse effects. This study pooled data from two large prospective trials on 10 kHz spinal cord stimulation (10 kH...
Abdominal pain is present in over two million people across the USA and is the most common presenting symptom in gastrointestinal clinics. Before being referred to chronic pain specialist, patients frequently undergo numerous imaging studies and surgical procedures. Despite extensive diagnostics, some of the causes of chronic abdominal pain remain...
Aim: This pilot case series examined feasibility of anterior radiofrequency approach under combined ultrasound and fluoroscopy guidance to control pain from avascular necrosis of the hip. Patients & methods: Data on 11 consecutive patients were collected on longevity of cooled radiofrequency ablation (CRFA), pain relief and opioid use. Results: The...
Introduction
Chronic pain and reduced function are significant problems for Military Service members and Veterans following amputation. Peripheral nerve stimulation (PNS) is a promising therapy, but PNS systems have traditionally been limited by invasiveness and complications. Recently, a novel percutaneous PNS system was developed to reduce the ri...
Objective: In the treatment of chronic diseases, remission is commonly used as a meaningful treatment goal, synonymous with the absence of significant clinical signs and symptoms of a disease, but not representing a cure. The objective of this paper is to propose a definition for remission for use as an outcome to evaluate the long-term efficacy of...
Background and objectives
Chronic neuropathic pain is a common challenging condition following amputation. Recent research demonstrated the feasibility of percutaneously implanting fine-wire coiled peripheral nerve stimulation (PNS) leads in proximity to the sciatic and femoral nerves for postamputation pain. A multicenter, double-blinded, randomiz...
Background
Stimulation of the dorsal root ganglion (DRG) in the treatment of chronic, intractable pain has shown excellent clinical results in multiple published studies, including a large prospective, randomized, controlled trial. Both safety and efficacy have been demonstrated utilizing this therapeutic approach for many chronic complaints. Conti...
Background
The spinal cord (SC) response to stimulation has yet to be studied in a pivotal clinical study. We report the study design of an ongoing multicenter, randomized, double‐blind, controlled, parallel‐arm study of an evoked compound action potential (ECAP) controlled closed‐loop spinal cord stimulation (SCS) system, which aims to gain U.S. F...
Introduction
ACCURATE, a randomized controlled trial comparing dorsal root ganglion (DRG) stimulation to spinal cord stimulation, showed that DRG stimulation is a safe and effective therapy in individuals with lower extremity chronic pain due to complex regional pain syndrome (CRPS) type I or II. Investigators noted that DRG stimulation programming...
Chronic low back pain represents one of the most common sources of disability and a significant healthcare burden for the U.S. military. Present treatments for chronic back pain are often ineffective, poorly tolerated, invasive, destructive, and/or associated with complications and lead to the progression to invasive surgical procedures. There have...
Background and objectives
As a follow-up to the 6-month report,12 this study investigated the analgesic effect of cooled radiofrequency ablation (CRFA) in patients with knee osteoarthritis (OA) 12 months postintervention and its ability to provide pain relief in patients who experienced unsatisfactory effects of intra-articular steroid injection (I...
Aim:
Neural blockade at the celiac plexus is less specific compared with splanchnic nerve block. This retrospective study compares duration and potency of celiac versus splanchnic block. Patients & methods: Analyzed were data of 16 consecutive patients with visceral abdominal nonmalignant pain treated using both celiac plexus and T11 splanchnic bl...
Objectives
High‐frequency spinal cord stimulation (HF‐SCS) at 10 kHz has proven to be efficacious in the treatment of chronic back and leg pain in a randomized, controlled, trial (SENZA‐RCT). However, large observational studies have yet to be published. Therefore, we performed a real‐world, multicenter, retrospective, review of therapy efficacy in...
Objectives
This was a sub‐analysis of the ACCURATE clinical trial that evaluated the accuracy and necessity of targeting paresthesia coverage of painful areas with dorsal root ganglion (DRG) stimulation vs. tonic spinal cord stimulation (SCS).
Materials and Methods
On diagrams of the torso and lower limbs, subjects marked where they felt pain at b...
Background and objectives
To investigate the possible effect of postoperatively applied analgesics—epidurally applied levobupivacaine or intravenously applied morphine—on systemic inflammatory response and plasma concentration of interleukin (IL)-6 and to determine whether the intensity of inflammatory response is related to postoperative cognitive...
Background and objective
We investigated whether an effective long-term pain relief could be achieved using subthreshold 1–1.2 kHz spinal cord stimulation (SCS) among patients who were initially implanted with traditional paresthesia-based SCS but who failed to maintain an adequate pain relief.
Methods
Retrospective chart review was conducted of p...
AIM To investigate the effect of clonidine on the cutaneous silent period (CSP) during spinal anesthesia. METHODS A total of 67 adult patients were included in this randomized, prospective, single-center, double-blind trial. They did not have neurological disorders and were scheduled for inguinal hernia repair surgery. This trial was registered on...
Aim:
To describe two consecutive cases of Postural Orthostatic Tachycardia Syndrome (POTS)-related chronic abdominal pain control in children after bilateral splanchnic block.
Patients & methods:
Two pediatric patients with chronic abdominal pain related to POTS received celiac and T11 splanchnic plexus block for pain control.
Results:
While c...
Objectives:
The objective of this study was to evaluate the use of percutaneous peripheral nerve stimulation (PNS) for the treatment of chronic low back pain (LBP). Percutaneous PNS offers the potential to provide an effective neuromodulation therapy using a system and fine-wire leads designed specifically for percutaneous use with history of an e...
Purpose:
Chronic axial low-back pain is a debilitating disorder that impacts all aspects of an afflicted individual's life. Effective, durable treatments have historically been elusive. Interventional therapies, such as spinal cord stimulation (SCS), have shown limited efficacy at best. Recently, a novel treatment, 10 kHz SCS, has demonstrated sup...
Background:
Low back pain (LBP) is the symptom of a group of syndromes with heterogeneous underlying mechanisms and molecular pathologies, making treatment selection and patient prognosis very challenging. Moreover, symptoms and prognosis of LBP are influenced by age, gender, occupation, habits, and psychological factors. LBP may be characterized...
Background:
Chronic hip joint pain is a common condition with an estimated prevalence of 7% in men and 10% in women, in a population sample aged over 45. Conservative treatment can include physical therapy, weight loss, a variety of pharmacologic agents ranging from nonsteroidal antiinflammatory drugs (NSAIDS) to opioids, and intraarticular inject...
Abdominal pain prompts about 16 million visits a year to primary care offices in the United States and is a major source of morbidity, lost productivity, and healthcare costs. About two million patients continue on to visit a specialist, usually a gastroenterologist [1]. Chronic abdominal pain of visceral origin can be difficult to treat. Over the...
Lumbar spinal stenosis (LSS), or the narrowing of the spinal canal and neuroforamina, is secondary to degenerative changes in the spine, causing hypertrophy of the ligamentum flavum, degenerative disc disease, facet arthropathy, and osteophyte formation (Fig. 2.1). Central LSS leads to compression of the spinal cord, and foraminal stenosis causes c...
Objective:
Despite the high prevalence of chronic multisite pain, there is little consensus on methods to characterize it. Commonly used assessments report only one dimension of pain, that is, intensity, thus ignoring the spatial aspect of pain. We developed a novel pain quantification index, the Integrated Pain Quantification Index (IPQI), on a s...
Severe chronic abdominal pain negatively impacts on patient’s quality of life and constitutes a major burden on the healthcare system. It is by far the most prevalent symptom in any gastrointestinal specialty clinic. Its etiology often remains elusive even after a multitude of imaging studies and surgical procedures. General characteristics of abdo...
Citations
... CPP is not currently an approved US Food and Drug Administration (FDA) indication for SNM. There is emerging data showing that SNM is effective in the treatment of CPP with multifactorial etiology (2,3,11). There are only a few studies showing good short-term results of SNM in the treatment of endometriosis related CPP (8-10), but long-term data is lacking. ...
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... The devices can be either responsive or nonresponsive, with the responsive ones offering real-time intervention through neurostimulation. 4,5 Closed-loop intervention has shown promise in promptly identifying anomalies and providing real-time responses, such as employing interventions such as spinal cord stimulation (SCS) 6 and epilepsy management. 7,8 Recently, Saluda Medical is the first company to have evaluated the first and only double-blind, FDA approval study for SCS in modalities as closed-loop vs open-loop. ...
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... Recent FDA guidance suggests that PCLC device manufacturers should characterize and consider disturbances affecting patients' response to the intervention, including interpatient variability in physiological response to stimulation and changes in this response over time due to disease progression or changes in patient sensitivity to stimulation. 11 Current solutions for OL therapy optimization include remote monitoring 15 and artificial intelligence-based 16 17 program changes and are based on SCS device utilization and subjective patient-reported outcomes, respectively; however, these non-PCLCSs cannot objectively evaluate and optimize dosing, automatically account for changes in physiological response to SCS over time, or objectively adjust for interpatient variability in response. The objective neural metrics are consistent with the FDA guidance for PCLCSs for objective therapy optimization and for guiding clinical practice. ...
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... The efficacy of RFA treatments of the SI joint is demonstrated by numerous observational, 88-90 retrospective, [91][92][93] and randomized controlled studies. 58,[94][95][96][97][98][99][100] However, the selection criteria, definitions of success, RFA techniques (conventional monopolar, bipolar, multielectrode combination mono-and bipolar, and monopolar cooled), and parameters (ie, temperature, duration, and location of RFA treatment), and imaging techniques (fluoroscopy, CT, ultrasound) have varied widely between studies. ...
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... There is vast literature reporting favorable results for opioid utilization with SCS therapy, independent of the waveform utilized [38]. Our findings reinforce the findings of previous studies reporting opioid utilization reduction with 10 kHz SCS therapy [39][40][41][42]. Kapural et al. analyzed patients with nonsurgical refractory back pain after a 10 kHz SCS implant at 12-month follow-up and reported a median reduction of 20 MME (p-value = 0.004), similar findings similar to ours with a mean reduction of 24.53 MME (p-value < 0.0001) [42]. ...
... Yet, recent advancements in technology and innovation in waveforms have yielded robust high-level clinical results, leading to the proposal for utilization of SCS earlier in the chronic pain treatment algorithm and for a broader range of painful conditions, such as painful diabetic neuropathy (PDN), chronic refractory neck pain, nonsurgical refractory back pain, in addition to FBSS and CRPS [13,14]. In particular, studies evaluating high-frequency (10 kHz) SCS for CLBP have demonstrated statistically significant and clinically meaningful improvement in pain and disability alone or when compared to conservative care [15][16][17][18][19][20][21][22]. ...
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... The exploration began with a 2015 case report [38] demonstrating that CRFA was effective in patients with chronic knee pain. Since then, many case reports, retrospective studies, and prospective studies have been published (Tables 1, 2) [15,38,[50][51][52][53][54][55][56][57][58][59][60][61][62][63][64]. This section discusses the growing body of evidence surrounding the clinical efficacy of CRFA for knee OA, covering various aspects such as pain relief, symptom management, functional improvement, patient-reported outcomes, long-term follow-up, and comparative analysis. ...
... The introduction of peripheral nerve stimulation (PNS) for treating chronic pain represents a paradigm change in neuromodulation, ushering in novel approaches to relieving suffering. A: PNS has significant clinical value in neuromodulation because it selectively inhibits erroneous pain signals (20,21). PNS offers a sophisticated option for managing chronic pain by altering peripheral nerve activity non-pharmacologically and localized. ...
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... Yet, recent advancements in technology and innovation in waveforms have yielded robust high-level clinical results, leading to the proposal for utilization of SCS earlier in the chronic pain treatment algorithm and for a broader range of painful conditions, such as painful diabetic neuropathy (PDN), chronic refractory neck pain, nonsurgical refractory back pain, in addition to FBSS and CRPS [13,14]. In particular, studies evaluating high-frequency (10 kHz) SCS for CLBP have demonstrated statistically significant and clinically meaningful improvement in pain and disability alone or when compared to conservative care [15][16][17][18][19][20][21][22]. ...
... Constant measure and response to changing electrophysiological and postural changes (ie more efficacious stimulation to target) [51] Greater pain relief as compared to open-loop systems from three months to two years [48,50], improvement in patient quality of life, emotional functioning and reduciton in opiate use at two years [51,53] ...
