kHz Spinal Cord Stimulation Research Articles

ID: 216095 High-Frequency Spinal Cord Stimulation (SCS) in Patients Converted From Traditional SCS: A Case Series

Spinal cord stimulation (SCS) is an evidence-based intervention for treating chronic neuropathic pain1. However, with traditional SCS, around 30% of patients may require explant for reasons including loss of efficacy during treatment2. High-frequency SCS (10kHz SCS) has been reported to demonstrate long-term superiority compared to traditional low-frequency (LF) SCS3. Furthermore, converting from LF to 10kHz SCS can restore pain relief in patients experiencing loss of efficacy4. In this study, we present a case series of 6 patients converted from LF SCS to 10kHz therapy due to loss of efficacy.

ID: 212826 Investigation of 10KHz Spinal Cord Stimulation on Small Fiber Painful Diabetic Neuropathy (PDN)

A large multicenter RCT1 recently demonstrated that spinal cord stimulation (SCS) at 10 kHz provides effective pain relief for patients with painful diabetic neuropathy (PDN). These outcomes remain durable to 24 months.2 Patient-reported outcomes suggest profound improvements in pain, function, and quality of life with 10kHz SCS in PDN patients, but more objective quantitative measures of nerve pathology and function can confirm these clinical outcomes and suggest the mechanism of action for the observed clinical improvements.

ID: 218017 10kHz Spinal Cord Stimulation Significantly Improves Foot Sensory Function in Patients With Painful Diabetic Neuropathy

Approximately 20% of persons with diabetes will develop neuropathic or neurological symptoms, including loss of protective sensation. In a large prospective randomized controlled trial, we assessed neurological function in patients with painful diabetic neuropathy (PDN) in response to 10 kHz spinal cord stimulation (SCS) [1,2].

ID: 218085 Treating Non-Surgical Refractory Back Pain With 10kHz Spinal Cord Stimulation: 24 Month Follow-Up From RCT

Patients with moderate to severe chronic back pain, refractory to available nonsurgical therapies (medications, physical therapy, nerve blocks and radio frequency ablation) have limited options if they are not candidates for surgery. In addition, access to spinal cord stimulation (SCS) may be difficult due to limited clinical evidence for SCS in this patient population (1). Here, 24-month follow-up is reported from a RCT that was designed to compare clinical and cost-effectiveness of 10kHz SCS versus CMM to treat non-surgical refractory back pain (NSRBP).

ID: 220477 Efficacy and Cost-Containment Assessment of 10kHz Spinal Cord Stimulation in Non-Surgical Refractory Back Pain Patients

Non-surgical refractory back pain (NSRBP) is persistent, severe back pain in patients for whom surgery is not deemed appropriate. Published studies, including a randomized controlled trial, have demonstrated clinically important long-term improvement in pain and functional capacity when 10kHz spinal cord stimulation (SCS) is used to treat NSRBP1. Here, we present real-world outcomes from patients in interventional pain practices and examine health care utilization (HCU) following 10kHz SCS implant.

ID: 220244 A Single-Center Review of 10 kHz Spinal Cord Stimulator Treatment Outcomes for Chronic Pain

Chronic pain is a prevalent worldwide condition, leading to diminished quality of life and workforce productivity (1). First-line therapies from conservative medical management to surgery have demonstrated varying degrees of efficacy, though sustained long-term pain management remains a challenge (2). Low-frequency spinal cord stimulation (LF-SCS) has been used in a subset of patients as a cost-effective and minimally invasive therapy to achieve pain control and improved quality of life (3). However, its limitations include diminished long-term relief, uncomfortable paresthesia, and incomplete pain control (4). The pivotal SENZA-RCT in 2015 demonstrated the efficacy of 10 kHz (high-frequency) spinal cord stimulation (HF-SCS) as a superior alternative to LF-SCS (5). The study, although promising, was industry-sponsored and potentially vulnerable to bias including withholding of negative data or exaggeration of beneficial effects. The goal of this single-center retrospective review was to compare outcomes of real-world/pragmatic HF-SCS pain outcomes to previously published studies without the potential bias of industry funding.

ID: 218207 10kHz Spinal Cord Stimulation for Non-Surgical Refractory Back Pain: Objective Functional Outcome to 24-Months

Chronic refractory back pain causes significant disability and has a major negative impact on mental health. 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-surgical refractory back pain (NSRBP). Access to spinal cord stimulation (SCS) is inconsistent in this population due to limited clinical evidence.1 Twenty-four-month outcomes including a functional test is reported from a RCT that compared 10kHz SCS to CMM in the treatment of NSRBP.

ID: 215564 10kHz SCS Normalizes Central Sensitization-Based Receptive Field Size in a Rodent Model of Neuropathy

Since a primary function of inhibition in sensory processing is to restrict receptive field (RF) size, disinhibition after nerve injuries can cause not only abnormal pain but also distinct enlargement of somatic receptive fields, thus reducing sensory acuity. Previously, we found that low intensity 10kHz spinal cord stimulation (10kHzSCS) preferentially activated inhibitory interneurons in the dorsal horn (DH). Here we explored the effect of 10kHzSCS on the receptive field of the hind paw of naïve and spinal nerve ligation (SNL) model rats.

ID: 219132 Variables Associated With Non-Responders to 10kHz Spinal Cord Stimulation: A Retrospective Review of Preliminary Data

Non-response to 10kHz spinal cord stimulation (SCS) treatment has been documented in the literature as less than 50% subjective improvement in pain at 3-months post-implant1-5. Appropriateness in selection criteria is one of the most important factors associated with successful outcomes, but limited literature reports predictive factors in non-responders. Therefore, we aim to identify such variables and help distinguish the subset less likely to benefit from SCS.

ID: 218088 10 kHz Spinal Cord Stimulation Durably Improves Foot Sensation in Patients With Painful Diabetic Neuropathy

Approximately 20% of persons with diabetes will develop neuropathic or neurological symptoms, including loss of protective sensation. In a large prospective, randomized controlled trial, we assessed neurological function in patients with painful diabetic neuropathy (PDN) in response to 10 kHz spinal cord stimulation (SCS) [1,2]. In that study, we demonstrated that 10kHzSCS significantly improves innocuous and noxious sensory responses after 3 months. Here, we assessed the long-term durability of these improvements over 24 months of continuous 10kHzSCS.

ID: 216388 Treatment of Post-Surgical Pain Following Mastectomy With 10 kHz Spinal Cord Stimulation: A Case Study

Post-surgical pain (PSP) following mastectomy is often neuropathic1 and focally located around the chest wall, armpit and or arm2. High-frequency spinal cord stimulation (10kHz SCS) could potentially be used as a treatment option for this indication as pre-clinical evidence for 10kHz SCS demonstrates an inhibitory effect of interneurons in the dorsal horn providing a useful mechanism of action (MOA) for paresthesia-free neuropathic pain relief3. Here we present a case study detailing the successful use of 10kHz SCS in the treatment of PSP following mastectomy.

ID: 222777 PICO10k (Periodic Infrequent Charge-Optimized 10kHz) Spinal Cord Stimulation Enables Monthly Device Recharging

In a recent study of pulse-dosed (PD) 10 kHz spinal cord stimulation (SCS), a plurality of subjects responded to 3% (20 seconds ON and 10 minutes OFF) pulse dosing [1]. Since 3% was the lowest setting studied, we hypothesized that many subjects may achieve good pain relief at even lower pulse dose settings. In particular, we studied the actual and theoretical device recharge requirements for minimal effective 10 kHzSCS dose settings.

ID: 209629 10 kHz Spinal Cord Stimulation for Chronic Leg Pain: Subanalysis From Two Prospective Studies

Chronic intractable leg pain frequently accompanies back pain arising from neural or musculoskeletal dysfunction of the lumbar spine and is characterized by poor quality of life, disability, and high economic burden [1]. We present a sub analysis of prospectively collected clinical outcome data for chronic intractable leg pain patients treated with 10 kHz spinal cord stimulation (10 kHZ SCS), pooled from two prospective studies.

ID: 222452 PICO10k (Periodic Infrequent Charge-Optimized 10kHz) Spinal Cord Stimulation Demonstrates Maintained Clinical Efficacy

Background: In a recent prospective clinical study of pulse-dosed (PD) 10 kHz spinal cord stimulation (SCS), a plurality of subjects responded to 3% (20 seconds ON and 10 minutes OFF) pulse dosing [1]. Since 3% was the lowest setting studied, we hypothesized that many subjects may achieve good pain relief at even lower pulse dose settings.

ID: 216535 Ten-Year Real-World Data on the Efficacy of High-Frequency 10 kHz Spinal Cord Stimulation

The efficacy of high frequency spinal cord stimulation (10 kHz SCS) for the treatment of chronic trunk and or limb pain has been demonstrated by the SENZA-RCT1 study. Real world data with a 12-month follow-up additionally support the efficacy of 10kHz SCS2. Previous work also demonstrated long-term durability of 10 kHz SCS and clinically meaningful results for patients with chronic lower back and or leg pain at 24 months (SENZA-EU)3. Here we present 10-year follow-up data on patients who originally participated in the SENZA-EU study3 and continued with usual care in a real-world setting over a mean period of 10 years.

ID: 205709 10 kHz SCS Significantly Improves Health-Related Quality of Life for Patients With Painful Diabetic Neuropathy

Painful diabetic neuropathy (PDN) affects approximately 9-11 million Americans.1-2 PDN pain can interfere with daily activities, cause psychosocial impairment, and reduce health-related quality of life (HRQoL).3 Unfortunately, conventional medical management (CMM), which includes pharmacotherapies, is ineffective for many PDN patients.2 Recently, high-frequency (10 kHz) spinal cord stimulation (SCS) has been shown to provide substantial pain relief for PDN,3 and here we report the associated benefits for multiple aspects of HRQoL.

ID: 200637 10 kHz SCS Provides Durable Pain Relief for Patients With Painful Diabetic Neuropathy

Approximately 37 million Americans have diabetes,1 with ∼25% experiencing painful diabetic neuropathy (PDN).2 Unfortunately, conventional medical management (CMM), which includes pharmacotherapies, is largely ineffective for many patients.2 High-frequency (10 kHz) spinal cord stimulation (SCS) has been shown to provide substantial symptom relief for PDN,3 and here we report durability of outcomes to 24 months (24M).

Abstract #1399039: Treatment of Painful Diabetic Neuropathy: 10 kHz SCS Provides Durable Pain Relief and Sensory Improvements

Of the 37 million Americans who have diabetes, up to 25% experience painful diabetic neuropathy (PDN). While conventional medical management (CMM), which includes pharmacotherapies, can be ineffective for many patients, high-frequency (10 kHz) spinal cord stimulation (SCS) has been shown to provide substantial symptom relief for PDN. Here we report durability of outcomes to 24 months (24M) months for 10 kHz SCS treatment of PDN. We conducted a prospective, multicenter, randomized, controlled trial (RCT) to evaluate 10 kHz SCS in PDN patients. Key inclusion criteria were: PDN symptoms ≥12M refractory to medications, lower limb pain intensity ≥5cm (0-10cm visual analog scale [VAS]), and hemoglobin A1c ≤10%. Patients (n=216) were randomized 1:1 to 10 kHz SCS plus CMM or CMM alone, with optional treatment group crossover at 6M. Patients randomized to 10 kHz SCS experienced average pain relief of 76% at 6M, while patients receiving CMM alone experienced average pain increase of 2%. After 6M, 93% of eligible CMM patients crossed over to 10 kHz SCS, while no 10 kHz SCS patients crossed over to CMM. At 24M, patients receiving 10 kHz SCS experienced durable pain relief, with average pain relief of 80%. Reductions in pain-associated sleep disturbance and pain interference with mood and daily activities were consistent with pain relief. At 6M, 10 kHz SCS provided substantial reductions vs. CMM. At 24M, patients receiving 10 kHz SCS experienced a 65% decrease in pain-associated sleep disturbance and a 67% decrease in pain interference with mood and daily activities. Clinician-assessed sensory function improvements in the feet and legs were observed with 10 kHz SCS. At 6M, improvements were observed in 59% of patients receiving 10 kHz SCS vs. only 9% of patients receiving CMM alone. Sensory improvements were durable as 65% of patients receiving 10 kHz SCS had improvements at 24M. In total, 154 patients received an SCS implant. There were eight (5.2%) study-related infections (n=3 resolved; n=5 (3.2%) explanted), which is within the range reported across all SCS patient populations (2.5-10%). The results of this RCT demonstrate that 10 kHz SCS provides durable reductions in pain and pain-associated effects on health-related quality of life with acceptable safety, now observed through 24-month follow-up. The durable sensory function improvements highlight the disease-modifying potential of 10 kHz SCS.

Painful Peripheral Neuropathies of the Lower Limbs and/or Lower Extremities Treated with Spinal Cord Stimulation: A Systematic Review with Narrative Synthesis.

Painful peripheral neuropathy (PPN) is a debilitating condition with varied etiologies. Spinal cord stimulation (SCS) is increasingly used when conservative treatments fail to provide adequate pain relief. Few published reviews have examined SCS outcomes in all forms of PPN. We conducted a systematic review of SCS in PPN. The PubMed database was searched up to February 7th, 2022, for peer-reviewed studies of SCS that enrolled PPN patients with pain symptoms in their lower limbs and/or lower extremities. We assessed the quality of randomized controlled trial (RCT) evidence using the Cochrane risk of bias tool. Data were tabulated and presented narratively. Twenty eligible studies documented SCS treatment in PPN patients, including 10 kHz SCS, traditional low-frequency SCS (t-SCS), dorsal root ganglion stimulation (DRGS), and burst SCS. In total, 451 patients received a permanent implant (10 kHz SCS, n=267; t-SCS, n=147; DRGS, n=25; burst SCS, n=12). Approximately 88% of implanted patients had painful diabetic neuropathy (PDN). Overall, we found clinically meaningful pain relief (≥30%) with all SCS modalities. Among the studies, RCTs supported the use of 10 kHz SCS and t-SCS to treat PDN, with 10 kHz SCS providing a higher reduction in pain (76%) than t-SCS (38-55%). Pain relief with 10 kHz SCS and DRGS in other PPN etiologies ranged from 42-81%. In addition, 66-71% of PDN patients and 38% of nondiabetic PPN patients experienced neurological improvement with 10 kHz SCS. Our review found clinically meaningful pain relief in PPN patients after SCS treatment. RCT evidence supported the use of 10 kHz SCS and t-SCS in the diabetic neuropathy subpopulation, with more robust pain relief evident with 10 kHz SCS. Outcomes in other PPN etiologies were also promising for 10 kHz SCS. In addition, a majority of PDN patients experienced neurological improvement with 10 kHz SCS, as did a notable subset of nondiabetic PPN patients.

10 kHz SCS Provides Durable Pain Relief and Neurological Improvements for Patients with Painful Diabetic Neuropathy: 24-Month RCT Results (PL4.004)

10 kHz SCS Provides Durable Pain Relief and Neurological Improvements for Patients with Painful Diabetic Neuropathy: 24-Month RCT Results (PL4.004)