Welcome to the e-INS 2023 Interactive Program

Introduction

Spinal Cord Stimulation (SCS) as a treatment for chronic pain has been historically designated for patients who have had at least one prior spinal surgery. Considering the opioid crisis, and the often-mixed clinical success of conservative treatment approaches and invasive back surgery procedures, there is growing interest in utilizing SCS in chronic pain patients who have not yet undergone previous surgical intervention.^1-4 Recent SCS devices offer substantially more novel technological or neurostimulative capabilities than older-generational SCS systems. Correspondingly, interventional treatment approaches capable of multimodal therapeutic strategies are now actively recommended by pain care advocates.^5,6

Materials / Methods

This is a prospective, multicenter randomized, controlled study (SOLIS) that compares SCS (Wavewriter^TM SCS Systems, Boston Scientific, Valencia, CA, USA) versus Conventional Medical Management (CMM) in patients with chronic low back and/or leg pain with no prior spinal surgery (Clinicaltrials.gov: NCT04676022). Enrolled non-surgical back pain (NSBP) patients who met inclusion criteria were randomized to SCS versus CMM. Key inclusion criteria include diagnosis of chronic low back pain, with or without leg pain, for ≥6 months, and documented care of chronic pain for ≥90 days. The primary endpoint is responder rate (≥ 50% reduction in pain) with no increase in baseline opioid medications to treat pain at 3-months following treatment activation. Other secondary and/or exploratory measures include Quality-of-Life (SF-36; EQ-5D-5L), Disability (Oswestry Disability Index, ODI), and Safety Outcomes.

Results

The study successfully met its primary endpoint (p < 0.0001) and secondary endpoints based on a prespecified cohort of 60 treatment activated subjects. The primary endpoint analysis demonstrated that multimodal SCS combined with CMM was superior to CMM alone (p<0.0001) in treating NSBP patients at 3-months follow-up (SCS: 88% versus CMM: 8%). A 27-point reduction in ODI score (improvement in disability) was noted in the SCS group in comparison to a 6-point reduction in the CMM group. Ninety-two percent of subjects with SCS reported treatment satisfaction (i.e., much, or very much improved) at 3-months versus only 6% in the CMM group.

Discussion

Given the prevalence of non-surgical, refractory back pain and the increasing economic and societal burden it poses, providing SCS as an additional tool within the therapeutic armamentarium for chronic pain represents a key opportunity to address a clinically important need.

Conclusions

SCS with multiple modalities is effective in treating chronic pain in patients with no prior back surgery demonstrating superior outcomes compared with CMM. SOLIS RCT outcomes are consistent with those reported in a preceding RCT assessing patients diagnosed with currently-approved “on-label” chronic pain indications.⁷

References

1. Finnerup NB, Attal N, Haroutounian S, McNicol E, Baron R, Dworkin RH, Gilron I, Haanpää M, Hansson P, Jensen TS, Kamerman PR, Lund K, Moore A, Raja SN, Rice AS, Rowbotham M, Sena E, Siddall P, Smith BH, Wallace M. Pharmacotherapy for neuropathic pain in adults: a systematic review and meta-analysis. Lancet Neurol. 2015 Feb;14(2):162-73.

2. Al-Kaisy A, Van Buyten JP, Kapural L, Amirdelfan K, Gliner B, Caraway D, Subbaroyan J, Edgar D, Rotte A. 10 kHz spinal cord stimulation for the treatment of non-surgical refractory back pain: subanalysis of pooled data from two prospective studies. Anaesthesia. 2020 Jun;75(6):775-784.

3. Kapural L, Jameson J, Johnson C, Kloster D, Calodney A, Kosek P, Pilitsis J, Bendel M, Petersen E, Wu C, Cherry T, Lad SP, Yu C, Sayed D, Goree J, Lyons MK, Sack A, Bruce D, Rubenstein F, Province-Azalde R, Caraway D, Patel NP. Treatment of nonsurgical refractory back pain with high-frequency spinal cord stimulation at 10 kHz: 12-month results of a pragmatic, multicenter, randomized controlled trial. J Neurosurg Spine. 2022 Feb 11:1-12.

4. Kapural L, Calodney A. Retrospective Efficacy and Cost-Containment Assessment of 10 kHz Spinal Cord Stimulation (SCS) in Non-Surgical Refractory Back Pain Patients. J Pain Res. 2022 Nov 16;15:3589-3595.

5. U.S. Department of Health and Human Services, Alliance to Advance Comprehensive Integrative Pain Management (2019). Pain Management Best Practices Inter-Agency Task Force Report. https://painmanagementalliance.org/resources/hhs-report-2019/. Accessed October 28th, 2022.

6. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical Practice Guideline for Prescribing Opioids for Pain - United States, 2022. MMWR Recomm Rep. 2022 Nov 4;71(3):1-95.

7. Wallace MS., et.al. Combination Therapy with Simultaneous Delivery of Spinal Cord Stimulation Modalities: COMBO Randomized Controlled Trial [Abstract]. NANS Annual Meeting, 2022.

Learning Objectives

1. To evaluate the use of SCS in the treatment of patients with non-surgical back pain (NSBP)

2. To compare pain relief outcomes of SCS versus Conventional Medical Management in a prospective randomized controlled trial for NSBP patients.

3, To compare quality-of-life outcomes of SCS versus Conventional Medical Management in a prospective randomized controlled trial for NSBP patients.

Introduction

The development of different waveforms and various spinal cord stimulation (SCS) systems increases the options for patients with chronic neuropathic pain. However, the choice for the used stimulation system is commonly made on an arbitrary basis. We therefore prospectively explored the influence of different providers during the temporary trial phase of SCS in a randomized clinical trial.

Materials / Methods

30 Patients with the indication for an SCS trial were included in the study. After implantation of a test lead, subjects were tested in a randomized order with two external pulse generators (EPG) of two different device manufacturers (A and B). Test leads from company A, the connection with the EPG from company B was made with an adapter. Tonic stimulation was used for two days with the first EPG. After that, stimulation was switched to burst stimulation for the following five days. There was a washout period of two days and then the second EPG was tested with burst stimulation only for another five days. After the trial, the test lead was removed and, if medically indicated, the entire system of the provider whose stimulator produced the best pain relief is implanted. A prospective data collection of these patients takes place in the following 6 months. During the different study phases, pain intensity and perception of pain were assed with visual analog scale (VAS), PainDETECT and Pain Castastrophizing Scale (PCS).

Results

Persistent spinal pain syndrome (type II) was the most frequent pain etiology, all the subjects had PainDETECT scores over 12 indicating neuropathic pain. Mean pain intensity at the baseline was 6.6 and achieved 6.4 after five days with burst stimulation from company B and 5.4 after burst stimulation from company A. Reduction in PCS was similar between the two groups – from 31.9 to 24.3 points with company B and to 23.3 points with company A. The tonic stimulation phase, which was done with the system of a single company for each patient, elicited 4.8% pain relief with B and 16.0% with A.

Discussion

Although different stimulation are provided for SCS devices, the differences among the features remain limited. According to our results, perioperative patient care is more important thean the choice of a particular device.

Conclusions

The choice of stimulator shows to have no influence over pain reduction (non-inferior). Both types of Burst stimulation were superior in terms of pain relief, however no difference was found among companies A and B.

Learning Objectives

The choice of stimulator shows to have no influence over pain reduction (non-inferior).

Introduction

Fast-Acting Sub-Perception Therapy (FAST) has demonstrated robust, profound pain relief with rapid (seconds to minutes) onset of analgesia in chronic pain patients implanted with Spinal Cord Stimulation (SCS) systems.¹ Initial results have been corroborated at other centers.² Sustained long-term improvement of up to 3 years has also been reported in an observational, real-world case-series.³ Recently published work suggests that FAST engages the surround inhibition mechanism of action, and computational modeling suggests that FAST activates dorsal column axons and inhibits dorsal horn projection neurons.⁴

Materials / Methods

The FAST study is a prospective, multi-center, single-arm study (with adaptive design) of patients implanted with SCS systems (WaveWriter^TM Systems, Boston Scientific, Valencia, CA, USA) for chronic pain. The primary endpoint is based on the targeted pain responder rate (≥50% reduction) 3-months post-activation with no increase in average daily opioid medications. Secondary endpoints include (but are not limited to) patient satisfaction (Patient Global Impression of Change, PGIC) and other functional outcomes including disability (Oswestry Disability Index, ODI) and sleep. Key inclusion criteria include diagnosis of predominantly neuropathic pain of trunk and/or limbs for at least 6- months, and no back surgery within 6-months prior to screening.

Results

The study successfully met its primary endpoint (p<0.0001) based on a prespecified cohort of 20 subjects. A 6.1-point reduction (p<0.0001) in mean low back pain score at 3 months was reported with a 95% responder rate (≥50% improvement in pain relief). A 31-point improvement in disability (ODI) and high patient satisfaction ratings (85% reported much improved or very much improved, PGIC) were found. At the FAST-SCS activation visit, FAST responders achieved maximum paresthesia-free pain relief within a mean of 5.4-minutes.

Discussion

Preliminary results from this ongoing FAST prospective study suggests that profound, significant pain relief along with improvement in functional outcomes may be achieved in chronic pain patients with FAST therapy and additional SCS therapy options. With availability of multiple modalities in SCS systems, the capability for rapid onset of analgesia is particularly useful in evaluating what may be best suited for patients.

Conclusions

Significant pain relief and improvement in functional outcomes were reported in the FAST prospective study. These study results are consistent with published real-world experience that has assessed over 200 patients.⁵

References

1. Metzger CS, et al. A novel fast-acting sub-perception spinal cord stimulation therapy enables rapid onset of analgesia in patients with chronic pain. Expert Rev Med Devices 2021 Mar; 18(3): 299-306.

2. Ferro R, Pei Y, Jain R. Significant Pain Relief Using an SCS System Delivering Novel, Fast-Acting Sub-Perception Therapy [Abstract e-poster] Annual Meeting of the North American Neuromodulation Society, 2023.

3. Bayerl S, Paz Solis JF, Matis G, et al. Clinical Outcomes Using A New Fast Acting Sub Perception Therapy For Chronic Pain A Multicenter European Observational Real World Study [Abstract Poster 113]. Annual Meeting of the North American Neuromodulation Society, 2023.

4. Gilbert JE, Titus N, Zhang T, Esteller R, Grill WM. Surround Inhibition Mediates Pain Relief by Low Amplitude Spinal Cord Stimulation Modeling and Measurement. eNeuro 2022. Sep 22.ENEURO.0058-22.

5. Metzger C, Hammond MB, Ferro R, et al. Outcomes of a Large, Multicenter, Real-World Study using an SCS System Engaging Surround Inhibition [Abstract Poster 80]. Annual Meeting of the North American Neuromodulation Society, 2023.

Learning Objectives

1. To assess the FAST-SCS responder rate (defined as >50% pain relief when using FAST-SCS) among patients implanted with an SCS system

2. To assess the duration of onset of pain relief following FAST-SCS activation in FAST-SCS responders

3. To assess pain relief and functional outcomes in patients with an SCS system capable of FAST-SCS.

Introduction

Spinal Cord Stimulation (SCS) is an effective therapy for chronic neuropathic pain, with its long-term efficacy well-established. However, some patients experience loss of efficacy (LoE) over time and become refractory over the course of follow-up.¹ Providing various waveforms and programming options in novel SCS systems can facilitate more customized delivery of analgesic neurostimulation to chronic pain patients implanted with an SCS device. However, technologies that offer such optimization capabilities are not accessible to long-term implanted patients using older devices, some of whom may experience loss or attenuation in therapeutic efficacy over time. These patients therefore may elect to undergo a "conversion" to a different SCS system that possesses these capabilities.

Materials / Methods

This is a real-world, multicenter retrospective study of patients who were previously implanted with an SCS system (commercially-available device) who went on to convert to a new device (Boston Scientific SCS Systems, Boston Scientific, Valencia, CA, USA) capable of multiple modality stimulation and/or combination therapy via an applicable device adaptor and new implantable pulse generator (IPG). Pain relief and other associated outcomes using both the previously-implanted SCS system and the newly connected device IPG are being collected.

Results

Fifty-one patients (mean age = 57.1 years) have been assessed to date. A mean baseline overall pain (NRS) score of 7.7 ± 2.0 (n = 40) was reported prior to receiving SCS. Sixty nine percent of patients (N = 35) chose to convert for better pain relief followed by the need to access multiple programs (35%) and/or to get coverage of new areas of pain (31%). Previous SCS devices represent a range of different manufacturers. Among all patients (regardless of reasons for conversion), a pain score of 3.4 was noted at last follow up and sustained improvement was noted up to 3.2 years with current systems. In patients for whom the conversion was performed to “rescue” suboptimal outcomes with the previous system (N=47), a mean 3.5-point improvement with the current system was noted at last follow-up (3.1 years post-implant, 7.0 ⇒ 3.6, p<0.0001).

Discussion

When experiencing problems with SCS device longevity and/or loss of efficacy, some previously-implanted patients may be able to obtain better outcomes using more advanced neuromodulation systems that offer a range of waveforms and programming options to address their chronic pain.

Conclusions

Significant improvement was noted in overall pain in patients who converted to a new SCS device capable of providing multiple device programming options including anatomically guided paresthesia-based stimulation, combination therapy, and novel sub-perception modalities.

References

1. Deer TR, Mekhail N, Provenzano D, et al Neuromodulation Appropriateness Consensus Committee The appropriate use of neurostimulation avoidance and treatment of complications of neurostimulation therapies for the treatment of chronic pain Neuromodulation Appropriateness Consensus Committee Neuromodulation 2014 Aug 17 6 571-97. discussion 597-8.

2. Kumar K, Hunter G, Demeria D Spinal cord stimulation in treatment of chronic benign pain challenges in treatment planning and present status, a 22-year experience Neurosurgery 2006 Mar 58 3 481 96 discussion 481-96.

Learning Objectives

1. To assess pain relief outcomes (including long-term outcomes) in an SCS-implanted population (with sub-optimal pain relief) who have replaced their older generation SCS batteries with a newer generation device that provides multiple modalities.

2. To assess the reasons for conversion in patients who converted to newer SCS systems.

3. To evaluate the programs that are most preferred by patients who have converted to a newer SCS system.

Introduction

Spinal cord stimulation (SCS) can improve pain relief, limb salvage, and microcirculatory blood flow in patients suffering from intractable ischemic pain due to peripheral vascular disease (PVD) who are not suitable for revascularization¹. Herein, we present long-term effectiveness and safety outcomes using SCS for PVD at a single center.

Materials / Methods

51 patients (37 men [mean age 68.9 ± 10.2 y], 14 women [mean age (68.7 ± 14.6 y]) underwent SCS (n = 49) or Dorsal Root Ganglion Stimulation (DRG-S, n = 2) implantation due to intractable ischemic pain because of PVD (Rutherford 3, 4 and 5) from 03/2007 – 04/2022. Patients were classified as Rutherford’s class 3 (n = 21), class 4 (n = 12), or class 5 (n = 8)[RM(2] . Walking distance (m), pain intensity (NRS), opioid consumption (mg MME [morphine milligram equivalents]/d), and quality of life (EQ-5D VAS) were determined during follow-up. Two patients were excluded due to loss to follow-up within 6 months. Relevant comorbidities, major amputations, and deaths were documented. The Kaplan-Meier survival curve was used for the primary endpoint analysis for survival and amputation rates. Because of the observed mortality over the total period of eleven years, the 48-month follow-up was chosen as the cut-off time to ensure a sufficient sample size (IBM SPSS Statistics 29, Armonk, NY, USA).

Results

The number of patients with follow-up data at respective time points includes n = 49 patients at 6M, 41 at 1Y, 37 at 2Y, 27 at 3Y, 21 at 4Y, 16 at 5Y, 14 at 6Y, 13 at 7Y, 8 at 8Y and 1 patient at 9 and 10Y. We observed a statistically highly significant reduction in the level of pain at rest and likewise in load-dependent pain. 75% of patients were walking more than 200 m at 48M. 42/49 did not undergo a major amputation post-implant. We observed a significant reduction in opioid consumption and an improvement in the quality of life of treated patients.

Discussion

Neuromodulation reduces pain and improves the functionality of the affected limb and patient quality of life for patients suffering from severe PVD. Compared to existing literature (SCS can reduce the amputation rate and pain in selected patients over a period of 12 months^{2, 3}) our data demonstrate a long-lasting therapeutic effect.

Conclusions

According to these results, neuromodulative therapy should be recommended for patients with non-reconstructable and non-unstable stage (Rutherford 3, 4, and 5) disease and shows favorable long-term results.

References

¹Giannopoulos, S. & Armstrong, E. J. Medical therapy for cardiovascular and limb-related risk reduction in critical limb ischemia. Vascular Medicine 26, 210-224, doi:10.1177/1358863X20987612 (2021).Asimakidou, E. & Matis, G. K. Spinal cord stimulation in the treatment of peripheral vascular disease: a systematic review – revival of a promising therapeutic option? Brit J Neurosurg, 1-9, doi:10.1080/02688697.2021.1884189 PMID - 33703962 (2021).

²Asimakidou, E. & Matis, G. K. Spinal cord stimulation in the treatment of peripheral vascular disease: a systematic review – revival of a promising therapeutic option? Brit J Neurosurg, 1-9, doi:10.1080/02688697.2021.1884189 PMID - 33703962 (2021).

³Cucuruz, B. et al. Treatment of end-stage peripheral artery disease by neuromodulation. Clinical hemorheology and microcirculation 81, 315-324, doi:10.3233/ch-221436 (2022).

Learning Objectives

1. Spinal cord stimulation (SCS) can improve pain relief, limb salvage, and microcirculatory blood flow in patients suffering from intractable ischemic pain due to peripheral vascular disease (PVD).

2. This form of therapy shows favorable long-term efficacy, is safe and has only minimal side effects.

3. According to these results, neuromodulative therapy should be recommended for patients with non-reconstructable and non-unstable stage (Rutherford 3, 4, and 5) disease.

Introduction

Diabetic polyneuropathy (DPN) is one of the most common complications occurring in patients with diabetes mellitus (DM). DPN manifests as sensory disturbance in the limbs and can be divided into painful/non-painful DPN. Due to complications associated with DPN, this disease could lead to high health care utilization. We aimed to analyse the cost structure and resource use in patients suffering from painful/non-painful DPN from the perspective of the German statutory health insurances (SHI) with the target creating a budget impact model (BIM) for the use of spinal cord stimulation (SCS).

Materials / Methods

The BIM was built using data from anonymized, age- and sex-adjusted routine data from 2014-2019 on approximately 4.9 million SHI-insured persons. With corresponding ICD- and ATC-codes, patients with DM were selected, stratified into patients with/without DPN and thereafter differentiated between painful/non-painful DPN. Cost analysis was based on mean annual costs per patient. For the BIM, we assumed a SCS therapeutic success of 85% (following Peterson et al. 2021) and for calculation of follow-up costs, an inflation rate of 2% was used. Costs (per patient) of painful DPN-patients with/without SCS were compared over the follow-up period (5 years).

Results

Patients with painful DPN showed total annual costs of 22,266€ compared to 9,727€ for patients with non-painful DPN, whereby the highest costs occurred in the inpatient sector. Sick pay and work incapacity days also increased especially with the presence of painful DPN. The BIM showed cost savings in SCS-treated patients with painful DPN from the 3rd year onwards (year 3: 4,122€ cost savings per patient).

Discussion

The results show that patients with painful DPN cause 2.3 times higher total annual costs for SHI compared to patients with non-painful DPN. Treatment options like SCS could help to relieve pain significantly and to save costs in those patients over the time.

Conclusions

From a payers’ perspective, patients with painful DPN are cost intensive and requiring special attention. Thus, care management and therapies increasing efficiency in order to reduce average costs are of particular interest in this area. Based on the BIM, SCS could play a significant role since it has the potential of saving costs from the third year after implantation.

References

Luecke, T., Siegel, E., Vogelmann, T.: „Kosten und Ressourcenverbrauch von Patient:innen mit schmerzhafter diabetischer Polyneuropathie“, in: „Monitor Versorgungsforschung“ (06/22), S. 61-67. http://doi.org/10.24945/MVF.06.22.1866-0533.2464.

Petersen EA, et al. (2021): Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy: A Randomized Clinical Trial. JAMA Neurol. 78(6):687-698.

Weinand, S., Luecke T., Siegel E., Vogelmann T.: „Pain Therapy With Spinal Cord Stimulation (SCS) in Patients With Painful Diabetic Neuropathy (PDN): Results of a Budget Impact Model”, in: Value in Health, Volume 25, Issue 12S (December 2022).

Learning Objectives

- Differentiation into cost drivers and impact of payer budgets

- Focus on increasing efficiency and cost savings