Effectiveness of high dose spinal cord stimulation for non‐surgical intractable lumbar radiculopathy

Pain Practice ◽  
2021 ◽  
Author(s):  
Vivek Mehta ◽  
Kavita Poply ◽  
Alia Ahmad ◽  
Joanne Lascelles ◽  
Amin Elyas ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
High Dose ◽  
Lumbar Radiculopathy

scholarly journals Protocolized High-Dose (HD) and Low-Dose (LD) Spinal Cord Stimulation (SCS) Workflow Results in Meaningful Pain and Opiate Reduction

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Sarah E Hodges ◽  
Shervin Rahimpour ◽  
Luis Alejandro Antezana ◽  
Abena A Ansah-Yeboah ◽  
Rajeev Dharmapurikar ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Pain Relief ◽  
Real World ◽  
Spinal Cord Stimulation ◽  
Low Dose ◽  
High Dose ◽  
Pain Medications ◽  
Long Term Follow Up ◽  
Permanent Implant

Abstract INTRODUCTION Various new waveforms for spinal cord stimulation (SCS) have emerged in recent years, with limited data supporting their utility in a real-world clinical setting. We report real-world results of a protocolized workflow algorithm that allows for high dose (HD) and low dose (LD) neurostimulation in patients with chronic pain undergoing SCS trial or permanent procedures. METHODS Prospective data was collected using the ManageMySurgery (MMS) mobile device platform in patients undergoing Medtronic SCS trial and permanent implant procedures. E-consent was obtained through the HIPAA compliant, mobile software platform. All data was de-identified, aggregated and analyzed. RESULTS In total, 104 patients (37 trial SCS and 67 permanent SCS) participated. For SCS trial and permanent procedures, the protocolized workflow algorithm resulted in a 91% trial success rate with >50% pain relief. At long-term follow-up (3 to 12 mo), 86% of permanent SCS patients reported they were getting the same or more relief as during their SCS trial. For permanent SCS patients, 79% reported >50% improvement in overall pain and 58% had >50% improvement in low back pain. The protocolized workflow algorithm resulted in a 37% “remitter rate,” with these patients reporting themselves essentially pain free (VAS 0–3). Importantly, 52% of permanent implant patients stopped or reduced their ‘as needed’ pain medications by >50%. Additionally, 87% would recommend the same procedure to a friend or family member, 87% found device charging ‘easy’ or ‘very easy’ and 66% reported charging a few times a week or weekly. CONCLUSION A protocolized workflow algorithm that allows for HD and LD neurostimulation appears to have robust utility in providing meaningful pain relief and opiate reduction during both the SCS trial and permanent stages and at longer-term follow-up. Randomized controlled trials with extended follow-up are in progress.

scholarly journals The influence of High Dose Spinal Cord Stimulation on the descending pain modulatory system in patients with failed back surgery syndrome

2019 ◽  
Vol 24 ◽  
pp. 102087
Author(s):  
Sander De Groote ◽  
Lisa Goudman ◽  
Ronald Peeters ◽  
Bengt Linderoth ◽  
Peter Van Schuerbeek ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Failed Back Surgery Syndrome ◽  
High Dose ◽  
Failed Back Surgery ◽  
Back Surgery

scholarly journals Options: A Prospective, Open-Label Study of HighDose Spinal Cord Stimulation in Patients with Chronic Back and Leg Pain

2020 ◽  
Vol 1;23 (1;1) ◽  
pp. 87-98 ◽  
Author(s):  
Ramsin Benyamin
Keyword(s):  
Spinal Cord ◽  
Pain Relief ◽  
Spinal Cord Stimulation ◽  
Pulse Width ◽  
Failed Back Surgery Syndrome ◽  
Leg Pain ◽  
High Dose ◽  
Failed Back Surgery ◽  
Global Impression Of Change

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 Design: This was a prospective cohort study. Setting: This study took place at 11 centers in North America. Methods: Forty-four SCS-naive patients underwent trialing, starting with 1,000 Hz frequency, 90 µs pulse width followed by 300 Hz frequency, 800 µs pulse width, if pain relief was inadequate. Patients with 50% or greater pain relief were eligible for permanent implantation. Patient’s pain rating, global impression of change, health-related quality of life, functional disability, satisfaction/ recommendation, stimulation perception, device programming, and adverse events were assessed at 3 months postimplant. Results: There were significant improvements from baseline in mean Numeric Rating Scale (NRS11) pain scores for overall pain (7.5 to 3.8; P < 0.01), back pain (7.2 to 3.4; P < 0.01), leg pain (7.2 to 3.1; P < 0.01), Oswestry Disability Index (ODI) score (51.5 to 32.1; P < 0.01), and European Quality of Life–Five Dimensions, version 5L score (EQ-5D-5L) (0.58 to 0.74; P < 0.01). Twentyeight of 32 patients (88%) had significant, favorable improvement in Patient Global Impression of Change (PGIC). Eighty-four percent of patients were “satisfied,” and 78.1% would “definitely” recommend SCS. Eighteen patients (56%) used 1,000 Hz frequency and 90 µs pulse width exclusively; these patients experienced mean NRS-11 overall pain score improvement of 4.7 points. Device-, therapy-, or procedure-related adverse events were experienced in 19 patients (40%, 19 of 48), and all events resolved without reoperation and were similar to those observed with traditional SCS systems. Limitations: There was no active or sham comparator group, and therefore the reported effects may not be solely attributable to therapy effects and may be related to other, nonspecific effects of SCS. Conclusions: Improvements in pain relief, PGIC, EQ-5D-5L, ODI, and patient satisfaction were all clinically relevant and statistically significant. Future studies are needed to understand how these high-dose parameters perform versus a standard comparator. Key words: Spinal cord stimulation, high-frequency electrical stimulation, failed back surgery syndrome, neurostimulation, prospective, nonrandomized study

scholarly journals Use of Spinal Cord Stimulator for Treatment of Lumbar Radiculopathy in a Patient with Severe Kyphoscoliosis

2008 ◽  
Vol 4;11 (8;4) ◽  
pp. 555-559 ◽  
Author(s):  
Joseph Atallah
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Failed Back Surgery Syndrome ◽  
Radicular Pain ◽  
Activity Level ◽  
Spinal Cord Stimulator ◽  
Lumbar Radiculopathy ◽  
Failed Back Surgery ◽  
Back Surgery ◽  
Technical Considerations

Spinal cord stimulation (SCS) has been a therapeutic option for chronic pain for over 40 years with a common indication being failed back surgery syndrome (FBSS). This case reports the successful implantation of a spinal cord stimulator in a patient with FBSS and kyphoscoliosis for treatment of radicular pain. Technical considerations and anatomical difficulties that may be encountered during placement with kyphoscoliosis will be discussed. This patient had failed other therapies including oral medications, epidural steroid injections, spinal surgeries, and physical and aquatic therapies. On physical examination the patient had a severely deformed lumbar spine. Careful review of the spine radiographs and CT scan revealed lead placement might be possible at the level of T12-L1 or L1-2. A Medline search did not reveal a case of kyphoscoliosis with radicular pain treated with SCS. After a successful percutaneous trial, a SCS was implanted. Fourteen weeks later, the patient reported being pain free with an increased physical activity level and opioid discontinuation. Technical considerations with kyphoscoliosis may discourage pain physicians from attempting SCS. This case illustrates that with careful selection, some of these patients may be candidates for SCS with good results. Key words: Spinal cord stimulator, spinal cord stimulation, failed back surgery syndrome, kyphoscoliosis, back pain, lumbar radiculopathy

scholarly journals The Influence of Missing Data on Disabilities in Patients Treated with High-Dose Spinal Cord Stimulation: A Tipping Point Sensitivity Analysis

2021 ◽  
Vol 10 (21) ◽  
pp. 4897
Author(s):  
Lisa Goudman ◽  
Geert Molenberghs ◽  
Rui V. Duarte ◽  
Maarten Moens
Keyword(s):  
Spinal Cord ◽  
Sensitivity Analysis ◽  
Missing Data ◽  
Spinal Cord Stimulation ◽  
Missing At Random ◽  
Tipping Point ◽  
High Dose ◽  
Shift Parameter ◽  
Disability Score ◽  
Failed Back Surgery

New waveforms have changed the field of Spinal Cord Stimulation (SCS) to optimize therapy outcomes, among which is High-Dose SCS (HD-SCS). Missing observations are often encountered when conducting clinical trials in this field. In this study, different approaches with varying assumptions were constructed to evaluate how conclusions may be influenced by these assumptions. The aim is to perform a tipping point sensitivity analysis to evaluate the influence of missing data on the overall conclusion regarding the effectiveness of HD-SCS on disability. Data from the Discover study were used, in which 185 patients with Failed Back Surgery Syndrome were included. Disability was evaluated before SCS and after 1, 3 and 12 months of HD-SCS. During the second, third and fourth visit, data from 130, 114 and 90 patients were available, respectively. HD-SCS resulted in a significant decrease in disability scores based on the analysis of observed data and with multiple imputations. The tipping point sensitivity analysis revealed that the shift parameter was 17. Thus, the conclusion concerning the time effect under a “missing at random” mechanism is robust when the shift parameter for the disability score is 17. From a clinical point of view, a shift of 17 points on disability is not very plausible. Therefore we tend to consider the conclusions drawn under “missing at random” as being robust.

scholarly journals The Added Value of High Dose Spinal Cord Stimulation in Patients with Failed Back Surgery Syndrome after Conversion from Standard Spinal Cord Stimulation

2020 ◽  
Vol 9 (10) ◽  
pp. 3126
Author(s):  
Mats De Jaeger ◽  
Lisa Goudman ◽  
Koen Putman ◽  
Ann De Smedt ◽  
Philippe Rigoard ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Failed Back Surgery Syndrome ◽  
Added Value ◽  
High Dose ◽  
Average Increase ◽  
Failed Back Surgery ◽  
Back Surgery ◽  
Over Time

Patients with Failed Back Surgery Syndrome (FBSS) report a considerably lower health- related quality of life (HRQoL), compared to the general population. Spinal cord stimulation (SCS) is an effective treatment to offer pain relief in those patients. Despite initial treatment success of SCS, its effect sometimes wears off over time. This study investigates the added value of high dose SCS (HD-SCS) in patients with unsatisfactory conventional SCS, from a quality of life perspective. Seventy-eight FBSS patients who were treated with conventional SCS that failed to provide pain relief, were recruited in 15 centers. HRQoL was assessed before converting to HD-SCS (baseline) and three times after converting to HD-SCS using the EuroQol-5D-3L. Quality adjusted life years (QALY) were calculated and compared with conventional SCS. An overall significant increase over time was seen in utility values of the EQ5D-3L, as the mean value at baseline 0.283 (±0.21) increased to 0.452 (±0.29) at 12 months of HD-SCS. This average increase in utility coincides with an average increase of 0.153 (±0.24) QALY’s in comparison to continued conventional SCS. Besides the potential of HD-SCS to salvage patients with failed responses to conventional SCS, this treatment seems to be a more efficient treatment than conventional SCS.

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