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 Efficacy and Safety of 10 kHz Spinal Cord Stimulation for the Treatment of Chronic Pain: A Systematic Review and Narrative Synthesis of Real-World Retrospective Studies

Biomedicines ◽  
2021 ◽  
Vol 9 (2) ◽  
pp. 180
Author(s):  
Ganesan Baranidharan ◽  
Deborah Edgar ◽  
Beatrice Bretherton ◽  
Tracey Crowther ◽  
Abdul-Ghaaliq Lalkhen ◽  
...  
Keyword(s):  
Systematic Review ◽  
Spinal Cord ◽  
Chronic Pain ◽  
Pain Relief ◽  
Real World ◽  
Spinal Cord Stimulation ◽  
Retrospective Studies ◽  
Incidence Rates ◽  
Efficacy And Safety

10 kHz spinal cord stimulation (SCS) is increasingly utilized globally to treat chronic pain syndromes. Real-world evidence complementing randomized controlled trials supporting its use, has accumulated over the last decade. This systematic review aims to summarize the retrospective literature with reference to the efficacy and safety of 10 kHz SCS. We performed a systematic literature search of PubMed between 1 January 2009 and 21 August 2020 for English-language retrospective studies of ≥3 human subjects implanted with a Senza® 10 kHz SCS system and followed-up for ≥3 months. Two independent reviewers screened titles/abstracts of 327 studies and 46 full-text manuscripts. In total, 16 articles were eligible for inclusion; 15 reported effectiveness outcomes and 11 presented safety outcomes. Follow-up duration ranged from 6–34 months. Mean pain relief was >50% in most studies, regardless of follow-up duration. Responder rates ranged from 67–100% at ≤12 months follow-up, and from 46–76% thereafter. 32–71% of patients decreased opioid or nonopioid analgesia intake. Complication incidence rates were consistent with other published SCS literature. Findings suggest 10 kHz SCS provides safe and durable pain relief in pragmatic populations of chronic pain patients. Furthermore, it may decrease opioid requirements, highlighting the key role 10 kHz SCS can play in the medium-term management of chronic pain.

Spinal Cord Stimulation in Treatment of Chronic Benign Pain: Challenges in Treatment Planning and Present Status, a 22-Year Experience

Neurosurgery ◽  
2006 ◽  
Vol 58 (3) ◽  
pp. 481-496 ◽  
Author(s):  
Krishna Kumar ◽  
Gary Hunter ◽  
Denny Demeria
Keyword(s):  
Quality Of Life ◽  
Spinal Cord ◽  
Pain Relief ◽  
Success Rate ◽  
Spinal Cord Stimulation ◽  
Pain Clinic ◽  
Axial Component

Abstract OBJECTIVE: To present an in-depth analysis of clinical predictors of outcome including age, sex, etiology of pain, type of electrodes used, duration of pain, duration of treatment, development of tolerance, employment status, activities of daily living, psychological status, and quality of life. Suggestions for treatment of low back pain with a predominant axial component are addressed. We analyzed the complications and proposed remedial measures to improve the effectiveness of this modality. METHODS: Study group consists of 410 patients (252 men, 58 women) with a mean age of 54 years and a mean follow-up period of 97.6 months. All patients were gated through a multidisciplinary pain clinic. The study was conducted over 22 years. RESULTS: The early success rate was 80% (328 patients), whereas the long-term success rate of internalized patients was 74.1% (243 patients) after the mean follow-up period of 97.6 months. Hardware-related complications included displaced or fractured electrodes, infection, and hardware malfunction. Etiologies demonstrating efficacy included failed back syndrome, peripheral vascular disease, angina pain, complex regional pain syndrome I and II, peripheral neuropathy, lower limb pain caused by multiple sclerosis. Age, sex, laterality of pain or number of surgeries before implant did not play a role in predicting outcome. The percentage of pain relief was inversely related to the time interval between pain onset and time of implantation. Radicular pain with axial component responded better to dual Pisces electrode or Specify-Lead implantation. CONCLUSION: Spinal cord stimulation can provide significant long-term pain relief with improved quality of life and employment. Results of this study will be effective in better defining prognostic factors and reducing complications leading to higher success rates with spinal cord stimulation.

Spinal Cord Stimulation for Chronic Pain Relief: First Experience in Baltics

2011 ◽  
Vol 11 (1) ◽  
pp. 180-181
Author(s):  
Iveta Golubovska ◽  
Aleksejs Miscuks ◽  
Vitolds Jurkevics ◽  
Sarmite Skaida
Keyword(s):  
Spinal Cord ◽  
Chronic Pain ◽  
Pain Relief ◽  
Low Income ◽  
Spinal Cord Stimulation ◽  
Pain Syndrome ◽  
Neuropathic Pain Syndrome ◽  
Patient Status ◽  
First Case

Spinal Cord Stimulation for Chronic Pain Relief: First Experience in BalticsWe report the first case of spinal cord stimulator implantation in Baltics to patient with massive posttraumatic plexus lumbosacralis dxtr lesion, severe neuropathic pain syndrome and drug addiction problems. Follow-up time is 6 month since December 2011 and we have observed an obvious clinical and social improvement in patient status. Besides significant pain relief she has got employed and is tax payer instead of low-income person.

Intrathecal Clonidine and Baclofen Enhance the Pain-Relieving Effect of Spinal Cord Stimulation

Neurosurgery ◽  
2010 ◽  
Vol 67 (1) ◽  
pp. 173-181 ◽  
Author(s):  
Gastón Schechtmann ◽  
Göran Lind ◽  
Jaleh Winter ◽  
Björn A. Meyerson ◽  
Bengt Linderoth
Keyword(s):  
Spinal Cord ◽  
Neuropathic Pain ◽  
Pain Relief ◽  
Spinal Cord Stimulation ◽  
Animal Experiments ◽  
Pain Reduction ◽  
Saline Control ◽  
Similar Data ◽  
Intrathecal Clonidine

Abstract OBJECTIVE Spinal cord stimulation (SCS) is a well-established treatment for neuropathic pain; nevertheless, 40% of patients fail to obtain satisfactory pain relief and in many patients, the effect tends to diminish with time. Based on animal experiments, intrathecal baclofen was previously introduced clinically to enhance suboptimal SCS effects. Later animal experiments demonstrated similar data for clonidine. The aim of this study was to elucidate whether intrathecal clonidine or baclofen enhances the effect of SCS in neuropathic pain patients in whom the pain relieving-effect of SCS is inadequate. METHODS A randomized, double-blind, placebo-controlled clinical trial was conducted with 10 patients experiencing neuropathic pain with insufficient pain relief with SCS alone. Clonidine, baclofen, and saline (control) were intrathecally administered by bolus injections in combination with SCS. RESULTS Seven of 10 patients reported significant pain reduction when SCS was combined with active drugs. The mean visual analog scale ratings were reduced by more than 50% with either drug combined with SCS. Four patients previously treated with SCS alone later underwent implantation of a pump for long-term administration of clonidine or baclofen. In the 2 patients with clonidine pumps with a mean follow-up of 15 months, the combined therapy produced pain reduction of 55% and 45%, respectively. The corresponding effect with baclofen was 32% and 82%, respectively, at 7 months follow-up. CONCLUSION A trial with clonidine and baclofen combined with SCS may be warranted in patients who do not obtain satisfactory pain relief with SCS alone or experienced a decreasing therapeutic effect.

A Real-World Analysis of High-Frequency 10 kHz Spinal Cord Stimulation for the Treatment of Painful Diabetic Peripheral Neuropathy

2021 ◽  
pp. 193229682110603
Author(s):  
Jeffrey L. Chen ◽  
Andrew W. Hesseltine ◽  
Sara E. Nashi ◽  
Shawn M. Sills ◽  
Tory L. McJunkin ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Peripheral Neuropathy ◽  
Pain Relief ◽  
Diabetic Neuropathy ◽  
Real World ◽  
Spinal Cord Stimulation ◽  
Diabetic Peripheral Neuropathy ◽  
High Frequency ◽  
Clinical Practices ◽  
Painful Diabetic Peripheral Neuropathy

Background: Diabetes is one of the most prevalent chronic health conditions and diabetic neuropathy one of its most prevalent and debilitating complications. While there are treatments available for painful diabetic peripheral neuropathy (pDPN), their effectiveness is limited. Method: This retrospective, multi-center, real-world review assessed pain relief and functional improvements for consecutive patients with diabetic neuropathy aged ≥18 years of age who were permanently implanted with a high-frequency (10 kHz) spinal cord stimulation (SCS) device. Available data were extracted from a commercial database. Results: In total 89 patients consented to being included in the analysis. Sixty-one percent (54/89) of participants were male and the average age was 64.4 years (SD = 9.1). Most patients (78.7%, 70/89) identified pain primarily in their feet or legs bilaterally. At the last assessment, 79.5% (58/73) of patients were treatment responders, defined as having at least 50% patient-reported pain relief from baseline. The average time of follow-up was 21.8 months (range: 4.3 to 46.3 months). A majority of patients reported improvements in sleep and overall function relative to their baseline. Conclusions: This real-world study in typical clinical practices found 10 kHz SCS provided meaningful pain relief for a substantial proportion of patients refractory to current pDPN management, similar to published literature. This patient population has tremendous unmet needs and this study helps demonstrate the potential for 10 kHz SCS to provide an alternative pain management approach.

Spinal Cord Stimulation for Complex Regional Pain Syndrome Type I: A Prospective Cohort Study With Long-Term Follow-Up

2013 ◽  
Vol 16 (6) ◽  
pp. 523-529 ◽  
Author(s):  
José W. Geurts ◽  
Helwin Smits ◽  
Marius A. Kemler ◽  
Florian Brunner ◽  
Alfons G. H. Kessels ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Cohort Study ◽  
Spinal Cord Stimulation ◽  
Prospective Cohort ◽  
Pain Syndrome ◽  
Type I ◽  
Syndrome Type ◽  
Long Term Follow Up

scholarly journals Long-term follow-up of spinal cord stimulation to restore cough in subjects with spinal cord injury

2013 ◽  
Vol 37 (4) ◽  
pp. 380-388 ◽  
Author(s):  
Anthony F. DiMarco ◽  
Krzysztof E. Kowalski ◽  
Dana R. Hromyak ◽  
Robert T. Geertman
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Spinal Cord Stimulation ◽  
Cord Injury ◽  
Long Term Follow Up

Long-Term Outcome of Spinal Cord Stimulation in Failed Back Surgery Syndrome: 20 Years of Experience With 224 Consecutive Patients

Neurosurgery ◽  
2018 ◽  
Vol 84 (5) ◽  
pp. 1011-1018 ◽  
Author(s):  
Mette Nissen ◽  
Tiina-Mari Ikäheimo ◽  
Jukka Huttunen ◽  
Ville Leinonen ◽  
Mikael von und zu Fraunberg
Keyword(s):  
Spinal Cord ◽  
Pain Relief ◽  
Spinal Cord Stimulation ◽  
Failed Back Surgery Syndrome ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Failed Back Surgery ◽  
Back Surgery

Abstract BACKGROUND Failed back surgery syndrome (FBSS) is a challenging condition that lacks a curative treatment. In selected patients, spinal cord stimulation (SCS) has provided a satisfactory outcome. OBJECTIVE To evaluate the long-term outcome of SCS in FBSS, as measured by (1) the explantation rate, (2) complications, and (3) patient satisfaction with the global perceived effect (GPE). METHODS We studied 224 consecutive FBSS patients who underwent an SCS trial with surgically implanted leads at our hospital between January 1996 and December 2014. The patients’ satisfaction with the GPE of treatment was measured through a postal questionnaire at the end of follow-up. RESULTS Based on a 1-wk trial, permanent SCS was implanted in 175 (78%) patients. Out of these patients, 153 (87%) reported satisfactory outcomes after 2 mo. During the mean follow-up of 6 yr, 34 (19%) of SCS devices were permanently explanted due to inadequate pain relief, and 11 (6%) were explanted for other reasons. Electrode revision due to inadequate pain relief was done for 22 patients. In total, 26 complications were reported due to: 7 deep infections, 11 hardware malfunctions, 1 subcutaneous hematoma, 4 instances of discomfort due to the pulse generator, and 3 electrode migrations. One hundred thirty patients (74%) continued with SCS until the end of follow-up. Of them, 61 (47%) returned the questionnaire, and 42 (69%) reported substantially improved or better GPE. CONCLUSION SCS can provide a good outcome in the treatment of FBSS. Patient selection could be further improved by developing novel predictive biomarkers.

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