Spinal cord stimulation: a real-world data analysis on outcomes and differences between rechargeable and non-rechargeable implantable pulse generators

Objective In this analysis, we examined differences between rechargeable and non-rechargeable spinal cord stimulation (SCS) devices in patients with pain. Methods We conducted a retrospective, longitudinal claims data analysis using a German research database comprising 5 million statutory insured patients (2012–2017). Outcomes of demographics, patient pathways, and health care resource utilization (HCRU) in patients with initial SCS were collected. Results Of 150 patients in the database, 73 (49%) received a rechargeable device and 77 (51%) a non-rechargeable device. The average age was 62.5 years (51% female and 49% male patients). A significant decrease over a 3-year follow-up was observed in analgesic prescriptions (−18%), number of patient visits to a physician, and number of patients who were hospitalized. HCRU-related figures for patients with non-rechargeable neurostimulators increased in the last follow-up year whereas the group receiving rechargeable neurostimulators showed a steady decrease. Conclusions SCS seems to be an effective way for patients with chronic pain to decrease pain and improve quality of life. Rechargeable devices seem to be superior to non-rechargeable devices owing to greater longevity and were found to be associated with continuous reduction of pain diagnoses, hospitalization, physician visits, and use of pain medication in our study.

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Spinal cord stimulation in the treatment of paraplegic pain

Journal of Neurosurgery ◽

10.3171/jns.1995.82.1.0035 ◽

1995 ◽

Vol 82 (1) ◽

pp. 35-39 ◽

Cited By ~ 58

Author(s):

Beatrice Cioni ◽

Mario Meglio ◽

Luigi Pentimalli ◽

Massimiliano Visocchi

Keyword(s):

Spinal Cord ◽

Pain Relief ◽

Spinal Cord Stimulation ◽

Neurological Status ◽

Intractable Pain ◽

Content Type ◽

Number Of Patients ◽

Status Level

✓ Twenty-five patients suffering from intractable pain due to a chronic spinal cord lesion underwent a percutaneous test of spinal cord stimulation. At the end of the test period, 40.9% of the patients reported a mean of 65% pain relief and these patients were selected for ongoing stimulation. At a mean follow-up time of 37.2 months the success rate, based on the number of patients with more than 50% pain relief, had fallen to 18.2%. Pain relief rates were analyzed in relation to quality of pain, neurological status, level and extent of the lesion, and electrode level to identify prognostic factors that could improve the clinical usefulness of spinal cord stimulation. Patients experiencing painful spasms or a constrictive type of pain and with incomplete thoracic lesions were found to be the best candidates for spinal cord stimulation.

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Retrospective analysis on the effect of spinal cord stimulation on opioid consumption

Pain Management ◽

10.2217/pmt-2020-0016 ◽

2020 ◽

Author(s):

Awinita Barpujari ◽

Michael A Erdek

Keyword(s):

Spinal Cord ◽

Chronic Pain ◽

Retrospective Analysis ◽

Spinal Cord Stimulation ◽

Alternative Therapy ◽

Opioid Consumption ◽

Opioid Use ◽

Number Of Patients ◽

Chronic Pain Conditions ◽

Post Trial

Aim: Spinal cord stimulation (SCS) is used to clinically manage and/or treat several chronic pain etiologies. A limited amount is known about the influence on patients' use of opioid pain medication. This retrospective analysis evaluated SCS effect on opioid consumption in patients presenting with chronic pain conditions. Materials & methods: Sixty-seven patients underwent a temporary trial device, permanent implant or both. Patients were divided for assessment based on the nature of their procedure(s). Primary outcome was change in morphine equivalent dose (MED), ascertained from preoperative and postoperative medication reports. Results: Postoperative MED was significantly lower in patients who received some form of neuromodulation therapy. Pretrial patients reported an average MED of 41.01 ± 10.23 mg per day while post-trial patients reported an average of 13.30 ± 5.34 mg per day (p < 0.001). Pre-implant patients reported an average MED of 39.14 ± 13.52 mg per day while post-implant patients reported an average MED of 20.23 ± 9.01 mg per day (p < 0.001). There were no significant differences between pre-trial and pre-implant MED, nor between post-trial and post-implant MED. Of the 42 study subjects who reported some amount of pre-intervention opioid use, 78.57% indicated a lower MED (n = 33; p < 0.001), 16.67% indicated no change (n = 7) and 4.76% (n = 2) indicated a higher MED, following intervention. Moreover, SCS therapy resulted in a 26.83% reduction (p < 0.001) in the number of patients with MED >50 mg per day. Conclusion: Spinal cord stimulation may reduce opioid use when implemented appropriately. Neuromodulation may represent alternative therapy for alleviating chronic pain which may avoid a number of deleterious side effects commonly associated with opioid consumption.

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Burst Spinal Cord Stimulation

Neurosurgery ◽

10.1227/01.neu.0000368153.44883.b3 ◽

2010 ◽

Vol 66 (5) ◽

pp. 986-990 ◽

Cited By ~ 201

Author(s):

Dirk De Ridder ◽

Sven Vanneste ◽

Mark Plazier ◽

Elsa van der Loo ◽

Tomas Menovsky

Keyword(s):

Spinal Cord ◽

Neuropathic Pain ◽

Visual Analog Scale ◽

Spinal Cord Stimulation ◽

Short Form ◽

Burst Stimulation ◽

Analog Scale ◽

Tonic Stimulation ◽

Better Than

Abstract INTRODUCTION Spinal cord stimulation is commonly used for neuropathic pain modulation. The major side effect is the onset of paresthesia. The authors describe a new stimulation design that suppresses pain as well as, or even better than, the currently used stimulation, but without creating paresthesia. METHODS A spinal cord electrode (Lamitrode) for neuropathic pain was implanted in 12 patients via laminectomy: 4 at the C2 level and 7 at the T8–T9 level for cervicobrachialgia and lumboischialgia, respectively (1 at T11 at another center). During external stimulation, the patients received the classic tonic stimulation (40 or 50 Hz) and the new burst stimulation (40-Hz burst with 5 spikes at 500 Hz per burst). RESULTS Pain scores were measured using a visual analog scale and the McGill Short Form preoperatively and during tonic and burst stimulation. Paresthesia was scored as present or not present. Burst stimulation was significantly better for pain suppression, by both the visual analog scale score and the McGill Short Form score. Paresthesia was present in 92% of patients during tonic stimulation, and in only 17% during burst stimulation. Average follow-up was 20.5 months. CONCLUSION The authors present a new method of spinal cord stimulation using bursts that suppress neuropathic pain without the mandatory paresthesia. Pain suppression seems as good as or potentially better than that achieved with the currently used stimulation. Average follow-up after nearly 2 years (20.5 months) suggests that this stimulation design is stable.

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The Challenge of Converting “Failed Spinal Cord Stimulation Syndrome” Back to Clinical Success, Using SCS Reprogramming as Salvage Therapy, through Neurostimulation Adapters Combined with 3D-Computerized Pain Mapping Assessment: A Real Life Retrospective Study

Journal of Clinical Medicine ◽

10.3390/jcm11010272 ◽

2022 ◽

Vol 11 (1) ◽

pp. 272

Author(s):

Philippe Rigoard ◽

Amine Ounajim ◽

Lisa Goudman ◽

Tania Banor ◽

France Héroux ◽

...

Keyword(s):

Spinal Cord ◽

Pain Intensity ◽

Spinal Cord Stimulation ◽

Pulse Generator ◽

Clinical Success ◽

Real Life ◽

Intensity Rating ◽

Pain Mapping

While paresthesia-based Spinal Cord Stimulation (SCS) has been proven effective as treatment for chronic neuropathic pain, its initial benefits may lead to the development of “Failed SCS Syndrome’ (FSCSS) defined as decrease over time related to Loss of Efficacy (LoE) with or without Loss of Coverage (LoC). Development of technologies associating new paresthesia-free stimulation waveforms and implanted pulse generator adapters provide opportunities to manage patients with LoE. The main goal of our study was to investigate salvage procedures, through neurostimulation adapters, in patients already implanted with SCS and experiencing LoE. We retrospectively analyzed a cohort of patients who were offered new SCS programs/waveforms through an implanted adapter between 2018 and 2021. Patients were evaluated before and at 1-, 3-, 6- and 12-month follow-ups. Outcomes included pain intensity rating with a Visual Analog Scale (VAS), pain/coverage mappings and stimulation preferences. Last follow-up evaluations (N = 27) showed significant improvement in VAS (p = 0.0001), ODI (p = 0.021) and quality of life (p = 0.023). In the 11/27 patients with LoC, SCS efficacy on pain intensity (36.89%) was accompanied via paresthesia coverage recovery (55.57%) and pain surface decrease (47.01%). At 12-month follow-up, 81.3% preferred to keep tonic stimulation in their waveform portfolio. SCS conversion using adapters appears promising as a salvage solution, with an emphasis on paresthesia recapturing enabled via spatial retargeting. In light of these results, adapters could be integrated in SCS rescue algorithms or should be considered in SCS rescue.

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High-frequency spinal cord stimulation for treating pain in the lower limbs accompanied by bilateral para-anesthesia: A case report

Journal of Neurorestoratology ◽

10.26599/jnr.2020.9040012 ◽

2020 ◽

Vol 8 (3) ◽

pp. 132-137

Author(s):

Zhuqiang Cheng

Keyword(s):

Spinal Cord ◽

Spinal Cord Stimulation ◽

High Frequency ◽

Severe Pain ◽

Traffic Accident ◽

Lower Limbs ◽

Sensory Impairment ◽

Remarkable Effect ◽

Muscle Twitching

A 46-year-old female patient experienced severe pain in both lower limbs following a traffic accident in 2008. The pain mainly presented in her feet; she also experienced sensory impairment, convulsions, and exercise function disorders. She was diagnosed with neuropathic pain, and no medicine had any remarkable effect. Therefore, spinal cord stimulation (SCS) was performed in October 2019. Her pain did not reduce after the initial adoption of conventional SCS until the application of high frequency SCS (HF-SCS). At the 6-month follow-up, the pain in her lower limbs was considerably reduced, lower limb motor function was slightly improved, and muscle twitching in both feet disappeared.

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

Neurosurgery ◽

10.1227/01.neu.0000192162.99567.96 ◽

2006 ◽

Vol 58 (3) ◽

pp. 481-496 ◽

Cited By ~ 264

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.

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Spinal Cord Stimulation Is Effective in Management of Complex Regional Pain Syndrome I: Fact or Fiction

Neurosurgery ◽

10.1227/neu.0b013e3182181e60 ◽

2011 ◽

Vol 69 (3) ◽

pp. 566-580 ◽

Cited By ~ 71

Author(s):

Krishna Kumar ◽

Syed Rizvi ◽

Sharon Bishop Bnurs

Keyword(s):

Quality Of Life ◽

Spinal Cord ◽

Functional Status ◽

Complex Regional Pain Syndrome ◽

Spinal Cord Stimulation ◽

Pain Syndrome ◽

Sf 36

Abstract BACKGROUND: Complex regional pain syndrome (CRPS) I is a debilitating neuropathic pain disorder characterized by burning pain and allodynia. Spinal cord stimulation (SCS) is effective in the treatment of CRPS I in the medium term but its long-term efficacy and ability to improve functional status remains controversial. OBJECTIVE: To evaluate the ability of SCS to improve pain, functional status, and quality of life in the long term. METHODS: We retrospectively analyzed 25 patients over a mean follow-up period of 88 months. The parameters for evaluation were visual analog scale (VAS), Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), EuroQoL-5D (EQ-5D) and Short Form 36 (SF-36), and drug consumption. Evaluations were conducted at point of entry, 3 months, 12 months, and last follow-up at 88 months (mean). RESULTS: At baseline, the mean scores were VAS 8.4, ODI 70%, BDI 28, EQ-5D 0.30, and SF-36 24. In general, maximum improvement was recorded at follow-up at 3 months (VAS 4.8, ODI 45%, BDI 15, EQ-5D 0.57, and SF-36 45). At last follow-up, scores were 5.6, 50%, 19, 0.57, and 40, respectively. Despite some regression, at last follow-up benefits were maintained and found to be statistically significant (P < .001) compared with baseline. Medication usage declined. SCS did not prevent disease spread to other limbs. Best results were achieved in stage I CRPS I, patients under 40 years of age, and those receiving SCS within 1 year of disease onset. CONCLUSION: SCS improves pain, quality of life, and functional status over the long term and consequently merits early consideration in the treatment continuum.

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Effect of Multicolumn Lead Spinal Cord Stimulation on Low Back Pain in Failed Back Surgery Patients: A Three-Year Follow-Up

Neuromodulation Technology at the Neural Interface ◽

10.1111/ner.12603 ◽

2017 ◽

Vol 20 (7) ◽

pp. 668-674 ◽

Cited By ~ 8

Author(s):

Thibault Yves Remacle ◽

Vincent Luce Bonhomme ◽

Henri-Jean Paul Renwart ◽

Jean Michel Remacle

Keyword(s):

Spinal Cord ◽

Low Back Pain ◽

Back Pain ◽

Spinal Cord Stimulation ◽

Low Back ◽

Failed Back Surgery ◽

Back Surgery

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

Acta Chirurgica Latviensis ◽

10.2478/v10163-012-0040-6 ◽

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.

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

Neurosurgery ◽

10.1093/neuros/nyz310_190 ◽

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.

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