scholarly journals 10 kHz spinal cord stimulation for the treatment of chronic back and/or leg pain: Summary of clinical studies

2020 ◽  
Vol 8 ◽  
pp. 205031212095136
Author(s):  
Thorsten Luecke ◽  
Deborah Edgar ◽  
Daniel Huse

Chronic pain has a major impact on sufferers and their families. The associated health care costs are substantial. In the context of increasing prevalence, effective treatment options are ever more important. 10 kHz spinal cord stimulation has been shown to effectively provide pain relief, aid in opioid reduction, and improve quality of life in patients with chronic intractable pain. The present review aims to summarize the clinical evidence related to the use of 10 kHz SCS in chronic back and/or leg pain. We searched the PubMed database between 2009 and 2 June 2020 for articles reporting clinical studies that included at least 10 human subjects permanently treated with a 10 kHz SCS system (Senza® system) for chronic back and/or leg pain for a minimum of 3 months. A randomized controlled trial (SENZA-RCT), as well as several prospective and retrospective studies, reported clinical outcomes in subjects with chronic back and leg pain treated with 10 kHz SCS. A high proportion of subjects (60%–80%) reported long-term response to therapy. Pain relief was provided without paresthesia. Other studies showed promising pain relief outcomes in subjects with back pain ineligible for spinal surgery, neuropathic limb pain, and in those with previously failed traditional low-frequency SCS. Most studies reported improved quality of life metrics and/or reduced opioid intake. Level 1 evidence has already been established for the use of 10 kHz SCS in treating chronic back and leg pain, corroborated by real-world, clinical experience. Exploratory studies also show the potential of the therapy in other refractory pain syndromes, although larger studies are desired to validate their findings. Overall, the literature suggests that 10 kHz SCS provides long-term pain relief in a high proportion of patients, along with improved quality of life and reduced opioid consumption.

Neurosurgery ◽  
2006 ◽  
Vol 58 (3) ◽  
pp. 481-496 ◽  
Author(s):  
Krishna Kumar ◽  
Gary Hunter ◽  
Denny Demeria

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.


2018 ◽  
Vol 27 (8) ◽  
pp. 2035-2044 ◽  
Author(s):  
Kasra Amirdelfan ◽  
Cong Yu ◽  
Matthew W. Doust ◽  
Bradford E. Gliner ◽  
Donna M. Morgan ◽  
...  

2012 ◽  
Vol 109 (5) ◽  
pp. 837 ◽  
Author(s):  
W.A. Pluijms ◽  
R Slangen ◽  
M Bakkers ◽  
C.G. Faber ◽  
I.S.J. Merkies ◽  
...  

Neurosurgery ◽  
2011 ◽  
Vol 69 (3) ◽  
pp. 566-580 ◽  
Author(s):  
Krishna Kumar ◽  
Syed Rizvi ◽  
Sharon Bishop Bnurs

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.


2008 ◽  
Vol 1;11 (1;1) ◽  
pp. 81-85
Author(s):  
Silviu Brill

We are presenting a paper on the effectiveness of spinal cord stimulation (SCS) in 2 patients suffering pain from brachial plexus injury (BPI). After a traumatic brachial plexus lesion about 80% of patients develop pain in the deafferentated arm. This pain is considered very resistant to many forms of therapy. In the early 1970s, SCS was introduced in the treatment of BPI pain with disappointing results. There are only about 20 published cases of BPI pain treated with SCS. Many injuries are due to motorcycle accidents, so that patients are often young and require long-term pain relief. During the SCS trial the pain relief was more than 50% with an absolute improvement in the quality of life and significant drug reduction. The results of the SCS were excellent in these 2 patients, defined as more than 50% pain relief at 6 and 18 months. Key words: Spinal cord stimulation, brachial plexus injury, neurophatic pain.


2020 ◽  
Vol 1;23 (1;1) ◽  
pp. 87-98 ◽  
Author(s):  
Ramsin Benyamin

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


2012 ◽  
Vol 109 (4) ◽  
pp. 623-629 ◽  
Author(s):  
W.A. Pluijms ◽  
R. Slangen ◽  
M. Bakkers ◽  
C.G. Faber ◽  
I.S.J. Merkies ◽  
...  

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