scholarly journals High Frequency Spinal Cord Stimulation at 10 kHz for the Treatment of Chronic Pain: 6-Month Australian Clinical Experience

2016 ◽  
Vol 4;19 (4;5) ◽  
pp. 267-280 ◽  
Author(s):  
Dr Marc A. Russo
Keyword(s):  
Spinal Cord ◽  
Pain Relief ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Leg Pain ◽  
Control Group ◽  
Intractable Pain ◽  
Positive Trial ◽  
Pain Clinics ◽  
Wide Range

Background: High frequency spinal cord stimulation at 10 kHz (HF10 therapy) represents a prominent advance in spinal cord stimulation (SCS) therapy, having demonstrated enhanced efficacy in patients with back and leg pain and pain relief without paresthesia that is sustained at 24 months post implant. Objective: To report on the effectiveness HF10 SCS therapy for a wide range of intractable pain conditions in clinical practice. Study Design: Retrospective investigation of 256 patients who trialed HF10 SCS for chronic intractable pain of various etiologies. Setting: Three Australian pain clinics. Methods: Two hundred fifty-six patients trialed HF10 SCS with view of a permanent implant if successful. Pain distributions included back + leg, back only, head ± neck, and neck ± arm/ shoulder. About 30% of patients had previously failed traditional low-frequency paresthesiabased stimulation, while the remaining cohort were either highly refractory to treatment or not recommended by the pain physician for traditional SCS. Pain scores (numerical pain rating scale – NPRS) and functional outcome measures (Oswestry Disability Index – ODI; and activity tolerance times) were assessed at baseline, post-trial, and at 3 and 6 months post-implant as available in the medical records. Results: Of the 256 patients, 189 (73%) reported a positive trial and were implanted. Patients with back + leg pain demonstrated the highest trial success rate (81%). A mean reduction in pain, among those for whom data were available, of 50% was sustained up to 6 months postimplant across the entire patient population. Sixty-eight percent of patients who failed traditional SCS reported a positive trial and mean pain relief at 6 months was 49% (P < 0.001). An 8.6 point reduction in ODI (21%) at 6 months and improved sitting, standing, and walking tolerances were also reported. Limitations: As data was collected retrospectively, missing data points were unavoidable; this was primarily due to inconsistent data collection and patients being lost to follow-up. Patient populations were diverse and a control group was not appropriate in this setting. Conclusions: These retrospective results demonstrate a significant advancement for patients suffering with chronic intractable pain and are consistent with recently published clinical results for HF10 SCS. HF10 SCS appears to be a viable, paresthesia-free alternative to traditional SCS, with high trial success rates, demonstrated effectiveness in a range of pain distributions including those typically difficult to treat with traditional SCS, and the possibility to restore pain control in patients who have previously failed traditional SCS. Key words: Spinal cord stimulation, high frequency stimulation, HF10, paresthesia-free stimulation, back pain, leg pain, cervical pain, neuromodulation

scholarly journals Paresthesia-Independence: An Assessment of Technical Factors Related to 10 kHz Paresthesia-Free Spinal Cord Stimulation

2017 ◽  
Vol 4 (20;4) ◽  
pp. 331-341
Author(s):  
Kerry Bradley
Keyword(s):  
Spinal Cord ◽  
Pain Relief ◽  
Study Design ◽  
Spinal Cord Stimulation ◽  
Pulse Generator ◽  
Pain Clinic ◽  
Leg Pain ◽  
Controlled Study ◽  
Intractable Pain ◽  
Technical Factors

Background: Spinal cord stimulation (SCS) has been successfully used to treat chronic intractable pain for over 40 years. Successful clinical application of SCS is presumed to be generally dependent on maximizing paresthesia-pain overlap; critical to achieving this is positioning of the stimulation field at the physiologic midline. Recently, the necessity of paresthesia for achieving effective relief in SCS has been challenged by the introduction of 10 kHz paresthesia-free stimulation. In a large, prospective, randomized controlled pivotal trial, HF10 therapy was demonstrated to be statistically and clinically superior to paresthesia-based SCS in the treatment of severe chronic low back and leg pain. HF10 therapy, unlike traditional paresthesia-based SCS, requires no paresthesia to be experienced by the patient, nor does it require paresthesia mapping at any point during lead implant or post-operative programming. Objectives: To determine if pain relief was related to technical factors of paresthesia, we measured and analyzed the paresthesia responses of patients successfully using HF10 therapy. Study Design: Prospective, multicenter, non-randomized, non-controlled interventional study. Setting: Outpatient pain clinic at 10 centers across the US and Italy. Methods: Patients with both back and leg pain already implanted with an HF10 therapy device for up to 24 months were included in this multicenter study. Patients provided pain scores prior to and after using HF10 therapy. Each patient’s most efficacious HF10 therapy stimulation program was temporarily modified to a low frequency (LF; 60 Hz), wide pulse width (~470 μs), paresthesiagenerating program. On a human body diagram, patients drew the locations of their chronic intractable pain and, with the modified program activated, all regions where they experienced LF paresthesia. Paresthesia and pain drawings were then analyzed to estimate the correlation of pain relief outcomes to overlap of pain by paresthesia, and the mediolateral distribution of paresthesia (as a surrogate of physiologic midline lead positioning). Results: A total of 61 patients participated across 11 centers. Twenty-eight men and 33 women with a mean age of 56 ± 12 years of age participated in the study. The average duration of implantable pulse generator (IPG) implant was 19 ± 9 months. The average predominant pain score, as measured on a 0 – 10 visual analog scale (VAS), prior to HF10 therapy was 7.8 ± 1.3 and at time of testing was 2.5 ± 2.1, yielding an average pain relief of 70 ± 24%. For all patients, the mean paresthesia coverage of pain was 21 ± 28%, with 43% of patients having zero paresthesia coverage of pain. Analysis revealed no correlation between percentage of LF paresthesia overlap of predominant pain and HF10 therapy efficacy (P = 0.56). Exact mediolateral positioning of the stimulation electrodes was not found to be a statistically significant predictor of pain relief outcomes. Limitations: Non-randomized/non-controlled study design; short-term evaluation; certain technical factors not investigated.Conclusion: Both paresthesia concordance with pain and precise midline positioning of the stimulation contacts appear to be inconsequential technical factors for successful HF10 therapy application. These results suggest that HF10 therapy is not only paresthesia-free, but may be paresthesia-independent. Key words: Spinal cord stimulation, paresthesia, high frequency, 10kHz, pain relief, physiologic midline, paresthesia-free

scholarly journals High-frequency spinal cord stimulation causing cardiac paresthesias after lead migration: a case report

2018 ◽  
Vol 12 (4) ◽  
pp. 217-219 ◽  
Author(s):  
Neil Majmundar ◽  
Eleonora Francesca Spinazzi ◽  
Joseph Doran ◽  
Antonios Mammis
Keyword(s):  
Spinal Cord ◽  
Case Report ◽  
Pain Relief ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Treatment Interruption ◽  
Adverse Outcomes ◽  
Leg Pain ◽  
Novel Therapy ◽  
Left Chest

Introduction: High-frequency (HF) spinal cord stimulation (SCS), a relatively new form of spinal cord stimulation, provides stimulation frequencies of up to 10 kHz and allows for paresthesia-free pain relief, an advantage that distinguishes it from traditional stimulation therapy. Without paresthesias, patients with HF SCS do not experience position-dependent painful stimulation and do not have to experience treatment interruption during sleep. Lead migration is a well-known complication of conventional spinal cord stimulation and usually results in a loss of efficacy along with other unpleasant sensory symptoms. In this case report, we present an incidence of lead migration in HF SCS that resulted in paresthesias, a symptom not expected to occur in this novel therapy. Case: The patient, a 60-year-old female with post-laminectomy syndrome, underwent a trial of HF SCS with standard lead placement at T8-T9. She initially had pain relief, but returned to the office on post-operative day 2 complaining of left chest wall and cardiac paresthesias, without frank pain or palpitations, in addition to loss of efficacy for her back and leg pain. Imaging showed that the leads had migrated, with one lead reaching the levels of T1-T3. Conclusion: While HF SCS has emerged as an effective paresthesia-free means of reducing back and leg pain, we provide the first report of paresthesias occurring with the HF SCS system as a result of cephalad lead migration. As HF SCS is only now being utilized as a treatment modality, we must remain cautious of potential adverse outcomes in patients, in particular above T8.

scholarly journals Comparison of 10-kHz High-Frequency and Traditional Low-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain

Neurosurgery ◽  
2016 ◽  
Vol 79 (5) ◽  
pp. 667-677 ◽  
Author(s):  
Leonardo Kapural ◽  
Cong Yu ◽  
Matthew W. Doust ◽  
Bradford E. Gliner ◽  
Ricardo Vallejo ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Back Pain ◽  
Pain Relief ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Low Frequency ◽  
Leg Pain ◽  
Long Term Results ◽  
End Point

Abstract BACKGROUND: Pain relief with spinal cord stimulation (SCS) has focused historically on paresthesias overlapping chronically painful areas. A higher level evidence supports the use of SCS in treating leg pain than supports back pain, as it is difficult to achieve adequate paresthesia coverage, and then pain relief, in the low back region. In comparison, 10-kHz high-frequency (HF10 therapy) SCS therapy does not rely on intraoperative paresthesia mapping and remains paresthesia-free during therapy. OBJECTIVE: To compare long-term results of HF10 therapy and traditional low-frequency SCS. METHODS: A pragmatic randomized, controlled, pivotal trial with 24-month follow-up was conducted across 11 comprehensive pain treatment centers. Subjects had Visual Analog Scale scores of ≥5.0/10.0 cm for both back and leg pain, and were assigned randomly (1:1) to receive HF10 therapy or low-frequency SCS. The primary end point was a responder rate, defined as ≥50% back pain reduction from baseline at 3 months with a secondary end point at 12 months (previously reported). In this article, 24-month secondary results are presented. Non-inferiority was first assessed, and if demonstrated the results were tested for superiority. RESULTS: In the study, 198 subjects were randomized (101 HF10 therapy, 97 traditional SCS). One hundred seventy-one subjects (90 HF10 therapy, 81 traditional SCS) successfully completed a short-term trial and were implanted. Subjects averaged 54.9 ± 12.9 years old, 13.6 ± 11.3 years since diagnosis, 86.6% had back surgery, 88.3% were taking opioid analgesics. At 3 months, 84.5% of implanted HF10 therapy subjects were responders for back pain and 83.1% for leg pain, and 43.8% of traditional SCS subjects were responders for back pain and 55.5% for leg pain (P &lt;.001 for both back and leg pain comparisons, non-inferiority and superiority). At 24 months, more subjects were responders to HF10 therapy than traditional SCS (back pain: 76.5% vs 49.3%; 27.2% difference, 95% CI, 10.1%-41.8%; P &lt;.001 for non-inferiority and superiority; leg pain: 72.9% vs 49.3%; 23.6% difference, 95% CI, 5.9%-38.6%; P &lt;.001 for non-inferiority and P =.003 for superiority). Also at 24 months, back pain decreased to a greater degree with HF10 therapy (66.9% ± 31.8%) than traditional SCS (41.1% ± 36.8%, P &lt;.001 for non-inferiority and superiority). Leg pain also decreased to a greater degree with HF10 therapy (65.1% ± 36.0%) than traditional SCS (46.0% ± 40.4%, P &lt;.001 for non-inferiority and P =.002 for superiority). CONCLUSION: This study demonstrates long-term superiority of HF10 therapy compared with traditional SCS in treating both back and leg pain. The advantages of HF10 therapy are anticipated to impact the management of chronic pain patients substantially.

scholarly journals 1-kHz high-frequency spinal cord stimulation alleviates chronic refractory pain after spinal cord injury: a case report

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Chiaki Yamada ◽  
Aiko Maeda ◽  
Katsuyuki Matsushita ◽  
Shoko Nakayama ◽  
Kazuhiro Shirozu ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Neuropathic Pain ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Cervical Vertebrae ◽  
Intractable Pain ◽  
Target Area ◽  
Positive Effects ◽  
Cord Injury

Abstract Background Patients with spinal cord injury (SCI) frequently complain of intractable pain that is resistant to conservative treatments. Here, we report the successful application of 1-kHz high-frequency spinal cord stimulation (SCS) in a patient with refractory neuropathic pain secondary to SCI. Case presentation A 69-year-old male diagnosed with SCI (C4 American Spinal Injury Association Impairment Scale A) presented with severe at-level bilateral upper extremity neuropathic pain. Temporary improvement in his symptoms with a nerve block implied peripheral component involvement. The patient received SCS, and though the tip of the leads could not reach the cervical vertebrae, a 1-kHz frequency stimulus relieved the intractable pain. Conclusions SCI-related symptoms may include peripheral components; SCS may have a considerable effect on intractable pain. Even when the SCS electrode lead cannot be positioned in the target area, 1-kHz high-frequency SCS may still produce positive effects.

scholarly journals High Frequency Spinal Cord Stimulation in a Patient with Bilateral Cochlear Implants

2021 ◽  
pp. 189-191
Keyword(s):  
Spinal Cord ◽  
Chronic Pain ◽  
Pain Relief ◽  
Cochlear Implant ◽  
Cochlear Implants ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Pain Clinic ◽  
Bilateral Cochlear Implants ◽  
Patient Reported

BACKGROUND: High-frequency spinal cord stimulation (HF-SCS) has become very popular in the management of chronic pain worldwide. As it relies on generating high-frequency electrical impulses, there is a risk of interference with other devices such as cochlear implants that utilize similar principles. A literature search did not reveal any case reports of HF-SCS implantation in a patient with cochlear implants. CASE REPORT: A 75-year-old White woman with a history of bilateral cochlear implants (Cochlear Americas Nucleus® with cp910 processor) for severe sensorineural hearing loss presented to our chronic pain clinic with lumbosacral radiculopathy. The patient underwent a HF-SCS trial with entry point at the L1-L2 space and the leads positioned at the top and bottom of T8. The patient did not experience any auditory interference with her Cochlear implant at triple the average SCS stimulation strength. During the follow-up visit the next week, the patient reported nearly 80% symptomatic pain relief and significant functional improvement. There was no change in her hearing and no evidence of interference. The patient ultimately underwent percutaneous SCS paddle electrode placement and at 3 months, continues to have excellent pain relief without any auditory interactions. CONCLUSION: We successfully implanted a HF-SCS at the thoracic level in a patient with bilateral cochlear implants without any auditory interference. KEY WORDS: Cochlear implant, lumbar radiculopathy, spinal cord stimulation

scholarly journals High-Frequency Spinal Cord Stimulation at T9/10 in Patients With Failed Back Surgery Syndrome

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Naoki Higashiyama ◽  
Takuro Endo ◽  
Taku Sugawara
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Low Frequency ◽  
The Elderly ◽  
Failed Back Surgery Syndrome ◽  
Leg Pain ◽  
Effective Treatment Option ◽  
Failed Back Surgery ◽  
Back Surgery

Abstract INTRODUCTION Spinal cord stimulation (SCS) is an effective treatment option for low back pain and radicular leg pain of failed back surgery syndrome (FBSS). In a recent study, high-frequency spinal cord stimulation (HFSCS) was found to be more effective in treating chronic pain than traditional paresthesia-based low-frequency SCS (paresthesia SCS). The purpose of this study is to evaluate the efficacy of paresthesia SCS and HFSCS in improving outcomes. METHODS We retrospectively reviewed the outcomes of patients who underwent paresthesia SCS or HFSCS between September 2016 and January 2019. Paresthesia SCS is generally characterized by programming stimulation parameters such that the patient experiences paresthesia, and the paresthesia topography overlaps the pain topography as much as possible. The patient in HFSCS had a placement of cylindrical lead at levels T9-10. Patients were programmed with the electrode overlying the inferior endplate of T9 (+) and the electrode overlying the superior endplate of T10 (–). RESULTS A total of 14 patients (4 males, 10 females) underwent paresthesia SCS implantation. Mean age was 77.2 ± 9.6 yr. A total of 5 patients (2 males, 3 females) underwent HFSCS implantation. Mean age was 78.2 ± 7.5 yr. Operative time was shorter for the HFSCS group compared to the paresthesia SCS group (53.4 ± 4.8 min vs 82.9 ± 20.3 min, respectively; P < .001). A total of 5 out of 5 patients in the HFSCS group (100%) and 10 out of 14 patients in the paresthesia SCS group (71.4%) achieved the outcome of 50% pain relief (P = .25) CONCLUSION To confirm paresthesia during the procedure in the elderly may be complicated by hearing/language difficulties or by sedative-related confusion. Compared to paresthesia SCS, HFSCS allows for lower operative times and a more efficient and accurate positioning of the electrodes.

scholarly journals High-frequency 10 kHz Spinal Cord Stimulation for Chronic Back and Leg Pain

2020 ◽  
Vol 36 (11) ◽  
pp. 852-861
Author(s):  
Rod S. Taylor ◽  
Anthony Bentley ◽  
Bruce Campbell ◽  
Kieran Murphy
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Leg Pain

scholarly journals High frequency spinal cord stimulation for chronic back and leg pain

2021 ◽  
Vol 23 ◽  
pp. 101009
Author(s):  
Sergio Torres-Bayona ◽  
Salvador Mattar ◽  
Maria Paula Arce-Martinez ◽  
Yeiris Miranda-Acosta ◽  
Hernan Felipe Guillen-Burgos ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Leg Pain

scholarly journals High Frequency Spinal Cord Stimulation for Complex Regional Pain Syndrome: A Case Report

2017 ◽  
Vol 1 (21;1) ◽  
pp. E177-E182
Author(s):  
Alan D. Kaye
Keyword(s):  
Spinal Cord ◽  
Case Report ◽  
Complex Regional Pain Syndrome ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Therapeutic Option ◽  
Low Frequency ◽  
Pain Syndrome ◽  
Leg Pain ◽  
Caucasian Woman

Complex regional pain syndrome (CRPS) is a chronic, debilitating, neuropathic pain condition which is often misdiagnosed, difficult to manage, and lacks proven methods for remission. Most available methods provide some relief to a small percentage of patients. Recent FDA approval and superiority of the Nevro Senza 10-kHz high frequency (HF10) spinal cord stimulation (SCS) therapy over traditional low-frequency spinal cord stimulation for treatment of chronic back and leg pain may provide a new interventional therapeutic option for patients suffering from CRPS. We provide a case report of a 53-year-old Caucasian woman who suffered with CRPS in the right knee and thigh for over 7 years. Implantation of the HF10 device provided over 75% relief of pain, erythema, heat, swelling, and tissue necrosis to the entire region within 1 month of treatment. Because the HP10 therapy provides pain relief without paresthesia typical of traditional low-frequency, this system may provide relief for patients suffering from chronic pain. Key words: Complex regional pain syndrome, spinal cord stimulation, Nevro Senza HF10, erythema, knee, thigh

Sign in / Sign up

Export Citation Format

Share Document