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 ◽  
...  

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.

2011 ◽  
Vol 11 (1) ◽  
pp. 180-181
Author(s):  
Iveta Golubovska ◽  
Aleksejs Miscuks ◽  
Vitolds Jurkevics ◽  
Sarmite Skaida

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.


Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Sarah E Hodges ◽  
Shervin Rahimpour ◽  
Luis Alejandro Antezana ◽  
Abena A Ansah-Yeboah ◽  
Rajeev Dharmapurikar ◽  
...  

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.


2020 ◽  
Vol 2020 ◽  
pp. 1-13
Author(s):  
Yuzhao Huang ◽  
Qiufang Deng ◽  
Liuqing Yang ◽  
Jiahui Ma ◽  
Ziyang Wang ◽  
...  

Background. Knee osteoarthritis (KOA) is a common degenerative disease associated with joint dysfunction and pain. Ultrasound-guided radiofrequency (RF) may be a promising therapy in the treatment of chronic pain for KOA patients. Objective. To evaluate the efficacy and safety of ultrasound-guided RF treatment for chronic pain in patients with KOA. Design. A systematic review was conducted, and a meta-analysis was carried out when possible. Setting. We examined the studies evaluating the clinical efficiency of ultrasound-guided RF on chronic pain in KOA population. Method. A systematic review for the efficacy and safety of ultrasound-guided RF treatment for pain management of KOA patients was carried out in PubMed, EMBASE, Cochrane Library, Web of Science, Wanfang Data, and China National Knowledge Infrastructure (CNKI) from the date of inception to February 2020, and a meta-analysis was conducted. The primary outcomes of pain intensity (visual analogue scale or numerical rating scale) and knee function [the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)] were evaluated from baseline to various follow-up times by random-effects model. Heterogeneity was assessed by I2 statistic and the potential sources of heterogeneity by subgroup and metaregression analyses, respectively. Results. Eight publications with 256 patients were included in the meta-analysis. RF could relieve pain with −4.196 of pooled mean difference and improve knee function by decreasing 23.155 points in WOMAC. Three patients had ecchymosis, two with hypoesthesia and one with numbness after the procedure, and improved within 6 months. Furthermore, study design and treatment target were the sources of heterogeneity by subgroup and metaregression analyses, accounting for 37% and 74% of variances, respectively. Target of genicular nerve achieved better pain relief than intra-articular or sciatic nerve. Sensitivity analysis showed that removal of any single study was unlikely to overturn the findings. Limitations. There were some limitations in the study. Firstly, the small number of relevant studies limited the confidence level of the meta-analysis. Also, the significant heterogeneity may not be explained due to the limited data. Secondly, the direct comparison of two different guidance methods (ultrasound vs. fluoroscopy) for RF therapy is lacking. In addition, the outcomes were blindly assessed in the meta-analysis from all studies according to evaluation of bias, which could affect the reality of the data. Finally, most of the studies only provided short follow-up times, so we could not analyze the long-term effectiveness of ultrasound-guided RF in the treatment of patients with KOA. Conclusions. Ultrasonography is an effective, safe, nonradiative, and easily applicable guidance method for RF in pain relief and functional improvement in KOA patients.


Neurosurgery ◽  
1991 ◽  
Vol 28 (1) ◽  
pp. 65-71 ◽  
Author(s):  
Roberto Spiegelmann ◽  
William A. Friedman

Abstract Forty-three patients with chronic pain disorders of different causes were selected for spinal cord stimulation. All underwent implantation of a ribbon electrode through a small laminotomy, under general anesthesia. Thirteen patients (30%) failed to obtain significant pain relief during a period of trial stimulation, and their electrodes were removed. The remainder underwent a definitive implant and were followed for a mean of 13 months (range, 3-33 months). Nineteen of them (63%) continued to experience pain relief. A detailed analysis of this series, as well as a literature review, is presented.


2021 ◽  
pp. 189-191

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


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.


Pain Medicine ◽  
2019 ◽  
Vol 20 (Supplement_1) ◽  
pp. S47-S57 ◽  
Author(s):  
Krishnan Chakravarthy ◽  
Rudy Malayil ◽  
Terje Kirketeig ◽  
Timothy Deer

2011 ◽  
Vol 15 (8) ◽  
pp. 783-788 ◽  
Author(s):  
Wouter A. Pluijmsl ◽  
Rachel Slangenl ◽  
Elbert A. Joostenl ◽  
Alfons G. Kesselsl ◽  
Ingemar S.J. Merkiesl ◽  
...  

Neurosurgery ◽  
2010 ◽  
Vol 67 (1) ◽  
pp. 173-181 ◽  
Author(s):  
Gastón Schechtmann ◽  
Göran Lind ◽  
Jaleh Winter ◽  
Björn A. Meyerson ◽  
Bengt Linderoth

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.


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