scholarly journals Comparing Effectiveness of Standard vs HF10 Spinal Cord Stimulator Implants for Chronic Intractable Pain

2021 ◽  
pp. 37-44
Author(s):  
Manasi Parikh

Background: There is limited real-world evidence regarding the long-term effectiveness and safety outcomes related to spinal cord stimulation (SCS) for patients with chronic refractory pain. Case Report: This study included a total of 132 patients (73 had HF10); 53% was female. Mean Pretrial Numeric Pain Score for all patients was 8.4 ± 1.1 which decreased to 4.4 ± 2.0 at the end of one year (P < 0.0001). A 6% decrease in the percent of responders, between one month and one-year post-implant, was noted in the HF10 SCS compared to the 15% in standard SCS. A statistically significant decrease in pain relief in the male population (P = 0.02) and obese patients (P = 0.002) was observed. Most common complications: “IPG malfunction” (17%) for standard SCS and “IPG site pain” (12%) for HF10 SCS. Conclusion: HF10 SCS is a viable alternative to standard SCS for chronic intractable pain conditions. Key words: Complications, HF10, high-frequency stimulation, neuromodulation, patient outcomes, spinal cord stimulation

2016 ◽  
Vol 1;19 (1;1) ◽  
pp. E33-E54
Author(s):  
Jay Grider

Background: Chronic neuropathic pain has been recognized as contributing to a significant proportion of chronic pain globally. Among these, spinal pain is of significance with failed back surgery syndrome (FBSS), generating considerable expense for the health care systems with increasing prevalence and health impact. Objective: To assess the role and effectiveness of spinal cord stimulation (SCS) in chronic spinal pain. Study Design: A systematic review of randomized controlled trials (RCTs) of SCS in chronic spinal pain. Methods: The available literature on SCS was reviewed. The quality assessment criteria utilized were Cochrane review criteria to assess sources of risk of bias and Interventional Pain Management Techniques – Quality Appraisal of Reliability and Risk of Bias Assessment (IPM – QRB) criteria for randomized trials. The level of evidence was based on a best evidence synthesis with modified grading of qualitative evidence from Level I to Level V. Data sources included relevant literature published from 1966 through March 2015 that were identified through searches of PubMed and EMBASE, manual searches of the bibliographies of known primary and review articles, and all other sources. Outcome Measures: RCTs of efficacy with a minimum 12-month follow-up were considered for inclusion. For trials of adaptive stimulation, high frequency stimulation, and burst stimulation, shorter follow-up periods were considered. Results: Results showed 6 RCTs with 3 efficacy trials and 3 stimulation trials. There were also 2 cost effectiveness studies available. Based on a best evidence synthesis with 3 high quality RCTs, the evidence of efficacy for SCS in lumbar FBSS is Level I to II. The evidence for high frequency stimulation based on one high quality RCT is Level II to III. Based on a lack of high quality studies demonstrating the efficacy of adaptive stimulation or burst stimulation, evidence is limited for these 2 modalities. Limitations: The limitations of this systematic review continue to require future studies illustrating effectiveness and also the superiority of high frequency stimulation and potentially burst stimulation. Conclusion: There is significant (Level I to II) evidence of the efficacy of spinal cord stimulation in lumbar FBSS; whereas, there is moderate (Level II to III) evidence for high frequency stimulation; there is limited evidence for adaptive stimulation and burst stimulation. Key words: Neuropathic pain, chronic spinal pain, failed back surgery syndrome, spinal cord stimulation, high frequency stimulation, burst stimulation, adaptive stimulation


2016 ◽  
Vol 21 (5) ◽  
pp. 795-803 ◽  
Author(s):  
M. van Beek ◽  
M. van Kleef ◽  
B. Linderoth ◽  
S.M.J. van Kuijk ◽  
W.M. Honig ◽  
...  

2021 ◽  
pp. 85-88
Author(s):  
Benjamin S. Chaney

Background: The mechanistic underpinnings of nerve stimulation technology is an area of active debate in interventional pain literature. Whether the technology is transcutaneous, subcutaneous, or directly on the spinal cord/dorsal root ganglion, there are ample theories without substantive evidence. Although, these technologies have been proven to be invaluable for pain relief. Direct spinal cord stimulation is purported to be effective for peripheral pain through centrally mediated stimulation. However, in select cases, there is evidence for superior analgesia from a peripherally directed device, such as a subcutaneously placed peripheral field nerve stimulator (PFNS), when compared to spinal cord stimulators (SCS). Case Report: An 81-year-old man was referred for left upper thoracic pain exacerbated by lipoma excision with diagnostic imaging unsupportive of musculoskeletal etiology. The patient was found to have soft tissue tenderness to palpation worsened by activity. He failed numerous conservative treatments and procedures. An epidural SCS was trialed, with appropriate paresthesia mapping, but was unsuccessful in providing significant relief. Ultimately, a PFNS was trialed and found to provide adequate relief. A PFNS was later implanted, resulting in successful pain relief. Conclusion: The case demonstrates the importance of developing evidence-based guidelines for the application of PFNS. Additionally, it is important to delineate the shared and unique targets of nerve stimulator technologies so that patients may minimize risk through trial-and-error procedures. Key words: Surgical procedures, operative, spinal cord stimulation, refractory pain, paroxysmal nerve pain, intractable pain, electric stimulation therapy, back pain without radiation,transcutaneous electric nerve stimulation


2014 ◽  
Vol 3;17 (3;5) ◽  
pp. 234-246
Author(s):  
Jason J. Song

Background: Spinal cord stimulation is an intervention that has become increasingly popular due to the growing body of literature showing its effectiveness in treating pain and the reversible nature of the treatment with implant removal. It is currently approved by the FDA for chronic pain of the trunk and limbs, intractable low back pain, leg pain, and pain from failed back surgery syndrome. In Europe, it has additional approval for refractory angina pectoris and peripheral limb ischemia. Objective: This narrative review presents the current evidence supporting the use of spinal cord stimulation for the approved indications and also discusses some emerging neuromodulation technologies that may potentially address pain conditions that traditional spinal cord stimulation has difficulty addressing. Study Design: Narrative review. Results: Spinal cord stimulation has been reported to be superior to conservative medical management and reoperation when dealing with pain from failed back surgery syndrome. It has also demonstrated clinical benefit in complex regional pain syndrome, critical limb ischemia, and refractory angina pectoris. Furthermore, several cost analysis studies have demonstrated that spinal cord stimulation is cost effective for these approved conditions. Despite the lack of a comprehensive mechanism, the technology and the complexity in which spinal cord stimulation is being utilized is growing. Newer devices are targeting axial low back pain and foot pain, areas that have been reported to be more difficult to treat with traditional spinal cord stimulation. Percutaneous hybrid paddle leads, peripheral nerve field stimulation, nerve root stimulation, dorsal root ganglion, and high frequency stimulation are actively being refined to address axial low back pain and foot pain. High frequency stimulation is unique in that it provides paresthesia free analgesia by stimulating beyond the physiologic frequency range. The preliminary results have been mixed and a large randomized control trial is underway to evaluate the future of this technology. Other emerging technologies, including dorsal root ganglion stimulation and hybrid leads, also show some promising preliminary results in non-randomized observational trials. Limitation: This review is a primer and not an exhaustive review for the current evidence supporting the use of spinal cord stimulation and precursory discussion of emerging neuromodulation technologies. This review does not address peripheral nerve stimulation and focuses mainly on spinal cord stimulation and touches on peripheral nerve field stimulation. Conclusions: Spinal cord stimulation has demonstrated clinical efficacy in randomized control trials for the approved indications. In addition, several open label observational studies on peripheral nerve field stimulation, hybrid leads, dorsal root ganglion stimulation, and high frequency stimulation show some promising results. However, large randomized control trials demonstrating clear clinical benefit are needed to gain evidence based support for their use. Key words: Spinal cord stimulation, chronic pain; low back pain, high frequency stimulation, peripheral nerve field stimulation, dorsal root ganglion stimulation, failed back surgery syndrome, complex regional pain syndrome, critical limb ischemia, refractory angina pectoris


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Chiaki Yamada ◽  
Aiko Maeda ◽  
Katsuyuki Matsushita ◽  
Shoko Nakayama ◽  
Kazuhiro Shirozu ◽  
...  

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.


2021 ◽  
Vol 49 (3) ◽  
pp. 030006052110040
Author(s):  
Kuen Su Lee ◽  
Yoo Kyung Jang ◽  
Gene Hyun Park ◽  
In Jae Jun ◽  
Jae Chul Koh

Spinal cord stimulation (SCS) has been used to treat sustained pain that is intractable despite various types of treatment. However, conventional tonic waveform SCS has not shown promising outcomes for spinal cord injury (SCI) or postamputation pain. The pain signal mechanisms of burst waveforms are different to those of conventional tonic waveforms, but few reports have presented the therapeutic potential of burst waveforms for the abovementioned indications. This current case report describes two patients with refractory upper limb pain after SCI and upper limb amputation that were treated with burst waveform SCS. While the patients could not obtain sufficient therapeutic effect with conventional tonic waveforms, the burst waveforms provided better pain reduction with less discomfort. However, further studies are necessary to better clarify the mechanisms and efficacy of burst waveform SCS in patients with intractable pain.


1994 ◽  
Vol 26 (6) ◽  
pp. 347-351 ◽  
Author(s):  
Michele Gilbert ◽  
Colleen M. Counsell ◽  
Pam Martin ◽  
Christie Snively

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