Cervical 10 kHz spinal cord stimulation in the management of chronic, medically refractory migraine: A prospective, open‐label, exploratory study

Arcioni, R.; Palmisani, Stefano; Mercieri, M.; Vano, Valentina; Tigano, Sara; Smith, Thomas J.; Fiore, Maria Rosaria; Al‐Kaisy, Adnan; Martelletti, Paolo

doi:10.1002/ejp.692

Cited by 52 publications

(55 citation statements)

References 35 publications

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“…Our outcomes and safety data are consistent with data from both the HF10 treatment cohort from the initial European trial and also the randomized trial comparing HF10 to conventional spinal cord stimulation for chronic back and leg pain .…”

Section: Discussionsupporting

confidence: 81%

10 kHz High-Frequency Spinal Cord Stimulation for Chronic Axial Low Back Pain in Patients With No History of Spinal Surgery: A Preliminary, Prospective, Open Label and Proof-of-Concept Study

Al‐Kaisy

Palmisani

Smith

et al. 2017

Neuromodulation: Technology at the Neural Interface

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Section: Discussionsupporting

confidence: 81%

10 kHz High-Frequency Spinal Cord Stimulation for Chronic Axial Low Back Pain in Patients With No History of Spinal Surgery: A Preliminary, Prospective, Open Label and Proof-of-Concept Study

Al‐Kaisy

Palmisani

Smith

et al. 2017

Neuromodulation: Technology at the Neural Interface

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“…Another possible indication for 10 kHz SCS to date beyond trunk and/or limb pain is intractable headache (HA). A prospective, open‐label study by Arcioni and associates trialed the therapy in 17 subjects with refractory chronic migraine (CM) . Of these, 15 elected to have a permanent system, and 14 completed six months of follow‐up.…”

Section: Resultsmentioning

confidence: 99%

“…A prospective, openlabel study by Arcioni and associates trialed the therapy in 17 subjects with refractory chronic migraine (CM). 66 Of these, 15 elected to have a permanent system, and 14 completed six months of followup. All subjects had failed botulinum toxin therapy and were overusing medication at baseline.…”

Section: Intractable Headache (Off-label Indication For Scs)mentioning

confidence: 99%

Pain relief and improvement in quality of life with 10 kHz SCS therapy: Summary of clinical evidence

et al. 2020

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Objective Chronic pain is a prevalent condition which has a significant effect on the lives of those it impacts. High‐frequency 10 kHz spinal cord stimulation (10 kHz SCS) has been shown to provide paresthesia‐free pain relief for a wide variety of pain indications. This article summarizes the current and emerging data as they relate to the clinical use of the therapy in various pain syndromes. Methods A literature search was conducted using the PubMed electronic database using keywords related to 10 kHz SCS. The database was queried from 2013 to May 2019. Articles reporting clinical studies that included human subjects permanently treated with 10 kHz SCS (Senza® system) were included in the review. Recent and relevant conference proceedings known to the authors were also included. Results The selected literature demonstrated significant evidence for the efficacy of 10 kHz SCS in treating chronic back and leg pain (CBLP), including a randomized, controlled trial as well as prospective and retrospective studies. One‐year follow‐up responder rates (pain relief ≥50%) ranged from 60% to 80%. Other studies and case series showed promising outcomes in specific conditions, including nonsurgical refractory back pain, neuropathic limb pain, complex regional pain syndrome, chronic widespread pain, chronic pelvic pain, and intractable headache. Subgroup analyses also pointed toward the potential of 10 kHz SCS being successful when low‐frequency SCS has failed. The vast majority of these studies reported improved quality of life (QOL) metrics and/or reduced opioid consumption. Conclusions Level I evidence already exists for the efficacy of 10 kHz SCS in treating CBLP, supported by real‐world clinical experience. Other studies demonstrate the potential of the therapy across a range of chronic pain etiologies, although larger confirmatory studies are recommended. Overall, the literature suggests that the therapy is associated with improved QOL as well as reduced opioid consumption.

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“…A recent non‐industry‐sponsored clinical trial comparing conventional SCS and HF10 in 60 subjects with FBSS found that both groups had improved from baseline at 12 months; however, the pain reduction was less than previously reported, and there were no differences in pain or functional scores between the 2 groups . Additional retrospective studies in patients with headaches and primarily neuropathic pain have been encouraging, supporting the use of HF10 for segmental pain pathologies …”

Section: High‐frequency Stimulationmentioning

confidence: 86%

Spinal Cord Stimulation: Clinical Efficacy and Potential Mechanisms

2018

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Spinal cord stimulation (SCS) is a minimally invasive therapy used for the treatment of chronic neuropathic pain. SCS is a safe and effective alternative to medications such as opioids, and multiple randomized controlled studies have demonstrated efficacy for difficult-to-treat neuropathic conditions such as failed back surgery syndrome. Conventional SCS is believed mediate pain relief via activation of dorsal column Aβ fibers, resulting in variable effects on sensory and pain thresholds, and measurable alterations in higher order cortical processing. Although potentiation of inhibition, as suggested by Wall and Melzack's gate control theory, continues to be the leading explanatory model, other segmental and supraspinal mechanisms have been described. Novel, non-standard, stimulation waveforms such as high-frequency and burst have been shown in some studies to be clinically superior to conventional SCS, however their mechanisms of action remain to be determined. Additional studies are needed, both mechanistic and clinical, to better understand optimal stimulation strategies for different neuropathic conditions, improve patient selection and optimize efficacy.

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Cervical 10 kHz spinal cord stimulation in the management of chronic, medically refractory migraine: A prospective, open‐label, exploratory study

Abstract: Paresthesia-free cervical HF10 SCS may be a safe and effective therapeutic option for chronic migraineurs refractory to conventional treatments.

Cited by 52 publications

References 35 publications

10 kHz High-Frequency Spinal Cord Stimulation for Chronic Axial Low Back Pain in Patients With No History of Spinal Surgery: A Preliminary, Prospective, Open Label and Proof-of-Concept Study

10 kHz High-Frequency Spinal Cord Stimulation for Chronic Axial Low Back Pain in Patients With No History of Spinal Surgery: A Preliminary, Prospective, Open Label and Proof-of-Concept Study

Pain relief and improvement in quality of life with 10 kHz SCS therapy: Summary of clinical evidence

Spinal Cord Stimulation: Clinical Efficacy and Potential Mechanisms

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