Long-Term Improvements in Chronic Axial Low Back Pain Patients Without Previous Spinal Surgery: A Cohort Analysis of 10-kHz High-Frequency Spinal Cord Stimulation over 36 Months

Al‐Kaisy, Adnan; Palmisani, Stefano; Smith, Thomas E.; Carganillo, Roy; Houghton, Russell; Pang, David; Burgoyne, W.; Lam, Khai S.; Lucas, Jonathan

doi:10.1093/pm/pnx237

Cited by 96 publications

(108 citation statements)

References 16 publications

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“…By the end of the 12‐month study period, the average daily opioid intake among all subjects decreased 64.3%, from 112 to 40 MME. More recent results from this study show the decreases in back and leg pain from 10 kHz SCS remained significant after 36 months of treatment . Additionally, the proportion of patients taking opioid analgesics fell from 18/20 (90%) at baseline to 2/17 (11.7%) at 36 months (Fig.…”

Section: Current Evidencesupporting

confidence: 50%

“…Overall, 10 kHz SCS has shown potential in treating types of chronic pain, including low back pain and neuropathic pain, that are often unresponsive to conventional medical treatments. Prospective, nonrandomized trials of 10 kHz SCS in patients with chronic back pain reported pain relief ranging from 54% to 87% after at least 1 year of treatment, and leg pain scores similarly improved by 57% to 72% in these patients . The mean daily dose of conventional opioids required by patients in these studies was halved or more after 10 kHz SCS treatment, and the number of opioid‐abstinent subjects increased in all the studies.…”

Section: Discussionmentioning

confidence: 80%

“…More recent results from this study show the decreases in back and leg pain from 10 kHz SCS remained significant after 36 months of treatment. 44 Additionally, the proportion of patients taking opioid analgesics fell from 18/20 (90%) at baseline to 2/17 (11.7%) at 36 months ( Fig. 2A).…”

Section: Intractable Low Back Pain Patients With No History Of Back Smentioning

confidence: 93%

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Opioid‐sparing effects of 10 kHz spinal cord stimulation: a review of clinical evidence

Al‐Kaisy

Buyten

Amirdelfan³

et al. 2019

Annals of the New York Academy of Sciences

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Chronic pain is a common condition that affects the physical, emotional, and mental well‐being of patients and can significantly diminish their quality of life. Due to growing concerns about the substantial risks of long‐term opioid use, both governmental agencies and professional societies have recommended prioritizing the use of nonpharmacologic treatments, when suitable, in order to reduce or eliminate the need for opioid use. The use of 10 kHz spinal cord stimulation (10 kHz SCS) is one such nonpharmacologic alternative for the treatment of chronic, intractable pain of the trunk and limbs. This review examines published clinical data regarding the efficacy of 10 kHz SCS for decreasing chronic pain in patients and its potential to reduce or eliminate opioid usage. Multiple prospective and retrospective studies in patients with intractable pain demonstrated that 10 kHz SCS treatment provided ≥50% pain relief in >70% patients after at least 1 year of treatment. Pain relief with 10 kHz SCS therapy ranged from 54% to 87% in the studies. More importantly, the mean daily dose of opioids required by patients in these studies was reduced after 10 kHz SCS treatment, and on average over 60% patients in studies either reduced or eliminated opioids at the last follow‐up.

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Section: Current Evidencesupporting

confidence: 50%

Section: Discussionmentioning

confidence: 80%

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Opioid‐sparing effects of 10 kHz spinal cord stimulation: a review of clinical evidence

Al‐Kaisy

Buyten

Amirdelfan³

et al. 2019

Annals of the New York Academy of Sciences

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“…The study investigators extended follow‐up for an additional 24 months and reported findings from the 36‐month assessment . At 36 months, 80% of subjects had ≥50% reduction in back pain intensity scores, and the average reduction in back pain intensity was 87%.…”

Section: Resultsmentioning

confidence: 99%

“…The study investigators extended follow-up for an additional 24 months and reported findings from the 36-month assessment. 58 At 36 months, 80% of subjects had ≥50% reduction in back pain intensity scores, and the average reduction in back pain intensity was 87%. ODI scores reduced from 53.0% at baseline to 19.8% at 36 months (P < .0001), and 50% (N = 10/20) of subjects were in the "minimal disability" category.…”

Section: Chronic Back Pain Ineligible For Spinal Surgery (Maiden Bamentioning

confidence: 94%

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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Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy

Stauss²,

et al. 2021

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IMPORTANCE Many patients with diabetic peripheral neuropathy experience chronic pain and inadequate relief despite best available medical treatments.OBJECTIVE To determine whether 10-kHz spinal cord stimulation (SCS) improves outcomes for patients with refractory painful diabetic neuropathy (PDN). DESIGN, SETTING, AND PARTICIPANTSThe prospective, multicenter, open-label SENZA-PDN randomized clinical trial compared conventional medical management (CMM) with 10-kHz SCS plus CMM. Participants with PDN for 1 year or more refractory to gabapentinoids and at least 1 other analgesic class, lower limb pain intensity of 5 cm or more on a 10-cm visual analogue scale (VAS), body mass index (calculated as weight in kilograms divided by height in meters squared) of 45 or less, hemoglobin A 1c (HbA 1c ) of 10% or less, daily morphine equivalents of 120 mg or less, and medically appropriate for the procedure were recruited from clinic patient populations and digital advertising. Participants were enrolled from multiple sites across the US, including academic centers and community pain clinics, between August 2017 and August 2019 with 6-month follow-up and optional crossover at 6 months. Screening 430 patients resulted in 214 who were excluded or declined participation and 216 who were randomized. At 6-month follow-up, 187 patients were evaluated.INTERVENTIONS Implanted medical device delivering 10-kHz SCS. MAIN OUTCOMES AND MEASURESThe prespecified primary end point was percentage of participants with 50% pain relief or more on VAS without worsening of baseline neurological deficits at 3 months. Secondary end points were tested hierarchically, as prespecified in the analysis plan. Measures included pain VAS, neurological examination, health-related quality of life (EuroQol Five-Dimension questionnaire), and HbA 1c over 6 months. RESULTSOf 216 randomized patients, 136 (63.0%) were male, and the mean (SD) age was 60.8 (10.7) years. Additionally, the median (interquartile range) duration of diabetes and peripheral neuropathy were 10.9 (6.3-16.4) years and 5.6 (3.0-10.1) years, respectively. The primary end point assessed in the intention-to-treat population was met by 5 of 94 patients in the CMM group (5%) and 75 of 95 patients in the 10-kHz SCS plus CMM group (79%; difference, 73.6%; 95% CI, 64.2-83.0; P < .001). Infections requiring device explant occurred in 2 patients in the 10-kHz SCS plus CMM group (2%). For the CMM group, the mean pain VAS score was 7.0 cm (95% CI, 6.7-7.3) at baseline and 6.9 cm (95% CI, 6.5-7.3) at 6 months. For the 10-kHz SCS plus CMM group, the mean pain VAS score was 7.6 cm (95% CI, 7.3-7.9) at baseline and 1.7 cm (95% CI, 1.3-2.1) at 6 months. Investigators observed neurological examination improvements for 3 of 92 patients in the CMM group (3%) and 52 of 84 in the 10-kHz SCS plus CMM group (62%) at 6 months (difference, 58.6%; 95% CI, 47.6-69.6; P < .001).CONCLUSIONS AND RELEVANCE Substantial pain relief and improved health-related quality of life sustained over 6 months demonstrates 10-kHz SCS can s...

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Long-Term Improvements in Chronic Axial Low Back Pain Patients Without Previous Spinal Surgery: A Cohort Analysis of 10-kHz High-Frequency Spinal Cord Stimulation over 36 Months

Abstract: These results suggest that 10-kHz high-frequency SCS may provide significant, long-term back pain relief, improvement in disability and quality of life, and reduction in opioids for nonsurgical refractory back pain.

Cited by 96 publications

References 16 publications

Opioid‐sparing effects of 10 kHz spinal cord stimulation: a review of clinical evidence

Opioid‐sparing effects of 10 kHz spinal cord stimulation: a review of clinical evidence

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

Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy

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