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, Adnan; Palmisani, Stefano; Smith, Thomas E.; Pang, David; Lam, Khai S.; Burgoyne, W.; Houghton, Russell; Hudson, Emma; Lucas, Jonathan

doi:10.1111/ner.12563

Cited by 69 publications

(98 citation statements)

References 35 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…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%

“…Furthermore, in their analysis of the SENZA‐RCT results, the authors concluded that the significant benefits and low risks of 10 kHz SCS relative to alternative treatments suggested that economic benefits might be associated with this treatment modality . Likewise, other investigators suggested that improvements in quality of life measures or reductions in conventional opioid use should result in lower long‐term healthcare costs. Finally, the finding by DiBenedetto and colleagues that patients treated with 10 kHz SCS required fewer interventional procedures than matched controls provides further support for the possible financial benefits of the treatment …”

Section: Explantsmentioning

confidence: 99%

See 1 more Smart Citation

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

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionmentioning

confidence: 80%

Section: Explantsmentioning

confidence: 99%

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

View full text Add to dashboard Cite

show abstract

“…In subjects with chronic, severe, low back pain who were not candidates for spinal surgery and were naïve to surgery, the 12-month response rate in the prospective study by Al-Kaisy and colleagues was strikingly high. 57 The results suggest that 10 kHz SCS may be a viable option in this population where treatment possibilities are limited. Promising reductions in pain were also found in retrospective studies of neuropathic limb pain, chronic widespread pain, and CRPS.…”

Section: Discussionmentioning

confidence: 91%

“…The benefits of 10 kHz SCS therapy for subjects with chronic back pain ineligible for spinal surgery and no history of such intervention were evaluated in a separate, single‐center, prospective study by Al‐Kaisy and colleagues . Twenty of 21 enrolled subjects (95%) had a successful trial, received an implantable pulse generator, and completed 12 months of follow‐up.…”

Section: Resultsmentioning

confidence: 99%

“…The results from studies and case series evaluating therapy outcomes in other indications, including chronic back pain ineligible for spinal surgery, neuropathic limb pain, CRPS, chronic widespread pain, chronic pelvic pain, and intractable headache, are promising. In subjects with chronic, severe, low back pain who were not candidates for spinal surgery and were naïve to surgery, the 12‐month response rate in the prospective study by Al‐Kaisy and colleagues was strikingly high . The results suggest that 10 kHz SCS may be a viable option in this population where treatment possibilities are limited.…”

Section: Discussionmentioning

confidence: 97%

See 1 more Smart Citation

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

et al. 2020

View full text Add to dashboard Cite

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.

show abstract

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

Stauss²,

et al. 2021

View full text Add to dashboard Cite

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...

show abstract

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

Abstract: HF10 therapy may provide significant back pain relief, reduction in disability, improvement quality of life, and reduction in opioid use in chronic low back pain not resulting from spinal surgery.

Cited by 69 publications

References 35 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

Contact Info

Product

Resources

About