Clinical Outcomes of 1 kHz Subperception Spinal Cord Stimulation in Implanted Patients With Failed Paresthesia-Based Stimulation: Results of a Prospective Randomized Controlled Trial

North, James; Hong, Kyung-soo Jason; Cho, Philip Young

doi:10.1111/ner.12441

Cited by 89 publications

(60 citation statements)

References 24 publications

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“…Before the 3-month follow-up, 87% of patients returned to their traditional LF-SCS settings (figure 1). This is not to say that the switch to 1–1.2 kHz did not provide modest relief for a short time than LF-SCS as evidenced by a small crossover study 7. However, over the span of many months, we found that most patients switched back to their low-frequency settings, which suggests the effects may be negligible beyond just a few weeks of therapy as described recently in a smaller case series 9 10.…”

Section: Discussionmentioning

confidence: 47%

Long-term efficacy of 1–1.2 kHz subthreshold spinal cord stimulation following failed traditional spinal cord stimulation: a retrospective case series

Kapural

Harandi

2019

Regional Anesthesia &Amp; Pain Medicine

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Background and objectiveWe investigated whether an effective long-term pain relief could be achieved using subthreshold 1–1.2 kHz spinal cord stimulation (SCS) among patients who were initially implanted with traditional paresthesia-based SCS but who failed to maintain an adequate pain relief.MethodsRetrospective chart review was conducted of patients’ electronic records who underwent a trial of subthreshold 1–1.2 kHz SCS. One hundred and nine patients implanted and programmed at traditional paresthesia-based frequencies 40–90 Hz (low-frequency SCS) with unsatisfactory pain relief or unpleasant paresthesias were identified. Patients’ settings were switched to 1–1.2 kHz and 60–210 µs, and variable amplitude adjusted to subthreshold. Pain scores and medication usage were collected. Complete data are presented on 95 patients.ResultsData were collected from 36 men and 59 women who were converted from above-threshold 40–90 Hz SCS to 1–1.2 kHz SCS, with a minimum follow-up of 12 months. Nearly a third (63/95 or 66.3%) of the subjects deemed 1–1.2 kHz SCS ineffective and returned to low-frequency SCS within 1 week after switch, and one-sixth (16/95 or 16.8%) of the subjects returned to low-frequency SCS within 1 month. Only 13 (13.7%) subjects continued using 1–1.2 kHz subthreshold SCS for 3 months or longer and 2.1% (2/95) of subjects continued using it at 12 months. A comparison of their pain scores and opioid use before and during the time we used 1–1.2 kHz SCS revealed no significant difference.ConclusionThe results from our single center failed to show additional long-term clinical benefit of 1–1.2 kHz subthreshold SCS in patients with chronic pain failing traditional low-frequency SCS.

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Section: Discussionmentioning

confidence: 47%

Long-term efficacy of 1–1.2 kHz subthreshold spinal cord stimulation following failed traditional spinal cord stimulation: a retrospective case series

Kapural

Harandi

2019

Regional Anesthesia &Amp; Pain Medicine

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“…Consistent with the results of the PROCO RCT, other RCTs have indicated that 1 kHz stimulation is effective 16, 17. Kriek et al compared 40, 500, 1200 Hz, burst, and placebo SCS, finding that the four stimulation programs were equally effective and they were all significantly more effective than placebo.…”

Section: Discussionmentioning

confidence: 59%

Effects of Rate on Analgesia in Kilohertz Frequency Spinal Cord Stimulation: Results of the PROCO Randomized Controlled Trial

Thomson

Tavakkolizadeh

Love‐Jones

et al. 2018

Neuromodulation: Technology at the Neural Interface

141

130

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ObjectiveThe PROCO RCT is a multicenter, double‐blind, crossover, randomized controlled trial (RCT) that investigated the effects of rate on analgesia in kilohertz frequency (1–10 kHz) spinal cord stimulation (SCS).Materials and MethodsPatients were implanted with SCS systems and underwent an eight‐week search to identify the best location (“sweet spot”) of stimulation at 10 kHz within the searched region (T8–T11). An electronic diary (e‐diary) prompted patients for pain scores three times per day. Patients who responded to 10 kHz per e‐diary numeric rating scale (ED‐NRS) pain scores proceeded to double‐blind rate randomization. Patients received 1, 4, 7, and 10 kHz SCS at the same sweet spot found for 10 kHz in randomized order (four weeks at each frequency). For each frequency, pulse width and amplitude were titrated to optimize therapy.ResultsAll frequencies provided equivalent pain relief as measured by ED‐NRS (p ≤ 0.002). However, mean charge per second differed across frequencies, with 1 kHz SCS requiring 60–70% less charge than higher frequencies (p ≤ 0.0002).ConclusionsThe PROCO RCT provides Level I evidence for equivalent pain relief from 1 to 10 kHz with appropriate titration of pulse width and amplitude. 1 kHz required significantly less charge than higher frequencies.

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“…These preclinical findings inspired a clinical investigation which showed that inhibition of the temporal summation of pain (e.g, windup) during an SCS trial greatly may be a biomarker for selecting appropriate patients (e.g., responders) for traditional SCS and predict who will respond to its effect long-term [47]. A recent animal study showed that low-intensity 1 kHz SCS induced greater pain inhibition than traditional SCS did [26], which provided important rationales that later helped clinicians to improve the treatment of chronic pain in patients by using paresthesia-free 1 kHz SCS for the first time [64]. Thus, these pre-clinical studies prove that animal studies can have significant medical implications and translational values.…”

Section: Summary Of Preclinical Findingsmentioning

confidence: 99%

“…They also found no differences in efficacy between 1-kHz and 10-kHz stimulation delivered at subperception strength. After that study, North and colleagues [64] published favorable results from a randomized, 2 × 2 crossover clinical study of low frequency supraperception SCS vs. subperception SCS at 1-kHz frequency. They tested whether subperception SCS at 1 kHz was sufficient to provide effective pain relief in human subjects.…”

Section: Review Of Clinical Datamentioning

confidence: 99%

“…Indeed, 95% of the 22 patients who completed the study reported improvements in average, best, and worst pain based on numeric rating scores. The treatment effect of subperception stimulation was also significantly greater than that of paresthesia-based SCS based on Oswestry Disability Index (ODI) scores and the Patient's Global Impression of Change (PGIC) scores [64]. Furthermore, a study in 2012 by Perruchoud and colleagues revealed no significant difference between 5-kHz HF-SCS and sham stimulation in a cohort of individuals with stable chronic back pain who already were receiving traditional SCS [21].…”

Section: Review Of Clinical Datamentioning

confidence: 99%

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Spinal Cord Stimulation for Treating Chronic Pain: Reviewing Preclinical and Clinical Data on Paresthesia-Free High-Frequency Therapy

Chakravarthy

Richter

Christo

et al. 2018

Neuromodulation: Technology at the Neural Interface

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To fully understand and utilize paresthesia-free HF-SCS, mechanistic study and translational research will be very important, with increasing collaboration between basic science and clinical communities to design better trials and optimize the therapy based on mechanistic findings from effective preclinical models and approaches. Future research in these vital areas may include preclinical and clinical components conducted in parallel to optimize the potential of this technology.

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Clinical Outcomes of 1 kHz Subperception Spinal Cord Stimulation in Implanted Patients With Failed Paresthesia-Based Stimulation: Results of a Prospective Randomized Controlled Trial

Cited by 89 publications

References 24 publications

Long-term efficacy of 1–1.2 kHz subthreshold spinal cord stimulation following failed traditional spinal cord stimulation: a retrospective case series

Long-term efficacy of 1–1.2 kHz subthreshold spinal cord stimulation following failed traditional spinal cord stimulation: a retrospective case series

Effects of Rate on Analgesia in Kilohertz Frequency Spinal Cord Stimulation: Results of the PROCO Randomized Controlled Trial

Spinal Cord Stimulation for Treating Chronic Pain: Reviewing Preclinical and Clinical Data on Paresthesia-Free High-Frequency Therapy

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