Analgesic Efficacy of High-Frequency Spinal Cord Stimulation: A Randomized Double-Blind Placebo-Controlled Study

Perruchoud, Christophe; Eldabe, Sam; Batterham, Alan M.; Madzinga, Grace; Brookes, Morag; Durrer, Anne; Rosato, Marilu; Bovet, Nora; West, Samantha; Bovy, Michèle; Rutschmann, B.; Gulve, Ashish; Garner, Fay; Buchser, Eric

doi:10.1111/ner.12027

Cited by 163 publications

(161 citation statements)

References 28 publications

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“…They documented improved pain relief compared to trials at standard parameters in the short term and at the 2-year follow-up [8] . This finding contrasts with the randomized double-blind study of Perruchoud et al [4] , which showed no difference between sham periods of stimulation and 5-kHz HFS in patients with a history of successful conventional SCS.…”

Section: Discussioncontrasting

confidence: 55%

“…A subsequent clinical trial showed that in patients with chronic axial back pain, HFS at 10,000 Hz led to improved pain relief compared to trials at standard frequencies which normally range below 100 Hz [6] . However, how high the frequency of stimulation must be to reach paresthesia-free efficacy still remains an area of debate since clinical studies remain conflicting [4,6] .…”

mentioning

confidence: 99%

“…Failures may be due to a range of reasons, including patient selection, ineffective treatment of the disease, loss of efficacy, and/or presence of paresthesias in unwanted areas of the body that are too intense with positioning [4] .…”

mentioning

confidence: 99%

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The Effect of High-Frequency Stimulation on Sensory Thresholds in Chronic Pain Patients

Youn¹,

Smith²,

Morris

et al. 2015

Stereotact Funct Neurosurg

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tection and vibratory detection thresholds also significantly increased with HFS compared to ON states (p = 0.04 and p = 0.01, respectively). In addition, HFS significantly decreased 10-and 40-gram pinprick detection compared to OFF states (both p = 0.01). No significant differences between OFF, ON and HFS states were seen in thermal and thermal pain detection. Conclusion: HFS is a new means of modulating chronic pain. The mechanism by which HFS works seems to differ from that of traditional SCS, offering a new platform for innovative advancements in treatment and a greater potential to treat patients by customizing waveforms.

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Section: Discussioncontrasting

confidence: 55%

mentioning

confidence: 99%

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The Effect of High-Frequency Stimulation on Sensory Thresholds in Chronic Pain Patients

Youn¹,

Smith²,

Morris

et al. 2015

Stereotact Funct Neurosurg

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“…In two previous RCTs investigating kilohertz frequencies, Perruchoud et al 51 found that 5 kHz was no more effective than sham, and Al‐Kaisy et al 52 found that 5.882 kHz was more effective than 1.2 and 3.030 kHz, which were no different from sham. However, methodological differences in programming may account for these apparent inconsistencies with PROCO RCT results.…”

Section: Discussionmentioning

confidence: 97%

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

144

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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“…In a rat sciatic nerve ligation model both frequencies (1 kHz and 10 kHz) were effective, but the higher frequency was more effective in terms of onset of effect and its magnitude [9]. Clinical experience, however, showed that 5-kHz stimulation did not result in desired effects [13], whereas 10-kHz stimulation does relieve pain, but only at a very specific position of electrode contacts [11,12]. The next steps in 10-kHz SCS will be to obtain regulatory approval in the USA based on an ongoing noninferiority study (NCT01609972) [14] and then test it in a variety of clinical conditions, perhaps defining those indications and those specific patient characteristics that are either unresponsive to conventional, lower-frequency SCS, or where a partial response makes more complete pain relief desirable.…”

Section: New Stimulation Paradigmsmentioning

confidence: 94%

Spinal Stimulation for Pain: Future Applications

Slavin

2014

Neurotherapeutics

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With continuous progress and rapid technological advancement of neuromodulation it is conceivable that within next decade or so, our approach to the electrical stimulation of the spinal cord used in treatment of chronic pain will change radically. The currently used spinal cord stimulation (SCS), with its procedural invasiveness, bulky devices, simplistic stimulation paradigms, and frustrating decline in effectiveness over time will be replaced by much more refined and individually tailored modality. Better understanding of underlying mechanism of action will allow us to use SCS in a more rational way, selecting patient-specific targets and techniques that properly fit each patient with chronic pain based on pain characteristics, distribution, and cause. Based on the information available today, this article will summarize emerging applications of SCS in the treatment of pain and theorize on further developments that may be introduced in the foreseeable future. An overview of clinical and technological innovations will serve as a basis for better understanding of SCS landscape for the next several years.

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Analgesic Efficacy of High-Frequency Spinal Cord Stimulation: A Randomized Double-Blind Placebo-Controlled Study

Cited by 163 publications

References 28 publications

The Effect of High-Frequency Stimulation on Sensory Thresholds in Chronic Pain Patients

The Effect of High-Frequency Stimulation on Sensory Thresholds in Chronic Pain Patients

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

Spinal Stimulation for Pain: Future Applications

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