ObjectiveChronic pain remains a serious public health problem worldwide. A spinal cord stimulation (SCS) therapy called HF10 SCS uses 10-kHz high-frequency stimulation to provide pain relief without paresthesia. In this article, we describe the therapy, device, and the methods of implant and then review the safety and effectiveness data for this therapy.ResultsHF10 SCS uses a charge-balanced stimulation waveform that has been shown to be safe in both animal and human studies. Data from a multicenter, prospective clinical trial shows that the therapy provides substantial back and leg pain relief. Numerous additional reports suggest improved pain relief in other body areas and for complex pain patterns, even for patients who have previously failed other neuromodulation therapies.ConclusionsThe clinical experience reported in this article supports the efficacy and pain relief provided by HF10 SCS therapy. Clinical studies have also concluded that HF10 SCS does not generate paresthesia nor was it necessary to provide adequate coverage for pain relief. As clinical evidence accumulates and technological innovation improves patient outcomes, neuromodulatory techniques will be sought earlier in the treatment continuum to reduce the suffering for the many with otherwise intractable chronic pain.
Summary
Spinal cord stimulation at 10 kHz is a promising therapy for non‐surgical refractory back pain; however, published data are currently limited. We present a subanalysis of prospectively collected clinical outcome data for non‐surgical refractory back pain patients treated with 10 kHz spinal cord stimulation, from the independent cohorts of two previous studies (
SENZA
‐
RCT
and
SENZA
‐
EU
). Clinical outcomes were evaluated at pre‐implantation (baseline), 3 months, 6 months and 12 months following 10 kHz spinal cord stimulator implantation. These included: pain relief; responder rate (≥ 50% pain relief from baseline); remission rate (
VAS
≤ 3.0 cm); disability (Oswestry Disability Index(ODI)); and opioid use. At 3 months, average back pain decreased by 70% in the combined cohort (60% in the
SENZA
‐
RCT
and 78% in the
SENZA
‐
EU
cohorts). This was sustained at 12 months, with a 73% back pain responder rate and 68% remission rate in the combined cohort. Leg pain relief results were generally comparable to those for back pain relief. At 12 months, the combined cohort had an average decrease in ODI scores of 15.7% points from baseline and opioid use more than halved. In conclusion, 10 kHz spinal cord stimulation reduced pain, disability and opioid consumption in non‐surgical refractory back pain subjects. Application of this therapy may improve the care of non‐surgical refractory back pain patients and reduce their opioid consumption.
In recent years, technical advances have allowed more significant structural spine surgery through small access portals. Minimally invasive spinal surgery (MISS) is commonly thought of as posterior approaches using muscle dilating tubular retraction systems, but these approaches are best suited to a single spinal level and require bony disruption at each level treated. Access through the sacral hiatus with a flexible endoscope allows an alternative, longitudinal approach to the entire lumbar epidural space. Surgical instruments can be introduced through the endoscope, including laser waveguide fibers. In this article, we expand upon previous reports and describe the combined clinical results of endoscopic laser decompression in 154 patients from 8 centers. All cases of anterior endoscopic neural decompression via sacral laminotomy between December 2009 and May 2011 were reviewed at participating centers and sent a follow‐up questionnaire. One hundred and fifty‐four cases were identified. There was a significant improvement in disability caused by low‐back and/or leg pain as measured by the RMQ. The postoperative level of pain improved from 7.5 to 3.4. By the MacNab scale, success was achieved in 82%. Overall, the patients demonstrated significant clinical recovery and improvement in both quality of life and overall pain levels.
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