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.
IntroductionThe publication of explant rates has established risk factors and a definitive objective outcome of failure for spinal cord stimulation (SCS) treating neuropathic pain. We present a UK study analyzing explants of electrical neuromodulation devices for different conditions over 11 years in a single center specializing in neuromodulation.MethodsA retrospective analysis was performed using a departmental database between 2008 and 2019. Explants were analyzed according to condition, mode of stimulation and other demographics using logistic regression and Kaplan-Meier graphs with log-rank (Mantel-Cox) test.ResultsOut of a total of 1177 patients, the explant rate was 17.8% at 5 years and 25.2% at 10 years. Loss of efficacy was the most frequent reason for explant 119/181 (65%). Multivariant regression analysis indicated patients with back pain without prior surgery had a reduced risk of explant (p=0.03). Patients with SCS systems that had 10 kHz, options of multiple waveforms, and rechargeable batteries also had a decreased risk of explant (p<0.001). None of these findings were confirmed when comparing Kaplan-Meier graphs, however. Contrary to other studies, we found gender and age were not independent variables for explant.ConclusionThese data contribute to a growing list of explant data in the scientific literature and give indications of what factors contribute to long-term utilization of electrical neuromodulation devices.
When administered according to the NICE guidance, BoNTA produced a clinically meaningful effect in the long-term management of CM with and without medication overuse headache. Treatment discontinuation when CM becomes episodic may be useful in clinical practice to identify those who may benefit from extended treatment intervals. Our clinical experience indicates a lack of additional benefit from using the 'follow-the-pain' paradigm.
Background: The recent interest in targeting the dorsal root ganglion (DRG) has led to the
development of new techniques of electrode placement. In this article, we describe a new
“Transgrade” approach to the DRG, accessing the contralateral interlaminar space and steering
the lead out the opposite foramen.
Objectives: The purpose of this study was to evaluate the Transgrade technique to the DRG in
the management of focal neuropathic pain, predominately complex regional pain syndrome in
terms of efficacy and safety.
Study Design: A retrospective, observational review of all patients selected for DRG stimulation
using the Transgrade technique to the DRG.
Setting: Pain Management and Neuromodulation Centre, Guys and St. Thomas NHS Foundation
Trust, London, United Kingdom.
Methods: Data were taken from a hospital password-protected database. All patients were
contacted by telephone for Numeric Rating Scale (NRS-11) score, Patient Global Impression of
Change (PGIC) score, and complications. A patient responder was defined as having a PGIC score
of 6 or 7, and a 2-point reduction from baseline NRS-11.
Results: A total of 39 patients (46% women) with a mean age of 46 years (± 2) underwent a trial
of DRG stimulation that resulted in an implantation rate of 82% (32 of 39). The responder rates,
according to NRS-11 and PGIC results, were 87% (28 of 32) at 6 weeks and 66% (21 of 32) at a
mean of 18 months (± 1.8) follow-up. Pocket pain was the most common complication, occurring
in 7 of 32 (22%) patients, and the lead migration rate was 3 out of 57 leads placed (5.2%). A
burst protocol was the favored method of stimulation in the majority of patients, 25 of 32 (78%).
Limitations: Retrospective nature of design, small sample size.
Conclusions: The Transgrade technique of placing DRG leads offers an alternative method that
is safe and effective. New methods of stimulation to the DRG offer more choice and potentially
better efficacy for patients with chronic neuropathic pain.
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