scholarly journals Options: A Prospective, Open-Label Study of HighDose Spinal Cord Stimulation in Patients with Chronic Back and Leg Pain

2020 ◽  
Vol 1;23 (1;1) ◽  
pp. 87-98 ◽  
Author(s):  
Ramsin Benyamin
Keyword(s):  
Spinal Cord ◽  
Pain Relief ◽  
Spinal Cord Stimulation ◽  
Pulse Width ◽  
Failed Back Surgery Syndrome ◽  
Leg Pain ◽  
High Dose ◽  
Failed Back Surgery ◽  
Global Impression Of Change

Background: Therapeutic approaches to spinal cord stimulation (SCS) continue to evolve and improve patient outcomes in patients receiving SCS therapy secondary to failed back surgery syndrome. Objectives: The aim of this study was to evaluate pain relief and other patient outcomes of SCS using selected high-dose programming parameters. Study Design: This was a prospective cohort study. Setting: This study took place at 11 centers in North America. Methods: Forty-four SCS-naive patients underwent trialing, starting with 1,000 Hz frequency, 90 µs pulse width followed by 300 Hz frequency, 800 µs pulse width, if pain relief was inadequate. Patients with 50% or greater pain relief were eligible for permanent implantation. Patient’s pain rating, global impression of change, health-related quality of life, functional disability, satisfaction/ recommendation, stimulation perception, device programming, and adverse events were assessed at 3 months postimplant. Results: There were significant improvements from baseline in mean Numeric Rating Scale (NRS11) pain scores for overall pain (7.5 to 3.8; P < 0.01), back pain (7.2 to 3.4; P < 0.01), leg pain (7.2 to 3.1; P < 0.01), Oswestry Disability Index (ODI) score (51.5 to 32.1; P < 0.01), and European Quality of Life–Five Dimensions, version 5L score (EQ-5D-5L) (0.58 to 0.74; P < 0.01). Twentyeight of 32 patients (88%) had significant, favorable improvement in Patient Global Impression of Change (PGIC). Eighty-four percent of patients were “satisfied,” and 78.1% would “definitely” recommend SCS. Eighteen patients (56%) used 1,000 Hz frequency and 90 µs pulse width exclusively; these patients experienced mean NRS-11 overall pain score improvement of 4.7 points. Device-, therapy-, or procedure-related adverse events were experienced in 19 patients (40%, 19 of 48), and all events resolved without reoperation and were similar to those observed with traditional SCS systems. Limitations: There was no active or sham comparator group, and therefore the reported effects may not be solely attributable to therapy effects and may be related to other, nonspecific effects of SCS. Conclusions: Improvements in pain relief, PGIC, EQ-5D-5L, ODI, and patient satisfaction were all clinically relevant and statistically significant. Future studies are needed to understand how these high-dose parameters perform versus a standard comparator. Key words: Spinal cord stimulation, high-frequency electrical stimulation, failed back surgery syndrome, neurostimulation, prospective, nonrandomized study

scholarly journals The Added Value of High Dose Spinal Cord Stimulation in Patients with Failed Back Surgery Syndrome after Conversion from Standard Spinal Cord Stimulation

2020 ◽  
Vol 9 (10) ◽  
pp. 3126
Author(s):  
Mats De Jaeger ◽  
Lisa Goudman ◽  
Koen Putman ◽  
Ann De Smedt ◽  
Philippe Rigoard ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Failed Back Surgery Syndrome ◽  
Added Value ◽  
High Dose ◽  
Average Increase ◽  
Failed Back Surgery ◽  
Back Surgery ◽  
Over Time

Patients with Failed Back Surgery Syndrome (FBSS) report a considerably lower health- related quality of life (HRQoL), compared to the general population. Spinal cord stimulation (SCS) is an effective treatment to offer pain relief in those patients. Despite initial treatment success of SCS, its effect sometimes wears off over time. This study investigates the added value of high dose SCS (HD-SCS) in patients with unsatisfactory conventional SCS, from a quality of life perspective. Seventy-eight FBSS patients who were treated with conventional SCS that failed to provide pain relief, were recruited in 15 centers. HRQoL was assessed before converting to HD-SCS (baseline) and three times after converting to HD-SCS using the EuroQol-5D-3L. Quality adjusted life years (QALY) were calculated and compared with conventional SCS. An overall significant increase over time was seen in utility values of the EQ5D-3L, as the mean value at baseline 0.283 (±0.21) increased to 0.452 (±0.29) at 12 months of HD-SCS. This average increase in utility coincides with an average increase of 0.153 (±0.24) QALY’s in comparison to continued conventional SCS. Besides the potential of HD-SCS to salvage patients with failed responses to conventional SCS, this treatment seems to be a more efficient treatment than conventional SCS.

scholarly journals High-Frequency Spinal Cord Stimulation at T9/10 in Patients With Failed Back Surgery Syndrome

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Naoki Higashiyama ◽  
Takuro Endo ◽  
Taku Sugawara
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Low Frequency ◽  
The Elderly ◽  
Failed Back Surgery Syndrome ◽  
Leg Pain ◽  
Effective Treatment Option ◽  
Failed Back Surgery ◽  
Back Surgery

Abstract INTRODUCTION Spinal cord stimulation (SCS) is an effective treatment option for low back pain and radicular leg pain of failed back surgery syndrome (FBSS). In a recent study, high-frequency spinal cord stimulation (HFSCS) was found to be more effective in treating chronic pain than traditional paresthesia-based low-frequency SCS (paresthesia SCS). The purpose of this study is to evaluate the efficacy of paresthesia SCS and HFSCS in improving outcomes. METHODS We retrospectively reviewed the outcomes of patients who underwent paresthesia SCS or HFSCS between September 2016 and January 2019. Paresthesia SCS is generally characterized by programming stimulation parameters such that the patient experiences paresthesia, and the paresthesia topography overlaps the pain topography as much as possible. The patient in HFSCS had a placement of cylindrical lead at levels T9-10. Patients were programmed with the electrode overlying the inferior endplate of T9 (+) and the electrode overlying the superior endplate of T10 (–). RESULTS A total of 14 patients (4 males, 10 females) underwent paresthesia SCS implantation. Mean age was 77.2 ± 9.6 yr. A total of 5 patients (2 males, 3 females) underwent HFSCS implantation. Mean age was 78.2 ± 7.5 yr. Operative time was shorter for the HFSCS group compared to the paresthesia SCS group (53.4 ± 4.8 min vs 82.9 ± 20.3 min, respectively; P < .001). A total of 5 out of 5 patients in the HFSCS group (100%) and 10 out of 14 patients in the paresthesia SCS group (71.4%) achieved the outcome of 50% pain relief (P = .25) CONCLUSION To confirm paresthesia during the procedure in the elderly may be complicated by hearing/language difficulties or by sedative-related confusion. Compared to paresthesia SCS, HFSCS allows for lower operative times and a more efficient and accurate positioning of the electrodes.

scholarly journals The influence of High Dose Spinal Cord Stimulation on the descending pain modulatory system in patients with failed back surgery syndrome

2019 ◽  
Vol 24 ◽  
pp. 102087
Author(s):  
Sander De Groote ◽  
Lisa Goudman ◽  
Ronald Peeters ◽  
Bengt Linderoth ◽  
Peter Van Schuerbeek ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Stimulation ◽  
Failed Back Surgery Syndrome ◽  
High Dose ◽  
Failed Back Surgery ◽  
Back Surgery

scholarly journals Wireless High-Frequency Spinal Cord Stimulation (10 kHz) Compared with Multiwaveform Low-Frequency Spinal Cord Stimulation in the Management of Chronic Pain in Failed Back Surgery Syndrome Subjects: Preliminary Results of a Multicenter, Prospective Randomized Controlled Study

Pain Medicine ◽  
2019 ◽  
Vol 20 (10) ◽  
pp. 1971-1979 ◽  
Author(s):  
Robert Bolash ◽  
Michael Creamer ◽  
Richard Rauck ◽  
Payam Vahedifar ◽  
Aaron Calodney ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Chronic Pain ◽  
Spinal Cord Stimulation ◽  
High Frequency ◽  
Low Frequency ◽  
Failed Back Surgery Syndrome ◽  
Leg Pain ◽  
Trial Period ◽  
Failed Back Surgery ◽  
Back Surgery

Abstract Background This study aimed to evaluate the wireless Freedom Spinal Cord Stimulator (WSCS) System for the treatment of chronic back and/or leg pain associated with failed back surgery syndrome (FBSS) refractory to standard medical treatment utilizing 10-kHz stimulation (high-frequency [HF]) in comparison with 10–1,500-Hz stimulation (low-frequency [LF]) waveforms. Methods Ninety-nine subjects were randomized in a 1:1 ratio to receive either HF or LF stimulation waveforms utilizing the same Freedom WSCS System. All subjects were implanted with two 8-electrode arrays in the exact same anatomical positions within the dorsal epidural spinal column, with the top electrode positioned at the T8 and T9 vertebrae levels, respectively, and the wireless receiver placed under the skin in a subcutaneous pocket. Results Seventy-two (HF: N = 38; LF: N = 34) subjects had completed the six-month follow-up after an initial 30-day trial period at the time of this report. For both the HF and LF arms, mean visual analog scale (VAS) scores for back and leg pain decreased significantly: 77% and 76%, respectively, for the HF arm and 64% and 64%, respectively, for the LF arm. In addition, most subjects experienced significant improvements in VAS, Oswestry Disability Index, European Quality of Life 5 Dimension questionnaire, Patient Global Impression of Change, and sleep duration. Conclusions These preliminary results demonstrate that WSCS devices can reduce FBSS chronic pain substantially with both LF and HF stimulation waveforms over a seven-month period (30-day trial period and six-month post-trial evaluation).

Long-Term Outcome of Spinal Cord Stimulation in Failed Back Surgery Syndrome: 20 Years of Experience With 224 Consecutive Patients

Neurosurgery ◽  
2018 ◽  
Vol 84 (5) ◽  
pp. 1011-1018 ◽  
Author(s):  
Mette Nissen ◽  
Tiina-Mari Ikäheimo ◽  
Jukka Huttunen ◽  
Ville Leinonen ◽  
Mikael von und zu Fraunberg
Keyword(s):  
Spinal Cord ◽  
Pain Relief ◽  
Spinal Cord Stimulation ◽  
Failed Back Surgery Syndrome ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Failed Back Surgery ◽  
Back Surgery

Abstract BACKGROUND Failed back surgery syndrome (FBSS) is a challenging condition that lacks a curative treatment. In selected patients, spinal cord stimulation (SCS) has provided a satisfactory outcome. OBJECTIVE To evaluate the long-term outcome of SCS in FBSS, as measured by (1) the explantation rate, (2) complications, and (3) patient satisfaction with the global perceived effect (GPE). METHODS We studied 224 consecutive FBSS patients who underwent an SCS trial with surgically implanted leads at our hospital between January 1996 and December 2014. The patients’ satisfaction with the GPE of treatment was measured through a postal questionnaire at the end of follow-up. RESULTS Based on a 1-wk trial, permanent SCS was implanted in 175 (78%) patients. Out of these patients, 153 (87%) reported satisfactory outcomes after 2 mo. During the mean follow-up of 6 yr, 34 (19%) of SCS devices were permanently explanted due to inadequate pain relief, and 11 (6%) were explanted for other reasons. Electrode revision due to inadequate pain relief was done for 22 patients. In total, 26 complications were reported due to: 7 deep infections, 11 hardware malfunctions, 1 subcutaneous hematoma, 4 instances of discomfort due to the pulse generator, and 3 electrode migrations. One hundred thirty patients (74%) continued with SCS until the end of follow-up. Of them, 61 (47%) returned the questionnaire, and 42 (69%) reported substantially improved or better GPE. CONCLUSION SCS can provide a good outcome in the treatment of FBSS. Patient selection could be further improved by developing novel predictive biomarkers.

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