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 ◽  
...  

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).

Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Naoki Higashiyama ◽  
Takuro Endo ◽  
Taku Sugawara

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.


Neurosurgery ◽  
2019 ◽  
Vol 66 (Supplement_1) ◽  
Author(s):  
Erin McCormack ◽  
Mansour H Mathkour ◽  
Lora Wallis Kahn ◽  
Maged Guirguis ◽  
Gassan Chaiban ◽  
...  

Abstract INTRODUCTION Complex regional pain syndrome (CRPS) is a disabling form of constant and intense chronic pain involving a limb. Failed back surgery syndrome (FBSS) is chronic back pain following back surgery. Burst stimulation is a novel concept applied recently to treat chronic pain through spinal cord stimulation (SCS). The impulses are thought to travel to the thalamus to treat sensory, affective, and attentional components of neuropathic pain by targeting both the somatosensory cortex and the limbic system. METHODS A 50-yr-old female presented 1 yr after L5-S1 posterior instrumentation and posterolateral arthrodesis for spondylolisthesis with disabling Type I CRPS of her left foot and back pain. Postoperative improvement in back pain was noted but her left leg pain became worse despite SCS reprogramming. Two months later, she underwent placement of a different paddle lead at T12 and a new pulse generator using burst therapy. This resulted in complete resolution of foot pain. She remains pain-free 5 mo postoperatively. RESULTS Our patient underwent a T9-T10 high frequency (10 kHz) SCS trial followed by permanent paddle lead placement at T9-10 which provided more than 50% foot pain relief resulting in improved range of motion. However, worsening back pain and pseudoarthrosis mandated a revision of her prior arthrodesis 6 mo after SCS surgery. CONCLUSION In selected patients with FBSS and CRPS, revision of arthrodesis combined with SCS may be needed to achieve adequate pain relief. Burst therapy may be superior to high frequency stimulation in select patients.


Pain Medicine ◽  
2017 ◽  
Vol 18 (12) ◽  
pp. 2401-2421 ◽  
Author(s):  
Jose De Andres ◽  
Vicente Monsalve-Dolz ◽  
Gustavo Fabregat-Cid ◽  
Vicente Villanueva-Perez ◽  
Anushik Harutyunyan ◽  
...  

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