Neuromodulation : journal of the International Neuromodulation Society
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Randomized Controlled Trial Multicenter Study
Analgesic Efficacy of "Burst" and Tonic (500 Hz) Spinal Cord Stimulation Patterns: A Randomized Placebo-Controlled Crossover Study.
The aim of this study was to compare the efficacy in reducing pain intensity in adult subjects suffering from chronic back and leg pain of burst (BST) and tonic sub-threshold stimulation at 500 Hz (T500) vs. sham stimulation delivered by a spinal cord stimulation (SCS) device capable of automated postural adjustment of current intensity. ⋯ The findings suggest a superior outcome versus sham from T500 stimulation over BST stimulation and a practical equivalence between BST and sham in a group of subjects with leg and back pain habituated to tonic SCS and having achieved a stable status with stimulation.
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Burst spinal cord stimulation (B-SCS) has been shown to reduce neuronal firing in the anterior cingulate cortex through selective modulation of the medial pain pathway tract. This pain pathway communicates the affective component of pain processing. The purpose of this study was to assess the effect of B-SCS on psychosocial functioning and its influence on pain and quality of life. ⋯ One-year outcomes after B-SCS show improvements across all evaluated psychological measures with the largest impact observed on catastrophizing and depression (the affective component of pain processing). These pain-related beliefs and behaviors, and not pain intensity, have been shown to put patients at greatest risk of a poor prognosis and quality of life.
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Heart rate variability recordings have the potential to examine the role of the autonomic nervous system. Several wearable devices are nowadays readily available. Up until now, no studies explored whether a wearable device is able to reliably measure a treatment response in chronic pain patients. Therefore, the aim of this study is to evaluate the reliability of a Polar V800 (Polar Electro Oy, Finland) wearable device to accurately measure RR intervals in patients with failed back surgery syndrome (FBSS) during spinal cord stimulation (SCS), as compared with an eMotion 2-lead ECG recording. ⋯ Similar pre- to posttreatment changes were revealed between a wearable device and 2-lead ECG with reliable HRV estimates for parameters that are able to capture the treatment changes. This suggests that a wearable heart rate monitor might be a reliable wearable tool for the detection of pre- to post treatment changes of SCS, in patients with FBSS.
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Spinal cord stimulation is an effective therapy for chronic back and/or leg pain. Amplitude dose-response studies are lacking; therefore, little guidance exists regarding the minimum amplitude requirements with specific high dose parameters. This study characterized the minimum amplitude level that maintained SCS therapy satisfaction and pain relief when stimulating at 1000 Hz and 90 μsec. ⋯ The qualified study patients defined an implanted population reporting good pain relief and satisfaction using HD SCS therapy at baseline. The majority of these patients were able to maintain therapy satisfaction and pain relief (70% and 63.3%, respectively) with 20% perception threshold amplitude. Amplitudes below perception threshold could potentially maintain effective SCS therapy with HD stimulation in a subset of patients.
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High-frequency 10 kHz spinal cord stimulation (10 kHz-SCS) has achieved analgesia superior to traditional SCS in a number of studies. However, there is concern regarding long-term outcomes of 10 kHz-SCS. Prior work has suggested that explant rates are higher with 10 kHz-SCS. Our primary objective was to determine the explant rate of 10 kHz-SCS in a large patient cohort from multiple centers followed for at least 12 months after implant surgery. ⋯ We found 10 kHz-SCS explant rates to be similar to prior reported explant rates for traditional SCS devices. Patient-related factors including female sex and radiculopathy as the primary SCS indication may be protective factors against explantation.