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
| Autor: | Payam Vahedifar, Robert Bolash, Mezaun Yasin, Michael Creamer, Ira Fox, Niek E. Vanquathem, Aaron K. Calodney, Sunil Panchal, Richard Rauck, Cuneyt Özaktay |
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| Rok vydání: | 2019 |
| Předmět: |
Male
Visual analogue scale Endpoint Determination Stimulation law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial 030202 anesthesiology law Medicine Humans Prospective Studies Failed Back Surgery Syndrome Aged Pain Measurement Spinal Cord Stimulation business.industry Chronic pain General Medicine Middle Aged medicine.disease Spinal cord stimulator Spinal column Lower limb pain Oswestry Disability Index Anesthesiology and Pain Medicine Treatment Outcome Anesthesia Female Neurology (clinical) business Low Back Pain Wireless Technology 030217 neurology & neurosurgery |
| Zdroj: | Pain medicine (Malden, Mass.). 20(10) |
| ISSN: | 1526-4637 |
| Popis: | 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). |
| Databáze: | OpenAIRE |
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