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).
AbstractObjectiveTo report a novel wireless neuromodulation system for treatment of refractory craniofacial pain.BackgroundPrevious studies utilizing peripheral nerve stimulation (PNS) of the occipital and trigeminal nerves reported positive outcomes for alleviating neuropathic pain localized to the craniofacial and occipital areas. However several technological limitations and cosmetic concerns inhibited a more widespread acceptance and use of neuromodulation. Also, a relatively high incidence of adverse events like electrode erosions, dislocation, wire fracture and/or infection at the surgical site mandates a change in our approach to neuromodulation technology and implant techniques in the craniofacial region.MethodsWe report a novel approach for the management of craniofacial pain with a wirelessly powered, minimally invasive PNS system. The system is percutaneously implanted and placed subcutaneously adjacent to affected facial nerves via visual guidance by the clinician. In this feasibility study, pilot evidence was gathered in a cohort of ten subjects suffering from a combination of chronic headaches, facial pain for at least 15 days per month and for at least 4 h/day.ResultsAt four weeks post-implant follow up, all patients reported sustained pain relief of the primary pain area. Electrode location and total number of electrodes used per subject varied across the cohort. The average pain reduction using the visual analog scale was >82%. The procedure had no adverse events or side effects.ConclusionsPercutaneous placement of a wireless neurostimulation device directly adjacent to affected craniofacial nerve (s) is a minimally invasive and reversible method of pain control in patients with craniofacial pain refractory to conventional medical managements. Preliminary results are encouraging and further larger scale studies are required for improved applications.
Subcutaneous placement of electrodes with our minimally invasive technique and wireless neuromodulation technology was safe and effective. Significant improvements in pain relief ensued, and no further adverse events had been reported at the end of 3 months' follow-up.
Wireless high-frequency stimulation of the DRG is a viable option to treat chronic low back pain. Preliminary results show a subject preference for stimulation at the T9 vertebral level.
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