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A Multi-center, Randomized Controlled Study of the Vertos MILD Procedure With Conventional Medical Management Versus Conventional Medical Management Alone in the Treatment of Lumbar Spinal Stenosis. (MILD)
Rochester, Minn.
The purpose of this study is to examine functional improvement in lumbar spinal stenosis (LSS) patients with neurogenic claudication who are treated with the MILD procedure plus conventional medical management (CMM) compared to those treated with CMM alone, as the control.
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A Prospective, Multi-Center, Open-Label Study of Programming Options in Spinal Cord Stimulation
Rochester, Minn.
The purpose of this study is to evaluate programming options in spinal cord stimulation for the management of chronic, intractable pain of the trunk and limbs.
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A Randomized Controlled Study to Evaluate the Safety and Effectiveness of the Precision Spinal Cord Stimulator System Adapted for High-Rate Spinal Cord Stimulation (ACCELERATE)
Rochester, Minn.
To evaluate the safety and effectiveness of the Precision Spinal Cord Stimulator System Adapted for High-Rate Spinal Cord Stimulation as an aid in the management of chronic intractable pain
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Extraforaminal Spinal Stimulation Compared to Conventional Spinal Cord Stimulation to Treat Axial Low Back Pain-A Pilot Study
Rochester, Minn.
Spinal cord stimulation (SCS) has been used for almost 30 years to treat many intractable back pain conditions. It has demonstrated efficacy in the co-called Failed Back Surgery Syndrome (FBSS) and a recent randomized controlled trial demonstrated significant superiority of SCS over conventional medical therapy to treat patients with FBSS. Another trial has demonstrated superiority of SCS over repeat surgery in the same patient population. However, the ability to reliably capture the low back with paresthesia coverage has remained challenging and elusive despite numerous strategies designed to overcome this limitation. Strategies that have been introduced but so far with limited success include transverse multiple lead stimulation, high frequency stimulation, peripheral field stimulation, and dorsal root ganglion (DRG) stimulation. To date, none of these strategies have been able to reliably overcome the long-term problems of paresthesia capture and pain relief of the low back.
This proposal describes a new spinal stimulation technique designed to improve the likelihood of low back stimulation by targeting the nerve supply to the two most commonly affected pain producing structures in the back, the facet joints and the intervertebral disks. The technique has proven to be feasible in a cadaver model with ease of lead placement at the desired targets
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MILD® Percutaneous Image-Guided Lumbar Decompression Versus Epidural Steroid Injections in Patients With Lumbar Spinal Stenosis Exhibiting Neurogenic Claudication
Rochester, Minn.
Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor.
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Safety of Lumbar Spine Radiofrequency Procedures in the Presence of Posterior Pedicle Screws: A Prospective Trial
Rochester, Minn.
The goal of the study is to determine if patients undergoing radiofrequency neurotomy of lumbar facet joints that are adjacent to previously placed pedical screws from a fusion, will lead to an increase in the temperature of the pedical screws.
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Shared Decision Making in Patients with Neck and Back Pain – “Options in Neck and Back Pain Management”
Rochester, Minn.
The purpose of this study is to develop, in close collaboration with stakeholders and the Mayo Clinic Spine Center, an evidence-based decision aid for the management of acute and sub-acute cervical and lumbar radiculopathies – “Options in Back Pain Management.”
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