Improvements in Therapy Experience With Evoked Compound Action Potential Controlled, Closed-Loop Spinal Cord Stimulation-Primary Outcome of the ECHO-MAC Randomized Clinical Trial.

Spinal cord stimulation (SCS) is a well-established treatment for chronic neuropathic pain. However, over- or underdelivery of the SCS may occur because the spacing between the stimulating electrodes and the spinal cord is not fixed; spacing changes with motion and postural shifts may result in variable delivery of the SCS dose and, in turn, a suboptimal therapy experience for the patient. The evoked compound action potential (ECAP)-a measure of neural activation-may be used as a control signal to adapt SCS parameters in real time to compensate for this variability.

Early Functional Outcomes in Low Back Pain Subjects with a Novel Interspinous Fusion Device: REFINE Study 6-Month Results.

Purpose: Lumbar interlaminar decompression with interspinous fixation is an established safe and effective treatment for spinal stenosis. Early maintenance of improvements in pain intensity and function are critical for durability of symptom relief. The purpose of this study was to investigate the efficacy of minimally invasive treatments for low back pain during the early period after treatment and their utility in setting the course for longer term success.

A Prospective, Observational, Open-Label, Non-Randomized, Multicenter Study Measuring Functional Outcomes in a Novel Interspinous Fusion Device in Subjects with Low Back Pain: REFINE Study.

Introduction: Lumbar degenerative disease and the accompanying pain and dysfunction affect a significant number of patients in the USA and around the world. As surgery and innovation are moving towards minimally invasive treatments, this study looks to explore interspinous fixation as a standalone posterior approach to treat lumbar degenerative disc disease in the presence of neurogenic claudication and spinal stenosis.

Methods: This study was approved by an institutional review board (IRB) and is actively enrolling in a single-arm, multicenter, prospective, open-label fashion.