![]() Importance The use of spinal cord stimulation for chronic pain after lumbar spine surgery is increasing, yet rigorous evidence of its efficacy is lacking. Shared Decision Making and Communication.Scientific Discovery and the Future of Medicine.Health Care Economics, Insurance, Payment.Clinical Implications of Basic Neuroscience.Challenges in Clinical Electrocardiography.For patients with 2 placebo stimulation or burst stimulation follow-up periods, the outcomes are presented as the mean of the 2 burst stimulation periods and the mean of the 2 placebo stimulation periods. The mean score at baseline was 44.7 points and the mean score changes were −10.6 points (95% CI, −14.1 to −7.2 points) for burst stimulation and −9.3 points (95% CI, −12.7 to −5.9 points) for placebo stimulation. ![]() Of these 180 treatment periods, follow-up scores were available for 178. Among the 47 patients who underwent randomization and had at least 1 follow-up score, there were 91 burst stimulation periods and 89 placebo stimulation periods. Among the 50 patients who were randomized, 2 patients allocated to burst stimulation and 1 allocated to placebo stimulation did not have follow-up scores starting at 3 months. ![]() Each bar extends from a patient’s baseline score to their mean score at the end of the treatment allocation periods. The minimal clinically important difference was 10 points. Scores greater than 40 indicate severe disability. Contact the study team to discuss study eligibility and potential participation.Oswestry Disability Index scores range from 0 points (no disability) to 100 points (maximum disability). There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Guidelines differ from study to study, and identify who can or cannot participate. Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. The technique has proven to be feasible in a cadaver model with ease of lead placement at the desired targets Participation eligibility 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. 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. 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. 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. Another trial has demonstrated superiority of SCS over repeat surgery in the same patient population. 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. Spinal cord stimulation (SCS) has been used for almost 30 years to treat many intractable back pain conditions. Sponsor Protocol Number: 13-003985 About this study
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