Chronic Pain Clinical Trial
Official title:
Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain (COMFORT 2)
This post market study is being conducted to document the comparative effectiveness and safety of peripheral nerve stimulation plus conventional medical management versus conventional medical management alone in the treatment of chronic, intractable peripheral neuralgia of post-traumatic or postsurgical origin. This is a prospective, minimal risk, multi-center, randomized control trial.
Multi-center, prospective, open-label, randomized controlled trial (RCT) comparing PNS plus CMM with CMM alone. Subjects will be randomized to receive: Arm 1: Nalu Neurostimulation System for PNS plus CMM Arm 2: CMM alone Consented subjects will receive a baseline evaluation and then be randomized 2:1 into one of two arms: 1) PNS+CMM arm or 2) CMM arm. Subjects assigned to Arm 1 will undergo a trial implant period using best clinical practices. Those subjects who pass the trial implant will receive the permanent implant. At the 3-month end point, subjects in Arm 2 will be given the option to crossover into Arm 1 beginning with a trial implant. All Arm 1 patients receiving a permanent implant will be followed for a total of 12 months after permanent implantation.Arm 2 patients who do not crossover will be followed for a total of 12 months from randomization. ;
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