Early Feasibility Study of the Nervonik Peripheral Nerve Stimulation Device for Chronic Knee, Elbow, or Shoulder Pain

What this Trial Is About

This research aims to evaluate the Nervonik peripheral nerve stimulation device in adults experiencing chronic severe pain in the knee, elbow, or shoulder areas. The study focuses on patients with peripheral nerve disorders causing significant pain, including post-surgical or traumatic nerve pain. It is an early-phase, multicenter trial involving 30 patients to assess the devices potential for pain relief. Participants are divided into two groups. The first group will use the Nervonik neurostimulator for up to 8 hours while staying near the care facility to allow adjustments until satisfactory pain relief is achieved, after which the device will be removed. The second group includes patients from the first group who found the device beneficial and agree to a permanent implant, as well as new patients meeting the trial criteria who consent to participate. During the study, participants will undergo evaluations to monitor pain relief and device effectiveness over different time periodsan average of 1 day for the first group and an average of 1 year for the second group. Researchers will collect data through study visits, monitor stable pain and medication use, and assess safety. The entire participation period varies depending on the group and treatment phase.

Early Feasibility of the Nervonik Peripheral Nerve Stimulation Device