Study of Safety and Effectiveness of Peripheral Nerve Stimulation for Adults with Peripheral Neuropathic Pain

What this Trial Is About

This research aims to evaluate the safety and effectiveness of percutaneous peripheral nerve stimulation in adults experiencing peripheral neuropathic pain, including conditions such as postherpetic neuralgia and trigeminal neuralgia. The study seeks to answer whether this nerve stimulation method can reduce pain and whether it is safe for patients. It is conducted as a randomized withdrawal trial involving multiple clinical sites. Participants will undergo implantation of a peripheral nerve stimulation electrode device produced by Jiangsu CED Medtech Co., Ltd. After implantation, their pain levels are monitored, and those with at least a 30% reduction in pain scores are randomly assigned to receive either active stimulation or placebo stimulation during a randomized withdrawal period. The study includes an enrollment and baseline period, a treatment period consisting of test, randomized withdrawal, and observation subperiods, and a follow-up period. The device remains implanted for 28 days, after which it is removed. Throughout the study, participants will keep a pain diary recording daily pain scores using the Visual Analogue Scale VAS, report analgesic medication use, number of awakenings, and any adverse events. Researchers will perform assessments including physical exams, vital signs, laboratory tests, and questionnaires on neuropathic pain and quality of life. Pain scores and other measures are recorded daily during various study phases and at follow-up visits to assess the interventions impact and safety.

Clinical Trial of the Safety and Efficacy of Peripheral Nerve Stimulation in the Treatment of Peripheral Neuropathic Pain.