A Study Comparing Cryoneurolysis and Sham Treatment for Pain Relief in Adults with Medically Resistant Trigeminal Neuralgia

What this Trial Is About

This research aims to evaluate a freezing technique called cryoneurolysis to see if it helps reduce pain in adults with trigeminal neuralgia, a condition causing severe facial pain. The study is a randomized, triple-blinded trial comparing the freezing treatment with a sham procedure to determine its safety and effectiveness. Researchers want to find out how many participants experience at least a 75% reduction in pain and will also collect other important information about pain relief and side effects. Participants will be randomly assigned to either receive the cryoneurolysis treatment or a sham stimulation device. Before treatment, all participants will keep a daily headache diary for two weeks. After treatment, they will continue recording pain for four weeks. Following this initial period, there is an extension phase lasting up to two years where all participants can receive treatment as needed. The study involves careful monitoring of pain levels and any treatment-related adverse events during weeks 1 to 4 post-intervention. During the study, participants will have their pain recorded daily using pain scales and diaries. Researchers will evaluate average daily pain intensity, responder rates based on various pain and impression scales, and safety outcomes. The study includes baseline and follow-up assessments to compare pain levels before and after treatment. Participants ability to maintain their usual medication regime is required, and safety monitoring will continue throughout the study period. Total participation time can last up to two years with long-term follow-up opportunities.

A Study to Investigate the Efficacy of Pain Reduction With Cryoneurolysis Compared With Sham-treatment in Adults With Trigeminal Neuralgia