The Efficacy and Safety of Fluoroscopic-Guided Bipolar Versus Monopolar Pulsed Radiofrequency for Refractory Trigeminal Neuralgia: An Exploratory Study

What this Trial Is About

Researchers are evaluating two types of pulsed radiofrequency ablation, bipolar and monopolar, in patients with trigeminal neuralgia that does not respond to medication. This exploratory study focuses on comparing the effects of these treatments on pain control in patients diagnosed with classical trigeminal neuralgia, including those with purely paroxysmal pain or with continuous pain. Patients will have undergone brain MRI without structural causes for their pain and have persistent pain despite medical treatment for over three months. Participants will be randomly assigned to receive either monopolar or bipolar pulsed radiofrequency ablation under fluoroscopic guidance. Both procedures involve using radiofrequency cannulas placed near the trigeminal nerve to deliver pulsed radiofrequency energy at a controlled temperature and duration. Monopolar treatment uses a single cannula at the posterior border of the foramen ovale, while bipolar treatment uses two cannulas positioned anteriorly and posteriorly. Sensory and motor testing will confirm correct nerve targeting before treatment delivery. During the study, pain levels will be measured using a numerical rating scale at baseline, two weeks, one month, three months, and six months after treatment. Patient satisfaction will also be assessed shortly after intervention. Researchers will monitor treatment success defined as at least a 50% reduction in pain, track the time to pain control and recurrence, and record any additional pain treatments needed. Safety will be closely monitored for complications during and after the procedure, with follow-up continuing through six months.

Fluoroscopic-Guided Bipolar Versus Monopolar Pulsed Radiofrequency for Refractory Trigeminal Neuralgia