Pulsed Radiofrequency for Neuropathic Pain

This trial explores a treatment called non-invasive pulsed radiofrequency (NIPRF) to determine its effectiveness in reducing chronic neuropathic pain from nerve injuries after surgery or trauma. Participants will receive either the active NIPRF treatment, which uses a device to send gentle pulses to the affected nerves, or a non-active treatment that mimics the process without delivering actual pulses. Individuals with persistent nerve pain after an injury, despite trying other treatments, might be suitable for this trial.

As a combined Phase 2 and Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval. Participants have the opportunity to contribute to advancing pain management solutions.

The trial requires that you keep your current pain medication dosage stable for at least 30 days before starting and not try any new pain medications for three weeks after joining the study.

Previous studies have shown that pulsed radiofrequency (PRF) is very safe for treating chronic pain. Research indicates a low rate of complications, making it a trusted option for many people. One study found that high-voltage PRF did not cause more side effects than the regular version, supporting its safety. PRF uses electrical fields to manage pain without destroying tissue. This method has proven effective for nerve pain, which results from nerve damage. Overall, PRF is considered a safe and effective choice for managing chronic pain.¹²³⁴⁵

Most treatments for neuropathic pain involve medications like gabapentin or pregabalin, which work by altering nerve signals. However, pulsed radiofrequency therapy offers a different approach by using a high-frequency magnetic field to target and treat nerves non-invasively. Researchers are excited about this treatment because it promises a non-drug alternative that might reduce pain with fewer side effects. Additionally, the use of a non-invasive device means there’s no need for surgical intervention, making it a much simpler and potentially safer option for patients. This innovation could be particularly beneficial for those who haven't found relief with traditional medications.

Studies have shown that pulsed radiofrequency (PRF) can greatly reduce nerve-related pain. Research indicates that PRF treatments lowered pain levels at two weeks, one month, and three months post-treatment. One study found that over 60% of patients experienced significant pain improvement without surgery. Another study demonstrated that PRF was more effective than standard treatments for certain types of nerve pain. In this trial, participants will receive either the active non-invasive pulsed radiofrequency treatment or a non-active sham treatment. Overall, these findings suggest that non-invasive pulsed radiofrequency could be a promising option for managing long-term nerve pain, especially after nerve injuries.¹³⁶⁷⁸