MedTrace Logo

Pulsed Radiofrequency Therapy on Peripheral Nerves Monitoring Pain, Quality of Life, Patient Satisfaction and Efficacy

NCT06270940 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2024-04-24

No results posted yet for this study

Summary

Neuropathic pain is a chronic condition caused by damage to the somatosensory nervous system. The pain associated with neuropathic pain is often severe and debilitating, and can significantly interfere with the quality of life and daily functioning of affected patients. Current pharmacologic treatments, such as antidepressants, antiepileptics, and opioids, can offer only partial relief for 40-60% of patients, and are often accompanied by severe side effects. This has led to increasing interest in non-pharmacologic management options for neuropathic pain. One such promising treatment option is pulsed radiofrequency (PRF) treatment applied to the affected peripheral nerve in conjunction with local anesthetic and/or corticosteroid medication. Several studies, including case reports, retrospective studies, and small randomized controlled trials, have shown that PRF treatment to the affected peripheral nerve can be beneficial and effective for managing chronic peripheral neuropathic pain. Several peripheral neuralgias, such as thoracic postherpetic neuralgia, occipital neuralgia, pudendal neuralgia, meralgia paresthetica, painful shoulder, post-thoracotomy syndrome, and carpal tunnel syndrome, have been successfully treated with PRF. PRF treatment has garnered significant interest among ultrasound-skilled pain physicians because of its superior, safe, and non-destructive percutaneous approach to peripheral nerves, visualized by today's excellent visual ultrasound guidance. Our academic pain center performs approximately more than 1000 ultrasound-guided peripheral nerve blocks per year on a wide range of peripheral nerves. Moderate evidence for treating peripheral nerves with PRF treatment is available; however, PRF treatment settings such as voltage, number of cycles, and treatment duration vary, and it is not clear which setting contributes most substantially to pain reduction results. The aim of this prospective longitudinal observational data collection is to evaluate the efficacy of PRF treatment applied to peripheral nerves, to observe the clinical course of chronic peripheral neuropathic pain under conditions of routine clinical practice, and to link these observations with clinical outcomes.

Conditions

  • Neuropathic Pain

Interventions

PROCEDURE

Pulsed Radiofrequency (PRF) Treatment

PRF treatment maintains a temperature below 42°C and does not produce structural tissue damage around the needle. PRF exposure to the Dorsal Root Ganglion (DRG) induces c-Fos gene expression in the dorsal horn, which suggests a cellular response to the electric forces generated within the DRG. PRF has been found to relieve neuropathic pain by inducing long-term depression of synaptic transmission in the spinal cord, leading to a decrease in allodynia and hyperalgesia. It also modulates the inflammatory response in the injured area by decreasing the expression of pro-inflammatory cytokines, such as TNF-α, in the peripheral nerve and spinal cord, which is a major player in the development and maintenance of neuropathic pain. PRF is characterized by a 500 kHz current applied for 2 pulses per second, with each pulse lasting 20 milliseconds.

Sponsors & Collaborators

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Monique Steegers, Prof · Amsterdam UMC

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-04
Primary Completion
2025-10-31
Completion
2026-02-28

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06270940 on ClinicalTrials.gov