NCT05024682

Pulsed Radiofrequency Versus Pulse Dose Pulsed Radiofrequency of the Pudendal Nerve in Patients With Pudendal Neuralgia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The relatively complex anatomical structure of the pelvis has been a focus of study in the medical field. The diagnosis of the causes of chronic pelvic pain is usually a complicated process. Pudendal neuralgia is a syndrome that is characterized by pelvic pain, including bowel, bladder regional pain or discomfort, sexual dysfunction, severe burning sensations and needle-like pain, which are aggravated when seated and relieved after standing. pudendal neuralgias are induced by pudendal nerve damage The mechanism of PRF has been studied repeatedly. It has been verified that PRF has definite safe treatment range, but during the PRF treatment, the tissue surrounding the electrode may have some degree of change and so it is difficult to assess any actual damage.7 Based on electric field intensity, PRF can actually produce tissue changes observable as in vitro changes to ultrastructure in early-phase histologic study. These biological changes were converted to biological effect to alleviate neuropathic pain in animal models.

Conditions

• Pain, Chronic

Interventions

Type	Name	Description
DEVICE	conventional pulsed radiofrequency	After connecting the electrode and the PRF needle, the interventionist determined whether the pudendal nerve innervation produced paresthesia in the sensory stimulation test with a frequency of 50 Hz, pulse width of 1 ms and a voltage of 0.3-0.5 V. Thereafter, the radiofrequency ablation therapy was performed in 42°C, 120 seconds pulse mode which consisted of four cycles (8 minutes)
DEVICE	pulse dosed pulsed radiofrequency	After connecting the electrode and the PRF needle, the interventionist determined whether the pudendal nerve innervation produced paresthesia in the sensory stimulation test with a frequency of 50 Hz, pulse width of 1 ms and a voltage of 0.3-0.5 V. Thereafter, the radiofrequency ablation therapy was performed in 42°C, 240 seconds pulse dose mode which consisted of two cycles (8 minutes).

Timeline

• Start date: 2022-01-03
• Primary completion: 2023-01-03
• Completion: 2023-02-03
• First posted: 2021-08-27
• Last updated: 2021-08-27

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated device study