NCT05831059

A Sympathetic Ganglion, High-voltage Pulsed Radiofrequency Ablation of Peripheral Neuralgia

A Randomized, Controlled, Double-blind, Multicenter, Sympathetic Ganglion, High-voltage Pulsed Radiofrequency Ablation of Peripheral Neuralgia in Patients With Diabetic Foot

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The Sham Operation Group was used as control, the patients were assessed with the Digital Rating Scale (NRS) , the quality of life-related scale (Euro Qol) , clinical outcome measures: physician's overall impression of changes in pain (CGIC) and patient's overall impression change scale (PGIC) , skin temperature measurement, toe Oxygenation measurement, and anxiety and depression scores (Gad-7, Phq-9) , objective: to evaluate the efficacy and safety of high voltage pulsed radiofrequency in the treatment of peripheral neuralgia in patients with diabetic foot.

Conditions

• Diabetic Foot

Interventions

Type	Name	Description
RADIATION	Pulsed radio frequency therapy	Pulse Radio Frequency mode is a high voltage and low temperature Radio Frequency mode formed by discontinuous and pulsed current around nerve tissue
OTHER	sham operation	The means to achieve double-blind treatment had no practical effect on the subjects

Timeline

• Start date: 2022-12-12
• Primary completion: 2023-11-15
• Completion: 2024-12-15
• First posted: 2023-04-26
• Last updated: 2024-05-30

Locations

1 site across 1 country: China