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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetic Foot
• Intervention / Treatment: Radiation: Pulsed radio frequency therapy; Other: sham operation

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Shanghai Xinhua hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects voluntarily participate in the study and sign the informed consent form;
• The age is between 18 (inclusive) and 85 (inclusive), regardless of gender;
• Body mass index (BMI) ≤ 45;
• Clinically diagnosed diabetes foot with moderate and severe pain in peripheral nerve of affected limb (defined as NRS score ≥ 4), the course of disease lasts for more than 12 months, and has been treated with clinical routine standard drugs (mecobalamin α- Lipoic acid, sodium valproate, carbamazepine, gabapentin/pregabalin, etc.) symptoms still exist at least 6 months later;
• Glycated hemoglobin<8%;
• Not participating in the drug/medical device test within 3 months before the test;

Exclusion Criteria:

• Patients who are in poor condition and cannot objectively describe symptoms or cooperate to complete the questionnaire score
• Ulcer is red and swollen, or active inflammatory infection;
• The affected limb has lesions such as blackening and gangrene of the toe skin;
• Those suffering from severe respiratory and cardiovascular diseases, liver and kidney insufficiency, and malignant tumors;
• Breast-feeding and pregnant women, or subjects with pregnancy plan within 1 month after the trial (also including male subjects);
• The daily dose of opioids is more than 120mg (different drug doses are converted into 120mg morphine sustained-release tablets);
• People with allergic diseases and allergic constitution;
• Have a history of drug abuse or drug addiction;
• There are contraindications to pulsed radio frequency therapy;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A group; First receive pulse radio frequency treatment and then receive sham operation treatment	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
Active Comparator: B group; First receive sham operation treatment and then receive pulse radio frequency treatment	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rating Scale	Numeric Rating Scale is the most widely used one-dimensional assessment scale，The higher the number, the more severe the pain	up to 4 months

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Actual): November 15, 2023
• Study Completion (Estimated): December 15, 2024

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 28, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Skin Diseases; Pain; Neurologic Manifestations; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Neuromuscular Diseases; Peripheral Nervous System Diseases; Foot Ulcer; Diabetic Foot; Neuralgia
• Other Study ID Numbers: XH-23-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No