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

Shanghai Jiao Tong University

Status: Active, not recruiting

Conditions: Diabetic Foot

Treatments: Radiation: Pulsed radio frequency therapy; Other: sham operation

Study type: Interventional

Funder types: Other

Identifiers

NCT05831059

XH-23-004

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

A group

Experimental group

Description:

First receive pulse radio frequency treatment and then receive sham operation treatment

Treatment:

Other: sham operation

Radiation: Pulsed radio frequency therapy

B group

Active Comparator group

Description:

First receive sham operation treatment and then receive pulse radio frequency treatment

Treatment:

Other: sham operation

Radiation: Pulsed radio frequency therapy