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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetic Foot

Intervention / Treatment
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* Radiation: Pulsed radio frequency therapy
* Other: sham operation


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A group<br>First receive pulse radio frequency treatment and then receive sham operation treatment | Radiation: Pulsed radio frequency therapy<br>* Pulse Radio Frequency mode is a high voltage and low temperature Radio Frequency mode formed by discontinuous and pulsed current around nerve tissue<br>Other: sham operation<br>* The means to achieve double-blind treatment had no practical effect on the subjects<br>|
| Active Comparator: B group<br>First receive sham operation treatment and then receive pulse radio frequency treatment | Radiation: Pulsed radio frequency therapy<br>* Pulse Radio Frequency mode is a high voltage and low temperature Radio Frequency mode formed by discontinuous and pulsed current around nerve tissue<br>Other: sham operation<br>* The means to achieve double-blind treatment had no practical effect on the subjects<br>|

What is the study measuring?
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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 |