A Sympathetic Ganglion, High-voltage Pulsed Radiofrequency Ablation of Peripheral Neuralgia
Diabetic Foot
About this trial
This is an interventional treatment trial for Diabetic Foot
Eligibility Criteria
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;
Sites / Locations
- Shanghai XINHUA Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
A group
B group
First receive pulse radio frequency treatment and then receive sham operation treatment
First receive sham operation treatment and then receive pulse radio frequency treatment