Diabetes foot with moderate to severe pain in peripheral nerve of affected limb
Conditions
Interventions
A group:Pulsed radiofrequency therapy, after two months of follow-up, they underwent sham surgery
B group:Sham surgery, after two months of follow-up, they underwent pulsed radiofrequency therapy
Sponsors
Xinhua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily participated in the study and signed the informed consent form; 2. The age is between 18 (inclusive) and 85 (inclusive), regardless of gender; 3. Body mass index (BMI) = 45; 4. 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 a- Lipoic acid, sodium valproate, carbamazepine, gabapentin, etc.) symptoms still exist at least 6 months later; 5. Glycated hemoglobin<8%; 6. Not participating in the drug/medical device test within 3 months before the test;
Exclusion criteria
Exclusion criteria: 1. Patients with poor general conditions who cannot objectively describe symptoms or cooperate in completing the questionnaire score; 2. The skin of the affected limb has ulcerative redness or active inflammatory infection; 3. The affected limb has lesions such as blackening and gangrene of the toe skin; 4. Those suffering from severe respiratory and cardiovascular diseases, liver and kidney insufficiency, and malignant tumors; 5. Breast-feeding and pregnant women, or subjects with pregnancy plan within 1 month after the trial (also including male subjects); 6. The daily dose of opioids is more than 120mg; 7. People with allergic diseases and allergic constitution; 8. Have a history of drug abuse or drug addiction; 9. There are contraindications to pulsed radio frequency therapy;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numerical scoring;Blood flow doppler; | — |
Secondary
| Measure | Time frame |
|---|---|
| European Quality of Life Scale;Skin temperature measurement;Toe oxygen saturation measurement;Anxiety and depression score; | — |
Countries
China
Contacts
Public ContactKe Ma
Xinhua Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed