Diabetic peripheral neuropathy
Conditions
Interventions
Tibial Nerve Pulse Radiofrequency Group:None
Sponsors
Shanghai Tenth People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. According to the DPN inclusion criteria: (1) diagnosed with T2DM; (2) presence of common clinical symptoms such as pain, numbness, or paresthesia in the extremities; (3) a score >=5 on the Michigan Neuropathy Screening Instrument and >=6 on the Toronto Clinical Score System (TCSS); (4) electromyography demonstrating multiple peripheral neuropathies. 2. Receive standardized pharmacological treatment (pramipexole/gabapentin/duloxetine) for at least 3 months with a visual analog pain score (VAS) still >=4, or experience intolerable drug side effects (e.g., dizziness, drowsiness, nausea) requiring dose reduction or discontinuation. 3. PRF group: Patients who underwent ultrasound-guided combined stellate ganglion and tibial nerve pulsed radiofrequency ablation (bilateral, with at least one complete treatment course completed); Drug control group: Patients receiving standardized pharmacological therapy (pramipexole/gabapentin/duloxetine) during the same period and who had never undergone any form of pulsed radiofrequency or neurodestruction therapy. 4. Completeness of clinical data: Core efficacy data including pre-treatment baseline values and at least one post-treatment follow-up visit (recommended at 1, 3, and 6 months). 5. Age: not less than 18 years.
Exclusion criteria
Exclusion criteria: 1. Peripheral neuropathy caused by other etiologies: radicular neuropathy caused by cervical spondylosis, lumbar disc herniation, spinal canal stenosis, etc.; compressive peripheral neuropathy such as carpal tunnel syndrome and cubital tunnel syndrome; peripheral neuropathy caused by other factors such as alcohol, uremia, hereditary, inflammatory (e.g., Guillain-Barré syndrome), etc. 2. Local infection at the puncture site before treatment (skin breakdown, redness and swelling, purulent discharge); platelet count 1.5, or currently taking anticoagulants (aspirin, clopidogrel, warfarin, etc.) without following the operation protocol to stop the medication. 3. Complicated with lower limb arteriosclerosis obliterans (ankle-brachial index 3 times the upper limit of normal), renal dysfunction (eGFR 30%). 6. Mental or cognitive impairment: severe mental illness (schizophrenia, bipolar disorder, etc.), cognitive dysfunction (MMSE <24 points) leading to inability to cooperate with assessment or follow-up. 7. Pregnancy or breastfeeding: pregnant, breastfeeding, or planning recent conception. 8. Participation in other interventional clinical trials during the treatment period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analogue scale,VAS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event incidence;Relief level of leg pain/numbness/coldness; | — |
Countries
China
Contacts
Public ContactWeisheng Xu
Shanghai Tenth People’s Hospital
Outcome results
None listed