Diabetic peripheral neuropathy
Conditions
Interventions
Experimental group:High-frequency spinal cord electrical stimulation, 10kHz
Control group:Conventional spinal cord electrical stimulation, 50-100Hz
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18 to 80 years old, gender not limited; (2) Diagnosed as diabetic peripheral neuropathy; (3) After consultation and evaluation by the endocrinology department, neurosurgery department and pain department, the DPN was >= phase II. Meet the surgical conditions; (4) Transcutaneous partial pressure of oxygen (TcPO2) >10 mmHg (1 mmHg=0.133 kPa) And =4 points or long-term stable use of painkillers And the history of pain is more than 3 months (6) Other invasive treatments cannot be performed, or TcPO2 remains <30 mmHg after treatment Or patients with insignificant relief of pain; (7) Hemoglobin (HbA1c)<=8%, and blood glucose has been well controlled recently.
Exclusion criteria
Exclusion criteria: (1) Suffering from neuropathy caused by other reasons, such as: autoimmune neuropathy Vasculitis neuropathy, infectious neuropathy, metabolic neuropathy, etc. (2) There are other diseases that have not been well controlled, including epilepsy and coagulation function Dysfunction, hemorrhagic diseases, platelet dysfunction, low platelet count, severe heart disease It is caused by lung diseases, hypertension, progressive peripheral vascular diseases or uncontrolled diabetes Its function has been severely weakened; (3) Failure to complete the follow-up as required by the trial or poor compliance; (4) Patients with underlying diseases and an expected survival period of no more than one year; (5) Patients who use painkillers irregularly (6) Coexisting with progressive neurological diseases, such as multiple sclerosis or chronic Inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord swelling Tumor, central neurotransmission disorder syndrome, complex regional pain syndrome, acute vertebral Intervertebral disc protrusion, severe spinal canal stenosis; (7) There is local infection at the surgical site or active systemic infection; (8) There are metastatic malignant tumors or untreated local malignant tumors; (9) Obvious spinal canal stenosis, objective evidence of epidural scar formation, and / Or any signs or symptoms of spinal cord disease are based on an MRI conducted within the past 12 months Examination: Posterior surgical history (laminectomy, posterior fusion), resulting in epidural space Damaged; (10) Patients with severe ischemic or mixed diabetic foot with TcPO2<10 mmHg; (11) Pregnant or lactating women (12) Those that other researchers consider unsuitable for inclusion in this trial, or those that the researchers consider For any situation that may increase the risk to the subjects or interfere with the clinical trial 3.4.3 Exclusion Remove, shed or terminate the standard
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spinal cord nerve electrophysiological signals;MDNS;Nerve Conduction Velocity;VAS ; | — |
Secondary
| Measure | Time frame |
|---|---|
| EuroQol5 ;PSQI ;ABI;Skin Temperature; | — |
Countries
China
Contacts
Public ContactZhu Lingyan
The First Affiliated Hospital of Nanchang University, Donghu District, Nanchang City, Jiangxi Province
Outcome results
None listed