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Clinical study of tibial nerve pulse radiofrequency in the treatment of diabetic peripheral neuropathy

Clinical study of tibial nerve pulse radiofrequency in the treatment of diabetic peripheral neuropathy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045917
Enrollment
Unknown
Registered
2021-04-28
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic peripheral neuropathy

Interventions

single arm:tibial nerve pulse radiofrequency

Sponsors

Tenth People's Hospital of Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 35 to 75 years, regardless of gender; 2. Patients meet the diagnostic criteria for type 2 diabetes (2014 American Diabetes Guidelines: Diabetes Diagnosis and Treatment Standards); 3. Neuropathy that occurs during or after the diagnosis of diabetes; if there are clinical symptoms (pain, numbness, paresthesia, etc.), or any one of the 5 tests (ankle reflex, acupuncture pain, vibration, pressure, temperature) is abnormal; if there are no clinical symptoms, any 2 of the 5 examinations are abnormal, and the clinical diagnosis is DPN patient; 4. DPN patients with numbness and pain in the feet and positive Tinel sign of the tibial nerve; 5. Traditional medications for diabetic peripheral neuropathy have unsatisfactory symptom relief for more than 3 months; 6. Patients voluntarily sign the informed consent and can follow up on schedule.

Exclusion criteria

Exclusion criteria: 1. Patients with type 2 diabetes with cervical and lumbar diseases that can cause compressive neuropathy; 2. Patients with type 2 diabetes who have foot ulcers or gangrene that affect nerve conduction and ultrasound examination; 3. Patients with a history of fractures or surgery in the legs, ankles, and feet; 4. Patients is concomitant with other metabolic complications of diabetes, such as diabetic ketoacidosis, hyperosmolar hyperglycemia syndrome, or hyperosmolar coma; 5. Patients who have received nerve pulsed radiofrequency therapy or other clinical trials within the last 3 months; 6. Suffer from serious, progressive, uncontrolled diseases of important organs and systems, autoimmune diseases, malignant tumors, etc., as well as other diseases that the researcher considers not suitable for participating in this study.

Design outcomes

Primary

MeasureTime frame
Foot sensation;Visual analogue scale;Two-point sense of discrimination;Tibial nerve conduction velocity;

Secondary

MeasureTime frame
ID Pain questionaire;Michigan Neuropathy Screening Instrument questionaire;Toronto Clinical Neuropathy Score;

Countries

China

Contacts

Public ContactLin Fuqing

Tenth People's Hospital of Tongji University

Paincenter10@163.com+86 18917684132

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026