Peripheral nerve decompression plus nerve stimulation for painful diabetic neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational analysis gathers patients with diabetic peripheral neuropathy who underwent lower-extremity peripheral nerve decompression combined with peripheral nerve stimulation. It involves multi-center data from four Chinese hospitals collected between January 2025 and May 2026. The aim is to document safety and potential pain relief, as well as the impact on numbness and function, in a real-world setting. The study builds on the idea that nerve compression contributes to symptoms and explores whether a combined surgical and neuromodulation approach offers benefits beyond standard pharmacologic therapy. No interventional randomization is described in this observational design.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients diagnosed with DPN who underwent lower extremity peripheral nerve decompression combined with PNS lead implantation in the Department of Neurosurgery of four hospitals (Qilu Hospital of Shandong University, Tangdu Hospital of Air Force Military Medical University, Army Medical Center of Army Medical University (Daping Hospital), and the First People's Hospital of Hangzhou Affiliated to Westlake University) between January 1, 2025 and May 31, 2026.
2. Patients with a confirmed diagnosis of diabetic peripheral neuropathy with pain as the predominant symptom.
3. Patients receiving lower extremity peripheral nerve decompression combined with PNS lead implantation for the first time.
4. Patients with complete electronic medical record data.

Exclusion Criteria:

1. Patients who have previously undergone lower extremity peripheral nerve decompression surgery.
2. Patients with severe comorbidities, including severe cardiac disease, hepatic or renal insufficiency, and immune system deficiency.
3. Patients with substantial missing data.

Where it's running

• Qilu hospital
  Jinan, Shandong, China Recruiting
• Department of Neurosurgery, Tang-Du Hospital
  Xi’an, Shanxi, China Recruiting
• Department of Neurosurgery, Hangzhou First People's Hospital
  Hangzhou, Zhejiang, China Recruiting
• Department of Neurosurgery,Daping Hospital of Army Medical University
  Chongqing, China Recruiting

Study contacts

• Principal investigator: Ning Yang, doctor — Department of Neurosurgery, Qilu Hospital of Shandong University
• Study coordinator: Ning Yang, doctor
• Email: yangning@sdu.edu.cn
• Phone: +86 18560088290

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.