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Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy

Key facts

Who runs it
Qilu Hospital of Shandong University
Where
China4 sites in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
100 people, planned
Started
15 Oct 2026
Expected to end
31 May 2027
Type of study
Observational, 2 groups
Record updated
2 November 2026

Who can take part

Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 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
  • Patients with a confirmed diagnosis of diabetic peripheral neuropathy with pain as the predominant symptom
  • Patients receiving lower extremity peripheral nerve decompression combined with PNS lead implantation for the first time
  • Patients with complete electronic medical record data

Who cannot take part

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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Diabetic peripheral neuropathy (DPN) is one of the most common chronic complications of diabetes mellitus and a major cause of lower extremity pain, numbness, sensory loss, balance disturbance, diabetic foot ulcer and amputation. Painful diabetic peripheral neuropathy (PDPN) is characterized by burning, stabbing or electric-shock pain, accompanied by numbness, paresthesia and sleep disturbance. Current treatments including glycemic control, neurotrophic agents and analgesics such as pregabalin and duloxetine only provide limited pain relief with adverse effects, and cannot effectively improve numbness or restore nerve function.

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Secondary peripheral nerve entrapment induced by nerve edema contributes to the progression of DPN. Peripheral nerve decompression can relieve nerve compression, improve nerve blood supply and alleviate pain and numbness, and reduce the risk of foot ulcer and amputation. However, numbness may not be fully relieved in some patients after decompression alone, due to chronic nerve injury. Peripheral nerve stimulation (PNS), a targeted neuromodulation technique, can modulate abnormal nerve discharge and reduce peripheral sensitization, which may further improve pain and sensory abnormalities. To date, there are limited studies evaluating combined peripheral nerve decompression plus PNS for PDPN.

This study aims to evaluate the safety and efficacy of combined peripheral nerve decompression and peripheral nerve stimulation compared with peripheral nerve decompression alone in patients with painful diabetic peripheral neuropathy. The primary objective is to explore whether the combined therapy yields superior pain relief and recovery of nerve function, to provide new clinical evidence for individualized treatment of PDPN.

The 2 groups in the trial

  • Patients with painful DPN receiving peripheral nerve decompression plus peripheral nerve stimulation

    From January 1, 2025 to May 31, 2026, patients with painful diabetic peripheral neuropathy who underwent peripheral nerve decompression combined with peripheral nerve electrical stimulation in the neurosurgery departments of four hospitals: Qilu Hospital of Shandong University, Tangdu Hospital of the Air Force Medical University, Army Specialized Medical Center of the Army Medical University (Daping Hospital), and the First People's Hospital of Hangzhou Affiliated to Westlake University

  • Patients with painful DPN receiving peripheral nerve decompression

    From January 1, 2025 to May 31, 2026, patients with painful diabetic peripheral neuropathy who underwent peripheral nerve decompression in the neurosurgery departments of four hospitals: Qilu Hospital of Shandong University, Tangdu Hospital of the Air Force Medical University, Army Specialized Medical Center of the Army Medical University (Daping Hospital), and the First People's Hospital of Hangzhou Affiliated to Westlake University

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Study on the Safety and Therapeutic Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for the Treatment of Painful Diabetic Peripheral Neuropathy
Record updated
2 November 2026