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

A legfontosabb adatok

Ki végzi
Qilu Hospital of Shandong University
Hol
Kína4 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toboroz
Résztvevők
100 fő, tervezett
Kezdés
2026. okt. 15.
Várható befejezés
2027. máj. 31.
A vizsgálat típusa
Megfigyeléses, 2 csoport
A regiszteradat frissítve
2026. november 2.

Ki vehet részt

Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 7 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • 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

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A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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.

A vizsgálat 2 csoportja

  • 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

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

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

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Study on the Safety and Therapeutic Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for the Treatment of Painful Diabetic Peripheral Neuropathy
A regiszteradat frissítve
2026. november 2.