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

Condition(s) studied

Study summary

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.

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.

Eligibility

Primary outcome measure(s)

• Change in Toronto Clinical Scoring System (TCSS) total score from baseline to 3 months after surgery — 3 months after surgery
  Change in total score of the Toronto Clinical Scoring System (TCSS) measured at 3 months after surgery relative to baseline. Full scale name: Toronto Clinical Scoring System Scale range: Minimum score = 0, Maximum score = 19 Interpretation: Higher total score indicates more severe diabetic peripheral neuropathy. Lower total score indicates less severe neuropathy.

Trial sites (4)

More Qilu Hospital of Shandong University trials in China

Other trials for the same condition