NCT06158529

High-frequency SCS Versus SCS in the Treatment of Diabetic Peripheral Neuropathic Pain

A Multicentre Clinical Study of High-frequency Electrical Spinal Cord Stimulation Versus Electrical Spinal Cord Stimulation in the Treatment of Diabetic Peripheral Neuropathic Pain

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (estimated)
• Sponsor: Fan BiFa · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Application of High-Frequency Spinal Cord Stimulation (HF-SCS) in the Treatment of Painful Diabetic Peripheral Neuropathy (PDPN): A multicenter, randomized controlled study comparing its clinical efficacy with traditional spinal cord stimulation for PDPN. The study aims to observe the impact of HF-SCS on the neurological function and microcirculation of PDPN patients, elucidating the correlation between the underlying diabetes and the efficacy of HF-SCS therapy on PDPN. The goal is to enhance the treatment standards for PDPN, improve the quality of life for this population, and overall treatment outcomes. Simultaneously, the study aims to contribute evidence-based medicine for the mechanistic exploration of PDPN.

Detailed description

The incidence rate of diabetes peripheral neuropathic pain (DPNP) is high, and there is no clear and effective treatment, which is a clinical problem to be solved urgently. Traditional spinal cord electrical stimulation (SCS) has the potential to treat DPNP, and its efficacy depends on the tingling sensation generated by the electrical stimulation covering the painful area of the patient. The neurological dysfunction of DPNP patients and the defects of traditional SCS lead to unsatisfactory therapeutic effects. The emerging high-frequency SCS (HF-SCS) technology can treat chronic pain without relying on tingling sensation. Multiple evidence shows that HF-SCS has better long-term efficacy in treating chronic neuropathic pain than traditional SCS. Our research group has also preliminarily confirmed the effectiveness and safety of HF-SCS in treating DPNP. Therefore, this study intends to use a multicenter prospective randomized controlled clinical research method to explore the superiority of HF-SCS in treating DPNP compared to traditional SCS, and establish a standardized diagnosis and treatment platform database for DPNP in Beijing. This project will provide high-level evidence-based medicine for the treatment of DPNP with HF-SCS, and also provide clinical big data support for the standardized diagnosis and treatment of DPNP in the future. On the basis of medical engineering integration, an innovative remote control system is applied to achieve real-time adjustment and precise regulation of SCS treatment parameters.

Conditions

• Painful Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
DEVICE	spinal cord stimulator	A spinal cord stimulator is an implanted device that sends low levels of electricity directly into the spinal cord to relieve pain.
DEVICE	high frequency spinal cord stimulation	A spinal cord stimulator is an implanted device that sends low levels and high frequency of electricity directly into the spinal cord to relieve pain.

Timeline

• Start date: 2025-01-06
• Primary completion: 2025-10-31
• Completion: 2025-12-31
• First posted: 2023-12-06
• Last updated: 2025-02-25

Locations

1 site across 1 country: China