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

NCT06158529 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-02-25

No results posted yet for this study

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.

Conditions

  • Painful Diabetic Peripheral Neuropathy

Interventions

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.

Sponsors & Collaborators

  • Peking University Third Hospital

    collaborator OTHER

  • Xuanwu Hospital, Beijing

    collaborator OTHER

  • Civil Aviation General Hospital

    collaborator OTHER

  • Shenzhen Sixth People's Hospital

    collaborator OTHER

  • Beijing Tiantan Hospital

    collaborator OTHER

  • Fan BiFa

    lead OTHER

Principal Investigators

  • BiFa Fan, master · China-Japan Friendship Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-06
Primary Completion
2025-10-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06158529 on ClinicalTrials.gov