Health Trials

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

ConditionPainful Diabetic Peripheral Neuropathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFan BiFa

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with diabetes, aged between 18 and 80 years old;

Symmetrical pain in the distal lower extremities with or without dysesthesia;

Duration of symptoms exceeding 6 months;

Pain described as stabbing and/or electric shock-like and/or burning sensation;

Disqualifiers

Concurrent severe cardiovascular and cerebrovascular diseases;

History of lumbar spine surgery, trauma, or spinal canal stenosis within the past 6 months, or a history of lumbar spine surgery, trauma, or spinal canal stenosis that would impact the SCS surgery and pain assessment in this study;

Presence of radicular symptoms;

Other spinal abnormalities, such as benign or malignant tumors, congenital abnormalities of the spine, spinal instability, etc.;

Trial design

Design model

Parallel

Treatments tested in this trial

  • spinal cord stimulator

    Device

    A spinal cord stimulator is an implanted device that sends low levels of electricity directly into the spinal cord to relieve pain.

  • high frequency spinal cord stimulation

    Device

    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.

Treatment groups

1 Participants
are divided into 2 treatment groups
Group A: spinal cord stimulationActive comparator 1 intervention
Group B: high frequency spinal cord stimulationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

treatment effectiveness

The treatment effectiveness is assessed based on the reduction of Numeric Rating Scale (NRS) scores for pain three months after treatment compared to before treatment. Specifically, a decrease of ≥50% in the pain NRS score \[(NRS score at 3 months post-treatment - NRS score before treatment) / NRS score before treatment\] ≥ 50% is considered the criterion for treatment effectiveness

Time frame
3months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fan BiFa

Lead sponsor

China-Japan Friendship Hospital

Sponsor institution

Peking University Third Hospital

Collaborator

Xuanwu Hospital, Beijing

Collaborator

Civil Aviation General Hospital

Collaborator

Shenzhen Sixth People's Hospital

Collaborator

Beijing Tiantan Hospital

Collaborator

Source ClinicalTrials.gov
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