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

Study Overview
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Brief Summary
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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.

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

Conditions
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Painful Diabetic Peripheral Neuropathy

Intervention / Treatment
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* Device: spinal cord stimulator
* Device: high frequency spinal cord stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Abnormal Quantitative Sensory Testing (QST); Presence of hyperalgesia and allodynia; Absence of lower limb reflexes and muscle strength abnormalities; Normal MRI or CT scans without spinal canal stenosis or other spinal abnormalities. Exclusion Criteria: 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.; Coexisting disorders of the coagulation system, malignant tumors, infections, and psychiatric or psychological disorders; Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: spinal cord stimulation<br> | Device: spinal cord stimulator<br>* A spinal cord stimulator is an implanted device that sends low levels of electricity directly into the spinal cord to relieve pain.<br>|
| Experimental: high frequency spinal cord stimulation<br> | Device: high frequency spinal cord stimulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord stimulation