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Short-term SCS for Refractory Diabetic Foot Neuropathic Pain
Sponsor: Nanchong Central Hospital
Summary
This single-center, assessor-blinded randomized controlled trial enrolls 88 patients with drug-refractory diabetic foot neuropathic pain unsuitable for revascularization surgery. Participants are randomized 1:1 to receive standard diabetic foot care alone (control) or standard care plus 14-day short-term spinal cord stimulation (intervention). The primary outcome is pain remission rate at 6 months, with repeated assessments of microcirculation, nerve function, quality of life and adverse events over 6 months. This study evaluates the efficacy and safety of short-term spinal cord stimulation and develops standardized clinical protocols for this minimally invasive therapy.
Official title: A Prospective Randomized Controlled Study on 14-day Short-term Spinal Cord Stimulation Minimally Invasive Intervention for Patients With Refractory Diabetic Foot Neuropathic Pain
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
88
Start Date
2026-08-01
Completion Date
2027-03-01
Last Updated
2026-08-03
Healthy Volunteers
No
Interventions
Standardized Routine Diabetic Foot Therapy
No spinal cord stimulation intervention; unified comprehensive clinical management throughout follow-up: 1. Precise glycemic control: Adjustment of oral hypoglycemic agents or insulin, regular HbA1c monitoring; 2. Basic medication: Neurotrophic agents, lower limb microcirculation improvers, stepwise multi-modal analgesics; 3. Standardized wound care: Debridement, dressing change and foot decompression; 4. Health education: Diabetic diet guidance, foot self-care training and individualized exercise advice; 5. Unified follow-up visits at 14 days, 1 month, 3 months and 6 months for indicator detection and adverse event documentation.
Standard Routine Therapy + 14-day Short-term Spinal Cord Stimulation
All routine management identical to the control group, with additional 14-day reversible epidural SCS intervention: 1. Epidural electrode implantation targeting T10-T12 spinal segments under local anesthesia; 2. Standardized stimulation parameters set in accordance with domestic clinical guidelines for spinal cord stimulation; electrodes retained for 14 days and removed after the intervention period; 3. Identical follow-up schedule and assessment indicators as the control group.