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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
88
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.
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.
Numerical Rating Scale (NRS) score
The primary outcome was pain intensity measured by the NRS(0-10) recorded at baseline, immediately after stimulation termination (study group)/at the corresponding time point after treatment (control group), and at 1, 3, and 6 months post-treatment. The proportions of patients with an NRS reduction of ≥30% and ≥50% from baseline were also recorded, with the latter defined as treatment response. NRS ranges from 0 (no pain) to 10 (worst possible pain). Higher scores indicate worse pain.
Time frame: Six months
Change in Sleep Quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
The PSQI total score ranges from 0 to 21. Higher scores indicate worse sleep quality
Time frame: Six months
Change in Physical Health assessed by the 36-Item Short Form Health Survey Physical Component Summary (SF-36 PCS)
The SF-36 PCS score ranges from 0 to 100. Higher scores indicate better physical health
Time frame: Six months
Change in Mental Health assessed by the 36-Item Short Form Health Survey Mental Component Summary (SF-36 MCS)
The SF-36 MCS score ranges from 0 to 100. Higher scores indicate better mental health
Time frame: Six months
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