Refractory Diabetic Foot Neuropathic Pain
Conditions
Brief 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.
Interventions
DRUGStandardized 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.
PROCEDUREStandard 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.
Sponsors
Nanchong Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years; 2. Confirmed type 2 diabetes mellitus, Wagner grade 1-3 diabetic foot; 3. Persistent moderate-to-severe neuropathic pain (Numeric Rating Scale, NRS ≥4) after ≥3 months of standardized conservative treatment including glycemic control, neurotrophic drugs, multi-modal analgesia and wound care; 4. Contraindications to lower extremity revascularization surgery, persistent pain after revascularization, or voluntary refusal of vascular surgery; 5. Clear consciousness, capable of completing scale assessments and multi-timepoint follow-up; 6. Voluntary participation with signed written informed consent.
Exclusion criteria
1. Spinal deformity, spinal infection, intraspinal tumor or history of spinal surgery, precluding epidural electrode implantation; 2. Severe coagulation disorders, systemic infection or uncontrolled severe active foot infection; 3. Severe dysfunction of heart, liver, kidney or respiratory system, unable to tolerate minimally invasive operation; 4. Previous spinal cord stimulation or peripheral nerve destructive surgery; 5. Psychiatric disorders interfering with assessment and follow-up cooperation; 6. Pregnant or lactating women; 7. Concurrent enrollment in other clinical trials targeting diabetic foot or chronic pain interventions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale (NRS) score | Six months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sleep Quality assessed by the Pittsburgh Sleep Quality Index (PSQI) | Six months | The PSQI total score ranges from 0 to 21. Higher scores indicate worse sleep quality |
| Change in Physical Health assessed by the 36-Item Short Form Health Survey Physical Component Summary (SF-36 PCS) | Six months | The SF-36 PCS score ranges from 0 to 100. Higher scores indicate better physical health |
| Change in Mental Health assessed by the 36-Item Short Form Health Survey Mental Component Summary (SF-36 MCS) | Six months | The SF-36 MCS score ranges from 0 to 100. Higher scores indicate better mental health |
Contacts
CONTACTZhenguo Gao
Outcome results
None listed