Short-term SCS for Refractory Diabetic Foot Neuropathic Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standardized Routine Diabetic Foot Therapy, Standard Routine Therapy + 14-day Short-term Spinal Cord Stimulation.
- Who it may be relevant to
- Registry conditions: Refractory Diabetic Foot Neuropathic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Drug 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 exerc - Procedure 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.
Primary outcome measures
- Numerical Rating Scale (NRS) score [Time frame: Six months]
Secondary outcome measures (3)
- Change in Sleep Quality assessed by the Pittsburgh Sleep Quality Index (PSQI) [Time frame: Six months]
- Change in Physical Health assessed by the 36-Item Short Form Health Survey Physical Component Summary (SF-36 PCS) [Time frame: Six months]
- Change in Mental Health assessed by the 36-Item Short Form Health Survey Mental Component Summary (SF-36 MCS) [Time frame: Six months]
Eligibility criteria
Inclusion criteria
- Age ≥18 years;
- Confirmed type 2 diabetes mellitus, Wagner grade 1-3 diabetic foot;
- 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;
- Contraindications to lower extremity revascularization surgery, persistent pain after revascularization, or voluntary refusal of vascular surgery;
- Clear consciousness, capable of completing scale assessments and multi-timepoint follow-up;
- Voluntary participation with signed written informed consent.
Exclusion criteria
- Spinal deformity, spinal infection, intraspinal tumor or history of spinal surgery, precluding epidural electrode implantation;
- Severe coagulation disorders, systemic infection or uncontrolled severe active foot infection;
- Severe dysfunction of heart, liver, kidney or respiratory system, unable to tolerate minimally invasive operation;
- Previous spinal cord stimulation or peripheral nerve destructive surgery;
- Psychiatric disorders interfering with assessment and follow-up cooperation;
- Pregnant or lactating women;
- Concurrent enrollment in other clinical trials targeting diabetic foot or chronic pain interventions.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07740707 · 2026010