A Prospective Randomized Controlled Study on 14-day Short-term Spinal Cord Stimulation Minimally Invasive Intervention for Patients With Refractory Diabetic Foot Neuropathic Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 88
- Primary Endpoint
- Numerical Rating Scale (NRS) score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Numerical Rating Scale (NRS) score
Time Frame: 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 Outcomes
- Change in Sleep Quality assessed by the Pittsburgh Sleep Quality Index (PSQI)(Six months)
- Change in Physical Health assessed by the 36-Item Short Form Health Survey Physical Component Summary (SF-36 PCS)(Six months)
- Change in Mental Health assessed by the 36-Item Short Form Health Survey Mental Component Summary (SF-36 MCS)(Six months)