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Short-term SCS for Refractory Diabetic Foot Neuropathic Pain

ConditionRefractory Diabetic Foot Neuropathic Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNanchong Central Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standardized Routine Diabetic Foot Therapy

    Drug

    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

    Procedure/Surgery

    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.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: Standard Routine Therapy + 14-day Short-term Spinal Cord StimulationExperimental treatment 1 intervention
Group B: Standardized Routine Diabetic Foot TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanchong Central Hospital

Lead sponsor

Source ClinicalTrials.gov

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