High-frequency spinal cord stimulation for leg pain from diabetic neuropathy and peripheral artery disease
Spinal Cord Stimulation for Patients With Painful Diabetic Neuropathy and Peripheral Arterial Disease: Mechanistic Insights From a Single-center, Randomized, Blinded, Sham-controlled Cross-over Proof-of-concept Trial
This study will test whether high-frequency spinal cord stimulation can reduce walking-related leg pain in people with painful diabetic neuropathy and peripheral arterial disease who responded to a temporary SCS trial.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 19 Years to 89 Years |
| Sex | All |
| Sponsor | University of Nebraska Academic / other |
| Locations | 1 site (Omaha, Nebraska) |
| Trial ID | NCT06480786 on ClinicalTrials.gov |
What this trial studies
Peripheral arterial disease causes exertional leg pain that limits walking and is often resistant to standard pain medicines, and many patients also have painful diabetic neuropathy. Spinal cord stimulation (SCS) is an established option for some chronic neuropathic and ischemic pains but has not been tested specifically for claudication pain from PAD using newer high-frequency waveforms. This small study will enroll up to 15 adults (ages 19–89) with PAD (ABI < 0.90 or vascular imaging), PDN, at least 3 months of exertional pain ≥6 cm on the visual analog scale, and who achieved >50% relief during an SCS trial and will receive a permanent SCS prior to study intervention. Participants will receive either active high-frequency SCS or sham stimulation and will be followed for walking-related pain and functional outcomes at the University of Nebraska Medical Center.
Who should consider this trial
Good fit: Ideal candidates are adults 19–89 with diabetes, painful diabetic neuropathy, PAD confirmed by ABI < 0.90 or vascular imaging, at least 3 months of exertional pain ≥6 cm on VAS, and who had >50% relief during an SCS trial and are eligible for a permanent SCS implant.
Not a fit: Patients with critical limb ischemia, non-healing wounds or gangrene, prior lower-extremity amputation, uncontrolled psychiatric illness, inability to hold antithrombotic therapy, or who fail an SCS trial are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce exertional leg pain and improve walking tolerance and daily function for patients with PAD plus diabetic neuropathy.
How similar studies have performed: High-frequency SCS has shown benefit for painful diabetic neuropathy in prior work and early reports suggest ischemic pain may respond, but it has not been tested specifically for PAD-related claudication in sham-controlled trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 19 years to 89 years old * Diagnosed diabetes mellitus * Signs or symptoms of neuropathy and maximum baseline visual-analog pain scale ≥ 5 cm and peripheral arterial disease (diagnosed by ankle-brachial index \< 0.90 or vascular imaging studies) with claudication and exertion-induced visual-analog pain scale ≥ 6 cm for a minimum of 3 months * Successful spinal cord stimulator (SCS) trial (\>50% relief of chronic lower extremity pain) and will have a new permanent SCS placed prior to study intervention Exclusion Criteria: * Uncontrolled psychological or psychiatric disorder * Inability to hold antithrombotic therapy per the American Society of Regional Anesthesia guidelines * Non-healing wounds * Gangrene * Critical limb ischemia * Prior lower extremity amputation * Inability to adhere to study follow-up * Mechanical spine instability based on flexion/extension radiographs of the lumbar spine * Prior or current spinal cord stimulator implant
Where this trial is running
Omaha, Nebraska
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
Study contacts
- Principal investigator: Peter Pellegrino, MD — University of Nebraska
- Study coordinator: Julia T Hoffman, MSN
- Email: outcomesresearch@unmc.edu
- Phone: 402-552-3077
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.