High-frequency spinal cord stimulation for leg pain from diabetic neuropathy and peripheral artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.