Peripheral arterial disease (PAD) affects over 230 million adults worldwide and is a highly morbid, costly, and disabling condition. Ischemic leg pain drives disability in PAD patients and results from oxygen supply-demand mismatch, autonomic dysfunction, and muscle breakdown. This leg pain, which is unresponsive to traditional pharmacotherapy, limits the patient's tolerance to exercise, which is an important disease-modifying intervention. Spinal cord stimulation is a well-established therapy for medically intractable pain, including painful diabetic neuropathy (PDN) and ischemic pain, but is not part of the standard-of-care for PAD despite limited promising clinical data. Early studies used first-generation, tonic stimulation devices, but with these it was impossible to perform sham-controlled trials to test the treatment. Since then, new types of waveform treatments, including high-frequency spinal cord stimulation (SCS), have been shown to be more effective in the treatment of intractable pain. While high-frequency SCS is approved for PDN treatment, it has never been tested in the treatment of claudication pain from PAD.
This study will enroll up to 15 participants between the ages of 19 and 89 who have PAD and PDN and are successfully implanted with a permanent SCS. Twelve weeks after SCS implantation, participants will receive two weeks of stimulation and two weeks of sham intervention, in random starting order. Blood flow, blood pressure, skin oxygen levels, and participant reported pain int the lower extremities will be assessed before SCS implantation, 12 weeks after SCS implantation and during each of the treatment periods. Participants will also complete a quality of life survey at the same time points. Comparisons of these measurements with the baseline and post-implantation measurements to determine the effects of SCS.
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
Uncontrolled psychological or psychiatric disorder
Inability to hold antithrombotic therapy per the American Society of Regional Anesthesia guidelines
Non-healing wounds
Gangrene
Crossover
Spinal cord stimulation
Deviceactive spinal cord stimulation
Sham stimulation
DeviceSham stimulation
High-frequency Spinal Cord Stimulation Effect on Analgesia
The visual analogue scale (VAS) will be used by participants to report lower extremity pain during interventions. The VAS score is a10-cm line that represents a continuum between "no pain" and "worst pain."
High-frequency Spinal Cord Stimulation Effect on Quality of Life
Quality of life changes from high-frequency high-frequency spinal cord stimulation (SCS) will be measured by the Vascular Quality of Life Questionnaire (VASCUQOL). This instrument has 25 questions covering pain, symptoms, activities, social, and emotional. Each question has seven responses from 1 (worst) to 7 (best).
High-frequency Spinal Cord Stimulation Effect on Blood Flow
Changes in blood flow from high-frequency spinal cord stimulation (SCS) will measure lower extremity capillary digit blood flow flow by laser speckle imaging.
High-frequency Spinal Cord Stimulation Effect on Autonomic Control
Changes in autonomic control from high-frequency spinal cord stimulation (SCS) will measure sympathetic vasomotion by volume-clamp method on digits of the hand and laser speckle imaging on the lower extremities.
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University of Nebraska
Lead sponsor
Nevro Corp
Collaborator
