Overview
The study involves permanent spinal cord stimulator (SCS) placement in participants with peripheral arterial disease (PAD) and painful diabetic neuropathy (PDN). Participants will be between 19 and 89 years old, have diabetes with symptoms of neuropathy, and have a starting pain level of at least 5 cm on a visual pain scale. They must also have PAD, confirmed by an ankle-brachial index under 0.90 or vascular imaging, and experience pain from walking with a pain level of at least 6 cm for at least 3 months. Their Vascular Quality of Life Questionnaire score should be 5.5 or less, and they must be good candidates for SCS.
The study includes initial evaluation visits, follow up after their permanent SCS is placed and optimized 12 weeks in the clinic at this time the study interventions begin and the patient is followed for four weeks; two weeks of stimulation and two weeks of sham intervention in random order, and intervention evaluations. At each follow up visit pain, sensory, functional, vascular, and autonomic outcomes will be assessed, after which patients will return to standard SCS care. The total time for the study intervention is 4 weeks.
Description
The study will include ten total participants with peripheral arterial disease (PAD) and painful diabetic neuropathy (PDN), who meet inclusion criteria for permanent spinal cord stimulator (SCS) placement. Participants will be between 19 and 90 years old, have diabetes with symptoms of neuropathy, and have a starting pain level of at least 5 cm on a visual pain scale. They must also have PAD, confirmed by an ankle-brachial index under 0.90 or vascular imaging, and experience pain from walking with a pain level of at least 6 cm for at least 3 months. Their Vascular Quality of Life Questionnaire score should be 5.5 or less, and they must be good candidates for SCS.
The interventions will include spinal cord stimulation versus sham stimulation using a cross over design. Evaluations will include 1 week follow up clinical visit, 2 week follow up clinical visit with vascular lab TcPO2 evaluation, 12-week post permanent SCS placement with randomization to receive either active spinal cord stimulation or sham stimulation at a 2 week interval, follow up visit 2 weeks later to change therapy, and finally 2 weeks later to resume regular spinal cord stimulation. At each follow up visit pain, sensory, functional, vascular, and autonomic outcomes will be assessed. The study intervention lasts for 4 weeks, after which patients will return to standard SCS care.
Eligibility
Inclusion Criteria:
- Patients aged 19 years to 89 years with 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.
- Patients who have undergone a successful (>50% relief of chronic lower extremity pain) SCS trial, are appropriate candidates for permanent SCS and will have had 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