SCS for Patient With Painful Diabetic Neuropathy and Peripheral Arterial Disease

Launched by UNIVERSITY OF NEBRASKA · Jun 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a permanent spinal cord stimulator (SCS) to help relieve pain in patients who have both painful diabetic neuropathy (nerve pain caused by diabetes) and peripheral arterial disease (poor circulation in the legs). The trial aims to see how effective this treatment is for individuals aged 19 to 89 who experience significant pain in their legs while walking and have been diagnosed with these conditions. To be eligible, participants must have a pain level of at least 5 on a scale of 0 to 10 and must have been experiencing pain for at least three months. They also need to be good candidates for the SCS procedure.

Participants in this study will first have the spinal cord stimulator placed and then will be followed up for about four weeks. During this time, they will experience two weeks of actual stimulation and two weeks of a sham (fake) treatment, which helps researchers understand how effective the SCS is compared to not using it. Throughout the study, participants will have their pain, ability to function, and overall quality of life assessed. After the study period, they will return to standard care for their spinal cord stimulator. This trial is currently recruiting participants, and it aims to provide valuable insights into managing chronic pain related to these two conditions.

Gender

ALL

Eligibility 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