Spinal Cord Stimulation to Treat Painful Diabetic Neuropathy and Peripheral Arterial Disease A Randomized, Blinded, Sham-Controlled Cross-Over Study Examining Effects on Pain and Blood Flow

What this Trial Is About

Peripheral arterial disease PAD affects over 230 million adults worldwide and causes serious disability and high medical costs. The main symptom driving disability is ischemic leg pain, which results from poor oxygen supply, nerve problems, and muscle damage. This pain limits exercise, a key treatment for PAD. Spinal cord stimulation SCS is a known therapy for difficult-to-treat pain like painful diabetic neuropathy PDN and ischemic pain, but it is not yet standard care for PAD. Newer high-frequency SCS has shown promise for pain relief but has not been tested for PAD-related leg pain before. This study will include up to 15 adults aged 19 to 89 with PAD and PDN who have a permanent spinal cord stimulator implanted. After 12 weeks of implantation and optimizing the device, participants will undergo two weeks of active high-frequency SCS and two weeks of sham stimulation without pain relief, in random order. Blood flow, blood pressure, skin oxygen, and pain levels in the legs will be measured before implantation, after 12 weeks, and during each treatment period. Quality of life surveys will also be completed during these times. Participants will start with an evaluation visit, followed by the 12-week post-implantation check. Then, they will be randomly assigned to receive either active or sham stimulation for two weeks, switching treatments after that period. After the 4-week intervention, participants will return to usual SCS care. Researchers will compare pain, blood flow, autonomic control, and quality of life data from before and after treatment to understand the effects of high-frequency SCS on PAD and PDN symptoms.

SCS for Patient With Painful Diabetic Neuropathy and Peripheral Arterial Disease