Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy: A Randomized Clinical Trial.
Erika A Petersen, Thomas G Stauss, James A Scowcroft...
https://pubmed.ncbi.nlm.nih.gov/33818600Actively Recruiting
Phase Not Applicable
Age: 19Years - 89Years
All Genders
ID06480786
Spinal Cord Stimulation for Patients With Painful Diabetic Neuropathy and Peripheral Arterial Disease: A Randomized, Blinded, Sham-controlled Cross-over Proof-of-concept Trial
Led by University of Nebraska · Updated on 2025-10-22
15
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
U
University of Nebraska
Lead Sponsor
N
Nevro Corp
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
SCS for Patient With Painful Diabetic Neuropathy and Peripheral Arterial Disease
Who Can Participate
Age: 19Years - 89Years
All Genders
Eligibility Criteria
You may qualify if you...
- 19 years to 89 years old
- Diagnosed with diabetes mellitus
- Signs or symptoms of neuropathy with a baseline pain score of at least 5 cm on a visual-analog scale
- Peripheral arterial disease diagnosed by ankle-brachial index below 0.90 or vascular imaging with claudication and exertion-induced pain of at least 6 cm for at least 3 months
- Successful spinal cord stimulator trial with more than 50% relief of chronic lower extremity pain
- Planned placement of a new permanent spinal cord stimulator prior to study intervention
You will not qualify if you...
- Uncontrolled psychological or psychiatric disorder
- Inability to hold antithrombotic therapy as recommended by guidelines
- Presence of non-healing wounds
- Presence of gangrene
- Critical limb ischemia
- Prior lower extremity amputation
- Inability to adhere to study follow-up requirements
- Mechanical spine instability based on spine radiographs
- Prior or current spinal cord stimulator implant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - 12 weeks
Participants undergo permanent spinal cord stimulator implantation and optimization as part of the study intervention.
1 baseline visit and 1 follow-up visit
Treatment
Duration - 4 weeks
Participants receive active or sham spinal cord stimulation in a randomized, blinded, crossover design to assess pain relief and other outcomes.
2 treatment periods of 2 weeks each
Follow-up
Duration - Ongoing after treatment
After the treatment periods, participants return to standard spinal cord stimulator care and are observed for ongoing outcomes.
Visits as part of routine care
Trial Site Locations
Total: 1 location
1
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
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Research Team
J
Julia T Hoffman, MSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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