Spinal Cord Stimulation for Diabetic Neuropathy

Recruiting in Palo Alto (17 mi)

Overseen byPeter Pellegrino, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Nebraska

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Peter Pellegrino, MD

Principal Investigator

University of Nebraska

Eligibility Criteria

This trial is for adults aged 19-90 with Type 2 Diabetes who suffer from painful diabetic neuropathy and peripheral arterial disease. They must have significant pain from neuropathy and walking, confirmed PAD via tests, a low quality of life score related to vascular issues, and be suitable candidates for spinal cord stimulation therapy.

Inclusion Criteria

I am between 19 and 89 years old and have diabetes.

I am a suitable candidate for a spinal cord stimulator implant.

I experience nerve pain with a severity of at least 5 out of 10.

See 1 more

Exclusion Criteria

My spine is unstable, as shown by specific spine X-rays.

I have wounds that are not healing.

My walking is impaired for reasons not related to peripheral artery disease.

See 8 more

Treatment Details

Interventions

Sham stimulation (Device)
Spinal cord stimulation (Device)

Trial OverviewThe study compares the effects of actual spinal cord stimulation (SCS) versus sham (fake) stimulation in managing pain due to diabetic neuropathy and poor blood flow in limbs. Participants will undergo SCS placement, followed by two weeks each of real and sham stimulations in random order over four weeks.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Spinal Cord StimulationExperimental Treatment1 Intervention

Therapeutic spinal cord stimulation titrated at 12 weeks post operative at standard clinical practice.

Group II: Sham StimulationPlacebo Group1 Intervention

Sub-threshold low frequency spinal cord stimulation to provide no analgesic benefit but serve as a sham control.