Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy

Recruiting now · Not applicable

Conditions studied: Diabetic Peripheral Neuropathy

In brief

This is a prospective randomized control trial. Participants enrolled into the study will be randomized into one of three groups, two of which are treatment groups and the third is a control group. A time course of measurements before and after spinal cord stimulation (SCS) treatment (where applicable) will assess pain, DPN severity, small fiber nerve activity, and metabolic health markers.

Key facts

Study ID

NCT06287736

Run by

Ohio State University

People needed

60

Starts

2024-04-17

Expected to finish

2028-07-03

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Over 18 years old
• Diagnosis of diabetic peripheral neuropathy refractory to treatment with gabapentin or pregabalin and at least 1 other class of analgesic
• Diagnosis of medically refractory pain secondary to diabetic neuropathy
• Presence of pain for 12 months
• Lower limb pain intensity score ≥4 on a visual analog scale
• DN4 ≥4
• Pass pre-operative neuropsychological assessment (surgical group only)
• Capable of providing informed consent

You may not qualify if…

• Severe medical comorbidities that, in the opinion of the surgeon, exclude the patient from surgical intervention
• Spinal disease with severe spinal stenosis or spinal cord compression in the region of the proposed spinal cord stimulator lead placement
• Coagulopathy that cannot be corrected
• Unable to discontinue blood thinning medications
• Hemoglobin A1c level greater than 10
• Presence of systemic infection
• Pregnancy

Where it is running

• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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