Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy

Launched by OHIO STATE UNIVERSITY · Feb 23, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how spinal cord stimulation (SCS) may help people with diabetic peripheral neuropathy (DPN), a condition that can cause painful nerve damage in the feet and legs due to diabetes. The study will enroll participants who have been struggling with pain despite trying multiple medications. They will be placed into one of three groups: two groups will receive different types of treatment involving spinal cord stimulation, while the third group will not receive the treatment and will act as a control.

To be eligible for this trial, participants must be over 18 years old and have had significant pain for at least a year that hasn't improved with standard pain medications. They should also be able to understand the study and give their consent to participate. Throughout the trial, participants will be monitored to see how their pain levels, nerve activity, and overall health change before and after the spinal cord stimulation treatment. This research could provide valuable insights into new ways to manage pain for those with diabetic neuropathy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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