Spinal Cord Stimulation and Small Fiber Peripheral Neuropathy

The Ohio State University

Status: Enrolling

Conditions: Diabetic Peripheral Neuropathy

Treatments: Device: Spinal Cord Stimulator Implantation (SCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06287736

2023H0386

Details and patient eligibility

About

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.

Full description

Peripheral neuropathy (PN) is caused by diabetes, aging, chemotherapy, and over 30 other conditions, and impacts more than 30 million patients in the US alone. Diabetes is the number one cause of peripheral neuropathy, and more than half of patients with diabetes will eventually develop diabetic peripheral neuropathy (DPN), a complex set of symptoms including pain, numbness, tingling, and burning. Spinal cord stimulation (SCS) is an approved intervention for the treatment of chronic pain, including DPN. Spinal cord stimulation has had FDA approval for the treatment of painful DPN since 2015. This study is being done to learn more about the diagnosis of DPN and treatment of DPN with SCS.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Conventional Medical Management (CMM). Group1

No Intervention group

Spinal Cord Stimulator (SCS) immediate activation. Group 2

Active Comparator group

Treatment:

Device: Spinal Cord Stimulator Implantation (SCS)

Spinal Cord Stimulator (SCS) Delayed activation. Group 3

Active Comparator group

Treatment:

Device: Spinal Cord Stimulator Implantation (SCS)