Status:
COMPLETED
Quantitative Assessment of Painful Diabetic Peripheral Neuropathy After High Frequency Spinal Cord Stimulation
Lead Sponsor:
Mayo Clinic
Conditions:
Painful Diabetic Neuropathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Will participants with painful lower extremity diabetic peripheral neuropathy (DPN) that are treated with high frequency spinal cord stimulation (HF10 SCS) have improvements in lower extremity periphe...
Detailed Description
This research study is being conducted to find out if spinal cord stimulation (SCS) can improve nerve function. SCS is FDA approved for the treatment of intractable neuropathic (nerve) pain related to...
Eligibility Criteria
Inclusion
- Type 2 diabetes mellitus
- Refractory predominantly lower extremity neuropathic pain for \> 1 year
- Presence of length dependent peripheral neuropathy on sudomotor testing
- Completed spinal cord stimulation trial with 40% or greater pain reduction from baseline
- Failed medication trials or contraindication to gabapentin medications (gabapentin, pregabalin) and/or serotonin/norepinephrine reuptake inhibitors (tricyclic antidepressant (TCA) or duloxetine or venlafaxine)
- Average pain score on a visual analog scale (VAS) of ≥ 5 (with 0 representing no pain and 10 the worst pain imaginable)
- Appropriate surgical candidate for spinal cord stimulator
Exclusion
- Severe Autonomic Neuropathy as measured by the composite autonomic scoring scale (10 point scale) with a score ≥ 7
- History of sympathectomy
- Uncontrolled arterial hypertension (Systolic Blood Pressure \>160)
- Baseline Foot TcPO2 \< 10 mmHg to exclude patients with severe peripheral arterial disease
- Hemoglobin A1c \> 8%
- Stable opioid regimen with oral morphine equivalent ≥ 100 mg/day
- Alternative principle cause for peripheral neuropathy or lower extremity neuropathic pain
- Disruptive psychiatric disorder (screened for during preoperative psychiatric evaluation)
- Pending litigations
- Women of child bearing potential unwilling to use contraception or found to be pregnant as part of perioperative screening
- Patients unable to hold medications that would impact autonomic testing
Key Trial Info
Start Date :
November 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03769675
Start Date
November 20 2018
End Date
April 15 2022
Last Update
April 11 2023
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905