Study to Assess Painful Diabetic Peripheral Neuropathy After High-frequency Spinal Cord Stimulation
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-004317
NCT ID: NCT03769675
Sponsor Protocol Number: 17-004317
About this study
The purpose of this study is to assess painful diabetic peripheral neuropathy after high-frequency spinal cord stimulation.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Type 2 diabetes mellitus.
- Refractory predominantly lower extremity neuropathic pain for > 1 year.
- Presence of length dependent peripheral neuropathy on sudomotor testing (Q-SWEAT).
- Completed spinal cord stimulation trial with 40% or greater pain reduction from baseline.
- Failed medication trials or contraindication to gabapentinoid 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 SCS56.
Exclusion Criteria:
- Severe Autonomic Neuropathy as measured by the composite autonomic scoring scale (10 point scale) with a score ≥ 752.
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Narayan Kissoon, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available