Study to Assess Painful Diabetic Peripheral Neuropathy After High-frequency Spinal Cord Stimulation

Overview

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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

Narayan Kissoon, M.D.

Open for enrollment

Contact information:

Anita Stoltenberg R.R.T., L.R.T.

(507) 422-0582

Stoltenberg.Anita@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20446787

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