N/A
N=10
Quantitative Assessment of Painful Diabetic Peripheral Neuropathy After High Frequency Spinal Cord Stimulation
Painful Diabetic Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT03769675 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Pain Assessment — 6.5; 1.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High Frequency Spinal Cord Stimulator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Assessment |
6.5; 1.0 | — |
| PRIMARY Neuropathy Symptoms and Change (NSC) Score |
21.5; 9.0 | — |
| PRIMARY Oswestry Disability Index |
37.0; 18.0 | — |
| PRIMARY Neuropathy Impairment Score (NIS) |
15.0; 13.0 | — |
| PRIMARY Lower Limb Function Test |
1; 0 | — |
| PRIMARY Modified Leads Assessment of Neuropathic Symptoms and Signs |
19.0; 17.0 | — |
| PRIMARY Positive Pain |
9.0; 3.0 | — |
| SECONDARY Patient Health Questionnaire |
4.0; 2.0 | — |
| SECONDARY Height |
173; 175 | — |
| SECONDARY Weight |
97.0; 97.2 | — |
| SECONDARY Body Mass Index (BMI) |
34.3; 34.5 | — |
| SECONDARY Hemoglobin A1c |
7.3; 7.85 | — |
| SECONDARY Forearm Sweat Volume Quantitative Axon Reflex Sweat Test (Q-SWEAT) |
1.3; 0.3 | — |
| SECONDARY Proximal Leg Laser Doppler Flowmetry (LDF) |
22.2; 29.0 | — |
| SECONDARY Extensor Digitorum Brevis Muscle Nerve Conduction |
3.1; 1.0 | — |
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 peripheral nerve function?
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT03769675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.