• Effect of High-frequency (10-kHz) Spinal Cord Stimulation in Patients With Painful Diabetic Neuropathy A Randomized Clinical Trial

    • Diabetic peripheral neuropathy and chronic pain Methods
    • Randomized, controlled trial of 10-kHz spinal cord stimulation
    • Prospective, multicenter, open-label
    • Spinal cord stimulation versus conventional medical management
    • SCS details
      • percutaneous leads, T8-T11 placement, 5-7 day trial period
      • 10-kHz frequency, 30 microsecond pulse width, amplitude 0.5-3.5 mA
    • Inclusion
      • Pain for at least 1 year
      • Refractory to gabapentin and at least 1 other medication
      • Pain intensity 5/10 or more on VAS
      • BMI < 45
      • Hemoglobin A1C < 10%
      • Daily morphine equivalents <120mg
    • 6 month follow up, optional crossover at 6 months
    • Primary endpoint: 50% reduction in VAS pain at 3 months with no neurological deficit
    • 430 screened: 214 excluded or declined, 216 randomized, 187 evaluated

    Results

    • 60% male; Mean age 60.8 (SD 10.7)
    • Intention-to-treat analysis
    • Primary endpoint met
      • 5/94 (5%) of control arm
      • 75/95 (79%) of intervention arm
    • Difference between control and intervention: 73.6%, 95% CI 64-83, p<0.001)
    • Mean VAS Score
      • Control 7.0 baseline à9 at 6 months
      • Intervention 7.6 baseline à7 at 6 months
    • Quality of life as secondary endpoint (EQ-5D): significant improvement in intervention group

    Limitations

    • No blinding
    • Possible placebo effect

    Source

    JAMA Network

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