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