Long-term efficacy of high-frequency (10 kHz) spinal cord stimulation for the treatment of painful diabetic neuropathy: 24-Month results of a randomized controlled trial
Authors' conclusion
Over 24 months, 10 kHz SCS provided durable pain relief and significant improvements in HRQoL and sleep. Furthermore, the majority of participants demonstrated neurological improvement. These long-term data support 10 kHz SCS as a safe and highly effective therapy for PDN.
Study context
- Population
- Patients with refractory painful diabetic neuropathy (PDN)142 with spinal cord stimulation (SCS) followed 24 months
- Participants
- 216 patients
- Comparison
- 10 kHz SCS plus conventional medical management (CMM) vs CMM alone
Methodological detailsprospective, multicenter, crossover permitted after 6 months
- Prospective
- Multicenter
- Crossover permitted after 6 months
Primary result
As reported in the abstract
Pain reduction vs baseline with 10 kHz SCS (84 initial SCS+CMM and 58 crossovers from CMM) · 24 months
Mean pain reduction vs baseline
79.9%
Participants with ≥50% pain relief
90.1%
Further findings
Health-related quality of life (HRQoL), sleep and neurological function · 24 months
- Clinically meaningful neurological improvement
- 65.7%
- Significantly improved HRQoL and sleep
Safety
SCS explant due to infection
- SCS systems explanted due to infection
- 5 (3.2%)
Original publication
Long-term efficacy of high-frequency (10 kHz) spinal cord stimulation for the treatment of painful diabetic neuropathy: 24-Month results of a randomized controlled trial. Diabetes Res Clin Pract. Published 1 August 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →