Publications by authors named "Kostandinos C Tsoulfas"

Aims: To evaluate the long-term efficacy of high-frequency (10 kHz) spinal cord stimulation (SCS) for treating refractory painful diabetic neuropathy (PDN).

Methods: The SENZA-PDN study was a prospective, multicenter, randomized controlled trial that compared conventional medical management (CMM) alone with 10 kHz SCS plus CMM (10 kHz SCS+CMM) in 216 patients with refractory PDN. After 6 months, participants with insufficient pain relief could cross over to the other treatment.

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Article Synopsis
  • A study evaluated the effectiveness of 10-kHz spinal cord stimulation (SCS) combined with conventional medical management (CMM) in patients with chronic, painful diabetic neuropathy who did not respond to standard pain treatments.
  • Participants who received 10-kHz SCS reported significant pain relief (average 74.3% reduction) and improved quality of life (HRQoL) compared to those receiving only CMM, with 92% expressing satisfaction with the treatment.
  • The results support the use of 10-kHz SCS as a viable option for individuals with poorly managed diabetic neuropathy pain, showing durable benefits over a 12-month period.
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Importance: Many patients with diabetic peripheral neuropathy experience chronic pain and inadequate relief despite best available medical treatments.

Objective: To determine whether 10-kHz spinal cord stimulation (SCS) improves outcomes for patients with refractory painful diabetic neuropathy (PDN).

Design, Setting, And Participants: The prospective, multicenter, open-label SENZA-PDN randomized clinical trial compared conventional medical management (CMM) with 10-kHz SCS plus CMM.

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