Objective To determine whether 10-kHz spinal cord stimulation (SCS) improves outcomes for patients with refractory painful diabetic neuropathy (PDN).ĭesign, Setting, and Participants The prospective, multicenter, open-label SENZA-PDN randomized clinical trial compared conventional medical management (CMM) with 10-kHz SCS plus CMM. Importance Many patients with diabetic peripheral neuropathy experience chronic pain and inadequate relief despite best available medical treatments. Shared Decision Making and Communication. Scientific Discovery and the Future of Medicine.Health Care Economics, Insurance, Payment.Clinical Implications of Basic Neuroscience.Challenges in Clinical Electrocardiography.Scores are shown for 93 patients in the CMM group and 87 in the 10-kHz SCS plus CMM group. D, Patient satisfaction with treatment at 6 months. The Global Assessment of Functioning represents the physician’s evaluation of how much a patient’s symptoms affect psychological, social, and occupational functioning. C, Mean scores on Global Assessment of Functioning at baseline and at 1, 3, and 6 months for 91 patients in the CMM group and 86 in the 10-kHz SCS plus CMM group. A score of 0 indicates never and a score of 10 indicates always. B, Mean scores for the Pain and Sleep Questionnaire assessing how often pain disturbs sleep. The minimally important difference in index scores is estimated between 0.03 to 0.05. A, Mean EuroQol 5-Dimension Questionnaire (EQ-5D-5L) overall health visual analogue scale (VAS) score (left) and index score (right) for 92 patients in the conventional medical management (CMM) group and 87 in the 10-kHz spinal cord stimulation (SCS) plus CMM group from baseline to 6 months.
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