Investigators observed neurological examination improvements for 3 of 92 patients in the CMM group (3%) and 52 of 84 in the 10-kHz SCS plus CMM group (62%) at 6 months (difference, 58.6% 95% CI, 47.6-69.6 P < .001).Ĭonclusions and Relevance Substantial pain relief and improved health-related quality of life sustained over 6 months demonstrates 10-kHz SCS can safely and effectively treat patients with refractory PDN. For the 10-kHz SCS plus CMM group, the mean pain VAS score was 7.6 cm (95% CI, 7.3-7.9) at baseline and 1.7 cm (95% CI, 1.3-2.1) at 6 months. For the CMM group, the mean pain VAS score was 7.0 cm (95% CI, 6.7-7.3) at baseline and 6.9 cm (95% CI, 6.5-7.3) at 6 months. Infections requiring device explant occurred in 2 patients in the 10-kHz SCS plus CMM group (2%). The primary end point assessed in the intention-to-treat population was met by 5 of 94 patients in the CMM group (5%) and 75 of 95 patients in the 10-kHz SCS plus CMM group (79% difference, 73.6% 95% CI, 64.2-83.0 P < .001). Additionally, the median (interquartile range) duration of diabetes and peripheral neuropathy were 10.9 (6.3-16.4) years and 5.6 (3.0-10.1) years, respectively. Results Of 216 randomized patients, 136 (63.0%) were male, and the mean (SD) age was 60.8 (10.7) years. Measures included pain VAS, neurological examination, health-related quality of life (EuroQol Five-Dimension questionnaire), and HbA 1c over 6 months. Secondary end points were tested hierarchically, as prespecified in the analysis plan. Main Outcomes and Measures The prespecified primary end point was percentage of participants with 50% pain relief or more on VAS without worsening of baseline neurological deficits at 3 months. Interventions Implanted medical device delivering 10-kHz SCS. At 6-month follow-up, 187 patients were evaluated. Screening 430 patients resulted in 214 who were excluded or declined participation and 216 who were randomized. Participants were enrolled from multiple sites across the US, including academic centers and community pain clinics, between August 2017 and August 2019 with 6-month follow-up and optional crossover at 6 months. Participants with PDN for 1 year or more refractory to gabapentinoids and at least 1 other analgesic class, lower limb pain intensity of 5 cm or more on a 10-cm visual analogue scale (VAS), body mass index (calculated as weight in kilograms divided by height in meters squared) of 45 or less, hemoglobin A 1c (HbA 1c) of 10% or less, daily morphine equivalents of 120 mg or less, and medically appropriate for the procedure were recruited from clinic patient populations and digital advertising. 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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