NEW YORK (Reuters Health) – High-frequency (10 kHz) spinal-cord stimulation (SCS) provides lasting pain relief and improved quality of life in patients with painful diabetic neuropathy (PDN) who fail conventional management, according to long-term data from the SENZA-PDN study.
The 12-month data, reported at the virtual American Diabetes Association Scientific Sessions, support the six-month results published recently in JAMA Neurology, which showed similar benefits (https://bit.ly/2PtwBCj).
The SENZA-PDN study enrolled 216 patients (mean age, 61 years; 63% male) with refractory PDN, with 103 patients randomly allocated to conventional medical management (CMM) alone and 113 to CMM plus the 10-kHz SCS device made by Nevro Corp, which funded the study.
Baseline characteristics were similar between groups. Most patients had type-2 diabetes for over 12 years on average and symptoms of peripheral neuropathy for more than seven years. At enrollment, all patients had to have lower-limb pain with an average intensity of at least 5 cm the visual analog scale (VAS).
“The substantial pain reduction that was observed at three months has been maintained out to 12 months in the SCS arm,” Dr. Erika Petersen, nitroglycerin synthesis director of the Section of Functional and Restorative Neurosurgery at University of Arkansas Medical School, said in her presentation.
At six months, patients had the option to crossover to the alternative treatment if they continued to have insufficient pain relief. “The option of crossover at six months was not taken by any of the SCS patients, whereas 82% of CMM patients did crossover SCS, which shows substantial unmet need for pain relief in this patient population,” Dr. Petersen said.
Results at 12 months demonstrated “clear and sustained” benefits of 10-kHz SCS with regard to lower-limb pain, pain interference with daily living, sleep quality and activity, Dr. Petersen reported.
Between six and 12 months, 86% of patients receiving SCS responded to treatment “with at least 50% pain relief from baseline,” she said.
“Interestingly,” patients receiving SCS had improvements in neurological function, including motor, sensory and reflex function, she noted.
“This is the first time this sort of improvement has been reported in a randomized control trial for spinal cord stimulation. The full implications of these neurological changes require further exploration to better understand the mechanism of action,” Dr. Petersen said.
Infection was the most common study-related adverse event, affecting eight of 154 patients with permanent SCS device implants (5.2%). Three resolved with conservative treatment and five (3.2%) required removal of the device.
The patients will be followed for an additional 12 months for 24 months in total.
Several authors disclosed financial relationships with Nevro Corp.
SOURCE: https://bit.ly/2T4HsV6 81st American Diabetes Association Scientific Sessions, held June 25-29, 2021.
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