Treatment with high-frequency spinal cord stimulation when added to conventional medical management could help in pain relief and improvements in quality of life among patients with refractory peripheral diabetic neuropathy, finds a new study published in JAMA Neurology.
Despite advances in diabetes care, research indicates a high percentage of patients with peripheral diabetic neuropathy struggle to address pain caused by their condition.With this in mind, a team led by Erika Petersen, MD, of the Department of Neurosurgery at the University of Arkansas conducted a randomised clinical trial of spinal cord stimulation in peripheral diabetic neuropathy. The study named as SENZA-PDN, was designed as a prospective, multicentre, open-label trial comparing conventional medical management to 10-kHz spinal cord stimulation plus conventional medical management in patients from 18 medical centers in the US.
The trial involved more than 200 patients with refractory peripheral diabetic neuropathy. The researchers demonstrated that 10-kHz spinal cord stimulation was associated with substantial pain relief and improve quality of life.
The trial’s primary endpoint was the percentage of patients with 50% pain relief or more on visual analogue scale (VAS) without deterioration of neurological deficits at 3 months. The trial’s secondary endpoints included change in pain VAS, neurological examinations, health-related quality of life, and HbA1c over 6 months.
Upon analysis, results indicated the primary endpoint was achieved by just 5 of the 94 patients in the conventional medical management arm compared to 75 of 95 patients in the spinal cord stimulation arm. Investigators noted infections requiring device plant occurred in 2 patients within the spinal cord stimulation arm of the trial.
When assessing secondary outcomes, investigators found the mean pain VAS score for the conventional medical management arm was 7.0 cm and 6.9 cm at baseline and 6 months, respectively. For the spinal cord stimulation arm, mean pain VAS score was 7.6 cm at baseline and 1.7 cm at 6 months followup.
When assessing data from neurological examinations investigators noted improvements among 3% of those in the conventional management arm and 62% of those in the spinal cord stimulation arm at 6 months.
“Patients with peripheral diabetic neuropathy refractory to best available treatments can be safely and effectively treated with high-frequency (10-kHz) spinal cord stimulation. Evidence-based treatment guidelines should contemplate positioning of 10-kHz spinal cord stimulation in the continuum of care. Follow-up of this study population will continue for 24 months and establish potential durability of this treatment beyond 6 months,” wrote study investigators.