Diabetic neuropathy pain relief with spinal cord stimulator sustained at 24 months
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Key takeaways:
- Adults with painful diabetic neuropathy reported less pain 24 months after receiving an implanted spinal cord stimulator.
- Improvements in sleep quality and quality of life were observed at 24 months.
An implanted 10 kHz spinal cord stimulator plus conventional management was associated with pain relief and quality of life improvements at 2 years for adults with painful diabetic neuropathy, according to study findings.
As Healio previously reported, adults with painful diabetic neuropathy who received treatment with an implanted 10 kHz spinal cord stimulator (Nevro) and continued conventional medical management had lower levels of pain and improvements in quality of life at 6 and 12 months in a randomized controlled trial. In long-term data from the trial published in Diabetes Research and Clinical Practice, the benefits of spinal cord stimulation observed during earlier follow-up continued up to 24 month after implementation.
“These results show there is a safe and effective way to treat refractory painful diabetic neuropathy, and the observed neurological symptom improvements have not been seen with other painful diabetes neuropathy treatments, including other spinal cord stimulation therapies,” Erika A. Petersen, MD, professor of neurosurgery at the University of Arkansas for Medical Sciences in Little Rock, told Healio. “Ten kHz spinal cord stimulation offers patients and physicians a treatment option unlike those that have historically been available. These results together with results of some real-world studies in patients with painful diabetic neuropathy enable physicians to be confident when recommending 10 kHz spinal cord stimulation to their patients.”
Petersen and colleagues conducted a prospective randomized controlled trial in which 216 adults with painful diabetic neuropathy for at least 1 year at baseline that did not respond to medications were enrolled (mean age, 60.8 years; 63% men). Adults had to have lower limb pain of at least 5 cm on a 10 cm visual analog scale, an HbA1c of 10% or less and be a suitable surgical candidate to participate. Participants were randomly assigned to the 10 kHz spinal cord stimulator plus conventional medical management (n = 113) or convention management alone (n = 103) for 6 months. At 6 months, participants could cross over to the other treatment arm if they had less than 50% pain relief, were dissatisfied with treatment and the trial investigator believed the switch was appropriate. Lower limb pain severity was assessed using a 10 cm visual analog scale, neuropathic pain was measured using the Douleur Neuropathique 4 (DN4) questionnaire scale ( 4 points consistent with clinically confirmed painful diabetic neuropathy), pain interference with sleep was assessed using the Pain and Sleep Questionnaire three-item index (PSQ-3) and the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire was administered to measure health-related quality of life. Data were collected at baseline, 6 months and during regular intervals up to 24 months.
More than 90% deemed responders to treatment
Of the enrolled participants, 84 in the spinal cord stimulator group had permanent implantation and completed 24 months of follow-up. Of those randomly assigned to conventional medical management alone, 77 crossed over to spinal cord stimulation at 6 months and 58 participants underwent permanent implantation and completed 24 months of follow-up.
Mean lower limb pain score decreased from 7.6 cm before implantation to 1.5 cm at 24 months (P < .001). At 24 months, 90.1% of participants were responders to treatment and 65.5% were defined as profound responders. Neuropathic pain score decreased from 6.6 before implantation to 3.5 at 24 months (P < .001). The percentage of adults with a score of less than 4 increased from 3.9% at baseline to 48.9% at 24 months. Clinically meaningful improvements in sensory, motor or reflex function without worsening in any category were reported by 65.7% of participants at 24 months.
“This is a groundbreaking result in that nine of 10 patients were treatment responders at 2 years,” Petersen said. “This level of effectiveness and durability has not been seen with low-frequency spinal cord stimulation, so it is great to have data showing it can be done with 10 kHz spinal cord stimulation.”
Quality of life, sleep quality improved at 24 months
Mean quality of life scores increased from preimplantation to 24 months (P < .001). Pain interference with sleep scores decreased from 6.5 cm preimplantation to 1.9 cm at 24 months (P < .001).
Changes in all measures were similar among adults originally assigned to the spinal cord stimulator group and those who crossed over to spinal cord stimulation except for neurological function, where the spinal cord stimulation group had a higher rate of improvement than the crossover group (P = .048).
Of adults with permanent implantation, 5.2% had a procedure-related infection. Five adults had a device removed, with four leaving the study and one undergoing reimplantation. Three adults had their infections resolved with standard treatment. No stimulation-related neurological deficits occurred during the study and no devices were removed due to lack of efficacy.
Petersen said recruitment for a randomized controlled trial focused specifically on the sensory impacts of 10 kHz spinal cord stimulation has begun and future research will focus on those specific aspects.
“People with diabetes often experience sensory loss in the feet, which can lead to foot ulcers and amputations,” Petersen said. “Given the opportunity to improve sensory function in these patients, FDA has granted breakthrough device designation for 10 kHz spinal cord stimulation therapy, and this new study will support future FDA approvals for this patient population.”
For more information:
Erika A. Petersen, MD, can be reached at eapetersen@uams.edu.
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