Spinal Stimulation Shines in Relief of Diabetic Neuropathic Pain
An implantable spinal cord stimulation device was effective at relieving diabetic neuropathy pain, according to a researcher presenting at an American Association of Clinical Endocrinology virtual meeting.
Presenting the trial results, Erika A Petersen, MD, of the University of Arkansas for Medical Sciences, said: “This is the largest randomised controlled trial evaluating spinal cord stimulation for refractory painful diabetic neuropathy.”
In total, more than 85% of patients treated with 10 kHz stimulation were considered responders to treatment — experiencing 50% or greater reduction in pain. On top of that, 60% achieved remission, defined as a pain visual analog scale (VAS) of less than 3.0 cm for 6 consecutive months.
Meanwhile, those receiving only normal medical management saw no significant pain score reduction (7.0 at baseline vs 6.9 at 6 months). More than half of those conventionally treated experienced worsening of their pain, and only about 5% were responders to this type of treatment. Overall, only 1% of patients achieved pain remission with conventional medical management.
Beyond pain improvement, those receiving high frequency spinal cord stimulation plus medical management also saw a 62% improvement in neurological examination versus 3.3% of conventional treatment-only patients (P<0.001). The neurological examination included such as lower limb motor strength, light touch sensation and a 10-point foot assessment with a pinprick and 10-g monofilament.
Patients with the stimulation device also reported a reduction in dysesthaesias or uncomfortable sensations such as itching. They also reported a 62% improvement in sleep disturbances.
Overall, 92% patients in the stimulation group said they were satisfied with their treatment, compared with 6% of those on the conventional treatment group said the same.
The trial included 216 adults with painful analgesic-resistant diabetic neuropathy of the lower limbs. Half of participants received only conventional medical management, which included pharmacotherapies.
The other half of participants received 10-kHz SCS therapy. These participants received temporary stimulation for 5 to 7 days with percutaneous leads placed epidurally along T8 to T11. If 50% pain relief was achieved, they could have a permanent implantation of the pulse generator, usually in the low back.
In terms of safety, three infections occurred in the stimulation group, two of which required device removal.
There was no change in BMI or HbA1c in either group during the trial.
After the 6-month trial, 82% of patients on conventional treatment were eligible to crossover — meaning they had less than 50% pain relief, were dissatisfied with treatment, and the investigator agreed it was medically appropriate — and chose to receive the stimulation device.
In this extension phase, those with the stimulation device continued to experience pain relief, achieving an average VAS of 1.7 at 12 months out.
“The responder rate remained stable as well, with 86% at 12 months suggesting the attrition seen with other stimulation approaches is not a concern with 10 kHz stimulation,” said Petersen. “We will continue our follow-up to 24 months, with further evaluation of health economic data and other indicators.”
Source: MedPage Today
Journal information: Petersen E, et al “Neuromodulation for treatment of painful diabetic neuropathy – sustained benefits of 10kHz spinal cord stimulation in a randomized controlled trial” AACE 2021.
